Rule: Fitness For Duty Programs

Monday,
March 31, 2008
Part II
Nuclear Regulatory
Commission
10 CFR Part 26
Fitness for Duty Programs; Final Rule
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16966 Federal Register / Vol. 73, No. 62 / Monday, March 31, 2008 / Rules and Regulations
NUCLEAR REGULATORY Subpart I must be implemented by I. Background

COMMISSION licensees and other applicable entities
A. Drug and Alcohol Testing Provisions,
no later than October 1, 2009. Licensees
10 CFR Part 26 and General Fitness-for-Duty Program
and other applicable entities shall
Provisions
RIN 3150–AF12 comply with the requirements of
Subpart K as of April 30, 2008. On June 7, 1989, the Commission
Fitness for Duty Programs announced the adoption of a new rule,
FOR FURTHER INFORMATION CONTACT: 10 CFR Part 26, Fitness for Duty
AGENCY: Nuclear Regulatory David Diec, Office of Nuclear Reactor Programs (54 FR 24468), that required
Commission. Regulation, U.S. Nuclear Regulatory each licensee authorized to operate or
ACTION: Final rule. Commission, Washington, DC 20555– construct a nuclear power reactor to
0001, telephone (301) 415–2834, implement an FFD program for all
SUMMARY: The Nuclear Regulatory Timothy McCune, Office of Nuclear personnel having unescorted access to
Commission (NRC) is amending its Security and Incident Response, the protected area of its plant. A
regulations for Fitness for Duty (FFD) telephone (301) 415–6474, Dr. David R. subsequent final rule published in the
programs to update these requirements Desaulniers, Office of New Reactors, Federal Register on June 3, 1993 (58 FR
and enhance consistency with advances telephone (301) 415–1043, or Dr. Valerie 31467), expanded the scope of Part 26
in other relevant Federal rules and Barnes, Office of Nuclear Regulatory to include licensees authorized to
guidelines, including the U.S. Research, telephone (301) 415–5944. All possess, use, or transport formula
Department of Health and Human of the above contacts may also be quantities of Strategic Special Nuclear
Services (HHS) Mandatory Guidelines reached by e-mail to Materials (SSNM).
for Federal Workplace Drug Testing FITNESSFORDUTY@NRC.GOV. At the time the FFD rule was
Programs, and other Federal drug and published in 1989, the Commission
alcohol testing programs that impose SUPPLEMENTARY INFORMATION: directed the NRC staff to continue to
similar requirements on the private analyze licensee programs, assess the
Table of Contents
sector. The amendments require nuclear effectiveness of the rule, and
power plant licensees and other entities, I. Background
A. Drug and Alcohol Testing Provisions,
recommend appropriate improvements
including facilities possessing Category or changes. The NRC staff reviewed
1A material, to strengthen the and General Fitness-for-Duty Program
Provisions information from several sources
effectiveness of their FFD programs. In including inspections, periodic reports
addition, the amendments require B. Worker Fatigue Provisions
C. Combined Part 26 Rulemaking by licensees on FFD program
nuclear power plant licensees and other performance, reports of significant FFD
D. Public Input Accepted Since 2000
entities to enhance consistency between events, industry-sponsored meetings,
‘‘Affirmed Rule’’
with the FFD programs with NRC’s and current research literature, as well
II. Petitions and Request for Exemption
access authorization requirements for A. Petition for Rulemaking PRM–26–1 as initiatives by industry, the Substance
nuclear power plants. The amendments B. Petition for Rulemaking PRM–26–2 Abuse and Mental Health Services
also require nuclear power plant C. Request for Exemption under 10 CFR Administration of the Department of
licensees to ensure against worker 26.6 HHS (SAMHSA, formerly the National
fatigue adversely affecting public health III. Abbreviations Institute on Drug Abuse), and
and safety and the common defense and IV. Discussion of Final Action SAMHSA’s Drug Testing Advisory
security by establishing clear and A. Overview Board, and recommended
enforceable requirements for the B. Goals of the Rulemaking Activity improvements and changes.
management of worker fatigue. The final C. Overview of Final Rule As a result, the NRC published
rule ensures that individuals who are D. Inclusion of Worker Fatigue Provisions proposed amendments to the FFD rule
subject to these regulations are in 10 CFR Part 26 in the Federal Register on May 9, 1996
trustworthy and reliable, as V. Summary of Public Comments Submitted (61 FR 21105). The 90-day public
demonstrated by avoiding substance on Proposed Rule comment period for the proposed rule
abuse; are not under the influence of VI. Section-by-Section Analysis of closed on August 7, 1996. The NRC staff
drugs or alcohol while performing their Substantive Changes reviewed and considered public
duties; and are not mentally or VII. Availability of Documents comments on the proposed rule, and
physically impaired from any other VIII. Criminal Penalties submitted a final rule to the
cause that would in any way adversely IX. Agreement State Compatibility Commission in a Commission paper
affect their ability to perform their X. Plain Language (SECY–00–0159), dated July 26, 2000.
duties safely and competently. XI. Voluntary Consensus Standards The Commission affirmed the rule in a
This final rule also grants, in part, a XII. Finding of No Significant Environmental Staff Requirements Memorandum
petition for rulemaking (PRM–26–1) Impact: Environmental Assessment
(SRM–M001204A) dated December 4,
submitted by Virginia Electric and XIII. Paperwork Reduction Act Statement
2000. The affirmed rule was sent to the
Power Company (now Dominion XIV. Regulatory Analysis
A. Aggregate Analysis
Office of Management and Budget
Virginia Power) on December 30, 1993, (OMB) to obtain a clearance under the
B. Screening Review for Disaggregation
by relaxing several required FFD Paperwork Reduction Act. The request
C. Disaggregation of Worker Fatigue
program audit frequencies, and partially Provisions for comments on the clearance was
grants a petition for rulemaking (PRM– XV. Regulatory Flexibility Act Certification published in the Federal Register on
26–2) submitted by Barry Quigley on XVI. Backfit Analysis February 2, 2001 (66 FR 8812). OMB
December 28, 1999. A. Consideration of Fuel Fabrication and NRC received public comments that
DATES: This final rule is effective April Facilities and Gaseous Diffusion Plants objected to some aspects of the rule. In
30, 2008. However, licensees and other B. Aggregate Backfit Analysis SECY–01–0134, dated July 23, 2001, the
applicable entities may defer C. Screening Review for Disaggregation NRC staff recommended withdrawing
implementation of this rule, except for XVII. References the request for clearance and preparing
Subparts I and K, until March 31, 2009. List of Subjects in 10 CFR Part 26 a new proposed rule. In a Staff
Federal Register / Vol. 73, No. 62 / Monday, March 31, 2008 / Rules and Regulations 16967
Requirements Memorandum (SRM– influence of any substance, legal or On January 10, 2002, in SRM–SECY–
SECY–01–0134) dated October 3, 2001, illegal, or mentally or physically 01–0113, the Commission approved a
the Commission approved the staff’s impaired from any cause’’ and ‘‘early rulemaking plan, ‘‘Fatigue of Workers at
recommendation to withdraw the detection of persons who are not fit to Nuclear Power Plants,’’ dated June 22,
request for clearance and prepare a new perform activities within the scope of 2001 (referred to in this document as
proposed rule. this part.’’ A requirement was also SECY–01–0113). Under the approved
included in § 26.20(a) for licensee plan, the NRC initiated a rulemaking to
B. Worker Fatigue Provisions
policies to ‘‘address other factors that incorporate fatigue management into 10
The NRC’s ‘‘Policy on Factors Causing could affect fitness for duty such as CFR Part 26 in order to strengthen the
Fatigue of Operating Personnel at mental stress, fatigue and illness.’’ effectiveness of FFD programs at nuclear
Nuclear Reactors’’ (referred to in this In a letter dated February 25, 1999, power plants in ensuring against worker
document as NRC’s Policy on Worker Congressmen Dingell, Klink, and fatigue adversely affecting public health
Fatigue) was first published in the Markey expressed concerns to former and safety and the common defense and
Federal Register on February 18, 1982 NRC Chairman Shirley Ann Jackson that security by establishing clear and
(47 FR 7352), and later issued through low staffing levels and excessive enforceable requirements for the
Generic Letter (GL) 82–12, ‘‘Nuclear overtime may present a serious safety management of worker fatigue.
Power Plant Staff Working Hours,’’ on hazard at some commercial nuclear During the development of the fatigue
June 15, 1982 (referred to in this power plants. The Union of Concerned management requirements, the NRC
document as GL 82–12). In GL 82–12, Scientists (UCS) expressed similar observed an increase in concerns (e.g.,
the NRC requested licensees to revise concerns on March 18, 1999, in a letter allegations, media and public
the administrative section of their from David Lochbaum to Chairman stakeholder reports) related to the
technical specifications to ensure that Jackson, and in the UCS report workload and fatigue of security
plant administrative procedures were ‘‘Overtime and Staffing Problems in the personnel following the terrorist attacks
consistent with the work-hour Commercial Nuclear Power Industry,’’ of September 11, 2001. Subsequent to an
guidelines. Those guidelines were: dated March 1999. In a letter dated May NRC review of the control of work hours
(1) An individual should not be 18, 1999, to the Congressmen, the for security force personnel, and public
permitted to work more than 16 Chairman stated that the NRC staff interactions with stakeholders, the
consecutive hours (excluding shift would assess the need to revise the Commission issued Order EA–03–038
turnover time); policy. on April 29, 2003, requiring
(2) An individual should not be On September 28, 1999, the compensatory measures related to
permitted to work more than 16 hours Commission received a petition for fitness-for-duty enhancements for
in any 24-hour period, nor more than 24 rulemaking (PRM–26–2) from Barry security personnel at nuclear power
hours in any 48-hour period, nor more Quigley. (The petition is discussed in plants, including work hour limits.
than 72 hours in any 7-day period (all greater detail in Section II.B of this The compensatory measures imposed
excluding shift turnover time); document.) The petition requested that by Order EA–03–038 were similar to the
(3) A break of at least 8 hours should the NRC amend 10 CFR Parts 26 and 55 guidelines of the NRC’s Policy on
be allowed between work periods to establish clear and enforceable work- Worker Fatigue. The compensatory
(including shift turnover time); and hour limits to mitigate the effects of measures differed from the Policy
(4) Except during extended shutdown fatigue for nuclear power plant guidelines in a few areas in which the
periods, the use of overtime should be personnel performing safety-related NRC believed it was necessary to
considered on an individual basis and work. address previously identified
not for the entire staff on a shift. The UCS petitioned the NRC on April deficiencies in the guidelines, including
Further, the guidelines permitted 24, 2001, under 10 CFR 2.206, to issue the need to address cumulative fatigue
deviations from these limits in very a Demand for Information (DFI) to from prolonged periods of extended
unusual circumstances if authorized by specified licensees. The petition work hours, matters unique to security
the plant manager, his deputy, or higher asserted that Wackenhut Corporation personnel and stakeholder input
levels of management in some cases. has the contractual right to fire security obtained through public meetings
The NRC’s Policy on Worker Fatigue guards who refuse to report for concerning the worker fatigue
was incorporated, directly or by mandatory overtime, and that this rulemaking and the order. The NRC
reference, and with variations in contractual right conflicts with 10 CFR imposed the requirements in the order
wording and detail, into the technical Part 26. The NRC denied the DFI request to provide the Commission with
specifications of all but three nuclear (ADAMS Accession No. ML013230169), reasonable assurance that the public
power plant sites who implemented the but addressed the concerns of the health and safety and common defense
concept using other administrative petition through the NRC’s generic and security continue to be adequately
controls. communication process. On May 10, protected. The provisions specified in
When 10 CFR Part 26 was issued on 2002, the NRC issued NRC Regulatory 10 CFR Part 26, Subpart I, Managing
June 7, 1989 (54 FR 24468), it focused Issue Summary (RIS) 2002–07, Fatigue, for security force personnel
on establishing requirements for ‘‘Clarification of NRC Requirements replace the requirements imposed by
preventing and detecting personnel Applicable to Worker Fatigue and Self- the order. Differences between the
impairment from drugs and alcohol. Declarations of Fitness-for-Duty.’’ The requirements in Subpart I and the
However, consistent with SRM–SECY– RIS addressed the applicability of 10 requirements imposed by the order, and
88–129, dated July 18, 1988, several CFR Part 26 to worker fatigue, the the rationale for those differences, are
requirements addressed other causes of potential for sanctions related to worker discussed in Section IV.D of this
impairment, including fatigue. Those FFD concerns to have adverse document.
requirements included general implications for maintaining a work

performance objectives [§ 26.10(a) and environment conducive to reporting C. Combined Part 26 Rulemaking
(b)] that provided for ‘‘reasonable FFD concerns, and the protections On March 29, 2004, in COMSECY–
assurance that nuclear power plant afforded workers by 10 CFR 50.7, 04–0014, the NRC staff informed the
personnel * * * are not under the ‘‘Employee Protection.’’ Commission of the status of both
rulemaking activities. The NRC staff resulted in changes. When a comment nominal 2-year frequency. Further,
also noted that because both rulemaking was included in a provision, the audits of C/V services that are
activities were being completed in comment is discussed in Section VI of performed on site and under the direct
parallel, the draft proposed fatigue rule this document. daily supervision or observation of
language was based on the draft Many comments were received during licensee personnel will be conducted as
language in the proposed overall the years the meetings were held. The part of the 2-year audits of the licensee
revision to Part 26, rather than on the draft proposed rule language was or other entity’s FFD program, under
former language in Part 26. Therefore, changed and re-posted to the Web § 26.41(b).
meaningful public comment could be numerous times. Section 26.41(c)(1) of the final rule
confounded by the simultaneous Following the publication of the partially denies two aspects of the
promulgation of two draft rules which August 25, 2005 (70 FR 50442) proposed petition. The nominal annual audit
are somewhat interdependent, and staff rule, the NRC proposed a 4-month requirement for HHS-certified
action to address a comment on one period to accept public comment laboratories has been retained. In
proposed rule could easily impact the submissions. However, the NRC addition, the annual audit requirement
other proposed rule, creating a high accepted comments for several months has been retained for FFD program
potential for the need to issue one or after the proposed deadline for the elements provided by C/Vs whose
both proposed rules. In SRM– submission of public comments. These personnel ‘‘are off site or are not under
COMSECY–04–0014, dated May 25, comments are discussed in Section V of the direct daily supervision or
2004, the Commission directed the staff this document. observation of licensee personnel.’’
to combine the rulemaking related to The NRC also held several public The bases for these changes to the
nuclear power plant worker fatigue with meetings after the proposed rule was audit requirements in the rule are
the ongoing Part 26 rulemaking activity. published to increase stakeholder addressed in the subsequent sections of
This combined final rule withdraws the involvement in the rulemaking. These this supplementary information.
proposed rule published on May 9, meetings were held on September 21, B. Petition for Rulemaking PRM–26–2
1996. 2005 (ADAMS Accession No.
ML052420363), November 7 and 9, 2005 On September 28, 1999, Barry Quigley
D. Public Input Accepted Since 2000 submitted a Petition for Rulemaking
‘‘Affirmed Rule’’ (ADAMS Accession No. ML052990048),
December 15, 2005 (ADAMS Accession (PRM–26–2) requesting that the NRC
In preparing this rule, the NRC No. ML053400002), and March 29–30, amend 10 CFR Parts 26 and 55 to
considered comments received by OMB 2006 (ADAMS Accession No. establish clear and enforceable work
on the prior Part 26 final rule affirmed ML060650535). hour limits to mitigate the effects of
by the Commission in an SRM dated fatigue for nuclear power plant
December 4, 2000. The NRC also II. Petitions and Request for Exemption personnel performing safety-related
considered feedback received from A. Petition for Rulemaking PRM–26–1 work. The PRM was published for
industry, as well as other interested public comment on December 1, 1999,
parties and members of the public. The On December 30, 1993, Virginia (64 FR 67202). As described in detail in
NRC held 11 stakeholder meetings on Electric and Power Company (now Attachment 3 to SECY–01–0113, the
the drug and alcohol testing portions of Dominion Virginia Power) submitted a petition requested the NRC to:
the rule during 2001–2004, and 13 Petition for Rulemaking (PRM–26–1) (1) Add enforceable working hour
stakeholder meetings on the fatigue requesting relaxation of the required 1- limits to 10 CFR Part 26;
portions of the rule during 2002–2003. year audit frequency of licensee FFD (2) Add a criterion to 10 CFR
Following the Commission’s decision to programs and the program elements of 55.33(a)(1) to require evaluation of
combine the two rulemaking efforts, the contractors and vendors (C/Vs) that are known sleeping disorders;
NRC held one stakeholder meeting on relied upon by licensees. The petition (3) Revise the NRC Enforcement
the combined rule in July, 2004, and requested that the first sentence of Policy to include examples of working
two subsequent meetings on the fatigue former 10 CFR 26.80(a) be amended to hour violations that warrant various
provisions of the combined rule in read: NRC sanctions; and
August and September 2004. Each licensee subject to this Part shall (4) Revise NRC Form 396 to include
Throughout the time the meetings audit the fitness-for-duty program nominally self-disclosure of sleeping disorders by
were being held, drafts of proposed rule every 24 months * * *. In addition, audits licensed operators.
language, regulatory and backfit analysis must be conducted, nominally every 24 The NRC received 176 comment
data, and other pertinent information months, of those portions of fitness-for-duty letters in response to the petition. The
were made available to the public on the programs implemented by contractors and majority of the comments (157) were in
Internet, as announced in the Federal vendors. favor of a rule. These comments were
Register on February 15, 2002 (67 FR In a letter dated March 14, 1994, the principally from individuals and public
7093). The NRC received feedback from NRC informed the petitioner that the interest groups. Comments received
stakeholders both through the public petition would be addressed in a from licensees, the Nuclear Energy
meetings and the NRC’s Web site. proposed rulemaking that was under Institute (NEI) and Winston and Strawn,
Address questions about our rulemaking development. The NRC has periodically a law firm representing several utilities,
Web site to Carol Gallagher (301) 415– communicated with the petitioner were opposed to PRM–26–2. A
5905; e-mail cag@nrc.gov. regarding the status of this rulemaking summary of the comments and
These interactions with stakeholders since that time. responses is available in SECY–01–0113
were a significant benefit to the NRC in Section 26.41(b) of the final rule as Attachment 2. This document may be
developing the language for the final partially grants two aspects of the obtained from the NRC’s Web site,
rule in a manner to ensure it is clearly petition. The required audit frequency http://www.nrc.gov, by selecting the
understandable, will be consistently for licensees and other entities who are electronic reading room and then
interpreted, and does not result in subject to 10 CFR Part 26 has been collections of documents by type. It is
unintended consequences. Many of the reduced from the nominal 1-year also available in the NRC’s Agencywide
stakeholders’ comments directly frequency in the former rule to a Documentation and Management
System (ADAMS) under Package Section IV.D of this document. In generally located within the PA. The
Accession Number ML010180224. addition, for item 3 of PRM–26–2, the ERC is located off site and is where the
Although the NRC received many NRC revised Inspection Procedure (IP) licensee evaluates and coordinates
comments concerning the specific 71130.08, ‘‘Fitness For Duty Programs’’ licensee activities related to an
requirements proposed in PRM–26–2, in on February 19, 2004, to reflect the emergency, and communicates to
general, letters in support of the requirements of Order EA–03–038, Federal, State and local authorities
rulemaking— dated April 29, 2003, which required responding to radiological emergencies.
(1) Cited the importance of ensuring compensatory measures related to The NRC requested public comment on
that personnel who perform safety- fitness-for-duty enhancements for the issue in the Federal Register of May
related functions are not impaired by security personnel at nuclear power 11, 1994 (59 FR 24373). Comments were
fatigue; plants, including work hour limits. The received from the nuclear industry,
(2) Expressed concern that the NRC NRC will similarly revise this which largely opposed a reduction in
does not have a regulation limiting inspection procedure following issuance the scope of random testing, and from
working hours and the perception that of the final rule. The self-disclosure of elements of the IBEW, including Local
the NRC lacks the authority to enforce sleeping disorders by licensed operators 1245, which favored it. In SRM–SECY–
the guidelines in the NRC’s Policy on (item 4) is being addressed by the NRC 04–0229, dated January 10, 2005
Worker Fatigue; as a separate effort from this rule (available on the NRC Web site at
(3) Asserted that the guidelines are through changes to Regulatory Guide http://www.nrc.gov/reading-rm/doc-
ambiguous and that licensees interpret 1.134, ‘‘Medical Evaluation of Licensed collections/commission/srm/), the
the guidelines as not applicable when Personnel at Nuclear Power Plants.’’ Commission denied the IBEW
the plant is in an outage; exemption request because it—
(4) Asserted that ‘‘the NRC appears to C. Request for Exemption Under 10 CFR
26.6 (1) Would endanger the common
look the other way’’ when licensee work defense and security (as a result of
scheduling practices appear The former rule required random drug increasing the likelihood of an insider
inconsistent with the guidelines; and and alcohol testing for personnel with threat); and
(5) Expressed the concern that utility unescorted access to the protected area (2) Was not in the public interest
restructuring and cost competition will of a nuclear power plant. By letter dated (because reducing the scope of random
cause reductions in staffing levels and March 13, 1990, the International drug testing could increase the risk to
increased working hours and fatigue. Brotherhood of Electrical Workers
Further, several commenters noted public health and safety due to a greater
(IBEW) Local 1245 requested an risk of both sabotage (insider threat due
that the Federal Government has exemption from random testing for
established work-hour limits for to vulnerability to coercion) and of an
clerical, warehouse, and maintenance accident (impaired worker)).
personnel in other industries and workers at the Diablo Canyon Nuclear Consequently, this final rule
suggested that similar limits should Power Plant (Diablo Canyon) under the maintains the former requirement for
apply to nuclear power plant workers. provisions of 10 CFR 26.6. The NRC
In general, comments that opposed random drug and alcohol testing for all
denied the request and IBEW Local 1245 personnel with unescorted access to the
the petition expressed the opinion that sought judicial review. In 1992, the
existing regulatory requirements (i.e., PA at a nuclear power plant.
Ninth Circuit Court of Appeals affirmed
technical specifications and 10 CFR Part the NRC’s denial of the request (IBEW, III. Abbreviations
26) are adequate to ensure that Local 1245 v. NRC, No. 90–70647, 9th The following abbreviations and
personnel are not impaired by fatigue, Cir., June 11, 1992). In its opinion, the acronyms are used in this Statement of
that the requirements would impose an court said that random testing may well Considerations.
unnecessary and excessive burden that be impermissible for clerical workers at
could not be justified through a backfit AEA Atomic Energy Act
Diablo Canyon who perform no safety-
analysis, and that industry performance ASDs Alcohol screening devices
sensitive work and have no access to BAC Blood alcohol concentration
data refute the petitioner’s argument vital areas. However, in the record CPL Conforming products list
that a rule is necessary to prevent before the court at that time, IBEW Local C/V Contractor/vendor
fatigued personnel from performing 1245 had not established that such a DOT Department of Transportation
safety-related work. group existed. On January 26 and EAP Employee assistance program
The NRC evaluated the merits of December 6, 1993, IBEW Local 1245 EBT Evidential breath testing device
PRM–26–2, the comments received in renewed its request for exemption, EPRI Electric Power Research Institute
response to the PRM, and assessed the specifically asking that the NRC exempt FFD Fitness for duty
Policy on Worker Fatigue. The NRC from 10 CFR Part 26 requirements for GC/MS Gas chromatography/mass
concluded that the petitioner proposed random drug testing, clerical employees spectrometry
a comprehensive set of requirements at Diablo Canyon who are members of HHS Department of Health and
that could reasonably be expected to Local 1245 of the IBEW and who have Human Services
effectively address fatigue from unescorted access to the protected area IBEW International Brotherhood of
individual and programmatic causes. (PA) only, but not to the radiologically Electrical Workers
However, the NRC concluded that it is controlled areas (RCAs) or vital areas ITAAC Inspections, Tests, Analyses,
possible to achieve these objectives (VAs) and who are not required to staff and Acceptance Criteria
through alternative requirements that the plant’s emergency response center KAs Knowledge and abilities
are more flexible, more directly focused (ERC). The PA is the area inside the LOD Limit of detection
on risk, and more aligned and integrated security fence of a nuclear power plant, LOQ Limit of quantitation
with current regulatory requirements. which surrounds the entire plant, and mg/dL Milligrams per deciliter
Therefore, the final rule grants, PRM– the immediately surrounding area, MRO Medical Review Officer
26–2, in part. A detailed discussion of whereas the VAs enclose key safety NEI Nuclear Energy Institute
the principal findings that led to the systems and are located within the PA. ng/dL Nanograms per deciliter
decision to grant, in part, PRM–26–2 The RCAs contain elevated levels of NHTSA National Highway
through rulemaking are included in radiation or contamination and are Transportation Safety Administration
NRC Nuclear Regulatory Commission (1) Update and enhance the drug testing program. HHS’ SAMHSA is
NSF National Sleep Foundation consistency of 10 CFR Part 26 with responsible for maintaining the HHS
OMB Office of Management and advances in other relevant Federal rules drug testing guidelines based on the
Budget and guidelines, including the HHS most recent research and the
PDFFDI Potentially disqualifying Guidelines and other Federal drug and accumulation of lessons learned from
fitness-for-duty information alcohol testing programs (e.g., those the Federal drug testing program, as
pH potential of hydrogen required by the U.S. Department of well as others who are regulated. The
POGO Project on Government Transportation [DOT]) that impose NRC has historically relied on HHS to
Oversight similar requirements on the private establish the technical requirements for
PROS Professional Reactor Operator sector; urine specimen collection, testing, and
Society (2) Strengthen the effectiveness of evaluation, and has only deviated from
QA/QC Quality assurance/quality FFD programs at nuclear power plants HHS’ guidelines for considerations that
control in ensuring against worker fatigue are specific to the nuclear industry.
SAE Substance Abuse Expert adversely affecting public health and Updating Part 26 to be consistent with
SAMHSA Substance Abuse and
safety and the common defense and the most recent HHS Guidelines ensures
Mental Health Services
security by establishing clear and that NRC regulations continue to be
Administration
enforceable requirements for the scientifically and technically sound.
SSNM Strategic special nuclear
management of worker fatigue; Further, the HHS-certified
material laboratories that Part 26 requires
(3) Improve the effectiveness and
THC Tetrahydrocannabinol, delta-9-
efficiency of FFD programs; licensees to use for drug testing are
tetrahydrocannabinol-9-carboxylic (4) Improve consistency between FFD required by HHS to follow the HHS
acid requirements and access authorization
UCS Union of Concerned Scientists Guidelines in order to retain their
6–AM 6-acetylmorphine requirements established in 10 CFR certification. Basing Part 26 on older
73.56, as supplemented by orders to versions of the HHS Guidelines, or
IV. Discussion of Final Action nuclear power plant licensees dated deviating from those Guidelines,
A. Overview January 7, 2003; increases the cost of drug testing for the
(5) Improve Part 26 by eliminating or nuclear industry. Therefore, updating
A review of FFD program experience modifying unnecessary requirements; Part 26 to increase consistency with the
confirms that the former regulatory (6) Improve clarity in the organization HHS Guidelines not only ensures that
approach of 10 CFR Part 26 was and language of the rule; and Part 26 is based on the best scientific
fundamentally sound and provided a (7) Protect the privacy and other and technical information available, but
means of deterrence and detection of rights (including due process) of also avoids imposing an unnecessary
substance abuse at licensee facilities. individuals who are subject to Part 26. and costly regulatory burden on the
FFD Program Performance Reports Each of these goals is expected to nuclear industry.
through 2005 are published on the result in substantial improvements in One example of an improvement from
NRC’s Web site, http://www.nrc.gov/ FFD programs. Many changes in the enhancing consistency with the HHS
reactors/operating/ops-experience/ final rule relate to each goal. The major Guidelines is that several cutoff levels
fitness-for-duty-programs/performance- changes for each subpart and the for detection of various drugs have been
reports.html. reasons for those changes are described updated, including a revised lower
Nonetheless, the NRC believes that in Section IV.C of this document. For cutoff level for the marijuana metabolite
revisions were needed to improve the each of the many specific changes, THC. The lower cutoff level will
effectiveness and efficiency of FFD detailed discussions are included in provide greater assurance that
programs; enhance consistency with Section VI. However, the following individuals who use marijuana are
advances in similar rules and discussion provides a description of identified.
guidelines, including HHS’ Mandatory each goal, a basis for the need to Additionally, a revision to the HHS
Guidelines for Federal Workplace Drug accomplish that goal, and several Guidelines, published in the Federal
Testing Programs (herein called the examples of changes to the former rule Register on April 13, 2004 (69 FR
HHS Guidelines) and other Federal drug that will contribute to meeting the goal. 19643) as a final rule, includes
and alcohol testing programs that place Goal 1—Update and enhance the requirements for specimen validity tests
similar requirements on the private consistency of 10 CFR Part 26 with to determine whether a urine specimen
sector; strengthen the effectiveness of advances in other relevant Federal rules has been adulterated, diluted, or
FFD programs at nuclear power plants and guidelines, including HHS substituted. This final rule adopts
in ensuring against worker fatigue Guidelines and other Federal drug and significant portions of the final HHS
adversely affecting public health and alcohol testing programs (e.g., those specimen validity testing provisions.
safety and the common defense and required by the DOT that impose similar The new validity testing requirements
security by establishing clear and requirements on the private sector.) will substantially improve the
enforceable requirements for the Goal 1 is central to this rulemaking effectiveness of the measures to guard
management of worker fatigue; enhance activity. Many changes are included in against subversion of the testing process
consistency with the NRC’s access the final rule to maintain consistency that are contained in former Part 26.
authorization requirements; improve with advances in the conduct of FFD Several other provisions for drug
clarity in the organization and language programs, including changes in the HHS testing are under consideration by HHS
of the rule; and improve Part 26 by Guidelines. The 1994, 1998, and 2004 and were published as a proposed rule
eliminating or modifying unnecessary revisions to the HHS Guidelines differ for public comment in the Federal
requirements. substantially from the 1988 version of Register on April 13, 2004 (69 FR
the HHS Guidelines, upon which the 19672). One change to 10 CFR Part 26
B. Goals of the Rulemaking Activity former rule was based. that is included from the proposed HHS
The NRC is amending 10 CFR Part 26, The President of the United States Guidelines is permission for licensees to
Fitness For Duty Programs. The goals designated HHS as the agency use validity screening tests to determine
are to: responsible for the Federal workplace whether a urine specimen must be
subject to further testing at an HHS- licensee management of worker fatigue authorization requirements established
certified laboratory because it may have to 10 CFR Part 26. The requirements in 10 CFR 73.56, as supplemented by
been adulterated, diluted, or reduce the potential for worker fatigue orders to nuclear power plant licensees
substituted, in lieu of the instrumented and therefore, strengthen the dated January 7, 2003. Part 26 and the
validity testing required in the April 13, effectiveness of FFD programs at nuclear access authorization requirements each
2004, final version of the HHS power plants and substantially increase contain provisions that require
Guidelines. Although the HHS the protection of public health and establishing the trustworthiness and
Guidelines that would permit Federal safety and the common defense and reliability of personnel before granting
drug testing programs to use validity security. Section VI of this document unescorted access to the protected areas
screening tests for initial testing of urine discusses the specific reasons for each of nuclear power plants. The NRC
specimens are not yet final, some NRC worker fatigue provision. Section IV.D determined that, because both sets of
licensees desired the flexibility to use provides a detailed discussion of the requirements share this same goal,
these testing methods. A technical basis overall basis for establishing fatigue revising Part 26 was necessary to clarify
for use of those methods is included in management requirements for FFD the relationship between these
section VI. However, the NRC is not programs, and the benefits expected to requirements, particularly for licensee
including other provisions in the result. access authorization decisions regarding
proposed HHS Guidelines at this time. Goal 3—Improve the effectiveness and personnel who move between sites with
Those provisions include permitting the efficiency of FFD programs. The NRC some interruption in their status of
drug testing of specimens other than has gained experience in the actual having unescorted access to a nuclear
urine (e.g., hair, saliva, sweat), implementation of FFD programs since power plant. In addition, some
requirements for split specimen Part 26 was originally promulgated. The requirements in former Part 26
procedures for all specimens, and HHS NRC is making many changes addressed the granting of temporary
certification of instrumented initial test throughout Part 26 based on that unescorted access. In response to the
facilities, which would be analogous to experience in order to improve the terrorist attacks of September 11, 2001,
licensee testing facilities. Should such industry’s programs, specifically to on the World Trade Center and the
provisions be included in final HHS increase both the effectiveness of the Pentagon, and the current threat
Guidelines in the future, the NRC will programs in achieving the goals of Part environment, the Commission took
consider incorporating them into 10 26 and the efficiency of program action to curtail the use of temporary
CFR Part 26 at that time. operations. Increasing the effectiveness unescorted access at commercial
In addition to the changes to 10 CFR and efficiency of FFD programs will nuclear power plants. Temporary
Part 26 that incorporate the recent enhance the protection of public health unescorted access was eliminated by
revisions to the HHS Guidelines, the and safety and the common defense and orders issued January 7, 2003, which
DOT revised its Procedures for security. imposed enhancements to existing
Transportation Workplace Drug and One example of a change related to
access authorization programs.
Alcohol Testing Programs (49 CFR Part Goal 3 is the reduction in the period
Therefore, it was necessary to revise the
40, 65 FR 41944; August 9, 2001) to within which pre-access testing must be
related provisions in Part 26.
include the use of oral fluids (i.e., performed from 60 days, in former
§ 26.24(a)(1), to 30 days or less, in Goal 5—Improve 10 CFR Part 26 by
saliva) as acceptable specimens for
Subpart C [Granting and Maintaining eliminating or modifying unnecessary
initial alcohol screening tests. This final
rule also reflects the new oral fluids Authorization]. This change improves requirements. The final rule
testing technology to provide FFD the effectiveness of the pre-access test in incorporates a number of changes to
programs with increased flexibility in detecting drug and alcohol use by eliminate or modify unnecessary
administering initial alcohol tests. individuals who are applying for requirements. The experience NRC has
Because the HHS Guidelines do not authorization to have the types of access gained over the years since Part 26 was
establish requirements for alcohol or perform the duties that require them promulgated has enhanced the agency’s
testing, NRC relies on the DOT to be subject to Part 26. Reducing the understanding of implementation issues
regulations, in part, to ensure that the number of breath specimens required experienced by the industry, and the
alcohol testing provisions of Part 26 for alcohol testing from two each for NRC is now eliminating or modifying
remain scientifically sound and legally initial and confirmatory testing, in some provisions, while at the same time
defensible. Because the DOT programs former Section 2.4(g)(18) in Appendix A maintaining protection of public health
test a much larger number of to Part 26, to one specimen for the and safety and the common defense and
individuals in comparison to the initial test and one for the confirmatory security.
number of alcohol tests that are test also increases the efficiency of FFD For example, because of
conducted under Part 26, basing the programs without compromising the inconsistencies in how licensees
NRC’s alcohol testing regulations on accuracy and validity of alcohol test interpreted the FFD and access
portions of the DOT regulations reflects results. authorization requirements for
the lessons learned from that larger Another example of rule changes conducting employment inquiries,
population. related to Goal 3 is establishing a many licensees contacted an
Goal 2—Strengthen the effectiveness regulatory framework for the individual’s previous employers twice—
of FFD programs at nuclear power management of worker fatigue that once to obtain the information required
plants in ensuring against worker appropriately balances the need for under Part 26 and once to obtain the
fatigue adversely affecting public health flexibility to manage plant exigencies information required for access
and safety and the common defense and with the need for more readily authorization. The revisions to Part 26
security by establishing clear and enforceable requirements and efficient clarify that licensees may obtain
enforceable requirements for the NRC oversight of licensee compliance information to satisfy FFD suitable
management of worker fatigue. This goal with the requirements and performance inquiry requirements and related access
is central to this rulemaking activity. objectives of the rule. authorization requirements at the same
Subpart I, Managing Fatigue, adds clear Goal 4—Improve consistency between time when conducting an employment
and enforceable requirements for FFD requirements and the access inquiry.
Goal 6—Improve clarity in the HHS have all gained experience in Subpart B Program Elements
organization and language of the rule. implementing workplace drug and Subpart B of the final rule reorganizes
The final rule is organized to facilitate alcohol testing programs. This and amends former §§ 26.10 through
implementation, as compared to the experience has led the DOT and HHS to 26.29. These sections of the former rule
former rule, which has generated many modify many of their requirements for specified the performance objectives
questions from licensees. Therefore, in such testing to more clearly protect that FFD programs were required to
the final rule, the NRC has substantially privacy and other rights of individuals. meet and the FFD program elements
reorganized the requirements to Many of the changes to Part 26 related that licensees and other entities were
eliminate redundancies, to group related to this goal are based on either DOT or required to implement to meet the
requirements, and to present HHS requirements. The NRC believes performance objectives. However, the
requirements in the order in which they the protection of individual rights to be
final rule does not include former
apply to licensees’ FFD processes. In of the highest importance and is making
§ 26.27 [Management actions and
addition, the NRC has made many changes to Part 26 to ensure that those
sanctions to be imposed] in Subpart B
language changes to improve clarity. rights are protected through rule
for two reasons. First, the final rule is
This substantial reorganization, which language developed using the best
reorganized to be consistent with the
substantially reduces the likelihood of available information. One example of
order in which licensees and other
variations in FFD programs across the such a change is that the final rule
entities implement their programs.
industry through differing prohibits any testing of ‘‘Bottle B, the
Because Subpart B is focused on
interpretations of the rule, improves the second portion of a split urine
establishing the framework of FFD
protection of public health and safety specimen, or retesting an aliquot of a
and the common defense and security. specimen’’ without the donor’s programs, it would be premature to
The final rule is clearer in both permission. present requirements related to
organization and language, and is implementing the FFD program (i.e.,
C. Overview of Final Rule imposing sanctions on an individual for
expected to result in more uniform
implementation, and, consequently, The final rule is divided into subparts violating the FFD policy) at this point in
more consistency in achieving the Part that contain related requirements. Each the rule. Second, the subject matter of
26 goals. subpart is assigned a descriptive title to former § 26.27 is sufficiently important
In contrast to certain NRC regulations, aid users in locating rule provisions and and complex that a separate subpart is
Part 26 includes a considerable number to simplify cross-referencing within the warranted. Therefore, the final rule
of detailed requirements. In the public final rule. By grouping related presents requirements related to
meetings held during the development requirements and presenting them management actions and sanctions in
of the final rule, industry generally in the order in which they Subpart D [Management Actions and
representatives indicated that they apply to licensees’ and other entities’ Sanctions to be Imposed].
consider this level of detail necessary to FFD processes, the final rule improves Subpart C Granting and Maintaining
help protect individual privacy and the ease of implementing the rule. For Authorization
ensure consistency in implementing the example, the final rule adds Subpart K
requirements. Additionally, industry [FFD Programs for Construction] to Subpart C of the final rule
representatives indicated that this high consolidate FFD requirements for new substantially amends former FFD
level of detail can help to avoid reactor construction. Also, the requirements related to the process that
unnecessary litigation between licensees provisions that were contained in licensees and other entities must follow
and individual personnel regarding Subparts J [Recordkeeping and in determining whether an individual is
worker non-compliance with specific Reporting Requirements] and K trustworthy and reliable, as
drug and alcohol testing performance [Inspections, Violations, and Penalties] demonstrated by avoiding substance
steps. Such litigation would be more of the proposed rule are now contained abuse, and can be expected to perform
likely if those specific performance in Subparts N and O, respectively, of the his or her job duties safely and
steps were not required by NRC rule. final rule. competently. The final rule introduces
The level of detail and the enhanced The major topics addressed in each the concept of (authorization( to Part 26
clarity in the new language and subpart and the reasons that the NRC to refer to the status of an individual
organization included in Part 26 have made major changes to the former rule who the licensee or other entity has
eliminated the need for a guidance are described below. A detailed cross- determined can be trusted to avoid
document for provisions pertaining to reference table between the former and substance abuse, and, therefore, may be
drug and alcohol testing. Industry final Part 26 provisions is included at permitted to have the types of access or
representatives commented that a the end of this notice. perform the duties described in § 26.4
guidance document would not have the [FFD program applicability to categories
Subpart A Administrative Provisions of individuals], as a result of the process
same weight as a rule, and that both
licensees and individuals should be The first subpart, Subpart A, replaces described in this subpart. For example,
protected fully with rigor and specificity the General Provisions portion of the in the case of nuclear power plant
in a rule. Therefore, industry desired the former rule, but continues to address the personnel, a licensee may permit an
rule to be more specific and detailed, in same subject matter. Thus, Subpart A individual who is ‘‘authorized’’ under
lieu of a guidance document. addresses the purpose and scope of the Part 26 to have unescorted access to
Goal 7—Protect the privacy rights and rule, provides definitions of important protected areas in nuclear power plants
other rights (including due process) of terms used in the final rule, and updates if the individual’s job requires such
individuals who are subject to 10 CFR former provisions related to requests for access.
Part 26. This goal was an implicit specific exemptions, interpretations of The NRC has published other
objective of the former rule, and the the rule, and communications with the requirements, such as 10 CFR 73.56,
final rule continues to protect the NRC. The final rule also adds a section that establish additional steps that
privacy and other rights of individuals to Subpart A that consolidates FFD licensees and other entities must take as
(including due process) who are subject program applicability requirements for part of the process of determining
to 10 CFR Part 26. The NRC, DOT, and categories of individuals. whether to grant unescorted access to an
individual or permit an individual to the specific provisions that incorporate other entities have information that is as
maintain unescorted access to protected them. complete as possible about an
areas. These additional requirements A second, related change to the NRC’s individual when making an
focus on aspects of an individual’s approach to authorization requirements, authorization decision. To address this
character and reputation other than which has informed Subpart C, is an need, the access authorization orders
substance abuse, and, among other increased concern with the sharing of issued by the NRC to nuclear power
steps, require the licensee or other information about individuals between plant licensees on January 7, 2003,
entities who are subject to the rule to licensees and other entities. At the time mandated increased sharing of
conduct a psychological assessment of the former Part 26 was developed, the information. In addition, Subpart C
the individual, perform a credit and industry structure was different and requires licensees and other entities to
criminal history check, and interview personnel transfers between licensees collect and share greater amounts of
individuals who have knowledge of the (i.e., leaving the employment of one information than under the former rule,
applicant for authorization. However, licensee to work for another licensee) subject to the protections of individuals’
historically there have been some with interruptions in authorization were privacy that are specified in § 26.37
inconsistencies and redundancies less common. Most licensees operated [Protection of information]. As a result,
between the Part 26 requirements plants at a single site and maintained an individuals who are subject to the rule
related to granting and maintaining FFD program that applied only to that will establish a detailed ‘‘track record’’
unescorted access and the other related site. When an individual left within the industry that will follow
regulations, particularly the NRC’s employment at one site and began them if they change jobs and move to a
access authorization requirements for working for another licensee, the new position that requires them to be
nuclear power plant personnel. The individual was subject to a different granted authorization by another
inconsistencies have led to many FFD program that often had different licensee or entity who is subject to the
implementation questions from requirements. Because some licensees rule. This increased information sharing
licensees, as well as inconsistencies in were reluctant to share information contributes to providing reasonable
how licensees have implemented the about previous employees with the new assurance that individuals who are
requirements. The redundancies have employer, licensees often did not have granted and maintain authorization
imposed an unnecessary burden on access to the information the previous under Part 26 are trustworthy and
licensees in other cases. Therefore, a licensee had gathered about the reliable when individuals move
central goal of adding Subpart C to the individual and were required to gather between FFD programs.
final rule is to eliminate those the necessary information again. The However, a consequence of increased
inconsistencies and redundancies to additional effort to collect information information sharing is that one violation
ensure that licensees and the other that another licensee held created an of any licensee’s FFD policy has greater
entities who are subject to the rule have unnecessary burden on both licensees. potential to end an individual’s career.
clear and easily interpretable But, because few individuals Although an individual who has an
requirements to follow when transferred, the burden was not active substance abuse problem cannot
determining whether to grant or excessive. be permitted to have unescorted access
However, since 1989, the industry has to protected areas, the NRC continues to
maintain an individual’s unescorted
undergone significant consolidation and affirm that individuals who pursue
access under Part 26 and also under
developed new business practices to use treatment, stop abusing drugs or
other, related requirements, including,
its workforce more efficiently. Industry alcohol, and maintain sobriety for an
but not limited to, the January 7, 2003
efforts to better use expertise and extended period of time should regain
access authorization orders issued by staffing resources have resulted in the the public’s trust. The length of time
the NRC to nuclear power plant development of a large transient that an individual must maintain
licensees. workforce within the nuclear industry sobriety in order to demonstrate that he
The requirements in Subpart C are that travels from site to site as needed, or she can again be trusted with the
based on several fundamental changes such as roving outage crews. Although public’s health and safety and the
to the NRC’s approach to the the industry has always relied on C/Vs common defense and security has been
authorization requirements in former for special expertise and staff for a matter of debate since Part 26 was
Part 26. The primary concern, which outages, the number of transient originally under development. However,
Subpart C is designed to address, is the personnel who work solely in the the research literature continues to
necessity of increasing the rigor of the nuclear industry has increased and the indicate that individuals who maintain
authorization process to provide length of time they are on site has sobriety past the first 3 years following
reasonable assurance that any decreased. Because the former FFD treatment have substantially reduced
individual who is granted and regulations were written on the basis recidivism rates (i.e., relapsing into
maintains authorization is trustworthy that individual licensees would substance abuse) than during the first 3
and reliable, as demonstrated by maintain independent, site-specific FFD years after treatment. There is also a
avoiding substance abuse. The necessity programs and shared limited further drop in recidivism rates after 5
for increased rigor in the authorization information, and that the majority of years of sobriety.
process is discussed in Section VI of nuclear personnel would remain at one Despite these research findings, some
this document with respect to § 26.23(a) site for years, the former regulations did individuals who have had one
in terms of the increased insider threat not adequately address the transfer of confirmed positive test result have been
since the terrorist attacks of September personnel between sites. prevented from working in operating
11, 2001. One change to former Part 26 These changes in the industry have nuclear power plants. The increased
authorization requirements that reflects increased the need for information information sharing required under
this concern is the elimination of sharing among licensees and C/Vs. The Subpart C has the potential to result in
temporary access authorization increased insider threat since September a greater number of these individuals
requirements in the second sentence of 11, 2001, has also heightened the need being banned from working in the
former § 26.27(a)(4). Other changes are for information sharing among licensees industry. Therefore, the NRC has added
discussed in Section VI with respect to and C/Vs to ensure that licensees and several requirements to Subpart C to
minimize these consequences for the industry have demonstrated their individuals who have not held
individuals who are able to demonstrate trustworthiness and reliability from authorization within the past 3 years.
that they are effectively coping with a previous periods of authorization, so Section 26.57 [Authorization update]
substance abuse problem. Additional they pose less potential risk to public establishes authorization requirements
requirements for protecting information health and safety and the common for individuals who previously held
to be gathered about individuals under defense and security than individuals authorization under Part 26, whose last
Part 26 are specified in § 26.37. The who are new to the industry. Much is period of authorization was terminated
detailed changes to former requirements known about these individuals. Not favorably more than 1 year ago but less
are discussed in Section VI with respect only were they subject to the initial than 3 years ago. Section 26.59
to the specific provisions that background screening requirements [Authorization reinstatement]
incorporate these requirements. before they were initially granted establishes authorization requirements
In general, the authorization authorization; but, while they were for individuals who previously held
requirements in Subpart C are working under a Part 26 program, they authorization under Part 26 and whose
structured according to whether an were watched carefully through on- last period of authorization was
individual who has applied for going behavioral observation, repeatedly terminated favorably within the past
authorization has previously held attained negative results from random year. Section 26.69 [Authorization with
authorization under Part 26. If an drug and alcohol tests, and potentially disqualifying fitness-for-duty
individual has not established a ‘‘track demonstrated the ability to consistently information] defines the steps that
record’’ in the industry, the final rule comply with the many procedural licensees and other entities must take in
requires licensees and other entities to requirements that are necessary to granting authorization to an individual
meet an extensive set of requirements perform work safely at operating power about whom potentially disqualifying
before granting authorization to the reactor facilities. FFD information has been disclosed or
individual. If an individual has Second, individuals who have discovered.
established a favorable track record in established a favorable work history in The time periods used to establish
the industry, the amount of original the industry and whose authorization these categories of authorization
information gathering that the final rule has been interrupted for only a short requirements are consistent with the
requires licensees and other entities to period are unlikely to develop an active categories established in the access
complete before granting authorization substance abuse problem during the authorization orders issued by the NRC
to the individual is reduced. The need interruption. The shorter the period of to nuclear power plant licensees on
for original information gathering in time since the individual’s last period of January 7, 2003. Basing the
these instances is reduced because authorization ended, the less likely it is requirements on elapsed time is
licensees and other entities will have that the individual has developed an consistent with the programs of other
access to all of the information that active substance abuse problem or Federal agencies who have similar
previous FFD programs have collected undergone other significant changes in needs to control access to sensitive
about the individual under the final lifestyle or character that would information and protected areas. In
rule. diminish his or her trustworthiness, addition, these time periods have been
For individuals who have established reliability, and ability to perform work used successfully within nuclear power
a favorable track record in the industry, safely and competently. plant access authorization programs
the steps that licensees and other Further, if the individual was also since 1989 and have met the NRC’s goal
entities are required to complete in subject to supervision under some of ensuring that individuals who are
order to grant authorization to an elements of a Part 26 program (e.g., granted unescorted access are
individual also depends upon the length behavioral observation, a requirement to trustworthy and reliable. Therefore, the
of time that has elapsed since the report any arrests, random drug and final rule incorporates these time
individual’s last period of authorization alcohol testing) during the period that periods within Part 26.
was terminated and the amount of his or her authorization was interrupted, In general, the steps that are required
supervision to which the individual was the higher the assurance that the under this part to grant authorization to
subject during the interruption. (The individual does not have an active an individual who has recently held
term ‘‘interruption’’ refers to the interval substance problem. And, it is less likely authorization and whose most recent
of time between periods during which that the individual could have period of authorization was terminated
an individual holds authorization under undergone significant changes in favorably are less extensive than the
Part 26.) In general, the more time that lifestyle or character that would be steps required for applicants for
has elapsed since an individual’s last undetected. authorization who are new to the
period of authorization ended, the more Therefore, the final rule establishes industry or those who have not recently
steps that the final rule requires categories of requirements for granting held authorization. In addition, the NRC
licensees and other entities to complete authorization to an individual that vary, has strengthened the requirements for a
before granting authorization to the based upon whether the individual has rigorous evaluation process contained in
individual. However, if the individual previously held authorization under the former § 26.27(e) that licensees and
was subject to behavioral observation Part 26; whether the individual’s last other entities are required to meet before
under a Part 26 program or continued to period of authorization was terminated granting authorization to an individual
be subject to random drug and alcohol favorably or unfavorably; how long it about whom potentially disqualifying
testing during the interruption, the final has been since the individual last held FFD information has been disclosed or
rule requires licensees and other entities authorization under Part 26; and discovered (see § 26.69). The final rule
to complete fewer steps in order to grant whether the individual was subject to requires licensees and other entities to
authorization to the individual. There any elements of a Part 26 program obtain and review a written self-
are several reasons that the final rule during the interruption period. Section disclosure from the applicant and an
requires fewer steps in the authorization 26.55 [Initial authorization] establishes employment history, and ensure that a
process for these individuals. authorization requirements for suitable inquiry and pre-access drug and
First, individuals who have individuals who have not previously alcohol testing are completed before
established a favorable work history in held authorization under Part 26 and granting authorization to an individual,
with certain exceptions. The exceptions by the use of illegal drugs. However, In general, the procedures in this
to the self-disclosure and employment some licensees have imposed lesser subpart are more detailed than those in
history, suitable inquiry, and pre-access sanctions for alcohol violations, an Appendix A to the former rule and NRC
testing requirements are specified in approach that is inconsistent with the regulations that are based on a risk-
§§ 26.61 [Self-disclosure and NRC’s intent. Therefore, the final rule informed, performance-based approach,
employment history], 26.63 [Suitable rectifies this situation by explicitly for several reasons. First, the more
inquiry], and 26.65 [Pre-access drug and requiring the same minimum sanctions detailed procedures in subpart E will
alcohol testing], respectively. The final for abuse of alcohol as formerly required increase the consistency of Part 26 drug
rule also requires licensees and other for the use of illegal drugs. and alcohol specimen collection
entities to ensure that applicants are Third, the final rule adds the sanction procedures with those of other Federal
subject to random testing, as specified of permanent denial of authorization for agencies and therefore, take advantage
in § 26.67 [Random drug and alcohol any individuals who subvert or attempt of the scientific and technical advances
testing of individuals who have applied to subvert the testing process. The that have been made in workplace drug
for authorization]. former rule permitted licensees and and alcohol testing programs since the
other entities to have flexibility in former Part 26 was promulgated, as
Subpart D Management Actions and
establishing sanctions for actions such discussed in Section IV.B of this
Sanctions
as refusing to submit to testing and document. Second, the final rule
Subpart D of the final rule replaces attempting to subvert the testing process permits FFD programs to accept and
former § 26.27(b) and (c) and divides the by submitting an adulterated or rely upon other FFD programs that are
former provisions into two separate implemented under this part, as well as
substitute specimen. As a result,
sections that specify requirements for the programs of other Federal and State
different FFD programs imposed
responding to FFD policy violations in agencies, to a much greater extent than
different sanctions and some
§ 26.75 [Sanctions], and indications of is permitted under the former rule. The
individuals were granted authorization
impairment in § 26.77 [Management permission to rely on other programs
or permitted to maintain authorization
actions regarding possible impairment]. improves the effectiveness and
when they committed such acts.
The final rule adds a new § 26.73 efficiency of FFD programs (Goal 3 of
However, acts to defeat the testing
[Applicability] to specify the entities the rulemaking) and improves the rule
process indicate that an individual is
and individuals to whom the by eliminating or modifying
not trustworthy and reliable, and
requirements of the subpart apply. The unnecessary requirements (Goal 5 of the
former rule has been reorganized to suggest that the individual may be
engaging in substance abuse that could rulemaking). For example, under
generally reflect the order in which the § 26.69(b)(6), the final rule permits
requirements apply to licensees’ and pose a risk to public health and safety
and the common defense and security. licensees and other entities to rely on
other entities’ FFD processes, and to another Part 26 program’s drug and
group related requirements into separate Therefore, the final rule establishes a
minimum sanction that all FFD alcohol followup testing of an
sections. Therefore, the NRC has made individual who has violated an FFD
these changes to meet Goal 6 of this programs must impose to deter attempts
policy and is consequently required to
rulemaking to improve clarity in the to subvert the testing process, as well as
have at least 15 followup tests within
organization and language of the rule. provide reasonable assurance that
the 3-year period following the
In general, subpart D includes three individuals who are granted and
violation, and is transferring from one
significant changes from the related maintain authorization can be trusted to
licensee’s site to another.
provisions in the former rule that are comply with the rules and regulations to The final rule requires the receiving
each intended to provide a stronger which they are subject. licensee or entity to continue the
deterrent to engaging in the unwanted These three changes have been made followup testing program. However, the
actions specified in the subpart. First, to meet Goal 3 of this rulemaking to final rule permits the licensee or other
the final rule increases the severity of improve the effectiveness of FFD entity to accept the followup testing that
the minimum sanctions that are programs. The NRC has made other was completed by the previous FFD
required if an individual violates a changes to former § 26.27(b) and (c) in program when determining the
licensee’s or other entity’s FFD policy. subpart D primarily to eliminate or remaining number of followup tests to
The more stringent sanctions are modify unnecessary requirements and which the individual must be subject
necessary in order to strengthen the clarify the intent of former provisions. and the period of time during which the
effectiveness of the rule in providing Subpart E Collecting for Testing individual must continue to be subject
reasonable assurance that individuals to followup testing. Therefore, because
who are subject to this part are Subpart E of the final rule reorganizes the final rule permits this reliance on
trustworthy and reliable, as and amends the requirements related to other programs, more detailed
demonstrated by avoiding substance collecting specimens for drug and requirements for conducting the
abuse, and by increasing the assurance alcohol testing that were contained in activities on which other FFD programs
that only individuals who are fit for former § 26.24 [Chemical and alcohol may rely, including drug and alcohol
duty are permitted to have the types of testing] and interspersed throughout testing, are necessary to provide greater
access or perform the duties listed in former Appendix A to Part 26. The assurance that all Part 26 programs meet
§ 26.4. subpart groups the related requirements minimum standards. Third, the final
Second, the final rule requires and presents them in the order in which rule incorporates a greater level of detail
licensees and other entities who are they would be implemented by FFD in the specimen collection procedures
subject to the rule to impose the same programs. The final rule also eliminates of the final rule for the reasons
sanctions for an FFD violation involving some redundancies in the provisions of discussed in Section IV.B.
the abuse of alcohol as required for the the former rule that were related to The NRC has made other major
abuse of illegal drugs. Impairment specimen collections. The NRC has changes to the former rule’s
caused by alcohol abuse creates a risk to made these changes to meet Goal 6 of requirements for collecting specimens
public health and safety that is the rulemaking to improve clarity in the for drug and alcohol testing to
fundamentally similar to the risk posed organization and language of the rule. incorporate specimen validity testing
requirements from the HHS Guidelines facilities. Thus, the rule permits testing have been shown to detect
into Part 26 (Goal 1 of this rulemaking) licensees and other entities to grant adulterants in urine specimens and
and modify former alcohol testing authorization to an individual who has creatinine concentrations on tests that
requirements to improve the efficiency negative initial test results from pre- were conducted on specimens that were
of FFD programs (Goal 3 of the access testing without further analysis spiked with drug analytes. However, the
rulemaking), while continuing to protect of the urine specimen by an HHS- results from the preliminary studies are
or enhance individuals’ rights to privacy certified laboratory. If the initial test variable. Therefore, the proposed HHS
and due process under the rule (Goal 7 results from the licensee testing facility Guidelines include extensive
of the rulemaking). are inaccurate because the urine performance testing requirements for
specimen was adulterated or these devices, which subpart F also
Subpart F Licensee Testing Facilities
substituted, the licensee or other entity incorporates. Such performance testing
Subpart F of the final rule presents could grant authorization to an is necessary to ensure that validity test
detailed requirements for conducting individual who poses a risk to public results based on using these devices are
initial urine specimen validity and drug health and safety and the common accurate.
tests at licensee testing facilities, as defense and security. Similarly, if an
permitted in § 26.24(d)(1) of the former Subpart G Laboratories Certified by the
individual who has been selected for
rule and § 26.31(d)(3)(ii) of the final Department of Health and Human
random testing submits an adulterated
rule. The subpart is entitled, ‘‘Licensee Services
or substituted specimen that is not
Testing Facilities,’’ for brevity, but detected by initial tests at the licensee Subpart G presents together in a
permits other entities who are subject to testing facility, the individual would be single subpart requirements related to
the rule to establish and operate drug permitted to maintain authorization if the HHS-certified laboratories that are
testing facilities under the final rule. the results of drug testing are negative. used by licensees and other entities who
The NRC has added this subpart to Therefore, in order to increase the are subject to Part 26 for validity and
the final rule to group together in a likelihood that individuals who may be drug testing. The requirements in this
single subpart the rule’s requirements using drugs and attempting to defeat the subpart group together the former
that are related to licensee testing testing process are detected, and to requirements in Appendix A to Part 26
facilities, which were intermixed with ensure that they are not permitted to be as they relate to HHS-certified
requirements related to drug testing at granted or maintain authorization, the laboratories. However, the final rule
HHS-certified laboratories in Appendix NRC has concluded that it is necessary updates the former requirements to be
A to Part 26 in the former rule. The final to require licensee testing facilities to consistent with the HHS Guidelines that
rule presents the requirements that are conduct urine specimen validity tests. were published in the Federal Register
applicable to licensee testing facilities However, in consideration of the on April 13, 2004 (69 FR 19643). The
and HHS-certified laboratories in two increased costs and burden that are most important changes to the former
separate subparts because the provisions associated with instrumented initial rule’s requirements for HHS-certified
of the former rule were not always clear validity testing, subpart F permits laboratories are the incorporation of
with respect to which requirements licensee testing facilities to use extensive requirements for urine
applied to which type of testing facility. commercially available validity specimen validity testing.
Also, the final rule includes the screening tests of urine specimens,
requirements that apply to both types of Subpart H Determining Fitness-for-
which may be a less expensive Duty Policy Violations and Determining
facilities in both subparts so that it is alternative than the instrumented initial
unnecessary for licensees and other Fitness
validity tests required in the current
entities who do not operate licensee HHS Guidelines. As discussed in Subpart H in the final rule
testing facilities to be concerned with Section VI with respect to § 26.5 reorganizes, clarifies, and enhances
any provisions in subpart F. Although [Definitions], the final rule uses the term former requirements related to the
many of the requirements in this ‘‘validity screening test’’ to refer to these decisions that medical review officers
subpart are redundant with similar commercially available tests. The term (MROs) and other healthcare
requirements in subpart G [Laboratories ‘‘initial validity test’’ refers to professionals must make under Part 26
Certified by HHS], these changes meet instrumented validity testing. to provide input to licensees’ and other
Goal 6 of this rulemaking to improve At the same time that the HHS entities’ management decisions with
clarity in the organization and language published its regulations to require respect to granting and permitting an
of the rule. specimen validity testing, which have individual to maintain authorization
The most important change in subpart been incorporated in the final rule, HHS under Subpart C and also with respect
F to the former requirements for also published a proposed revision to to imposing sanctions and taking
licensee testing facilities is the addition the Guidelines (69 FR 19673; April 13, actions to prevent an individual from
of new requirements for licensee testing 2004) that would permit the use of performing duties that require an
facilities to conduct initial urine validity screening devices for the individual to be subject to this part
specimen validity testing, based on detection of substitution and the under Subpart D. The former
similar provisions contained in the most presence of adulterants in urine requirements, which were interspersed
recent revision to the HHS Guidelines specimens. These devices include non- throughout the rule, are grouped
(69 FR 19643; April 13, 2004). The instrumented devices with visually-read together in Subpart H to make them
reasons for requiring initial urine endpoints as well as semi-automated or easier to locate within the final rule,
specimen validity testing are discussed automated instrumented testing devices consistent with Goal 6 of this
with respect to § 26.31(d)(3)(ii). The with machine-read end points. rulemaking to improve clarity in the
NRC believes that it is necessary for Specimen validity tests conducted with organization and language of the rule.
licensee testing facilities to conduct these devices use colorimetric assays, The subpart also makes several
specimen validity testing because Part which is the same scientific principle as significant changes to the former
26 permits licensees and other entities the initial tests conducted at HHS- requirements.
to make authorization decisions based certified laboratories. Non-instrumented In general, Subpart H includes more
on initial drug test results from such specimen validity devices for urine detailed requirements for determining
FFD policy violations and conducting results. That is, there may be legitimate who have the necessary qualifications to
determinations of fitness than were medical reasons for the adulterated or conduct determinations of fitness if the
included in the former rule. The NRC substituted test result and the test result MRO does not meet the SAE
has added these more detailed may not indicate that the donor has qualification requirements.
requirements in response to violated the FFD policy, which in this Second, the NRC believes that
implementation questions that the NRC case would mean that he or she has not healthcare professionals other than
has received from licensees since Part attempted to subvert the testing process. licensed physicians may have the
26 was first promulgated, lessons The NRC added a requirement for the requisite knowledge and skills to serve
learned from NRC inspections of FFD MRO to review adulterated or as SAEs under the rule. Therefore, the
programs, and the experience of other substituted validity test results to meet final rule defines the position of SAE in
Federal agencies that similarly require Goal 7 of this rulemaking to protect the terms of the knowledge and skills
workplace drug and alcohol testing. privacy and other rights (including due required, and permits healthcare
However, the NRC’s primary concern in process) of individuals who are subject professionals other than licensed
establishing more detailed requirements to Part 26 and ensure that the physicians to serve in this role.
is to enhance the consistency in how individuals are afforded accurate and Third, under the final rule, FFD
FFD policy violations and fitness are consistent testing. The HHS Guidelines programs are permitted to accept
determined among Part 26 programs. also require the MRO to review determinations of fitness and treatment
The final rule permits licensees and adulterated and substituted validity test plans from other Part 26 programs, if an
other entities to rely on the results. Therefore, adding this individual who has had a substance
determinations made by other Part 26 requirement to the final rule also meets abuse problem will be granted
programs to a greater extent than the Goal 1 of this rulemaking to update and authorization by another licensee or
former rule. For example, § 26.63(b) of enhance the consistency of Part 26 with entity. Consequently, detailed
the final rule permits licensees and advances in other relevant Federal rules requirements for the qualifications and
other entities to rely upon a previous and guidelines. responsibilities of the SAE are necessary
licensee’s or other entity’s Another significant change that the to ensure consistency among FFD
determinations of fitness, as well as final rule makes to former requirements programs. Detailed requirements for the
their reviews and resolutions of is the establishment of a new position qualifications and responsibilities of the
potentially disqualifying FFD within FFD programs—the ‘‘substance SAE are necessary because of the key
information, from previous periods of abuse expert’’ (SAE). The SAE is role the SAE plays in assuring the
authorization. The reasons for adding responsible for performing a common defense and security and
these permissions were discussed determination of fitness, which is public health and safety when making a
determining whether there are determination of fitness on which
previously in this section, with respect
indications that an individual may be in licensees and other entities will rely
to Subpart C. However, to ensure that all
violation of the licensee’s or other when making authorization decisions. It
licensees’ and other entities’
entity’s FFD policy or is otherwise is critical that SAEs understand the
determinations of FFD policy violations
unable to safely and competently potential impact on the common
and fitness can be relied upon by other
perform his or her duties, in those defense and security and public health
FFD programs, it is necessary to
instances in which an individual may and safety when determining that an
enhance the former requirements and
not be fit for duty for reasons related to individual who has had an active
establish clear minimum standards for
drug or alcohol abuse. The NRC has substance abuse problem has resolved
those processes. Therefore, the subpart
added the SAE position for several the problem and is again worthy of the
includes greater detail to meet Goal 3 of
reasons. public’s trust. A sophisticated
this rulemaking to improve the First, some MROs who provide understanding of substance abuse
effectiveness and efficiency of FFD services under Part 26 have indicated problems and the types of adverse
programs. that they do not feel qualified to assess behaviors they may involve, including
Under the final rule, licensees and the presence and severity of substance knowledge of the research literature and
other entities continue to be prohibited abuse disorders, make treatment clinical experience, is necessary to
from imposing sanctions on an recommendations, and determine when inform the SAE’s clinical judgments in
individual who has a positive an individual who has had a substance these circumstances.
confirmatory drug test result from abuse disorder may again be able to The NRC has adapted many of the
testing at the HHS-certified laboratory safely and competently perform duties provisions in the subpart from related
until the MRO has had an opportunity under this part. The focus of MRO DOT requirements regarding the
to discuss the result with the individual responsibilities under Part 26 and other ‘‘substance abuse professional’’ [49 CFR
and determines that there is no Federal workplace drug testing Part 40, subpart O; 65 FR 41944; August
legitimate medical explanation for the programs is on the medical evaluation 9, 2001]. The SAE role is not defined in
positive result(s). The final rule extends of positive, adulterated, substituted, or former Part 26.
this requirement to the review of invalid test results, which requires a
positive confirmatory validity test knowledge of substance abuse. Subpart I Managing Fatigue
results, consistent with the addition of However, some MROs do not have the Subpart I of the final rule strengthens
requirements to conduct validity testing extensive knowledge of substance abuse the effectiveness of FFD programs at
throughout the final rule, as discussed disorders that is necessary to make nuclear power plants in ensuring
in Section VI with respect to determinations of fitness and treatment against worker fatigue adversely
§ 26.31(d)(3)(I). An MRO review of recommendations as required under this affecting public health and safety and
adulterated or substituted validity test part. Therefore, the final rule permits the common defense and security by
results from an HHS-certified laboratory MROs to serve as SAEs if they meet the establishing clear and enforceable
before a licensee or other entity imposes qualifications for this role that are requirements for the management of
sanctions on an individual is necessary established in this subpart. But, the rule worker fatigue. Because the overall
for the same reasons that an MRO requires licensees and other entities to rationale for including Subpart I,
review is required of positive drug test rely on other healthcare professionals Managing Fatigue, in Part 26, is detailed
and extensive, this discussion is reporting reflect the addition of industry and the public to discuss
presented separately in Section IV.D. requirements for specimen validity provisions for the final rule.
testing to the final rule, the addition of The NRC has determined that an
Subpart J [Reserved]
requirements for managing worker integrated approach is necessary to
As a result of adding Subpart K [FFD fatigue at nuclear power plants, and a effectively manage worker fatigue
Programs for Construction] to the final relaxation of the required frequency because individuals experience fatigue
rule, several subparts of the proposed with which Part 26 programs must for many reasons, including long work
rule have been renumbered. The submit FFD program performance hours, inadequate rest, and stressful or
provisions contained in Subpart J of the reports to the NRC from bi-annually to strenuous working conditions.
proposed rule have been moved to annually. Shiftwork, home-life demands, and
Subpart N of the final rule. sleep disorders can all contribute to
Subpart O Inspections, Violations, and
Subpart K FFD Programs for Penalties inadequate sleep and excessive fatigue.
Construction Individual differences in workers’
As a result of reorganizing the tolerance of these conditions also
As a result of reorganizating the final proposed rule, the NRC has moved the influence worker fitness for duty. As a
rule, the NRC has moved the provisions provisions contained in Subpart K of the consequence, fatigue is a complex
contained in Subpart K of the proposed proposed rule [Inspections, Violations, phenomenon that requires an integrated
rule [Inspections, Violations, and and Penalties] to this subpart of the final approach to manage effectively. The
Penalties] to Subpart O of the final rule. rule. The NRC added Subpart O to the requirements in Subpart I were
The final rule adds a new Subpart K final rule to combine into one subpart developed on the premise that fatigue
to revise and increase the level of detail former §§ 26.70 [Inspections], 26.90 management requires the collaboration
of FFD requirements contained in [Violations], and 26.91 [Criminal of individual workers and licensees.
§ 26.3(e) of the proposed rule pertaining penalties]. The NRC has grouped these Each of the requirements in Subpart I
to FFD programs for new reactor sections together in one subpart because
is discussed in detail in Section VI.
construction. The NRC has added this they each establish requirements related
However, because Subpart I presents an
subpart to the final rule to clarify the to the NRC’s oversight of the
integrated fatigue management
requirements applicable to entities implementation of FFD programs.
approach, this section discusses the
conducting construction activities in Section 26.821 [Inspections] retains the
principal findings that led to the NRC’s
response to public comments that raised requirements in former § 26.70. Section
decision to include fatigue management
concerns with the proposed 26.823 [Violations] retains the
provisions in Part 26, as well as
requirements. A detailed description of requirements in former § 26.90
supporting information on the causes
these public comments, as well as a [Violations]. Section 26.825 [Criminal
and problems with worker fatigue in the
summary of the features and objectives penalties] retains the requirements in
former § 26.91 [Criminal penalties]. nuclear power industry.
of Subpart K can be found in Section V
The Commission approved a
of this document. A detailed section-by- D. Inclusion of Worker Fatigue rulemaking plan to include worker
section analysis of the provisions of Provisions in 10 CFR Part 26 fatigue provisions for nuclear power
Subpart K can be found in Section VI of
The NRC has determined that the plants in 10 CFR Part 26 on January 10,
this document.
effectiveness of FFD programs in 2002, (SRM–SECY–01–0113), as
Subpart L [Reserved] ensuring against worker fatigue described in Section I. Since that time,
Subpart M [Reserved] adversely affecting public health and the NRC has continued to analyze the
safety and the common defense and need for work-hour provisions in the
Subpart N Recordkeeping and security should be strengthened by final rule. The considerations listed in
Reporting Requirements establishing clear and enforceable the numbered paragraphs that follow
As a result of reorganizing the requirements for the management of summarize the NRC’s considerations
proposed rule, the NRC has moved the worker fatigue at nuclear power plants. concerning the appropriate regulatory
provisions contained in Subpart J of the Subpart I, Managing Fatigue, of the final action to address the potential for
proposed rule [Recordkeeping and rule includes these requirements and worker fatigue to affect public health
Reporting Requirements] to this subpart establishes an integrated approach to and safety and the common defense and
of the final rule. The NRC has added fatigue management for nuclear power security. These considerations include:
Subpart N to the final rule to reorganize plant workers, with fatigue prevention, (1) The research literature
the former rule’s requirements for detection, and mitigation as the demonstrating the substantive effects of
maintaining records and submitting fundamental components. The fatigue and decreased alertness on an
reports to the NRC. The subpart requirements in Subpart I provide a individual’s ability to safely and
combines and amends two sections of substantial increase in the protection of competently perform his or her duties;
the former rule: Section 26.71 public health and safety and common (2) The conditions that contribute to
[Recordkeeping requirements] and defense and security. In establishing the worker fatigue in the U.S. nuclear power
§ 26.73 [Reporting requirements], and provisions of this final rule, the NRC industry;
incorporates the record retention has taken into consideration the effects (3) With the exception of orders
requirements of former §§ 26.21(b), of fatigue; the specific work practices of limiting the work hours of security
26.22(c), and 26.80(c). The final rule the nuclear power industry that personnel, the NRC’s former regulatory
adds a new § 26.709 [Applicability]. The contribute to and mitigate fatigue; the framework did not include consistent or
NRC has made these changes to meet inadequacy of the former regulatory readily enforceable requirements to
Goal 6 of this rulemaking to improve framework; the excessive hours formerly address worker fatigue;
clarity in the organization and language worked by many nuclear power (4) Reviews of industry control of
of the rule, by grouping related workers; and the practices of other work hours have repeatedly identified
requirements together in the subpart. industries and countries for regulating practices that were inconsistent with the
Major changes to the former rule’s work hours. In addition, the NRC held NRC’s Policy on Worker Fatigue,
requirements for recordkeeping and many public meetings with the nuclear including excessive use of extended
work weeks and the overuse of work- 2000). The lack of adequate days off and important to the protection of public
hour limit deviations; extended workdays (overtime) can health and safety and the common
(5) The former regulatory framework result in a cumulative sleep debt (i.e., defense and security rely on their ability
included requirements that were the difference between the amount of to sustain attention, analyze problems,
inadequate and incomplete for effective sleep an individual needs and the make rapid, accurate decisions, and
fatigue management; amount of sleep that individual actually communicate and work as a team. The
(6) Ensuring effective management of obtains) and performance impairment following effects of fatigue on cognitive
worker fatigue through rulemaking (Webb and Agnew, 1974; Baker, et al., abilities are the primary focus of the
substantially enhances the effectiveness 1994; Colquhoun, et al., 1996; Tucker, et fatigue management requirements:
of FFD programs, but additional orders al., 1999; Williamson and Feyer, 2000; (a) Sustaining attention—Vigilance
are not presently warranted to ensure Department of Transportation (DOT), and attention to detail are fundamental
adequate protection of public health and May 2, 2000, 65 FR 25546). Across a for plant safety, whether an individual
safety or the common defense and broad range of industries, studies is operating or maintaining equipment
security; and concerning extended work hours important to plant safety, performing
(7) Addressing the fatigue of workers suggest that fatigue-induced personnel surveillance procedures in the plant,
in safety-critical positions through impairment can increase human error monitoring system status in the control
regulation is consistent with practices in probabilities by a factor of more than 2 room, or monitoring plant security
foreign countries and other industries in to 3 times (Hanecke, et al., 1998; systems or barriers. Tasks requiring
the U.S. Colquhoun, et al., 1996; Akerstedt, sustained attention (e.g., vigilance tasks)
Each of these considerations is 1995; U.S. DOT, 49 CFR parts 350, et al., are among the most susceptible to
discussed in greater detail below. Final Rule, May 2, 2000; 65 FR 25544). fatigue-induced degradation (Monk and
(1) Fatigue and decreased alertness Studies of the nuclear power industry Carrier, 2003). The sensitivity to fatigue
can substantively degrade an indicate that normal daily variations in of vigilance tasks is one of the primary
individual’s ability to safely and alertness associated with human reasons that tests, such as the
competently perform his or her duties. circadian rhythms (i.e., physiological psychomotor vigilance task (Dinges, et
The NRC previously noted in its processes that vary on an approximate al., 1997; Doran, et al., 2001), are
‘‘Policy Statement on the Conduct of 24-hour cycle) may be responsible for standard measurement tools used in
Nuclear Power Plant Operations,’’ dated daily variations in the incidence of studies of the effects of sleep
January 24, 1989 (54 FR 3424), that personnel errors at nuclear power plants deprivation and fatigue. Of particular
‘‘nuclear power plant operators on each (Bobko, et al., 1998; Dorel, 1996; note are research findings showing that,
shift must have knowledge of those Maloney, 1992). The findings of these in operational settings, individuals may
aspects of plant status relevant to their studies are consistent with the results of experience periods of sleep up to a few
responsibilities to maintain their a survey of more than 100 nuclear seconds (called microsleeps), during
working environment free of power plant shift supervisors—over 90 which they fail to respond to external
distractions, and using all their senses, percent stated that they notice times of stimuli, and are completely unaware
be alert to prevent or mitigate any day, and days in the schedule, during that these episodes have occurred
operational problems.’’ The degradation which control room operators are less (Cabon, et al., 2003; Priest, et al., 2001;
in an individual’s cognitive functioning alert, less vigilant, or make more Summala, et al., 1999).
resulting from inadequate rest includes, mistakes (Baker, et al., 1990 [EPRI NP– (b) Decision-making—Conservative
but is not limited to, a reduced ability 6748]). These studies suggest that decision-making is central to safe
to sustain attention; maintain situational despite controls, such as standardized nuclear power plant operations. Fatigue
awareness; make timely and work practices and independent is associated with more risky strategies
conservative decisions; communicate; verification, to ensure correct and and decreases in the effort individuals
and work effectively as a team member. reliable human performance, factors that exert in decision-making (Schellekens,
These degradations in performance, if influence alertness may increase the et al., 2000). Furthermore, Harrison and
exhibited by individuals performing incidence of human errors in nuclear Horne (2000) reviewed the impact of
risk-significant functions, can adversely power plants. sleep deprivation on decision-making
affect the safety and security of a Fatigue has generalized effects on and reported that, contrary to popular
nuclear power plant. human performance capabilities, and is belief, sleep deprivation impairs
The NRC evaluated the research associated with performance decision-making even if individuals try
available on the degradation of worker decrements at a base level, across a to compensate for lack of sleep when
abilities that are important to safe plant variety of tasks (Dinges, 1995). Fatigue responding to heightened stimulation.
operation. The research supports the can impair both physical and cognitive As noted by Cabon, et al. (2003), studies
fatigue management provisions in (i.e., mental) functioning. have shown reductions in aircrew
subpart I. Many of the specific research Generally, cognitive task performance alertness, even during the critical
citations are listed in detail in section is affected more readily by fatigue than descent phase. These findings suggest
VI. The following is a discussion of the physical or psychomotor tracking that the alerting stimuli of off-normal
fundamental concerns associated with performance (Krueger, 1989; 1991). conditions (e.g., landing an airplane,
worker fatigue, and some of the overall General cognitive fatigue decreases an acknowledging control room
research that forms the basis for the individual’s ability to remain alert, annunciators) may not fully negate the
integrated fatigue management approach process complex information, and effects of fatigue on performance. The
in Subpart I. correctly grasp a complex set of National Transportation Safety Board
Many studies have shown that fatigue circumstances. Fatigue has been shown (NTSB) reviewed the performance of
impairs human alertness and to cause memory problems, slowed flight crews involved in 37 major
performance (e.g., Alluisi and Morgan, responses, lapses and false responses accidents and found that those crew
1982; Rosa, 1991; Scott, 1990; Dinges, (Williams, et al., 1959; Morgan, et al., members who had been awake longer
1992; Dinges, 1995; Dawson and Reid, 1974; Dinges, 1992; Dinges, 1995). Many than 12 hours before their accidents
1997; Bobko, et al., 1998; Harrison and of the cognitive tasks performed by made more errors overall, and
Horne, 2000; Williamson and Feyer, nuclear power plant personnel that are specifically more tactical decision
errors, than did crew members who had than crews that had been awake for a shown that task performance declines
been awake for less time (NTSB, 1994). shorter period (an average of 5.3 hours after 12 hours on a task (Rosa, 1991;
(c) Problem solving—Perseveration is for captains and 5.2 hours for first Folkard, 1997; Dawson and Reid, 1997).
a term used to describe poor problem officers) (NTSB, 1994). Similar to Other studies have shown that the
solving performance, characterized by control room personnel in nuclear relative risk of having an accident
an individual or group of individuals power plants, aircraft cockpit crews increases dramatically after 9
maintaining a faulty diagnosis or make extensive use of secondary checks consecutive hours on the job
mitigation plan despite contrary to verify that decisions and performance (Colquhoun, et al., 1996; Hanecke, et al.,
information. An example of are correct, and to mitigate the 1998; U.S. DOT, 49 CFR parts 350, et al.,
perseveration from the nuclear power consequences of errors. Although the Final Rule; 65 FR 25544; May 2, 2000).
industry was the initial response by difference was not statistically The effects of extended working hours
plant operators to events at Three Mile significant, analysis of the crew errors on worker performance can be
Island Unit 2 in 1979. The operators’ indicated that crews that had been exacerbated when many extended shifts
initial response was based on a faulty awake longer made nearly 50 percent are scheduled in succession. The
diagnosis of the plant condition (the more errors in failing to challenge a National Institute for Occupational
operators failed to recognize they were faulty action or inaction by another safety and Health published a report in
dealing with a loss of coolant accident), crew member. These studies highlight 2004 (Caruso et al., 2004) that reviewed
which the operators maintained how fatigue cannot only degrade the 52 recent reports examining the
throughout the first 2 hours of the event fitness of an individual, but also the association between long work hours
in the face of numerous conflicting overall performance of a crew. and illness, injuries, health behaviors,
indications. Many factors contributed to Although fatigue has long been and performance. NIOSH reported that
human performance problems during widely recognized as causing degraded ‘‘a pattern of deteriorating performance
the Three Mile Island accident and the performance, recent research has helped on psychophysiolgical tests as well as
NRC is not suggesting that operator characterize the magnitude of these injuries while working long hours was
fatigue was a contributing factor. effects relative to a historical FFD observed across study findings,
However, fatigue is one factor that has concern: impairment from alcohol particularly when 12-hour shifts
been found to contribute to this type of intoxication. Part 26 prohibited the use combined with more than 40 hours of
performance degradation (Harrison and of alcohol on site and within several work a week.’’
Horne, 2000), which may have serious hours before a tour of duty, and The use of 12-hour shifts has become
consequences for public health and established alcohol testing requirements increasingly common at U.S. nuclear
safety. Sleep-deprived workers fail to for personnel on duty. The NRC power plants. Schedules that include 5
appropriately allocate attention, set task established these requirements based on or more 12-hour shifts in succession
priorities, or sample for sources of the recognition that alcohol can have during routine operations are sometimes
potentially faulty information (Hockey, significant adverse effects on a worker’s popular with workers because they
1970; Krueger, 1989). Mental fatigue ability to safely and competently allow a long sequence of days off.
also contributes to decreased originality perform his or her duties. Recent studies However, scheduling more than 4
and flexibility in problem solving and have shown that fatigue can cause consecutive 12-hour shifts is not a
sub-optimal planning (Van der Linden, performance degradations that are recommended means of managing
et al., 2003; Lorist, et al., 2000; Horne, comparable to the levels observed from fatigue (Baker, et al., 1990 [EPRI NP–
1988). blood alcohol concentrations (BACs) in 6748]; NUREG/CR–4248,
(d) Communication and teamwork— excess of those that would result in a ‘‘Recommendations for NRC Policy on
Fatigue affects skills important to positive breath alcohol test under the Shift Scheduling and Overtime at
written and oral communication and provisions of Part 26. In those studies, Nuclear Power Plants’’). As noted in the
teamwork. Fatigue degrades speech individuals who were awake for 17–19 2000 Sleep in America Poll, ‘‘waking up
articulation, verbal fluency, grammatical hours had cognitive and psychomotor unrefreshed’’ was more likely to be
reasoning (the ability to process oral and performance comparable to individuals reported by individuals working more
written instructions), and memory with a BAC of 0.05 percent (Dawson and than 60 hours per week (58 percent vs.
(Harrison and Horne, 1997; 1998). Reid, 1997; Williamson and Feyer, 42 percent of those working 41–60
Studies of individuals in simulated 2000). Part 26 establishes breath alcohol hours per week and 39 percent of those
combat and command and control cutoff level below 0.05 percent. The working 31–40 hours) (National Sleep
conditions have shown that fatigue NRC considers the insight that fatigue Foundation, 2000).
slows the encoding, decoding, and can impair a worker at levels During the public meetings described
transcription of information (Banderet, comparable to those prohibited for in the preamble to the proposed rule,
1981; Angus and Heslegrave, 1985). alcohol to be particularly significant. industry stakeholders noted that the use
Fatigued individuals also tend to be less (2) Conditions that contribute to of 6 or more consecutive 12-hour shifts
communicative and have greater worker fatigue are prevalent in the U.S. is now standard practice during plant
difficulty performing multiple tasks nuclear power industry. outages. In SECY–01–0113, the NRC
concurrently, as demonstrated in Fatigue may result from an individual staff reported that more than 80 percent
simulated aircraft cockpit tasks remaining awake continuously for an of the authorizations written by
requiring monitoring and excessive period of time, or from the licensees to exceed the technical
communications (Pascoe, et al., 1995; individual obtaining an inadequate specification work-hour limits during
Harrison and Horne, 2000). These amount or quality of sleep, or both. outages were for exceeding 72 hours
effects have been found in the analysis Conditions that contribute to worker (e.g., six 12-hour shifts) in a 7-day
of incidents and accidents. In a study of fatigue include: period. The NRC’s more recent review
major aircraft accidents, crews that had (a) Extended work shifts with five or of deviations authorized at six plants for
been awake longer (an average of 13.8 more consecutive work days—Although refueling outages during 2003 and 2004
hours for captains and 13.4 hours for the effects of shift length on worker also indicated that deviations from the
first officers) made significantly more performance are influenced by the limit of 72 hours in 7 days continue to
procedural and tactical decision errors nature of the task, various studies have account for more than 80 percent of the
deviations authorized. During the public sleep loss, and circadian rhythms play has been demonstrated by a number of
meetings, industry stakeholders also in contributing to errors and accidents recent events. For example, there have
reported that, during outages, some (Kryger, et al., 1994; Akerstedt, 1995a; been instances of operators falling
licensees have scheduled personnel for Dinges, 1995; Folkard, 1997; asleep in the control rooms at the
three or more weeks of consecutive 12- Comperatore and Krueger, 1990; Miller Pilgrim nuclear power station (2004)
hour shifts without intervening days off. and Mitler, 1997). These findings range and the test and research reactor at the
(b) Extensive Overtime—Many from reduced response speed on a Massachusetts Institute of Technology
research studies report that excessive variety of tasks, to missing warning (2003), as well as a security officer
working hours cause worker fatigue signals, to minor hospital incidents and falling asleep at the Braidwood nuclear
(Akerstedt, 1995b; Rosa, 1995; Buxton, accidents (Krueger, 1994). In addition, power plant while driving a patrol
et al., 2002). The U.S. nuclear power as previously described in this section, vehicle (2004), despite these individuals
industry makes extensive use of circadian variations have also been recognizing the potential safety and
overtime, creating a combined effect of noted in studies of the incidence of disciplinary consequences.
long work hours with reduced break personnel errors at nuclear power plants (d) Early start times and extended
periods. As noted in SECY–01–0113, at (Bobko, et al., 1998; Dorel, 1996; commutes —Although many plant
approximately one-fourth of the sites, Maloney, 1992) and noted in personnel do not work rotating shifts,
more than 20 percent of the personnel observations by a large number of start times before 7 a.m. can interfere
covered by working hour limits work nuclear power plant shift supervisors with a worker’s ability to obtain
more than 600 hours of overtime (Baker, et al., 1990 [EPRI NP–6748]). adequate rest if the schedule is not
annually. This amount of overtime is In addition to causing individuals to aligned with his or her circadian cycle
more than two to three times the level perform work at periods of depressed and naturally occurring tendency for
permitted for personnel at some foreign alertness, shiftwork also conflicts with sleep and wakefulness. Such start times
nuclear power plants and more than circadian variations in alertness by typically cause workers to wake before
twice the level recommended by an requiring individuals to sleep during 6 a.m., thereby reducing the amount of
expert panel Commissioned by the NRC naturally occurring periods of increased sleep that can be obtained between
in 1985 (NUREG/CR–4248). In SECY– cognitive arousal. Circadian rhythms, midnight and 6 a.m., the most effective
01–0113, the NRC also noted that some and naturally occurring tendencies for time period for most people to sleep. In
licensees authorized hundreds to sleep and wakefulness, do not fully addition, long commutes to remote work
several thousand deviations from the adapt to shiftwork schedules. In sites such as nuclear power plants,
limits of 16 hours of work in any 24- addition, daylight, noise and the which are frequently located in rural
hour period, 24 hours of work in any 48- ‘‘regular day’’ schedules of other family areas and distanced from major
hour period, 72 hours of work in a 7-day members challenge the ability of population centers, contribute to the
period, and from the minimum break shiftworkers to obtain adequate rest. As potential for fatigue associated with
requirement of 8 hours between work a result, shiftworkers generally obtain early start times.
periods. The NRC also noted the less sleep, and report a higher incidence (e) Sleep disorders—Sleep disorders,
continued excessive use of such of sleepiness and sleep-related such as sleep apnea, insomnia, and
deviations in its survey of six plants in complaints. For example, in a survey of restless leg syndrome (i.e., a condition
2004. 1,154 U.S. adults, the National Sleep that is characterized by uncomfortable
(c) Shiftwork—The nuclear power Foundation (NSF) found that or unpleasant sensations in the legs,
industry is a round-the-clock operation shiftworkers, on average, get less sleep causing an overwhelming urge to move
requiring individuals to be awake and (6 hours, 30 minutes) than regular day them, often contributing to difficulty in
working at times when they would workers (6 hours, 54 minutes). Almost staying or falling asleep), are conditions
normally be asleep. Although half of the shiftworkers they surveyed that can significantly reduce the
individuals can function in these obtained less than 6.5 hours of sleep per quantity and quality of sleep that
circumstances, human alertness and ‘‘night’’ during the work-week, 30–90 individuals are able to obtain, affect an
task performance are cyclically affected minutes less than recommended by individual’s ability to remain alert, and
by a daily biological clock, which runs most sleep experts. In comparison to ultimately degrade an individual’s
on about a 24-hour (circadian) cycle, as regular day workers, shiftworkers were ability to safely and competently
it assists in timing numerous more likely to be sleepy at work 2 or perform his or her duties (Kryger, et al.,
physiological and psychological more days per week (34 percent vs. 23 1994; Lewis and Wessely, 1992). These
phenomena (such as core body percent) (National Sleep Foundation, factors are not effectively addressed by
temperature, the daily release of various 2000). Many studies have demonstrated limits on working hours in the absence
hormones, mood swings, and wake- that decreased performance and of other fatigue management practices.
sleep cycle) (Liskowsky, et al., 1991). increased errors and accidents are Although the NRC does not have data
The circadian trough, or lowest levels of associated with night work and are for the incidence of sleep disorders that
function reflected in, for example, affected by varying sleep schedules and are specific to U.S. nuclear power plant
alertness, performance, subjective durations of sleep periods (e.g., Balkin, workers, in the general U.S. population,
mood, and body temperature, occurs et al., 2000). these conditions are not uncommon. For
around 3 a.m. to 5 a.m., with many The challenge for shiftworkers to example, the prevalence of sleep apnea
human functions showing reduced remain alert during the early morning is estimated to be 4 percent for adult
levels between 12 a.m. and 6 a.m. hours of a shift can be exacerbated by males and 2 percent for adult females
Sleepiness is most severe between 3 and extended shift lengths, overtime, and (Strollo and Rogers, 1996). The
5 a.m., with a less marked but the inability of many shiftworkers to incidence of sleep apnea may in fact be
significant expression again between 3 obtain adequate sleep during the day higher for shiftworkers at power plants,
and 5 p.m. (Hanecke, 1998). The powerful drive for as this condition is more common in
There is substantial scientific sleep that is associated with circadian middle-age adult males than in the
literature on circadian variations in factors, and the fact that shiftwork is a general population. A survey by the
alertness that clearly demonstrates the daily influence on the alertness of all NSF of 1,154 adults living in
significant roles that worker fatigue, shiftworkers at nuclear power plants, households in the continental U.S.
found self-reports of sleep apnea were NRC reviewed and assessed the —The technical specifications contain
more common from shiftworkers than implementation and enforceability of varying scopes of requirements. Some
regular day workers (15 percent vs. 9 the NRC’s former regulatory framework plant technical specifications require
percent) (National Sleep Foundation, applicable to worker fatigue, including periodic reviews of overtime
2000). Similarly, the NSF found that licensee technical specifications for the approvals to ensure that excessive
shiftworkers reported a higher incidence administrative control of work hours. hours have not been assigned, while
of insomnia (66 percent vs. 55 percent) This review was documented in detail other technical specifications contain
than regular day workers. in Attachment 1 to SECY–01–0113. The no equivalent requirements. Although
Although worker motivation can NRC continued this evaluation during the observed variability in the
mitigate to a limited degree the effects development of this final rule, and the controls does not by itself present a
of fatigue, fatigue has a physiological principal findings include: safety concern, such variability is
basis, including changes in glucose (a) NRC’s Policy on Worker Fatigue— inconsistent with establishing a
metabolism in the brain (Wu, et al., NRC guidance documents do not uniform level of assurance that
1991; Thomas, et al., 2000). These prescribe requirements. Guidance personnel are not in a fatigued
changes are beyond the individual’s documents establish policy or provide condition that could significantly
control. In addition, several studies advice on meeting a regulatory reduce their mental alertness and
have suggested caution with regard to requirement. As a result, a policy is decision-making capabilities.
the abilities of individuals to self- enforceable only to the extent that the —Licensees have inconsistently
monitor their capacity to safely and guidelines have been incorporated into interpreted the scope of personnel
competently perform their duties when a license condition or technical who must be subject to the technical
fatigued (Dinges, et al., 1997; Belenky, et specifications. For the three nuclear specification work-hour limits. The
al., 2003; Akerstedt, 2003). These power plant sites that have not NRC’s Policy on Worker Fatigue
studies note that individuals experience incorporated the guidelines from the applies to personnel who are
microsleeps without being aware of NRC’s Policy on Worker Fatigue into a performing safety-related functions.
their lapses in attention and license condition or technical The NRC’s review of work-hour data
underestimate their propensity for specification, the guidelines are gathered by NEI regarding the work
uncontrolled sleep episodes. As a unenforceable. These plant sites have hours of personnel subject to the
consequence, a worker’s motivation to implemented the concept using other technical specifications (Nuclear
remain alert does not provide administrative controls that the NRC has Energy Institute, 2000) identified
reasonable assurance that an individual determined to be adequate. However, variation in the numbers and types of
will be able to safely and competently had the NRC determined that the personnel covered by these controls.
perform his or her duties. controls were inadequate, it would have A limited number of sites may not
Considering the above factors, fatigue
had no basis for taking enforcement have been applying work-hour
can have a significant adverse effect on
action. controls to all personnel performing
worker abilities. Further, the likelihood
(b) Technical Specifications—For safety-related functions. At least two
of a nuclear power plant worker being
those licensees who have incorporated nuclear plant sites do not apply the
impaired from fatigue is not trivial, and
the NRC’s Policy on Worker Fatigue into work hour controls to any
potentially greater than the likelihood of
a license condition or technical maintenance personnel even though
impairment from drugs and alcohol,
specifications, consistent enforcement GL 83–14, ‘‘Definition of ‘Key
which the NRC requires licensees to
has been complicated by the following Maintenance Personnel’ (Clarification
address through their FFD programs.
factors: of GL 82–12),’’ issued March 7, 1983,
Therefore, the NRC believes that
regulatory action is warranted to ensure —The language in plant technical defined key maintenance personnel to
that fatigue is adequately addressed specifications is largely advisory (e.g., include individuals who work on
through licensee FFD programs. Further, an individual should not be permitted safety-related equipment.
the NRC asserts that rulemaking is the to work more than 16 hours straight) —The basic measure used to determine
appropriate regulatory action for the and key terms have not been defined. whether an individual’s work hours
following reasons: This deficiency has resulted in are within or above the technical
(3) With the exception of orders inconsistent interpretation and specification limits has not been
limiting the work hours of security implementation of technical implemented consistently from one
personnel, the NRC’s former regulatory specifications by licensees, as well as nuclear power plant to another. Work
framework did not include consistent or difficulty for the NRC in enforcing the hours included within the limits at
readily enforceable requirements to requirements. For example, many some nuclear power plants have not
address worker fatigue. technical specifications use the terms, been included at others, effectively
The principal components of the ‘‘routine heavy use of overtime,’’ creating substantively different work-
former regulatory framework for matters ‘‘unforeseen problems,’’ and hour limits among plants.
pertaining to working hours and fatigue ‘‘temporary basis.’’ The NRC has not (c) 10 CFR Part 26, ‘‘Fitness for Duty
for non-security personnel were (a) defined any of these terms and has Programs’’—The general performance
NRC’s Policy on Worker Fatigue, as not consistently pursued enforcement objectives of former § 26.10 required
issued on June 15, 1982, in GL 82–12, on the basis of the amount or that licensees provide ‘‘reasonable
and (b) plant technical specifications frequency of overtime authorized. assurance that nuclear power plant
related to this policy statement, and (c) —The technical specifications have personnel * * * are not * * * mentally
certain limited requirements of 10 CFR inconsistent levels of detail from one or physically impaired from any cause,
Part 26. nuclear power plant licensee to which in any way adversely affects their
As part of the assessment of PRM–26– another. Only three-quarters of the ability to perform their duties.’’
2, in which Barry Quigley petitioned for licensees’ technical specifications Although former 10 CFR Part 26
rulemaking to establish enforceable include the quantitative work-hour contained specific requirements
requirements addressing fatigue of limit guidelines of the NRC’s Policy pertaining to alcohol and drug usage, it
workers at nuclear power plants, the on Worker Fatigue. did not include prescriptive
requirements regarding fatigue. Rather, personnel averaged more than 500 hours which showed that approximately one-
former § 26.20 used general, non- of overtime annually at 80 percent of the third of the respondents were
mandatory language to state that the plants and more than 700 hours of authorizing more than a thousand, to as
FFD policy ‘‘should’’ address other overtime at 14 percent of the plants. many as 7,500, deviations in a year to
factors that can affect a worker’s ability The NRC’s Policy on Worker Fatigue exceed the policy guidelines. The
to safely and competently perform his or included provisions for licensees to frequency of deviations did not appear
her duties, ‘‘such as mental stress, authorize deviations from the NRC’s to be consistent with either the specific
fatigue, and illness.’’ As a result, it has work and rest guidelines for individual guidelines or the general objective of the
been difficult for the NRC to justify a workers in ‘‘very unusual policy. As previously described in this
violation of the regulation based on a circumstances.’’ On June 10, 1991, section, the policy permits deviations
licensee’s failure to limit overtime following several NRC inspections from the guidelines in ‘‘very unusual
hours. In addition, without a numerical noting concerns related to licensee work circumstances.’’
limit on overtime hours, or a provision hour control, the NRC issued Subsequent to the Commission’s
limiting overtime, a range of overtime Information Notice (IN) 91–36, Nuclear decision to initiate rulemaking for
practices could be viewed as Power Plant Staff Working Hours, to worker fatigue, the NRC staff also
‘‘reasonable,’’ and therefore in alert licensees of potential problems obtained data from six sites in 2004.
compliance with the regulation. resulting from inadequate controls to Those data indicated that between 95
In summary, the broad and non- prevent excessive working hours. The and 603 deviations, with an average of
prescriptive provisions of Part 26, and conditions cited in the notice included 311 deviations, were issued for
the technical specifications and license an event attributed to fatigue, excessive individuals. The data were provided by
conditions pertaining to fatigue, in the use of deviations and overtime, and the six sites for each plant’s most recent
absence of clearly defined terms or overtime deviations authorized after the refueling outage and one month of
measures of fatigue, have made it fact. Subsequent NRC reviews power operation, and therefore do not
difficult for the NRC to enforce worker completed in 1999 and 2001 identified reflect the total number of deviations
fatigue requirements and work-hours continued problems with industry issued for individuals during all of
limits in an effective, efficient, and control of work hours. In 1999, the NRC 2004, except for one of the six sites that
uniform manner that ensures that all reviewed licensee event reports and provided its deviation data (101
licensees provide reasonable assurance NRC inspection reports from January deviations) for all of 2004. Data on the
that workers are able to safely and 1994 through April 1999. The NRC deviations from 2004 in this sample are
competently perform their duties. The found that only a few events of limited reported in detail in Appendix 3 of the
NRC believes that a consistent fatigue risk significance had been attributed to Regulatory Analysis. The NRC believes
management program and its uniform fatigue. However, the staff found several that licensee use of deviations and
implementation across the industry is instances each year in which licensee overtime at some sites has been
essential, and the most effective use of overtime appeared to be excessive, and has been inconsistent
regulatory mechanism is to incorporate inconsistent with the general objectives
with the intent of the NRC’s Policy on
worker fatigue requirements into 10 CFR or specific guidelines of the NRC’s
Worker Fatigue.
Part 26. Policy on Worker Fatigue.
(4) Reviews of industry control of NEI conducted a survey in the In addition to excessive work hours
work hours have repeatedly identified summer of 2000 concerning industry and work-hour guidelines deviations,
practices that were inconsistent with the control of work hours for personnel the NRC has recently identified other
NRC’s Policy on Worker Fatigue, subject to the technical specifications concerns related to licensee policies and
including excessive use of work hours (letter dated August 29, 2000, from J. W. practices applicable to worker fatigue.
and work hour limit deviations. Davis, NEI, to G. M. Tracy, NRC, On May 10, 2002, the NRC issued
The policy states, in part, ‘‘Enough ADAMS Accession No. ML003746495). Regulatory Issue Summary (RIS) 2002–
plant operating personnel should be Forty-seven sites responded to the 007, ‘‘Clarification of NRC Requirements
employed to maintain adequate shift survey, providing data from 1997–1999. Applicable to Worker Fatigue and Self-
coverage without routine heavy use of The NRC staff’s review of the data is Declaration of Fitness-for-Duty.’’ The
overtime.’’ Surveys and expert panels documented in Attachment 1 to SECY– NRC issued the RIS following several
have suggested that tolerance for 01–0113. The NRC evaluated the results allegations made to the NRC regarding
overtime is generally limited to 300–400 of the survey concerning overtime and the appropriateness of licensee actions
hours of overtime per year (ADAMS found that 8 of 36 sites providing data or policies related to individuals
Accession No. ML05270310; NUREG/ had more than 20 percent of the declaring they are not fit due to fatigue.
CR–4248). Baker, et al. (1994) reviewed personnel covered by the policy These concerns indicate a need to
the hours worked by nuclear power working in excess of 600 hours of ensure that individuals and licensees
plant operations, technical, and overtime per year. Considering all clearly understand their responsibilities
maintenance personnel during 1986, plants that provided data, the with respect to self-declarations of
four years after the NRC issued its percentage of personnel working in worker fatigue. The final rule
policy. Based on a sample of 63 percent excess of 600 hours of overtime per year establishes requirements to address this
of U.S. nuclear power plants operating increased from 7 percent in 1997 to 11 need.
at that time, Baker and colleagues found percent in 1999. The percentage of (5) The former regulatory framework
that operations personnel averaged more licensed operators working in excess of included requirements that were
than 500 hours of overtime annually at 600 hours of overtime per year inadequate and incomplete for effective
20 percent of the plants, and more than increased from 13 percent in 1997 to fatigue management.
700 hours of overtime at 9 percent of the more than 16 percent in 1999. The NRC (a) The NRC’s Policy on Worker
plants. Technical personnel averaged considers these percentages to represent Fatigue did not establish clear
more than 500 hours of overtime excessive use of overtime in the nuclear expectations for the control of work
annually at 30 percent of the plants, and industry. hours. As previously noted in this
more than 700 hours of overtime at 18 The NRC also reviewed the data section, the NRC did not define key
percent of the plants. Maintenance collected by NEI concerning deviations, terms of the policy, and, as a
consequence, implementation has been supporting the basis for cumulative adequate protection of public health and
varied across the industry. fatigue, led the NRC to conclude that the safety or the common defense and
(b) Certain policy guidelines and work hour guidelines of the policy were security.
technical specifications were inadequate inadequate for addressing cumulative Adequate protection of public health
to provide reasonable assurance that fatigue. The NRC obtained additional and safety and the common defense and
individuals remain capable of safely and worker feedback supporting this security were ensured under the former
competently performing their duties. conclusion through a review of worker regulatory framework, including Order
For example, the requirement for an 8- fatigue concerns and work hours during EA–03–038 (for security personnel), the
hour break between work periods has a long-term outage at the Davis Besse NRC’s Policy on Worker Fatigue, and
been revised to a 10-hour break. The nuclear plant (NRC Inspection Report licensee technical specifications.
basis for this revision to increase the 05000346/2004003, dated March 31, Licensee FFD programs included
length of this break period is described 2004, ADAMS Accession No. behavioral observation programs to
in detail in Section VI with respect to ML040910335). identify individuals whose behavior
§ 26.205(d)(2)(i). The comprehensive fatigue indicates they may not be fit to safely
In addition, although the policy management approach in Subpart I, and competently perform their duties,
established an objective of a nominal Managing Fatigue, establishes controls and ensure that those individuals are
40-hour work week, the specific work to address cumulative fatigue. Limits to removed from duty until any question
hour guidelines of the policy and most mitigate cumulative fatigue for nuclear regarding their fitness has been
technical specifications for the power plant security personnel were resolved. The former work-hour
administrative control of work hours implemented by Order EA–03–038. The controls, in conjunction with licensee
have principally focused on acute final rule codifies, with changes, these behavioral observation programs,
fatigue. These guidelines did not requirements. Changes to those limits automatic reactor protection systems
adequately address the longer term that have been imposed by this rule are and other administrative controls on
control of work hours and the discussed in detail in Section VI, which worker activities (e.g., post-maintenance
cumulative fatigue that can result from also includes a detailed discussion of testing, peer checks, independent
prolonged periods of extended work the limits and other controls to mitigate verifications) ensured adequate
hours. Acute fatigue results from cumulative fatigue for other personnel protection of public health and safety
restricted sleep, sustained wakefulness, who perform safety-related duties at and the common defense and security.
or continuous task demands over the nuclear power plants. However, there were substantial
past 24 hours or more. Cumulative (c) The former regulatory framework limitations to the former regulatory
fatigue results from inadequate rest over did not effectively ensure that fatigue framework, as detailed in this section.
consecutive sleep-wake periods when from causes other than work hours was Therefore, although the previous
the worker obtains less sleep than he or addressed. Work hour controls are regulatory framework provided
she requires. An individual incurs a necessary, but not sufficient, to adequate protection, including work-
sleep debt for each day during which effectively manage worker fatigue. As a hour controls in 10 CFR Part 26
the worker obtains insufficient sleep. If consequence, training and fatigue provides a substantial increase in public
the individual continues to obtain assessments are essential. Worker health and safety and the common
insufficient sleep, this debt accumulates fatigue, and its effects on worker defense and security. The NRC has
over successive days, resulting in alertness and performance, can result incorporated worker fatigue provisions
increasing fatigue and impairment from many causes in addition to work in Part 26 in light of the substantial
(Belenky, et al., 2003). hours (e.g., stress, sleep disorders, daily increase in safety and security that is
The inadequacy of the former living obligations) (Rosa, 1995; Presser, expected to result.
regulatory framework for addressing 2000). In addition, there are substantial (7) Addressing fatigue of workers in
cumulative fatigue became particularly individual differences in the abilities of safety-critical positions through
apparent in the months following the individuals to work for extended regulation is consistent with practices in
terrorist attacks of September 11, 2001. periods without performance foreign countries and other industries in
The NRC received numerous allegations degradation from fatigue (Gander, 1998; the U.S.
from nuclear security officers that Van Dongen, et al., 2004a; Van Dongen, The NRC reviewed the limits on work
certain licensees required them to work et al., 2004b; Jansen, et al., 2003). hours for nuclear plant workers in eight
excessive amounts of overtime over long Subpart I, Managing Fatigue, requires a other countries, as well as six other
periods due to the post-September 11, comprehensive fatigue management industries in the United States and
2001, threat environment. These program. One example is the Canada. These are summarized in
individuals questioned their readiness strengthening of FFD training Attachment 1 of SECY–01–0113.
and ability to perform their required job requirements concerning worker fatigue. Although many factors influence
duties due to the adverse effects of The training requirements will improve specific regulatory limits, and
cumulative fatigue. The NRC reviewed the effectiveness of behavioral requirements for other industries should
the actual hours worked by security observation and the assessment of be considered in context, the NRC found
personnel and determined that, in the worker fatigue, self-declaration as a that the NRC’s former guidelines are the
majority of cases, individual work hours means for early detection of fatigue, least restrictive among those reviewed.
did not exceed the guidelines specified worker self-management of fatigue, the The work hours of nuclear power
in the NRC’s Policy on Worker Fatigue, ability of workers to obtain adequate plant personnel in other countries are
but the review confirmed that rest on a shiftwork schedule, and largely based on labor laws or union
individuals had been working up to 60 licensee use of effective fatigue counter- agreements that apply to multiple
hours per week for extended periods. measures. industries. With the exception of Spain,
The concerns expressed by individuals (6) Ensuring effective management of which has limits consistent with the
regarding their FFD, in light of work worker fatigue through rulemaking will NRC’s Policy on Worker Fatigue, each of
schedules that did not exceed the substantially enhance the effectiveness the other eight countries has more
specific guidelines of the policy, as well of FFD programs, but additional orders stringent requirements. The more
as relevant technical research are not presently warranted to ensure stringent requirements have largely
preempted the need in those countries prevent cumulative fatigue (68 FR to temporarily mitigate the effects of
for regulation of work hours based on 22456–22517; April 28, 2003, as fatigue on alertness. However, there is
nuclear safety concerns. amended by 70 FR 50071; August 25, no evidence to indicate that worker
The Department of Transportation 2005). motivation or the stimulating effects of
(DOT) has established regulatory limits Nuclear power plant licensees in the the job or environment alter the
on the work hours of pilots, air traffic U.S. have sometimes asserted that the underlying physiological processes.
controllers, and maintenance personnel characteristics of the work tasks in Although crew interactions and other
in the commercial aviation industry (14 nuclear power plants differ from other job characteristics may serve to bolster
CFR parts 121 and 135); in the maritime occupations that have work hour worker alertness temporarily,
industry (46 U.S.C. 8104; 46 CFR parts controls (e.g. transportation equipment environmental stimulation only masks
15.705, 15.710 and 15.111); in the rail operators); therefore information from individuals’ physiological need for
industry (49 U.S.C. 211; 49 CFR Part other occupations may not be sleep. Removing the stimulation (e.g.,
228); and for drivers of heavy trucks in applicable. In addition, licensees have transitioning from the activity of shift
the commercial trucking industry (49 suggested that the level of automation in turnover to monitoring steady state
CFR Part 395). The DOT recognized that nuclear power plants provides an plant operations during a night shift)
fatigue can substantively degrade the important barrier to human errors will increase the potential for lapses in
ability of individuals to perform these resulting from fatigue, and that the attention and uncontrolled sleep
duties and, therefore, promulgated amount of control room crew interaction episodes among individuals who may
regulatory requirements for each of and oversight of operators’ actions be partially sleep deprived or otherwise
these modes of transportation in assures that fatigue-induced errors will fatigued.
keeping with the department’s mission be detected and corrected before they Another consideration regarding the
to protect public safety. In the late 1980s have an opportunity to impact plant relevance of other regulations limiting
and early 1990s, the National operations. The NRC concurs that work hours is that adverse fatigue
Transportation Safety Board (NTSB) requirements for other industries should effects are observed across a broad range
identified equipment operator fatigue as be considered in context. Nevertheless, of cognitive functions in addition to
a significant issue affecting all the fact that other Federal agencies with alertness. Whereas crew interactions
transportation modes (Beal and a safety mission have established may help sustain alertness, sleep
Rosekind, 1995). As a result, DOT regulations to address fatigue is relevant deprivation and sustained periods of
classified operator fatigue management for several reasons. wakefulness continue to degrade other
as a DOT ‘‘Flagship Initiative’’ and First, the human need for sleep and cognitive functions (e.g., memory and
several proactive fatigue management the deleterious effects of sleep decision making) and elements of
activities ensued across the deprivation have a physiological basis performance that are important to safe
transportation industries (e.g. U.S. DOT, (e.g., changes in brain glucose nuclear plant operations, such as
1995; Rogers, 1996, 1997; Hartley, 1998; metabolism) that is independent of the communications and following written
Carroll, 1999). nature of the work being performed and oral instructions. For example, as
In 1999, the NTSB evaluated DOT’s (Wu, et al., 1991). Second, circadian discussed earlier in this section, studies
decade of efforts on operator fatigue variations in alertness and performance, of crew performance in critical phases
(NTSB, 1999). Not satisfied that enough and the underlying changes in of commercial aircraft flight (e.g., take-
was being done, NTSB subsequently physiological processes, have been off and landings) and in simulated battle
offered DOT three recommendations: (1) observed in individuals performing a command station operations have
expedite a coordinated research wide range of tasks across many shown fatigue-related degradations in
program on the effects of fatigue, industries (Kecklund, et al., 1997). For performance despite the stimulation of
sleepiness, sleep disorders, and all individuals, time since awakening, the interactions, the intense level of
circadian factors on transportation the time of day, and the amount of prior activity, and the implications of
safety; (2) develop and disseminate sleep that an individual obtains relative degraded performance for the loss of
educational materials for transportation to his or her sleep needs are primary human life. Regulations limiting work
industry personnel and management determinants of fatigue and the need for hours in other industries that use
regarding shift work, work rest sleep. operating crews (e.g., aviation) and
schedules, and proper regimens of The NRC acknowledges that task allow greater freedom of movement than
health, diet, and rest; and (3) review and characteristics and time on task may trucking (e.g. maritime) are consistent
upgrade regulations governing hours of exacerbate the effects of fatigue on the with this understanding of the broad
service for all transportation modes to ability of individuals to remain alert. effects of fatigue on cognitive
assure they are consistent and For example, a concern for task-specific performance. There is no reason to
incorporate the results of the latest effects is reflected in the DOT hours-of- believe that nuclear power plant
research on fatigue and sleep issues service regulations for commercial truck workers’ physiological processes and
(NTSB, 1999). drivers, which establish a daily limit on the adverse effects of fatigue on their
On April 28, 2003, the DOT issued driving time of 11 hours per day. This abilities to perform their tasks would
revised hours-of-service regulations to limit is in addition to the requirements differ. In addition, the notion that
require motor carriers to provide drivers prohibiting driving after 14 hours on human performance practices in the
with better opportunities to obtain duty and mandating minimum 10-hour nuclear industry prevent fatigue-related
sleep. Among other provisions, the break periods, which reflect the human performance decrements from resulting
regulations (1) increase the required off- physiological need for rest that is in human errors is not supported by
duty time from 8 to 10 consecutive necessary to maintain performance (68 studies that have shown circadian
hours; (2) limit driving time to 11 FR 22456–22517; April 28, 2003). variations in performance at nuclear
cumulative hours following 10 By comparison to driving a truck, the power plants (Bobko, et al., 1998; Dorel,
consecutive hours off duty; (3) prohibit characteristics of some jobs in nuclear 1996; Maloney, 1992).
work after the end of the fourteenth power plants (e.g., reactor operator) The NRC acknowledges that the
hour after the driver began work; and (4) permit greater freedom of movement nuclear power industry is perhaps
require long break recovery periods to and social interaction, which may serve unique, relative to many other
industries, in its use of automated safety health and safety and common defense applicable to the licensing and approval
systems to protect against the and security by: processes for future nuclear power
consequences of equipment failure and (1) Establishing specific, integrated, plants. The Part 52 final rule also
human error. Nevertheless, reliable comprehensive, and enforceable clarified portions of the former Part 26
human performance remains an requirements for the effective to explicitly extend the applicability of
essential element in the protection of prevention, detection, and mitigation of sections of the former Part 26 to a
public health and safety and the worker fatigue; combined license holder after the date
common defense and security. NRC (2) Ensuring that personnel who that the NRC makes the finding under
requirements, such as the minimum perform functions that are significant to § 52.103(g), a combined license holder
onsite staffing requirements of 10 CFR the protection of public health and before the date that the NRC makes the
50.54(m) and minimum security staffing safety or the common defense and finding under § 52.103(g), a
requirements in site security plans, are security are subject to appropriate work manufacturing license holder under
predicated on the expectation that all hour controls, including: individuals Subpart F of 10 CFR Part 52, and a
personnel in these positions are fit for performing risk significant operations or person authorized to conduct the
duty and are able to safely and maintenance duties; health physics, construction activities under
competently perform their duties. As a chemistry, and fire brigade duties § 50.10(e)(3). The Part 52 final rule
consequence, the NRC does not consider important to emergency response; and accomplished this by:
the use of automated safety systems to individuals performing security duties (1) Revising the former § 26.2(a) to
be an appropriate basis for permitting important to maintaining the security of refer to combined license holders after
conditions that could allow fatigue to the plant; the date that the NRC makes the finding
degrade the important line of defense of (3) Establishing work hour controls under § 52.103(g);
reliable human performance. Further, that provide increased assurance that (2) Revising the former § 26.2(c) to
despite automated systems, the workers will have adequate opportunity refer to a holder of a combined license
contribution of human error to risk in for rest and that deviations from the before the date that the NRC makes the
operating events continues to be notable work hour limits will only be finding under § 52.103(g), a holder of a
(NUREG/CR–6753, ‘‘Review of Findings authorized as necessary for plant safety manufacturing license under Subpart F
for Human Error Contribution to Risk in or security and following appropriate of Part 52, and a person authorized to
Operating Events’’). assessment of the worker’s ability to conduct the activities under
Because the NRC concurs that task safely and competently perform his or § 50.10(e)(3);
characteristics are an appropriate her duties; (3) Revising the former § 26.10(a) to
consideration, the final rule differs from (4) Ensuring that work hour refer to the personnel of a holder of a
other Federal agencies’ requirements deviations are only permitted when manufacturing license and those
with respect to specific work hour necessary for plant safety or security, authorized to conduct the activities
requirements and requires licensees to and following assessment of the under § 50.10(e)(3); and
consider task characteristics when worker’s ability to safely and (4) Revising the former Appendix A to
authorizing any waiver from the work competently perform his or her duties; Part 26, paragraph 1.1(1) to include a
hour controls. Nevertheless, the NRC (5) Establishing controls to prevent
reference to a holder of a combined
believes that it remains relevant that cumulative fatigue that can result from
license after the date that the NRC
other Federal agencies with public consecutive weeks of extended work
makes the finding under § 52.103(g).
safety missions have chosen to address hours;
(6) Ensuring workers are provided The Part 52 final rule changes to Part
worker fatigue through regulation. 26 went into effect on September 27,
with sufficient break periods to provide
In summary, the NRC believes that the for adequate opportunity for sleep to 2007. Each of the Part 26 provisions
requirements in Subpart I will provide mitigate acute and cumulative fatigue; revised by the Part 52 final rule has
a substantial increase in the protection (7) Ensuring that, in addition to work been modified by this final rule, as
of public health and safety and common hours, other factors that can affect discussed in section VI of this
defense and security. In determining the worker fatigue and the ability of workers document.
provisions of this final rule, the NRC to remain alert are adequately addressed On October 9, 2007 (72 FR 57416), the
has taken into consideration the effects through licensee FFD programs; Commission issued a final rule
of fatigue on human performance, the (8) Encouraging effective fatigue amending its regulations applicable to
specific work practices of the nuclear management by permitting licensees to limited work authorizations (LWAs),
power industry that both mitigate and use alternate measures for prevention which allow certain construction
contribute to fatigue, the inadequacy of and mitigation of fatigue; and activities on production and utilization
the former regulatory framework, the (9) Strengthening FFD training facilities to commence before a
excessive hours formerly worked by requirements concerning worker fatigue. construction permit or combined license
many nuclear power plant personnel, This will improve behavioral is issued. The LWA final rule modified
and the relevant research and practices observation and assessment of worker the scope of activities that are
of other industries and countries for fatigue; self-declaration as a means for considered construction for which a
regulating work hour limits. In addition, early detection of fatigue; worker self- construction permit, combined license
many public meetings were held with management of fatigue; the ability of or LWA is necessary, specified the
the nuclear industry and the public to workers to obtain adequate rest on a scope of construction activities that may
discuss draft provisions for the final shiftwork schedule; and licensee use of be performed under a LWA, and
rule. The specific basis for each effective fatigue counter-measures. changed the review and approval
provision of the fatigue management process for LWA requests. By making
E. Subsequent Rulemakings
portions of the final rule are discussed these changes in the LWA final rule, the
in Section VI. On August 28, 2007 (72 FR 49352), Commission also revised the scope of
The requirements for managing the Commission issued a final rule Part 26 by clarifying which entities
fatigue will provide a substantial amending its regulations by revising the could be subject to Part 26. The extent
increase in the protection of public provisions, particularly 10 CFR Part 52, to which the LWA final rule impacted
Part 26 is discussed in section VI in this rulemaking. Virtually all of the § 26.197(e) [Reporting] which would
document. comments supported the objectives of have required licensees to provide
the proposed rule. information concerning the
V. Summary of Public Comments
implementation of certain work hour
Submitted on Proposed Rule Public Comment on Subpart I
requirements as part of an annual FFD
Description of Public Comments and The NRC has reorganized the overall program report.
Public Meetings structure of the proposed rule and
renumbered several subparts. This Proposed Requirements for a Minimum
The NRC received 81 written public necessitated renumbering the affected 24-Hour Break in Any 7-Day Period
comments on the proposed Part 26 sections of Subpart I [Managing Section 26.199(d)(2)(ii) of the
published on August 26, 2005. The NRC Fatigue]. proposed rule would have required a
also considered six comments submitted Subpart I contains requirements for minimum 24-hour break in any 7-day
on a previous working draft of the the management of worker fatigue at period. Commenters noted that
proposed rule that NRC posted on its nuclear power plants. Most comments licensees who currently use 8-hour
Web site on May 19, 2005, but which recommended modifications to Subpart schedules often include periods of 7
were received too late to consider at that I to address specific concerns with the consecutive work days in their
time. These 87 written comments proposed rule language or certain schedules. These schedules limit the
contained more than 350 pages of provisions of the rule. However, the vast frequency of shift rotations and enable
material. The stakeholders who majority of the stakeholders licensees to conduct training on a
submitted these 87 comments are as commenting on Subpart I expressed Monday-through-Friday schedule. The
follows: 25 (29 percent) from nuclear their general support for the NRC’s commenters also asserted that the
energy industry representatives, objective of establishing a set of clear requirement for a minimum 24-hour
including several substantive comments and enforceable requirements to address break in any 7-day period would
from NEI; five (6 percent) from other the management of worker fatigue at substantially reduce licensee flexibility
organizations; seven (8 percent) from nuclear power plants. Commenters in scheduling 8-hour shifts and would
unions; 21 (24 percent) from individuals supported the fatigue provisions for cause them to switch to 12-hour shifts.
who work in the nuclear energy various reasons. In particular, The NRC agrees that the proposed
industry (i.e. operators, maintenance commenters expected that the rule requirement for a minimum 24-hour
workers); 15 (17 percent) from other would increase the clarity of work hour break in any 7-day period would have
individuals; and 14 (16 percent) from requirements, reduce forced overtime, adversely affected licensee scheduling
anonymous commenters. provide reasonable assurance that the of 8-hour shifts as described in the
The NRC considered comments risk of fatigue-related events is comments and has revised the
contained in the transcript of a public managed, increase staffing levels, and maximum number of work days that the
meeting held on September 21, 2005, in prevent worker injuries. Those who rule permits between breaks.
which 28 individuals, including NRC opposed the rule asserted that it would Section 26.205(d)(2)(ii) of the final
staff, spoke. Four written comments place an unnecessary burden on rule replaces proposed § 26.199(d)(2)(ii)
were submitted anonymously at this licensees, reduce worker income, and and requires a minimum 34-hour break
meeting. The NRC also considered make it more difficult for licensees to in any 9-day period. In revising the
comments from several other public attract supplemental workers during requirement, the NRC considered that,
meetings: November 7 and 9, 2005 outages. although the final rule permits more
(ADAMS Accession No. ML052990048) The NRC received several substantive consecutive work shifts for 8-hour and
to provide clarification on the proposed comments that addressed specific 10-hour shift schedules, the additional
rule; and December 15, 2005 (ADAMS provisions in proposed § 26.199 [Work flexibility allows licensees to more
Accession No. ML053400002) regarding hour controls]. This section would have readily optimize their 8-hour shift
NEI’s proposed alternative approach to established requirements for the control schedules to minimize the transitions
the work-hour portions of the proposed of work hours for a limited scope of between day, evening, and night shifts
rule. personnel at a nuclear power plant. In that can lead to worker fatigue.
The written comments received on general, the individuals who would Although this relaxation also allows
the proposed rule addressed many have been subject to these requirements more consecutive shifts for individuals
issues that were of stakeholder concern. perform functions that most directly on 10-hour shifts, these individuals
The NRC analyzed all of these affect the protection of public health typically do not work a rotating
comments as part of the process for and safety and common defense and schedule and therefore do not
developing this final rule. In particular, security. The provisions that were the experience the disruption of their
commenters raised several important subject of these comments were circadian cycle that exacerbates the
concerns relating to fatigue proposed § 26.199(d)(2)(ii), which cumulative fatigue effects of consecutive
management, the application of FFD would have required a minimum 24- work shifts. The rule also establishes
requirements to entities involved in new hour break in any 7-day period; minimum day of requirements in
plant construction and manufacturing proposed § 26.199(d)(2)(iii), which § 26.205(d)(3) that effectively limit
activities, and validity testing of urine would have required a minimum 48- within each shift cycle the number of
specimens. These concerns are hour break in any 14-day period; and times individuals can work the 8
discussed in some detail below. As proposed § 26.199(f) [Collective work consecutive work days allowed by
discussed in Section VI, commenters hour limits], which would have § 26.205(d)(2)(ii). The scheduling of 12-
also raised numerous other smaller required licensees to control the average hour shifts is unaffected by this
issues that led the NRC to modify many work hours of specified duty groups requirement because § 26.205(d)(1)(iii)
final rule provisions. Finally, many (e.g., operations, security). The NRC also effectively limits the scheduling of 12-
comments resulted in minor changes to received substantive comments on the hour shifts to not more than 6
the proposed rule to improve clarity in reporting requirements in Subpart I of consecutive days. The final rule also
the rule’s organization and language, the proposed rule. Specifically, the provides the licensee with sufficient
consistent with Goal 6 of this comments concerned the proposed flexibility to accommodate other
practical considerations, such as an additional rest period and allows the requirement, individual work hour
scheduling training on a Monday- worker to maintain a consistent pattern limits, individual break requirements,
through-Friday basis, and allows a of work and sleep habits, thus reducing and the provisions concerning fatigue
contingency day for 8-hour shift the risk of accidents on the job. assessments and the self-declaration
schedules that include a series of seven However, two days off may interfere process, adequately address the
consecutive 8-hour shifts. with a worker’s sleep cycle, requiring possibility of cumulative fatigue.
The final rule also revises the the individual to readjust to the night The NRC agrees, in part, with certain
minimum duration of the break period shift after a 2-day break. Commenters comments on the proposed 48-hour
from 24 hours, as specified in also asserted that a 1-day break in any break requirement and the collective
§ 26.199(d)(2)(ii) of the proposed rule, to 7-day period is more than adequate work hour limits of the proposed rule,
a minimum of 34 hours. The revision when combined with other rule and has revised the final rule
more clearly reflects the NRC’s intent to provisions to address cumulative accordingly. To address cumulative
require a periodic ‘‘day off’’ in which fatigue. fatigue during periods when a plant is
individuals have the opportunity for The NRC considered public operating, the NRC replaced the
two consecutive sleep periods without comments on the proposed 48-hour proposed rule requirement for a
an intervening work period. The 34- break requirement in conjunction with minimum 48-hour break in
hour break duration provides this public comments on the collective work § 26.199(d)(2)(iii) and the collective
opportunity, supports use of forward hour limits of the proposed rule. The work hour limits in § 26.199(f) with the
rotating and fixed shifts, and allows for collective work hour limits in proposed requirements in § 26.205(d)(3) of the
the possibility that individuals may § 26.199(f) would have required final rule. This section requires that
work 26 hours in a 48-hour period licensees to control the average work each individual subject to the work hour
contiguous to the break. hours of specified groups of personnel requirements has a minimum average
that perform the same job function. In number of days off per week while the
Proposed Requirement for a Minimum
general, this provision would have plant is operating. This provision
48-Hour Break in Any 14-Day Period
required licensees to ensure that the addresses comments on the proposed
and Collective Work Hour Limits
collective work hours of individuals 48-hour break requirement and
Section 26.199(d)(2)(iii) of the within each group did not average more collective work hour limits as follows:
proposed rule would have required a than 48 hours per week, when averaged • The minimum day-off requirements
minimum 48-hour break in any 14-day over a period of up to 13 weeks. The of § 26.205(d)(3) address cumulative
period. This requirement would have objective of the collective work hour fatigue on an individual basis. In
provided periodic breaks to prevent and limits, like the 48-hour break contrast to the proposed collective work
mitigate cumulative fatigue. Although requirement, was to prevent cumulative hour limits, the final rule provides more
this requirement would have also been fatigue. In contrast to the 48-hour break uniform assurance of worker FFD and
applicable when a reactor was requirement, the collective work hour addresses the concern that, although
operating, the NRC considered it limits would typically have been duty groups could have met the
particularly important for the control of applicable only when a reactor was collective work hour requirements,
work hours during outages. During these operating. Thus, the 48-hour break individuals in those groups may have
periods, successive weeks of extended requirement in conjunction with the 24- worked excessive hours.
work hours (i.e., up to 72 hours per hour break requirement of proposed • The minimum day-off requirements
week) are common. However, the NRC § 26.199(d)(2)(i) would have been the of § 26.205(d)(3) establish limits that in
received substantive comments principal mechanism to address most circumstances are tailored to the
regarding this provision. cumulative fatigue during outages, and duration of the shifts that individuals
Several commenters expressed collective work hour limits would have work (e.g., individuals on 8-hour shifts
concern that a mandatory 48-hour break been the principal means of preventing must average at least 1 day off per week;
would limit the ability of licensees to cumulative fatigue while a plant was individuals on 10-hour shifts must
provide adequate coverage for operating. average 2 days off per week). As a
unplanned maintenance (e.g., to quickly Some commenters stated that the consequence, in contrast to the single
restore inoperable equipment). Several collective work hour limits would be an set of break requirements in the
commenters also stated that the break ineffective means for addressing fatigue proposed rule, the final rule provides a
requirements would encourage because it is experienced on an better correlation between the number
supplemental workers to seek jobs in individual basis. That is, the collective of hours an individual works and the
other industries that offer more work hour limits could not ensure that amount of restorative rest required by
overtime. Therefore, commenters were each individual would be protected the rule.
concerned that this unintended from cumulative fatigue. One • The minimum day-off requirements
consequence of the break requirements commenter stated that the collective of § 26.205(d)(3) establish a flexible
would harm the licensees’ ability to work hour controls would allow approach to addressing cumulative
attract and retain qualified workers. licensees to force individuals to work fatigue. This provision requires a
Other commenters stated that, although overtime. Other commenters stated that minimum average number of days off
the recovery concept is scientifically licensees may be able to manipulate the per week, averaged over a shift cycle of
supported, the approach used to prevent collective work hour calculations. Still up to 6 weeks. Accordingly, the rule
cumulative fatigue should consider other commenters asserted that the does not require that individuals meet
existing work schedules and scheduling collective work hour controls were the average each week, but does ensure
practices. Commenters also asserted that unnecessary to mitigate the effects of that individuals receive a minimum
a 48-hour break during a series of night cumulative fatigue and that they would number of days off over the course of
shifts would adversely affect the limit licensee flexibility to increase the shift cycle. As a consequence, the
circadian cycle of those workers who work hours for a job-duty group based NRC has established a requirement that
had adjusted to the night shift. These on operational needs. These accommodates a wide range of
commenters stated that for workers on commenters stated that other rule scheduling practices and short-term
the night shift, having 1 day off provides provisions, such as the work scheduling fluctuations in workload. The
requirement also allows licensees licensees are better able to establish extended to 10 weeks to accommodate
considerable flexibility in schedules that minimize the potential extended outages for activities such as
accommodating individual worker for disrupting the circadian cycle of reactor vessel head and steam generator
preferences concerning the timing and individuals who are on fixed night replacements. In conjunction with these
distribution of days off. shifts. comments, industry stakeholders
• The minimum day-off requirements • The minimum day-off requirements asserted at public meetings held for this
of § 26.205(d)(3) establish limits that are of § 26.205(d)(4) allow licensees rulemaking that cumulative fatigue was
practical and likely to impose less substantial flexibility in scheduling the not a concern during these extended
administrative burden on licensees than required days off within the 15-day outages because individuals often had
would have been required by the outage periods. As a result, licensees are periods when they were not required to
collective work hour limits in the able to implement a range of scheduling work the extended work hours typically
proposed rule.1 By establishing limits options to meet known outage schedule associated with outages. In response to
that require the control of work hours demands and have the flexibility to this comment, the NRC includes a
on an individual basis, licensees need revise schedules as necessary to address provision in § 26.205(d)(6) of the final
not define and track membership in emergent needs. rule which allows licensees to extend
duty groups. In addition, the • The minimum day-off requirements the 60-day exception for individuals by
requirements in the final rule largely of § 26.205(d)(4) allow licensees to use 1 week for each 7-day period the
adopt an approach proposed by NEI as a predictable, repeating schedule. The individual worked not more than 48
an industry-recommended alternative to requirements permit a schedule of four hours during the outage. Thus, the rule
the group work hour controls. Thus, the consecutive 12-hour shifts followed by allows the outage exception to be
NRC expects that licensees will consider 1 day off. This 5-day sequence can extended when directly justified by an
the administrative requirements of this repeat three times in each 15-day period individual’s actual work history. In light
work hour control method to be less creating a schedule that is predictable of the significant work hours allowed by
burdensome. and repeatable, characteristics typically the requirements, as discussed in the
To address cumulative fatigue during desired by workers and schedulers. This preceding paragraph, the NRC considers
periods when a plant is in a unit or schedule limits the number of this approach to be better justified for
planned security system outage, the consecutive work shifts to prevent the management of worker fatigue than
NRC has replaced the proposed rule cumulative fatigue and includes the proposal for a blanket extension of
requirements for a minimum 48-hour sufficient periodic days off to mitigate the outage exclusion to 10 weeks.
break (§ 26.199(d)(2)(iii)) and the fatigue. For individuals performing the Section 26.205(d)(5) of the final rule
collective work hour limits applicable to maintenance duties described in applies to individuals who perform the
security personnel during outages § 26.4(a)(4) the requirement permits a security duties described in § 26.4(a)(5)
(§ 26.199(f)(2)(i)) with the requirements predictable, repeating schedule of 6 and requires a minimum of 4 days off
in § 26.205(d)(4) and (d)(5) of the final consecutive work days followed by 1 in each successive 15-day period of a
rule. Section 26.205(d)(4) requires that day off. unit outage or planned security system
licensees provide individuals who • The minimum day-off requirements outage. This minimum days-off
perform the operations, health physics of § 26.205(d)(4), in conjunction with requirement is comparable to the work
or chemistry, and fire brigade duties the other requirements in § 26.205 hour limits imposed for security
described in § 26.4(a)(1) through (a)(3) [Work hours], allow a maximum personnel by order EA–03–038 and the
of the final rule a minimum of 3 days workweek of 72 hours and an average 60-hour collective work hour average
off in each successive 15-day period of workweek of 67.2 to 72 hours for a that the proposed rule would have
a unit outage. Section 26.205(d)(4) also period of up to 60 days. As a result, the required. The NRC replaced the
requires that licensees provide requirements allow licensees to offer collective work hour limits for security
individuals who perform the substantial amounts of overtime within personnel with the requirements in
maintenance duties described in these limits to attract supplemental § 26.205(d)(5) of the final rule for the
§ 26.4(a)(4) at least 1 day off in any 7- workers for outage activities. The NRC following three reasons:
day period. Section 26.205(d)(5) applies acknowledges that some individuals (1) In addition to other commenters,
to individuals who perform the security may want to work more than 72 hours, security personnel expressed concerns
duties described in § 26.4(a)(5) of the or even more than 84 hours, per week. about the effectiveness of the collective
final rule and requires a minimum of 4 However, the NRC notes that the work work hour controls to fully protect
days off in each successive 15-day hour limits of § 26.205 apply only to against impairment from fatigue for all
period of a unit outage or planned those duties that the agency believes personnel in a group.
security system outage. These final rule have the most direct impact on the (2) Elimination of the 48-hour break
provisions address those comments on protection of public health and safety requirement sets aside a key
the 48-hour break and collective work and common defense and security. As a requirement for preventing an excessive
hour requirements applicable to outage result, the requirements do not prevent number of consecutive work days that
periods as follows: individuals from working more than 72 would have otherwise been allowed
• The minimum day-off requirements hours per week, unless those under the collective work hour limits.
of § 26.205(d)(4) do not mandate that individuals are performing (1) duties on As a result, the NRC concluded that the
licensees schedule 2 consecutive days structures, systems, and components collective work hour limits, absent the
off as would have been required by the (SSCs) that a risk-informed evaluation 48-hour break requirement, would not
48-hour break requirement. As a result, process has shown to be significant to provide reasonable assurance that
public health and safety, (2) critical nuclear power plant security personnel
1 Although the NRC believes that the minimum emergency or fire response duties, or (3) would be protected from cumulative
day off requirements of § 26.205(d)(3) will impose duties as members of the site security fatigue from excessive work hours.
less administrative burden on licensees than the force that are necessary for the (3) Revision of the outage
collective work hour limits of the proposed rule, the
NRC has conservatively retained the administrative execution of the site security plan. requirements to a minimum of 4 days
burden estimate of the collective work hour limits • Several commenters recommended off in a 15-day period avoids the
for § 26.205(d)(3) of the final rule. that the 8-week exclusion period be potential confusion and additional
burden of two different approaches and outages are periods when individuals allow licensed operators 2 and other
accounting systems (i.e., minimum day may perceive increased schedule plant personnel to work regularly
off requirements and collective work pressure and is aware that at least one occurring periods of multiple
hour limits) for the control of personnel site offered bonuses for perfect consecutive 72-hour work weeks with
work hours at a site. attendance during outages. Self- minimum break periods. The NRC notes
The NRC believes that the minimum declaration would likely cause that a federal appeals court vacated the
day-off requirements of § 26.205(d)(3) individuals to forfeit a portion of that 2005 provision of the FMCSA
through (d)(6) of the final rule address overtime and possibly a bonus. As a requirements that would have permitted
the range of comments on the rule, result, despite the best efforts of a 34-hour break to restart the weekly
several of which expressed opposing licensees to emphasize safety and limits. Among the reasons cited by the
views regarding the need to relax the worker FFD, the NRC anticipates that court was that FMCSA’s operator-fatigue
requirements or to make them more self-declaration and training in methods model did not ‘‘account for cumulative
restrictive. to obtain adequate rest may not be fatigue due to the increased weekly
The NRC does not agree with the implemented as effectively or driving and working hours permitted by
comments that asserted that the consistently during outage periods as the 34-hour restart provision.’’ FMCSA
proposed requirements to address during periods of routine plant at 206.
cumulative fatigue were unnecessary operation, and therefore, they are not a (3) Contrary to the NEI assertion that
and that a 1-day break in any 7-day substitute for work hour controls that a 34-hour break is ‘‘more than adequate’’
period is more than adequate when effectively prevent cumulative fatigue. the expert panel commissioned by the
combined with the other rule provisions In asserting that a 1-day break is more FMCSA described the 34-hour break as
(e.g., self-declaration and training) to than adequate to address cumulative ‘‘absolutely minimal.’’ Further, the
address cumulative fatigue. The NRC fatigue, industry stakeholders have cited expert panel noted that a fundamental
has concluded that, given a broad range the basis for the Federal Motor Carrier assumption for the adequacy of the 34-
of considerations, a 1-day break in any Safety Administration’s (FMCSA) hour break is that it will provide two
7-day period is an appropriate minimum 34-hour break provision for consecutive nights of uninterrupted
requirement for individuals performing commercial motor vehicle (CMV) sleep between midnight and 6 a.m.
the maintenance duties described in operators. The NRC reviewed the Given common outage scheduling
§ 26.4(a)(4) for a limited time period FMCSA regulations (49 CFR Part 395), practices, the NRC believes that no
during unit outages. The NRC has also associated statements of considerations workers on night shifts and few workers
concluded that additional days off are (65 FR 25540 (May 2, 2000); 70 FR on day shifts would meet this
necessary for individuals performing 49978 (Aug 25, 2005), the findings of an assumption.
other duties described in § 26.4(a) to expert panel commissioned by the In addition, the NRC does not agree
ensure that those individuals are not FMCSA (Belenky et al., 1998), a petition with industry stakeholder comments
impaired by the cumulative fatigue that for review of the final rule (Brief of that an opportunity for 8 hours of sleep
would result if they routinely worked Public Citizen, et al., Owner-Operator between shifts prevents cumulative
the maximum work hours that would Independent Drivers Ass’n, Inc. v. fatigue. This argument is contrary to
otherwise be allowed by the Federal Motor Carrier Safety Admin., common experience in that it implies
requirements in § 26.205(d)(1) and 494 F.3d 188 (D.C. Cir. July 24, 2007) workers should be able to work 12 hours
(d)(2). Accordingly, the final rule (No. 06–1035) (‘‘FMCSA’’)), and the per day, without degradation in their
requires more than a 1-day break in any decision of the court with regard to the performance, for an unlimited number
7-day period for individuals performing petition. FMCSA. The NRC concluded of days. To the contrary, the National
the duties described in § 26.4(a)(1) that, for a limited range of conditions, Institute for Occupational Safety and
through (a)(3) and (a)(5) during unit the studies cited by FMCSA support a Health (NIOSH) found that ‘‘up to five
outages. For periods when the plant is 34-hour break as an appropriate consecutive 12/14-hour shifts * * *
operating, the final rule requires that all minimum rest period. However, the creates the potential for excessive
individuals working 10 or 12-hour shifts NRC staff does not agree that the basis fatigue, even when 8 hours of sleep per
receive on average more than one day cited by the FMCSA supports a day are obtained’’ (2000 NIOSH 3).
off per week. The rule requires only one requirement that would routinely allow Similarly, the NRC notes that it has
day off per week on average for 72 hours of work for all nuclear power received increased reports of excessive
individuals working 8-hour shifts plant workers performing functions fatigue following extended periods of
because individuals on 8-hour shifts important to the protection of public 12-hour shifts, such as in the months
could not be practically scheduled at health and safety before such a break is following the terrorist attacks of
the maximum work hours allowed by required. The NRC notes that: September 11, 2001, and during the
the requirements in § 26.205(d)(1) and (1) The FMCSA regulations for CMV
extended head replacement outage at
(d)(2). operators include requirements that
The NRC acknowledges the important Davis Besse (NRC Inspection Report
prohibit driving after 60 hours of duty
role of self-declaration and training in 05000346/2004003, dated March 31,
in 7 days. By contrast the NEI proposal
fatigue management, as noted by some would allow 72 hours of work in a 7- 2004, ADAMS Accession No.
commenters, but also recognizes the day period, excluding turnover. ML040910335). The NRC found that
inherent limitations of these provisions (2) The statement of considerations workers typically did not average more
to effectively address fatigue, for the FMCSA regulation establishes than 60 work hours per week during
particularly during periods of outage that long work weeks with minimum these periods. As a result, even if a 34-
schedule conditions. As noted by break periods are the exception for CMV hour break was adequate to mitigate
Michael T. Coyle, NEI, comment letter operators. The FMCSA sets forth this cumulative fatigue from 72 or more
hours of work, the 1 day off in a 7-day
#49, and supported by several other information as a premise for the

commenters, ‘‘for many supplemental adequacy of the 34-hour break. By 2 At multi-unit sites with common control rooms,
workers the availability of overtime is a contrast, application of the industry all licensed operators would be subject to the limits
key factor in where they decide to proposed requirement to the control of applicable to unit outages, including operators
work.’’ The NRC also recognizes that work hours during unit outages would responsible for operating units.
period that the industry’s proposed assessments conducted during the part of changes to other provisions of
would not ensure that breaks would be calendar year. the rule.
provided on a sufficient frequency to Several commenters from industry Section 26.203(e) [Reporting] of the
prevent weekly occurrences of asserted that the reporting requirements final rule presents the reporting
cumulative fatigue. A NIOSH review in the proposed § 26.197(e) should be requirements associated with licensee
(Caruso, et al., 2004) of 52 recent reports deleted from the rule because they implementation of Subpart I. This
examining the association between long would not provide new or unique section does not retain the requirements
work hours and illness, injuries, health information to the NRC, would be in proposed § 26.197(e)(2) for the
behaviors, and performance, reported ‘‘a unnecessary to protect public health reporting of information pertaining to
pattern of deteriorating performance on and safety, would be unnecessary to the control of collective work hours
psychophysiological tests as well as facilitate NRC oversight of the revised because the final rule does not include
injuries while working long hours was rule, and would be unduly burdensome. collective work hour controls. In
observed across study findings, One commenter further stated that the addition, the agency revised the
particularly when 12-hour shifts NRC’s proposed FFD rule and requirements in proposed § 26.197(e)(1)
combined with more than 40 hours of supporting materials did not and (e)(2) in response to comments that
work a week.’’ demonstrate that the industry would fail the required information would not
Considering the limitations of the to comply with the requirements of the provide a meaningful indication of
technical basis cited by the industry and revised rule without the imposition of licensee performance in managing work
its applicability to outage scheduling these reporting requirements. The hours because a number of valid
practices and operating experience and commenter asserted that the existing conditions may warrant waivers of work
technical literature indicating that 1 day regulatory process is adequate to ensure hour controls. Through its review of
off in 7 days is not adequate for recovery compliance with the rule. Some authorized waivers from the work hour
when individuals are working in excess commenters believed that the reporting limits in plant technical specifications,
of 60 hours per week, the NRC requirement would create a significant the NRC has found that waivers are
concluded that the industry proposal duplication in licensee efforts, noting most frequently associated with outage
would not effectively prevent that proposed § 26.199(j) required activities. Accordingly, the NRC has
cumulative fatigue for individuals periodic reviews by licensees to assess revised the final rule to require
performing the operations, health the effectiveness of the work hour licensees to report whether a waiver of
physics, chemistry, fire brigade and controls, and that these reviews are the work hour requirements in § 26.205
security duties described in § 26.4(a)(1) documented and trended under the was associated with an outage activity.
through (a)(3) and (a)(5) for multiple licensee’s corrective action program As a result of these revisions, the NRC
consecutive weeks of extended work which is periodically inspected by the will be better able to interpret a
hours. The NRC considers the minimum NRC. licensee’s changes in waiver use over
day off requirements of the final rule Some commenters stated that the time and understand why certain
provide adequate flexibility to reports the rule would require would annual reports for a given licensee may
accommodate emergent work and a not be a meaningful indicator of indicate a heightened level of waiver
range of scheduling practices while licensee performance in managing work use relative to the licensee’s previous
supporting reasonable assurance of hours because a number of valid reports. The NRC recognizes that
worker FFD. By limiting the use of the conditions may warrant waivers of work outages are not the only cause of
maximum work hours and minimum hour controls. Two commenters waivers; however, the agency expects
break guidelines to a ‘‘temporary basis,’’ suggested that the rule require licensees that most other causes of waiver use
the requirements of § 26.205(d)(3) to report the number of workers covered will be for substantially shorter periods
through (d)(6) are consistent with the under § 26.199(a) [Individuals subject to of time or involve smaller groups of
NRC’s long-standing ‘‘Policy on Factors work hour controls] of the proposed rule workers and that these other conditions
Causing Fatigue of Operating Personnel to provide appropriate context for the would not have a substantive effect on
at Nuclear Reactors.’’ annual reporting of waivers. overall waiver use. For unique causes
Several commenters from industry that may have more substantive effects
Proposed Reporting Requirements also stated that the NRC did not meet its (e.g., licensee response to hurricanes),
Many comments addressed the obligation under the Paperwork the NRC is likely to be aware of or able
reporting requirements for the fatigue Reduction Act with respect to the to identify these conditions if they were
provisions. Section 26.197(e) of the information collection requirements to significantly affect waiver use. The
proposed rule would have required proposed in § 26.197(e). They argued NRC notes that the frequency of waiver
licensees to submit, as part of the that the NRC failed to adequately justify use (i.e., how often individuals exceed
annual FFD program report required the need for these provisions to achieve the work hour limits while performing
under § 26.717 [Fitness-for-duty the objectives of the proposed FFD rule functions important to safety and
program performance data] of the final and failed to objectively support its security) indicates the potential for
rule, information concerning the estimate of the burden placed on worker fatigue to affect the performance
licensee’s implementation of the work affected licensees. The commenters of these functions, regardless of whether
hour controls and management of asserted that the annual report would a waiver is the result of an activity
worker fatigue. The proposed rule require at least 30 clerical hours to associated with an outage or a cause that
would have required the annual report develop and 20 management hours to is beyond the licensee’s control.
to include a summary of the waivers the review. In addition to requiring an indication
licensee approved during the calendar In response to public comments on of whether a waiver was associated with
year, information pertaining to instances the reporting requirements, the NRC an outage activity, the NRC revised the
of job duty groups exceeding a revised certain requirements for the annual report requirement to require a
collective work hour average of 48 hours inclusion of fatigue management frequency distribution of waivers for
in any averaging period during the information in the annual FFD program each of the five duty groups described
calendar year, and information report. The NRC also made conforming in § 26.4(a) of the final rule. As a result,
pertaining to instances of fatigue changes to the reporting requirements as the annual report would include, for
example, a table that shows the number As a result, information concerning maintain consistency among inspectors
of operators who received just one licensee use of waivers indicates (1) the conducting the oversight process. In
waiver during the year, the number of number of hours worked on risk- addition, the annual reports can
operators who received two waivers significant activities by individuals who enhance the efficiency of the NRC
during the year, and so on. The NRC are at increased potential for inspection process by providing
incorporated this requirement in the impairment, and (2) how often a information necessary to allow the
final rule in response to comments that licensee must mitigate or prevent a agency to focus inspection resources on
the rule should also require licensees to condition adverse to safety while duty groups (e.g., security or
report the number of workers covered relying on individuals who are at maintenance) that may warrant review.
under § 26.199(a) of the proposed rule to increased potential for impairment. The The reports will enable the NRC to be
provide an appropriate context for the NRC considers this unique information, better focused in preparing for the
annual reporting of waivers. The NRC not otherwise reported, to be relevant to inspection, reduce the burden of onsite
understood that the intent of this the agency’s mission. inspection hours, and potentially reduce
comment was to provide a basis for The NRC similarly considered the the total number of hours required for
evaluating the number of waivers from need to retain reporting requirements a baseline inspection. Further, the
the work hour controls relative to the regarding fatigue assessments and any annual reporting will also help to
number of individuals subject to those management actions in response to the achieve a more complete and
controls. The NRC chose not to require fatigue assessments. The NRC continuous assessment of licensee
licensees to report the number of concluded that the fatigue assessment performance because the NRC intends to
individuals covered under § 26.4(a) of information that would have been conduct the baseline inspection of FFD
the final rule because that number will reported under the requirements of the programs only once every 2 years.
vary throughout the course of the proposed rule is more the purview of a • Evaluation of rule implementation
reporting period, particularly when the licensee’s corrective action program, for lessons learned—Although the NRC
reporting period includes a unit outage. and would have been more detailed and stakeholders have made extensive
In addition, the NRC believes that the than the program performance data for efforts to ensure clear and enforceable
required distribution of waivers more drug and alcohol testing required under requirements that are effective and
effectively provides context to the § 26.717(c) of the final rule. practical for the management of worker
waiver use information by indicating Accordingly, the final rule requires fatigue, the rule introduces the potential
whether the waivers were concentrated licensees to report a summary of for unintended consequences and
among individuals performing a certain corrective actions, if any, resulting from lessons learned. In addition, changes in
duty and whether the waiver use in a the licensee’s analysis of waiver and the size and composition of the nuclear
duty group was associated with fatigue assessment data. As a industry may have unforeseen
relatively few individuals or distributed consequence, the required reports will implications for site staffing and fatigue
among many individuals. provide information that will focus management. The NRC expects that the
more on licensee performance in site-specific and normative information
The NRC does not agree with managing worker fatigue and will obtained through the annual reports can
comments that the requirements for enable NRC to review licensee reporting provide important insights regarding
including fatigue management of waivers in the context of associated opportunities to amend the rule to
information should be deleted from the corrective actions. improve its effectiveness or reduce
rule because they would not provide The NRC expects that the information unnecessary burden. The NRC notes
new or unique information to the NRC, provided by licensees in response to the that information provided by the FFD
would be unnecessary to protect public annual reporting requirements in program performance reports was the
health and safety, would be unnecessary Subpart I will facilitate NRC oversight of basis for reducing the random testing
to facilitate NRC oversight of the revised the implementation of the requirements rate for drugs and alcohol required in a
rule, and would be unduly burdensome. through the following means: previous amendment to Part 26.
In choosing to retain reporting • Consistency, efficiency, and • Consistent interpretation of waiver
requirements for waiver use, the NRC continuity of NRC oversight— criterion—The final rule provides
considered several aspects of the work Information provided through the licensees the discretion to use waivers
hour requirements in the final rule. annual FFD program performance to exceed the work hour limits, thereby
First, the NRC established the work reports concerning fatigue management allowing levels of work hours that could
hour limits in the final rule at levels will enable the NRC to achieve a higher adversely affect worker FFD. The
such that the potential for fatigue is level of consistency and efficiency in principal basis for allowing waivers is to
substantive for individuals working in the oversight of the implementation of reduce the additional staffing burden
excess of those limits. Second, the rule the requirements in Subpart I and in the that licensees would otherwise incur if
permits licensees to authorize waivers enforcement of those requirements. waivers were not available to address
of the limits only for circumstances in Without the reporting requirements, the exigent circumstances. The annual
which the additional work hours are NRC’s inspection of licensee FFD reporting of waiver use in conjunction
necessary to prevent or mitigate a programs would likely be limited to with the corrective action summaries
condition adverse to safety or security. individual inspectors evaluating will enable the NRC to ensure that
Finally, the rule only requires a waiver licensee fatigue management for a licensees use this discretion in a manner
if the individual is operating or sample of workers at a site for a limited consistent with the objectives of the rule
maintaining an SSC that a risk-informed time period. These assessments would and not as a means to compensate for
evaluation process has shown to be necessarily be conducted without the a lack of adequate staffing. Further,
important to the protection of public benefit of broader contextual although the use of waivers is limited to
health and safety or if the individual is information from the site or the industry conditions when the work hours are
performing specified functions that are normative information that would be ‘‘necessary to prevent or mitigate a
essential to an effective response to a available through the annual reports. In condition adverse to safety or security,’’
fire, plant emergency, or contrast, the annual reports will help the NRC recognizes the potential for
implementation of the site security plan. ensure a common perspective and licensees to develop different
interpretations regarding this criterion. commented at public meetings that effective implementation of the
Some industry commenters on the relevant information regarding worker requirements in Subpart I.
proposed rule took exception to the fatigue is withheld to either protect
Public Comments on FFD Programs for
NRC’s characterization of high levels of alleger identity or, in the case of
Construction and Manufacturing
waiver use at some sites as abuse. These security personnel, plant security. In
commenters suggested that differences addition, several public media articles In response to substantive public
in licensee waiver practices could be have been published during the past 2 comments and industry efforts to
attributed to the policy being subject to years reporting instances of guards develop guidance on the subject, the
a number of interpretations during the sleeping and guards fearing NRC has added Subpart K to the final
many years that it has been in effect. repercussions for refusing forced and rule to clarify § 26.3(e) of the proposed
Regardless of the cause of the excessive overtime. Information rule, which contained requirements for
differences in licensee use of work hour submitted by licensees in the annual combined license holders, combined
control waivers, the NRC considers it reports will be publicly available and license applicants, construction permit
prudent to address, through rulemaking, will reassure public stakeholders that holders, construction permit applicants,
the lessons learned from past the NRC is appropriately cognizant of as well as manufacturing license holders
implementation of the policy and licensee actions regarding fatigue under Part 52.
provide a level of oversight through the management and that the NRC’s Subpart K’s FFD program is intended
annual reporting requirement that will oversight of these activities is to provide reasonable assurance that
ensure consistent implementation of the transparent to all stakeholders. individuals involved in the construction
waiver criteria in the future. of a nuclear power plant who perform
• The burden is limited and
In addition to the reasons cited in the specified duties at the site are fit for
justified—Section 26.203(e) of the final duty, trustworthy, and reliable,
preceding paragraphs explaining the rule requires licensees to report
need for reporting requirements to commensurate with the potential risks
information concerning fatigue to public health and safety and the
ensure the effective and efficient management as part of the annual FFD
oversight of the implementation of the common defense and security that their
program report. As a result, the burden activities and access to certain
rule, the NRC considers the reporting associated with this reporting
requirements to be justified and information would pose.
requirement is an incremental change to Proposed § 26.3(e) would have
beneficial for the following additional the reporting requirement for drug and
reasons: retained and updated the requirements
alcohol testing. In addition, the fatigue
• Consistency with other Part 26 of § 26.2(c) of the former rule. However,
management information required by proposed § 26.3(e) would not have
requirements and performance
§ 26.203(e) of the final rule is largely revised the basic approach taken in
objective—The final rule retains the
requirement of the former rule that information that licensees will have former § 26.2(c). The former rule
licensees must report the results of drug already generated to demonstrate specified the regulations in Part 26 that
and alcohol testing and the performance compliance with other provisions of applied to licensees holding permits to
objective for reasonable assurance that Subpart I. As a result, the burden construct a nuclear power plant. Section
individuals are not impaired from any associated with the report will be 26.2(c) of the former rule required each
cause (§§ 26.719 [Reporting largely associated with compiling the construction permit holder with a plant
requirements] and 26.23(b) of the final information in an appropriate form and under active construction to comply
rule). In addition, several studies reviewing that compilation. The NRC with §§ 26.10 [General performance
discussed in detail in Section IV.D of has reviewed the public comments objectives], 26.20 [Written policy and
this document have demonstrated that suggesting that the agency procedures], 26.23 [Contractors and
worker fatigue can produce levels of underestimated the number of clerical vendors], 26.70 [Inspections], and 26.73
impairment that are comparable to and management hours associated with [Reporting requirements] of the former
blood alcohol concentrations above the this requirement and has taken these rule. This provision also explained that
levels permitted by this rule. Further, comments into consideration in permit holders with plants under active
given the frequency of worker concerns estimating the burden of the reporting construction were required to
regarding fatigue and the work requirements in § 26.203(e) of the final implement a chemical testing program,
scheduling practices that are common rule. Nevertheless, the NRC considers including random tests, and make
during outages, the incidence of the burden associated with the annual provisions for employee assistance
impairment from fatigue is likely to be reporting requirements to be justified for programs (EAPs), imposition of
greater than the very low incidence of the reasons described in this and the sanctions, appeals procedures, the
drug and alcohol use that is detected preceding paragraphs. protection of information, and
through testing. Therefore, the NRC The NRC also considered comments recordkeeping.
considers the reporting of information that the reporting requirement ignores Proposed § 26.3(e) would have
pertaining to licensee management of significant duplication in licensee explicitly reflected the NRC’s combined
worker fatigue to be consistent with the efforts. The NRC agrees that § 26.205(e) licensing procedure for nuclear power
requirements for reporting information of the final rule requires licensees to plants under 10 CFR Part 52, ‘‘Early Site
pertaining to drug and alcohol testing, periodically review and assess the Permits; Standard Design Certifications;
the performance objective of this effectiveness of the work hour controls and Combined Licenses for Nuclear
rulemaking for licensees to implement a and that the licensee’s corrective action Power Plants.’’ It would have specified
comprehensive FFD program, and the program, which is routinely inspected the entities that are regulated by the
NRC’s belief that the management of by the NRC, will document and trend NRC (specifically, combined license
worker fatigue is no less important to these reviews. However, as noted holders before the Commission has
worker FFD than the effective detection previously, the NRC considers the made the finding under § 52.103
and deterrence of drug and alcohol use. annual reports to be a limited burden [Operation under a combined license],
• Public confidence—Public interest that will enable the NRC to provide combined license applicants who have
groups such as the UCS and the Project more effective and consistent oversight received authorization to construct
on Government Oversight have and achieve other objectives for the under § 50.10(e)(3), construction permit
holders under Part 50, ‘‘Domestic FFD programs for construction in other as a specimen collection and alcohol
Licensing of Production and Utilization industries, developed a new Subpart K, testing site, a licensee testing facility, an
Facilities,’’ construction permit ‘‘FFD Programs for Construction,’’ and FFD training program, and expert staff
applicants who have received revised other sections of the rule to (e.g., a substance abuse expert, MRO, or
authorization to construct under clarify the scope of requirements for EAP representative). However, other
§ 50.10(e)(3), and holders of construction activities. new reactors may be constructed at
manufacturing licenses under Part 52) The results of the NRC staff’s locations that are distant from the FFD
who would be responsible for meeting benchmarking activities indicated that, program resources of an operating plant.
certain Part 26 requirements. (The Part as a result of the higher incidence of Therefore, the NRC concluded that
52 final rule amended § 26.2(c) of the substance problems among construction applying some of the requirements in
former rule to include in § 26.2(c) workers than other occupational groups, the proposed rule would be overly
combined license holders before the pre-employment, for-cause, and post- burdensome, such as requiring random
date that the Commission makes the accident drug and alcohol testing are testing of all construction workers, the
finding under § 52.103(g), holders of increasingly common at large, requirement for all nuclear power plant
manufacturing licenses, and persons commercial construction projects and construction workers to have access to
authorized to conduct the activities some labor union coalitions have an EAP, and the proposed requirement
under § 50.10(e)(3).) implemented drug and alcohol testing for a determination of fitness process
The proposed rule would have and substance abuse treatment-referral performed by a substance abuse expert
replaced the cross-references to other programs for their members. In addition, under § 26.189 of the final rule.
sections of the former rule with updated the staff also identified several private-
To streamline administration of the
cross-references to the related sections sector entities in the petrochemical and
FFD program for construction, add
in the proposed rule (i.e., §§ 26.23 steel manufacturing industries that
flexibility, and implement an approach
[Performance objectives], 26.41 [Audits require drug and alcohol testing,
that is commensurate with the potential
and corrective action], and 26.189 including random testing, for
risks resulting from new plant
[Determination of fitness]). The construction workers on large projects,
construction, the final rule requires two
proposed rule would also have as well as employment history
different levels of FFD requirements for
stipulated that the specified entities evaluations and other background
workers in different job roles. Because
should implement a drug and alcohol checks. Where safety and/or security
of their important oversight
testing program, including random during construction are critical, large
testing, and make provisions for EAPs, construction projects initiated by some responsibilities, the first category of
imposition of sanctions, procedures for Federal agencies (e.g., the Department of workers, specified in § 26.4(e), includes
the objective and impartial review of Energy) require drug and alcohol any individual whose duties, once
authorization decisions, protection of testing, including random testing, construction activities begin, require
information, and recordkeeping. extensive background checks, and him or her to perform the following
However, the proposed rule did not continuous behavioral observation for activities at the location where the
specify in detail how the FFD programs the most sensitive construction tasks. nuclear power plant will be constructed
of the entities listed in proposed The NRC concluded that (1) and operated: serve as security
§ 26.3(e) were to address these topics or implementing FFD requirements for personnel required by the NRC; perform
the categories of workers who would be new nuclear power plant construction quality assurance, quality control, or
subject to the programs. activities is consistent with the practices quality verification activities related to
Some comments received during the of other industries, and (2) taking a safety- and security-related construction
public comment period stated that the graded approach to FFD requirements, activities; based on a designation under
proposed rule did not clearly describe by imposing requirements that are § 26.406 by a licensee or other entity,
the type of FFD programs the NRC commensurate with the potential risks monitor the fitness of the individuals
expected under proposed § 26.3(e). to public health and safety and the specified in § 26.4(f); witness or
Commenters stated that because the common defense and security that the determine inspections, tests, and
proposed rule required FFD programs results of construction activities may analyses certification required under
for construction to comply with a few pose when a plant begins operations, is Part 52; supervise or manage the
specific sections of the rule, it would consistent with the approach construction of safety- or security-
have imposed virtually all of the rule’s implemented by other government related SSCs; or direct or implement the
requirements on FFD programs for agencies when constructing facilities licensee’s or other entity’s access
construction, because it would be that have the potential to affect public authorization program. These
difficult to ensure compliance with the health and safety or the common individuals must be subject to a full
referenced sections of the rule without defense and security. FFD program that meets the same
applying the entire rule. Other The NRC also determined that some requirements as FFD programs for
comments received from industry of the requirements in proposed operating plants (including random
representatives during the public § 26.3(e) would be difficult to drug and alcohol testing at the 50
comment period indicated that the NRC implement. For example, much of the percent annual rate, behavioral
should not require FFD programs for nuclear power plant construction observation training, and a suitable
construction that are more rigorous than workforce will likely be transient and inquiry/employment history check but
industrial safety programs implemented rapidly changing. As a result, it may be excluding the requirements of Subpart I)
during construction of other large, challenging to conduct random drug when they are performing duties at the
commercial facilities because and alcohol testing in a manner that location where the nuclear power plant
construction activities do not pose risks would meet all of the random testing is being constructed and will operate.
to public health and safety or the requirements Part 26 includes for However, individuals who serve as
common defense and security until operating plants. In addition, some new security personnel required by the NRC
nuclear fuel arrives on site. In response reactors will be constructed near an must meet the requirements applicable
to these comments, the NRC staff operating plant that has readily to security personnel in § 26.4(a)(5) at
gathered additional information about accessible FFD program resources, such the time the licensee or other entity
receives special nuclear material in the alcohol testing. Subpart K requires an meeting to obtain stakeholder feedback.
form of fuel assemblies. FFD program for construction to include The concepts described included a
A new definition of ‘‘supervises or sanctions for FFD policy violations, a requirement for FFD policies and
manages’’ in § 26.5 explains that these system of files and procedures to protect procedures on a limited set of topics;
terms mean the exercise of control over personal information, and procedures pre-access drug and alcohol testing, for-
work activity by an individual who is for reviewing determinations that an cause drug and alcohol testing, and
not directly involved in the execution of individual has violated the FFD policy. post-event testing for accidents;
the work activity, but who either makes The entity who elects to implement a requirements for protection of
technical decisions for that activity program under Subpart K must conduct information; requirements for collecting
without subsequent technical review, or periodic audits, maintain records, specimens and conducting alcohol tests;
is ultimately responsible for the correct provide reports to the NRC, and develop the option to test specimens at a
performance of that work activity. The and apply procedures for suitability and licensee testing facility; initial and
reference to security personnel is fitness evaluations to determine confirmatory testing of urine specimens
modified by the addition of the words whether to assign individuals to for drugs and validity at an HHS-
‘‘required by the NRC’’ to clarify that the constructing safety- and security-related certified laboratory; a review of drug test
FFD requirements are meant to apply to SSCs. The program description will be results by an MRO; and annual reports
security personnel who perform duties evaluated as a part of the application for of FFD program performance. The
specified by NRC regulations and the license, permit, or limited work notice listed fatigue management
orders, while other security personnel, authorization and the NRC’s finding on requirements, random drug and alcohol
if any, are not covered by the the application will include a finding on testing, the requirement for an EAP, and
requirements. the FFD program description. Before the determination of fitness process
By contrast to the requirements for work begins on the foundations, described in the proposed Part 26 rule
those individuals listed under § 26.4(e), including placement of concrete, for the as concepts the NRC was not currently
§ 26.4(f) provides that the FFD program safety- or security-related SSCs under pursuing for FFD programs for
in Subpart K applies only to individuals the license, permit, or limited work construction. These concepts, along
who are constructing or directing the authorization, the entity will be with draft guidance for construction
construction of safety- or security- required to implement the FFD program programs being prepared by nuclear
related SSCs. Section 26.5 explains that that it has described in its application. industry representatives, were discussed
‘‘construction or construction activities’’ To detect and deter substance abuse at the public meeting held on March 29,
means the tasks involved in building a by individuals who are constructing 2006.
nuclear power plant that are performed safety- and security-related SSCs,
at the location where the nuclear power Subpart K of the final rule permits a On October 24, 2006, the NRC
plant will be constructed and operated, licensee or other entity listed in published the entire draft final rule text
and that these tasks include fabricating, § 26.3(c) of the final rule to subject these of 10 CFR Part 26 on the NRC’s
erecting, integrating, and testing safety- individuals either to random testing for rulemaking Web site and, on November
and security-related SSCs and the drugs and alcohol or a fitness 7, 2006, held a second public meeting
installation of their foundations, monitoring program. Subpart K also with stakeholders to present the
including the placement of concrete. At permits FFD programs for construction technical basis for Subpart K and to
a minimum, these individuals must be to— describe the fitness monitoring option
subject to an FFD program that meets (1) Collect specimens other than urine included in Subpart K as an alternative
the requirements of Subpart K, which for drug testing and/or rely on collection to random drug and alcohol testing of
emphasizes performance objectives and sites at local hospitals or clinics that construction workers. The NRC staff
does not incorporate all of the conduct testing under U.S. DOT described four primary reasons for
requirements of Part 26, unless the procedures, rather than those specified imposing regulatory requirements for
licensee or other entity chooses to in Subpart E, ‘‘Collecting Specimens for FFD programs during construction: (1)
subject them to an FFD program that Testing,’’ of Part 26; The quality of work could be adversely
meets the Part 26 requirements for (2) Rely on healthcare professionals affected by construction workers who
operating plants, except the fatigue other than a substance abuse expert to are impaired by substance abuse where
management requirements in Subpart I evaluate an individual’s fitness; studies indicate that members of this
of the final rule. The rule adds new (3) Designate the persons who will group have the highest rates of
definitions of ‘‘safety-related SSCs’’ and perform fitness monitoring, if the entity substance abuse problems among
‘‘security-related SSCs’’ (described elects this option, and adjust the occupational groups in the U.S. (e.g.,
further in Section VI.A of this SOC) that number of fitness monitors performing SAMHSA’s NHSDA covering the years
clarify the intended coverage of monitoring and the frequency of 2000–2001 and SAMHSA’s National
§ 26.4(f). monitoring to accommodate the stage of Survey on Drug Use and Health
If a licensee or other entity specified construction and local conditions; and covering the years 2002–2004), (2)
in § 26.3(c) of the final rule chooses to (4) Establish the random testing rate individuals who have become addicted
implement an FFD program for and limit the selection of individuals for to illegal drugs are susceptible to
construction under Subpart K, the entity testing to only those who are present coercion and will interact with others
must submit to the NRC a description of and constructing safety- or security- involved in the drug trade, (3) past
the FFD program and its related SSCs on a given day, if the entity experience has demonstrated that errors
implementation as part of the license, elects this option. during construction can adversely affect
permit, or limited work authorization In the course of its analysis and subsequent plant operations (NUREG/
application. The description must development of Subpart K of the final CR–6819, Vols. 1–4, ‘‘Common-Cause
include a written FFD policy that will rule, the NRC published a Federal Failure Event Insights,’’ (May 2003) and
be given to all individuals covered by Register notice (71 FR 13782; March 17, NUREG–1837, ‘‘Regulatory Effectiveness
the program and FFD procedures. The 2006) that described the NRC’s Assessment of Generic Issue 43 and
program must include pre-assignment, alternative concepts for FFD programs Generic Letter 88–14,’’ (October, 2005)),
for-cause, and post-accident drug and during construction and announced a and (4) quality assurance by design uses
a sampling process. The staff stated that, Stakeholder responses to the staff’s (2) Relying on voluntary FFD
despite having a high degree of presentation varied. Industry programs that include only pre-
confidence in the effectiveness of stakeholders asserted that Part 26 employment, for-cause, and post-
quality assurance/quality control requirements during nuclear power accident testing would not provide the
programs (required under 10 CFR Part plant construction are not warranted on-going detection and deterrence of
50) and the inspections, tests, analyses, until shortly before fuel arrives on site. substance abuse that is achieved by
and acceptance criteria (ITAAC) Some industry commenters indicated either random testing or a fitness
programs (required under 10 CFR Part that, because there are no immediate monitoring program;
52) to detect construction errors, it is radiological risks to public health and (3) The extensive programs required
prudent to require an FFD program safety or the common defense and for operating plants are not warranted
during construction to provide security during the construction of new for all nuclear power plant construction
reasonable assurance that impaired plants, the NRC should not require FFD activities, but consistent
construction workers do not introduce programs for construction that are more implementation of FFD programs that
faults in safety- or security-related SSCs rigorous than the industrial safety provide on-going detection and
that may cause the SSCs to fail when the programs implemented during deterrence of substance abuse is
plant is operational. In addition, the construction of other large, commercial warranted; and
staff expressed concern that some facilities. Industry stakeholders also (4) Public confidence in new plant
construction personnel who have asserted that NRC requirements for FFD construction will be enhanced by a
substance abuse problems will have programs during construction are program to provide reasonable
access to sensitive information that unnecessary because the NRC-mandated assurance that individuals who
could be useful to an adversary, as well quality assurance processes will detect construct safety- and security-related
as physical access to safety- and any errors in construction and are SSCs are fit for duty.
security-related SSCs that may provide adequate to protect public health and The NRC believes that the
opportunities for malicious acts. safety and the common defense and requirements for FFD programs for
The staff acknowledged, in part, that security, and the industry will construction in Subpart K of the final
the full defense-in-depth approach of voluntarily implement FFD programs rule (1) provide reasonable assurance
the FFD program for operating plants is during construction for industrial safety that individuals who are responsible for
not appropriate for all construction and business reasons. Industry constructing and assuring the quality of
workers because many construction stakeholders also commented that the safety- and security-related SSCs are fit
activities do not have the potential to fitness monitoring program, which is for duty, trustworthy, and reliable,
impact subsequent plant operations, permitted under Subpart K in lieu of commensurate with the potential risk to
and, before fuel arrives on site, do not random drug and alcohol testing of public health and safety and the
impose immediate radiological risks. workers who are constructing safety- common defense and security, (2)
The staff stated that, therefore, the rule’s and security-related SSCs, is an permit licensees and other entities the
requirements for construction require a unfamiliar concept and asked several flexibility to implement programs that
full FFD program for only a limited implementation questions. The staff are appropriate for local circumstances
number of personnel who have critical indicated that it will work with and the challenges created by a large
oversight responsibilities for verifying stakeholders to develop a guidance and transient workforce, and (3) ensure
that safety- and security-related SSCs document that would provide examples that the privacy and other rights
are constructed properly. For workers of acceptable means to implement an (including due process) of individuals
who will construct the safety- and FFD program under Subpart K, who are subject to the requirements will
security-related SSCs, the FFD program including fitness monitoring. be protected.
requirements in Subpart K are less A representative from a public Public Comment on Drug and Alcohol
stringent. For example, Subpart K does interest group stated that the Subpart K
Testing Provisions
not require a suitable inquiry/ requirements are necessary for FFD
employment history check for these during construction. However, this The NRC received several detailed
workers. In addition, the staff representative questioned the staff’s comments on the drug and alcohol
acknowledged the many complex concerns about construction workers testing provisions contained in Subparts
logistical challenges associated with having unfettered access to sensitive E, F, and G. Most significantly, no
implementing FFD requirements during information as partial justification for comments disagreed with NRC’s
construction. Therefore, the Subpart K the FFD requirements before fuel proposed inclusion of specimen validity
requirements provide a licensee or other receipt. This individual stated that testing of all urine specimens collected
entity listed in § 26.3(c) of the final rule safety considerations alone, under Part 26 provisions. Most
greater flexibility in implementing FFD independent of any potential security comments related to improving the
programs for construction than the rule concerns, warrant regulations for FFD clarity and intent of the proposed rule.
permits for FFD programs at operating programs for construction before fuel Many comments received were of a
plants. receipt. technical nature and addressed
The staff also stated that the NRC has Based on the staff’s assessment of the inconsistencies between the NRC’s
decided to defer adopting requirements potential risks to public health and proposed rule and requirements in other
for reactor manufacturing facilities in safety and the common defense and federal testing programs, mainly the
the final rule. Although proposed security that the results of construction HHS’s Mandatory Guidelines for
§ 26.3(e) would have covered these activities may pose when a plant begins Federal Workplace Drug Testing and
facilities, and the Part 52 final rule operations, the staff concluded that— DOT drug and alcohol testing
amended § 26.2(c) of the former rule to (1) Relying on voluntary FFD regulations (49 CFR Part 40). The NRC,
include holders of manufacturing programs would not ensure that all in large part, agrees with many of the
licenses, the NRC has concluded that it workers who construct safety- and comments and has made clarifying
needs additional information before security-related SSCs or provide revisions to the final rule.
proceeding with FFD requirements for oversight of those construction activities Stakeholder commenters raised
these facilities. are subject to a program; several concerns relating to the drug and
alcohol provisions of the proposed rule. Subpart H—Determining Fitness-for-Duty new § 26.4 [FFD program applicability
First, numerous comments were Policy Violations and Determining Fitness to categories of individuals], as
received on the validity testing Subpart I—Managing Fatigue discussed with respect to that section, to
provisions for screening and initial Subpart J—[Reserved] clarify the rule text. Also, the final rule
Subpart K—FFD Programs for Construction
validity tests conducted at licensee Subpart L—[Reserved]
makes a substantive change to the
testing facilities. Some stakeholders Subpart M—[Reserved] proposed rule by adding § 26.3(c),
disagreed with the NRC’s proposal to Subpart N—Recordkeeping and Reporting which modifies the requirements of
permit licensee testing facilities to use Requirements proposed § 26.3(e) pertaining to
point-of-collection type tests to conduct Subpart O—Inspections, Violations, and combined license holders and
validity screening tests. The NRC Penalties applicants and construction permit
considered the comments, but has A detailed cross-reference table holders and applicants. As in § 26.3(e)
retained in the final rule the proposed between the former and final Part 26 of the proposed rule, § 26.3(c) of the
provision to allow licensee testing provisions is included at the end of this final rule specifies the requirements to
facilities to use point-of-collection type document. which these entities are subject.
tests to conduct validity screening tests. The NRC has deleted Appendix A of However, the final rule modifies these
However, in response to the comments the former rule and moved the detailed requirements and moves them to a new
received, the NRC has revised the requirements for conducting drug and Subpart K [FFD Programs for
performance testing provisions in alcohol testing that were contained in Construction]. These changes are
§ 26.137 to ensure that the functional Appendix A to 10 CFR Part 26 to discussed in more detail with respect to
capabilities of the performance testing Subpart E [Collecting Specimens for § 26.3(c).
of screening tests meet the criteria of the Testing], Subpart F [Licensee Testing Section 26.3(a) of the final rule
final rule. In addition, another set of Facilities], and Subpart G [Laboratories specifies that licensed nuclear power
comments pointed out that the proposed Certified by the Department of Health reactor operators and combined license
rule did not afford licensee testing and Human Services] of the final rule. holders after the Commission has made
facilities the opportunity to conducting the finding in § 52.103(g) shall comply
Subpart A—Administrative Provisions with the requirements of this part, with
specific gravity testing on specimens,
which is a required component of Section 26.1 Purpose the exception of Subpart K. The Part 52
reporting specimens as dilute, final rule modified former § 26.2(a) to
Section 26.1 of the final rule amends expressly require combined license
substituted, or invalid. The NRC the language of the corresponding
continues to believe that any specimen holders after the Commission has made
section of the former rule. The final rule the finding in § 52.103(g) to comply
that has a creatinine concentration deletes the term ‘‘certain aspects’’ and
below 20 mg/dL must be forwarded for with the requirements of Part 26.
adds the term ‘‘implementation’’ to the The final rule clarifies that the
additional testing at an HHS certified phrase in the former rule which stated, regulations contained in Subpart K do
laboratory (including specific gravity ‘‘for the establishment and maintenance not apply to the licensees and other
testing). Finally, the NRC received of * * * fitness-for-duty programs,’’ in entities specified in § 26.3(a) because
numerous comments on the use of the order to convey more accurately that the only entities specified in § 26.3(c) are
term ‘‘non-negative.’’ Some commenters final rule includes requirements for permitted to implement an FFD program
believed that the term created implementing FFD programs, in under the more flexible program
significant confusion with respect to addition to requirements for requirements in Subpart K. The final
understanding specimen test results. establishing and maintaining such rule also adds a requirement that
The NRC agrees with the commenters programs. The NRC has moved the licensees who receive their operating
and has replaced the term ‘‘non-negative portion of former § 26.1 that referred to license under § 50.57 after the date of
test result’’ in the final rule with the the entities who are subject to the rule publication of the final rule in the
term ‘‘positive’’ (for drug test results) to § 26.3 [Scope] in order to meet Goal Federal Register and holders of a
and the term ‘‘adulterated, substituted, 6 of the rulemaking to improve clarity combined license under Part 52 after the
and invalid’’ (for validity test results). In in the organization and language of the Commission has made the finding in
addition, the NRC has replaced the term final rule, by consolidating related § 52.103(g) must implement an FFD
‘‘non-negative test result’’ with the new requirements into one section. program meeting all of the requirements
term ‘‘questionable validity’’ for of Part 26 except Subpart K before
licensee testing facility test results that Section 26.3 Scope
receipt of special nuclear material in the
indicate that a specimen may be The NRC has reorganized, form of fuel assemblies. The NRC
adulterated, substituted, dilute, or renumbered, and amended § 26.3 believes that once fuel assemblies have
invalid. relative to both former § 26.2 [Scope], as arrived on site, the full range of
VI. Section-by-Section Analysis of modified by the Part 52 final rule, and potential risks to public health and
Substantive Changes proposed § 26.3 [Scope] based upon the safety and the common defense and
NRC’s consideration of issues raised by security that Part 26 is designed to avert
The final rule is organized into twelve public comments on the proposed rule. are possible. Therefore, the NRC
subparts that are comprised of related In general, the final rule retains and believes that a more rigorous FFD
requirements, as follows: clarifies most of the provisions program must be in place at this time.
Subpart A—Administrative Provisions pertaining to the scope of the former Section 26.3(b) of the final rule
Subpart B—Program Elements and proposed rules. However, one combines § 26.3(b) and (c) of the
Subpart C—Granting and Maintaining public comment stated that the proposed rule. This section retains the
Authorization proposed rule was confusing with requirement in the first sentence of
Subpart D—Management Actions and
Sanctions to be Imposed
regard to the entities and individuals former § 26.2(a) that licensees who are
Subpart E—Collecting Specimens for Testing who are subject to the different authorized to possess, use, or transport
Subpart F—Licensee Testing Facilities requirements of this part. Therefore, the formula quantities of are subject to the
Subpart G—Laboratories Certified by the final rule amends this section of the regulations in this part. Section 26.3(b)
Department of Health and Human Services proposed and former rules and adds a also retains the requirements of former
§ 26.2(d) and specifies that corporations Commission has made the finding under backfill, concrete or permanent
and entities other than a corporation are § 52.103(g) and construction permit retaining walls within an excavation for
subject to the regulations of this part holders, respectively, are subject to the safety- and security-related SSCs, it will
because there may be entities who are requirements of Part 26, except for not be required to comply with Part 26.
organized as firms, partnerships, limited Subpart I. Entities who are authorized under the
liability companies, or associations who The final rule, however, to be LWA to perform installation of the
may also obtain a certificate or approved consistent with the LWA final rule, foundation, including placement of
compliance plan under Part 76 and elect amends the proposed rule with respect concrete, for safety- or security-related
to engage in activities involving formula to combined license applicants and SSCs, however, will be required to
quantities of SSNM. construction permit applicants. Section comply with Part 26 and establish either
However, the entities specified in this 26.3(c)(1) and (c)(3) addresses combined an FFD program under Subpart K of Part
paragraph are not subject to the license applicants and construction 26 or an FFD program that complies
requirements contained in Subpart I permit applicants, respectively. with all of Part 26 except Subparts I and
[Managing Fatigue] for the reasons that Although the proposed rule specified K.
are discussed with respect to § 26.201 combined license applicants and The NRC based its decision to
[Applicability]. With respect to the construction permit applicants who distinguish the installation of the
proposed rule, the final rule adds a have ‘‘received the authorization to foundation, including placement of
specification that the entities listed in construct under § 50.10(e)(3),’’ revisions concrete, from the other activities listed
§ 26.3(b) are not subject to the to Part 50 in the LWA final rule have under § 50.10(d)(1) on the following
requirements contained in Subpart K, changed the content and applicability of considerations. First, until the NRC
because the requirements of Subpart K § 50.10(e)(3). As a result, the Part 26 broadened the concept of construction
apply only to the entities specified in final rule specifies combined license because of its early interpretation of the
§ 26.3(c). The provision also eliminates applicants and construction permit National Environmental Policy Act,
the cross reference to § 26.25(a)(3) of the applicants who ‘‘have been issued a construction requiring NRC approval in
proposed rule because the final rule has limited work authorization under the form of a construction permit was
moved the proposed provisions in § 50.10(e), if the limited work defined in § 50.10 as ‘‘pouring the
§ 26.25 to § 26.4 of the final rule for authorization authorizes the applicant foundation for, or the installation of,
increased clarity in the rule’s to install the foundations, including the any portion of the permanent facility on
organization. placement of concrete, for safety- and the site.’’ Thus, installation of the
Section 26.3(c) of the final rule retains security-related [SSCs] under the foundation has in the past been
but modifies the provisions of former limited work authorization.’’ Similarly, identified by the agency as a key step in
§ 26.2(c) and proposed § 26.3(e). in § 26.3(c)(5), the final rule, with construction.
Proposed § 26.3(e) would have retained respect to the proposed rule, adds a new Second, the NRC concluded that
and updated the requirements of specification for early site permit installation of the foundation is
§ 26.2(c) of the former rule before Part holders ‘‘who have been issued a different in kind from the other
26 was amended by the Part 52 final limited work authorization under activities listed under § 50.10(d)(1). A
rule. However, proposed § 26.3(e) did § 50.10(e), if the limited work common meaning of ‘‘foundation’’ is the
not revise the basic approach taken in authorization authorizes the early site underlying base or support for a
former § 26.2(c), and specified the permit holder to install the foundations, building or the substructure of a
regulations in Part 26 that applied to the including the placement of concrete, for building. Therefore, the foundation is an
entities listed in proposed § 26.3(e). safety- and security-related SSCs under integral component of the fabric of a
Section 26.3(c) of the final rule specifies the limited work authorization.’’ (The safety- or security-related SSC, while
that the entities listed are subject to the final rule contains definitions of safety- piles, backfill, and retaining walls are
requirements of Part 26, except Subpart and security-related SSCs in § 26.5, and not. The foundation must be installed
I. those definitions are discussed with properly on the first attempt, as any
The NRC received a public comment, respect to that section.) flaws in the foundation or voids or
discussed in detail in Section V of this The LWA final rule modified the concrete will be difficult to detect and
document, that argued that proposed scope of activities that are considered impossible to correct without complete
§ 26.3(e) was unclear regarding the type construction for which a construction re-installation of the foundation. The
of FFD program the NRC expected from permit, combined license, or LWA is individuals who install foundations for
the licensees specified in this necessary, and specified the scope of safety- and security-related SSCs must
paragraph. The NRC acknowledged construction activities that may be therefore be fit-for-duty and trustworthy
these concerns, and for the reasons performed under an LWA. Under an and reliable. Thus, the installation of
discussed in Section V of this LWA, entities are allowed to perform foundations has a closer and more
document, the final rule amends the some or all of the following activities: significant nexus with public health and
requirements of proposed § 26.3(e) and driving of piles, subsurface preparation, safety and common defense and
moves them to a separate Subpart K. placement of backfill, concrete, or security, and the individuals who
The specific requirements applicable to permanent retaining walls within an construct or direct the construction of
the entities specified in § 26.3(c) are excavation, and installation of the such SSCs should be subject to an FFD
discussed in this document with respect foundation, including placement of program.
to Subpart K. concrete, any of which are for an SSC Third, the public can be expected to
Like the proposed rule, the final rule of a production or utilization facility for view installation of foundations as
specifies the requirements that are which either a construction permit or different from, and more important
applicable to combined license holders combined license is otherwise required than, other activities under an LWA
before the Commission has made the under 10 CFR 50.10(c). because of the integral nature of
finding under § 52.103(g) and to The NRC has concluded that if the foundations with the SSCs and the
construction permit holders. Section entity is authorized under the LWA to nexus with public health and safety and
26.3(c)(2) and 26.3(c)(4) specifies that perform only the driving of piles, common defense and security. An FFD
combined license holders before the subsurface preparation, or placement of program that provides reasonable
assurance that the individuals who elements to meet the requirements of requirements in the final rule that relate
perform installation of foundations of Part 26. The provision adds C/Vs to the to conducting drug and alcohol testing.
safety- or security-related SSCs are list of entities who are subject to Part 26 However, if a C/V chooses to conduct
trustworthy and reliable and fit to in § 26.3 to more clearly convey that drug and alcohol testing under some or
perform their duties will enhance public C/Vs may be directly subject to NRC all of the conditions specified in
confidence in the NRC’s regulatory inspection and enforcement actions § 26.31(c) [Conditions for testing], such
processes and the safety and security of than the former rule language implied. as for cause testing, and a licensee or
newly constructed nuclear power The former rule text presented the other entity specified in § 26.3(a)
plants. applicability of the rule’s requirements through (c) relies upon the results of the
Further, § 26.3(c) of the final rule to a C/V’s FFD program in terms of the C/V’s tests in determining whether to
explains that if the licensees and other contractual relationship between a grant authorization to an individual (see
entities specified in § 26.3(c)(1) through licensee and the C/V. For example, Subpart C [Granting and Maintaining
(5) receive special nuclear material in former § 26.23(a)(1) stated, ‘‘The Authorization]), then the use of these
the form of fuel assemblies, then those contractor or vendor is responsible to phrases in the provision would be
entities must comply with all of the the licensee [emphasis added] for correctly interpreted to mean that the
requirements of Part 26. This adhering to the licensee’s fitness-for- C/V’s drug and alcohol testing program
requirement is consistent with the duty policy, or maintaining and element must meet the final rule’s
requirement in § 26.3(a) that licensees adhering to an effective fitness-for-duty requirements related to drug and
who receive their operating license program; which meets the standards of alcohol testing when conducting the
under § 50.57 after the date of this part.’’ This paragraph, and others in tests on which the licensee or other
publication of the final rule in the the former rule, could be interpreted as entity relies. In contrast, if a C/V
Federal Register and holders of a implying that a C/V is accountable to implements an FFD program element
combined license under Part 52 after the the licensee but not to the NRC, should that is addressed in this part, but that
Commission has made the finding in significant weaknesses be identified in program element is not relied upon by
§ 52.103(g) must comply with the the C/V’s FFD program upon which a a licensee or other entity specified in
requirements of Part 26, except Subpart licensee relies. However, this paragraphs (a) through (c) of this
K, before the receipt of special nuclear interpretation would be incorrect. section, then the provision does not
material in the form of fuel assemblies. Therefore, § 26.3(d) of the final rule require the C/V to meet the applicable
Under both § 26.3(a) and (c), no later includes C/V FFD programs and Part 26 requirements for that FFD
than when fuel arrives on site, the program elements upon which the program element. Section 26.3(d)
applicable licensees and other entities licensees and other entities specified in requires C/Vs to meet the requirements
must implement an FFD program that paragraphs (a) through (c) of this section of Subpart I of the final rule, if any
complies with the requirements of Part rely within this section to convey more nuclear power reactor licensees
26 for the reasons discussed with accurately that C/Vs are directly specified in § 26.3(a) through (c) rely
respect to § 26.3(a). accountable for meeting the applicable upon a C/V’s fatigue management
The NRC has decided to defer program element to meet the
requirements of Part 26, not only
adopting requirements for reactor requirements of Subpart I. The
through their contractual relationships
manufacturing facilities. Although these applicability of Subpart I to C/Vs is
with the licensees and other entities
facilities would have been covered discussed with respect to § 26.201.
who are subject to the rule. This
under proposed § 26.3(e) and were The NRC has either eliminated or
clarification also is necessary to
temporarily included in the former moved to other places of the final rule
maintain the internal consistency of the
§ 26.2(c) as amended by the Part 52 final other provisions of former § 26.23
rule, the agency has concluded that it final rule because some provisions of
[Contractors and vendors]. The NRC has
needs additional information before the rule apply only to C/Vs, including,
moved the former requirement for
going forward with FFD requirements but not limited to § 26.717(g). The final
licensees to retain written agreements
for such facilities, particularly when rule makes this change to meet Goal 6
with C/Vs in the second sentence of
FFD requirements are closely linked to of the rulemaking to improve the clarity
§ 26.23 to Subpart N [Recordkeeping
issues of access authorization and in the organization and language of the
and Reporting Requirements] of the
physical security. The NRC is rule. final rule. The NRC has moved the
considering, but has not yet completed, The phrases ‘‘program elements’’ and requirement in former § 26.23(a)(1) to
regulatory requirements on those ‘‘licensees and other entities specified Subpart C of the final rule. That
subjects for reactor manufacturing in paragraphs (a) through (c) of this provision requires that individuals who
facilities. Any industry stakeholders section’’ are used in § 26.3(d) of the final have violated an FFD program must not
with a potential interest in pursuing a rule because C/Vs need only meet the be assigned to work within the scope of
license for a reactor manufacturing requirements of Part 26 for those FFD this part without the knowledge and
facility should ensure that they engage program elements upon which licensees consent of the licensee. The NRC has
in early discussions with the NRC so and other entities rely to meet the addressed the audit requirement
that suitable requirements can be requirements of the rule. For example, contained in former § 26.23(b) in
developed in a timely manner. a C/V may choose to implement all of § 26.41(d) [Contracts] of the final rule.
Section 26.3(d) of the final rule the program elements that are required By moving the former requirements to
retains the meaning of a portion of for a full FFD program under the final different sections of the final rule and
former § 26.23(a)(1), but amends some of rule except drug and alcohol testing. In grouping related requirements together
the terminology used in the former rule. this case, the final rule does not require in one section or subpart that addresses
Like the proposed rule, the final rule the C/V to address drug and alcohol similar topics, the NRC has met Goal 6
requires that a C/V FFD program must testing in the C/V’s FFD policy, of this rulemaking to improve clarity in
meet the standards of Part 26 if procedures, and training program; the organization and language of the
licensees and other entities specified in establish contracts with drug-testing rule.
paragraphs (a) through (c) of § 26.3 rely laboratories; collect specimens for drug The NRC has amended and moved the
upon the C/V’s FFD program or program and alcohol testing; or meet any other requirements of proposed § 26.3(e) to
§ 26.3(c) and Subpart K of the final rule. The final rule specifies that the persons Proposed § 26.25(a)(2) amended
The requirements contained in who are granted unescorted access to portions of former § 26.2(a) and (d) and
proposed § 26.3(e) are discussed in this nuclear power reactor protected areas by described the individuals whose duties
document with regard to those sections. the licensees and other entities in require them to be subject to Part 26.
Section 26.3(e) of the final rule, like § 26.3(a) and (c), as applicable, and who Section 26.4(c) of the final rule states
the proposed rule, retains the second perform the duties in § 26.4(a)(1) that all persons who are required by a
sentence of former § 26.2(b) and through (a)(5) shall be subject to an FFD licensee or other entity in § 26.3(a), and,
addresses entities who are not subject to program that meets the requirements of as applicable, (c) to physically report to
the rule. The NRC has moved the first this part, except Subpart K but the licensee’s Technical Support Center
sentence of former § 26.2(b), which including Subpart I. The NRC has or Emergency Operations Facility shall
addressed individuals who are not moved the categories of individuals be subject to an FFD program that meets
subject to the rule, to § 26.4(i) of the specified in § 26.199(a)(1) through (a)(5) all of the requirements of this part,
final rule for organizational clarity. of the proposed rule to § 26.4(a)(1) except § 26.205 through § 26.209 and
Section 26.4 FFD Program through (a)(5) of the final rule in order Subpart K. Section 26.4(c) of the final
Applicability to Categories of to group together all related rule does not permit these individuals
Individuals applicability requirements for to be subject to an FFD program that
individuals in one section. This change meets the more flexible requirements of
In the proposed rule, the NRC moved is consistent with Goal 6 of this Subpart K because they may be granted
the provisions in former § 26.2 that rulemaking to improve clarity in the unescorted access by the licensees in
specified the individuals whose duties organization and language of the rule. § 26.3(a), to whom all of the
require them to be subject to the rule Additional concerns regarding the requirements of this part, except
and exempt certain other individuals to reasons why individuals performing Subpart K, apply, and the entities in
§ 26.25 [Individuals subject to the these duties shall be subject to the § 26.3(c), as applicable, to whom all of
fitness-for-duty program]. However, the fatigue management provisions of the requirements of this part apply. This
NRC has deleted § 26.25 from the final Subpart I are discussed with respect to paragraph also does not require the
rule, and has amended, reorganized, and § 26.205(a) [Individuals subject to work specified individuals to be subject to an
moved all of the provisions in proposed hour controls]. The final rule clarifies FFD program that meets the
§ 26.25 to a new § 26.4 to group related that these individuals may not be requirements of § 26.205 through
applicability requirements together in subject to the more flexible FFD § 26.209 for the reasons discussed with
one section. program described in Subpart K because regard to § 26.205(a).
The provisions moved into new § 26.4 they may be granted unescorted access Section 26.4(d) of the final rule
include the second sentence of former by the licensees in § 26.3(a), to whom all retains and amends portions of
§ 26.2(a), the first sentence of former of the requirements of this part, except proposed § 26.25(a)(3). Proposed
§ 26.2(b), and the portion of the second Subpart K, apply, and entities in § 26.25(a)(3) amended the portions of
sentence of former § 26.2(d) that § 26.3(c), as applicable, to whom all of former § 26.2(a) and (d) and described
pertained to personnel. The NRC the requirements of this part apply. the individuals whose duties require
determined that separating into two Section 26.4(b) of the final rule retains them to be subject to Part 26. Section
different sections the requirements that portions of and amends proposed 26.4(d) of the final rule specifies that
address the entities who are subject to § 26.25(a)(1). The final rule adds any individual whose duties for the
the rule and the requirements that § 26.4(b) to clarify that individuals who licensees and other entities in § 26.3(b)
address the individuals who must be are granted unescorted access to nuclear require him or her to have the types of
subject to the rule makes the two sets of power reactor protected areas by the access or perform the activities in
provisions easier to locate within the licensees and other entities in § 26.3(a) paragraphs (d)(1) through (d)(5) shall be
final rule without compromising the and (c), as applicable and who do not subject to an FFD program that meets all
intended meaning of these provisions. perform the duties described in of the requirements of this part, except
Also, moving the applicability § 26.4(a), shall be subject to an FFD Subparts I and K. Section 26.4(d) of the
requirements for individuals into program that meets all of the final rule does not require these
Subpart A [Scope] from Subpart B requirements of Part 26, except § 26.205 individuals to be subject to an FFD
[Program Elements], where they were [Work hours] through § 26.209 [Self- program that meets the requirements of
located in the proposed rule, is declarations] and Subpart K. Section Subparts I or K, which is consistent
appropriate because some categories of 26.4(b) does not permit these with the provisions of the proposed
individuals who are subject to the rule individuals to be subject to an FFD rule.
are not subject to Subpart B of the final program that meets the more flexible The NRC has added § 26.4(e) to the
rule. The applicability requirements in requirements of Subpart K because they final rule to specify that individuals
§ 26.4 clearly specify the categories of may be granted unescorted access to whose duties when construction
individuals who are subject to Part 26. protected areas by the licensees in activities begin require them to have the
The NRC determined that grouping all § 26.3(a), to whom all of the types of access or perform the activities
of the applicability requirements into requirements of this part, except specified in § 26.4(e)(1) through (e)(6) at
one subpart of the final rule increases Subpart K, apply, and the entities in the location where the nuclear power
the ease of locating these provisions, § 26.3(c), as applicable, to whom all of plant will be constructed and operated
consistent with Goal 6 of this the requirements of this part apply. This must be subject to a rigorous FFD
rulemaking to improve clarity in the paragraph does not require the program that complies with the
organization of the rule. individuals in this paragraph to be requirements of Part 26, except for the
Section 26.4(a) of the final rule retains subject to an FFD program that meets requirements of Subparts I and K. These
portions of proposed § 26.25(a)(1). the requirements of § 26.205 through individuals have direct responsibility
Proposed § 26.25(a)(1) amended § 26.209 for the reasons discussed with for assuring the quality and security of
portions of former § 26.2(a) and (d) and regard to § 26.205(a). construction activities and, thereby, the
described the individuals whose duties Section 26.4(c) of the final rule retains safety and security of the completed
require them to be subject to Part 26. and amends proposed § 26.25(a)(2). nuclear power plant. The NRC considers
it prudent that these personnel are implement the licensee’s or other respect to § 26.31(b)(1)(v) and (b)(2). The
verified to be trustworthy and reliable, entity’s access authorization program NRC has added the requirements of
as demonstrated by the avoidance of during construction must be subject to § 26.4(e)(6) in accordance with Goal 1 of
substance abuse, and fit for duty with an an FFD program that complies with the this rulemaking, which is to update and
FFD program that is equivalent to the requirements of Part 26, except the enhance the consistency of 10 CFR Part
program required for an operating plant, requirements of Subparts I and K. The 26 with advances in other relevant
which includes a 50 percent random NRC expects that, in the absence of an Federal rules and guidelines.
testing rate and a suitable inquiry and order or regulation requiring a specific Section 26.4(e)(1) includes the phrase
employment history check. These access authorization program during ‘‘until the licensees or other entities
individuals include all individuals construction, an access authorization receive special nuclear material in the
whose duties at the location where the program during construction would form of fuel assemblies, at which time
nuclear power plant will be constructed require individuals to perform the same individuals who serve as security
and operated require them to: (1) Serve duties and activities as would a personnel required by the NRC must
as security personnel required by the licensee’s access authorization program meet the requirements applicable to
NRC, until the licensee or other entity under § 73.55 and § 73.56 when the security personnel in paragraph (a)(5) of
receives special nuclear material in the plant is operating. These duties and this section’’ to clarify that, once fuel is
form of fuel assemblies, at which time activities include having access to the received on site, security personnel
individuals who serve as security information used by the licensee or must be subject to all the requirements
personnel required by the NRC must other entity to make access of this part, except the requirements of
meet the requirements applicable to Subpart K, and including the
authorization determinations, including
security personnel in § 26.4(a)(5); (2) requirements of Subpart I. The
information stored in electronic format,
perform quality assurance, quality individuals listed in § 26.4(e)(2) through
as specified in (e)(6)(i); making access
control, or quality verification activities (6), once construction activities begin
authorization determinations, as
related to safety- and security-related and until a licensee or other entity
specified in (e)(6)(ii); issuing entry-
construction activities; (3) based on a specified in § 26.3(a) or (c) grants them
control picture badges in accordance
designation under § 26.406 by a licensee unescorted access to the nuclear power
with access authorization
or other entity, monitor the fitness of the plant protected areas, must be subject to
determinations, as specified in
individuals specified in § 26.4(f) (and the requirements of this part, except the
(e)(6)(iii); conducting background requirements of Subparts I and K.
thus has also received fitness investigations or psychological
monitoring training); (4) witness or However, once the individuals listed in
assessments used by the licensee or § 26.4(e)(2) through (6) are granted
determine inspections, tests, and other entity to make access
analyses certification required by Part unescorted access to the nuclear power
authorization determinations, as plant protected areas, they must be
52; (5) supervise or manage the specified in (e)(6)(iv); adjudicating
construction of safety- or security- subject to the requirements of § 26.4(b),
reviews or appeals of access which require them to be subject to the
related SSCs; or (6) direct, as defined in authorization determinations, as
§ 26.5, or implement the access requirements of this part, except those
specified in (e)(6)(v); auditing the access in (§§ 26.205 through 26.209 and
authorization program. Section authorization program, as specified in
26.4(e)(5) specifies that an individual Subpart K.
(e)(6)(vi); or performing any of the The NRC has added § 26.4(f) to the
who ‘‘supervises or manages the activities or having any of the duties final rule to specify the individuals
construction of safety- or security- listed in § 26.4(e)(6) for any C/V upon involved in the construction of a new
related SSCs’’ must be subject to an FFD whom the licensee’s or other entity’s reactor plant who, at the licensee’s or
program that complies with the access authorization program will rely, other entity’s discretion, must be subject
requirements of Part 26, except the as specified in (e)(6)(vii). Section to either a more flexible FFD program
requirements of Subparts I and K. The 26.4(e)(6)(iv) includes the following under Subpart K, or a more rigorous
NRC has added this provision based exception for individuals who conduct FFD program that meets the
upon information from stakeholders at background investigations or requirements in the other portions of
public meetings at which the conceptual psychological assessments used by the Part 26, except Subparts I and K. These
framework for Subpart K was discussed. licensee or other entity to make access individuals include any individual who
The NRC has included a definition of authorization determinations: ‘‘He or is constructing or directing the
‘‘supervises or manages’’ in the final she shall be subject to behavioral construction of safety- or security-
rule, which means ‘‘exercises control observation only when he or she is related SSCs at the location where the
over a work activity by an individual present at the location where the nuclear power plant will be constructed
who is not directly involved in the nuclear power plant will be constructed and operated. However, if and when a
execution of the work activity.’’ The and operated, and licensees and other licensee or entity specified in § 26.3(a)
final rule specifies that this requirement entities may rely on a local hospital or or (c) grants these individuals
applies only to those individuals who other organization that meets the unescorted access to the nuclear power
supervise or manage the construction of requirements of 49 CFR Part 40, plant protected area, these individuals
safety- or security-related SSCs ‘‘at the ‘Procedures for Department of must be subject to the requirements of
location where the nuclear power plant Transportation Workplace Drug and § 26.4(a) or (b), as applicable. As
will be constructed and operated’’ (i.e., Alcohol Testing Programs’ (65 FR specified by the definition of
only those individuals whose activities 41944; August 9, 2001) to collect his or (constructing or construction activities’
at the site where the nuclear power her specimens for drug and alcohol in § 26.5, these tasks include fabricating,
plant will be constructed and operated testing.’’ The requirements for persons erecting, integrating, and testing safety-
may negatively impact public health
conducting background checks and or security-related SSCs and the

and safety and the common defense and psychological assessments are relaxed installation of their foundations,
security). for reasons similar to requirements for including the placement of concrete.
Section 26.4(e)(6)(i) through (e)(6)(vii) MROs and certain FFD program The final rule also contains a definition
specifies that individuals who direct or personnel, as described in detail with of ‘‘directing’’ in § 26.5, which means
the exercise of control over a work clarified the NRC’s original intent that or notifying individuals for testing, as
activity by an individual ‘‘who is FFD program personnel must be subject specified in § 26.4(g)(4); or (5) are
directly involved in the execution of the to the FFD program. Although former involved in the collection or on-site
work activity.’’ This definition is Section 2.3 in Appendix A to Part 26 testing of specimens, as specified in
distinguished from the term ‘‘supervises required licensees to carefully select § 26.4(g)(5).
or manages,’’ used in § 26.4(e)(5), which and monitor individuals who are Although job titles and
means the exercise of control over a responsible for administering the drug responsibilities may differ among
work activity by an individual ‘‘who is and alcohol testing program based upon different Part 26 FFD programs,
not directly involved in the execution of the highest standards of honesty and examples of FFD program personnel
the work activity.’’ The NRC determined integrity, some licensees’ testing who are subject to Part 26 under the
that it is necessary to impose FFD programs did not include all of the FFD final rule include, but are not limited to,
requirements on individuals who are program personnel who the NRC the following: The FFD program
constructing or directing the originally intended to be subject to manager under § 26.4(g)(1) through
construction of safety- or security- testing. The final rule clarifies the NRC’s (g)(5); the MRO and MRO staff under
related SSCs because (1) the quality of original intent because the actions of § 26.4(g)(1); the licensee’s or other
work could be adversely affected by these individuals have an ongoing effect entity’s reviewing officials under
construction workers who are impaired on public health and safety and the § 26.4(g)(3); specimen collectors under
by substance abuse where studies common defense and security as a result § 26.4(g)(5); SAEs who are under
indicate that members of this group of their responsibility to ensure that contract to or employed by the FFD
have the highest rates of substance program under § 26.4(g)(2); and licensee
FFD programs are effective. In addition,
abuse problems among occupational testing facility personnel under
these individuals’ actions affect the
groups in the U.S. (e.g., SAMHSA’s § 26.4(g)(5). In some cases, information
confidence that the public,
NHSDA covering the years 2000–2001 technology personnel who design and
management, and individuals who are
and SAMHSA’s National Survey on implement software programs for
subject to testing have in the integrity of
Drug Use and Health covering the years selecting individuals for random testing
the program and the accuracy and
2002–2004), (2) individuals who have also may be subject to the rule under
reliability of test results. Individuals
become addicted to illegal drugs are § 26.4(g)(4) if such personnel have
who are involved in the day-to-day
susceptible to coercion and will interact knowledge of who was selected for
operations of an FFD program are in a random testing before the individual is
with others involved in the drug trade, position to permit substance abusers to
(3) past experience has demonstrated notified or the ability to affect the
remain undetected. For example, selection of specific individuals for
that errors during construction can specimen collectors could inadvertently
adversely affect subsequent plant random testing.
commit errors when testing others as a Section 26.4(g) of the final rule
operations (NUREG/CR–6819, Vols. 1–4, result of being impaired from drug or amends the proposed rule to clarify the
‘‘Common-Cause Failure Event alcohol abuse or intentionally omit requirements that the FFD programs
Insights,’’ (May 2003) and NUREG– testing an individual because of motives specified in this paragraph must meet.
1837, ‘‘Regulatory Effectiveness associated with maintaining a The section specifies that FFD program
Assessment of Generic Issue 43 and collector’s substance abuse or empathy personnel who are involved in the day-
Generic Letter 88–14,’’ (October 2005)), with an abuser. Further, several to-day operations of the program, as
and (4) quality assurance by design uses reported incidents have confirmed the defined by the procedures of the
a sampling process. Despite having a need to assure that FFD program licensees or other entities, and whose
high degree of confidence in the personnel meet the highest standards of duties require them to have the types of
effectiveness of quality assurance and honesty, integrity, reliability, and access and perform the activities in
ITAAC programs to detect construction trustworthiness. For example, one § 26.4(g)(1) through (g)(5) shall be
errors, the NRC believes it is prudent to licensee added specimen collectors to subject to an FFD program that meets all
require an FFD program during the testing pool after investigating an of the requirements of Part 26, except
construction to provide reasonable allegation and determining that two Subparts I and K, and at the licensees’s
assurance that impaired construction collectors were substance abusers. In discretion, Subpart C. The final rule
workers or individuals directing another instance, a contracted MRO clarifies that the procedures referenced
construction workers do not introduce who was not in the testing pool was are those of the licensees and other
faults in safety- or security-related SSCs reported to be an alcoholic and an entities specified in § 26.3(a) through (c)
that may cause the SSCs to fail to abuser of prescription drugs. Some and, as applicable, (d). Licensees may
perform their intended functions when MROs who provide their services to use different FFD program personnel for
the plant is operating. In addition, the other Federally regulated industries also a Subpart K program, in which case,
NRC is concerned that some have been identified as substance those FFD program personnel would be
construction personnel who have abusers. Therefore, the revision to subject to a full program under the rule.
substance abuse problems will have former § 26.2(a) fulfills the NRC’s However, individuals specified in
access to sensitive information that original objective and requires licensees § 26.4(i)(1) are not subject to an FFD
could be useful to an adversary, as well and other entities to extend their program under Part 26. The term ‘‘as
as physical access to safety- and programs to include FFD personnel who applicable’’ in this provision specifies
security-related SSCs that may provide (1) can link test results with the that entities listed in § 26.3(d) must
opportunities for malicious acts. individual who was tested before an subject FFD program personnel to all of
Therefore, the NRC is requiring FFD policy violation determination is the requirements of this part if they
individuals who are directly involved in made, including, but not limited to, the perform the activities specified in
constructing safety- and security-related
MRO, as specified in § 26.4(g)(1); (2) § 26.4(g). The final rule also clarifies
SSCs to be subject to an FFD program. make determinations of fitness, as that the FFD programs for FFD program
Section 26.4(g) of the final rule specified in § 26.4(g)(2); (3) make personnel performing the listed
contains the provisions in proposed authorization decisions, as specified in activities in § 26.4(g) must meet all the
§ 26.25(a)(4). Proposed § 26.25(a)(4) § 26.4(g)(3); (4) are involved in selecting requirements of Part 26, except Subparts
I and K, which is consistent with the delineated the FFD program personnel (2) They do not routinely provide
provisions of proposed rule. The final who must be subject to Part 26 was too services to the licensee’s or other
rule clarifies that the licensees and other broad. Stakeholders agreed that FFD entity’s FFD program; and
entities may subject FFD program program personnel who work on site (3) They do not normally work at a
personnel to an FFD program that meets and are involved in the day-to-day licensee’s or other entity’s facility.
the requirements of Subpart C, for the operations of the FFD program should Examples of individuals who are not
reasons discussed with respect to be subject to the rule. However, the subject to the rule under this provision
§ 26.31(b). These clarifications are stakeholders noted that the language may include, but are not limited to, a
consistent with Goal 6 of this used in the affirmed rule was so vague nurse at a local hospital who collects a
rulemaking to improve clarity in the that it could be interpreted as requiring, single specimen for a post-event test
organization and language of the final for example, that offsite human from an individual who has been
rule. resources staff at a licensee’s or other injured, and a counselor at a residential
Section 26.4(h) retains and amends entity’s corporate offices, who may have substance abuse treatment facility who
the requirements contained in proposed access to some FFD information about performs behavioral observation of a
§ 26.25(d). Proposed § 26.25(d) clarified individuals, must be covered, as well as patient while the individual is in
that individuals who have applied for any medical or treatment personnel and residence. Personnel who meet the three
authorization or perform duties that their managers, at a hospital or criteria specified in the paragraph are
require them to be subject to Part 26 also substance abuse treatment facility who excluded from the FFD program because
would be subject to some provisions of provide an occasional FFD program the limited nature of their involvement
Part 26. The former Part 26 required an service. These interpretations of the with the FFD program makes it unlikely
applicant for authorization to provide a intent of the affirmed rule provisions that they would be subject to coercion
written statement related to his or her would be incorrect. or influence attempts to subvert the
past activities under this part in former The stakeholders also strongly testing process and the NRC is not
§ 26.27(a)(1); provide permission to the disagreed with the requirement in the aware of any reports indicating that
licensee to conduct a suitable inquiry in these types of individuals have been
affirmed rule that some FFD program
former § 26.27(a)(2); and submit to pre- involved in any adverse incidents.
personnel who maintain offices at
access testing in former § 26.24(a)(1). However, § 26.4(g) of the final rule
locations other than a licensee’s or other requires MROs and SAEs to be subject
Although the proposed rule used entity’s facilities and are not involved in
general terms, such as ‘‘applicable to Part 26 (see the discussion of § 26.187
day-to-day program operations, such as [Substance abuse expert] in Section VI
requirements of this part’’ and EAP counselors and some contract
‘‘applicable protections of this part,’’ the of this document for a detailed
MROs, should be subject to the rule. description of the SAE’s roles and
final rule clarifies the requirements to The stakeholders indicated that they
which the individuals specified in this responsibilities under the FFD
believe the honesty and integrity of such program), as well as any EAP counselor
paragraph are subject. The final rule
off-site personnel is maintained through who serves as the SAE for a licensee’s
requires that individuals who have
their professions’ oversight and or other entity’s FFD program.
applied for authorization to have the
standards, with the result that requiring Individuals who serve in these positions
types of access or perform the activities
these individuals to be subject to the play the key roles of determining
described in § 26.4(a) through (d) shall
rule would create a significant and whether a positive, adulterated, or
be subject to the requirements in
unnecessary regulatory burden. substituted drug test result is an FFD
§§ 26.31(c)(1), 26.35(b), 26.37, 26.39 and
Stakeholders stated that the regulatory policy violation (i.e., the MRO under
the applicable requirements of Subparts
burden would result from the significant § 26.185) and whether an individual is
C, and E [Collecting Specimens for
Testing] through H [Determining logistical difficulties involved in fit to safely and competently perform
Fitness-for-Duty Violations and ensuring that these individuals are the duties that require the individual to
Determining Fitness]. These subject to behavioral observation and be subject to this part (i.e., the SAE).
clarifications ensure the internal drug and alcohol testing, and excessive Although the NRC recognizes the
consistency of the final rule and meet costs to hire additional MRO(s) to significant logistical difficulties and
Goal 6 of this rulemaking to improve review any positive, adulterated, costs that may be associated with
clarity in the organization and language substituted, or dilute drug test results covering these individuals, the NRC
of the rule. from MRO(s) who serve the FFD concluded that MROs and SAEs play
Section 26.4(i)(1) through (i)(3) program. such critical roles in the effective
contains the provisions of proposed Based on the stakeholders’ input, functioning of an FFD program that
§ 26.25(b)(1) through (b)(3). The final lessons learned from FFD program ensuring their continuing honesty and
rule groups together in one paragraph experience since the rule was first integrity by requiring them to be subject
the former rule’s provisions that identify implemented, the experience gained by to the rule is warranted.
individuals who would not be subject to other Federal agencies and their Section 26.4(i)(2) and (i)(3) retains the
the rule. This change has been made to regulated industries, and the continuing first sentence of former § 26.2(b) but
meet Goal 6 of this rulemaking to need to ensure that FFD program divides it into two paragraphs. This
improve clarity in the organization and personnel meet the highest standards of organizational change makes it easier to
language of the rule. honesty and integrity, the NRC added locate these requirements within the
The NRC has added § 26.4(i)(1) to the § 26.4(i)(1) to the final rule. The rule text and to support cross-
final rule as a result of extensive provision excludes from the rule referencing to these paragraphs from
discussions with industry stakeholders individuals who may be called upon to other portions of the rule. The NRC has
at the public meetings mentioned in the provide an FFD program service to a moved the second sentence of former
Section I.D of this document. Industry licensee or other entity in special § 26.2(b) to § 26.3(e) of the final rule,
stakeholders expressed strong concern circumstances and who meet all of the rather than retain it in this provision,
that the related language in the affirmed following criteria: because it addressed entities who would
rule (which was discussed in the (1) They are not employed by the not be subject to the rule, rather than
preamble to the proposed rule) that licensee or other entity; individuals. The NRC has made these
changes to meet Goal 6 of this and an alternative program. Paragraphs FFD programs and program elements
rulemaking to improve clarity in the 26.4(j)(1) and (j)(3) permit licensees and that are implemented by others, when
organization and language of the rule. other entities to rely on the alternative those programs or program elements
The final rule adds a new § 26.4(i)(4), program to meet the final rule’s drug meet the requirements of this part,
which specifies that FFD program testing requirements if the alternative fulfills the rule’s performance objectives
personnel of a program that is regulated program tests for the drugs and drug and improves Part 26 by eliminating or
by another Federal agency or State upon metabolites that are specified in the modifying unnecessary requirements,
which a licensee or other entity relies to final rule at or below the cutoff levels which is Goal 5 of this rulemaking.
meet the requirements of this part, as established in the final rule and an However, an important difference
permitted in § 26.4(j), § 26.31(b)(2), and HHS-certified laboratory conducts the between the final rule’s permission for
§ 26.405(e)(3) are not subject to a program’s specimen validity and drug licensees and other entities to rely on
licensee’s or other entity’s program if testing. Similarly, § 26.4(j)(2) permits the programs of other Federal and State
the FFD program personnel are not licensees and other entities to rely on agencies, compared to the final rule’s
employed by the licensee or other entity the alternative program to meet the final permission for licensees and other
and their normal workplace is not at the rule’s alcohol testing requirements if the entities to rely on C/V programs, is that
licensee’s or other entity’ facility. alternative program’s alcohol testing the final rule does not require licensees
Section 26.4(j) contains the provisions procedures and devices meet the final and other entities to audit the alternate
of proposed § 26.25(c). This provision rule’s requirements and the alternative Federal and State programs under
provides that persons who are covered program uses cutoff levels that are at § 26.41 [Audits and corrective action].
by a program regulated by another least as stringent as those specified in Auditing Federal and State programs is
Federal agency or State need not also be § 26.103(a). Section 26.4(j)(4) permits unnecessary because these programs are
covered by duplicate elements of a the licensee or other entity to rely on an subject to other, equally effective audit
licensee’s or other entity’s FFD program. alternative program’s FFD training if and inspection requirements. Relieving
Duplicate testing and training that training addresses the knowledge licensees and other entities who are
requirements applicable to an and abilities listed in § 26.29(a)(1) subject to this part from an audit
appreciable number of individuals through (a)(10). If the licensee or other requirement also is in keeping with Goal
working at nuclear facilities have entity relies on the alternative program, 5 of this rulemaking.
become an increasing problem as the § 26.4(j)(5) requires the licensee or other
facilities have implemented the DOT’s Section 26.5 Definitions
entity to ensure that the alternative
drug and alcohol testing requirements program informs the licensee or other Section 26.5 amends former § 26.3
[49 CFR Part 40, 65 FR 41944, August entity of any FFD violations. [Definitions] to (1) clarify some
9, 2001]. This revision reduces the The final rule deletes the provision definitions; (2) make the listed terms
burden on some individuals who are that was contained in proposed and their definitions more consistent
currently subject to Federal and State § 26.25(c)(5). The proposed provision with those used by other Federal
programs with requirements that allowed individuals subject to Part 26 agencies (including SAMHSA and
duplicate those of Part 26. Minor and to a Federal agency- or State- DOT); (3) define new terms used in
differences in specific program regulated program to be covered only by other sections of the rule; and (4) move
requirements for conducting drug and those elements of an FFD program that definitions into this section from former
alcohol testing would be unlikely to are not included in the Federal agency Section 1.2 in Appendix A to 10 CFR
adversely affect the ability of a or State program if an impartial and Part 26, which contained definitions of
licensee’s or other entity’s FFD program objective procedure is provided for the important terms used in Appendix A to
to meet the performance objectives of review and reversal of any findings of Part 26. The rule also eliminates six
this part. The licensee or other entity an FFD policy violation. The NRC has terms in former § 26.3 and Section 1.2
continues to be responsible for deleted this provision because it in Appendix A to Part 26 because they
implementing any Part 26 program recognizes that it would be impractical are fully defined in the provisions of the
elements that may not be addressed by to require a licensee to ensure that a final rule or are not used in the final
the alternate Federal or State program. Federal agency or State program would rule. In addition, the rule eliminates
These program elements may include, include an impartial and objective redundant definitions of some terms,
but are not limited to, providing procedure for the review and reversal of which appear in both former § 26.3 and
behavioral observation and initiating for any findings of an FFD policy violation. Section 1.2 in Appendix A to Part 26.
cause testing, if necessary, when an Such assurance would be beyond the Finally, the NRC has revised some
individual who is covered by an licensee’s ability to obtain or provide definitions to make them simpler and
alternate program is on site at a because the licensee would not control easier to understand, consistent with the
licensee’s or other entity’s facility and is the Federal agency or State program. NRC’s commitment to using plain
performing the duties that require the Therefore, this change is consistent with language. For example, some definitions
individual to be subject to the rule, as Goal 5 of this rulemaking to improve in the former rule included
well as immediate removal from duty of Part 26 by eliminating or modifying requirements that were also contained
persons whose fitness may be unnecessary requirements. in other sections of the rule. In these
questionable. These provisions are consistent with instances, the final rule eliminates the
Section 26.4(j)(1) through (j)(5) of the the former and final rules’ approaches to embedded requirements from within the
final rule contains the provisions in permitting licensees and other entities definitions, but retains the definitions in
proposed § 26.25(c)(1) through (c)(4) to rely on C/V FFD programs and this section. The NRC has moved these
and (c)(6). The final rule lists the program elements to meet the requirements to the related sections of
necessary characteristics of an requirements of this part if the C/V’s the final rule for organizational clarity.
alternative Federal or State program program or program element meets the The final rule modifies several
that, under the final rule, licensees and requirements of this part, as discussed definitions of the proposed rule due to
other entities may rely upon to satisfy with respect to § 26.21 [Fitness-for-duty public comment or to increase clarity in
the requirements of this part for an programs]. In general, permitting the language of the rule, consistent with
individual who is subject both to Part 26 licensees and other entities to rely on Goal 6 of the rulemaking. These changes
are discussed below. Otherwise, the HHS-certified laboratory that a to distinguish among the types of
final rule adopts the definitions of this specimen contains a drug or drug quality control samples that are
section as proposed, without change. metabolite below the cutoff associated with urine specimen testing
The NRC has made the majority of the concentration is also a positive result. in Subparts F [Licensee Testing
changes to this section as a result of The final rule also changes the former Facilities] and G [Laboratories Certified
adding new requirements for urine drug term ‘‘confirmed positive test’’ to by the Department of Health and Human
testing, including specimen validity ‘‘confirmed test result’’ to clarify that Services] of the final rule.
testing, to the rule. The rule this term refers to the results of the The final rule changes certain terms
incorporates advances in the science MRO’s review of both drug and validity that describe drug and alcohol tests to
and technology of urine drug testing tests of urine specimens, rather than to reflect the addition of urine specimen
that are based on the most recent a type of testing. The final rule also validity testing requirements. The
revision to the HHS Guidelines, as removes the reference to testing of blood changes include replacing the term
published in the Federal Register on specimens for alcohol that is contained ‘‘initial or screening test’’ with more
April 13, 2004 (69 FR 19643). These in the former definition of ‘‘confirmed specific terms to distinguish between
changes require adding terms to § 26.5, positive test’’ from the definition of drug testing and testing for urine
modifying a number of the terms that ‘‘confirmed test result’’ because blood specimen validity. The NRC has added
were used in the former rule, and specimens are no longer collected at the the terms ‘‘validity screening test,’’
revising the definitions of some terms in donor’s request for confirmatory alcohol ‘‘initial drug test,’’ and ‘‘initial validity
the former rule that are also used in the testing, as discussed with respect to test’’ to refer to the first tests of a urine
final rule, as described in the following § 26.83(a). With respect to the proposed specimen that are performed to
paragraphs. rule, the final rule specifies that a determine whether a urine specimen is
The final rule modifies several terms confirmed test result demonstrates that free of drugs and drug metabolites and
that are used in the former and an individual has used drugs ‘‘and/or’’ has the expected characteristics of
proposed rules to describe the results of alcohol. The NRC has made these normal urine, or whether further testing
drug and alcohol testing, in order to changes to meet Goal 6 of this of the specimen is required. The final
reduce the number of terms, increase rulemaking, as it relates to improving rule modifies the proposed definition of
consistency with terms used by other clarity in the language of the final rule. ‘‘validity screening test’’ to clarify that
Federal agencies, and address the The final rule adds several terms to
both non-instrumented tests, in which
addition of urine specimen validity refer to urine specimens that have
the endpoint result is obtained by visual
testing requirements. The final rule has characteristics that are inconsistent with
evaluation, and instrumented (machine
deleted the term ‘‘non-negative’’ from those expected of normal human urine,
read) tests are acceptable methods to
the proposed rule. The NRC has added as identified through validity testing.
the term ‘‘non-negative’’ to the proposed The terms include ‘‘adulterated determine the need for initial validity
rule to refer to any adverse test result specimen,’’ ‘‘dilute specimen,’’ testing of urine specimen. The NRC has
from the different types of urine testing ‘‘substituted specimen,’’ and ‘‘invalid made these changes to improve clarity
that are required under the final rule. result.’’ The final rule also adds the term in the language of the rule, consistent
However, the NRC received a public ‘‘oxidizing adulterant’’ to refer to one with Goal 6 of this rulemaking.
comment that requested clarification of class of substances that may be used to The final rule also modifies the
‘‘non-negative’’ with respect to adulterate urine specimens. These new definition of ‘‘initial or screening test’’
‘‘positive’’’’ in the proposed rule. terms and definitions have been adapted in the former rule to eliminate the
Therefore, the NRC has deleted ‘‘non- from the HHS Guidelines. requirement that the test must be
negative’’ from the final rule and With respect to the proposed rule, the performed using immunoassay
replaced it with more specific final rule adds the term ‘‘questionable techniques because the NRC addresses
terminology. The final rule uses the validity’’ to mean the results of validity that requirement in other sections of the
term ‘‘positive’’ to refer to results from screening or initial validity tests at a rule. The final rule replaces the general
drug and alcohol testing indicating the licensee testing facility indicating that a term ‘‘confirmatory test’’ in the former
presences of drugs or drug metabolites urine specimen may be adulterated, rule with the more specific terms,
in a urine specimen or the presence of substituted, dilute, or invalid. The NRC ‘‘confirmatory drug or alcohol test’’ and
alcohol above the cutoff levels has added this term based on the ‘‘confirmatory validity test.’’ In
established in this part in breath or oral consideration identified by a commenter addition, the definitions of these terms
fluids specimens. The final rule uses the that licensee testing facilities may not be in the final rule do not include
terms ‘‘adulterated, dilute, substituted, able to determine whether a specimen is requirements for the methods to be used
or invalid,’’ as appropriate, to refer to substituted, dilute, or meets some of the in performing confirmatory tests
results of validity tests of urine invalid criteria because they are not because these requirements are
specimens indicating that the specimen required to test for specific gravity of a addressed in other sections of the rule.
may not be normal human urine. specimen. This term replaces the term Therefore, the NRC has removed the
Consequently, the NRC has replaced the ‘‘suspect specimens’’ in the former rule. requirement that confirmatory drug
term ‘‘non-negative’’ in the following Therefore, the NRC has made this testing be performed using gas
definitions in this section: ‘‘confirmed change to improve clarity in the chromatography/mass spectrometry
test result,’’ ‘‘cutoff level,’’ and language of the rule, consistent with (GC/MS) testing from the definition. The
‘‘Medical Review Officer (MRO).’’ Goal 6 of this rulemaking. final rule also eliminates the reference
The final rule, with respect to both The final rule also adds several terms to GC/MS testing of blood samples for
the former and proposed rules, adds the that are associated with new confirmatory alcohol testing in the
term ‘‘positive result’’ to specify what requirements for maintaining quality definition of ‘‘confirmatory drug or
positive results mean for drug and control of urine specimen validity and alcohol test’’ because the final rule does
alcohol testing. The definition clarifies drug testing, such as the term ‘‘quality not allow donors the option to provide
that, when the laboratory has conducted control sample.’’ The final rule also a blood sample for alcohol confirmatory
the special analysis permitted in adds definitions of the terms testing, as discussed with respect to
§ 26.163(a)(2), a result reported by an ‘‘calibrator,’’ ‘‘control,’’ and ‘‘standard’’ § 26.83(a).
The final rule also adds two terms terms, ‘‘unescorted access The final rule also adds several terms
that refer to testing for very low levels authorization’’ and ‘‘unescorted access,’’ that are necessary to implement the
of drugs, drug metabolites, or that are used by nuclear power plant requirements of Subpart I. These terms
adulterants in a urine specimen, ‘‘limit licensees to refer to individuals who are include ‘‘fatigue,’’ ‘‘acute fatigue,’’ and
of detection (LOD)’’ and ‘‘limit of subject to both Part 26 and related ‘‘cumulative fatigue,’’ which refer to the
quantitation (LOQ).’’ The NRC has access authorization requirements under degradation in an individual’s cognitive
adapted the definitions of these terms 10 CFR 73.56 [Personnel access (mental) and motor (physical)
from the HHS Guidelines. authorization requirements for nuclear functioning resulting from inadequate
In addition, the final rule modifies the power plants]. The NRC created a new rest within the past 24 hours or over
definitions of two terms in the former term because some categories of successive days and weeks,
and proposed rules to be consistent with individuals who are subject to Part 26 respectively. The rule also uses the term
the new drug and alcohol testing are not required to meet the additional ‘‘alertness’’ to refer to an individual’s
terminology that is used throughout the requirements of 10 CFR 73.56. For ability to remain awake and sustain
rule. The final rule amends the example, the NRC has not promulgated attention, which is adversely affected by
definition of ‘‘cutoff level’’ in the former access authorization requirements in fatigue. The new term ‘‘circadian
rule to clarify that the term is also § 73.56 for FFD program personnel. variation in alertness and performance’’
applicable to the interpretation of Therefore, the final rule uses the term defines a factor that licensees would
results from specimen validity testing. ‘‘authorization’’ to refer to the consider when conducting a fatigue
The final rule further modifies this determination that these categories of assessment under § 26.211 [Fatigue
definition to refer to test results as individuals may perform the duties or assessments]. The final rule also adds
‘‘positive,’’ ‘‘of questionable validity,’’ have the types of access specified in the term ‘‘increased threat condition’’ to
and ‘‘adulterated, substituted, dilute, or § 26.4 to distinguish the requirements in refer to circumstances in which the rule
invalid’’ to account for validity tests this part from the additional provides licensees with some flexibility
results from a licensee testing facility. requirements that a licensee or other in implementing the work hour controls
The final rule amends the definition of entity must meet in order to grant of § 26.205. With respect to the
‘‘Medical Review Officer (MRO)’’ to individual ‘‘unescorted access proposed rule, the final rule modifies
refer to a ‘‘drug and validity’’ test result, authorization’’ or ‘‘unescorted access’’ the term ‘‘increased threat condition’’ to
rather than a ‘‘positive’’ test result, to to nuclear power plant protected areas. clarify that any increase in the
clarify that the MRO reviews validity protective measure level is relative to
test results in addition to drug test The final rule adds a definition of
the lowest protective measure
results. ‘‘maintenance’’ to clarify the scope of
applicable to the site during the
The rule also adds six terms that are duties described as maintenance in
previous 60 days.
related to the requirements contained in § 26.4(a)(4) of the final rule. The The final rule, with respect to the
Subpart C. The term ‘‘potentially definition also distinguishes duties proposed rule, adds a definition of
disqualifying FFD information’’ refers to performed by individuals covered by ‘‘shift cycle’’ to mean a series of
the types of information that licensees § 26.4(a)(4) from duties performed by consecutive work shifts and days off
and other entities who are subject to the individuals that are subject to different that is planned by the licensee or other
rule consider when deciding whether to work hour limits, such as the duties entity to repeat regularly, thereby
grant or maintain an individual’s described in § 26.4(a)(1) through (3). constituting a continuous shift
authorization to have the types of access Specifically, the definition clarifies that schedule. Similarly, the final rule adds
or perform the duties that are listed in § 26.205(a) requires that individuals ‘‘8-hour shift schedule,’’ ‘‘10-hour shift
§ 26.4. The final rule also adds identified in § 26.4(a)(4) (i.e., schedule,’’ and ‘‘12-hour shift schedule’’
definitions for four terms that are used individuals who are maintaining or to define these schedules in terms of
within the definition of ‘‘potentially providing onsite direction for the allowable hours of a workday averaged
disqualifying FFD information,’’ maintenance of systems and over a shift cycle.
including ‘‘substance abuse,’’ ‘‘legal components that ‘‘a risk informed Also, the NRC has added the term
action,’’ ‘‘employment action,’’ and evaluation process has shown to be ‘‘unit outage’’ to the final rule to clarify
‘‘reviewing official.’’ The NRC has also significant to public health and safety’’) that the specific reactor unit has to be
added the term ‘‘best effort’’ to refer to must be subject to the work hour disconnected from the electrical grid to
the actions that a licensee or other entity requirements. These requirements apply be declared in an outage. This term was
who is subject to the rule must take to to those individuals who perform the added in response to stakeholder
obtain the information that is necessary following maintenance activities within comment raised at a public meeting on
to complete a suitable inquiry and the licensee’s owner-controlled area: whether, for purposes of implementing
employment history check, as discussed modification, surveillance, post- the work hour controls, a unit was
with respect to § 26.63(a). maintenance testing, and corrective and considered to be in an outage if reactor
The final rule, with respect to the preventive maintenance. This definition power was reduced for repair or
proposed rule, also adds a definition of is similar to the language used in GL maintenance of a system or component,
the term ‘‘authorization’’ in response to 83–14, ‘‘Definition of ‘Key Maintenance but the reactor was not shutdown.
public comment. The final rule uses the Personnel,’ (Clarification of Generic Consequently, the NRC defined unit
term, ‘‘authorization,’’ to refer to an Letter 82–12)’’ and 10 CFR 50.65, outage as the reactor being disconnected
individual’s status as having been ‘‘Requirements for Monitoring the from the electrical grid. This definition
determined by a licensee or other entity Effectiveness of Maintenance at Nuclear provides a clearly identifiable plant
to be eligible to perform the duties or Power Plants.’’ The definition of state for applying the work hour
have the types of access listed in ‘‘maintenance’’ in § 26.5 of the final rule controls in § 26.205(d)(4) and (d)(5).
§ 26.4(a) through (e), and at the excludes the term ‘‘calibration,’’ found The term ‘‘directing’’ clarifies new
licensee’s or other entity’s discretion, in GL 83–14, because the NRC considers requirements for MRO staff under
§ 26.4(f) and (g) of the final rule. The ‘‘calibration’’ to be part of ‘‘preventive § 26.183(d) and the scope of individuals
agency selected this term to differentiate maintenance’’ and, therefore, within the who would be subject to work hour
‘‘authorization’’ under Part 26 from the definition of ‘‘maintenance.’’ controls in § 26.205. The NRC has
revised this definition in response to public comments that recommended involving safety- and security-related
public comment regarding the lack of that the NRC reconsider the proposed SSCs at the location where the new
clarity of the term ‘‘directing’’ as used requirements for licensees or other plant will be constructed and operated
in Subpart I in the proposed rule and entities who will build new nuclear will lead licensees and other entities to
the scope of personnel that should be power plants. The NRC defined these ensure that the program covers all those
subject to work hour controls. Specific terms to clarify the point in the individuals who perform construction
comments included remarks regarding construction process at which an FFD activities within the footprint of the new
the scope of engineering functions that program for construction is required, the power reactor (e.g., the exterior
should or should not be subject to work physical location where the FFD boundary of the reactor building once it
hour controls. The revised definition in program for construction must be is completed) as well as the nearby areas
the final rule clarifies the NRC’s implemented, and to specify the where safety- and security-related SSCs
expectations that a limited scope of individuals who are subject to an FFD will be installed and operated when the
personnel providing technical input program for construction in terms of the plant begins operations.
would be subject to the requirements of duties they will perform. The former rule and the proposed rule
§ 26.205. The definition explicitly states The former rule in § 26.2(c) imposed also did not specify the individuals who
the criteria that the term ‘‘directing’’ FFD requirements on construction would be subject to an FFD program for
refers to an individual who is ‘‘directly permit holders ‘‘with a plant under construction. The NRC recognizes that
involved in the execution of the work active construction’’ but did not define there will be other construction work
activity’’ or ‘‘is ultimately responsible that term. The proposed rule in § 26.3(e) performed at the location where a new
for the correct performance of that work would have required an FFD program plant will be constructed and operated
activity’’ as opposed to, for example, the for construction following NRC that will not have the potential to affect
planning, development or scheduling of authorization to construct. However, the public health and safety and the
the activity, and that the technical input NRC recognizes that there may be a common defense and security when the
does not receive ‘‘subsequent technical period of time that elapses between the nuclear power plant begins operations,
review.’’ The NRC believes that, in the authorization to construct and the such as constructing a building that will
context of Subpart I, the revised commencement of specific construction be used only for training or
definition more clearly focuses on activities that have the potential to administration purposes. The NRC does
activities that have the potential to affect public health and safety and the not intend that individuals who are
substantively and immediately affect common defense and security when the performing these other construction
safety. These changes are consistent nuclear power plant begins operations.
activities must be subject to the FFD
with the changes that the NRC has made Therefore, the NRC has added a
program. Therefore, the final rule also
to the final rule in Subpart I and meet definition of ‘‘constructing and
includes definitions of safety- and
Goal 6 of this rulemaking as it relates to construction activities’’ to clarify that an
security-related SSCs to clarify that only
improving clarity in the language of the FFD program for construction is not
those individuals who are constructing
rule. required until a licensee or other entity
(i.e., fabricating, erecting, integrating,
Similarly, with respect to the begins ‘‘fabricating, erecting, integrating,
testing, and installing foundations of)
proposed rule, the NRC has added the and testing safety- and security-related
these specific SSCs must be subject to
term ‘‘supervises or manages’’ to the SSCs, and the installation of their
a Subpart K program. Thus, as one
final rule. The definition of ‘‘supervises foundations, including the placement of
or manages’’ explicitly states the criteria concrete.’’ example of a safety-related SSC, the rule
that the term refers to an individual who In addition, this definition specifies requires individuals who are
is ‘‘not directly involved in the that the FFD program for construction constructing the containment structure
execution of the work activity,’’ but who applies only to construction activities that surrounds the reactor to be subject
either makes technical decisions that are performed at the location where to an FFD program because the
without technical review, or is the new plant will be constructed and containment is relied on to mitigate the
‘‘ultimately responsible for the correct operated. The NRC added this phrase to consequences of accidents that could
performance of that work activity,’’ as the definition of construction activities result in potential offsite exposure.
opposed to, for example, the planning, to clarify that any fabrication, Similarly, individuals who are
development or scheduling of the integration, or testing of safety- or constructing security-related SSCs, such
activity, and that the technical input security-related SSCs that is not as the central and secondary alarm
does not receive ‘‘subsequent technical performed within or near the licensee’s stations, physical barriers,
review.’’ This definition is intended to or other entity’s owner-controlled area communications systems, guard towers,
clearly focus on activities that have the in which the new plant will be operated surveillance and detection systems, or
potential to substantively and would not be subject to Subpart K. For installing locks and illumination
immediately affect safety. These example, fabricating, integrating, and systems, that will be necessary to
changes are consistent with the changes testing safety- or security-related SSCs implement the physical security and
that the NRC has made to the final rule at a vendor’s or manufacturer’s facility safeguards contingency plans that are
in Subpart I and meet Goal 6 of this that is located in another city or state or required under 10 CFR Part 73 also are
rulemaking as it relates to improving outside of the U.S. would not be subject subject to an FFD program for
clarity in the language of the rule. to Subpart K, whereas producing the construction.
The final rule, with respect to the concrete to be used for the foundation The development of the revised
proposed rule, also adds several terms of the reactor building in a facility requirements contained in Subpart K
that are necessary to interpret and located on the site where the nuclear (described in Sections V and VI of this
implement the requirements in Subpart power plant will be constructed and document) compelled the NRC to define
K. The final rule includes definitions of operated would be subject to Subpart K these terms in the final rule. Adding
‘‘constructing or construction (although the construction of the cement definitions of these terms satisfies Goal
activities,’’ ‘‘safety-related SSCs,’’ and mixing facility would not). The NRC 6 of this rulemaking as it relates to
‘‘security-related SSCs.’’ The NRC has anticipates that the focus of the Subpart improving clarity in the language of the
added these definitions in response to K program on construction activities rule.
The final rule also adds many terms The NRC has modified the definition plain language in its regulations and to
related to other revisions to the former of ‘‘collection site’’ in the final rule to meet Goal 6 of this rulemaking to
rule. Specifically, the final rule adds include a reference to oral fluids as improve clarity in the organization and
‘‘analytical run’’ for use in establishing specimens that are acceptable for initial language of the final rule.
amended performance testing alcohol testing. The basis for permitting
Section 26.8 Information Collection
requirements for licensee testing the use of oral fluids for initial alcohol
facilities in § 26.137 [Quality assurance testing is discussed in Section VI of this Requirements: OMB Approval
and quality control]. For consistency document with respect to § 26.83(a). Section 26.8 in the final rule amends
with the use of the term in the related The final rule replaces the term former § 26.8 [Information collection
regulations of other Federal agencies, ‘‘collection site person’’ with the term requirements: OMB approval] to reflect
the term ‘‘donor’’ replaces the former ‘‘collector’’ to simplify the terminology the modified sections of the final rule in
terms that are used to refer to an used to refer to individuals who collect which recordkeeping requirements are
individual from whom a specimen is specimens for testing and for incorporated.
collected for drug or alcohol testing. The consistency with the terminology used
by other Federal agencies. In addition, Section 26.9 Specific Exemptions
new term ‘‘nominal’’ refers to the
leeway in the time periods within the definition no longer includes the Section 26.9 in the final rule revises
which certain requirements must be qualifications required for collectors former § 26.6 [Exemptions] to include
met, such as the requirement for annual because they are specified in § 26.85 the citation of 10 CFR 50.12 and 70.17.
FFD refresher training in § 26.29(c)(2). [Collector qualifications and The NRC has made this change in the
The term ‘‘other entity’’ refers to responsibilities]. final rule to ensure consistency between
organizations who are subject to Part 26, The final rule adds the term Part 26 and these related requirements.
but who are not licensed by the NRC, ‘‘contractor/vendor (C/V),’’ combining
the definitions of ‘‘contractor’’ and Section 26.11 Communications
including, but not limited to, the
organizations who hold the NRC ‘‘vendor’’ in the former rule, because the New § 26.11 in the final rule improves
certificates or permits listed in § 26.3. final rule does not distinguish between consistency with similar sections in
The terms ‘‘formula quantity’’ and the two types of entities. other parts of 10 CFR and ensures that
‘‘strategic special nuclear material’’ The final rule updates the definition communications with the NRC are
(SSNM) have been defined consistently of ‘‘HHS-certified laboratory’’ to addressed and, therefore, processed
with the definitions of the same terms reference the most recent version of the properly.
in 10 CFR 70.4. The term ‘‘subversion HHS Mandatory Guidelines for Federal
Subpart B—Program Elements
and subvert the testing process’’ clarifies Workplace Drug Testing Programs.
the language of provisions related to In addition, the final rule simplifies Throughout Subpart B, the final rule
urine specimen validity testing, as the definition of ‘‘licensee testing makes minor clarifications to the
discussed with respect to facility’’ by eliminating the reference to proposed rule because of public
§ 26.31(d)(3)(i), and sanctions in collecting specimens for alcohol testing comment, to make conforming changes,
§ 26.75(b) that are imposed on in the former definition, because alcohol and to meet Goal 6 of this rulemaking
individuals who are subject to Part 26. testing typically occurs at a collection to improve clarity in the organization
Section 26.5 of the final rule also site rather than at the licensee testing and language of the rule.
retains and amends a number of other facility. Also, with respect to the The final rule also makes more
definitions formerly contained in § 26.3 proposed rule, the NRC has clarified substantive changes to the proposed
and Section 1.2 in Appendix A to Part this definition in the final rule to be rule in this subpart because of public
26, as described in the following consistent with the inclusion of comment or to improve clarity in the
paragraphs. specimen validity testing at licensee organization and language of the rule.
The rule revises the former definition testing facilities. The substantive changes in this subpart
of ‘‘aliquot’’ to clarify that an aliquot is Finally, the final rule eliminates six can be found in §§ 26.21; 26.27(b)(3),
a representative sample of a urine terms that were defined in former § 26.3 (c)(1), (c)(2)(ii), (c)(3), and (c)(3)(ii);
specimen that may be used for testing. and Section 1.2 in Appendix A to Part 26.29(c)(2); 26.31(d)(1)(ii), (d)(1)(iii),
The amended definition is consistent 26. Specifically, the rule eliminates (d)(2)(i)(A), (d)(2)(v), (d)(3)(i), and
with the same definition in the HHS ‘‘followup testing,’’ ‘‘random test,’’ (d)(3)(iii); 26.35(b); 26.37(a), (b)(5) and
Guidelines. ‘‘suitable inquiry,’’ ‘‘reason to believe,’’ (d); 26.39(c) and (e); and 26.41(a). These
The final rule simplifies the former and ‘‘split specimen’’ because the text of changes are discussed in detail below.
definition of ‘‘blood alcohol the rule defines them in the section However, other than the changes
concentration (BAC)’’ by deleting where each term is used. The rule also mentioned above, the final rule adopts
references to the instruments that eliminates the term ‘‘permanent record the provisions of this subpart as
licensees and other entities are book’’ in former Section 1.2 in proposed, without change.
permitted to use for alcohol testing. The Appendix A to Part 26 because Section 26.21 Fitness-for-Duty
text of § 26.91 [Acceptable devices for laboratories now use other mechanisms Program
conducting initial and confirmatory to maintain testing records. Therefore,
tests for alcohol and methods of use] this term is no longer used in the rule. The final rule modifies the proposed
specifies acceptable devices for alcohol rule’s text in this section to specify
Section 26.7 Interpretations which entities and individuals are
testing under the final rule.
The final rule revises the definition of Section 26.7 in the final rule retains subject to the requirements of this
‘‘category IA material’’ to conform with former § 26.4 [Interpretations] but subpart. This section requires that the
the former definition contained in 10 moves the qualifying phrase, ‘‘other licensees and other entities specified in
CFR 74.4. than a written interpretation by the § 26.3(a) through (c) must establish,
The final rule expands the definition General Counsel,’’ to the end of the implement, and maintain FFD programs
of ‘‘chain of custody’’ to indicate that sentence to improve its clarity. The NRC that, at a minimum, comprise the
the terms ‘‘chain of custody’’ and has made this change in keeping with program elements contained in this
‘‘custody and control’’ are synonymous. the Commission’s commitment to using subpart. This new statement serves as
an introduction to the remaining text of systems, their trustworthiness and their trustworthiness and reliability. In
the final rule and eliminates the need reliability are essential. This level of combination with other measures the
for the phrase ‘‘[licensees and other emphasis is necessary to reduce the risk NRC has taken since September 11,
entities] who are subject to this subpart’’ of an insider threat, maintain public 2001, a number of the changes to the
(or a derivation of this phrase) from health and safety, and provide for the former rule provide further assurance
several provisions in this subpart. These common defense and security in the that individuals who are subject to the
changes are consistent with Goal 6 of post-September 11, 2001, threat rule are trustworthy and reliable.
this rulemaking to improve clarity in the environment. Substance abuse by these Changes to strengthen the effectiveness
organization and language of the rule. individuals presents an unacceptable of the final rule in assuring individuals’
The NRC has also added a sentence to risk to public health and safety and the trustworthiness and reliability include,
this section to specify which common defense and security in several but are not limited to, the following:
individuals are subject to FFD programs. ways. (1) Adding requirements for specimen
The sentence in the final rule includes First, by increasing an individual’s validity testing to identify individuals
cross-references to provisions in § 26.4 vulnerability to coercion, substance who are willing to attempt to subvert
[FFD program applicability to categories abuse increases the likelihood that such the testing process, and may be willing
of individuals], which eliminates the individuals may pose an insider threat. to subvert other rules and regulations
need for the phrase ‘‘[individuals] who Under 10 CFR 73.1 [Purpose and scope], that are important for public health and
are subject to this part’’ (or a derivation a passive insider is defined as an safety and the common defense and
of this phrase) from several provisions individual who obtains or attempts to security;
in this subpart. This change is obtain safeguards or other relevant (2) Increasing the rigor of the
consistent with Goal 6 of this information, such as a nuclear power evaluations that licensees and other
rulemaking to improve clarity in the plant’s physical configuration and entities must perform before granting
organization and language of the rule. design, and who does not have a authorization to an individual who has
The third sentence of the section of functional or operational need to know previously violated Part 26
the final rule is based on former this information. Section 73.1 defines an requirements to ensure that the
§ 26.23(b). This provision retains active insider as a knowledgeable individual has ceased abusing drugs or
permission for licensees and other individual who, while within the alcohol; and
entities to rely upon the FFD program or protected area of a nuclear power plant (3) Imposing more stringent sanctions
program elements of a C/V to meet the in an unescorted status, takes direct on individuals who violate Part 26
requirements of this part, if the FFD action to facilitate entrance and exit, requirements, including, but not limited
program or program element of a C/V disable alarms and communications, to, permanently denying authorization
meets the applicable requirements of and/or participates in a violent attack. to any individual who attempts to
this part. The other requirements An individual who uses illegal drugs subvert the drug and alcohol testing
contained in former § 26.23 [Contractors may be coerced into cooperating, process.
and vendors] are discussed with respect actively or passively, with a terrorist in The NRC believes that
to § 26.23 [Performance objectives]. an attempt to commit radiological implementation of these provisions of
sabotage if, for example, the terrorist the final rule, in addition to related
Section 26.23 Performance Objectives measures the agency has taken in the
were to threaten the individual with
Section 26.23 amends former § 26.10 revealing his or her illegal drug use or post-September 11, 2001, threat
[General performance objectives] as was somehow able to withhold drugs environment, provides an increased
described in the following paragraphs. from an individual who is addicted. level of requirements appropriate for the
The final rule divides the Second, an individual’s judgment and new threat environment, as well as
performance objectives contained in self-control are impaired while an reasonable assurance that individuals
§ 26.10(a) into two provisions (§ 26.23(a) individual is abusing drugs or alcohol. who are subject to the rule are
and (b), respectively) to clarify that the When an individual is intoxicated from trustworthy and reliable.
performance objective of assuring that abusing any of the substances for which Section 26.23(b) of the final rule
personnel are trustworthy and reliable is testing is conducted under Part 26, retains the performance objective of
separate and distinct from the including alcohol, the individual is providing reasonable assurance that
performance objective of assuring that more likely to inadvertently reveal personnel are fit for duty, which
personnel are fit for duty. sensitive information that terrorists appeared in former § 26.10(a). The use
Section 26.23(a) of the final rule could use in a radiological sabotage of the term ‘‘reasonable’’ to describe the
requires that FFD programs provide attempt than when he or she is not level of assurance required by the rule
reasonable assurance that persons who intoxicated. reflects the NRC’s awareness that many
are subject to this part are trustworthy Third, the use of illegal drugs different factors may affect an
and reliable as demonstrated by the establishes that an individual is willing individual’s fitness at any particular
avoidance of substance abuse and the to disobey the law, thus indicating that moment in time. Some of these factors
adverse behaviors that accompany it. the individual will disregard other rules may be difficult for the licensee or other
The NRC has placed an increased and regulations. The use of illegal drugs entity to detect and many (such as a
emphasis on the trustworthiness and raises questions about the individual’s transitory illness) may not warrant
reliability of individuals who have trustworthiness and reliability in terms management action or the imposition of
access to certain types of sensitive of scrupulously following the sanctions because they do not pose a
information, certain types of regulations, procedures, and other significant risk to public health and
radiological materials, and protected requirements, such as safeguards safety.
areas in nuclear power plants since requirements, that ensure the protection As mentioned above, the level of
September 11, 2001. These are the same of public health and safety. requirements associated with achieving
individuals who are subject to the final Many provisions of the former rule reasonable assurance of trustworthiness
rule. Because these individuals have provided means to identify and reduce and reliability is greater than that
unimpeded access to sensitive the risks posed by any individuals associated with achieving reasonable
information and safety equipment and whose substance abuse casts doubt on assurance that individuals are not
impaired. Another example of this the individual to resume his or her effects of such substances’’ do not
relates to the sanctions that the final duties after the headache is resolved. accurately capture the NRC’s intent with
rule requires licensees and other entities Another difference between the respect to this performance objective.
to impose on individuals who performance objectives of providing These terms could be misunderstood as
demonstrate questionable ‘‘reasonable’’ assurance of requiring FFD programs to have the goal
trustworthiness and reliability trustworthiness and reliability and of preventing any drugs and their effects
compared to the management actions ‘‘reasonable’’ assurance that the from being present in the workplace,
licensees are expected to take with individuals who are subject to the final which could include medications that
individuals who may be impaired. For rule are fit for duty lies in the severity individuals who are subject to the rule
example, if an individual demonstrates of the enforcement actions that the NRC may take to treat health problems.
dishonesty by attempting to bring a would be likely to take against an FFD Therefore, the final rule replaces ‘‘drug-
substitute urine specimen to the program that failed to meet these free’’ and ‘‘free of the effects of such
collection site with a clear intent to performance objectives. The NRC’s substances’’ with the more specific
enforcement actions would be severe in phrase ‘‘free from the presence and
subvert the testing process or
the case of an FFD program that, for effects of illegal drugs and alcohol’’ to
demonstrates a willingness to break the
example, granted authorization to an refer to the specific substances that are
law by possessing illegal drugs on site,
individual who had previously had his proscribed. This revision clarifies that
the final rule (under § 26.75(b) and or her authorization permanently the NRC does not intend for FFD
26.75(c), respectively) requires the denied under § 26.75(b) but would take programs to prohibit individuals from
licensee or other entity to terminate the less severe enforcement action in the taking the medications they need to
individual’s authorization. Terminating case of an FFD program that failed to maintain their health or bringing those
the individual’s authorization is remove an individual who was medications to the workplace. The NRC
necessary to provide reasonable experiencing impairment related to has made this change to meet Goal 6 of
assurance that the individual could pose family stress from his or her duties this rulemaking to improve clarity in the
no further risk to public health and under § 26.77(b)(3). organization and language of the rule.
safety or the common defense and Section 26.23(c) of the final rule The final rule also replaces the phrase
security. In contrast, the final rule does retains the performance objective in ‘‘have a goal of’’ in the former rule with
not require a licensee or other entity to former § 26.10(b) to ‘‘provide reasonable the phrase ‘‘provide reasonable
terminate an individual’s authorization measures for the early detection of assurance’’ which more accurately
if he or she is mentally or physically persons who are not fit to perform captures the intent of this performance
impaired while on duty from such activities within the scope of this part.’’ objective. The NRC has eliminated the
transitory causes as illness or emotional However, the final rule replaces the phrase ‘‘have a goal of’’ because
stress resulting from a family problem. phrase ‘‘perform activities within the § 26.23(d) is a performance objective
For example, an individual who scope of this part’’ with the phrase and, therefore, the phrase is
arrives at work with a severe migraine ‘‘perform the duties that require them to unnecessary. The NRC has made this
headache may suffer impairment on the be subject to the FFD program.’’ The change to meet Goal 6 of this
job that would adversely affect the final rule requires that certain rulemaking to improve clarity in the
individual’s ability to perform his or her individuals must be subject to an FFD organization and language of the rule
duties safely and competently while the program based on their duties. These without changing the intended meaning
duties include performing activities, of the performance objective.
headache persists. The final (and
such as measuring, guarding, or Section 26.23(e) of the final rule adds
former) rule (under § 26.77(b)(3) and
transporting Category IA material. They a provision to require licensees and
former § 26.27(b)(1), respectively)
also include having access to certain other entities to provide reasonable
require the licensee or other entity to
locations, material, and sensitive assurance that the effects of fatigue and
take action to prevent the individual
information, such as nuclear power degraded alertness on individuals’
from performing the duties that require plant protected areas, Category IA abilities to safely and competently
the individual to be subject to this part material, procedures and records for perform their duties are managed
if the individual’s fitness is safeguarding SSNM, and the drug test commensurate with maintaining public
questionable. These actions could results of an individual before the MRO health and safety. This new
include, for example, assigning the reviews those results. Therefore, the performance objective, consistent with
individual to other duties until phrase ‘‘perform the duties that require Goal 2 of this rulemaking to strengthen
medication brings the headache under them to be subject to the FFD program’’ the effectiveness of FFD programs at
control or sending the individual home is more accurate. Replacing the former nuclear power plants in ensuring
until the headache resolves. Such phrase with the more accurate phrase is against worker fatigue adversely
actions ‘meet the performance objective consistent with Goal 6 of the rulemaking affecting public health and safety and
of providing reasonable assurance that to improve clarity in the organization the common defense and security by
the individual is fit when he or she and language of the rule. establishing clear and enforceable
resumes his or her normal duties. Section 26.23(d) of the final rule requirements for the management of
However, it would be unreasonable for amends former § 26.10(c) to require that worker fatigue, specifies the objective of
a licensee’s FFD policy to impose FFD programs must provide reasonable the requirements concerning worker
sanctions on the individual, such as assurance that the workplaces subject to fatigue that the NRC has added to the
terminating his or her authorization. this part are free from the presence and final rule. Worker fatigue cannot be
Sanctions could have no deterrent effect effects of illegal drugs and alcohol. The measured or controlled with precision.
on the recurrence of the individual’s final rule revises the former Also, licensees and other entities do not
headache, which is one purpose of performance objective to ‘‘have a goal of have direct control over all matters that
including requirements for minimum achieving a drug-free workplace and a may influence worker fatigue.
sanctions in Part 26. In addition, there workplace free of the effects of such Therefore, § 26.23(e) establishes a
would not be any continuing risk to substances’’ for several reasons. First, ‘‘reasonable assurance’’ criterion for the
public health and safety from permitting the terms ‘‘drug-free’’ and ‘‘free from the performance objective. Worker fatigue
can result from many causes (e.g., work other than licensees are subject to this with respect to, for example, the
hours, sleep disorders, demands outside requirement, as discussed with respect sanctions that are applied for confirmed
the workplace). In addition, individuals to § 26.3 [Scope]. The final rule adds the positive, adulterated, or substituted test
differ in their responses to conditions term ‘‘maintain’’ to the former results, the cutoff levels used in drug or
that cause fatigue. As a consequence, requirement to ‘‘establish and alcohol testing, or the time periods
work-hour limits alone do not address implement’’ written policies and within which an individual who has
all causes of fatigue, nor do they prevent procedures to reflect the fact that been selected for random testing must
fatigue related to work hours for all licensees and other entities who are report to the collection site.
workers. Contemporary methods for subject to Part 26 must occasionally Under this final rule, the written FFD
addressing worker fatigue (e.g., Rogers, revise FFD program policies and policy continues to be the primary
1996, 1997; Hartley, 1998; Carroll, 1999) procedures to keep them current when means by which a licensee or other
are commonly referred to as ‘‘fatigue FFD program personnel or other aspects entity communicates local variations in
management’’ programs and use diverse of the FFD program change. The final FFD policy. In the past, however, a few
methods (e.g., training, behavioral rule replaces ‘‘specific’’ with the term individuals challenged determinations
observation, fatigue countermeasures) in ‘‘applicable’’ in the final sentence that they had violated a licensee’s FFD
addition to work-hour controls to because all the requirements in Part 26 policy on the basis that they were not
prevent, detect, and mitigate fatigue. do not apply to all the licensees and aware of the specific provisions of the
Accordingly, § 26.23(e) establishes a other entities who are subject to the policy to which they were subject.
performance objective of reasonable rule, as discussed with respect to § 26.3. Therefore, the final rule adds
assurance that the effects of fatigue and The final rule also eliminates ‘‘designed requirements that the FFD policy must
degraded alertness on individuals’ to’’ from this sentence because it is be clear, concise, and readily available
abilities to safely and competently unnecessary. The NRC has moved the in order to promote individuals’
perform their duties are ‘‘managed’’ records retention requirements awareness of the site-specific FFD
commensurate with maintaining public contained in the second sentence of the policy to which they are subject. The
health and safety. The performance former provision to § 26.713(d) in NRC has made this change to meet Goal
objective permits licensees and other Subpart N [Recordkeeping and 7 of this rulemaking to protect the rights
entities to apply risk-informed fatigue Reporting Requirements] of the final (including due process) of individuals
management controls for individuals rule. Subpart N groups together the who are subject to Part 26.
consistent with the significance of their recordkeeping and reporting The final rule also adds examples of
work activities to the protection of requirements that are interspersed acceptable methods to make the written
public health and safety. throughout the former rule. The NRC policy ‘‘readily available’’ to individuals
has made these changes to the who are subject to the FFD policy,
Section 26.25 [Reserved]
organization and language of former
The final rule has amended and including, but not limited to, posting
§ 26.20 to meet Goal 6 of this
moved the requirements from proposed the policy in various work areas
rulemaking to improve clarity in the
§ 26.25 [Individuals subject to the throughout the licensee’s or other
organization and language of the rule.
fitness-for-duty program] to § 26.4 of the Section 26.27(b) of the final rule entity’s facilities, providing individuals
final rule. This change is discussed in amends former § 26.20(a). The former with brochures, or allowing individuals
detail in this document with regard to provision established requirements for to print the policy from a computer. The
§ 26.4. the written FFD policy, and the final NRC has added these examples to meet
rule expands the list of topics that the Goal 6 of this rulemaking to improve
Section 26.27 Written Policy And clarity in the organization and language
Procedures FFD policy must address as a result of
discussions with stakeholders during of the rule.
Section 26.27 of the final rule the public meetings mentioned in Section 26.27(b)(1) amends the
reorganizes and amends former § 26.20 Section I.D. Stakeholders noted that the second sentence of former § 26.20(a).
[Written policy and procedures. The list of topics in the former rule is Former § 26.20(a) required that ‘‘the
final rule divides into separate incomplete because it does not include policy must address the use of illegal
paragraphs the requirements related to many topics about which individuals drugs and abuse of legal drugs (e.g.,
the FFD policy and FFD program who are subject to the policy should be alcohol, prescription and over-the-
procedures that are intermixed within aware in order to be able to comply with counter drugs).’’ Section 26.27(b)(1) of
the former section. This organizational the policy. Therefore, the final rule adds the final rule expands this sentence to
change makes the requirements related topics to the policy content require the FFD policy to describe the
to the FFD policy and procedures easier requirements in former § 26.20(a) to consequences of onsite or offsite use,
to locate within this section, consistent ensure that FFD policies will be sale, or possession of illegal drugs in
with Goal 6 of this rulemaking to complete. The NRC has made this § 26.27(b)(i); the abuse of legal drugs
improve clarity in the organization and change to meet Goal 7 of this and alcohol in § 26.27(b)(ii); and the
language of the rule. rulemaking to protect the rights misuse of prescription and over-the-
Section 26.27(a) of the final rule (including due process) of individuals counter drugs in § 26.27(b)(iii). The final
amends the first paragraph of former who are subject to Part 26. rule replaces the phrase ‘‘must address’’
§ 26.20. The former provision required Section 26.27(b) of the final rule also in the former sentence with the phrase
licensees to establish and implement adds requirements for the written FFD ‘‘must describe the consequences of.’’
written policies and procedures policy to be clear, concise, and readily The updated phrase clarifies the
designed to meet the performance available to all individuals who are information that the policy must convey
objectives and specific requirements of subject to the policy because neither the to ensure that individuals who are
this part and to retain superseded copies former nor final rules require licensees subject to the policy are aware of the
of the policies and procedures. The final and other entities to provide site- consequences of these actions, as
rule replaces the term ‘‘licensee’’ in the specific FFD training to individuals. specified in the licensee’s or other
former rule with the phrase ‘‘licensees However, FFD policies may vary entity’s FFD policy. The NRC has made
and other entities’’ because entities between licensees and other entities these changes to meet Goal 6 of this
rulemaking to improve clarity in the with Goal 6 of the rulemaking to BACs above the cutoff levels specified
organization and language of the rule. improve clarity in the language and in § 26.103 [Determining a confirmed
The final rule adds § 26.27(b)(2) that organization of the rule. This provision positive test result for alcohol]
requires the FFD policy to state the time ensures that persons who are subject to preceding a scheduled tour of duty,
period specified by the licensee or other the rule are aware of § 26.75(b), which depending on the amount of alcohol and
entity within which individuals must requires licensees and other entities to food that the individual consumed
report to the collection site after being impose the sanction of permanent before the abstinence period began,
notified that they have been selected for denial of authorization for these actions. body weight, and other factors. By
random testing. The provision does not Section 26.27(b)(3) protects the due ensuring that individuals who are
establish a time limit because there are process rights of individuals who are subject to this part are aware that the
a variety of circumstances among the subject to drug and alcohol testing required 5-hour abstinence period may
different licensees and other entities under this part by ensuring that they are be insufficient to ensure they have a
who are subject to this rule that make informed, in advance, of the licensee’s BAC below the cutoff levels in this part
it impractical to establish a universal or other entity’s policies to which they when arriving at the licensee’s or other
time limit. However, adding the are subject. Therefore, adding this entity’s facility, this provision to meet
requirement for the licensee’s or other requirement to the final rule meets Goal Goal 7 of this rulemaking to protect the
entity’s FFD policy to establish and 7 of this rulemaking to protect the rights rights (including due process) of
convey a time limit is necessary because (including due process) of individuals individuals who are subject to alcohol
some programs have not done so. As a who are subject to Part 26. testing under Part 26.
result, circumstances have arisen in Section 26.27(b)(4)(i) amends former
Section 26.27(b)(6) amends the last
which individuals who were selected § 26.20(a)(1). Former § 26.20(a)(1)
sentence of former § 26.20(a). That
for random testing intentionally delayed required the FFD policy to prohibit the
sentence required the FFD policy to
reporting to the collection site in order consumption of alcohol within an
address other factors that could affect
to take steps to subvert the testing abstinence period of at least 5 hours
individuals’ abilities to perform their
process, such as obtaining an adulterant preceding ‘‘any scheduled working
duties safely and competently, such as
to bring to the collection site or drinking tour.’’ The final rule replaces the phrase
mental stress, fatigue, and illness. The
large amounts of liquid to be able to ‘‘any scheduled working tour’’ with the
final rule adds a requirement for the
provide a dilute specimen. Furthermore, phrase ‘‘the individual’s arrival at the
FFD policy also to address the use of
the longer that an individual who has licensee’s or other entity’s facility’’ as a
abused illegal drugs or alcohol is able to result of stakeholder comments on the prescription and over-the-counter
delay providing specimens for testing, language in the former rule at the public medications that could cause
the more likely it is that the meetings mentioned in Section I.D. The impairment at work. For example, some
concentrations of an illegal drug or stakeholders commented that the former licensees or other entities may require
alcohol in the individual’s urine, breath, phrase lacked clarity and could be individuals to self-report to the FFD
or oral fluids will decrease because of misinterpreted as meaning, ‘‘any program their use of any prescription
metabolism. As a result, the working tour scheduled by the licensee medications that are labeled with a
concentrations may fall below the cutoff or other entity.’’ If the phrase was so warning indicating that use of the
levels for those substances by the time interpreted, individuals who are subject medication may cause impairment. The
the specimens are collected and the to the rule may believe that, if they work licensee’s or other entity’s FFD policy
individual’s substance abuse would not on a weekend or work overtime that is may require that an individual who is
be detected. Therefore, the requirement not part of their normally scheduled taking a medication that can cause
to establish a time limit within which working tour, the rule would permit impairment must be temporarily
individuals must report for random them to consume alcohol within the 5- reassigned to duties that the individual
testing after notification meets Goal 3 of hour period before they arrive at work, can perform without posing a risk to the
this rulemaking to improve the which would be incorrect. Therefore, individual or public health and safety
effectiveness and efficiency of FFD the revised language of the final rule while he or she is taking the medication.
programs. The final rule also requires clarifies that the pre-work abstinence Therefore, the final rule requires
the FFD policy to convey this time limit period applies to the 5 hours before an licensees and other entities to include
to ensure that individuals are aware of individual arrives at the licensee’s or such information in the FFD policy to
it, given that a failure to appear for other entity’s facility for any purpose, ensure that individuals are aware of the
testing within the prescribed time limit except if an individual is called in to actions they may be required to take
may lead to the imposition of sanctions perform an unscheduled working tour, when using these substances, consistent
under the FFD policy. The NRC has as discussed with respect to with Goal 7 of this rulemaking with
made this change to meet Goal 7 of this § 26.27(c)(3). The NRC has made this respect to protecting the rights
rulemaking to protect the rights final change to meet Goal 6 of this (including due process) of individuals
(including due process) of individuals rulemaking to improve clarity in the who are subject to the policy. The
who are subject to Part 26. organization and language of the rule. addition of this requirement also
Section 26.27(b)(3) adds a Section 26.27(b)(4)(ii) retains former increases the internal consistency of the
requirement that the FFD policy inform § 26.20(a)(2) without change. rule because other portions of the final
individuals of the consequences of The NRC has added § 26.27(b)(5) to rule establish requirements related to
refusing to be tested and attempting to the final rule to require that the FFD using prescription and over-the-counter
subvert the testing process. With respect policy inform individuals that medications. For example, § 26.29(a)(6)
to the proposed rule, the final rule abstinence from alcohol during the 5 requires FFD training to address use of
clarifies that the written policy hours preceding any scheduled tour of prescription and over-the-counter
statement must also describe the actions duty may not be sufficient to ensure that medication. Also, § 26.185(j)(2) requires
that constitute a refusal to provide a an individual is fit for duty upon the MRO to determine whether a
specimen for testing. This change, in reporting to work. Some individuals positive confirmatory drug test result
response to a public comment, clarifies who have complied with the 5-hour that results from using a prescription or
the intent of the provision, consistent abstinence requirement could have over-the-counter medication represents
substance abuse. Therefore, the entity would implement if an individual effectiveness of Part 26 by ensuring the
requirement for the FFD policy to violates the FFD policy to § 26.27(c) of early detection of individuals who are
address the use of prescription and the final rule, which addresses FFD not fit to perform the duties that require
over-the-counter medications that could program procedures, for organizational them to be subject to this part. This is
cause impairment at work also meets clarity. one of the performance objectives that
Goal 6 of this rulemaking to improve Section 26.27(b)(9) adds a FFD programs must meet, as discussed
clarity in the organization and language requirement that licensees’ and other with respect to § 26.23(c). This
of the rule. entities’ FFD policies must describe the provision also improves consistency
Section 26.27(b)(7) amends former individual’s responsibility to report between FFD requirements and access
§ 26.20(b). Former § 26.20(b) required legal actions, as defined in § 26.5 authorization requirements established
the FFD policy to describe programs [Definitions]. The new requirement to in 10 CFR 73.56 [Personnel access
that are available to individuals desiring report legal actions is discussed with authorization requirements for nuclear
assistance in dealing with drug, alcohol, respect to § 26.61 [Self-disclosure and power plants] as supplemented by
or other problems that may adversely employment history]. The final rule orders to nuclear power plant licensees
affect their performance of their duties. requires the FFD policy to address the dated January 7, 2003, as discussed in
Section 26.27(b)(7) of the final rule adds reporting of legal actions to ensure that Section IV.B of this document. The
fatigue as one of the problems for which individuals are aware of this and are not specific requirement in § 26.27(b)(11)
individuals may be seeking assistance at risk of sanctions for failing to report for licensees’ and other entities’ FFD
because sleep disorders (e.g., sleep any legal actions. Thus, the NRC has policies to state that individuals must
apnea, insomnia, restless leg syndrome) made this change to meet Goal 7 of this report FFD concerns is necessary to
can substantially affect individuals’ rulemaking to protect the rights ensure that individuals are aware of
abilities to obtain sufficient quality (including due process) of individuals their responsibility to report concerns
sleep. Poor quality sleep causes fatigue who are subject to the policy. (and that sanctions may be imposed if
that may degrade an individual’s ability Section 26.27(b)(10) adds a they do not) to meet Goal 7 of this
to safely and competently perform his or requirement for the FFD policy to rulemaking to protect the rights
her duties. Sleep disorders affect a describe the responsibilities of (including due process) of individuals
sizeable portion of the U.S. work force. managers, supervisors, and escorts to who are subject to the policy.
According to polls conducted by NSF, report FFD concerns. The former rule Section 26.27(c) of the final rule
about two-thirds of U.S. adults report implied that managers and supervisors combines the requirements related to
experiencing one or more symptoms have the responsibility to report FFD procedures contained in former
associated with insomnia, sleep apnea, concerns in § 26.22(a)(5), which § 26.20(c) through (e), and adds other
or restless leg syndrome at least a few required managers and supervisors to be requirements, as described in the
nights a week (National Sleep trained in procedures ‘‘for initiating following paragraphs.
Foundation, 2003) and nearly one out of appropriate corrective action.’’ Section 26.27(c)(1) retains the
five (19 percent) report making Similarly, the last phrase of former requirements in former § 26.20(c). The
occasional or frequent errors because of § 26.22(b) required that escorts be NRC has replaced the phrase in the
sleepiness (National Sleep Foundation, trained in procedures ‘‘for reporting proposed rule ‘‘privacy and due process
2000). Section 26.27(b)(7) ensures that problems to supervisory or security rights of an individual who provides a
individuals are aware of the services personnel’’ and, therefore, also implied specimen’’ with the phrase ‘‘privacy and
that are available for diagnosing and that escorts have a reporting other rights (including due process) of
treating sleep disorders that can responsibility. However, the former rule an individual who provides a
adversely affect their job performance. did not explicitly state that the FFD specimen’’ in the final rule. The NRC
The NRC has made this change to meet policy must convey this requirement. has made this change in response to a
Goal 2 of this rulemaking to strengthen Therefore, the final rule adds public comment that stated the
the effectiveness of FFD programs at § 26.27(b)(10) to enhance the internal proposed phrase may be interpreted to
nuclear power plants by reducing the consistency of the rule. The NRC has limit individuals’ protected rights to
potential for worker fatigue to adversely made this change to meet Goal 6 of this due process. This phrase clarifies the
affect public health and safety and the rulemaking to improve clarity in the requirement for ‘‘protecting the
common defense and security, through organization and language of the rule. employee’’ contained in former
establishing clear and more readily Section 26.27(b)(11) adds a § 26.20(c). For example, individuals’
enforceable requirements concerning requirement for the FFD policy to state privacy rights under the final rule
the management of worker fatigue. In that individuals who are subject to the include, but are not limited to,
addition, the final rule replaces the rule must report FFD concerns, requirements for the protection of
phrase ‘‘adversely affect the consistent with § 26.33 [Behavioral personal information that is collected
performance of activities within the observation]. Section 26.33 requires about the individual and individual
scope of this part’’ in the former individuals who are subject to the rule privacy during specimen collections.
provision with the phrase ‘‘could to perform behavioral observation and Other examples of individuals’ rights
adversely affect an individual’s ability to report an FFD concern if they detect under the final rule include, but are not
to safely and competently perform the behaviors that may indicate possible limited to, the right to an objective and
duties that require an individual to be use, sale, or possession of illegal drugs; impartial review of a determination that
subject to this part’’ for the reasons use or possession of alcohol on site or the individual has violated the FFD
discussed with respect to § 26.23(c). while on duty; or impairment from policy, the right to advance knowledge
Section 26.27(b)(8) retains the fatigue or any cause that, if left of rule provisions and FFD policy
requirement in former § 26.20(d) that unattended, may constitute a risk to the requirements that affect the individual,
the FFD policy must specify the health and safety of the public. Section and the right to request testing of a split
consequences of violating the policy. 26.29 [Training] requires individuals to specimen or retesting an aliquot of a
The NRC has moved the former be trained in behavioral observation. single specimen, if the individual
requirements that were related to the The agency has added these questions a confirmed positive,
procedures that the licensee or other requirements to enhance the adulterated, or substituted test result.
The NRC has made this change to meet Section 26.27(c)(2)(v) adds a that this alternative would be less
Goal 6 of this rulemaking to improve requirement that the written procedures protective of public health and safety, as
clarity in the organization and language must describe immediate and followup an affirmative obligation to provide a
of the rule. actions for individuals who have had statement may dissuade individuals
Section 26.27(c)(2)(i) and (c)(2)(ii) drug- or alcohol-related legal actions who would be tempted to remain silent.
divides former § 26.20(d) into separate taken against them, as defined in § 26.5. Requiring individuals to report other
paragraphs that address different topics. This provision supports related conditions that may cause them to be
Section 26.27(c)(2)(i) retains the former provisions in § 26.69(d). Section impaired when called in under
requirement that licensees and other 26.69(d), in general, requires licensees § 26.27(c)(3)(i), strengthens the
entities must have procedures that and other entities to take certain steps effectiveness of FFD programs by
specify the immediate and followup if an individual has had drug- or providing the licensee or other entity
actions that must be taken if an alcohol-related legal actions taken with more complete information about
individual is determined to have been against them while they are maintaining the individual’s condition to determine
involved in the use, sale, or possession authorization to perform the duties that whether there is a need to establish
of illegal drugs. Like the former require them to be subject to this part. controls and conditions under which
provision, § 26.27(c)(2)(ii) requires Adding the requirement for procedures the individual may safely perform work,
licensees’ and other entities’ procedures to address these circumstances ensures as required under § 26.27(c)(3)(iii).
to specify the immediate and followup the internal consistency of the final rule Therefore, the NRC has adopted the
actions to be taken if an individual is and meets Goal 6 of this rulemaking to proposed provision as final. The NRC
determined to have consumed alcohol improve clarity in the organization and has made these changes to meet Goal 3
to excess before the mandatory prework language of the rule. of this rulemaking to improve the
abstinence period, or while on duty, as The NRC has reorganized § 26.27(c)(3) effectiveness and efficiency of FFD
determined by a test that measures BAC. of the final rule, with respect to the programs.
With respect to the proposed rule, the proposed rule, to clarify which
Section 26.27(c)(3)(ii) specifies the
final rule also adds the phrase ‘‘or provisions apply to ‘‘emergencies’’ and
procedures to follow if the individual
consumed any alcohol during the which apply to ‘‘unscheduled working
has consumed alcohol in the pre-duty
mandatory prework abstinence period’’ tours.’’ The NRC received a public
abstinence period and is called in for an
to clarify the prohibition against any comment that suggested the term
unscheduled working tour, including an
alcohol consumption, not only excess ‘‘emergency’’ may be too limiting.
consumption, during the pre-work However, the NRC believes the term unscheduled working tour to respond to
abstinence period. The NRC has made ‘‘emergency’’ accurately reflects NRC’s an emergency. Section 26.27(c)(3)(ii)(A)
these changes to meet Goal 6 of this intent and has retained this term in the retains former § 26.20(e)(2). The
rulemaking to improve clarity in the final rule. Section 26.27(c)(3) amends provision requires that an individual
organization and language of the rule. former § 26.20(e). The provision who reports that he or she has used
Section 26.27(c)(2)(iii) and (c)(2)(iv) requires licensees and other entities to alcohol and is called in must be subject
adds requirements that licensees and have procedures to describe the process to a determination of fitness by breath
other entities must prepare written that the licensee or other entity will use analysis. The NRC has added a new
procedures for implementing the FFD to ensure that individuals who are § 26.27(c)(3)(ii)(B) to the final rule to
program that describe immediate and called in to perform an unscheduled permit the licensee or other entity to
followup actions for attempted working tour are fit for duty. assign the individual to duties that
subversion of the testing process. The final rule retains and modifies the require him or her to be subject to this
Section 26.27(c)(2)(iii) requires other requirements of former § 26.20(e), part, if the results of the determination
procedures to specify immediate and as described in the following of fitness indicate that the individual is
followup actions if an individual has paragraphs. fit to safely and competently perform
attempted to subvert the testing process Section 26.27(c)(3)(i) retains former his or her duties. The NRC has also
by adulterating, substituting, or diluting § 26.20(e)(1). The provision requires the added a new § 26.27(c)(3)(ii)(C) to the
specimens (in vivo or in vitro), or by individual who is called in to state final rule to prohibit the licensee or
any other means. Section 26.27(c)(2)(iv) whether the individual considers other entity from assigning the
requires procedures to address the himself or herself fit for duty and individual to duties that require him or
actions to be taken if an individual has whether he or she has consumed her to be subject to this part, if the
refused to provide a specimen for alcohol within the pre-duty abstinence individual is not required to respond to
testing. The final rule adds these period stated in the FFD policy. The an emergency and the results of the
provisions for consistency with final rule adds the requirement to state determination of fitness indicate that
§ 26.75(b). Section 26.75(b) requires whether he or she considers himself or the individual may be impaired. The
licensees and other entities to terminate herself to be fit for duty, in addition to NRC has also added § 26.27(c)(3)(ii)(D)
an individual’s authorization and, stating whether he or she has consumed that retains a portion of former
thereafter, permanently deny alcohol because the NRC recognizes that § 26.20(e)(3). The provision requires the
authorization to any individual who has conditions other than the consumption procedures to state that consumption of
committed or attempted any act to of alcohol may cause an individual to be alcohol during the 5-hour abstinence
subvert the testing process, including unable to safely and competently period required in paragraph (b)(4)(i) of
refusing to provide a specimen and perform duties, including, but not this section may not by itself preclude
providing or attempting to provide a limited to, fatigue (as discussed with a licensee or other entity from using
substituted or adulterated specimen for respect to Subpart I [Managing Fatigue]). individuals who are needed to respond
any test required under § 26.31(c). The NRC received a comment to an emergency. This provision also
Adding the requirements for procedures suggesting that individuals who are retains and modifies a portion of former
to address these circumstances meets called in should only be required to § 26.20(c)(3). It states that if the
Goal 6 of this rulemaking to improve report if they are not fit for duty or have determination of fitness indicates that
clarity in the organization and language consumed alcohol during the pre-duty an individual who has been called in for
of the rule. abstinence period. The NRC believes an unscheduled working tour to
respond to an emergency may be example, behavioral observation, training to inform individuals who are
impaired, the procedure must require whereas former § 26.22 required that subject to the rule of any EAPs that are
the establishment of controls and only supervisors and escorts must available to them. The final rule
conditions under which the individual receive behavioral observation training. eliminates the reference to EAPs
who has been called in can perform Increasing the number of individuals ‘‘provided by the licensee’’ in the former
work if necessary. who are trained in behavioral provision and amends it as ‘‘EAP
The NRC has added § 26.27(c)(3)(ii)(E) observation enhances the effectiveness services available to the individual’’
to the final rule to clarify that licensees of FFD programs by increasing the because other entities are also subject to
and other entities may not impose likelihood of detecting potential this requirement under the final rule.
sanctions if an individual is called in for impairment, consistent with Goal 3 of Section 26.29(a)(5) amends former
an unscheduled working tour for having this rulemaking. § 26.21(a)(2) by replacing the phrase
consumed alcohol during the preduty Section 26.29(a) of the final rule ‘‘abuse of drugs and misuse of alcohol’’
abstinence period specified in the FFD combines the training topics listed in with ‘‘abuse of illegal and legal drugs
policy. This change ensures that, if an former §§ 26.21(a)(1) through (a)(5), and alcohol’’ for greater accuracy in
individual who is called in 26.22(a)(1) through (a)(5), and 26.22(b). describing the required knowledge. The
unexpectedly has a confirmed positive The agency has rewritten the required NRC has made these changes to meet
test result for alcohol, he or she would training topics in terms of knowledge Goal 6 of this rulemaking to improve
not be subject to the sanctions that are and abilities (KAs) to be consistent with clarity in the language of the rule.
otherwise required under this part for a terminology used by licensees and other Section 26.29(a)(6) retains the portion
confirmed positive alcohol test result. entities in other required training of former § 26.21(a)(3) that required
The NRC believes that sanctions for the programs. This change meets Goal 6 of licensees to ensure that individuals
consumption of alcohol in these this rulemaking to improve clarity in the understand the effects of prescription
circumstances would be inappropriate organization and language of the rule. and over-the-counter drugs and dietary
because the individual would have been Section 26.29(a)(1) combines former factors on job performance. The final
unaware that he or she would be called § 26.21(a)(1) with the latter portion of rule adds a requirement for FFD training
in to work. The revision is also former § 26.21(a)(5). Consistent with the to address the effects of alcohol, illness,
consistent with the original intent of the former training requirements, the mental stress, and fatigue on job
rule. Therefore, the NRC has made these provision requires licensees and other performance, in order to ensure that
changes to meet Goal 6 of this entities to ensure that individuals who individuals understand the bases for the
rulemaking to improve clarity in the are subject to this subpart have licensee’s or other entity’s FFD policy
organization and language of the rule. knowledge of the FFD policy and regarding these conditions. The NRC
Section 26.27(c)(4) adds a procedures that apply to them, the has moved the requirement in the last
requirement that FFD procedures must methods used to implement the policy sentence of former § 26.20(a) to
describe the process to be followed and procedures, and the consequences § 26.27(b)(6) of the final rule because
when another individual’s behavior of violating the policy and procedures. that section addresses FFD policy
raises an FFD concern and the process Section 26.29(a)(2) retains the requirements. The NRC has made these
for reporting the concern. As discussed requirement in former § 26.22(a)(1) that changes to meet Goal 6 of this
with respect to § 26.27(b)(11), this licensees and other entities must ensure rulemaking to improve clarity in the
provision is consistent with § 26.33, that individuals understand their roles organization and language of the rule.
which establishes a requirement that all and responsibilities under the FFD Section 26.29(a)(7) retains the portion
individuals must perform behavioral program, such as avoiding substance of former § 26.21(a)(3) that required
observation and report any FFD abuse and reporting for testing within licensees and other entities to ensure
concerns. This provision is also the time limit specified in FFD program that individuals who are subject to the
consistent with § 26.29, which requires procedures. rule understand the effects of
individuals to be trained to perform Section 26.29(a)(3) amends the prescription and over-the-counter drugs
behavioral observation. The NRC has terminology used in former and dietary factors on drug and alcohol
added this requirement to meet Goal 3 § 26.22(a)(2). Former § 26.22(a)(2) test results. Examples of medications,
of this rulemaking to improve the required FFD training to address the supplements, and dietary factors that
effectiveness and efficiency of FFD roles and responsibilities of others, such can affect drug and alcohol test results
programs and Goal 4 to improve as the personnel, medical, and EAP may include, but are not limited to,
consistency between FFD requirements staffs. The final rule replaces the ingesting foods containing poppy seeds,
and access authorization requirements references to the ‘‘personnel’’ function drinking coca tea, using some liquid or
established in 10 CFR 73.56, as and ‘‘medical’’ staff in former inhalant cold and cough preparations
supplemented by orders to nuclear § 26.22(a)(2) with ‘‘human resources’’ containing alcohol or codeine, and
power plant licensees dated January 7, and ‘‘FFD’’ staff, respectively. The final taking supplements containing hemp
2003. rule also moves the reference to the oil.
Section 26.27(d) of the final rule MRO into this section from former Section 26.29(a)(8) and (a)(9) of the
retains the requirements of former § 26.21(a)(3). These updates to the final rule retains the requirements in
§ 26.20(f) without changes. terminology in this section are former § 26.22(a)(3) and (a)(4),
consistent with other terms used respectively, without changes.
Section 26.29 Training throughout the final rule to meet Goal Section 26.29(a)(10) amends former
Section 26.29 of the final rule 6 of this rulemaking to improve clarity § 26.22(a)(5). The provision retains the
combines and amends former § 26.21 in the organization and language of the former requirement for FFD training to
[Policy communications and awareness rule. address the licensee’s or other entity’s
training] and § 26.22 [Training of Section 26.29(a)(4) and (a)(5) amends process for initiating appropriate
supervisors and escorts]. This section former § 26.21(a)(4) and (a)(2), corrective action if an individual has an
clarifies that all individuals subject to respectively, by changing some of the FFD concern about another person,
this subpart must receive the same language used in the former provisions. including referral to the EAP. The final
scope of training, to include, for Former § 26.21(a)(4) required FFD rule adds a requirement for FFD training
to ensure that individuals understand rulemaking to improve the efficiency of that may indicate this need. Adding
their responsibility to report FFD FFD programs. The permission also these examples clarifies the NRC’s
concerns to the person(s) who are meets Goal 5 to improve Part 26 by intent and meets Goal 6 of the
designated to receive such reports in eliminating or modifying unnecessary rulemaking to clarify the language of the
FFD program procedures. This change is requirements through providing rule. The final provision permits
consistent with § 26.33, which requires flexibility in the methods that licensees individuals who pass a comprehensive
individuals to perform behavioral and other entities may use to administer annual examination that demonstrates
observation and report any FFD the required examination. their continued understanding of the
concerns, as discussed with respect to Section 26.29(c) of the final rule FFD program requirements to be
§ 26.27(b)(11). The change is also combines and amends the portions of excused from the refresher training that
consistent with § 26.27(c)(4), which former §§ 26.21(b) and 26.22(c) that the provision otherwise requires. The
requires procedures for implementing required FFD training for individuals examination is necessary to meet the
the requirement. The NRC has added who are subject to this section before examination requirements specified in
this group of interrelated requirements they are permitted to perform duties § 26.29(b) [Comprehensive
to meet Goal 3 of this rulemaking to that require them to be subject to this examination]. Individuals who do not
improve the effectiveness and efficiency part. pass must undergo remedial training.
of FFD programs and Goal 4 to improve Section 26.29(c)(1) requires that all Permitting individuals to pass a
consistency between FFD requirements personnel who are subject to this comprehensive examination rather than
and access authorization requirements section must complete FFD training take refresher training each year ensures
established in 10 CFR 73.56, as before the licensee or other entity grants that they are retaining their FFD KAs
supplemented by orders to nuclear initial authorization to the individual, while reducing some costs associated
power plant licensees dated January 7, as defined in § 26.55 [Initial with meeting the annual refresher
2003. authorization]. The final rule also training requirement. Therefore, this
Section 26.29(b) of the final rule adds requires that an individual’s training change meets Goal 5 of this rulemaking
a requirement that individuals must must be current before the licensee or to improve Part 26 by eliminating or
demonstrate attainment of the KAs other entity grants an authorization modifying unnecessary requirements.
specified in § 26.29(a) by passing a update or reinstatement to the Section 26.29(c)(3) permits licensees
comprehensive examination. The NRC individual, as defined in § 26.57 and other entities to use various media,
has added this requirement because in [Authorization update] and § 26.59 in addition to traditional classroom
several instances since Part 26 was first [Authorization reinstatement], instruction, for presenting initial and
promulgated, individuals were able to respectively. The provision also refresher training for the same reasons
overturn determinations that they had eliminates the requirement in former discussed with respect to the portion of
violated a licensee’s FFD policy on the § 26.22(c) to upgrade training for newly § 26.29(b) that permits licensees and
basis that they had not understood the assigned supervisors within 3 months of other entities to use various media to
information they received during FFD a supervisory assignment because all administer the comprehensive
training and could not be expected to personnel will receive the same scope of examination. The requirements for a
comply with the requirements of the training and be required to complete the licensee or other entity to monitor the
policy. Therefore, the final rule requires training before a licensee or other entity completion of training and provide
individuals to demonstrate their grants authorization to any individual. access to an instructor or subject matter
attainment of the KAs listed in These changes are consistent with the expert ensures that individuals who are
§ 26.29(a) to ensure that the FFD requirements related to granting and trained using different media achieve
training has been effective. The final maintaining authorization that are the same understanding as persons who
rule requires remedial training for those established in Subpart C [Granting and are trained in a classroom setting with
who fail to achieve a passing score of 80 Maintaining Authorization] of the final an instructor present. This flexibility
percent on the examination. Section rule, as discussed in this document with may reduce the costs associated with
26.29(b) also requires the examination respect to that subpart. The changes also presenting initial and refresher training
to include at least one question for each meet Goal 3 of this rulemaking to only in a classroom setting. Therefore,
KA. These requirements are modeled on improve the effectiveness and efficiency this change meets Goal 5 of this
other required training programs that of FFD programs. rulemaking to improve Part 26 by
have been successful in ensuring that Section 26.29(c)(2) retains and eliminating or modifying unnecessary
examinations are valid and individuals combines the requirements for annual requirements.
have achieved an adequate refresher training in former §§ 26.21(b) To meet the annual refresher training
understanding of the subject matter. and 26.22(c). Former § 26.21(b) requirement for individuals, § 26.29(d)
Establishing a method to ensure that addressed individuals who are subject of the final rule permits licensees and
individuals understand the to this part and former § 26.22(c) other entities to accept the training of
requirements with which they must addressed supervisors and escorts. The individuals who have been subject to
comply meets Goal 3 of this rulemaking final rule combines the former another training program that meets the
to improve the effectiveness of FFD requirements because all personnel requirements of this section. Licensees
programs. receive the same scope of training under and other entities are also permitted to
The provision also permits the use of the final rule. The final rule specifies accept a passing result from a
various media for administering the that individuals must complete the comprehensive examination that was
comprehensive examination, in order to refresher training every 12 months, or administered by another training
achieve the efficiencies associated with more frequently when the need is program that meets the requirements of
computer-based training and testing, for indicated. With respect to the proposed this section in lieu of refresher training,
example, and other new training rule, the final rule gives some examples if the examination meets the
delivery technologies that may become of situations that indicate a need to requirements of § 26.29(b). This
available. Permitting the use of various conduct the refresher training more requirement meets Goal 3 of this
media to administer the examination frequently than every 12 months, but rulemaking to improve the effectiveness
meets the portion of Goal 3 of this this list is not inclusive of all situations and efficiency of FFD programs.
Section 26.31 Drug and Alcohol consider when selecting and monitoring background checks and psychological
Testing the honesty and integrity of FFD assessments that had not already been
Section 26.31 of the final rule program personnel. The NRC has made identified through other avenues,
renames former § 26.24 [Chemical and these changes to meet Goal 6 of this including self-reports by FFD program
alcohol testing]. The final rule, in rulemaking to improve clarity in the personnel, drug and alcohol testing, and
general, replaces the former term language of the rule. behavioral observation. However, the
Section 26.31(b)(1)(i) amends former NRC continues to believe that the
‘‘chemical testing’’ with ‘‘drug testing’’
Section 2.3(2) in Appendix A to Part 26 required updates provide an
because the testing for chemicals that is
in response to implementation independent method to verify the
required in the rule is performed only
questions regarding the former ongoing honesty and integrity of FFD
in the context of urine drug testing.
requirements. The provision clarifies program personnel that is necessary
Therefore, the term ‘‘drug testing’’ more
that the background investigations, because of the critical importance of
accurately conveys the nature of the credit and criminal history checks, and
testing that is performed. The NRC has FFD program personnel in assuring
psychological evaluations that are program effectiveness. Therefore, the
made these changes to meet Goal 6 of required for persons who are granted
this rulemaking to improve clarity in the final rule retains the former requirement
unescorted access to protected areas in for updated background checks and
organization and language of the rule. nuclear power plants are acceptable
Section 26.31(a) [General] of the final psychological assessments, but reduces
when determining the honesty and the required frequency of these updates
rule retains but updates the language in integrity of FFD program personnel. The
former § 26.24(a) to be consistent with from every 3 years to every 5 years
final rule retains the term ‘‘appropriate’’ under the final rule. The NRC has made
the new terminology used throughout in the former rule for two reasons. First,
the rule as discussed in § 26.5. The NRC this change to meet Goal 5 of this
it indicates that FFD program personnel rulemaking to improve Part 26 by
has made this change to meet Goal 6 of who are employed by entities who are
this rulemaking to improve clarity in the eliminating or modifying unnecessary
subject to the rule but are not nuclear requirements. In addition, the frequency
language of the rule. power plants, may meet the
Section 26.31(b) [Assuring the for these updates increases the
requirements through investigations, consistency of Part 26 with access
honesty and integrity of FFD program checks, and evaluations that provide the
personnel] of the final rule amends authorization requirements established
information needed to determine the in 10 CFR 73.56, as supplemented by
former Section 2.3 in Appendix A to honesty and integrity of FFD program
Part 26. Other than making minor orders to nuclear power plant licensees
personnel, but the investigations, dated January 7, 2003, which is Goal 4
clarifications to the rule text as checks, and evaluations may differ from
explained below, the NRC has adopted of this rulemaking.
those required under nuclear power
the requirements of paragraph (b) of this plant access authorization programs. In Section 26.31(b)(1)(ii) amends and
section as proposed, without change. addition, the final rule retains the term clarifies former Section 2.3(1) in
Section 26.31(b)(1) amends the first ‘‘appropriate’’ because it has particular Appendix A to Part 26 in response to
paragraph of former Section 2.3 in relevance to the requirement for the many implementation questions that
Appendix A to Part 26. This paragraph licensees and other entities to conduct have arisen after the regulation was
required licensees to carefully select criminal history checks for FFD program published. The former rule prohibited
and monitor persons responsible for personnel. In some cases, licensees and individuals who have a personal
administering the testing program to other entities cannot legally obtain the relationship with the individual being
ensure that they meet the highest same type of criminal history tested (i.e., a donor), such as the donor’s
standards of honesty and integrity. The information about FFD program ‘‘supervisors, coworkers, and relatives,’’
final rule replaces the former list of personnel as they are able to obtain for from performing any ‘‘collection,
individuals who are subject to this other individuals who are subject to Part assessment, or evaluation procedures’’
requirement with a cross-reference to 26. Therefore, the term ‘‘appropriate’’ is involving the individual being tested.
§ 26.4(g) of the final rule, which used to indicate that local criminal The NRC included the restriction on
specifies in detail the FFD program history checks for FFD program ‘‘supervisors, coworkers, and relatives’’
personnel who must be subject to the personnel who do not have unescorted in the former rule to provide examples
FFD program. This cross-reference access to nuclear power plant protected of the ‘‘personal relationships’’
avoids repeating the list of personnel in areas are acceptable. The NRC has made referenced in the introductory
this provision. these changes to meet the portion of paragraph of former Section 2.3 in
The provision also adds a reference to Goal 6 of this rulemaking that pertains Appendix A to Part 26. Some licensees
factors, other than a personal to improving clarity in the language of have misinterpreted the restriction on
relationship with an individual who is the rule. coworkers in the former rule as meaning
subject to testing, that have the potential The NRC has relaxed the requirement that no one who is an employee of the
to cause an individual to be subject to in former Section 2.3(2) in Appendix A same corporation may be involved in
influence attempts or may adversely to Part 26 for appropriate background collection, assessment, or evaluation
affect the honesty and integrity of FFD checks and psychological evaluations to procedures. However, in a large
program personnel. In addition to a be conducted at least once every 3 years corporation, many individuals
personal relationship with an individual to require that credit and criminal employed by the same corporation will
who is subject to testing, factors that history checks and updated not have personal relationships with
could cause an individual to be psychological assessments be conducted FFD program personnel, specifically, or
compromised may include, but are not nominally every 5 years. The final rule with other individuals who are subject
limited to, a substance abuse problem or relaxes the former requirement for to testing, in general. Therefore, in
financial problems. Therefore, the final several reasons. First, the NRC is not § 26.31(b)(1)(ii), the phrase ‘‘in the same
rule adds a reference to these additional aware of any instances in which work group’’ clarifies that the example
factors to more accurately characterize licensees and other entities have regarding coworkers pertains to
the scope of potential concerns that identified new information about FFD individuals who report to the same
licensees and other entities must program personnel from updating the manager. For example, FFD program
personnel report to the FFD program has added this provision to meet Goal Transportation Workplace Drug and
manager and would be considered 7 of this rulemaking, relating to Alcohol Testing Programs’’ (65 FR
‘‘coworkers in the same work group’’ to protecting the privacy rights of 41944; August 9, 2001). As discussed
whom the restriction applies. In individuals who are subject to Part 26. with respect to § 26.31(b)(1), some FFD
addition, the section adds a reference to Section 26.31(b)(1)(v) amends former program personnel, such as contract
determinations of fitness (discussed Section 2.3(3) in Appendix A to Part 26 MROs and EAP staff members, normally
with respect to § 26.189 [Determination to require that MROs who are on site at work at locations that are so distant
of fitness]) to provide a clarifying a licensee’s or other entity’s facility from a licensee’s collection site(s) as to
example of the assessment and must be subject to behavioral make it impractical for them to be
evaluation procedures that FFD program observation. For the purposes of randomly tested at a licensee’s or other
personnel are prohibited from § 26.31(b)(1)(v), a ‘‘facility’’ includes, entity’s collection site. Permitting these
performing if the FFD program staff but is not limited to, a licensee’s or FFD program personnel to be tested at
member has a personal relationship other entity’s corporate offices and any local collection sites that follow similar
with the subject individual. The NRC medical facilities that the licensee or procedures is adequate to meet the goal
has made these changes to meet Goal 6 other entity operates. The NRC has of ensuring their continuing honesty
of this rulemaking to improve clarity in added this requirement because MROs and integrity. Therefore, the NRC has
the organization and language of the are ‘‘persons responsible for added this provision to meet Goal 5 of
rule. administering the testing program,’’ but this rulemaking to improve Part 26 by
Section 26.31(b)(1)(iii) relaxes the some FFD programs have not included eliminating or modifying unnecessary
prohibition on individuals who have MROs in the behavioral observation requirements.
‘‘personal relationships’’ with the donor element of their programs. However, the Section 26.31(c) [Conditions for
from performing specimen collection final rule limits the behavioral testing] replaces former § 26.24(a)(1)
procedures in former Section 2.3(1) in observation of MROs to those times through (a)(4). The provision lists the
Appendix A to Part 26. The NRC when they are on site at a licensee’s or situations in which testing is required in
acknowledges that the former restriction other entity’s facility in order to permit separate paragraphs, such as ‘‘pre-
imposed an unnecessary burden when licensees and other entities to continue access,’’ ‘‘for cause,’’ and ‘‘post-event’’
the objective of ensuring the integrity of relying on the services of MROs who testing to clarify that each situation for
specimen collections in these normally work independently, often which testing is required stands on its
circumstances could be achieved by alone, in offices at a geographical own. The former provision in
other means. Therefore, in distance from the licensee’s or other § 26.24(a)(3), in particular, has led to
§ 26.31(b)(1)(iii), individuals who have a entity’s facilities so that behavioral confusion and misinterpretation of the
personal relationship with a donor are observation is impractical. Limiting the requirements, to be corrected as noted
permitted to collect specimens, if requirement for behavioral observation below. Subparts E [Collecting
another individual who does not have a of MROs to those instances in which the Specimens for Testing], F [Licensee
personal relationship with the donor MRO is working on site at a licensee’s Testing Facilities], and G [Laboratories
and is not a supervisor, a coworker in or other entity’s facility is adequate to Certified by the Department of Health
the same work group, or a relative of the ensure the continuing honesty and and Human Services] address the
donor monitors the collection and integrity of these MROs because MROs specific requirements for conducting the
preparation of the specimens for who work off site would not interact on testing. The final rule reorganizes and
shipping. The section also provides a daily basis with other individuals who amends former § 26.24(a)(1) through
examples of the types of individuals are subject to the FFD program. (a)(4) to meet Goal 6 of this rulemaking
who may monitor the integrity of Therefore, off site MROs would be less to improve clarity in the organization
specimen collection procedures in these likely to be subject to potential and language of the rule.
circumstances, including but not influence attempts than MROs who Section 26.31(c)(1) [Pre-access]
limited to, security force or quality normally work on site because they are amends former § 26.24(a)(1). Former
assurance personnel. By permitting generally inaccessible. The final rule § 26.24(a)(1) required pre-access testing
monitored collections in these continues to require all MROs to be within 60 days before the initial
circumstances while continuing to subject to the other FFD program granting of unescorted access to
assure the integrity of specimen elements that are required in this protected areas or assignment to duties
collections from FFD program subpart. These elements include drug within the scope of this part. Section
personnel, this provision meets Goal 5 and alcohol testing and regular 26.31(c) of the final rule introduces the
of this rulemaking to improve Part 26 by psychological assessments and concepts of ‘‘initial authorization,’’
eliminating or modifying unnecessary background investigations, which ‘‘authorization update,’’ and
requirements. The final rule retains the permit licensees and other entities to ‘‘authorization reinstatement,’’ which
prohibition for individuals who have monitor the honesty and integrity of off refer to categories of requirements that
personal relationships with the donor site MROs. The NRC has added this licensees and other entities must meet
from performing assessment and relaxation to meet Goal 5 of this in order to assign an individual to
evaluation procedures because rulemaking to improve Part 26 by duties that require the individual to be
monitoring of these activities by eliminating or modifying unnecessary subject to Part 26. Section 26.65 [Pre-
qualified personnel is not feasible. requirements. access drug and alcohol testing] in
If a directly observed collection is A new § 26.31(b)(2) provides another Subpart C of the final rule specifies
required, § 26.31(b)(1)(iv) of the final relaxation from the former rule related detailed requirements for conducting
rule adds a prohibition for an individual to collecting specimens from FFD pre-access testing.
who has a personal relationship with program personnel. The provision Section 26.31(c)(2) [For cause] and
the donor from acting as a urine permits FFD program personnel to (c)(3) [Post event] clarifies and amends
collector or observer. This prohibition is submit specimens for testing at former § 26.24(a)(3), as follows:
necessary to minimize embarrassment to collection sites that meet the Section 26.31(c)(2) continues to
the donor (and the collector) during a requirements of 49 CFR Part 40, require for-cause testing in response to
directly observed collection. The NRC ‘‘Procedures for Department of any observed behavior or physical
condition indicating possible substance individuals who must be subject to post- illnesses and injuries that meet the
abuse. The final rule also retains the event testing. Some licensees have threshold for post-event testing at the
former requirement for testing if the misinterpreted the former provision as time they occur. For example, if an
licensee or other entity receives credible requiring the testing of all individuals individual has been injured on site but
information that an individual is who are involved in a significant event, does not report the injury to the licensee
engaging in substance abuse. Section including individuals whose behavior or other entity and waits for several
26.3 defines the term ‘‘substance played no causal or contributing role in days to seek treatment from his or her
abuse.’’ the event. For example, these licensees’ private physician, the licensee or other
Section 26.31(c)(3) [Post event] FFD programs would require testing an entity may not learn of the injury. The
amends the portion of former individual who was exposed to extent of an injury may be unclear at the
§ 26.24(a)(3) that required drug and radiation in excess of regulatory limits, time it occurs and may appear to fall
alcohol testing when an event involving even if other individuals’ actions (or below the threshold for post-event
a failure in individual performance failures to act) were responsible for the testing until several days have passed.
leads to significant consequences. The event and the individual who suffered In these examples, if the licensee or
final rule amends the former provision the exposure was a bystander. other entity learns after several days that
because it has been subject to Therefore, the second sentence of the the injury would have met the threshold
misinterpretation and numerous provision clarifies the original intent of for post-event testing, it would be too
questions from licensees. this section by stating that only the late for post-event testing to be of any
The phrase ‘‘if there is reasonable individual(s) who committed the value in determining whether the
suspicion that the worker’s behavior error(s) is subject to post-event testing. individual’s use of drugs or alcohol may
contributed to the event’’ in former Section 26.31(c)(3)(i) provides a have contributed to the event. If alcohol
§ 26.24(a)(3) has been subject to threshold for the types of workplace or drug use had contributed to the
misinterpretation. The location of this personal injuries and illnesses for which event, testing several days later would
phrase at the end of the list of post-event testing is required in be unlikely to detect it because of the
conditions under which post-event response to implementation questions effects of metabolism. Further, it would
testing must be performed has led some related to former § 26.24(a)(3). Some be difficult to prove that any positive
licensees to conclude that this phrase licensees have misinterpreted the test results reflected the individual’s
applies only to events involving actual former provision as requiring post-event condition at the time the event occurred
or potential substantial degradations of testing for any personal injury, no rather than subsequent drug or alcohol
the level of safety of the plant. Other matter how minor. This section clarifies use. Therefore, the final rule limits post-
licensees have misinterpreted the term the type of personal injuries and event testing to situations in which the
‘‘reasonable suspicion’’ as meaning illnesses for which post-event testing licensee or other entity can determine
‘‘reasonable suspicion of substance would be required by establishing a that an injury or illness meets the
abuse’’ or some other ‘‘illegal’’ or threshold that is based on the general threshold within four hours after the
‘‘disreputable’’ activity. Neither of these criteria contained in 29 CFR 1904.7, event has occurred, and can conduct the
interpretations is consistent with the ‘‘General Recording Criteria,’’ of the testing within a time frame that will
intent of this provision. Therefore, to regulations of the Occupational Safety provide useful information about the
clarify the intent of the provision, the and Health Administration (OSHA) for individual’s condition at the time of the
final rule eliminates the phrase ‘‘if there recording occupational injuries and event. However, the section should not
is reasonable suspicion that the worker’s illnesses. As defined in the OSHA be misinterpreted as requiring post-
behavior contributed to the event’’ from standard and the final rule, these event testing to be completed within
the end of the list of significant events include any injuries and illnesses which four hours after the event. Section
that require post-event testing and, result in death, days away from work, 26.31(c)(3) defines the time period after
instead, requires post-event testing as restricted work, transfer to another job, the event within which testing must be
soon as practical after significant events medical treatment beyond first aid, loss completed as ‘‘as soon as practical.’’ The
(as listed in § 26.31(c)(3)(i) through of consciousness, or other significant NRC has made this change to meet Goal
(c)(3)(iii)) involving a human error that injury or illness as diagnosed by a 3 of this rulemaking to improve the
may have caused or contributed to the physician or other licensed health care effectiveness and efficiency of FFD
event. The final rule uses the term professional. In the case of a significant programs.
‘‘human error’’ rather than the former injury or illness diagnosed by a Section 26.31(c)(3)(ii) retains the
term ‘‘worker’s behavior’’ to emphasize physician or health care professional, a relevant language in the corresponding
that post-event testing is required for serious injury or illness does not need portion of former § 26.24(a)(3) without
acts that unintentionally deviated from to result in death, days away from work, change.
what was planned or expected in a restricted work, transfer to another job, Section 26.31(c)(3)(iii) retains the
given task environment (see NUREG/ medical treatment beyond first aid, or relevant language in the corresponding
CR–6751, ‘‘The Human Performance loss of consciousness. The final rule portion of former § 26.24(a)(3).
Evaluation Process: A Resource for adds this clarification to reduce the However, as discussed with respect to
Reviewing the Identification and number of unnecessary post-event tests § 26.31(c), the final rule eliminates the
Resolution of Human Performance performed for minor injuries and former qualifying phrase ‘‘if there is
Problems’’) as well as failures to act (i.e., illnesses and meet Goal 3 of this reasonable suspicion that the worker’s
errors of omission). Therefore, testing is rulemaking to improve the effectiveness behavior contributed to the event.’’ The
required regardless of whether there was and efficiency of FFD programs. NRC has eliminated this phrase because
‘‘reasonable suspicion’’ that the Section 26.31(c)(3)(i) also includes the it is preferable to determine the need for
individual was abusing drugs or alcohol qualifying phrase, ‘‘within 4 hours after post-event testing using an objective
for the consequences listed in the the event,’’ with reference to the standard based on the severity of the
section. recordable personal injuries and underlying event. The experience of the
In addition, the NRC has added the illnesses that would trigger post-event DOT with post-accident testing, for
second sentence of § 26.31(c)(3) to testing. The NRC acknowledges that in example, is that it is more effective to
clearly delineate the scope of some cases it is difficult to detect separate completely ‘‘for cause’’
concepts (such as ‘‘reasonable but clarifies that for some drugs the this reporting requirement and replaces
suspicion’’ of substance abuse) from testing is conducted to detect drug it with requirements for an independent
post-event testing. Under the final rule’s metabolites. The NRC has moved the forensic toxicologist who has no
approach, if one of the events occurs provisions detailing the circumstances relationships that could be construed as
that is defined in the regulations as in which testing for these substances potential conflicts of interest to conduct
requiring post-event testing, then that must be performed (i.e., pre-access, the review that the NRC currently
testing should be carried out post-event, random) to § 26.31(c) for performs. The final rule requires the
irrespective of the presence or absence organizational clarity. In addition, the independent forensic toxicologist to
of any ‘‘reasonable suspicion’’ of section adds adulterants to the list of certify, in advance and in writing, that
substance abuse. substances for which testing must be the assay to be used in testing for any
Section 26.31(c)(4) [Followup] retains conducted, consistent with the addition additional drugs or drug metabolites,
the intent of former § 26.24(a)(4) but of specimen validity testing and the cutoff levels to be applied, are
amends its language. The final rule requirements to the final rule, as scientifically sound and legally
eliminates the former phrase ‘‘to verify discussed with respect to defensible. This section also specifies
an individual’s continued abstention § 26.31(d)(3)(i). Section 26.31(d)(1)(i) the required qualifications for the
from the use of substances covered retains the permission in the second forensic toxicologist.
under this part’’ because it could be sentence of former § 26.24(c) for Certification of the assay and cutoff
misinterpreted as limiting the licensees and other entities to consult levels are not required in two
substances for which followup testing is with local law enforcement agencies or circumstances: (1) If the HHS
permitted to only those listed in other sources of information to identify Guidelines are revised to permit use of
§ 26.31(d)(1) [Substances tested]. The drugs that may be abused by individuals the assay and the cutoff levels in
final rule revises this phrase as ‘‘to in the geographical locale of the FFD Federal workplace drug testing
verify continued abstinence from program. programs and the licensee or other
substance abuse’’ to clarify that FFD Section 26.31(d)(1)(i)(A) retains the entity uses the cutoff levels established
programs are permitted to conduct permission in former § 26.24(c) for in the HHS Guidelines for drug or drug
followup testing for any substances an licensees and other entities to add to the metabolites; and (2) if the licensee and
individual may have abused, subject to panel of drugs for which testing is other entity received written approval of
certain additional requirements required in § 26.31(d)(1). Additional the NRC to test for the additional drug
discussed with respect to drugs may include, but are not limited or drug metabolites before the
§ 26.31(d)(1)(i). Section 26.69 to, ‘‘designer drugs,’’ such as ecstasy or implementation date of the final rule,
[Authorization with potentially ketamine, and illegal drugs that are which is 365 days after the date the final
disqualifying fitness-for-duty popular in some geographical areas, rule is published in the Federal
information] establishes detailed such as lysergic acid diethylamide-25 Register. Certification by a toxicologist
requirements for conducting followup (LSD). The provision also requires that is unnecessary in these two
testing, where they apply to licensees’ any additional drugs must be listed on circumstances because it would be
and other entities’ processes for granting Schedules I–V of section 202 of the redundant. By eliminating or modifying
and maintaining authorization. The Controlled Substances Act [21 U.S.C. unnecessary requirements, while
final rule makes these changes to meet 812], which is consistent with the continuing to ensure that any drug
Goal 6 of this rulemaking to improve definition of ‘‘illegal drugs’’ in former testing conducted under Part 26 is
clarity in the organization and language § 26.3. scientifically sound and legally
of the rule. Section 26.31(d)(1)(i)(B) retains the defensible, this provision meets Goal 5
Section 26.31(c)(5) [Random] last sentence in former § 26.24(c). The of this rulemaking.
simplifies former § 26.24(a)(2) to define provision requires licensees and other Section 26.31(d)(1)(ii) amends former
random testing as one of the conditions entities to establish appropriate cutoff Section 2.1(b) in Appendix A to Part 26.
under which testing is required. The levels for any additional substances for The provision permits licensees and
NRC has moved the detailed which testing will be conducted. other entities, when conducting for-
requirements for implementing random Section 26.31(d)(1)(i)(C) retains the cause, post-event, and followup testing,
testing that were contained in former requirement in former Section 2.1(c) in to test for any drugs listed on Schedules
§ 26.24(a)(2) to § 26.31(d) [General Appendix A to Part 26. The provision I–V of the Controlled Substances Act
requirements for drug and alcohol specifies that licensees and other that the licensee or other entity suspects
testing] of the final rule. The NRC has entities must establish rigorous testing the individual may have abused, as
made these changes to meet Goal 6 of procedures for any additional drugs. follows:
this rulemaking to improve clarity in the Section 26.31(d)(1)(i)(D) further The section adds a reference to post-
organization and language of the rule. clarifies the requirement in event testing for consistency with the
The NRC has added § 26.31(d) to the § 26.31(d)(1)(i)(C) for ‘‘rigorous testing intent of former Section 2.1(b) in
final rule to better organize procedures.’’ The provision replaces the Appendix A to Part 26, which permitted
requirements related to the general portion of former Section 1.1(2) in testing for any illegal drugs during a for-
administration of drug and alcohol Appendix A to Part 26 that required cause test. The former rule included
testing. The final rule presents more licensees to obtain written approval post-event testing within the definition
detailed requirements for conducting from the NRC to test for additional of for-cause testing. The final rule uses
drug and alcohol testing in Subparts E, drugs. The purpose of the former a distinct term ‘‘post-event’’ testing to
F, and G. The NRC has made these requirement was to provide an refer to the testing that is required
changes to meet Goal 6 of this opportunity for the NRC to verify that following certain events as discussed
rulemaking to improve clarity in the the assays and cutoff levels licensees with respect to § 26.31(d)(3). Therefore,
organization and language of the rule. use in testing for additional drugs are it is necessary to add a reference to post-
Section 26.31(d)(1) [Substances scientifically sound and legally event testing to this section to retain the
tested] retains the list of drugs for which defensible. However, the former full intent of the former provision.
testing must be conducted in former requirement also imposed a reporting The section also adds a reference to
Section 2.1(a) in Appendix A to Part 26, burden. The final provision eliminates followup testing, which permits the
licensee or other entity to test for an drugs to for-cause, post-event, and rights of individuals (including due
additional drug if an individual who is followup testing. The section requires process) who are subject to Part 26, by
subject to followup testing is suspected that a forensic toxicologist certify the requiring that individuals who are
of having abused it. For example, if an assays and cutoff levels to be used in subject to for-cause, post-event, and
SAE, in the course of performing a testing for the additional drugs. The followup testing must be subject to the
determination of fitness under § 26.189 provision provides consistency with same testing procedures and cutoff
found that an individual was abusing § 26.31(d)(1)(i)(D) and ensures that the levels as others who are tested under
barbiturates, this provision would testing is scientifically sound and this part.
permit followup testing to verify that legally defensible. The NRC has made With respect to the proposed rule, the
the individual is abstaining from such this change to protect donors’ rights as NRC has added § 26.31(d)(1)(iii) to the
abuse. The NRC has made this change it relates to minimizing the possibility final rule to require the licensee or other
to strengthen the followup testing of false positive test results. The entity to document the additional
element of FFD programs by ensuring provision also strengthens the drug(s) for which testing will be
that followup testing would detect effectiveness of FFD programs by performed in written policies and
continued drug abuse. Therefore, this ensuring that tests for additional drugs procedures. A public comment
provision is consistent with Goal 3 of that are conducted for cause, post-event, suggested that licensees and other
this rulemaking to improve the or as part of a followup program will entities should not screen for drugs in
effectiveness and efficiency of FFD accurately detect drugs that an addition to those listed in paragraph
programs. individual may have abused. Therefore, (d)(1) of this section without identifying
The section retains the limitation in the NRC has made this change to meet them in advance. The NRC agrees that
former Section 2.1(b) in Appendix A to Goal 7 of this rulemaking to protect the informing individuals of the substances
Part 26 that permitted testing only for rights (including due process) of for which testing will routinely occur
illegal drugs that the individual is individuals who are subject to Part 26 and the cutoff levels to be applied may
suspected of having abused and extends and Goal 3 to improve the effectiveness deter abuse of those substances.
that limitation to followup testing. The and efficiency of FFD programs. Information about the drugs for which
final rule extends this limitation to testing will occur, and their potential
The NRC has added the last sentence
followup testing to protect donors’ effects on job performance, is also an
of § 26.31(d)(1)(ii) to prohibit
rights to privacy, which is the same important part of the FFD training that
inappropriate practices that some FFD
reason that the limitation was individuals must receive under § 26.29,
established in the former rule with programs have implemented. The NRC to assist individuals in meeting their
respect to for-cause testing. Licensees is aware that some FFD programs have responsibilities under the rule. This
and other entities are prohibited from directed their HHS-certified laboratories added provision is also consistent with
conducting a wide spectrum of tests for to test specimens that are collected for § 26.31(d)(3)(iii)(A) that requires
any drugs without suspicion that the for-cause, post-event, or followup licensees and other entities to document
individual had abused them because testing at the assay’s LOD without first more stringent cutoff levels for drug
such tests could reveal personal medical subjecting the specimens to initial testing than those specified in § 26.163
information about the individual that is testing. In addition, if a drug or drug in written policies and procedures.
irrelevant to the performance objectives metabolite is detected at the LOD, the However, the NRC does not agree that
of this part, as discussed with respect to MROs in these programs have a licensee should be prohibited from
§ 26.23. Thus, extending the former confirmed the test result as an FFD testing for drugs in addition to those
limitation on for-cause testing to policy violation even if the quantitative listed in the rule without identifying
followup testing meets Goal 7 of this test result falls below the FFD program’s them in advance. Although deterring
rulemaking to protect the privacy rights established confirmatory cutoff level. substance abuse is an important goal of
and other rights (including due process) Although these practices may increase the rule, detecting substance abuse is
of individuals who are subject to Part the likelihood of detecting drug abuse, equally important. Therefore, both the
26. they are inconsistent with one of the former and final rules permit licensees
The final rule replaces the term bases for establishing cutoff levels for to add drugs to the panel of substances
‘‘illegal drugs’’ in former Section 2.1(b) drug testing. This basis is to minimize for which they routinely test, as well as
in Appendix A to Part 26 with a specific the likelihood of false positives that to conduct tests to detect any drugs
reference to the drugs that are listed on could result in the imposition of listed on Schedules I–IV of the CSA in
Schedules I–V of the Controlled sanctions on an individual who has not followup, post-event, and for-cause
Substances Act. These schedules list abused drugs. It also subjects testing that the individual is suspected
drugs with abuse potential and include individuals who are undergoing for- of abusing. The NRC has added this
many drugs with legitimate medical cause, post-event, or followup testing to requirement to meet Goal 3 of this
uses that are not ‘‘illegal’’ when used unequal treatment when compared to rulemaking to improve the effectiveness
with a valid prescription for medical individuals who are subject to random and efficiency of FFD programs and
purposes. Therefore, replacing the term and pre-access testing, in which the Goal 6 to improve clarity in the
‘‘illegal drugs’’ with the reference to established cutoff levels must be organization and language of the rule.
Schedules I–V of the Controlled applied. Therefore, the final rule Section 26.31(d)(2) [Random testing]
Substances Act (CSA) more accurately specifically prohibits these practices, reorganizes and amends the
characterizes the specific drugs for but adds, with respect to the proposed requirements for conducting random
which testing is permitted. The NRC has rule, an exception for a situation in testing. These requirements appeared in
made this change to meet Goal 6 of this which the specimen is dilute and the former § 26.24(a)(2), as described in the
rulemaking to improve clarity in the licensee or other entity has requested following paragraphs.
language of the rule. the HHS-certified laboratory to evaluate Section 26.31(d)(2)(i) adds a
Section 26.31(d)(1)(ii) also applies the the specimen under §§ 26.163(a)(2) and requirement for licensees and other
new requirements in § 26.31(d)(1)(i)(D) 26.185(g)(3). The NRC has made these entities to administer random testing in
related to testing for drugs that are not changes to meet Goal 7 of this a manner that provides reasonable
included in the FFD program’s panel of rulemaking as it relates to protecting the assurance that individuals are unable to
predict the time periods during which Section 23.31(d)(2)(i)(A) requires Section 26.31(d)(2)(ii) retains the
specimens will be collected. The NRC licensees and other entities to take third sentence of former § 26.24(a)(2).
has added this provision because the reasonable steps to minimize the cues Section 26.31(d)(2)(ii) states that
NRC is aware of instances when that persons may use to detect that random testing must be administered on
individuals who believed they would specimens will be collected at a certain a nominal weekly frequency. The former
have a positive test result if tested have time. These cues may include, but are requirement to collect specimens for
been able to determine the days on not limited to, the presence of a mobile random testing at ‘‘various times during
which collections were being collection facility on site and the the day’’ is retained in
conducted. This determination then presence of collectors at the site only on § 26.31(d)(2)(i)(B).
gave them the opportunity to leave work days that collections occur, or having Section 26.31(d)(2)(iii) requires
under the guise of illness in order to the lights on in a designated collection individuals who are selected for random
avoid the possibility of being tested. The site and occupying it only when the testing to report to the collection site as
ability to detect that specimens are collection site is in use. A reasonable soon as reasonably practicable after they
being or will be collected for random step to minimize cues associated with have been notified that they have been
testing also provides an opportunity for activities inside a collection site could selected for testing within the time
individuals to be prepared to subvert be covering any outside windows so period established in the FFD policy.
the testing by procuring an adulterant or that a passerby cannot detect whether The necessity for the FFD policy to
urine substitute and keeping it available the collection site is occupied. Other establish a time limit within which
on their persons during the periods that steps to meet the requirement could individuals must report for testing is
specimens are collected. However, the include, but would not be limited to, discussed with respect to § 26.27(b)(2).
NRC also recognizes that it is impossible stationing a mobile collection facility on Section 26.31(d)(2)(iii) further clarifies
to ensure that individuals are unable to site for some part of the day on 4 days this requirement by emphasizing the
detect the periods when specimens are each week or assigning individuals to individual’s responsibility to report as
being collected. At a minimum, staff the designated collection site soon as reasonably practicable after
coworkers will be suspicious that during periods that specimens are not notification. For example, in order to
collections are occurring if they observe being collected during some portion of cover all of the possible situations when
an individual leaving the work site and each day on at least 4 days in each it may not be possible for an individual
returning within a short time, even if calendar week. Maintaining the to immediately report for testing after
the supervisor and individual do not appearance that the collection site is notification (which could include the
discuss the reason for the individual’s active on more than half of the days in time required to travel to a collection
short absence. Therefore, the section each week makes it more difficult for site or to change clothes and be
requires licensees and other entities to individuals to plan to subvert the testing monitored for contamination after
conduct random testing in a manner process by leaving work when they working under a radiation work permit),
that would provide ‘‘reasonable believe specimens are being collected. the FFD policy may permit individuals
assurance’’ that individuals are unable By reducing the opportunities for up to two hours to report for testing
to predict when specimens will be individuals to subvert the testing after notification. However, if no
collected, rather than requiring them to process by having advanced warning legitimate work, travel, or other
‘‘ensure’’ that the period of time during that specimens are being collected, the demands would prevent an individual
from immediately reporting for testing,
which specimens will be collected requirements in § 26.31(d)(2)(i) and
the provision requires the individual to
cannot be detected. However, licensees paragraph (A) of this section meet Goal
report as soon as he or she is notified.
and other entities are required to 3 of this rulemaking to improve the
This provision strengthens FFD
minimize the likelihood that effectiveness of FFD programs.
programs by further reducing
individuals who are subject to testing Section 26.31(d)(2)(i)(B) amends the opportunities for individuals to subvert
know that they are more likely to be third sentence of former § 26.24(a)(2). the testing process and, therefore, meets
called for testing at certain times than This sentence required that specimens Goal 3 of this rulemaking to improve the
others. must be collected ‘‘at various times effectiveness of FFD programs.
Within this context, § 26.31(d)(2)(i)(A) during the day.’’ The final rule expands Section (d)(2)(iv) retains the portion
adds a requirement that licensees and the former requirement to require of the first sentence of former
other entities take reasonable steps to licensees and other entities to collect § 26.24(a)(2) that required licensees to
either conceal from the workforce that specimens on an unpredictable ensure that individuals subject to testing
collections will be performed during a schedule, including weekends, have an equal probability of being
scheduled collection period, or create backshifts, and holidays, and at various selected and tested. The final rule splits
the appearance that specimens are being times during a shift. The purpose of the proposed § 26.31(d)(2)(iv) into two
collected during a portion of each day former and final provisions is to ensure paragraphs after the first sentence of the
on at least 4 days in each calendar week that individuals cannot predict the proposed paragraph, and renumbers the
at each site. With respect to the times they will be tested, as well as subsequent paragraphs to accommodate
proposed rule, the final rule clarifies prevent them from perceiving that there this change. This reorganization is an
that in the latter instance, the portions are ‘‘safe’’ periods during which they effort to clarify the requirements of this
of each day and the days of the week will not be tested, which may lead them section, consistent with Goal 6 of this
must vary in a manner that cannot be to believe they could engage in rulemaking to improve clarity in
predicted by donors. The NRC, after substance abuse without fear of organization and language of the rule.
publishing the proposed rule, detection. Varying the time periods As a result of this renumbering,
recognized the need for additional during which specimens are collected § 26.31(d)(2)(v) of the final rule amends
clarity in this provision to illustrate the on an unpredictable schedule also the first sentence of former § 26.24(a)(2)
NRC’s intent. Therefore, the NRC has increases the rule’s effectiveness in to clarify that individuals who are off
made this change to meet Goal 6 of this deterring substance abuse, which meets site when selected for testing and not
rulemaking to improve clarity in the Goal 3 of this rulemaking to improve the reasonably available for testing when
language of the rule. effectiveness of FFD programs. selected, must be tested at the earliest
reasonable and practical opportunity. immediately eligible for another individuals who are not subject to Part
However, the final rule, with respect to unannounced test, as required in 26, all individuals at a site, or all
the proposed rule, adds a clarification § 26.31(d)(2)(vi), but does not ensure individuals who are subject to the
that individuals who are on site and not that all individuals who are subject to licensee’s FFD program. This provision
reasonably available for testing also this part have an equal probability of clarifies that the number of random tests
must be tested at the earliest reasonable being tested. Therefore, the requirement that must be performed in a year must
and practical opportunity. The NRC has that individuals who are off site when equal 50 percent of the population of
made this change in response to a selected for testing or who are on site individuals who are subject to random
public comment, which suggested that and not reasonably available for testing testing under the FFD program. If a
the second sentence of proposed when selected must be tested at the common FFD program covers several
§ 26.31(d)(2)(iv) could be interpreted as earliest reasonable and practical sites, the ‘‘population’’ would include
requiring individuals who are on site opportunity meets Goal 3 of this all individuals who are subject to the
but not reasonably available for testing rulemaking to improve the effectiveness common FFD program. The population
to be tested immediately. The of FFD programs. also includes individuals who have
commenter gave the example of an The section includes the phrase ‘‘at applied for authorization and who are
individual who is suited up for work in the earliest reasonable and practical subject to random testing under § 26.67
a radiologically controlled area from opportunity when both the donor and [Random drug and alcohol testing of
which he or she could not exit to be collectors are available to collect individuals who have applied for
tested in a reasonable period of time. specimens for testing’’ to clarify that authorization]. The NRC has made this
The NRC notes that in these cases, licensees and other entities are not change to meet Goal 6 of this
individuals who are on site but not required to call an individual back to rulemaking to improve clarity in the
reasonably be available for testing are the site if he or she is off site when organization and language of the rule.
required to report to the collection site selected for testing. In addition, the The NRC has added § 26.31(d)(3)
as soon as reasonably practical after provision does not require licensees and [Drug testing] to the final rule to group
notification (emphasis on other entities to make special requirements in one section that are
‘‘notification’’), under § 26.31(d)(2)(iii). arrangements to ensure that a collector related to the general administration of
In the given example, the supervisor is available to collect the specimens as drug testing. The NRC has made this
would only notify the individual about soon as the individual returns to the change because requirements that
testing after he or she is out of site. The NRC is aware that some address this topic were dispersed
containment and has changed back to licensees have called in individuals and throughout the former rule. Grouping
street clothes. If this were to occur at the collectors in the past under these them together in a section makes them
end of the shift when collectors have circumstances. However, these practices easier to locate within the final rule.
left the site, this individual would not may permit individuals to predict that This reorganization meets Goal 6 of this
be notified that he or she must report for they will be subject to testing when they rulemaking to improve clarity in the
testing until the next time both the return to the site. This prediction would organization and language of the rule.
provide them with an opportunity to Section 26.31(d)(3)(i) combines and
donor and the collectors are available to
take actions to subvert the testing modifies some of the requirements in
collect specimens for testing. Because
process, as discussed with respect to former Section 1.1(3) in Appendix A to
there would be no known reason that
§ 26.31(d)(2)(i). Therefore, the provision Part 26, former § 26.24(f), the first
this individual will test positive at the
requires licensees and other entities to sentence of former Section 2.8(e)(1) in
time of collection, any possible delays
collect specimens from an individual Appendix A, and former Section 2.8(a)
in testing should not compromise the and (b) in Appendix A to Part 26. These
who is off site when selected for testing
performance objectives of the FFD former provisions required licensees
or on site and not reasonably available
program. However, the FFD program is and other entities to use only HHS-
for testing, in a manner that also ensures
responsible for preventing potential certified laboratories to perform drug
that the individual does not have
abuses brought on by such delays, testing, except if initial tests were
advance notification that he or she has
which could include a supervisor performed at a licensee testing facility.
been selected for testing. The NRC has
protecting known substance abusers However, the final rule has clarified the
made this change to meet Goal 3 of this
through improper notifications or rulemaking to improve the effectiveness first sentence of this section, with
delaying testing until completion of a and efficiency of FFD programs. respect to the proposed rule, to include
critical job. Therefore, based on this Section 26.31(d)(2)(vi) of the final validity tests, validity screening tests,
analysis, the NRC has clarified this rule, renumbered from (d)(2)(v) in the and initial validity tests. The NRC has
provision to reflect the public comment proposed rule, retains the second retained other detailed requirements in
and clarify the NRC’s intent, consistent sentence of former § 26.24(a)(2). This these sections, but they are presented in
with Goal 6 of this rulemaking to provision requires that an individual the appropriate sections in Subparts E,
improve clarity in the language of the who has completed a test is F, and G of the final rule. The agency
rule. immediately eligible for another random has made these changes to meet Goal 6
The requirements of § 26.31(d)(2)(v) test. of this rulemaking to improve the
prohibit licensees and other entities Section 26.31(d)(2)(vii) of the final organizational clarity of the rule.
from returning the names of the rule, renumbered from (d)(2)(vi) in the In addition, § 26.31(d)(3)(i) requires
individuals who are offsite when proposed rule, amends the last sentence that specimens sent to the HHS-certified
selected for testing or who are on site of former § 26.24(a)(2). The NRC has laboratory by the licensee or other entity
and not reasonably available for testing made this change in response to must be subject to initial validity and
when selected to the random testing licensee implementation questions with drug testing by the laboratory. However,
pool without conducting a test, as has respect to the meaning of the term the final rule clarifies the language of
been the practice of some licensees. ‘‘workforce’’ in the former rule. These the proposed rule to require that any
Returning these individuals’ names to questions related to whether specimens that yield ‘‘positive initial
the random testing pool without ‘‘workforce’’ means all individuals who drug test results or are determined by
conducting a test ensures that they are are employed by the licensee, including initial validity testing to be of
questionable validity’’ must be subject testing to strengthen FFD programs by to that section. The NRC has made these
to confirmatory testing by the improving current laboratory changes to meet Goal 6 of this
laboratory. The final rule deletes the procedures to detect specimens that are rulemaking to improve clarity in the
term ‘‘non-negative’’ from the proposed diluted, adulterated, or substituted. This organization and language of the rule.
rule and adds the term ‘‘questionable change is consistent with Goal 1 of this Section 26.31(d)(3)(iii)(A) retains the
validity’’ for the reasons discussed with rulemaking to update and enhance the third and fourth sentences of former
respect to § 26.5. The NRC has made consistency of Part 26 with advances in § 26.24(b) regarding management
these changes to meet Goal 6 of this other relevant Federal rules and actions and sanctions for confirmed
rulemaking to improve the guidelines. Detecting specimen positive drug test results based on any
organizational clarity of the rule. tampering is necessary to identify lower cutoff levels established by the
Specimen validity testing refers to individuals who may attempt to hide FFD program. The final rule adds a
testing conducted by a laboratory to drug abuse. Attempts to tamper with a requirement that the FFD program’s
identify attempts to tamper with a specimen provide clear evidence that written policy and procedures must
specimen. Attempts to tamper with a the individual is not trustworthy and document the FFD program’s lower
specimen may include: reliable. Also, these individuals’ drug cutoff levels in the written policy and
(1) Adulteration, which means putting use may pose a risk to public health and procedures to ensure that individuals
a substance into a specimen that is safety and the common defense and who are subject to testing are aware of
designed to mask or destroy the drug or security, as discussed with respect to the cutoff levels that would be applied
drug metabolite that the specimen may § 26.23. to their drug test results in order to
contain or to adversely affect the assay Section 26.31(d)(3)(ii) amends the protect their rights. The NRC has made
reagent; first sentence of former § 26.24(d)(1). this change to meet Goal 7 of this
(2) Dilution, which means adding a This sentence permits licensees and rulemaking to protect the privacy and
liquid that, in contrast to an adulterant, other entities to conduct initial testing other rights (including due process) of
would not be detected by validity of urine specimens at a licensee testing individuals who are subject to Part 26.
testing, to the urine specimen to facility, provided that the licensee Section 26.31(d)(3)(iii)(B) requires the
decrease the concentration of a drug or testing facility staff possesses the uniform application of the FFD
metabolite below the cutoff necessary training and skills for the program’s cutoff levels for drugs and
concentration; and tasks assigned, the staff’s qualifications drug metabolites, including any more
(3) Substitution, which means are documented, and adequate quality stringent cutoff levels in all tests
replacing a valid urine specimen with a controls for the testing are implemented. conducted under this part and equally
drug-free specimen. The final rule adds permission for to all individuals who are subject to
When HHS published its Notice of licensees and other entities to perform testing, except as permitted under
Final Revisions to the HHS Guidelines initial validity testing at a licensee § § 26.31(d)(1)(ii), 26.163(a)(2) for dilute
(66 FR 43876; August 21, 2001) to testing facility for the reasons discussed specimens, and § 26.165(c)(2) for
establish requirements for specimen with respect to § 26.31(d)(3)(i). Subpart retesting specimens. As discussed with
validity testing performed by HHS- F establishes detailed requirements respect to § 26.31(d)(1)(ii), some FFD
certified laboratories, HHS reported that related to specimen validity testing at programs have adopted the practice of
the number of adulterated and licensee testing facilities. testing specimens at the assay’s LOD for
substituted urine specimens has been Section 26.31(d)(3)(iii) is based upon for-cause, post-event, and followup
increasing among the specimens tested the portions of former Section 2.7(e)(1) tests, which results in some individuals
under the Federal agency workplace and (f)(2) in Appendix A to Part 26. receiving unequal treatment under the
drug testing program and the DOT These former sections established the rule. Therefore, the NRC has added the
regulations (49 CFR Part 40). Program cutoff levels for initial and confirmatory section to meet Goal 7 of this
experience gained after Part 26 was first drug testing, respectively, which rulemaking to protect the privacy and
promulgated has also indicated an licensees must apply under the former other rights (including due process) of
increasing number of adulterated and rule. However, the final rule requires individuals who are subject to Part 26.
substituted urine specimens submitted FFD programs to apply the updated The NRC has added
to HHS-certified laboratories from Part cutoff levels specified in § 26.163(a)(1) § 26.31(d)(3)(iii)(C) to the final rule to
26 testing programs. for initial drug testing and § 26.163(b)(1) specify requirements for establishing
Although former Part 26 contained a for confirmatory drug testing. The final more stringent cutoff levels. Before
number of requirements related to rule clarifies the language of the implementing the more stringent cutoff
specimen validity (e.g., the fifth proposed rule by adding that either the levels, licensees and other entities are
sentence of former Sections 2.1(e), licensee testing facility or HHS-certified required to obtain certification from a
2.4(f)(2), 2.4(g)(14) through (g)(16), and lab conducts the initial drug testing and forensic toxicologist that the more
2.7(d) in Appendix A to Part 26), the the HHS-certified laboratory conducts stringent cutoff levels are technically
methods available to tamper with the confirmatory testing. Consistent sound and legally defensible, with two
specimens have become more with the first sentence of former exceptions. Certification by a forensic
sophisticated after the rule was first § 26.24(b), the second sentence of this toxicologist is not required if: (1) If the
published and more sophisticated provision permits FFD programs to HHS Guidelines are revised to lower the
methods of detecting tampering are implement more stringent cutoff levels cutoff levels for the drug or drug
necessary. Therefore, the final rule than specified in the rule, but metabolites in Federal workplace drug
incorporates new requirements for HHS- establishes additional requirements testing programs and the licensee or
certified laboratories to conduct related to lower cutoff levels, as is other entity implements the cutoff levels
specimen validity tests that are discussed with respect to paragraphs published in the HHS guidelines; or (2)
consistent with similar provisions (d)(3)(iii)(A) through (C). The NRC has if the licensee or other entity received
contained in the most recent revision to relocated the permission in the first written approval of the NRC to test for
the HHS Guidelines (69FR 19643; April sentence of former § 26.24(b) to lower cutoff levels before the
13, 2004). The NRC has added these implement a broader panel of drugs to implementation date of this rule, which
new requirements for specimen validity § 26.31(d)(1), as discussed with respect is 365 days after the date the final rule
is published in the Federal Register. 26.31(d)(5)(ii) clarifies that necessary Section 26.35(a) retains the former
Certification by a toxicologist is medical treatment may not be delayed provision without change and specifies
unnecessary in these two circumstances in order to conduct drug and alcohol that licensees and other entities shall
because it would be redundant. The testing. These sections are consistent maintain EAPs that offer confidential
NRC has made this change to meet Goal with the requirements of other Federal assessment, short-term counseling,
5 of this rulemaking to improve Part 26 agencies and meet Goal 1 of this referral services, and treatment
by eliminating or modifying rulemaking to update and enhance the monitoring to individuals who have
unnecessary requirements, while consistency of Part 26 with advances in problems that could adversely affect the
continuing to protect donors’ right to other relevant Federal rules and individuals’ abilities to safely and
accurate and reliable drug testing. guidelines. competently perform their duties. The
Section 26.31(d)(4) [Alcohol testing] Section 26.31(d)(6) [Limitations of provision also requires that the EAP be
updates former § 26.24(g) that contained testing] retains and amends former designed to achieve early intervention
general requirements for conducting Section 2.1(d) in Appendix A to Part 26. and provide for confidential assistance.
alcohol testing. The update reflects This former section stated that The NRC has added § 26.35(b) to the
other changes that have been made in specimens collected under Part 26 may final rule to clarify that licensees and
the final rule. The NRC has amended only be designated or approved for other entities are not required to provide
the former cross-reference to Section testing as described in this part and may EAP services to C/V employees,
2.7(o)(3) in Appendix A to Part 26 to not be used for any other analysis or test including those who are working at a
refer to § 26.91(a) in Subpart E, which without the permission of the tested licensee’s or other entity’s facility. With
contains detailed requirements for individual. The final rule adds respect to the proposed rule, the final
conducting alcohol testing. The NRC examples of the types of analyses and rule clarifies that licensees and other
has added the reference to oral fluids as tests that are prohibited without the entities are not required to provide EAP
acceptable specimens for initial alcohol donor’s written permission. Although services to C/V employees whose work
testing to this section. The basis for the NRC is not aware of any instances location is a licensee’s or other entity’s
adding oral fluids as acceptable when such unauthorized testing has
facility. This provision is consistent
specimens for initial alcohol testing is with the interpretation of the former
occurred in FFD programs under this
discussed with respect to § 26.83 rule in item 13.1.4 of NUREG–1354. The
part, the technology for performing
[Specimens to be collected]. The NRC final rule continues to require that C/V
these analyses and tests has become
has changed the BAC at which a employees who are subject to Part 26
increasingly available since the
confirmatory test is required to 0.02 must have access to an EAP, and that
regulation was first promulgated. The
percent (from 0.04 percent) in the licensees and other entities who rely
NRC has added these examples to meet
provision for consistency with the upon the FFD program of a C/V
Goal 7 of this rulemaking to protect the
revised alcohol cutoff levels in § 26.99 continue to be required to ensure that
privacy and other rights (including due
[Determining the need for a the EAP of a C/V meets the
process) of individuals who are subject
confirmatory test for alcohol] and requirements of this part.
§ 26.103 [Determining a confirmed to Part 26. The provision also states that
positive test result for alcohol]. The Section 26.33 Behavioral Observation licensees and other entities need not
basis for the revised alcohol cutoff provide EAP services to individuals
levels is discussed with respect to those The NRC has added § 26.33 to the who have applied for but have not yet
sections of the final rule. The agency final rule to emphasize that behavioral been granted authorization under
has deleted reference to blood testing for observation is a required element of FFD Subpart C. Licensees and other entities
alcohol because the final rule no longer programs. The first sentence of § 26.33 are not required to provide an EAP to
permits donors to request blood testing requires behavioral observation of applicants for authorization because
for alcohol, as discussed with respect to individuals subject to this subpart. The these individuals would not yet be
§ 26.83(a) of the final rule. second sentence retains former performing duties that could affect
The NRC has added § 26.31(d)(5) § 26.22(a)(3), (a)(4), and (b), which public health and safety or the common
[Medical conditions] to the final rule to stated that the individuals who perform defense and security. The NRC has
address circumstances when it may be behavioral observation must be trained. added this clarification because
impossible or inadvisable to test an The third sentence of the section applicants are subject to other
individual using the procedures requires that individuals must report requirements under the final rule as
specified in this part. Circumstances FFD concerns arising from behavioral discussed with respect to § 26.4(h).
have arisen under Part 26, as well as the observation to the appropriate personnel Section 26.35(c) amends the last
programs of other Federal agencies, designated in the FFD program sentence of former § 26.25. The
when an individual’s medical condition procedures. The NRC has added these provision emphasizes that the identity
has made it inadvisable to implement requirements to the final rule to and privacy of an individual who seeks
testing procedures under the relevant strengthen the behavioral observation EAP services must be protected and
requirements. Therefore, § 26.31(d)(5)(i) element of FFD programs by increasing clarifies the conditions under which
permits alternative specimen collection the likelihood that the licensees and EAP personnel may or must violate an
and evaluation procedures for rare other entities detect and appropriately individual’s confidentiality. The final
instances when it would be difficult or address impairment and other adverse rule permits EAP personnel to
hazardous to the donor to collect breath, behaviors. These changes are consistent communicate information about an
oral fluids, or urine specimens, with Goal 3 of the rulemaking to individual by name to the licensee or
including, but not limited to, required improve the effectiveness and efficiency other entity under only two conditions:
post-event testing when an individual of FFD programs. (1) If the individual waives the right to
has been seriously injured. Only the privacy, or (2) EAP personnel determine
Section 26.35 Employee Assistance
MRO is permitted to authorize an that the individual’s condition or
Programs
alternative evaluation procedure that actions pose or have posed an
may include, but is not limited to blood Section 26.35 amends former § 26.25 immediate threat to himself or herself or
testing for alcohol. Section [Employee assistance programs]. others. By clarifying the NRC’s intent
with respect to EAP confidentiality, the individuals who self-refer to the EAP addition to evidence that the
provision meets Goal 6 of this and the nature of assistance the individual’s personal relationships,
rulemaking to improve clarity in the individuals sought. The provision is financial condition, and/or health are
language of the rule because the former necessary to eliminate some licensees’ suffering from his or her alcohol
provision has been misinterpreted. practices of requiring these reports, consumption, and any indications that
The last sentence of former § 26.25 protect individuals’ privacy, and the individual has been impaired while
required confidentiality for individuals strengthen the EAP element of FFD in a work status, would constitute
who seek EAP services, except if EAP programs by eliminating a former barrier substantive reasons to believe that the
professionals determine that the to self-referrals in some FFD programs. individual’s condition poses an
individual’s condition ‘‘constitutes a The term ‘‘routinely’’ is used to indicate immediate hazard and must be reported.
hazard to himself or herself or others.’’ that the final rule permits EAP The NRC has added § 26.35(c)(2)(i)
Some licensees have over-interpreted personnel to report individuals’ names through (iii) to the final rule to provide
this phrase and routinely require EAP and the nature of their problems if the several examples of conditions and
staff to report individuals who self-refer individuals have waived the right to actions that require EAP personnel to
for any reason, which is not the intent privacy in writing or EAP personnel provide a report about an individual
of this provision. The NRC is also aware determine that an individual’s condition who has self-referred to licensee or
that some individuals who are subject to or actions pose or have posed an other entity management. Section
the rule have misinterpreted this phrase immediate risk to public health and 26.35(c)(2)(i) requires reporting if the
as meaning that no self-referral to the safety or the common defense and EAP staff has substantive reasons to
EAP would remain confidential and that security. The provision does not believe that an individual may harm
EAP staff always report self-referrals to prohibit EAPs from reporting program himself or herself or others, including,
licensee management. This perception utilization statistics or aggregated data but not limited to, plans threatening
appears to be widely shared, including that characterize the types of problems suicide, radiological sabotage, or
by individuals who are subject to FFD for which the program has provided physical violence against others. Section
programs that have not misinterpreted services because this type of 26.35(c)(2)(ii) requires reporting if the
the former rule and who correctly information does not compromise EAP staff has substantive reasons to
permit EAP staff to make the individuals’ privacy. believe that an individual has been
determination of whether to report an impaired from drugs or alcohol while in
The NRC has added § 26.35(c)(2) to
individual’s condition to licensee a work status and is likely to be
management. the final rule to provide further clarity impaired in the future, as discussed
A key purpose of requiring EAPs in the language of the rule with respect with respect to § 26.35(c)(2). Section
under Part 26 is to encourage to the conditions under which EAP 26.35(c)(2)(iii) requires reporting if the
individuals and their family members to personnel are excepted from the EAP staff has substantive reasons to
self-refer for any type of problem that confidentiality requirement in § 26.35(c) believe that an individual has
could potentially impair job and required to report a concern about committed any of the acts that would
performance, so that early intervention an individual to the licensee or other require a report to the NRC under
may be offered to prevent the problem entity. The NRC is confident that EAP § 26.719(b)(1) through (b)(3), including
from adversely affecting the individuals’ personnel have the qualifications and but not limited to, the use, sale,
job performance. Upon assessment, it is training necessary to continue to make distribution, possession, or presence of
not uncommon for EAP staff to find that the professional judgments required illegal drugs, or the consumption or
a developing substance abuse problem under the regulations in these presence of alcohol within a protected
is contributing to a financial or family circumstances. However, the final rule area or while performing duties that
problem for which an individual has includes more detail with respect to the require the individual to be subject to
sought assistance. As a result, the EAP conditions and actions that an EAP this part. The examples included in
provides an important means to detect professional is required to report to these sections are illustrative, and do
and achieve early resolution of ensure that licensees, other entities, and not represent an exhaustive list of the
developing substance abuse and other individuals who are subject to the rule conditions and actions that EAP staff
problems, which if left untreated could better understand the intent of the may encounter that would be reported
have the potential to adversely affect an former and final provisions. The final to licensee or other entity management
individual’s ability to safely and rule requires EAP personnel to report a under the final rule.
competently perform his or her duties. concern about a specific individual to For additional clarity, the NRC has
The knowledge or perception among licensee or other entity management added § 26.35(c)(3) to the final rule to
individuals who are subject to the rule only when they have substantive cross-reference the provisions in the
that self-referrals to the EAP will be reasons to believe that an individual’s final rule that specify the actions that
reported to management and will condition or actions pose or have posed licensees and other entities would take
routinely result in the loss of an immediate hazard to themselves or after receiving a report from EAP
authorization represents a significant others. The phrase ‘‘substantive reasons personnel that an individual’s condition
barrier to the effectiveness of the EAP to believe’’ is used to clarify that casual or actions pose or have posed an
element of FFD programs. Therefore, the and/or contextually appropriate immediate hazard to himself or herself
section amends the last sentence of comments made by an individual or others. As discussed with respect to
former § 26.25 to clarify that an during a counseling session are not a (§§ 26.69(d) and 26.77(b) of the final
individual’s use of the licensee’s or sufficient basis for reporting to the rule, those provisions require the
other entity’s EAP must remain licensee or other entity. For example, an licensee or other entity to take
confidential, except in very limited individual’s statement that he or she is immediate action to prevent the
circumstances. concerned about becoming an alcoholic individual from performing any duties
The NRC has added § 26.35(c)(1) to would not constitute a substantive that require the individual to be subject
the final rule to prohibit licensees and reason to believe that the individual’s to this part, ensure that a determination
other entities from requiring the EAP to condition poses an immediate hazard. of fitness is performed by a professional
routinely report the names of In contrast, this stated concern, in who has specific qualifications and
training to address the nature of the listed in the section with the written discussed with respect to § 26.183(d) of
individual’s problem, and either consent of the subject individual the final rule.
terminate the individual’s authorization because some licensees have Section 26.37(b)(5) amends the former
or ensure that the condition is resolved misinterpreted the former requirement reference to licensee representatives
before permitting him or her to return to as prohibiting them from releasing the who have a need to have access to the
performing duties under this part. personal information under any information in performing assigned
These changes to former § 26.25 are circumstances, except to the parties duties. The former rule referred only to
consistent with Goal 7 of this listed in this section. In some instances, individuals who are performing audits
rulemaking to protect the privacy and such failures to release information have of FFD programs. As a result, some
other rights (including due process) of inappropriately inhibited an licensees have misinterpreted the
individuals who are subject to Part 26, individual’s ability to obtain former rule as limiting the release of
as well as Goal 3 to improve the information that was necessary for a personal information only to such
effectiveness and efficiency of FFD review or appeal of the licensee’s individuals. This was not the intent of
programs. determination that the individual had the provision. Rather, the NRC intended
violated the FFD policy. Therefore, the that licensees and other entities were
Section 26.37 Protection of
NRC has added the explicit permission permitted to release information to their
Information
for licensees and other entities to release representatives who must have access to
Section 26.37 amends former § 26.29 personal information when an the personal information in order to
that contained requirements for individual consents to the release, in perform assigned duties.
protecting the personal information that writing, to meet Goal 7 of this With respect to the proposed rule, the
must be collected under Part 26. In rulemaking to protect the privacy rights final rule modifies proposed
general, this section of the final rule and other rights (including due process) § 26.37(b)(5) to clarify the NRC’s intent
groups requirements related to the that the only licensee or other entity
of individuals who are subject to Part
protection of personal information that representatives who may have access to
26.
were dispersed throughout the former the personal information collected
rule to aid in locating these Section 26.37(b)(1) through (b)(8) lists
under this part are persons who have a
requirements in the final rule. The NRC the individuals to whom licensees and
need for that information to implement
has moved the records retention other entities are permitted to release
the requirements of the rule. The NRC
requirement in former § 26.29(a) to personal information about an
made this change to provide greater
Subpart N of the final rule. The NRC has individual. Section 26.37(b)(3), (b)(4),
assurance that personal information,
made these changes to meet Goal 6 of and (b)(8) retains unchanged the
such as medical records that an
this rulemaking to improve clarity in the permission for the release of
individual has submitted to the MRO to
organization of the rule. information to NRC representatives,
document prescription medication for a
Section 26.37(a) combines and retains appropriate law enforcement officials
‘‘shy bladder’’ situation, is not released
the first sentence of former § 26.29(a) under court order, and other persons as to persons who do not have assigned
and the second sentence of former required by court order. Section duties under the FFD program that
Section 3.1 in Appendix A to Part 26. 26.37(b)(1), (b)(2), (b)(5), (b)(6), and specifically require access to that
The final rule modifies the language of (b)(7) amends the related requirements information. Reviewing officials, MROs,
the proposed rule to require licensees contained in former § 26.29(b) to meet SAEs, and other FFD program
and other entities to establish, use, and Goal 6 of this rulemaking to improve personnel, as well as auditors, require
maintain a system of files and clarity in the organization and language access to some personal information
procedures that protects the individuals’ of the rule. The specific changes to about individuals in order to perform
privacy. The NRC, after publishing the former § 26.29(b) include the following: their assigned duties to implement the
proposed rule, recognized the need for Section 26.37(b)(1) retains the FFD program. Human resources
more clarity in the language of this permission for the release of personnel may need to know that an
provision to illustrate the NRC’s intent. information to the subject individual individual has violated the FFD policy,
Therefore, this change meets Goal 6 of and his or her designated representative. if the licensee or other entity terminates
the rulemaking to improve clarity in the The provision adds requirements for the an individual’s employment in response
language of the rule. individual to designate his or her to an FFD policy violation, but do not
Section 26.37(b) amends former representative in writing and specify the need access to the personal information
§ 26.29(b) and divides it into several FFD matters to be disclosed. The NRC collected about the individual under the
sections for clarity. The first sentence of has made these changes in response to FFD program to carry out the process of
the section amends the first sentence of implementation questions from terminating the individual’s
former § 26.29(b) that prohibited licensees. Licensees have sought employment. The NRC has determined
licensees and other entities from guidance from the NRC related to the that this additional clarification is
disclosing personal information way an individual must ‘‘designate’’ a necessary to provide further protection
collected under this part to any representative. of the privacy of persons who are
individuals other than those listed in Section 26.37(b)(2) retains the subject to the rule.
the sentence. The final rule continues to permission for the release of Section 26.37(b)(6) and (b)(7) amends
permit disclosure of the personal information to the licensee’s or other the portion of former § 26.29(b) that
information to the listed individuals entity’s MROs. The final rule also referred to ‘‘persons deciding matters on
and adds permission for the licensee or permits the release of information to review or appeal.’’ The NRC has
entity to disclose the personal MRO staff members for consistency with amended the provision in response to
information to others if the licensee or § 26.183(d), which permits MRO staff to implementation questions from
other entity has obtained a signed serve some MRO functions under the licensees, including whether the rule
release for such a disclosure from the direction of the MRO. MRO staff require covers persons deciding matters in
individual. The NRC has added the access to the personal information in judicial proceedings or only the internal
permission to release the personal order to perform their duties. The role appeals process specified in former
information to individuals who are not of MRO staff in FFD programs is § 26.28 [Appeals], as well as whether
information could be released in a verify the accuracy of FFD records, and testing of applicants for authorization. If
judicial proceeding that the subject to meet Goal 7 of this rulemaking to applicants are not provided with a
individual did not initiate. The final protect the privacy and other rights review process, it is possible that some
rule clarifies that the permission (including due process) of individuals of them would be effectively barred
includes individuals who are presiding subject to Part 26. Section 26.37(e) and from the industry based on test results
in a judicial or administrative (f) retains former Section 3.1 in erroneously determined to be a violation
proceeding, but only if the subject Appendix A to Part 26 and the last of the licensee’s or other entity’s FFD
individual in § 26.37(b)(6) initiates the sentence of former § 26.29(b), policy. Providing applicants with the
proceeding. Section 26.37(b)(7) covers respectively. opportunity to request a review also
‘‘persons deciding matters under review enhances program credibility.
Section 26.39 Review Process for Section 26.39(b) specifies that FFD
in § 26.39’’ [Review process for fitness-
Fitness-for-Duty Policy Violations procedures must describe the contents
for-duty policy violations], as discussed
with respect to that section. The NRC Section 26.39 amends former § 26.28 and purpose of the notice that licensees
has made these changes to meet Goal 6 and separates it into several sections. and other entities would be required to
of this rulemaking relating to improving The change from the former section provide to an individual who has
clarity in the organization and language heading eliminates the implication that violated an FFD policy. The provision
of the rule. the internal management review is a also requires that the procedures must
The NRC has added § 26.37(c) to the legal proceeding. The agency has added state that the individual may submit
final rule to require the disclosure of several requirements to clarify and additional relevant information as part
relevant information to licensees and strengthen individuals’ rights during the of the review process. This clarification
other entities, including C/Vs, and their review, consistent with Goal 7 of this is necessary because experience with
authorized representatives who have a rulemaking, as described in the implementing former § 26.28 has
legitimate need for the information and following paragraphs. indicated that individuals do not
a signed release from an individual who Former § 26.28 required that understand the purpose of the review
is seeking authorization under this part. individuals who are subject to the rule process and their associated rights in
This provision clarifies former have an opportunity for a management some cases.
§ 26.29(b) because some licensees have review of a determination that the Section 26.39(c) specifies that the
misinterpreted the former provision as individual has violated the licensee’s or procedure must ensure that the
prohibiting the release of information to other entity’s FFD policy. Section individual who conducts the review is
C/Vs who have licensee-approved FFD 26.39(a) retains the requirement that the not associated with the administration
programs and conduct suitable inquiries review must be impartial and adds a of the FFD program. The final rule
on behalf of licensees and other entities. requirement that the review must be modifies the proposed rule by requiring
The NRC has made this change to meet objective. The NRC has added the that only one representative of the
Goal 6 of this rulemaking to improve requirement for an objective review licensee’s or other entity’s management
clarity in the organization and language because some licensees have permitted shall conduct the review. The final rule
of the rule. the same individuals who were allows only one individual to conduct
Section 26.37(d) through (f) retains involved in the initial determination the review in response to a public
several requirements related to the that an individual violated the FFD comment that stated that the review
protection of information in the former policy to provide the review that was process required by this section should
rule but moves them into this section for required under former § 26.28. The be consistent with that required by 10
organizational clarity. Section 26.37(d) impartiality of individuals who are CFR 73.56(e) (personnel access
combines requirements in former reviewing their own decisions is authorization) because this would
§ 26.29(b) and Section 3.2 in Appendix questionable and calls into question the simplify licensee procedures and would
A to Part 26 as they relate to an effectiveness of the review process. improve the consistency between FFD
individual’s access to records that are Therefore, the requirement for the requirements and access authorization
necessary for a review of an FFD policy review to be both impartial and requirements. In specifying that the
violation. However, the final rule objective emphasizes the NRC’s intent reviewer may not be anyone associated
modifies the language of the proposed that the review process be effective. with the administration of the FFD
rule by specifying that it is the FFD In keeping with revisions to several program, including anyone who made
program that is required to promptly other sections that are intended to the initial determination that the
provide all requested records. The NRC counter subversion of the testing individual violated the FFD policy, the
has made this change to meet Goal 6 of process, § 26.39(a) extends this final rule strengthens the impartiality
the rulemaking to improve clarity in the opportunity to request a review to all and objectivity of the review process in
language of the rule. The final rule also FFD violations, including, but not order to further enhance individuals’
adds ‘‘collection site’’ and ‘‘SAE’’ to the limited to, violations based upon rights. The NRC has made these changes
list of entities who must provide records confirmed positive, adulterated, or to meet Goal 3 of the rulemaking to
to an individual or his or her designated substituted, or invalid test results. The increase the effectiveness and efficiency
representative. The final rule also section also clarifies that applicants for of FFD programs, and Goal 7 to protect
expands the proposed language to authorization must be given the the privacy and other rights (including
specify the types of records that must be opportunity for a review. Experience due process) of individuals who are
provided. The examples given for the with implementing this section of Part subject to Part 26.
types of records that must be provided 26 has indicated that some licensees did Section 26.39(d) adds a requirement
to the individual are illustrative, but are not provide a review process to that any records associated with the
not comprehensive of all the types of individuals who tested positive on pre- FFD policy violation must be deleted or
records that must be provided upon access tests. However, the factors that corrected, as appropriate, if the policy
request. The agency has made these could produce false positive test results violation decision is overturned. This
changes in response to public comment, among licensee and C/V employees requirement is necessary because the
to clarify the rule language, to ensure (e.g., administrative or testing errors) are final rule permits licensees and other
that individuals and representatives can equally likely to occur during pre-access entities to share and rely on information
gathered by other Part 26 programs to a improve clarity in the organization and audit activities and clarify that programs
greater extent than is currently possible. language of the rule. must be audited following a significant
Therefore, incorrect records related to Section 26.41(a) [General] of the final change in personnel, procedures, or
an FFD policy violation could rule amends the last sentence in former equipment as soon as reasonably
significantly inhibit an individual from § 26.80(a). This sentence stated that practicable. The NRC recognizes that
further employment under a Part 26 licensees retain responsibility for the FFD programs evolve and new issues
program if this information is effectiveness of C/V programs and the and problems continue to arise.
transmitted to other licensees and implementation of appropriate Turnover of FFD program personnel and
entities who are considering whether to corrective action. The final rule revises contracted services personnel, such as
grant authorization to an individual. this requirement to include HHS- specimen collectors, exacerbates this
The requirement to delete or correct any certified laboratories, as well as any concern. Licensee audits have identified
records associated with an FFD policy C/V FFD program elements and FFD problems that were associated in some
violation that has been overturned will programs that the licensee or other way with personnel changes, such as
protect individuals from such potential entity relies upon, consistent with the new personnel not understanding their
adverse consequences. intent of the former requirement. The duties or procedures, the implications of
Section 26.39(e) of the final rule final rule has added a phrase to the actions that they took or did not take,
amends the last sentence of former proposed rule that requires licensees to or changes in processes. The purpose of
§ 26.28. This sentence stated that be responsible for the continuing these focused audits is to ensure that
licensees and other entities are not effectiveness of any FFD program changes in personnel, procedures, or
required to provide a review procedure services a subcontractor provides to the equipment do not adversely affect the
to C/V employees and applicants when C/V. The NRC has made these changes operation of the particular program
the C/V is administering its own drug to meet Goal 6 of this rulemaking to element or function in question.
and alcohol testing. The final rule improve clarity in the language of the Accordingly, the audit requirement
amends the former paragraph in rule. ensures that any programmatic
response to implementation questions Section 26.41(b) [FFD program] of the problems that may result from
from licensees who have asked whether final rule amends the required audit significant changes in personnel,
the former provision excuses them from frequency in former § 26.80(a). (Other procedures, or equipment are detected
providing a review process for C/V provisions of § 26.41 address the other and corrected on a timely basis. By
employees at any time, including requirements contained in former requiring more frequent audits of FFD
situations when the FFD policy § 26.80(a), as discussed with respect to program performance that may require
violation was determined as a result of the sections of the final rule that address closer monitoring than a nominal 24-
testing conducted by the licensee. The those topics.) The final rule decreases month frequency would provide, these
final rule revises this sentence to clarify the former 12-month FFD program audit changes meet Goal 3 of this rulemaking
that the licensee or other entity need not frequency to a nominal 24-month to improve the effectiveness and
provide a review process if the C/V’s frequency, which grants a petition for efficiency of FFD programs.
drug and alcohol testing program rulemaking (PRM–26–1) submitted by Section 26.41(c) [C/Vs and HHS-
identified the FFD violation to be Virginia Power on December 30, 1993. certified laboratories] of the final rule
reviewed. If the licensee’s drug and Experience with implementing Part 26 amends the audit and inspection
alcohol testing determined the FFD has shown that annual audits of the requirements that are contained in the
violation, the licensee is required to entire FFD program are unnecessary to second sentence of former § 26.80(a) and
provide the impartial and objective ensure continued program effectiveness the third sentence of Section 2.7(m) in
review. The final rule modifies the and, therefore, place an unnecessary Appendix A to Part 26, as follows:
proposed rule to state that the licensee burden on those entities who are subject Section 26.41(c)(1) further amends the
need not provide a review procedure to to the rule. The NRC decreased the audit requirement in former § 26.80(a) for
a C/V subcontractor when the FFD frequency to 24 months to relieve this annual audits of C/V FFD programs and
policy violation was determined under burden and to be consistent with the program elements and HHS-certified
a C/V’s program. These changes are NRC’s schedule for inspecting FFD laboratories. The former annual audit
consistent with Goal 6 of this programs. The change is consistent with frequency is retained only for those
rulemaking to improve clarity in the Goal 5 of this rulemaking to improve portions of C/V FFD programs whose
organization and language of the rule. Part 26 by eliminating or modifying personnel work off site and are not
unnecessary requirements. under the daily supervision of FFD
Section 26.41 Audits and Corrective Although the final rule decreases the program personnel. The activities of
Action required audit frequency, licensees and C/V personnel who work on site and are
Section 26.41 of the final rule other entities are required to monitor under the daily supervision of
renames and amends former § 26.80 program performance indicators and FFD program personnel are audited
[Audits]. The NRC has added the phrase operating experience, consistent with a under § 26.41(b). Retention of the
‘‘and corrective action’’ to the section performance-based approach, and audit annual audit requirement for C/Vs
heading to emphasize the NRC’s intent FFD program elements more frequently whose personnel work off site meets
that licensees and other entities must than every 24 months as needed. In Goal 3 of this rulemaking to improve the
ensure that corrective actions are taken determining the need for more frequent effectiveness and efficiency of FD
in response to any adverse findings audits, the final rule requires licensees programs. The provision is necessary to
resulting from an audit. In addition, the and other entities to consider FFD ensure that the services provided
final rule reorganizes the audit performance, including but not limited continue to be effective because other
requirements in former § 26.80, and to, the frequency, nature, and severity of means of monitoring their effectiveness,
moves several audit and inspection discovered problems, testing errors, such as daily oversight, are unavailable.
requirements into this section that were personnel or procedural changes, and The section also retains the annual audit
addressed in Appendix A to Part 26. previous audit findings. The provision requirement for HHS-certified
The NRC has made these changes to is intended to promote performance- laboratories. The NRC has retained this
meet Goal 6 of this rulemaking to based rather than compliance-based audit frequency because of the key role
the laboratories play in the overall ensure that annual audits of the HHS- conduct audits at any time, including
effectiveness of Part 26 programs. certified services related to those cutoff unannounced times, and to review all
Retention of these annual audit levels and drug tests are performed. information and documentation that is
requirements in the section denies the The NRC has added the last sentence reasonably relevant to the audits. The
petition for rulemaking (PRM–26–1) of § 26.41(c)(2) to clarify the scope of the provision extends the former
submitted by Virginia Power on former audit requirements. The final requirement to any C/V with whom the
December 30, 1993. rule does not require licensees and other licensee or other entity contracts for
Section 26.41(c)(2) relaxes some entities to audit organizations that do FFD program services to enhance the
requirements related to annual audits not routinely provide FFD services to effectiveness of the licensees’ and other
and inspections of the HHS-certified the licensee or other entity, such as entities’ audits should unannounced
laboratories that licensees and other local hospitals or a substance abuse audits appear to be necessary. For
entities rely upon for drug testing treatment facility. It is unnecessary to example, a licensee or other entity may
services. The final rule permits audit these organizations because the receive allegations that an offsite C/V is
licensees and other entities who are FFD program would use their services falsifying records or that a contract MRO
subject to the rule to rely upon the infrequently, there would be a or SAE is using drugs. The licensee or
inspections of HHS laboratories that are reasonable expectation of quality, and other entity may determine that an
performed for HHS-certification reviews weaknesses in these services could be unannounced audit would provide the
and no longer requires licensees and identified through other means. For most effective means to investigate these
other entities to audit the effectiveness example, § 26.187 [Substance abuse allegations. This provision ensures that
of services that HHS inspectors review. expert] requires the SAE to monitor the the licensee’s or other entity’s contract
The former rule contained a number of substance abuse treatment of with the C/V permits the unannounced
requirements that are inconsistent with individuals who require it and the SAE audit as well as access to any
the requirements for drug testing under would have the qualifications and information necessary to conduct the
other Federally mandated programs. For information necessary to assess the audit. Therefore, the NRC has made this
example, the former rule permitted quality of the treatment services an change to meet Goal 3 of this
donors to request confirmatory alcohol individual receives. The SAE has the rulemaking to improve the effectiveness
testing of a blood specimen at an HHS- authority to seek other services on and efficiency of FFD programs.
certified laboratory, which other Federal behalf of the FFD program if he or she The NRC had added § 26.41(d)(2) to
agencies do not permit. Also, some of identifies weaknesses in a treatment ensure that licensees’ and other entities’
the cutoff levels established in the program. Therefore, the NRC has made contracts with C/Vs and HHS-certified
former rule are higher, in the case of these changes to meet Goal 5 of this laboratories permit the licensee or other
testing for marijuana metabolite, or rulemaking to improve Part 26 by entity to obtain copies of and take away
lower, in the case of testing for opiates, eliminating or modifying unnecessary any documents that auditors may need
than those of other Federal agencies. requirements. to assure that the C/V, its
These programmatic discrepancies have Section 26.41(d) [Contracts] of the subcontractors, or the HHS-certified
made licensee audits of HHS-certified final rule incorporates and amends the laboratory are performing their
laboratories necessary to ensure the requirements of former Section 2.7(m) functions properly and that staff and
effectiveness of the unique drug and in Appendix A to Part 26 and others procedures meet applicable
alcohol testing services required for Part that addressed contractual relationships requirements. This provision responds
26 programs because HHS inspections to permit licensees and other entities to several incidents when parties under
do not address these services. The final access to the HHS-certified laboratories contract to licensees did not permit Part
rule eliminates the majority of these for the purposes of conducting the 26 auditors to remove documents from
discrepancies. Therefore, the annual audits and inspections required under a premises of a C/V that were necessary
audits of HHS-certified laboratories by the rule. The portions of former Section to document audit findings, develop
licensees that have been necessary 2.7(m) in Appendix A to Part 26 that corrective actions, and ensure the
under the former rule would be related to NRC inspections of HHS- effectiveness of the corrective actions.
redundant under the final rule, except certified laboratories have been moved Therefore, the new requirement meets
in certain conditions described below. to § 26.821 [Inspections] in Subpart O Goal 3 of this rulemaking to improve the
The NRC has made these changes to [Inspections, violations, and penalties] effectiveness and efficiency of FFD
meet Goal 5 of this rulemaking to of the final rule, consistent with Goal 6 programs. The provision permits HHS-
improve Part 26 by eliminating or of this rulemaking to improve clarity in certified laboratories to reasonably limit
modifying unnecessary requirements. the organization and language of the the use and dissemination of the
Section 26.41(c)(2) continues to rule. documentation that auditors copy and
require licensees and other entities to Section 26.41(d)(1) amends the take off site. This change meets Goal 7
conduct annual audits of any services second sentence of former Section of this rulemaking to protect the privacy
provided to the licensee or other entity 2.7(m) in Appendix A to Part 26. The of individuals who are subject to Part 26
that the annual HHS-certification review former section required licensee and protects the trade secrets of HHS-
did not address. The NRC has retained contracts with HHS-certified certified laboratories who are subject to
this annual audit requirement because laboratories for drug testing and alcohol auditing under the final rule.
§ 26.31(d) retains the permission in the confirmatory testing, as well as Section 26.41(d)(3) amends the third
former rule for licensees and other contracts for collection site services, to sentence of former Section 2.7(m) in
entities to establish lower cutoff levels permit the licensee to conduct Appendix A to Part 26. This sentence
and test for drugs in addition to those unannounced inspections. The final required licensees and other entities to
for which testing is required under this rule retains the former requirement with carry out inspections and evaluations of
part. If a licensee or other entity chooses respect to HHS-certified laboratories the procedural aspects of an HHS-
to implement more stringent cutoff and expands it to require that contracts certified laboratory drug testing
levels or a broader panel of drugs than with any C/V (which would include operations before awarding a contract to
required under the final rule, the collection services providers) must the laboratory. The final rule adds a
licensee or other entity is required to permit the licensee or other entity to cross-reference to § 26.41(g). Section
26.41(g) permits licensees and other NUREG–1354, and items 11.4 and 11.5 Section 26.41(g)(4) retains the fourth
entities to forego the otherwise required of NUREG–1385, ‘‘Fitness for Duty in sentence of former § 26.80(a). This
pre-award evaluation under certain the Nuclear Power Industry: Responses provision requires licensees and other
specific circumstances, as discussed to Implementation Questions.’’ entities to retain copies of the shared
with respect to that section. Section 26.41(g) amends the former audit reports.
Section 26.41(e) [Conduct of audits] of provision to incorporate specific The NRC has added § 26.41(g)(5) to
the final rule retains the requirements in permission for licensees and other the final rule. The provision permits
former § 26.80(b). entities to jointly conduct audits as well licensees and other entities to
Section 26.41(f) [Audit results] of the as rely on one another’s audits. The immediately obtain drug testing services
final rule retains the portion of former NRC has also added a reference to HHS- from another HHS-certified laboratory,
§ 26.80(c) that required licensees and certified laboratories to indicate the subject to certain conditions, if the
other entities to document audit applicability of these permissions to laboratory used by the licensee or other
findings and recommendations, report licensees’ and other entities’ audits of entity loses its certification. Within 3
them to senior management, and HHS-certified laboratories. These months of obtaining services from the
document corrective actions taken in changes are consistent with the replacement laboratory, the section
response to any identified adverse guidance issued by the NRC in the requires the licensee or other entity to
conditions. The final rule adds two documents referenced above and ensure that an audit is conducted of any
requirements. The second sentence of current licensee practices. Therefore, aspects of the laboratory’s services that
§ 26.41(f) specifies the required content the NRC has made these changes to the licensee or other entity use that have
of audit reports, including identification meet Goal 6 of this rulemaking to not been audited within the past 12
of any conditions that are adverse to the improve clarity in the organization and months by another licensee or entity
proper performance of the FFD program, language of the rule. who is subject to this subpart. This
the cause of the condition(s), and provision enhances the effectiveness of
The NRC has added § 26.41(g)(1) and
recommended corrective actions. The FFD programs by ensuring that drug
(g)(2) to the final rule to require
third sentence of the section requires testing will not be interrupted or
licensees and other entities to identify
licensees and other entities to review delayed if an HHS-certified laboratory
any areas that were not covered by a
the audit findings and take corrective loses its certification as some licensees
shared or accepted audit and ensure that
actions, including reauditing of have experienced. The reliability of
indicated deficient areas, to preclude, any unique services used by the licensee
drug testing services provided by the
within reason, repetition of the or other entity that were not covered by
replacement laboratory is ensured by
condition. The final rule adds these two the shared audit are audited. For
the auditing and inspection activities of
sentences for consistency with Criterion example, an FFD program may use
other licensees and entities who have
XVI in Appendix B to 10 CFR Part 50 lower cutoff levels for drug testing than
been using the services of the
[Domestic licensing of production and the FFD program(s) that conducted a
replacement laboratory, as well as the
utilization facilities] to indicate that the shared audit with the result that the audit conducted by the licensee or other
corrective action programs of licensees shared audit did not address the HHS- entity of any services that have not been
and other entities must include FFD certified laboratories’ procedures for audited by other licensees or entities
audit reports. Some licensees have testing at the first FFD program’s lower who are subject to this part. The NRC
handled FFD audit reports outside of cutoff levels. In this case, the first FFD has made this change to meet Goal 3 of
their normal corrective action programs program is not permitted to rely on the this rulemaking to improve the
that address other conditions adverse to shared audit with respect to the lower effectiveness and efficiency of FFD
quality. As a result, some corrective cutoff levels and is required to ensure programs.
actions for FFD program weaknesses that the HHS-certified laboratories’
have not been timely or effective. procedures for testing at the lower cutoff Subpart C—Granting and Maintaining
Therefore, the final rule adds these levels are audited separately (or in Authorization
requirements to meet Goal 3 of this conjunction with other FFD programs Throughout Subpart C, the final rule
rulemaking to improve the effectiveness that use the same cutoff levels). These makes minor clarifications to the
and efficiency of FFD programs. provisions are consistent with the proposed rule based on public
The NRC has deleted the last sentence guidance issued by the NRC in the comment, to accommodate conforming
of former § 26.80(c) that referred to the documents referenced above and changes, and to meet Goal 6 of this
requirements for auditing HHS-certified current licensee practices. Therefore, rulemaking to improve clarity in the
laboratories in Appendix A to Part 26 the NRC has made these changes to organization and language of the rule.
because it is redundant with § 26.41(c). meet Goal 6 of this rulemaking to One clarification that the final rule
The NRC has made this change to meet improve clarity in the organization and makes in numerous sections in this
Goal 6 of this rulemaking to improve language of the rule. subpart is to state that licensees or other
clarity in the organization of the rule. Section 26.41(g)(3) retains the portion entities subject to this subpart shall
Section 26.41(g) [Sharing of audits] of of the third sentence of former § 26.80(a) ‘‘ensure’’ that a requirement under this
the final rule responds to licensees’ that stated that licensees and other subpart has been met. This language
implementation questions related to the entities need not re-audit the same C/V differs from that of the proposed rule,
third and fourth sentences in former for the same period of time. This which stated that the licensee or other
§ 26.80(a) that permitted licensees and provision extends this permission to entity shall explicitly perform the
other entities to accept audits of C/Vs audits of HHS-certified laboratories, activity (i.e., obtain, review, conduct,
that other FFD programs conduct. The which is consistent with the guidance complete) to meet the requirement. For
section clarifies the former permission issued by the NRC in the documents example, in § 26.55(a)(1), the proposed
to accept and rely on others’ audits in referenced above and current licensee rule stated that the licensee or other
response to implementation questions practices. Therefore, the NRC has made entity shall ‘‘obtain and review a self-
that the NRC has received from this change to meet Goal 6 of this disclosure.’’ The final rule states that
licensees with respect to the sharing of rulemaking to improve clarity in the the licensee or other entity shall ‘‘ensure
audits, as documented in Section 17 of organization and language of the rule. that a self-disclosure has been obtained
and reviewed.’’ This modified language [FFD programs for Construction] of this and § 26.59 to refer to the interval of
clarifies the NRC’s intent that licensees rule to meet the requirements of this time between periods during which an
or other entities may rely on other subpart. The reasons for adding these individual holds authorization under
entities to assist in performing the paragraphs are discussed with respect to Part 26. Licensees and other entities
activities necessary to meet the the specific paragraphs. shall calculate an interruption in
requirements of this subpart. For Section 26.53(a) of the final rule authorization as the total number of
example, many licensees rely on introduces four new terms to Part 26: days falling between the day the
contractors to conduct the suitable ‘‘Initial authorization,’’ ‘‘authorization individual’s last period of authorization
inquiry required under § 26.63. update,’’ ‘‘authorization reinstatement,’’ ended and the day the licensee or other
However, the final rule retains the and ‘‘authorization with potentially entity grants authorization to the
language of the proposed rule in disqualifying FFD information.’’ The individual. Section 26.53(b) also
§ 26.69(b) for the reasons discussed with final rule uses these terms to describe specifies that if potentially disqualifying
respect to that paragraph. In another categories of requirements for granting FFD information is disclosed or
change from the proposed rule text, the authorization. These categories are discovered about an individual,
NRC has eliminated the term ‘‘non- based on whether an applicant has licensees and other entities must
negative’’ and replaced it with the previously held authorization under implement the applicable requirements
phrase ‘‘positive, adulterated, or Part 26 and the length of time that has in § 26.69 in order to grant or maintain
substituted’’ for the reasons discussed elapsed after the individual’s last period an individual’s authorization, rather
with respect to § 26.5 [Definitions]. of authorization ended, and are than relying on the requirements in
The final rule also makes more described in § 26.55 [Initial § § 26.55, 26.57, or 26.59.
substantive changes to the proposed authorization], § 26.57 [Authorization Section 26.53(c) of the final rule
rule in this subpart because of public update], § 26.59 [Authorization references the FFD training
comment or to improve clarity in the reinstatement], and § 26.69 requirements in § 26.29 [Training] and
organization and language of the rule. [Authorization with potentially the fatigue training requirements in
The substantive changes in this subpart disqualifying fitness-for-duty § 26.203(c) [Training and examinations]
can be found in § § 26.51; 26.53(d) information]. Section 26.53(a) directs to clarify that all individuals who are
through (i); 26.57(b); 26.61(c) and (d); licensees or other entities to use the subject to Subpart C must meet the
26.63(c), (c)(3), (d) and (f); 26.65(c), criteria for granting authorization to applicable requirements for initial or
(c)(2), (d)(1)(i), (d)(2)(ii), (e) and (f); and individuals found in § § 26.55, 26.57, refresher FFD training, as appropriate,
26.69(c), (c)(1) and (e)(1). These changes 26.59, or 26.69, depending on which of
before the licensee or other entity may
are discussed in detail below. However, these sections applies to the individual
grant authorization to the individuals.
other than the changes mentioned seeking authorization. The former rule
This provision references the training
above, the final rule adopts the in § 26.27 [Management actions and
requirements for organizational clarity
provisions of this subpart as proposed, sanctions to be imposed] discussed
because they apply to the authorization
without change. actions that the licensee must take
process. As discussed in the preamble to
before initially granting access or
Section 26.51 Applicability the proposed rule, stakeholders
assigning specified duties to an
The final rule amends § 26.51 of the requested that the regulation present
individual, but did not use the concepts
proposed rule to describe the requirements in the order in which they
of ‘‘initial authorization,’’
applicability of the subpart. The NRC ‘‘authorization update,’’ ‘‘authorization would apply to licensees’ and other
has changed the heading of this section reinstatement,’’ or ‘‘authorization with entities’ FFD processes. The NRC has
from ‘‘Purpose’’ to ‘‘Applicability’’ potentially disqualifying FFD added this paragraph to meet Goal 6 of
because the NRC has revised the content information.’’ The final rule uses these this rulemaking to improve clarity in the
of the section to specify the licensees, concepts to focus the requirements for organization and language of the rule.
entities, and categories of individuals to authorization more precisely on Section 26.53(d) of the final rule
whom the requirements Subpart C apply whether the individual has an permits licensees and other entities to
by using cross-references to the relevant established record (i.e. authorization rely on other licensees’ or entities’ FFD
paragraphs in § § 26.3 [Scope] and 26.4 history) in the industry. The NRC also programs and program elements to meet
[FFD program applicability to categories uses these concepts to specify the the requirements of this subpart for
of individuals]. The NRC made this amount of original information- granting and maintaining authorization.
change in response to public comments gathering activities licensees or other Section 26.53(d) expands upon a section
requesting this clarification in the rule entities are required to perform, of the former rule that similarly
text and to meet Goal 6 of this according to whether previous FFD permitted licensees and other entities to
rulemaking. programs have collected information accept and rely on other FFD programs
about the individual. In addition, the and program elements. Specifically,
Section 26.53 General Provisions former § 26.24(a)(1) permitted licensees
NRC uses similar concepts in access
The NRC has added § 26.53 to the authorization requirements found in 10 to accept results from drug and alcohol
final rule to provide an overview of the CFR 73.56 [Personnel access tests that were administered under
requirements and process for authorization requirements for nuclear another Part 26 program within the past
determining when individuals may be power plants] and access authorization 60 days. Consistent with the principle of
granted and maintain authorization. orders issued by the agency to nuclear permitting licensees to accept and rely
With respect to the proposed rule, power plant licensees. The NRC has on other Part 26 programs in their
paragraph (e) has been added to this incorporated these concepts into Part 26 authorization decisions, guidance
section to specify the requirements for to increase the consistency between the contained in NUREG–1385, ‘‘Fitness for
relying on the FFD program of a C/V related regulations in accordance with Duty in the Nuclear Power Industry:
when granting or maintaining Goal 4 of this rulemaking. Responses to Implementation
authorization. Paragraph (f) specifies Section 26.53(b) of the final rule Questions,’’ also indicates that licensees
that licensees and other entities may not defines the meaning of the term may ‘‘accept’’ an authorization granted
rely on FFD programs under Subpart K ‘‘interruption’’ which is used in § 26.57 by a previous licensee for individuals
who transfer between licensees with The final rule adds this permission to required him or her to have unescorted
only a short break in authorization. rely on a C/V’s FFD program elements access to the protected area of a nuclear
The final rule substantially increases to codify a long-standing industry power plant at the time he or she was
the specificity of the requirements that practice that has been endorsed by the convicted, this provision requires the
licensees or other entities must meet for NRC and to provide clarity in the C/V to inform the FFD program of the
granting authorization and establishes language of the rule. licensee or other entity of the
detailed minimum standards that all Section 26.53(e)(1) permits a C/V to conviction. The licensee would then
programs must meet. The agency grant, maintain, deny, or unfavorably either terminate the individual’s
designed these detailed minimum terminate an individual’s authorization unescorted access on the day that the
standards to address recent changes in under the C/V’s FFD program. As licensee or other entity receives the
industry practices that have resulted in defined in § 26.5, granting authorization information from the C/V or, in unlikely
a more transient workforce. Because the in this case means that a C/V has circumstances, may implement the
FFD programs of licensees and other determined that the individual has met process established in § 26.69(d) for
entities will be substantially more the requirements in this subpart and is determining whether an individual may
consistent than in the past under these eligible to have the types of access and maintain authorization after potentially
detailed standards, permitting licensees perform the duties specified in § 26.4. disqualifying FFD information is
and other entities to rely on other FFD Maintaining authorization under a C/V’s disclosed or discovered. This provision
programs to meet the rule’s FFD program means that the individual codifies a long-standing industry
requirements is reasonable and continues to meet the requirements of practice that has been endorsed by the
appropriate. Section 26.53(d) eliminates this subpart and be eligible to perform NRC and adds clarity in the rule
unnecessary redundancies in the steps the duties specified in § 26.4. However, language. The NRC has also added this
required to grant authorization to an the second sentence of § 26.53(e)(1) requirement in recognition of the need
individual who is transferring from one retains the intent of the provisions in for additional consistency between the
FFD program to another, consistent with former § 26.23 that placed responsibility final rule and the access authorization
Goal 5 of this rulemaking to improve on licensees for ensuring that requirements. Therefore, this change
Part 26 by eliminating or modifying individuals who are ‘‘performing helps meet Goal 4 of this rulemaking to
unnecessary requirements. With respect activities within the scope of this part’’ improve consistency between FFD
to the proposed rule, the final rule meet the requirements in Part 26. requirements and access authorization
specifies that the receiving FFD program However, the final rule updates the requirements established in 10 CFR
shall ensure that the program elements terminology used to convey this intent 73.56, as supplemented by orders to
to which the individual is subject under and adds cross-references to other nuclear power plant licensees dated
the transferring FFD program remain sections of the rule for clarity and January 7, 2003.
current. The NRC has made this change consistency with other rule changes. The final rule has added § 26.53(e)(3)
to the proposed rule in recognition of Section 26.53(e)(2) further clarifies to the final rule to explicitly permit the
the need for additional consistency the relationship between authorization licensees and other entities in § 26.3(a)
between the final rule and the access under a C/V’s FFD program and through (c) to rely on a C/V’s FFD
authorization requirements. Therefore, authorization under the FFD programs program and program elements, or a
this change helps meet Goal 4 of this of licensees and other entities in combination of program elements from
rulemaking to improve consistency § 26.3(a) through (c). This provision the licensee’s or other entity’s FFD
between FFD requirements and access addresses circumstances when a C/V’s program and the C/V’s FFD program, to
authorization requirements established FFD program determines that an satisfy the requirements of Subpart C for
in 10 CFR 73.56, as supplemented by individual does not meet the maintaining an individual’s
orders to nuclear power plant licensees requirements of this subpart to be authorization. This paragraph repeats
dated January 7, 2003. granted or maintain authorization and the language in § 26.53(d), which
In response to public comment, the denies or unfavorably terminates the permits licensees and other entities to
final rule adds paragraph (e) to § 26.53 individual’s authorization under the rely on one another’s FFD programs and
to clarify the relationship between C/V’s program. The rule requires that if program elements, but applies it to C/V
licensees’ and other entities’ FFD the C/V’s FFD program denies or FFD programs and program elements for
programs and those of C/Vs. Section unfavorably terminates the additional clarity in the language of the
26.53(e) retains the permission in authorization of an individual who is rule. The final rule also clarifies that the
former § 26.23 [Contractors and performing the duties for a licensee that receiving licensee’s or other entity’s
vendors] for licensees to rely upon C/Vs’ are listed in the specified sections of FFD program shall ensure that the
FFD programs that have been formally § 26.4, the C/V must inform the affected program elements to which the
reviewed and approved by the licensee. licensee or other entity of the denial or individual is subject under the C/V’s
The paragraph also permits the unfavorable termination. In this case, FFD program remain current. The NRC
licensees and other entities in § 26.3(a) the licensee or other entity shall, on the has made this change to the proposed
through (c) to rely on a C/V’s FFD day the licensee receives the rule in recognition of the need for
program elements that meet the information from the C/V, deny or additional consistency between the final
requirements of Part 26. For example, unfavorably terminate the individual’s rule and the access authorization
some C/Vs ensure that their employees authorization or implement the requirements. Therefore, this change
receive initial and refresher FFD applicable process in § 26.69 to helps meet Goal 4 of this rulemaking to
training so that, when the employee is maintain the individual’s authorization. improve consistency between FFD
assigned to work on a contract that For example, if a C/V’s employee is requirements and access authorization
requires him or her to have unescorted convicted of selling illegal drugs and requirements established in 10 CFR
access to a nuclear power plant reports the conviction to the C/V, the 73.56, as supplemented by orders to
protected area, it is unnecessary for the C/V would unfavorably terminate this nuclear power plant licensees dated
licensee to provide FFD training to the individual’s authorization under the January 7, 2003.
C/V’s employee in order to grant C/V’s FFD program. If the individual The NRC has also added § 26.53(f) to
unescorted access to this individual. was also assigned to a contract that the final rule to prohibit licensees and
other entities from relying on an FFD individual withdraws his or her and access authorization requirements
program that has been implemented consent. The NRC has added this established in 10 CFR 73.56, as
under Subpart K of this part when provision to provide additional supplemented by orders to nuclear
granting authorization to an individual. protection of individuals’ privacy by power plant licensees dated January 7,
This prohibition is necessary because ensuring that licensees and other 2003.
Subpart K permits the licensees and entities do not gather personal Section 26.55 Initial Authorization
other entities specified in § 26.3(c) information about an individual without
greater flexibility in establishing and his or her permission. The requirements The NRC has added § 26.55 to the
implementing an FFD program than is to inform the individual that he or she final rule, which defines the category of
permitted in Subpart C. For example, may withdraw consent and for licensees ‘‘initial authorization’’ requirements as
Subpart K does not require the licensees and other entities to inform the applying both to individuals who have
and other entities in § 26.3(c) to conduct individual of what information will be not previously held authorization under
a suitable inquiry of individuals who documented and shared with other Part 26 and those whose authorization
are permitted to perform the duties licensees or entities following a has been interrupted for a period of 3
described in § 26.4(f). Therefore, in withdrawal of consent are necessary to years or more and ended favorably.
order to grant authorization to such an protect individuals’ other rights under Two considerations support the
individual to have the types of access or the rule, including due process. mandate for individuals whose last
perform the duties in § 26.4(a) or (b), for Therefore, this provision meets Goal 7 period of authorization ended 3 or more
example, a licensee in § 26.3(a) would of this rulemaking to protect the privacy years previously to satisfy the same
be required to ensure that a suitable and other rights (including due process) requirements as individuals who have
inquiry has been completed under of individuals subject to Part 26. This never previously held authorization. In
§ 26.63. However, this new provision general, the longer the period of time
provision meets Goal 4 of this
would permit a licensee or other entity since the individual’s last period of
rulemaking to improve consistency
to rely on the program elements of a authorization ended, the greater the
between FFD requirements and access
Subpart K FFD program if the program possibility that the individual has
authorization requirements established
elements meet the applicable developed an active substance abuse
in 10 CFR 73.56, as supplemented by
requirements of Subpart C. For example, problem or undergone significant
orders to nuclear power plant licensees
if a Subpart K program included changes in lifestyle or character that
dated January 7, 2003.
suitable inquiry requirements and would diminish his or her
The NRC has added § 26.53(i) to the trustworthiness, reliability, and ability
implemented them under § 26.63, a
final rule to require licensees and other to perform work safely and competently.
licensee or other entity could rely on
entities specified in § 26.3(a) and, as Therefore, it is reasonable to require a
those suitable inquiry results when
applicable, (c) and (d), to inform full and extensive screening identical to
granting authorization under Subpart C.
individuals applying for authorizations that given an individual who has not
This section satisfies Goal 3 of this
of the actions related to providing and held authorization, and has not been
rulemaking by improving the
sharing personal information that are subject to drug and alcohol testing and
effectiveness and efficiency of FFD
programs. sufficient cause for denial or behavioral observation, for 3 years or
The NRC has added 26.53(g) to the unfavorable termination of more. For similar reasons, access
final rule to require licensees and other authorization. The actions that are authorization requirements also require
entities to identify any FFD violation to sufficient cause for denial or that individuals who have not held
any licensee who has relied or intends unfavorable termination of authorization for 3 years or more must
to rely on the FFD program element that authorization include refusal to provide be subject to the same screening as
is determined to be in violation of this written consent, as specified in individuals who have not previously
part. The NRC has made this change to § 26.53(i)(1), and refusal to provide or held authorization. Therefore,
the proposed rule in recognition of the the falsification of any personal mandating that individuals whose last
need for additional consistency between information required under this subpart, period of authorization ended 3 or more
the final rule and the access including the failure to report any years previously must satisfy the same
authorization requirements. Therefore, previous denial or unfavorable requirements as individuals who have
this change helps meet Goal 4 of this termination of authorization, as never held authorization increases the
rulemaking to improve consistency specified in § 26.53(i)(2). These consistency of Part 26 with the related
between FFD requirements and access provisions were moved from § 26.63(d) access authorization requirements,
authorization requirements established and § 26.61(d) of the proposed rule, consistent with Goal 4 of this
in 10 CFR 73.56, as supplemented by respectively. The NRC has added rulemaking.
orders to nuclear power plant licensees § 26.53(i)(3) and (i)(4) to specify that a Section 26.55(a)(1) requires the
dated January 7, 2003. refusal to provide written consent for licensee or other entity, before granting
In the final rule, the NRC has added the sharing of personal information with initial authorization to an individual, to
a new provision in § 26.53(h) to prohibit other licensees or other entities, as ensure that a self-disclosure has been
licensees and other entities from required in § 26.53(h), and a failure to obtained and reviewed in accordance
initiating any actions under Subpart C, report any legal actions, respectively, with the applicable requirements of
such as beginning to gather information are also sufficient cause for denial or § 26.61 [Self-disclosure and
about the individual’s authorization unfavorable termination of employment history]. As discussed with
history from other licensees or entities, authorization. Also, the NRC has made respect to § 26.61, the self-disclosure
without the knowledge and consent of these changes to the proposed rule in and employment history requirements
the individual who is applying for recognition of the need for additional mandate that the individual report
authorization. The new provision in the consistency between the final rule and violations, if any, involving drugs or
final rule also informs individuals that the access authorization requirements. alcohol and the individual’s current and
they may withdraw consent at any time, Therefore, this change helps meet Goal past employment history. The
and specifies the actions that licensees 4 of this rulemaking to improve requirement is similar to that in
and other entities must take if an consistency between FFD requirements § 26.27(a)(1) of the former rule that a
written statement must be obtained from tests imposed in a statistically random (1) A self-disclosure has been
the individual addressing the topics that and unpredictable manner. The obtained and reviewed under the
are specified in former § 26.27(a)(1). The discussion of § 26.67 in this document applicable requirements of § 26.61;
discussion of § 26.61 in this document compares the random drug and alcohol (2) A suitable inquiry has been
compares the topics required to be testing requirements for initial completed under the applicable
addressed in the written statement authorization in this rule to the requirements of § 26.63;
under the former rule with the topics requirements in the former rule. (3) The individual has been subject to
that are addressed in the self-disclosure Section 26.55(b) of the final rule pre-access drug and alcohol testing
under this final rule. As discussed with mandates that the licensee or other under the applicable requirements of
respect to § 26.61(b)(3), an applicant for entity must meet the requirements in § 26.65; and
initial authorization must address in the § 26.69 to grant authorization to the (4) The individual has been subject to
self-disclosure the shorter period of individual, if potentially disqualifying random drug and alcohol testing under
either the past 5 years or the interval of FFD information is disclosed or the applicable requirements of § 26.67.
time that has elapsed since the discovered about the individual who is However, § 26.61(b)(3)(iii) and (c)(3)
individual’s eighteenth birthday. limits the period of time to be addressed
applying for authorization that another
Section 26.55(a)(2) requires the in the self-disclosure and employment
licensee or other entity has not
licensee or other entity to ensure that a history to the interruption period. If an
suitable inquiry has been completed previously evaluated.
individual’s last period of authorization
under the applicable requirements of Section 26.57 Authorization Update ended 2 years ago, the self-disclosure
§ 26.63 [Suitable inquiry] before and employment history would cover
granting initial authorization to an The NRC has added § 26.57 to the
final rule, which defines the category of only the past 2 years. Similarly,
individual. The requirement is similar
‘‘authorization update’’ requirements for § 26.63(f)(2) provides that the suitable
to that in § 26.27(a)(2) of the former rule
granting authorization to individuals inquiry for an authorization update
that a suitable inquiry must be
whose authorization has been must cover the interruption period. The
completed addressing the topics that are
interrupted for more than 365 days but final rule requires the self-disclosure,
specified in § 26.27(a)(2). The
less than 3 years and whose last period employment history, and suitable
discussion of § 26.63 in this document
of authorization was terminated inquiry to address only the interruption
compares the topics that the suitable
favorably. period because the licensee or other
inquiry must address under the former
entity may obtain information from
rule with the topics that it addresses As noted in the discussion of Subpart earlier periods in the individual’s
under the final rule. Section 26.63(f)(1) C in Section IV.C, the requirements for
specifies that the suitable inquiry for an history from the licensee or other entity
granting an authorization update are who had last granted authorization to
initial authorization must address the less stringent than the requirements for
shorter period of either the past 3 years the individual.
granting initial authorization. The The NRC has added § 26.57(b) to
or the interval of time that has elapsed requirements are less stringent because
since the individual’s eighteenth specify that if potentially disqualifying
(1) the individual who is applying for an FFD information is disclosed or
birthday. authorization update will have a more
Section 26.55(a)(3) requires the discovered about the individual who is
recent history of successful performance applying for authorization, the licensee
licensee or other entity to ensure that within the industry, and (2) the licensee
the individual has been subject to pre- or other entity may not grant
or other entity will have access to authorization to the individual, except
access drug and alcohol testing under information about the individual from
the applicable requirements of § 26.65 under § 26.69.
the licensee or other entity who last
[Pre-access drug and alcohol testing] granted authorization to him or her Section 26.59 Authorization
before granting initial authorization to because of the increased information- Reinstatement
an individual. Former § 26.24(a)(1)
sharing requirements of the final rule. The NRC has added § 26.59 to the
required testing within the 60 days
However, the requirements in the final final rule, which establishes two
before initially granting unescorted
rule for an authorization update focus categories of authorization
access to protected areas or assignment
on gathering and evaluating information reinstatement requirements for
to activities within the scope of Part 26.
from the interruption period because the individuals whose authorization has
The discussion of § 26.65 in this
licensee or other entity will not have been interrupted for a short period and
document compares the pre-access drug
information about the individual’s whose last period of authorization was
and alcohol testing requirements for
activities during the period of the terminated favorably.
initial authorization in this rule to the
interruption. For example, in the case of One category of authorization
requirements in the former rule. Section
26.65 requires the licensee or other an individual whose last period of reinstatement requirements applies to
entity to ensure that the individual had authorization ended 2 years ago, the individuals whose authorization has
negative drug and alcohol test results licensee or other entity will focus on been interrupted for more than 30 days
from testing that had been completed gathering information about the but no more than 365 days in § 26.59(a),
within the past 30 days before granting individual’s activities within the 2-year and the other to individuals whose
authorization to the individual. interruption period. If an individual’s authorization has been interrupted for
Section 26.55(a)(4) requires the last period of authorization ended 13 30 or fewer days in § 26.59(c). The steps
licensee or other entity also to ensure months ago, the licensee or other entity for reinstating an individual’s
that the individual has been subject to will focus on gathering information authorization after an interruption of
random drug and alcohol testing under about the individual’s activities within 365 or fewer days are less stringent than
those 13 months.
the applicable requirements of § 26.67 those required for initial authorization

[Random drug and alcohol testing of Section 26.57(a) of the final rule, like or an authorization update because
individuals who have applied for § 26.55(a), requires the licensee or other these individuals will have a recent,
authorization]. Former § 26.64(a)(2) entity before granting authorization to positive record within the industry and
required unannounced drug and alcohol ensure that: pose little risk to public health and
safety or the common defense and individuals will have a recent, positive that the individual is required to
security. record within the industry and pose disclose the administrative action if the
The requirements that are related to little risk to public health and safety or individual’s authorization was
an individual whose authorization has the common defense and security. As is subsequently denied or terminated
been interrupted for more than 30 days required for an authorization update, unfavorably. The NRC has made this
but no more than 365 days are more this provision limits the period of time change to the proposed rule in
extensive than the requirements for to be addressed by the suitable inquiry recognition of the need for additional
granting authorization to an individual to the interruption period in consistency between the final rule and
whose authorization has been § 26.63(f)(3). However, this provision the access authorization requirements.
interrupted for 30 or fewer days. The requires licensees and other entities to Therefore, this change helps meet Goal
requirements for the 31–365-day ensure that the suitable inquiry is 4 of this rulemaking to improve
category are consistent with those completed within 5 business days after consistency between FFD requirements
contained in the access authorization reinstating the individual’s and access authorization requirements
orders issued by the NRC to nuclear authorization. If the suitable inquiry is established in 10 CFR 73.56, as
power plant licensees dated January 7, not completed within the 5-day period, supplemented by orders to nuclear
2003. However, the requirements for the licensee or other entity can maintain power plant licensees dated January 7,
individuals whose authorization has the individual’s authorization for up to 2003. Section 26.59(b) is necessary to
been interrupted for 30 or fewer days 10 business days following the day meet Goal 7 of this rulemaking to
are more stringent than those contained authorization was reinstated, but only if protect the privacy and other rights
in those orders. Under the access the licensee or other entity is unaware (including due process) of individuals
authorization orders, licensees are of any potentially disqualifying who are subject to Part 26 by ensuring
required to obtain and review a self- information about the individual. If the that they are not subject to any adverse
disclosure and employment history suitable inquiry is not completed within consequences for the licensee’s or other
from the applicant before reinstating the 10 business days, the rule requires the entity’s delay in completing the suitable
individual’s authorization. Under this licensee or other entity to inquiry.
amendment, licensees and other entities administratively withdraw the Section 26.59(c) of the final rule
are also required to subject the individual’s authorization until the establishes authorization requirements
individual to the possibility of selection suitable inquiry is completed. for individuals whose authorization has
for pre-access testing under § 26.65(e) Section 26.59(a)(3) requires the been interrupted for 30 or fewer days.
[Authorization reinstatement after an licensee or other entity to ensure that Section 26.59(c)(1) requires the licensee
interruption of 30 or fewer days]. The the individual whose authorization has or other entity to ensure that a self-
NRC has determined that this additional been interrupted for 31–365 days has disclosure has been obtained and
requirement is necessary to meet the been subject to pre-access drug and reviewed with certain exceptions that
final rule’s performance objective of alcohol testing, and § 26.59(a)(4) are specified in § 26.61. The licensee or
providing reasonable assurance that requires the licensee or other entity to other entity is permitted to forego
individuals are trustworthy and reliable ensure that the individual whose conducting a suitable inquiry for
by extending the deterrent effect of pre- authorization has been interrupted for individuals whose authorization has
access testing to individuals who have 31–365 days is subject to random been interrupted for such a short period.
had an interruption in authorization of testing. Section 26.65(d) [Authorization Section 26.59(c)(2) permits licensees
30 or fewer days in length. reinstatement after an interruption of and other entities also to forego pre-
For individuals whose authorization more than 30 days] establishes pre- access drug and alcohol testing of
has been interrupted for 31–365 days, access drug and alcohol testing individuals whose authorization has
§ 26.59(a)(1) requires the licensee or requirements for authorization been interrupted for 5 or fewer days.
other entity to ensure that a self- reinstatements. Section 26.67 specifies However, pre-access testing may be
disclosure and employment history has the requirements for the random testing required under § 26.65(e) for individuals
been obtained and reviewed in order to of individuals who are applying for an whose authorization has been
reinstate authorization. Consistent with authorization reinstatement. interrupted for 6 to 30 days. Sections
the requirements for authorization The NRC has added § 26.59(b) to the 26.61 and 26.65 specify the exceptions
updates in § 26.57, the final rule in final rule to ensure that any to the self-disclosure and pre-access
§ 26.61(b)(3)(iii) and (c)(3) limits the administrative withdrawal of testing requirements in this provision,
period of time to be addressed in the authorization required under respectively.
self-disclosure and employment history § 26.59(a)(2) is not reported or recorded
to the period of the interruption in as an unfavorable termination of Section 26.61 Self-Disclosure and
authorization. A self-disclosure and authorization until the suitable inquiry Employment History
employment history for earlier periods is completed and it indicates that The NRC has added § 26.61 to the
of time is unnecessary because the authorization should not be granted. final rule to replace former § 26.27(a)(1)
granting licensee or other entity will This provision ensures that a temporary for the reasons discussed in Section
have access to information about the administrative withdrawal of IV.C. The final rule replaces the term
individual from the licensee or other authorization caused by a licensee’s or ‘‘written statement’’ in the former rule
entity who recently terminated the other entity’s delay in completing the with the phrase ‘‘self-disclosure and
individual’s authorization. suitable inquiry is not treated as an employment history’’ to more accurately
Section 26.59(a)(2) permits the unfavorable termination caused by an characterize the requirement. The NRC
licensee or other entity to reinstate an FFD violation. The final rule specifies has made this change to meet Goal 6 of
individual’s authorization without first that the individual may not be required this rulemaking to improve clarity in the
ensuring that a suitable inquiry has been to disclose the administrative action in language of the rule.
completed, in contrast to the response to requests for self-disclosure The NRC has added § 26.61(a) to the
requirements for an initial authorization of potentially disqualifying FFD final rule to require licensees and other
and an authorization update. The final information. With respect to the entities to ensure that a written self-
rule permits this because these proposed rule, the final rule clarifies disclosure and employment history has
been obtained from every applicant attempted to subvert a drug or alcohol applicants must provide information
before granting authorization to the testing program, or refused to take a about current and past employers,
individual, except in two drug or alcohol test. Both former which the licensee or other entity then
circumstances, as follows. § 26.27(a)(2) and § 26.61(b)(1) require uses for the suitable inquiry if a suitable
Section 26.61(a)(1) permits the information on whether the applicant inquiry is required under § 26.63.
licensee or other entity to forego has been subject to a plan for substance However, the final rule requires the
obtaining a self-disclosure and abuse treatment (except for a self- individual to provide a list of employers
employment history if all three of the referral). Both require information about to include the employer by whom he or
following conditions are met: previous denials or terminations of she claims to have been employed on
(1) The individual previously held authorization. the day before he or she completes the
authorization under Part 26; The NRC has added § 26.61(b)(2) to employment history. The agency has
(2) The individual’s last period of the final rule to require the applicant to also made this change in § 26.63(c). The
authorization was terminated favorably; disclose the circumstances surrounding NRC has made this change in response
and any potentially disqualifying FFD to a public comment, which stated that
(3) The individual has been subject to information and the resolution of the a licensee or other entity has the ability
a behavioral observation and arrest- matter. For example, § 26.61(b)(1) to ensure that a suitable inquiry has
reporting program that meets the requires an applicant to report an arrest been conducted only of those employers
requirements of this part throughout the on drug-related charges, while that are listed in the self-disclosure or
time the individual’s authorization was § 26.61(b)(2) requires the applicant to employment history. The NRC believes
interrupted. report the outcome of the arrest (e.g., that this revision provides more
The information to be obtained from charges, a conviction, a finding of not
the self-disclosure and employment specificity in cases when an
guilty, the dropping of the charges). individual’s current employer changes
history is unnecessary in these Section 26.61(b)(3) defines the time
circumstances because it will already be after he or she submits the self-
period that the self-disclosure must disclosure. This change is consistent
available to the granting licensee or address. The final rule establishes a
other entity from the FFD program that with Goal 6 of the rulemaking to
time limit on the number of years in the improve clarity in the organization and
had been implementing the behavioral past for which an individual is required
observation and arrest-reporting language of the rule.
to report and account for potentially
program during the interruption in the disqualifying FFD information. One The NRC has moved the provision in
individual’s authorization. A purpose of the self-disclosure is to proposed § 26.61(d) to § 26.53(i)(2) of
requirement for licensees and other identify indicators of an active the final rule to meet Goal 6 of this
entities to conduct another suitable substance abuse problem or an rulemaking to improve clarity in the
inquiry is redundant and imposes an increased risk of recidivism into an organization of the rule.
unnecessary burden. active substance abuse problem after Section 26.63 Suitable Inquiry
Section 26.61(a)(2) permits licensees treatment. The relevant research
and other entities to forego obtaining an literature indicates that post-treatment The NRC has added § 26.63 to the
employment history from applicants for recidivism (i.e., relapse) rates decrease final rule. This section amends former
an authorization reinstatement whose after 3 years of no further substance § 26.27(a)(2) and the requirements
authorization has been interrupted for abuse, and a larger decrease occurs in related to conducting a suitable inquiry
30 or fewer days. The employment the recidivism rate after 5 years. If the that are contained within the definition
history information is unnecessary in applicant discloses no indicators of a of the term ‘‘suitable inquiry’’ in former
this case because the final rule does not substance abuse problem within the § 26.3. The former rule defined a
require licensees or other entities to past 5 years (or since the applicant’s suitable inquiry as a ‘‘best-effort
conduct a suitable inquiry for eighteenth birthday, in the case of an verification of employment history for
individuals who have had such a short applicant who is less than 23 years of the past 5 years, but in no case less than
break in authorization. age), an applicant for initial 3 years, obtained through contacts with
The NRC has added § 26.61(b) to the authorization (see § 26.55) is not previous employers to determine if a
final rule to specify the required content required to disclose earlier events person was, in the past, tested positive
of the written self-disclosure. related to substance abuse. For for illegal drugs, subject to a plan for
Affirmative responses to any of the applicants who held authorization treating substance abuse, removed from,
questions in § 26.61(b)(1) are considered within the past 3 years, the self- or made ineligible for activities within
potentially disqualifying FFD disclosure addresses only the time the scope of 10 CFR Part 26, or denied
information, as defined in § 26.5. The interval after the individual’s last period unescorted access at any other nuclear
final rule expands the scope of the of authorization ended. However, the power plant or other employment in
questions to be asked from those licensee or other entity shall obtain accordance with a fitness-for-duty
required in former § 26.27(a)(1) in order further information about the applicant policy.’’ In general, the NRC intends
to provide greater assurance that over the past 5 years by reviewing the that the changes to the former
individuals will disclose information information made available by licensees requirements better focus the suitable
indicating an active substance abuse or other entities who granted inquiry on indicators of an active
problem or an increased risk of authorization to the applicant in the substance problem and/or an increased
recidivism into an active substance past. This includes information risk of recidivism into an active
abuse problem after treatment. Former developed as part of previous suitable substance abuse problem following
§ 26.27(a)(2) required information about inquiries (see § 26.63) as well as treatment, as discussed in Section IV.C;
whether the applicant ‘‘tested positive information from the period(s) during increase the consistency in
for drugs or use of alcohol that resulted which the individual was subject to implementing suitable inquiries among
in on-duty impairment.’’ Section other FFD programs. FFD programs by providing more
26.61(b)(1) requires information about Section 26.61(c) in the final rule detailed requirements, also as discussed
whether the applicant used, sold, or modifies this provision as proposed. in Section IV.C; and improve Part 26 by
possessed illegal drugs, subverted or The proposed rule specified that eliminating or modifying unnecessary
requirements, which is Goal 5 of this previous licensees and other entities the applicant has listed on his or her
rulemaking. who are subject to this subpart. This employment history), but recognizes
For all authorization categories, the provision reduces the number of that it may not be forthcoming. The
suitable inquiry required by the final redundant suitable inquiries that ‘‘best effort’’ criterion in the paragraph
rule is more thorough than previous licensees and other entities must is consistent with the ‘‘best-efforts
industry practices to increase the conduct when the suitable inquiries basis’’ in former § 26.27(a)(2). However,
likelihood that any potentially would address the same employers and the final rule provides more detailed
disqualifying FFD information is same time periods. The provision also requirements in response to questions
identified and provide reasonable permits licensees and other entities to that the NRC has received from
assurance that individuals are accept the results of determinations of licensees about implementing a suitable
trustworthy and reliable, as fitness that were performed under a inquiry on a ‘‘best effort’’ basis after Part
demonstrated by avoiding substance previous Part 26 program, rather than 26 was first promulgated. Also, the final
abuse. For individuals who have requiring each new licensee and other rule modifies the proposed rule to more
established a recent, favorable work entity to reevaluate the same clearly specify which employers must
history under Part 26, as demonstrated information that was reviewed and be questioned as discussed with respect
by having held authorization that was resolved under the same requirements to § 26.61(c).
terminated favorably within the past 3 in another Part 26 program. The NRC The NRC has added § 26.63(c)(1) to
years, the NRC has reduced the period has made this change to meet Goal 5 of the final rule, which specifies the type
of time addressed in the suitable inquiry this rulemaking to improve Part 26 by of information that the licensee or other
from the past 5 years in every case, to eliminating or modifying unnecessary entity must seek from employers
the past 3 years or fewer, depending on requirements. regarding the applicant for
how recently the applicant held With respect to the proposed rule, the authorization. This provision requires
authorization. If potentially final rule adds a cross-reference to the licensee or other entity to ascertain
disqualifying FFD information within § 26.189 [Determination of fitness] in the reason that the individual’s
the past 5 years is identified regarding § 26.63(b) to specify that licensees and employment was terminated, his or her
an applicant and a previous licensee or other entities may only rely on eligibility for rehire, and other
other entity has not addressed and determinations of fitness that were information that could reflect on the
favorably resolved it, the suitable conducted under § 26.189. This change individual’s fitness to be granted
inquiry requirements are more is necessary because the licensees and authorization. The requirement to
extensive, as described in § 26.69. other entities specified in § 26.3(c) have obtain this information is consistent
The NRC has added § 26.63(a) to the greater latitude in conducting fitness with long-standing industry practices
final rule to require licensees and other evaluations under Subpart K than is related to granting access authorization
entities to ensure that a suitable inquiry permitted under § 26.189. However, as and related requirements in the access
has been conducted to verify the discussed with respect to § 26.53(f), a authorization requirements established
information provided by the applicant licensee or other entity who is subject in 10 CFR 73.56, as supplemented by
in the self-disclosure and employment to this subpart is permitted to rely on a orders to nuclear power plant licensees
history obtained under § 26.61 and to determination of fitness conducted dated January 7, 2003.
determine if additional potentially under a Subpart K program if the Section 26.63(c)(2) specifies the type
disqualifying FFD information is determination of fitness met the of information that licensees and other
available regarding the applicant. The requirements in § 26.189. entities must seek when an applicant’s
provision also establishes the The NRC has added § 26.63(c) to the claimed periods of employment include
circumstances in which a licensee or final rule, which specifies requirements military service. The NRC has added
other entity is permitted to forego the for conducting suitable inquiries. this requirement for consistency with
suitable inquiry in order to grant Licensees and other entities shall ensure related requirements in the access
authorization to individuals. A licensee that a ‘‘best effort’’ is demonstrated to authorization requirements established
or other entity is permitted to forego the complete the suitable inquiry. The ‘‘best in 10 CFR 73.56, as supplemented by
suitable inquiry if the individual effort’’ criterion recognizes licensees’ orders to nuclear power plant licensees
previously held authorization under and other entities’ status as commercial dated January 7, 2003.
Part 26, his or her last period of entities with no legal authority to The NRC has added § 26.63(c)(3) to
authorization was terminated favorably, require the release of the information the final rule to address circumstances
and the individual was subject to a from other private employers and in which a primary source of
behavioral observation and arrest- educational institutions. Because of information refuses to provide the
reporting program that meets the privacy and potential litigation necessary suitable inquiry information
requirements of this part throughout the concerns, some private employers and or indicates an inability or
period during which the individual’s educational institutions may be unable unwillingness to provide it within 3
authorization was interrupted. The or unwilling to release qualitative days of the request. Licensees and other
information to be obtained from a information about a former employee or entities are required to document that
suitable inquiry is unnecessary in these student. For example, a former the request for information was directed
circumstances because it will already be employer may verify the dates that the to the primary source and the nature of
available to the granting licensee or company employed an individual, but the response (i.e., a refusal, inability, or
other entity from the Part 26 program may be unwilling to reveal that the unwillingness). If a licensee or other
that implemented the behavioral individual had been in treatment for entity encounters the circumstances
observation and arrest-reporting drug or alcohol abuse while employed addressed in § 26.63(c)(3), the provision
program during the interruption in with the company. Therefore, the ‘‘best requires the licensee or other entity to
authorization. effort’’ criterion requires licensees and seek suitable inquiry information from
The final rule adds § 26.63(b) to the other entities to ensure that suitable an alternate source to the extent of the
final rule to permit licensees and other inquiry information is sought from the alternate source’s ability to provide the
entities to rely on suitable inquiry primary source (e.g., a company, private information. An alternate source may
information that was gathered by employer, or educational institution that include, but is not limited to, a co-
worker or supervisor at the same because after publishing the proposed no potentially disqualifying FFD
company who had personal knowledge rule, it recognized the need for information is known at the time the
of the applicant, if such an individual additional clarity to reflect the NRC’s suitable inquiry is initiated. The NRC
could be located. However, the final intent beyond what the proposed rule added this provision to meet Goal 6 of
rule prohibits the licensee or other contained. the rulemaking to improve clarity in the
entity from using the alternate source of Section 26.63(d) clarifies that the organization and language of the rule.
suitable inquiry information to meet any information must also be released to Section 26.63(f) specifies the
other access authorization requirements C/Vs who have licensee-approved FFD following additional requirements for
for a character reference. The provision programs when the C/V has obtained conducting the suitable inquiry for these
permits licensees and other entities to the required signed release from the authorization categories. Section
grant authorization, if warranted, when applicant. This clarification is necessary 26.63(f)(1) [Initial authorization]
a response has been obtained from an because some licensees have requires licensees and other entities to
alternate source without waiting more misinterpreted former § 26.29(b) as conduct a suitable inquiry to address
than 3 days after the request for prohibiting the release of suitable the 3-year period preceding the date the
information was directed to a primary inquiry information to C/Vs who have individual applies for authorization.
source. With respect to the proposed licensee-approved FFD programs. The The NRC has reduced the period of time
rule, the final rule clarifies that the provision also imposes the requirement that the suitable inquiry must address
licensee shall evaluate and document on licensees and other entities who may for applicants for initial authorization
the response if it is received. The NRC be implementing an FFD program under who do not disclose any potentially
has made this change to the proposed Subpart K of this part. The NRC has disqualifying FFD information. The
rule in recognition of the need for made this change for consistency with NRC has reduced the period of time to
additional consistency between the final the new requirements in Subpart K of be addressed in the suitable inquiry
rule and the access authorization this rule and to meet Goal 3 of the from 5 years in the former regulation to
requirements. Therefore, this change rulemaking to improve the effectiveness 3 years to better focus the suitable
helps meet Goal 4 of this rulemaking to and efficiency of FFD programs. inquiry on identifying indicators of an
improve consistency between FFD The NRC has moved the portion of active substance abuse problem or an
requirements and access authorization proposed § 26.63(d) that specified that a increased risk of recidivism following
requirements established in 10 CFR failure of an individual to authorize the treatment. If an applicant for initial
73.56, as supplemented by orders to release of information for the suitable authorization discloses no potentially
nuclear power plant licensees dated inquiry is sufficient cause for a denial disqualifying FFD information from the
January 7, 2003. These alternative of authorization to § 26.53(i)(1) of the past 5 years and none is identified
final rule. The NRC has made this through the suitable inquiry or other
methods of meeting the suitable inquiry
change to meet Goal 6 of the rulemaking means, it is unlikely that the applicant
requirement are necessary because some
to improve clarity in the organization has an active substance abuse problem.
employers are unwilling or unable to
and language of the rule. Therefore, seeking a full 5 years of
provide suitable inquiry information. The NRC has added § 26.63(e) to the information about the individual would
The NRC has added § 26.63(d) to the final rule to permit licensees and other be unlikely to provide useful data and
final rule, which requires licensees and entities to use electronic means to imposes an unnecessary burden.
other entities to share suitable inquiry obtain the suitable inquiry information. Industry experience has shown that
information that they have collected This permission is consistent with employers are often reluctant to disclose
when contacted by another licensee or access authorization requirements adverse information to other private
entity who has a release signed by the established in 10 CFR 73.56, as employers about former employees.
applicant for authorization that permits supplemented by orders to nuclear Also, the longer it has been since an
the sharing of that information. This power plant licensees dated January 7, individual was employed, the less likely
provision restates the permission to 2003. The paragraph also adds cross- it is that a former employer will disclose
release suitable inquiry information in references to the applicable records useful information. Therefore, rather
former § 26.29(b) as a requirement that retention requirements in § 26.711 than retaining the requirement for a 5-
licensees and other entities must share [General provisions] and § 26.713 year suitable inquiry in all cases, the
the information necessary to conduct [Recordkeeping requirements for final rule increases the thoroughness of
the suitable inquiry. With respect to the licensees and other entities] in Subpart the suitable inquiry over the past 3
proposed rule, the final rule clarifies N [Recordkeeping and Reporting years.
this provision as a result of a public Requirements] to the final rule to ensure Section 26.63(f)(1) requires the
comment that disagreed with the use of that licensees and other entities are licensee or other entity to ensure that
the word ‘‘presentation’’ in the aware of the applicability of these the suitable inquiry has been conducted
proposed provision. The NRC concurred requirements to the suitable inquiry with every employer by whom the
with the comment and believes that information obtained electronically. applicant claims to have been employed
current practices in the industry allow These changes are consistent with Goal within the past year. This requirement
for verification of a signed release 6 of this rulemaking to improve clarity leads to a more rigorous suitable inquiry
without the licensee presenting the in the organization and language of the than was common industry practice
actual document. Therefore, the NRC rule. before the issuance of the January 7,
has made this change to meet Goal 6 of The NRC has added § 26.63(f) to the 2003, access authorization orders,
the rulemaking to improve clarity in the final rule, which specifies the period(s) which imposed additional
organization and language of the rule. of time that the suitable inquiry must compensatory measures related to
Also, the final rule expands the list of address for applicants for initial access authorization. The purpose of
the types of information that licensees authorization, authorization update, and contacting every employer is to ensure
and other entities must make available authorization reinstatement. The final that the licensee or other entity sought
and on which the denial or unfavorable rule specifies that the suitable inquiry information related to any active
determination of authorization was requirements in this provision apply substance abuse problem. For the earlier
based. The NRC has made this change only to those individuals about whom years of the suitable inquiry period, the
provision requires the licensee or other substance abuse or other problem that or other entity, the final rule permits the
entity to ensure that the suitable inquiry would adversely affect his or her fitness granting licensee or other entity to
has been conducted with every to have authorization reinstated. accept negative test results from the
employer by whom the applicant claims The time periods and approach to random test in lieu of performing a pre-
to have been employed the longest conducting the suitable inquiry access test, if the random test was
within each calendar month. Contacting established in § 26.63(f)(1) through (f)(3) conducted within 30 days before the
these employers increases the likelihood are consistent with those established in day authorization is granted to the
that the employers would have the access authorization orders issued to individual. A requirement for the
knowledge of the applicant and may nuclear power plant licensees dated licensee or other entity to conduct pre-
provide more useful information than January 7, 2003. access testing in these circumstances is
contacting employers who employed the Section 26.65 Pre-Access Drug and redundant and unnecessary.
applicant only briefly. The NRC has added § 26.65(c) [Initial
Alcohol Testing
The NRC has added § 26.63(f)(2) authorization and authorization update]
[Authorization update] to the final rule, Section 26.65 of the final rule amends to the final rule, which establishes pre-
which specifies the period of time that former § 26.24(a)(1). The former access testing requirements for
the suitable inquiry must address for provision required drug and alcohol individuals who are applying for initial
applicants for an authorization update ‘‘testing within 60 days prior to the authorization and an authorization
(i.e., those who held authorization initial granting of unescorted access to update. The final rule, with respect to
within the past 3 years and whose last protected areas or assignment to the proposed rule, has added a
period of authorization was terminated activities within the scope of this part.’’ specification that before granting initial
favorably, but who have not held The final rule amends the former pre- authorization, any pre-access drug and
authorization within the past year). The access drug and alcohol testing alcohol tests must be conducted within
paragraph requires the licensee or other requirement for individuals who are the 30-day period preceding the day the
entity to ensure that the suitable inquiry seeking authorization under Part 26 to licensee or other entity grants
has been conducted in the same manner strengthen the effectiveness of FFD authorization to the individual. Under
as described in § 26.63(f)(1). However, programs. former § 26.24(a)(1), licensees and other
for an authorization update, the suitable The NRC has added § 26.65(a) entities were permitted to complete pre-
inquiry addresses only the period [Purpose] to the final rule to describe access testing within the 60-day period
during which the individual’s the purpose of the section and identify before authorization is granted. The
authorization was interrupted, rather the individuals to whom the inclusion in the final rule of a shorter
than the full 3 years that is required for requirements in the section apply. The time period within which pre-access
initial authorization. A 3-year period for pre-access testing requirements in this testing must be conducted, if required,
the suitable inquiry is unnecessary for section cover applicants for increases the likelihood of detecting an
these individuals because the licensee authorization who have never held active substance abuse problem among
or other entity will have access to the authorization under Part 26 or have held applicants for unescorted access to
information about the individual that authorization under Part 26 and whose nuclear power plants and others who
was gathered by the licensee or other most recent period of authorization was are subject to Part 26 by increasing the
entity under whose program the terminated favorably, and about whom number of pre-access tests that are
individual had been granted and no potentially disqualifying FFD performed. In addition, the decreased
successfully maintained authorization information has been discovered or time period for pre-access testing
within the past 3 years. disclosed that was not reviewed and increases the likelihood that recent drug
Section 26.63(f)(3) [Authorization favorably resolved by another licensee use, particularly marijuana, is detected
reinstatement after an interruption of or entity who is subject to Subpart C. before the concentration of metabolites
more than 30 days] specifies the period Requirements for granting authorization in an individual’s body could decrease
of time that the suitable inquiry must to individuals whose previous periods below the cutoff levels prescribed in the
address for applicants who held of authorization were terminated final rule. Also, the final rule’s
authorization within the past year and unfavorably or denied, or about whom provision for a decreased time period
whose last period of authorization was new potentially disqualifying FFD within which pre-access testing must be
terminated favorably, but who have not information has been discovered or performed provides greater assurance
held authorization within the past 30 disclosed, are contained in § 26.69. that individuals subject to this part are
days. The final rule requires licensees The NRC has added § 26.65(b) trustworthy and reliable, as
and other entities to ensure that the [Accepting tests conducted within the demonstrated by the avoidance of
suitable inquiry has been conducted past 30 days] to the final rule to permit substance abuse, as discussed with
with the employer by whom the licensees and other entities to forego respect to § 26.23(a).
applicant claims to have been employed pre-access testing of an individual who The final rule requires negative
the longest in each calendar month of has negative results from drug and results from pre-access testing before the
the interruption. This provision does alcohol tests that were performed under licensee or other entity grants
not require licensees and other entities the requirements of Part 26 within the authorization to the individual, except
to ensure that every employer by whom 30-day period before the licensee or in the two circumstances described in
the individual claimed to have been other entity grants authorization to the § 26.65(c)(1) and (c)(2). Pre-access
employed during the interruption is individual, including tests that were testing in these two circumstances is
contacted for the reasons discussed with conducted before the individual applied unnecessary because there is sufficient
respect to § 26.59(a)(2). Because these for authorization from the licensee or opportunity to detect substance abuse
individuals have had only a short break other entity. For example, if an without the testing. In § 26.65(c)(1),
in authorization, a sampling of individual was subject to random licensees and other entities are
employers from the interruption period testing under another Part 26 program permitted to forego pre-access testing if
is sufficient to determine if any and was selected for testing under the the applicant had been subject to drug
indications exist that the individual has other program before applying for and alcohol testing (including random
developed a previously undetected authorization from the granting licensee testing), behavioral observation, and
arrest-reporting requirements under a record of successfully maintaining provisions from paragraph (e)(3) of the
Part 26 FFD program throughout the authorization under Part 26, and had proposed rule into this paragraph of the
period the individual’s authorization only a short break in authorization. final rule to improve clarity in the
was interrupted. Section 26.65(d) of the final rule organization of the final rule, consistent
In proposed § 26.65(c)(2), licensees specifies pre-access testing requirements with Goal 3 of the rulemaking. This
and other entities were permitted to for individuals whose authorization has provision permits licensees and other
forego pre-access testing of an applicant been interrupted for more than 30 days entities also to forego subjecting an
who had negative results from Part 26 but no more than 1 year. Section individual to the possibility of selection
drug and alcohol tests that were 26.65(d)(1)(i) requires the licensee or for pre-access testing if the applicant
performed within the past 30 days and other entity to administer an alcohol test has been subject to the drug and alcohol
who was subject to behavioral and collect a urine specimen for drug testing (including random testing),
observation and arrest-reporting testing. The final rule, with respect to behavioral observation, and arrest-
requirements during the time interval the proposed rule, clarifies that before reporting elements of a Part 26 FFD
between the day the specimens were granting initial authorization, any program throughout the interruption in
collected and the day the licensee or required pre-access drug and alcohol the individual’s authorization. The NRC
other entity grants authorization to the tests must be conducted within the 30- believes that being subject to these
individual. However, the NRC received day period preceding the day the program elements during the
a public comment regarding this licensee or other entity grants interruption period is sufficient to deter
provision, which stated that licensees authorization to the individual. The substance abuse and provide assurance
should be able to rely on drug and licensee or other entity is permitted to that substance abuse would be detected.
alcohol tests that were conducted before reinstate the individual’s authorization Section 26.65 enhances the deterrent
the individual applied for authorization if the alcohol test results are negative effect of pre-access testing for
if the individual has been subject to a before the drug test results are available. individuals who have had a very short
behavioral observation and arrest- Section 26.65(d)(1)(ii) permits the break in authorization without imposing
reporting program, and random drug licensee or other entity to maintain the the burden of requiring that every
and alcohol testing, during the time individual’s authorization for 5 business individual must be tested.
period following the drug and alcohol days after reinstatement without Section 26.65(e)(2) of the final rule
tests. The NRC agrees that pre-access receiving the drug test results. However, requires licensees and other entities to
testing within 30 days before if the licensee or other entity does not subject applicants whose authorization
authorization is granted is unnecessary receive negative drug test results within has been interrupted for 6 to 30 days to
in these circumstances and has removed 5 business days of reinstating the the possibility of selection for pre-access
reference to § 26.65(b) in this provision. individual’s authorization, the final rule testing in order to deter any potential for
This amendment clarifies that licensees requires the licensee or other entity to substance abuse. However, this
may rely on drug and alcohol tests that administratively withdraw the provision specifies that the licensee or
were conducted at any time before the individual’s authorization until negative other entity may forego subjecting an
individual applied for authorization, drug test results are received. These individual to the possibility of being
provided that the individual has been requirements ensure that individuals selected for pre-access testing if the
subject to a random drug and alcohol whose authorization has been applicant has been subject to the drug
testing program, a behavioral interrupted for more than 30 days are and alcohol testing (including random
observation program, and an arrest- subject to pre-access drug and alcohol testing), behavioral observation, and
reporting program that meet the testing to deter substance abuse and to arrest-reporting elements of a Part 26
applicable requirements of this part. detect any current substance abuse FFD program throughout the
The NRC has made this change under problem. However, the provisions do interruption in the individual’s
Goal 5 of the rulemaking to improve the not unduly delay authorization authorization.
rule by eliminating or modifying reinstatement because these individuals’ Section 26.65(e)(2)(i) requires the
unnecessary requirements. recent successful histories of licensee or other entity to subject the
The NRC has added § 26.65(d) maintaining authorization under Part 26 applicant to a one-time chance of being
[Authorization reinstatement after an indicate that they are at low risk of selected for testing at a probability of
interruption of more than 30 days] and engaging in substance abuse. approximately 4 percent. This
(e) [Authorization reinstatement after an Section 26.65(d)(2) permits licensees probability approximates the likelihood
interruption of 30 or fewer days] to the and other entities to forego pre-access that individuals who are subject to
final rule, which establish requirements testing of these applicants for random testing at the 50-percent annual
for the pre-access testing of individuals reinstatement in the circumstances testing rate in § 26.31(d)(2)(vii) are
who are applying for an authorization discussed with respect to § 26.65(c)(1) selected for testing at some point within
reinstatement. The requirements for pre- and (c)(2). The discussion with regard to a 30-day period. Section 26.65(e)(2)(ii)
access testing of these individuals are § 26.65(c)(2) also specifies the reasons clarifies that if an applicant is not
less stringent than the requirements for for the changes from the proposed rule selected for pre-access testing under the
initial authorization and an in § 26.65(d)(2)(ii). preceding section, the licensee or other
authorization update. The provision The NRC has added § 26.65(e)(1) to entity is not required to perform a pre-
relaxes the pre-access testing the final rule to permit licensees and access test. Section 26.65(e)(2)(iii)(A)
requirements in former § 26.24(a)(1), other entities to forego pre-access testing and (B) specifies requirements for
which mandated that all applicants for of applicants whose authorization has conducting the pre-access testing if an
authorization must be subject to pre- been interrupted for 5 or fewer days. individual is selected for testing under
access testing within 60 days before This provision is consistent with § 26.65(e)(2)(i). The licensee or other
granting authorization. Less stringent current licensee practices and entity shall complete an alcohol test and
pre-access testing requirements are recommendations regarding short breaks collect a specimen for drug testing
appropriate because these individuals in authorization in NUREG–1385 and before reinstating the individual’s
have met the rigorous criteria for initial other access authorization requirements. authorization. In order to maintain the
authorization, established a recent The final rule also has moved the individual’s reinstated authorization,
the final rule requires that the licensee or terminated unfavorably by a licensee added the requirements in this section
or other entity must receive negative or entity. However, if the drug test to the access authorization requirements
drug test results within 5 business days results are positive, adulterated, or that were established by orders to
after reinstatement or administratively substituted and the licensee or other nuclear power plant licensees dated
withdraw the individual’s authorization entity terminates the individual’s January 7, 2003, to enhance the
until negative drug test results are authorization for cause, the termination effectiveness of FFD programs by
received. is then recorded as unfavorable. increasing the likelihood that substance
The NRC has deleted from the final However, with respect to the proposed abuse will be detected before
rule § 26.65(f) [Time period for testing] rule, the final rule adds a clarification authorization is granted and to deter the
of the proposed rule. The proposed that the individual is required to potential for substance abuse among
provision mandated that specimens that disclose administrative action if the applicants. Therefore, the NRC has
are collected for any pre-access testing individual’s authorization was made these changes to meet Goal 3 of
required in this section must be subsequently denied or terminated this rulemaking to improve the
collected within the 30-day period unfavorably. The NRC has made this effectiveness and efficiency of FFD
preceding the day the licensee grants change to the proposed rule in programs.
authorization to an individual. The NRC recognition of the need for additional The NRC has added § 26.67(a) to the
received a public comment that stated consistency between the final rule and final rule, which requires licensees and
that licensees currently conduct pre- the access authorization requirements. other entities to conduct random testing
access drug and alcohol testing within Therefore, this change helps meet Goal of applicants under the requirements of
the 30-day period preceding the date the 4 of this rulemaking to improve § 26.31(d)(2). The licensee or other
licensee grants authorization and that consistency between FFD requirements entity must add applicants for
proposed § 26.65(f) only requires and access authorization requirements authorization to the FFD program’s
licensees to collect a sample in this established in 10 CFR 73.56, as normal population of individuals who
timeframe. The NRC agrees with the supplemented by orders to nuclear are subject to random testing, select
comments and, therefore, has deleted power plant licensees dated January 7, individuals for testing at the 50-percent
this provision from the final rule to 2003. annual rate, and otherwise subject
increase efficiency, consistent with Goal The NRC has added § 26.65(g) applicants to the same random testing
5 of the rulemaking to eliminate [Sanctions] (changed from § 26.65(h) in requirements as individuals who
unnecessary requirements. However, the the proposed rule because of currently hold authorization under Part
NRC has added requirements to renumbering) to the final rule, which 26. An applicant is subject to random
§ 26.65(c) and (d)(1)(i) to specify that specifies the minimum sanctions to be testing beginning when the licensee or
any pre-access testing required in this imposed on an individual whose pre- other entity collects the specimens for
section must be conducted within the access test results the MRO confirms as any required pre-access test and
30-day period preceding the day upon an FFD policy violation. Section continues thereafter, if the licensee or
which the licensee grants authorization 26.65(g)(1) and (g)(2) contains cross- other entity grants authorization to the
to an individual, consistent with the references to the relevant sanctions individual.
proposed rule’s intent. Under former specified in Subpart D [Management Licensees and other entities are
§ 26.24(a)(1), licensees and other entities Actions and Sanctions To Be Imposed] permitted to forego random testing of
were permitted to complete pre-access to clarify that those sanctions apply to applicants in the two circumstances
testing within the 60-day period before applicants for authorization. For described in § 26.67(a)(1) and (a)(2).
authorization is granted. The reason example, if the MRO determines that an Section 26.67(a)(1) permits a licensee or
why the final rule shortens this time individual has submitted an adulterated other entity to discontinue random
period to 30 days is discussed with urine specimen for a pre-access drug testing of any applicant to whom the
respect to § 26.65(c). test, the licensee or other entity is licensee or other entity does not grant
The NRC has added § 26.65(f) required to impose the sanction for an authorization for any reason, including
[Administrative withdrawal of attempt to subvert the testing process a termination or denial of authorization
authorization] (changed from § 26.65(g) (i.e., permanent denial of authorization) or a withdrawal of the application for
in the proposed rule because of in § 26.75(b). authorization by the individual or the
renumbering) to the final rule to ensure The NRC has added § 26.65(g)(3) to individual’s employer, in the case of a
that the licensee or other entity does not the final rule to permit licensees and C/V. Section 26.67(a)(2) addresses the
record or report as an unfavorable other entities to grant authorization to circumstance described in § 26.65(b), in
termination any administrative an individual whose confirmed positive, which the licensee or other entity is
withdrawal of authorization that may be adulterated, or substituted test result is permitted to meet pre-access testing
required under paragraphs (d)(1)(ii) or a first drug- or alcohol-related violation requirements by relying on negative test
(e)(2)(iii)(B) of this section. The time a under a Part 26 program, consistent results from specimens collected under
licensee or other entity receives drug with former § 26.27(b)(2). However, the another Part 26 program within 30 days
test results is not under the applicant’s final rule permits authorization to be before granting authorization to the
control and does not reflect on the granted only under the stringent individual. Under § 26.67(a)(2), the
applicant’s fitness, trustworthiness, or requirements contained in § 26.69. licensee or other entity shall begin
reliability, if the licensee or other entity subjecting the applicant to random
is unable to obtain drug test results Section 26.67 Random Drug and testing when the licensee or other entity
within the 5 days permitted and must Alcohol Testing of Individuals Who takes the first formal action to process
administratively withdraw the Have Applied for Authorization the individual’s application for
individual’s authorization. Therefore, The NRC has added § 26.67 to the authorization.
subjecting the individual to the severe final rule, which extends former random The formal actions may include, but
consequences associated with a record testing requirements to individuals who are not limited to, the time when the
of an unfavorable termination is have applied for authorization under licensee or other entity receives the
inappropriate, except if the individual’s Part 26 but who have not yet been individual’s signed consent form and
authorization was subsequently denied granted authorization. The NRC has begins creating a record of the
individual’s application that would be Section 26.69 Authorization With However, although the NRC continues
accessible to other licensees and Potentially Disqualifying Fitness-for- to affirm that individuals who pursue
entities; conducts a psychological Duty Information treatment and maintain sobriety may be
evaluation; begins a suitable inquiry; or The NRC adds § 26.69 to the final rule considered for authorization, both the
takes other actions that are required to replace and clarify the requirements former and final rules assign the
under NRC regulations to grant contained in former § 26.27(b)(4). responsibility for making authorization
authorization. The first formal action Former § 26.27(b)(4) established decisions to the licensee or other entity.
that the licensee or other entity takes to requirements for granting authorization Therefore, the paragraph clarifies that
process an individual’s application for to an individual who has violated an granting or maintaining the
authorization will vary, depending on FFD policy and had his or her authorization of an individual about
the licensee’s FFD and access authorization terminated unfavorably or whom potentially disqualifying FFD
authorization program procedures, denied for a period of 3 or more years information has been disclosed or
whether the applicant’s FFD training is discovered is ‘‘at the licensee’s or other
under the former rule. Consistent with
up-to-date, and other factors. These entity’s discretion.’’
Goal 6 of this rulemaking to improve
considerations make it impractical to The NRC has added § 26.69(b)
clarity in the organization and language [Authorization after a first confirmed
establish a single point in the of the rule, this section of the final rule
authorization process established in the positive drug or alcohol test result or a
addresses problems that have arisen in 5-year denial of authorization] to the
rule when random testing must begin. implementing the former rule and
Therefore, the provision requires the final rule to define requirements for
clarifies the NRC’s intent with respect to granting authorization at the licensee’s
licensee or other entity to begin several situations that the former rule
subjecting the individual to random or other entity’s discretion to an
did not address. individual who had confirmed positive
testing when the licensee or other entity The NRC has added § 26.69(a)
takes the first formal action, but does drug or alcohol test results and whose
[Purpose] to the final rule to describe authorization was previously terminated
not define a specific formal action that the purpose of the section and the
would initiate random testing of unfavorably or denied for 5 years. The
applicants who are subject to these requirements in this section apply to:
applicants in all cases. requirements. The provision requires (1) An applicant who had a first
The NRC has added § 26.67(b) to the licensees and other entities to meet the confirmed positive test result on a pre-
final rule, which permits licensees and applicable requirements in this section access test and was consequently denied
other entities to grant authorization to before granting authorization to an authorization by a licensee;
an individual before random testing is individual or permitting an individual (2) An individual who is returning to
completed if the individual has met all to maintain his or her authorization duty following the 14-day assessment
of the requirements for authorization when potentially disqualifying FFD period required in § 26.75(e)(1) (The
but has been selected for one or more information is obtained about the NRC has moved the provisions in
random tests while in applicant status. individual through any means and a former § 26.26(b)(2) to § 26.75(e)(1));
The final rule does not require the previous licensee or other entity has not (3) An individual whose authorization
testing to be completed before the assessed and favorably resolved the was terminated unfavorably under
licensee or other entity grants information. Section 26.63(b) permits another Part 26 program and who had
authorization to the individual because licensees and other entities to rely on an interruption in authorization that
the primary purpose of randomly testing the results of determinations of fitness was longer than 14 days; and
applicants is to deter substance abuse that previous licensees or other entities (4) An individual whose authorization
rather than to provide information for conducted, rather than requiring each was denied for 5 years under the
the authorization decision. Pre-access new licensee or other entity to requirements of § 26.75(c), (d), (e)(2), or
testing provides the necessary reevaluate the same information that (f).
information for authorization decision was reviewed and resolved under This provision replaces and
making. another Part 26 program. However, if strengthens the requirements contained
Section 26.67(c) of the final rule the potentially disqualifying FFD in former § 26.27(b)(2) and expands
cross-references the minimum sanctions information was not previously them to address confirmed positive
to be imposed on an individual whose reviewed and favorably resolved by alcohol test results, which were
drug or alcohol results from random another FFD program under this excluded from this process in former
testing are confirmed as positive, subpart, licensees and other entities § 26.27(b)(5). The paragraph includes
adulterated, or substituted. The final must implement the requirements confirmed positive alcohol test results
rule also makes a minor language contained in this section. for the reasons discussed with respect to
clarification to the proposed rule by Section 26.69(a) also revises the § 26.75(e).
modifying the term ‘‘non-negative’’ of language contained in former The NRC has retained the language of
this section. Section 26.67(c)(1) and § 26.27(b)(2) to recognize that licensees the proposed rule to state that the
(c)(2) refers to the relevant sanctions and other entities may decide not to licensee or other entity shall perform
specified in Subpart D. Section grant authorization to the subject the activities listed in paragraphs (b)(1)
26.67(c)(3) continues to permit licensees individual and so, in that case, are not through (b)(6) of this section. In the
and other entities to grant authorization required to implement these situations presented in this section, the
to an individual whose confirmed requirements. At the public meetings NRC believes that the licensees or other
positive, adulterated, or substituted test discussed in Section I.D, stakeholders entities will likely conduct these tasks
result is a first drug- or alcohol-related noted that some individuals have themselves because another licensee has
violation under a Part 26 program, misinterpreted the former rule as not reviewed and resolved the
consistent with former § 26.27(b)(2). requiring licensees to provide individual’s situation. Therefore, the
However, the final rule permits individuals who have violated an FFD licensees will have to collect more
authorization to be granted only under policy with the opportunity to seek original data about the individual,
the stringent requirements contained in treatment for a substance abuse problem rather than relying on that collected by
§ 26.69. and to have authorization reinstated. another licensee. However, by retaining
the language of the proposed rule in this individual’s fitness and the licensee’s or the role, responsibilities, and required
section, the NRC does not intend to other entity’s reviewing official uses it qualifications of an SAE. Therefore,
require that the licensees or other to determine whether authorization is § 26.69(b)(4) requires that the individual
entities must conduct these tasks warranted. must be referred to an SAE for a
themselves in these situations. The NRC Section 26.69(b)(3) applies only to determination of fitness. However, the
maintains that the licensee may rely on individuals whose authorization was final rule does not require the SAE to be
information collected by others to meet denied for 5 years under the former rule an EAP employee. Permitting licensees
the requirements of § 26.69 if that is the or under § 26.75(c), (d), (e)(2), or (f) of and other entities to rely on a
most reasonable way to proceed. For the final rule. The paragraph requires professional who meets the required
example, if the licensee or other entity the licensee or other entity to verify, qualifications for an SAE rather than
uses a background screening company, before granting authorization, that the only on EAP personnel, more
they would most likely continue to have individual had not abused alcohol or appropriately focuses this requirement
the company perform the employment drugs during the 5-year interruption, at on ensuring that the professional who
history required in this section. a minimum. The requirement is performs the assessment and treatment
Section 26.69(b)(1) requires the consistent with the portion of former planning is qualified, rather than on the
licensee or other entity to obtain and § 26.27(b)(4) that required licensees to professional’s organizational affiliation.
review a self-disclosure and obtain ‘‘satisfactory medical assurance The NRC received a comment
employment history from the applicant that the person has abstained from drugs requesting that the rule rely on a
to verify that it does not contain any for at least 3 years.’’ However, the final Substance Abuse Professional (SAP) to
previously undisclosed potentially rule extends the requirement to 5 years meet the requirement of this section.
disqualifying FFD information. The to ensure that such an individual is at The NRC acknowledges that the SAP
final rule has added ‘‘employment the lowest risk of recidivism into an training and credentialing process
history,’’ with respect to the proposed active substance abuse problem before emphasizes knowledge about the SAP
rule, to state the intent that both a self- the licensee or other entity grants role in programs under 10 CFR Part 40,
disclosure and employment history authorization to the individual. ‘‘Domestic Licensing of Source
shall be reviewed. When an individual’s Section 26.69(b)(4) amends the Material.’’ However, although an SAP
last period of authorization was requirement in former § 26.27(b)(2). The under Part 40 meets many of the criteria
terminated unfavorably or denied, former provision mandated that an established in the rule, thorough
licensees and other entities are not individual who has a first confirmed knowledge of Part 26 requirements is
permitted to forego obtaining a self- positive test result must be referred to also necessary. Therefore, the NRC has
disclosure and employment history the EAP for assessment and counseling not modified the proposed provision in
under any circumstances because it is before the licensee or other entity may the final rule.
important to review the individual’s grant authorization to the individual. Section 26.69(b)(4)(i) through
activities during the interruption period. The final rule makes several changes to (b)(4)(iii) replaces and strengthens the
The period of time the self-disclosure the former provision. First, the final rule requirement in former § 26.27(b)(2). The
must address is the shorter of either the replaces the term ‘‘management and former provision stated that ‘‘any
past 5 years or the intervening period medical assurance of fitness’’ which was rehabilitation program deemed
after the individual last held used in former § 26.27(b)(2) and (b)(4), appropriate must be initiated during
authorization. with the term ‘‘determination of fitness’’ such suspension period.’’ The final rule
Section 26.69(b)(2) increases the to improve the accuracy of the language requires that the individual must be in
scope of the suitable inquiry by in the final rule. The final rule does not compliance with or have successfully
requiring the licensee or other entity to use ‘‘management’’ because the completed treatment and follow-up
conduct the suitable inquiry with every licensee’s or other entity’s reviewing testing plans, rather than simply started
employer by whom the applicant claims official [see the discussion of treatment, in order for the licensee or
to have been employed during the § 26.69(c)(3) and the definition of other entity to grant authorization to the
period of time addressed in the ‘‘reviewing official’’ in § 26.5] is the individual and maintain the
individual’s employment history. The individual who licensees and other individual’s authorization after it has
final rule replaces ‘‘self-disclosure’’ in entities currently designate to make been granted.
the proposed rule with ‘‘employment authorization decisions and the The NRC has added § 26.69(b)(5) to
history’’ to clarify that the time period reviewing official may not be a manager. the final rule to impose more stringent
covered is that which the employment In addition, the final rule permits pre-access testing requirements on an
history addresses. This extensive professionals other than a licensed individual who is being considered for
suitable inquiry is necessary to physician to conduct a determination of authorization following an unfavorable
determine if any indications exist that fitness, for the reasons discussed with termination or denial of authorization
the individual has continued to engage respect to § 26.189. The NRC has made than those required for individuals
in substance abuse. The final rule also these change to meet Goal 6 of this whose last period of authorization was
requires licensees and other entities to rulemaking to improve clarity in the terminated favorably. The provision
obtain and review any records that other organization and language of the rule. requires negative results from an alcohol
licensees or entities may have Consistent with the intent of the test performed within 10 business days
developed related to any potentially former requirement, the provision before authorization is granted.
disqualifying FFD information about the requires the licensee or other entity to Similarly, the provision requires
individual from the past 5 years. These ensure that an SAE has conducted a negative results from a urine specimen
records may include, but are not limited determination of fitness, as defined in that was collected under direct
to, the results of past suitable inquiries § 26.189, as part of the authorization observation for drug testing within 10
or other investigations, records of arrests decision. Section 26.187 [Substance business days before authorization is
or convictions, drug and alcohol test abuse expert] requires that an SAE must granted. The provision prohibits the
results, treatment records, and the perform determinations of fitness that licensee or other entity from granting
results of determinations of fitness. The are conducted for authorization authorization to the individual before
SAE uses this information to assess the decisions. Section 26.187 also defines the drug test results are reported to the
licensee’s or other entity’s MRO. The are both unannounced, may be used to § 26.185(o), is required to determine
MRO may then determine whether the meet this final requirement. The final whether the results indicate new drug
drug test results indicate that the rule requires licensees and other entities use or are consistent with results that
individual has not engaged in any to distribute the unannounced tests over are expected from the drug use that
further drug abuse [see the discussion of the 3-year period, with at least one resulted in the previous confirmed
§ 26.69(f)]. Completing drug and alcohol unannounced test conducted each positive test result. The rule adds this
testing within 10 business days before quarter. requirement in response to
granting authorization rather than the 30 The NRC has added § 26.69(b)(6)(i) inconsistencies in the way some MROs
days that is permitted in § 26.65 for the through (b)(6)(iii) to the final rule to have implemented former requirements
other authorization categories provides address circumstances when an related to return-to-duty drug testing.
evidence that the individual has individual is not continuously subject to Some MROs have been inappropriately
abstained from abusing proscribed a Part 26 program during the 3 years reluctant to declare a second drug test
substances during the interruption following the restoration of result as negative if any concentration of
period and that the individual is able to authorization. Section 26.69(b)(6)(i) the drug or drug metabolites that
safely and competently perform duties requires that an individual who resulted in a first confirmed positive
under this part when authorization is intermittently holds authorization over drug test result are detected in the
reinstated, if the individual’s the 3-year period must be subject to specimen. The change permits an
authorization has been interrupted for unannounced testing at least once in individual who has not engaged in
the 14-day assessment period required each quarter during which the further drug use after a first confirmed
under former § 26.27(b)(2) and retained individual is authorized. Section positive drug test result to regain
in § 26.75(e)(1). Requiring direct 26.69(b)(6)(ii) permits the licensee or authorization at the licensee’s discretion
observation of the urine specimen other entity to extend the followup rather than be incorrectly denied
collection is necessary to provide added testing period to 5 years, if the authorization for 5 years on the basis of
assurance that the specimen is valid and requirement for 15 tests over the 3-year a subsequent FFD policy violation,
yields accurate drug test results. period has not been met because the under § 26.75(e)(2).
Section 26.69(b)(6) applies only to individual has not been authorized a The NRC has added § 26.69(c)
individuals whose authorization has sufficient number of times or for [Granting authorization with other
been unfavorably terminated or denied sufficient periods of time during the potentially disqualifying FFD
for at least 14 days for a first confirmed first 3 years to meet the final 15-test information] to the final rule to establish
positive drug or alcohol test result. The requirement. Section 26.69(b)(6)(iii) requirements for granting authorization
provision replaces the third sentence of permits the licensee or other entity to to an individual about whom potentially
former § 26.27(b)(4). This sentence have an SAE conduct a determination of disqualifying FFD information is
established requirements and a schedule fitness to determine whether further discovered or disclosed that was not a
for followup drug and alcohol testing for followup testing is required, if an confirmed positive, adulterated,
an individual whose authorization was individual is unable to meet the 15-test substituted, or invalid drug or alcohol
denied for 3 years under the former rule. requirement after 5 years because of test result or 5-year denial of
The final rule applies the requirement brief and infrequent periods of authorization. For example, this type of
for followup testing to individuals who authorization. The revision of these potentially disqualifying FFD
have had a first confirmed positive test requirements increase the flexibility information may include, but is not
result for drugs or alcohol. This with which licensees and other entities limited to:
requirement provides greater deterrence may implement followup testing, but (1) A report of an arrest for an alcohol-
of further drug and alcohol use than retains the former effectiveness of related traffic violation;
former § 26.27(b)(4), which required this followup testing in detecting and (2) Information from the suitable
followup testing only for the more deterring substance abuse. inquiry that a previous private-sector
serious FFD violations that result in a The NRC has added § 26.69(b)(7) to employer terminated an individual’s
denial of authorization for 3 years or the final rule, which requires the employment because of drug- or
longer. The more stringent requirement licensee or other entity to verify that the alcohol-related job performance
provides higher assurance that results of all drug and alcohol tests that problems; or
individuals who are subject to this part are administered to the individual (3) Information obtained from the
are trustworthy, reliable, and fit for under a Part 26 program following the suitable inquiry or other sources of
duty. restoration of the individual’s information indicating that the
Section 26.69(b)(6) amends the former authorization indicate no further drug or individual is known to abuse illegal
fixed schedule for followup testing by alcohol abuse. The provision does not drugs or alcohol or is experiencing
requiring licensees and other entities to specify that the drug test results must be significant mental or emotional stress.
subject the individual to the possibility negative because the metabolites of This provision is necessary because
of being selected for followup testing, some drugs, such as marijuana, may be the former rule did not address the
during any period in which he or she present in an individual’s urine for authorization process in these
holds authorization under Part 26, for a several weeks after the individual has circumstances and the NRC is aware
period of 3 calendar years after the stopped using the drug. If an individual that licensees and other entities have
individual’s authorization is restored is tested again soon after the original handled these circumstances
following termination or denial for the test that resulted in an FFD violation inconsistently. Therefore, the final rule
first confirmed positive drug or alcohol was conducted, the specimen may yield adds these requirements to establish the
test result. The rule requires licensees positive results which would not, in NRC’s intent with respect to these
and other entities to ensure that the fact, reflect new drug use. Therefore, if circumstances and increase consistency
individual is subject to unannounced subsequent drug test results show the between Part 26 programs.
testing at least 15 times within the 3- presence of the same drug or drug The NRC has added a second sentence
year period and to verify that the metabolites in the individual’s urine as to § 26.69(c) in the final rule to clarify
individual’s test results are negative. detected in the original confirmed that if potentially disqualifying FFD
Either random or followup tests, which positive test result, the MRO, under information is obtained about an
individual by any means, the licensee period of authorization was terminated provision because the former rule did
shall perform the activities in favorably in order to make an not address maintaining an individual’s
paragraphs (c)(1) through (c)(5) of this appropriate authorization decision. authorization in these circumstances.
section before granting authorization to The NRC has added § 26.69(c)(3) to Also, the NRC is aware that licensees
the individual. The NRC has made this the final rule, which uses the term and other entities have handled these
change to meet Goal 6 of the rulemaking ‘‘reviewing official’’ to refer to the circumstances inconsistently. Therefore,
to improve clarity in the organization employee whom the licensee or other the final rule adds these requirements to
and language of the rule. entity designates to make authorization establish the NRC’s intent with respect
The NRC has added § 26.69(c)(1) to decisions as discussed with respect to to these circumstances and to increase
the final rule, which requires the § 26.5. This provision permits the consistency between Part 26 programs.
licensee or other entity to obtain and reviewing official to grant or deny The NRC has added § 26.69(e)
review the individual’s self-disclosure authorization based upon his or her [Accepting followup testing and
and employment history. The final rule review of the circumstances associated treatment from another Part 26 program]
has added the term ‘‘employment with the potentially disqualifying FFD to the final rule to establish continuity
history’’ to clarify that the licensee must information. Because of the variety of of care requirements for individuals
obtain and review that in addition to the circumstances that may arise, the who were subject to a followup testing
self-disclosure. The final rule also provision also grants discretion to the and/or a substance abuse treatment plan
modifies the language of the proposed reviewing official in deciding whether a under one Part 26 program and transfer
rule by eliminating reference to determination of fitness is required to another FFD program, or leave and
§ 26.31(b)(3) and instead adding rather than requiring a determination of then return to the same FFD program.
paragraphs (c)(1)(i) through (c)(1)(iii) to fitness in every case. However, if the Section 26.69(e)(1) requires the
§ 26.69 to specify exactly the time reviewing official requests a receiving licensee or other entity to
period that the self-disclosure and determination of fitness and the continue the testing and treatment plan
employment history must address. The professional who performs it to which the individual was subject
NRC has made this change in response recommends any form of treatment or under the previous FFD program.
to a public comment suggesting that this drug and alcohol testing, including the However, with respect to the proposed
provision needed clarification and to collection of urine specimens under rule, the final rule clarifies that the
meet Goal 6 of the rulemaking to direct observation, § 26.69(c)(4) requires licensee or other entity who imposed
improve clarity in the organization and the licensee or other entity to the treatment and/or followup testing
language of the rule. implement the treatment and testing plan shall ensure that information
Section 26.69(c)(2) requires the recommendations. documenting the treatment and/or
licensee or other entity to conduct a The NRC has added § 26.69(c)(5) to followup testing plan is identified to
suitable inquiry with every employer for the final rule to require pre-access and any subsequent licensee or other entity
the period that the employment history random testing of the applicant for who seeks to grant authorization to the
addresses. In this section, the final rule authorization. This provision requires individual. The NRC has made this
deletes ‘‘self-disclosure’’ and replaces it the licensee or other entity to verify that change to clarify the intent of the
with the phrase ‘‘employment history the results of pre-access drug and provision and in recognition of the need
required under paragraph 26.63(a) alcohol tests are negative before granting for additional consistency between the
through (e)’’ to clarify the time period authorization to the individual, to final rule and the access authorization
addressed. If the potentially provide evidence that the individual is requirements. Therefore, this change
disqualifying FFD information was avoiding substance abuse. helps meet Goal 4 of this rulemaking to
identified during the course of The NRC has added § 26.69(d) improve consistency between FFD
conducting a suitable inquiry under [Maintaining authorization with other requirements and access authorization
§ 26.63(f) so that the suitable inquiry potentially disqualifying FFD requirements established in 10 CFR
was partially completed, § 26.69(c)(2) information] to the final rule, which 73.56, as supplemented by orders to
requires the licensee or other entity to establishes requirements for nuclear power plant licensees dated
conduct a more complete suitable maintaining an individual’s January 7, 2003.
inquiry by contacting every employer authorization when new potentially Section 26.69(e)(1) of the final rule
that the individual listed during the disqualifying FFD information is also adds a specification that if it is
interruption period. The provision also disclosed or discovered that was not a impractical for the individual to comply
requires that if the individual held confirmed positive drug or alcohol test with the treatment plan that was
authorization within the past 5 years, result, or 5-year denial of authorization, developed under another FFD program,
the licensee or entity shall obtain and if the reviewing official determines that the granting FFD program shall ensure
review any records that other licensees maintaining authorization is warranted. that an SAE develops a comparable
or entities who are subject to this part A self-disclosure, suitable inquiry, and treatment plan. The NRC has made this
may have developed with regard to pre-access testing are not required change because it received a public
potentially disqualifying FFD because the individual would not be comment stating that the proposed
information about the individual from applying for authorization. However, provision that required the licensee to
the past 5 years. The final rule, with the provision requires the reviewing assume responsibility for overseeing the
respect to the proposed rule, has added official to consider the circumstances continuation of treatment and follow-up
the phrase ‘‘if the individual held related to the information and, at his or testing for an employee who had a
authorization within the past 5 years’’ to her discretion, ensure that a positive test result under another FFD
meet Goal 6 of the rulemaking to professional with the appropriate program could be burdensome,
improve clarity in the language of the qualifications makes a determination of especially if the individual is applying
rule. This more complete suitable fitness. The provision mandates that the for authorization at a new site that
inquiry is necessary to ensure that the licensee or other entity must implement makes it impossible to use the same
licensee or other entity has more any treatment or testing requirements treatment providers.
information about the individual than is resulting from the determination of Section 26.69(e)(2) permits the
required for individuals whose last fitness. The NRC has added the receiving licensee or other entity to
accept and rely on any followup testing policy must have information on the training before the licensee or other
that was completed while the individual expectations of them and the entity grants initial authorization.
was subject to the previous Part 26 consequences that may result from a Thereafter, as specified in § 26.29(c)(2),
program to determine how long lack of adherence to the policy. Section the rule requires individuals to
followup testing must continue. For 26.71 also requires that in order to complete refresher training or pass a
example, if an individual met all of the maintain authorization, an individual comprehensive examination on a
requirements for authorization by a new must report any legal actions as defined nominal 12-month frequency. Section
licensee but had completed only 2 of the in § 26.5. Finally, although not 26.29(d) provides that licensees and
3 years of followup testing required explicitly specified in § 26.71(a)(1), other entities may accept the training of
under a previous Part 26 program, the § 26.33 [Behavioral observation] individuals who have been subject to
granting licensee would then administer requires individuals to report any FFD another Part 26 program and have either
the final year of the followup testing. concern to the personnel designated in had initial or refresher training or
However, the licensee is not required to the FFD policy. successfully passed a comprehensive
conduct another 3 full years of followup Section 26.71(a)(2) establishes that an examination within the past 12 months
testing after the individual was individual may maintain authorization that meets the requirements of § 26.29.
authorized. If the transferring individual if the individual remains subject to a Section 26.71(b) of the final rule
successfully completed any followup drug and alcohol testing program that requires a licensee or other entity to
testing and treatment program required complies with the requirements of Part terminate an individual’s authorization
under the first FFD program, a previous 26, including random testing. Licensees if the individual is not subject to an FFD
determination of fitness indicated that and other entities who are subject to program that meets the requirements of
the individual is fit for duty, and the Part 26 are responsible for Part 26 for more than 30 (consecutive)
individual’s authorization by the first implementing drug and alcohol testing days. The requirements of the paragraph
licensee or other entity was terminated programs that comply with the permits an individual to be away from
favorably, this provision permits the requirements in § 26.31 [Drug and all elements of a Part 26 program for this
receiving licensee or other entity to alcohol testing]. The failure of a licensee period of time in order to accommodate
accept the previous determination of or other entity to maintain a program vacations and significant illnesses when
fitness and does not require the granting would terminate the authorizations of the individual is not reasonably
licensee to develop and implement an individuals who have been granted available for behavioral observation or
additional testing and treatment plan. authorization by the licensee or other to collect specimens for random drug
The NRC has added § 26.69(f) entity (see the discussion of § 26.71(b)). and alcohol testing. The NRC has added
[Sanctions] to the final rule to clarify the Section 26.31 also places certain this paragraph to the final rule in
minimum sanctions to be imposed on responsibilities on individuals who are response to stakeholder requests, and it
an individual who has confirmed subject to the testing program. In is consistent with related requirements
positive, adulterated, or substituted particular, under § 26.31(d)(2)(iii), in the access authorization orders issued
drug and alcohol test results on any individuals who are selected for random to nuclear power plant licensees on
tests that may be required under this testing are required to report to the January 7, 2003.
section. Section 26.69(f)(1) and (f)(2) collection site as soon as reasonably
cross-references the relevant sanctions practicable after notification within the Subpart D—Management Actions and
specified in Subpart D to establish that time period specified in FFD program Sanctions To Be Imposed
those sanctions apply to individuals procedures, as well as to cooperate in Throughout this subpart, the final rule
about whom potentially disqualifying the testing process. In appropriate makes minor clarifications to the
FFD information has been discovered or circumstances, an individual’s failure to proposed rule due to public comment,
disclosed. report or cooperate could be the basis to accommodate conforming changes,
for terminating the individual’s and to meet Goal 6 of this rulemaking
Section 26.71 Maintaining
authorization. to improve clarity in the organization
Authorization Section 26.71(a)(3) establishes that an and language of the rule. The final rule
The NRC has added § 26.71 to the individual may maintain authorization makes other substantive changes in
final rule to state the requirements for if the individual remains subject to a §§ 26.73; 26.75(e)(1) and (h); and
maintaining authorization under this behavioral observation program that 26.77(b)(2) that are discussed with
part and has adopted the provisions in complies with the requirements of Part regard to those sections. Otherwise, the
this section as proposed without 26. Behavioral observation, as required final rule has adopted the provisions in
change. Section 26.71(a) of the final rule by § 26.33, is performed by individuals, this section as proposed without
provides that individuals may maintain including coworkers, who have been change.
authorization under the conditions trained to detect behaviors that may
listed in § 26.71(a)(1) through (a)(4), as indicate possible use, sale, or possession Section 26.73 Applicability
follows: of illegal drugs; use or possession of The NRC has added § 26.73 to the
Section 26.71(a)(1) establishes that an alcohol on site or while on duty; or final rule to describe the applicability of
individual must comply with the impairment from fatigue or any cause the subpart. The new § 26.73 specifies,
licensee’s or other entity’s FFD policies that, if left unattended, might constitute by using applicable cross-references to
to which the individual is subject. This a threat to the health and safety of the §§ 26.3 [Scope] and 26.4 [FFD program
requirement relates, although it does not public or the common defense and applicability to categories of
refer to § 26.27 [Written policy and security. individuals], the licensees and other
procedures] that requires the licensee or Section 26.71(a)(4) establishes that a entities, as well as individuals, to whom
other entity to prepare a clear and condition for maintaining authorization the requirements of this subpart apply.
concise statement of its FFD policy and is the individual’s successful

make that policy readily available to all completion required of FFD training, Section 26.75 Sanctions
individuals who are subject to the according to the schedule in § 26.29(c). The first sentence of § 26.75(a) of the
policy. The final rule requires that all As specified in § 26.29(c)(1), the final final rule introduces the purpose of the
individuals who are subject to the FFD rule requires the individual to complete section, which is to define the minimum
sanctions that licensees and other examples are not intended to be the sale, use, or possession of illegal
entities must impose when an exhaustive. For example, if a licensee or drugs within a protected area of any
individual has violated the drug and other entity determines that several nuclear power plant, within a facility
alcohol provisions of an FFD policy. individuals colluded to notify potential that is licensed to possess or use
The second sentence of the paragraph donors that they would be selected for formula quantities of SSNM, or within
restates the second sentence of former random testing on a particular day, so a transporter’s facility or vehicle. The
§ 26.27(b). This sentence permits that the potential donors could plan to final rule retains the former sanction of
licensees and other entities to impose avoid work on that day or take other a 5-year denial of authorization in these
more stringent sanctions than those actions to ensure that their illegal drug instances and adds two other instances
specified in the final rule. The final rule use would not be detected, the NRC in which a 5-year denial of
adds a cross-reference to paragraph (h) expects the licensee or other entity to authorization is required.
of this section, which establishes limits permanently deny authorization to all of First, the final rule requires licensees
on the sanctions that licensees and other the individuals who were involved in and other entities to impose a 5-year
entities may impose for positive, the collusion. denial of authorization on any
adulterated, substituted, or invalid drug The final rule does not include individual who is determined to have
test results. Adding a cross-reference to submitting a dilute specimen as an consumed alcohol within a protected
paragraph (h) of this section clarifies example of a subversion attempt area of any nuclear power plant, within
that the blanket permission to impose without additional evidence that the a facility that is licensed to possess or
more stringent sanctions granted in this donor had diluted the specimen in order use formula quantities of SSNM, or
paragraph has one exception, as to mask the presence of drugs or drug within a transporter’s facility or vehicle.
discussed with respect to paragraph (h) metabolites in the specimen, for the This change from the former rule is
of this section. The NRC has made these reasons discussed with respect to necessary because consuming alcohol
changes to meet Goal 6 of this § 26.185(g). Submitting a dilute causes impairment, which poses the
rulemaking to improve clarity in the specimen, in itself, does not necessarily same risks to public health and safety as
organization and language of the rule. indicate an attempt to subvert the impairment from illegal drugs.
The NRC has added § 26.75(b) to the testing process because there are many Extending the scope of the former
final rule to require licensees and other legitimate causes for a dilute specimen, sanction to alcohol consumption is also
entities to permanently deny including drinking liquids in order to consistent with the revised FFD
authorization to individuals who refuse provide a specimen of sufficient program performance objective in
to be tested or who in any way subvert quantity, as permitted in Section
§ 26.23(d), which is to provide
or attempt to subvert the testing process. 2.4(g)(11) in Appendix A of the former
reasonable assurance that the
This sanction is necessary because acts rule and in § 26.109(b)(1) of the final
workplaces subject to this part are free
to subvert the testing process reflect a rule. Therefore, the final rule does not
from the presence and effects of alcohol
sufficiently egregious lack of require licensees and other entities to
as well as illegal drugs. Therefore, by
trustworthiness and reliability to apply the sanction of permanent denial
reducing the risk to public health and
warrant permanent denial of of authorization for submitting a dilute
safety and the common defense and
authorization. An individual’s specimen, unless there is other evidence
security that the onsite use of alcohol
willingness to subvert or attempt to that the donor had diluted the specimen
poses, this change meets Goal 3 of this
subvert the testing process provides in an attempt to subvert the testing
strong evidence that the individual will process. rulemaking to improve the effectiveness
also be willing to disregard other rules The NRC used the phrase ‘‘for any test of FFD programs.
and regulations, such as safeguards required under this part’’ in § 26.75(b) Second, the final rule adds the phrase
requirements, which ensure the in the proposed rule to indicate that ‘‘or while performing the duties that
protection of public health and safety applicants for authorization who require the individual to be subject to
and the common defense and security. subvert or attempt to subvert a pre- this part’’ to address circumstances in
In addition, if an individual succeeds in access or random test are also subject to which an individual may be performing
subverting the testing process in order permanent denial of authorization. the duties that require him or her to be
to hide substance abuse, the individual However, the NRC has changed this subject to this part but is not doing so
may pose an undetected and phrase in the final rule to ‘‘for any test within the protected area of a nuclear
unacceptable risk to public health and required under 26.31(c).’’ This change power plant, within a facility that is
safety or the common defense and clarifies the intent of the provision and licensed to possess or use formula
security by performing the duties that is consistent with Goal 6 of this quantities of SSNM, or within a
require him or her to be subject to this rulemaking to improve clarity in the transporter’s facility or vehicle. As one
part while impaired. Therefore, by organization and language of the rule. example, many nuclear power plant
deterring acts to defeat the testing Although these individuals would not licensees’ designated collection sites are
process as well as preventing any yet be performing any duties that could located outside of the plant’s protected
individuals who engage in them from affect public health and safety or the area. The intent of the former rule was
posing any further risk to public health common defense and security, an to prohibit the presence, sale, and use
and safety and the common defense and attempt to subvert the testing process of alcohol or illegal drugs by FFD
security, this change meets Goal 3 of while in an applicant status provides program personnel at a collection site
this rulemaking to improve the strong evidence that the individual that is located outside of the protected
effectiveness of FFD programs. cannot be trusted to perform those area, but the former rule did not
The final rule specifies three duties. Therefore, it is necessary to specifically address such circumstances.
examples of actions that are considered ensure that any applicant who subverts The majority of licensees have
subversion or an attempt to subvert the or attempts to subvert the testing appropriately interpreted the intent of
testing process. These include refusing process is denied authorization. the former rule, but the final rule adds
to provide a specimen and providing or Section 26.75(c) of the final rule this phrase to meet Goal 6 of this
attempting to provide a substituted or amends former § 26.27(b)(3). Former rulemaking to improve clarity in the
adulterated specimen. However, these § 26.27(b)(3) established sanctions for organization and language of the rule.
In addition, the final rule deletes the ensures that such an individual is not Therefore, in order to deter individuals
list of activities in the paragraph of the granted authorization without having from abusing alcohol and ensure that
former rule that an individual is demonstrated that he or she has individuals who may be impaired from
prohibited from performing. The final overcome the substance abuse problem. alcohol are not permitted to perform the
rule replaces this list with the summary Therefore, the NRC has made this duties that require individuals to be
term ‘‘authorization’’ for consistency change to meet Goal 3 of this subject to this part, this final rule
with the use of this term throughout the rulemaking to improve the effectiveness imposes the same sanctions for abusing
final rule. As discussed with respect to and efficiency of FFD programs. alcohol as those required for abusing
§ 26.4, the NRC presents the list of In addition, for any type of FFD drugs. The NRC has made this change
duties that require individuals to policy violation, this provision requires to meet Goal 3 of this rulemaking to
maintain authorization and to be subject the licensee or other entity to record the improve the effectiveness of FFD
to this part once in that section, rather fact that the individual had resigned or programs.
than repeatedly throughout the rule, for withdrawn his or her application for Section 26.75(e)(1) retains but amends
consistency with Goal 6 of this authorization, the nature of the FFD the intent of the second sentence of
rulemaking to improve clarity in the policy violation, and the sanction that former § 26.27(b)(2). The former
organization and language of the rule. would have been imposed if the § 26.27(b)(2) stated that licensees and
Section 26.75(d) of the final rule individual had not resigned or other entities must remove an
amends a portion of former § 26.27(c) withdrawn. Recording this information individual from performing activities
that required licensees or other entities is necessary to ensure that any licensees under this part for at least 14 days
to record as a removal ‘‘for cause’’ an or other entities who may consider following a first confirmed positive test
individual’s resignation that occurs granting authorization to the individual result. However, the final rule requires
before the licensee removes the in the future are aware of the licensees and other entities to
individual for violating the FFD policy. individual’s behavior and the nature of immediately unfavorably terminate the
This portion of the former provision has the FFD policy violation. Subsequent individual’s authorization for at least 14
raised implementation questions from licensees and other entities will then be days from the date of the unfavorable
licensees regarding the appropriate able to ensure that the minimum termination, rather than ‘‘remove’’ the
action to take in these circumstances. requirements of this section are met. For individual. With respect to the proposed
Licensees have questioned whether the example, if the FFD policy violation was rule, the final rule adds a clarification
former requirement was intended to a third confirmed positive drug or that the 14-day termination begins on
deny authorization to an individual for alcohol test result, § 26.75(g) prohibits a the date of the unfavorable termination.
some period of time, as required under subsequent licensee or other entity from The NRC has made this change because
former § 26.27(b)(2) through (b)(4), granting authorization to the individual after publishing the proposed rule, it
permanently deny authorization to the under any circumstances. The NRC has recognized the need for additional
individual, or merely to record the made this change to meet Goal 3 of this clarity in this provision to illustrate the
resignation. Therefore, the final rule rulemaking to improve the effectiveness NRC’s intent. At the public meetings
clarifies the intent of the former and efficiency of FFD programs. discussed in Section I.D, the
provision as follows: The NRC has moved the portion of stakeholders indicated that the term
The final rule establishes the sanction former § 26.27(c) that referred to a ‘‘remove’’ is confusing because it could
of a 5-year denial of authorization for an refusal to provide a specimen for testing be interpreted as requiring licensees and
individual who resigns before a licensee to § 26.75(b) of the final rule to meet other entities to terminate the
or other entity terminates the Goal 6 of this rulemaking, regarding individual’s employment, which is not
individual’s authorization or denies organizational clarity. the intent of this paragraph. The
authorization to an applicant for a first Section 26.75(e) of the final rule stakeholders suggested using the phrase
violation of the FFD policy involving a amends former § 26.27(b)(2) and ‘‘terminate the individual’s
confirmed positive drug or alcohol test expands its scope to include alcohol. authorization’’ to more accurately
result. The paragraph establishes a 5- The NRC no longer excludes the abuse characterize the required action. This
year denial of authorization because the of alcohol from the sanctions specified change is consistent with Goal 6 of this
confirmed positive drug or alcohol test in this section for several reasons. First, rulemaking to improve clarity in the
result in combination with such a although the possession and use of organization and language of the rule.
resignation, is a strong indication that alcohol are legal for adults and do not The stakeholders also requested that
the individual has an active substance adversely reflect on an individual’s the agency eliminate from § 26.75(e)(1)
abuse problem. However, because the trustworthiness and reliability, a the requirements in the former
individual resigned or withdrew his or perceived need to conceal an untreated paragraph related to referring the
her application for authorization, the active alcohol abuse problem could individual to the EAP for assessment
individual would not be available for cause an individual to be vulnerable to and counseling. The stakeholders noted
the SAE to evaluate the seriousness of influence to act in ways that are adverse that many licensees terminate an
his or her substance abuse problem and to the common defense and security. individual’s employment at the same
devise an appropriate treatment plan, as Second, alcohol-related impairment in time that they terminate the individual’s
required under § 26.189 [Determination the nuclear workplace poses an undue authorization after a first confirmed
of fitness]. Therefore, prohibiting the potential risk to public health and safety positive test result. They suggested that
individual from being granted that is comparable to the risk imposed if the licensee or other entity terminates
authorization for a 5-year period gives by impairment from the use of drugs. the individual’s employment and does
the individual an opportunity to seek Third, some licensees have not imposed not intend to provide the individual
treatment and establish a 5-year history appropriately stringent sanctions on with an opportunity to regain
of sobriety, which is required to regain individuals who have abused alcohol in authorization, it is inappropriate to
authorization under § 26.69 a manner that could cause the require the licensee or other entity to
[Authorization with potentially individual to be impaired while provide assessment and counseling
disqualifying fitness-for-duty performing the duties that require services to the individual. However,
information]. This prohibition also individuals to be subject to this part. some licensees have interpreted the
former provision as requiring them to FFD policies to establish sanctions that former § 26.27(b)(5). Section 26.75(f)
provide EAP services to individuals are sufficient to deter the misuse of retains the former requirement that
whom they no longer employ. The NRC those substances. The final rule requires sanctions for the misuse of prescription
concurs that the intent of the former the same minimum sanctions for and over-the-counter drugs must be
rule is for licensees and other entities to alcohol abuse as those required for drug sufficient to ‘‘deter abuse of legally
provide assessment and counseling abuse. Impairment caused by alcohol obtainable substances’’ because such
services only in those instances when abuse creates a risk to public health and misuse may lead to impairment on the
the licensee or other entity desires to safety that is fundamentally similar to job. However, the final rule eliminates
reinstate the individual’s authorization. the risk posed by the use of illegal the phrase ‘‘as a substitute for abuse of
Therefore, the NRC has made this drugs. However, some licensees have prescribed drugs’’ in the last sentence of
change, consistent with Goal 6 of this imposed lesser sanctions for alcohol former § 26.27(b)(5) because it
rulemaking to improve clarity in the violations, an approach that is unnecessarily limited the circumstances
organization and language of the rule. inconsistent with the NRC’s intent. in which sanctions for the misuse of
The final rule also moves the Therefore, the final rule rectifies this prescription and over-the-counter drugs
requirements in former § 26.27(b)(2) that situation by explicitly requiring the must be imposed. The NRC has made
were related to permitting the same minimum sanctions for the abuse these changes to meet Goal 3 of the
individual to regain authorization to of alcohol as currently required for the rulemaking to improve the effectiveness
Subpart C [Granting and Maintaining use of illegal drugs. The NRC has made and efficiency of FFD programs, and
Authorization] of the final rule instead this change to meet Goal 3 of this Goal 6 to improve clarity in the
of retaining them in § 26.75(e)(1) rulemaking to improve the effectiveness organization and language of the rule.
because § 26.75(e)(1) addresses and efficiency of FFD programs and Section 26.75(g) of the final rule
sanctions for FFD policy violations, Goal 6 to improve clarity in the amends former § 26.27(b)(4). The NRC
rather than FFD requirements for organization and language of the rule. has moved the portions of the former
granting authorization. Subpart C In addition, § 26.75(f) of the final rule paragraph that established requirements
addresses the requirements for granting requires licensees and other entities to for granting authorization to an
authorization to an individual after his impose the same sanctions as mandated individual who has violated the
or her authorization has been for the abuse of illegal drugs if the MRO licensee’s or other entity’s FFD policy to
terminated unfavorably for a first determines that the misuse of § 26.69 in Subpart C of the final rule for
confirmed positive drug or alcohol test prescription drugs or over-the-counter organizational clarity because § 26.75(g)
result in § 26.69(b). The NRC has made medications resulting in a positive drug only addresses sanctions for FFD policy
this change to meet Goal 6 of this or alcohol test result represents violations. This provision retains the
rulemaking to improve organizational substance abuse. The MRO makes this portion of the former paragraph that
clarity in the rule. determination under § 26.185(j). Misuse required licensees and other entities to
Section 26.75(e)(2) increases the of prescription and over-the-counter permanently deny authorization to an
length of the period for which licensees medications may include, for example, individual who has repeatedly violated
and other entities must deny an the use of a spouse’s or other family a licensee’s or other entity’s FFD policy.
individual’s authorization for a second member’s prescription medications that The final rule requires the permanent
confirmed positive drug or alcohol test may cause impairment, such as some denial of an individual’s authorization if
result from 3 years in former pain relievers, or the excessive use of he or she has another confirmed
§ 26.27(b)(vii) to 5 years in the final some over-the-counter cold and cough positive drug or alcohol test result after
rule. This change provides greater preparations containing alcohol or other he or she has had authorization denied
assurance that individuals who have active ingredients that may cause for 5 years under other paragraphs in
had a second confirmed positive drug or impairment. However, an individual this section. Requiring this more
alcohol test result are able to abstain who has a substance abuse problem may stringent sanction meets Goal 3 of this
from substance abuse for at least 5 years use the same substances. For example, rulemaking to improve the effectiveness
before a licensee or other entity may an individual who has become addicted and efficiency of FFD programs because
again consider granting authorization to to opiates may use a spouse’s or other this provides reasonable assurance that
them. The 5-year period is based on the family member’s codeine tablets or individuals are trustworthy and reliable,
research literature indicating that other opiates that were prescribed for as demonstrated by avoiding substance
individuals who abstain from substance pain relief to assist the addicted abuse, and increases the assurance that
abuse for 5 years after treatment are less individual in avoiding withdrawal only individuals who are fit for duty are
likely to relapse than individuals who symptoms. Under this provision, if the permitted to perform the duties listed in
have been able to abstain for 3 years. In MRO determines that an individual’s § 26.4.
addition, the more stringent sanction for use of a prescription or over-the-counter Section 26.75(h) and (i) of the final
a second confirmed positive drug or medication represents substance abuse, rule amends former § 26.24(d)(2). The
alcohol test result provides greater the licensee or other entity is required former provision permitted licensees to
deterrence to recidivism than the former to impose the minimum sanctions temporarily suspend an individual’s
3-year period. The NRC has made this specified in this section for a confirmed authorization or take other
change to meet Goal 3 of this positive drug or alcohol test result, as administrative action if an individual
rulemaking to improve the effectiveness appropriate. If the MRO determines that has a positive drug test result for
and efficiency of FFD programs. the misuse of a prescription or over-the- marijuana or cocaine metabolites that is
Section 26.75(f) of the final rule counter medication does not represent identified through initial testing at the
amends former § 26.27(b)(5). Former substance abuse, the final rule requires licensee testing facility. For
§ 26.27(b)(5) stated that the sanctions for the licensee or other entity to impose organizational clarity, consistent with
confirmed positive drug test results in the sanctions for substance misuse that Goal 6 of this rulemaking, the final rule
former § 26.27 [Written policy and the licensee or other entity specifies in divides the former paragraph into two
procedures] did not apply to the misuse the FFD policy. paragraphs to separate the requirements
of alcohol, valid prescriptions, and over- The final rule also retains but revises related to the conditions under which
the-counter drugs, but required licensee the requirement in the last sentence of licensees and other entities may and
may not take action on the basis of validity testing (see the discussion of his or her fitness is questionable. This
initial test results. § 26.31(d)(3)(i) with respect to the section of the final rule adds cross-
Section 26.75(h) prohibits licensees addition of validity testing requirements references to § § 26.27(c)(3), 26.207, and
and other entities from taking in this rule and the requirement that the 26.209 (updated from the proposed rule)
administrative actions or imposing specimen for which action will be taken because those provisions provide
sanctions on an individual based on a must appear to be valid, based on exceptions to the requirement for
positive test result from any initial drug validity screening or initial validity test immediate action. Section 26.27(c)(3)
test result reported by an HHS-certified results from the licensee testing facility). permits licensees and other entities to
laboratory. This section also permits The final rule also revises the use individuals who have consumed
licensees and other entities to take terminology used in the former alcohol if they are needed to respond to
administrative actions on the basis of provision to be consistent with the an emergency and the licensee or other
positive initial drug test results for terminology used throughout the final entity establishes controls and
marijuana and cocaine from a licensee rule (see the discussion of § 26.5 with conditions under which the individual
testing facility. However, in order for respect to the new terminology adopted may perform work safely. Sections
the licensee or other entity to take in the final rule) and updates the cross- 26.207 and 26.209 contain the
action, the final rule requires that the references to other sections of the rule provisions for waivers and exceptions
urine specimen that yields a positive, to be consistent with the organization of and self-declarations, which exempt
adulterated, or substituted drug test the final rule. The NRC has made these individuals from the work hour controls
result(s) must also appear to be a valid changes to meet Goal 6 of this of Subpart I [Managing Fatigue] under
specimen, based on the results of rulemaking to improve clarity in the certain circumstances. The NRC has
validity screening or initial validity test organization and language of the rule. added the cross-references to meet Goal
results at the licensee testing facility. In 6 of this rulemaking to improve clarity
addition, this section prohibits licensees Section 26.77 Management Actions
in the organization and language of the
and other entities from imposing Regarding Possible Impairment
rule.
sanctions or taking other actions in The NRC has added § 26.77 The final rule also revises some
response to adulterated, substituted, or [Management actions regarding possible terminology used in the former
invalid screening or initial validity test impairment], which amends the provision in response to stakeholder
results from a specimen in which no requirements of former § 26.27(b)(1). requests during the public meetings
drug metabolites were detected. The The former section required licensees discussed in Section I.D. The
NRC has added this prohibition because and other entities to remove impaired stakeholders indicated that, because the
the procedures, instruments, and workers, or those whose fitness may be former rule requires them to ‘‘remove’’
devices used in conducting validity questionable, from performing activities individuals whose fitness may be
screening and initial validity tests have within the scope of this part. The former questionable, some FFD programs have
not yet been proven to be sufficiently provision also permitted licensees and interpreted the former paragraph as
accurate and reliable to support other entities to return the individuals requiring them to terminate the
management actions or sanctions to duty only after the individuals were individual’s authorization. This was not
without confirmatory testing. Permitting determined to be fit to safely and the intent of the former provision. In
licensees and other entities to take competently perform their duties. The this instance, the intent of the rule was
actions on the basis of validity screening final rule retains the intent of the former for licensees and other entities to
or initial validity test results risks provision, but the terminology used in prevent the individual from performing
imposing substantial burdens on the section is consistent with the the duties that would require the
individuals from false positive, terminology used throughout the final individual to be subject to this part in
adulterated, substituted, or invalid test rule. The NRC has updated cross- order to ensure that any potential
results. Therefore, the NRC has added references to other sections of the rule, impairment could not result in errors or
this prohibition to meet Goal 7 of this consistent with Goal 6 of this lapses in judgment that may pose a risk
rulemaking to protect the privacy and rulemaking to improve clarity in the to public health and safety or the
other rights (including due process) of organization and language of the rule. In common defense and security until the
individuals who are subject to Part 26. addition, the agency has added several cause of the problem could be identified
With respect to the proposed rule, the new requirements. and resolved. Therefore, the final rule
final rule adds a provision that the The NRC has added § 26.77(a) to the replaces the phrase, ‘‘removed from
licensee or other entity may not subject final rule to introduce and describe the activities within the scope of this part,’’
an individual to administrative action purpose of the section, which is to with the phrase, ‘‘prevent the individual
based upon validity testing results prescribe the management actions that from performing the duties,’’ and makes
indicating that a specimen is of licensees and other entities must take other minor changes to the wording of
questionable validity. This change is when an individual shows indications the former requirement to clarify the
based on analysis of public comment, that he or she is not fit to safely and intent of the provision. The NRC has
which is discussed with respect to the competently perform their duties. The made these changes to meet Goal 6 of
term ‘‘questionable validity’’ in § 26.5 NRC has added this paragraph to meet this rulemaking to improve clarity in the
[Definitions]. Goal 6 of this rulemaking to improve language of the rule.
Section 26.75(i)(1) through (i)(4) clarity in the organization and language Section 26.77(b)(1) retains the intent
retains the requirements in former of the rule. of former § 26.24(a)(3). This provision
§ 26.24(d)(2)(i) through (iv) that Section 26.77(b) of the final rule requires licensees and other entities to
established the conditions under which retains the portion of former conduct drug and alcohol testing for
licensees and other entities may take § 26.27(b)(1) that required the licensee cause. The final rule requires for-cause
administrative actions on the basis of a or other entity to take immediate action testing based upon a ‘‘reasonable
positive initial drug test result for to prevent an individual from suspicion’’ that the individual may be
marijuana or cocaine metabolites from a performing the duties that require him impaired from possible substance abuse.
licensee testing facility. The final rule or her to be subject to this part if an Reasonable suspicion of substance
adds a requirement for specimen individual appears to be impaired, or abuse could be based upon an observed
behavior, such as unusual lack of the requisite training to evaluate discussed in detail below. However,
coordination or slurred speech, or a whether the observed behavior is caused other than the changes mentioned
physical condition, such as the smell of by fatigue. The NRC has made this above, the final rule adopts the
alcohol. If the only basis for a change to meet Goal 2 of this provisions of this subpart as proposed
reasonable suspicion is the smell of rulemaking to ensure against worker without change.
alcohol, then alcohol testing is required. fatigue at nuclear power plants and Goal
However, the final rule does not require 3 to improve the effectiveness and Section 26.81 Purpose and
the licensee or other entity to perform efficiency of FFD programs. Applicability
a drug test unless other physical or The NRC has added § 26.77(b)(3) to
This added section describes the
behavioral indicators of possible specify the actions that licensees and
purpose of Subpart E, which is to
impairment are present. other entities must take when there are
establish requirements for collecting
The stakeholder comments received indications that an individual may be
during the public meetings discussed in impaired, other than behavior or a specimens for drug and alcohol testing.
Section I.D reported that many of the for physical condition that creates a The new section assists in locating
cause tests they perform are initiated as reasonable suspicion of substance abuse provisions within the rule and is
a result of a security officer or other (or fatigue, in the case of licensees who consistent with Goal 6 of the rulemaking
person reporting that an individual are subject to Subpart I). Consistent with to improve clarity in the organization
smells of alcohol without behavioral former § 26.27(b)(1), the final rule and language of the rule.
indications of impairment. They also permits the licensee or other entity to The NRC revised the title of this
noted that the very large majority of the return the individual to duty only after section from ‘‘Purpose’’ in the proposed
for-cause drug tests that they conduct in identifying and resolving the cause of rule to ‘‘Purpose and applicability’’ in
these circumstances yields negative the impairing condition and making a the final rule to reflect other
results, including those instances in determination of fitness indicating that modifications to this paragraph that the
which the alcohol test results are the individual is fit to safely and agency has made in response to public
positive. The stakeholders suggested competently perform his or her duties comments that the applicability of the
that the former requirement to conduct (see the discussion of § 26.189 for more proposed rule’s requirements was
drug tests in these circumstances details regarding the determination of unclear. This paragraph specifies that
imposes a significant burden because fitness process). This section does not the requirements of Subpart E apply to
the drugs tests impose costs, not only require licensees and other entities to the licensees and other entities in
for collecting and testing the urine unfavorably terminate an individual’s § 26.3(a) through (d) to the extent that a
specimens, but also because they cannot authorization for illness, fatigue, C/V conducts drug and alcohol testing
permit the individual to resume temporary mental and emotional stress, on which a licensee or other entity in
performing his or her duties until the or other conditions that may affect an § 26.3(a) through (d) relies. The
drug test results are available, which individual’s fitness, but prohibits the provision further specifies the
may take several days. The stakeholders licensee or other entity from assigning applicability of Subpart E’s
argued that the burden is unnecessary the impaired individual to perform the requirements by also listing the
because the drug tests yield positive duties that require him or her to be categories of individuals who are
results so infrequently and, therefore, do subject to this subpart until a subject to the subpart. These include the
not serve their intended purpose of determination is made that the categories of individuals listed in
detecting drug abuse. Based on these individual is fit to return to duty. The § 26.4(a) through (e). In addition,
stakeholders’ arguments and the FFD NRC has made this change to meet Goal licensees and other entities may choose
program performance data that support 2 of this rulemaking to ensure against
to conduct specimen collections and
them, the NRC concurs that drug testing worker fatigue at nuclear power plants
alcohol testing under the requirements
is unnecessary when the smell of and Goal 3 to improve the effectiveness
of this subpart for the categories of
alcohol is the only indication that for and efficiency of FFD programs.
Section 26.77(c) of the final rule individuals specified in § 26.4(f) and (g).
cause testing is required, and has
updates former § 26.27(d) to be However, §§ 26.4(j), 26.31(b)(2), and
eliminated it from the final rule. The
final rule continues to require drug consistent with current NRC notification Subpart K [FFD Programs for
testing if there are behavioral or procedures. Construction] permit licensees and
physical indications of impairment in other entities to rely on specimen
Subpart E—Collecting Specimens for collections and alcohol testing that are
addition to the smell of alcohol. Testing
The NRC has added § 26.77(b)(2) to conducted under the requirements of 49
apply only to nuclear power plant Throughout Subpart E, the final rule CFR Part 40, ‘‘Procedures for
licensees and C/Vs who are subject to makes minor clarifications to the Transportation Workplace Drug Testing
Subpart I. With respect to the proposed proposed rule because of public Programs’’ (65 FR 41944; August 9,
rule, the final rule modifies the language comment, to accommodate conforming 2001), for the reasons discussed with
of this provision to improve its clarity changes, and to meet Goal 6 of this respect to those sections. In these
and to more clearly specify the NRC’s rulemaking to improve clarity in the instances, § 26.81 permits the specimen
intent. This section permits these organization and language of the rule. collections and alcohol testing to be
entities to forego drug and alcohol The final rule also makes more performed under DOT’s procedures,
testing and the determination of fitness substantive changes to the proposed rather than those contained in Subpart
process required by § 26.189 if a fatigue rule in this subpart because of public E, for individuals who are subject to
assessment conducted under § 26.211 comment or to improve clarity in the another Federal or State FFD program in
confirms that the individual’s observed organization and language of the rule. § 26.4(j), FFD program personnel in
behavior or physical condition is solely The substantive changes in this subpart § 26.31(b)(2), and the categories of
a result of fatigue. This section applies can be found in §§ 26.81; 26.85(c)(1), individuals identified in § 26.4(f). These
only to licensees and C/Vs who are (c)(2), and (e); 26.87(e); 26.89(a)(2) and changes meet Goal 6 of the rulemaking
subject to Subpart I because licensees (c); 26.91(e)(4); 26.109(b)(1); and to improve clarity in the organization
not subject to Subpart I would not have 26.111(a), (c) and (d). These changes are and language of the rule.
Section 26.83 Specimens To Be percent BAC due to alcohol metabolism will establish acceptable collection
Collected during the period of the delay. Some procedures and testing methods.
The NRC has added § 26.83, which licensees have been reluctant to apply However, HHS has not yet published
specifies the types of specimens that sanctions for a positive alcohol test final guidelines for collecting and
licensees and other entities must collect result in these instances even though testing these alternate specimens.
for initial and confirmatory drug and alcohol metabolism over time explains Therefore, it is necessary to add
alcohol testing. the lower test result from the blood § 26.83(b) to the final rule to clarify that
Section 26.83(a) requires licensees sample. Further, experience has shown the NRC intends to continue prohibiting
and other entities to collect either breath that few donors request testing of a the collection and drug testing of
or oral fluids (i.e., saliva) for initial blood sample. Data gathered from a specimens other than urine in this
alcohol tests. The final rule continues to sampling of representative FFD rulemaking except as permitted under
require collecting only breath specimens programs show that individuals § 26.31(d)(5) [Medical conditions]. The
for confirmatory alcohol testing. The requested an average of fewer than one reasons are as discussed with respect to
final rule permits the use of oral fluids blood test per program within the that section.
(i.e., saliva) for initial alcohol tests period reviewed (January–May 2002). Section 26.85 Collector Qualifications
because devices for testing oral fluids Additionally, the use of EBTs for and Responsibilities
for alcohol have matured sufficiently to confirmatory alcohol tests has
consistently withstood legal challenge. This added section replaces the
provide valid and reliable initial test collector qualifications and training
results. Circumstances may arise, such The added protection of donors’ rights
that the NRC envisioned when requirements specified in the definition
as collecting a specimen of oral fluids of ‘‘collection site person’’ in the former
from a donor who has impaired lung promulgating the provisions for
voluntary testing of blood specimens rule and in former Sections 1.2, 2.2(d),
functioning, in which the use of these and 2.4(b) in Appendix A to Part 26.
devices is more efficient than collecting has not been realized in practice. The
former requirement has also been costly This section retains the intent of the
breath specimens for both donors and former provisions, but the final rule
the FFD program. Therefore, the for licensees. Licensees must ensure that
an individual who is trained to draw groups the requirements together to
permission to collect oral fluids for improve organizational clarity. In
initial alcohol testing meets Goal 3 of blood is available to do so should a
donor request blood testing. Based on addition, the final rule amends the
this rulemaking to improve the former collector qualifications and
efficiency of FFD programs. information provided by stakeholders at
training requirements to increase the
Additionally, other Federally mandated the public meetings discussed in the
consistency of Part 26 with the
alcohol testing programs permit the use preamble to the proposed rule, the NRC
requirements of other Federal agencies
of these devices for initial alcohol determined that the costs associated
and incorporates the lessons learned
testing. Therefore, adding permission to with retaining this provision are not
from those programs as discussed with
collect oral fluids for initial alcohol justified because of the very few
respect to Goal 1 of this rulemaking.
testing to the final rule is consistent instances in which donors have Section 26.85(a) [Urine collector
with Goal 1 of the rulemaking to update requested blood alcohol testing. qualifications] provides more detailed
and enhance the consistency of Part 26 Therefore, the agency has deleted from requirements for urine collector
with advances in other relevant Federal the final rule references to collecting qualifications and training than are
rules and guidelines. and testing blood specimens for alcohol. contained in the former definition of
The final rule eliminates the use of Section 26.83(b) retains, but makes ‘‘collection site person’’ and former
blood as a specimen for alcohol testing explicit, the implied requirement in the Section 2.2(d) in Appendix A to Part 26.
at the donor’s discretion, which was first sentence of former § 26.24(b) (and The final rule requires urine collectors
permitted in former § 26.24(g) and other provisions that are interspersed to be knowledgeable of the requirements
Section 2.2(d)(4) in Appendix A to Part throughout the former rule) for licensees of this part, the FFD policy and
26. The final rule eliminates the former and other entities to collect only urine procedures of the licensees or other
provisions related to blood alcohol specimens for drug testing. When the entities for whom they perform
testing for several reasons. Since the former rule was promulgated, it was collections, and to keep current on any
former rule was first promulgated, unnecessary to establish an explicit changes to urine collection procedures.
licensees have repeatedly raised requirement to collect and test only These changes increase the consistency
questions related to the proper urine specimens for drugs in Part 26 of urine collector qualification
interpretation of a confirmatory alcohol programs because methods for testing requirements with those of other
test result using an evidential breath other specimens were not available and Federal workplace drug testing
testing device (EBT) and an alcohol test the HHS Guidelines only addressed programs as well as consistency in urine
result derived from a blood specimen testing urine specimens. Since that time, collection procedures among FFD
when the results from the two types of methods for testing alternate specimens, programs that are subject to this subpart.
testing differ. Specifically, if a such as oral fluids, sweat, and hair, have Section 26.85(a) retains the
confirmatory alcohol test result using an become commercially available and requirements in former Section 2.2(d)
EBT is positive, but the result from HHS has published proposed revisions that urine collectors must receive
testing a blood specimen is negative, to its guidelines (69 FR 19673; April 13, training to perform their duties and
licensees have asked which test result 2004) that would permit the use of demonstrate proficiency in applying the
they should rely on in determining alternate specimens for drug testing in requirements of this section before
whether the donor has violated the FFD Federal workplace drug testing serving as a collector. Section
policy. Although the NRC’s original programs. The NRC is considering 26.85(a)(1) through (a)(4) lists the topics
intent was that the result from the blood permitting the use of alternate that the final rule requires collector
test was to be definitive, delays in specimens for drug testing when HHS training to address. Section 26.85(a)(1)
obtaining a blood specimen sometimes has published final revisions to its requires collectors to be trained in the
resulted in blood test results that fell guidelines related to these types of steps that are necessary to complete a
below the alcohol cutoff level of 0.04 specimens. The revised HHS Guidelines collection correctly and the proper
completion and transmission of the requirements of this part and methods specified in § 26.85(c)(1) through (c)(5).
custody-and-control form to the licensee to address ‘‘problem’’ collections. These These conditions may include, but are
testing facility or HHS-certified include, but are not limited to, not limited to, the collection of
laboratory, as appropriate. Section collections involving ‘‘shy lung’’ specimens for post-event testing by a
26.85(a)(2) requires training in methods problems or attempts by a donor to nurse or medical technician at a
to address ‘‘problem’’ collections. These tamper with a specimen. In contrast to hospital. The final rule limits the
may include, but are not limited to, § 26.85(a)(2), which addresses ‘‘shy circumstances in which an untrained
collections involving ‘‘shy bladder’’ (see bladder’’ problems in urine collections, medical professional, technologist, or
the discussion of proposed § 26.119 the final rule does not incorporate the technician may perform collections for
[Determining ‘‘shy’’ bladder] for an related DOT procedures for evaluating a licensee or other entity because the
explanation of this term and the ‘‘shy lung’’ problems in alcohol experience of other Federal agencies has
procedures involved) and attempts by a collections. During the public meetings shown that medical personnel who are
donor to tamper with a specimen. discussed in the preamble to the untrained in specific collection
Section 26.85(a)(3) requires the training proposed rule, stakeholders requested procedures have committed errors in
to instruct collectors on correcting that the proposed rule incorporate collections that resulted in unnecessary
collection problems. These may include, DOT’s ‘‘shy bladder’’ procedures, but legal challenges to test results. At the
but are not limited to, a donor refusing did not believe that adding DOT’s ‘‘shy same time, the NRC is also aware that
to cooperate with the collection process lung’’ procedures to the final rule is licensees and other entities may
or an incident in which a urine necessary. The stakeholders reported occasionally have to rely on these
specimen is spilled. Section 26.85(a)(4) that donors have not experienced individuals to collect specimens for
requires training so that a collector is problems related to ‘‘shy lung,’’ based drug and alcohol testing, as discussed
knowledgeable in maintaining the on their experience implementing the with respect to § 26.4(i)(1). Therefore,
integrity of the specimen collection and breath testing requirements of Part 26 the final rule permits untrained medical
transfer process, and ensuring that since the rule was first promulgated. personnel to collect specimens to
donors’ privacy and modesty are Therefore, § 26.85(b)(3) requires alcohol facilitate the collection of specimens for
maintained. The NRC added these collectors to be able to implement the testing in rare circumstances in which a
requirements to meet Goal 1 of this ‘‘shy lung’’ procedures established by qualified collector could not reasonably
rulemaking to update and enhance the any FFD program for whom the be expected to be available, but
consistency of Part 26 with advances in collectors are providing collection otherwise requires medical personnel
other relevant Federal rules and services, but does not establish who do not meet the criteria specified
guidelines. requirements for responding to ‘‘shy in § 26.85(c)(1) through (c)(5) to receive
Section 26.85(a)(4) retains the portion lung’’ problems in the rule. the same training as non-medical
of former Section 2.2(d)(1) in Appendix The final rule adds § 26.85(b)(2) to collectors. The NRC made this change to
A to Part 26 that required collector require alcohol collectors to be trained meet Goal 3 of the rulemaking to
training to emphasize the collector’s in the operation of the particular alcohol improve the effectiveness and efficiency
responsibility for maintaining the testing device(s) (i.e., the ASDs and of FFD programs, by reducing the
integrity of the specimen collection and EBTs) to be used in conducting alcohol likelihood of errors and legal challenges
transfer process, carefully ensuring the tests, consistent with the most recent to test results. In addition, the final rule
modesty and privacy of the donor, and version of the manufacturers’ also makes minor changes to the
avoiding any conduct or remarks that instructions. The final rule adds this organization of this paragraph in
might be construed as accusatorial or requirement because the NRC is aware response to a public comment
otherwise offensive or inappropriate. that some FFD programs did not indicating a lack of clarity in the same
The NRC added § 26.85(b) [Alcohol implement device manufacturers’ provision in the proposed rule.
collector qualifications] to specify recommended changes to instructions The NRC has eliminated former
requirements related to alcohol collector for using the testing devices. Although Section 2.2(d)(4) in Appendix A to Part
qualifications and training. Portions of the NRC staff is not aware of any testing 26, which required that donors must be
this section are the same as the errors or instances in which donors informed of the option to request blood
requirements for urine collectors in have challenged the results of alcohol testing. The agency eliminated the
§ 26.85(a), including the first three tests that were not performed in former requirement because the final
sentences of § 26.85(b), and (b)(4) and accordance with the most recent version rule no longer permits donors to request
(b)(5). The agency added these of the device manufacturer’s blood testing for alcohol, as discussed
requirements here for the same reasons instructions, the final rule adds this with respect to § 26.83(a).
discussed with respect to the first three requirement to ensure that alcohol test Section 26.85(d) amends former
sentences of § 26.85(a), and (a)(3) and results continue to be accurate and Section 2.7(o)(5) [Personnel available to
(a)(4), respectively. The final rule cannot be challenged on this basis. The testify at proceedings] in Appendix A to
repeats the requirements that are changes are also consistent with the Part 26. This section required the
applicable to both urine and alcohol alcohol collector training requirements licensee testing facility and HHS-
collectors in each of these paragraphs of other Federal agencies. certified laboratory to make available
because some FFD programs may not Section 26.85(c) [Alternative qualified individuals to testify in
train collectors to perform both types of collectors] amends the last sentence of administrative or disciplinary
collections. Repeating the requirements former Section 2.2(d)(2) in Appendix A proceedings related to drug and alcohol
makes it easier to locate the to Part 26. The former provision test results. The final rule adds an
requirements that apply to urine or permitted medical personnel to perform explicit requirement for collection site
alcohol collectors and meets Goal 6 of specimen collections without receiving personnel to be available to testify at
the rulemaking to improve clarity in the the required training for non-medical proceedings because the former
organization of the rule. collectors. The final rule permits provision implied, but did not explicitly
Section 26.85(b)(1) and (b)(3) requires medical personnel to conduct specimen state this requirement. When the rule
alcohol collectors to receive training collections for the purposes of this was first published, licensee testing
that addresses the alcohol testing subpart only under the conditions facilities and collection sites were
typically co-located at a site. However, change to meet Goal 6 of this to conduct audits under § 26.41 [Audits
this is no longer the case. In some rulemaking to improve clarity in the and corrective action]. Adding this term
current FFD programs, alcohol testing language of the rule. This section retains to this paragraph increases the clarity of
and urine specimen collections occur at the permission in the former rule for its language, consistent with Goal 6 of
the collection site, but initial testing of licensees and other entities to use the rulemaking.
urine specimens is performed at a properly equipped mobile collection Section 26.87(d) revises former
licensee testing facility that may not be facilities. Section 2.4(c) in Appendix A to Part 26
co-located with the collection site. Section 26.87(b) revises the first to clarify requirements for assuring
Therefore, the NRC has added this sentence of former Section 2.4(f) in collection site security and the integrity
paragraph to retain the former rule’s Appendix A to Part 26 to require visual of specimen collection procedures. For
original intent that licensees and other privacy for donors while the donor and organizational clarity, the final rule
entities must make available collection collector are viewing the results of an groups requirements related to assuring
site personnel to testify, as needed, in alcohol test and retains the former the security of a licensee’s or other
administrative and/or legal proceedings requirement for individual privacy entity’s designated collection site in this
related to an alcohol or drug test result. during urine specimen collections, paragraph. For the same reason, the
For organizational clarity, the final rule except if the urine specimen collection final rule moves to § 26.87(f) the
moves the requirements in the former must be conducted under direct requirements contained in former
paragraph that addressed the observation. The new requirement for Section 2.4(c) in Appendix A to Part 26
availability of personnel to testify in visual privacy while viewing alcohol that address assuring collection security
proceedings related to drug test results test results increases the consistency of when a designated collection site is
from the licensee testing facility to Part 26 with the alcohol testing inaccessible and there is an immediate
§ 26.139(c) of Subpart F [Licensee procedures of other Federal agencies requirement to collect a urine specimen.
Testing Facilities] and those related to and assures greater privacy for donors Section 26.87(d) includes other
HHS-certified laboratories to who are subject to FFD programs that clarifying changes to former Section
§ 26.153(f)(2) of Subpart G [Laboratories did not provide visual privacy under the 2.4(c) in Appendix A to Part 26, in
Certified by the Department of Health former rule. The NRC made this change response to stakeholder requests at the
and Human Services]. to meet Goal 7 of this rulemaking to public meetings discussed in Section
The NRC added § 26.85(e) to the final protect the privacy of individuals who IV.D.
rule in response to a public comment are subject to Part 26. For organizational Section 26.87(d)(1) retains the first
noting that the proposed rule did not clarity, the final rule moves the former sentence of former Section 2.4(e) in
include a requirement for licensees and requirements in Section 2.4(f) in Appendix A to Part 26 and permits only
other entities to ensure that personnel Appendix A to Part 26 that are related authorized personnel to have access to
files are maintained for collectors. The to collecting a specimen under direct any part of a collection site in which
new paragraph establishes requirements observation to § 26.115 [Collecting a specimens are collected and stored. For
for personnel files for collectors to urine specimen under direct organizational clarity, the final rule
document their training and other observation]. moves this requirement to this section
qualifications for the positions they Section 26.87(c) retains only the because it addresses the topic of
hold. This documentation may be portion of former Section 2.7(m) in collection site security.
necessary in administrative and/or legal Appendix A to Part 26 that required Section 26.87(d)(2) amends the
proceedings related to an alcohol or licensees’ and other entities’ contracts second sentence of former Section 2.4(c)
drug test result. for collection site services to permit in Appendix A to Part 26. The former
unfettered NRC, licensee, and other provision required collection sites to be
Section 26.87 Collection Sites entity access to collection sites for secure, and the final rule adds examples
The NRC has reorganized unannounced inspections. The final of acceptable methods to assure
requirements related to specimen rule moves the portions of the former collection site security. The NRC added
collection sites in the former rule and section that apply to HHS-certified these examples in response to
grouped them together in this section. laboratories to § 26.153(f) of Subpart G stakeholder requests during the public
Requirements related to collection sites for organizational clarity. In addition, meetings discussed in the preamble to
were distributed among several different § 26.87(c) adds a requirement that the proposed rule. The stakeholders
sections in Appendix A to Part 26 of the licensees’ and other entities’ contracts noted that the requirement that
former rule. The agency made this for collection site services must permit collection sites ‘‘must be secure’’ has
change to improve organizational clarity unfettered NRC, licensee, and other raised many implementation questions.
in the rule. entity access to all information and Therefore, the final rule adds examples
Section 26.87(a) amends former documentation that is reasonably of acceptable means to ensure collection
Section 2.4(a) in Appendix A to Part 26. relevant to inspections and audits. The site security, including, but not limited
This former section required FFD final rule adds this requirement for to, physical measures to control access,
programs to designate collection sites access to documentation for consistency such as locked doors, alarms, or visual
and ensure that they are fully equipped with the HHS Guidelines, which also monitoring of the collection site when it
to collect specimens for testing. The require collection sites to provide is not occupied. The agency made this
final rule deletes references to blood information and documentation as part change to meet Goal 6 of this
specimens because the final rule no of inspections and audits. Therefore, rulemaking to improve clarity in the
longer provides donors with the option this change meets Goal 1 of this language of the rule.
to request blood testing for alcohol for rulemaking to update and enhance the Section 26.87(d)(3) amends the third
the reasons discussed with respect to consistency of Part 26 with advances in sentence in former Section 2.4(c) in
§ 26.83(a). The final rule adds a other relevant Federal rules and Appendix A to Part 26. The former
requirement for collection sites to be guidelines. The agency also added the provision required that the portion of
capable of alcohol testing that the term ‘‘audit’’ to this section because, any facility that is not dedicated solely
former section implied but did not although the NRC conducts inspections, to drug and alcohol testing must be
explicitly state. The agency made this licensees and other entities are required secured during testing. The final rule
retains that requirement and combines it subvert the testing process by unavailable, the rule permits another
with the third sentence of former adulterating a urine specimen with person of the same gender who is
Section 2.4(c)(1) in Appendix A to Part materials that are available at the instructed in the requirements of
26. The provision requires the collection site. This provision meets Subpart E [Collecting Specimens for
protection of the facility against Goal 3 of this rulemaking to improve the Testing] to assist in the collection. The
unauthorized access during the effectiveness of FFD programs. The provision requires either the collector or
collection. The final rule replaces the provision is also consistent with the the observer to remain outside the area
phrase, ‘‘in the case of a public related requirements of other Federal in which the donor will provide the
restroom,’’ in the last sentence of former agencies. urine specimen to protect the donor’s
Section 2.4(c)(1) in Appendix A to Part Section 26.87(f) reorganizes former privacy and the integrity of the
26, with the phrase, ‘‘if a collection site Section 2.4(c)(1), portions of Section collection process. The rule requires
cannot be dedicated solely to collecting 2.4(c)(2), and Section 2.4(g)(10) in documentation of the observer’s identity
specimens,’’ to clarify that a specimen Appendix A to Part 26 to prescribe on the custody-and-control form so that
may be collected at locations other than acceptable procedures for collecting the observer may be located should any
public restrooms. The NRC makes these specimens at locations other than a subsequent questions arise with respect
changes to meet Goal 6 of this designated collection site in unusual to the collection in a review under
rulemaking to improve clarity in the circumstances, such as a specimen § 26.39 [Review process for fitness-for-
organization and language of the rule. collection for post-event testing at a duty policy violations] or legal
The agency has added § 26.87(e) to hospital. The final rule groups these proceedings. The flexibility to rely on a
specify the steps that licensees and requirements together in a single person of the same gender as an
other entities must take to deter dilution paragraph and separates them from observer, if a collector of the same
and adulteration of specimens during those related to collecting specimens at gender is unavailable, is consistent with
urine collections. This section retains a designated collection site in § 26.87(d) the procedures of other Federal agencies
and amends portions of former Section and (e) to make it easier to locate these and reduces potential embarrassment to
2.4(g) in Appendix A to Part 26. requirements within the rule. The NRC the donor. Therefore, this change meets
Section 26.87(e)(1) relaxes the former made this change to improve Goal 1 of this rulemaking to update and
requirement in Section 2.4(g)(1) of organizational clarity in the rule. enhance the consistency of Part 26 with
Appendix A to Part 26 to use a bluing Section 26.87(f)(1) amends former advances in other relevant Federal rules
agent in any source of standing water, Section 2.4(c)(1) in Appendix A to Part and guidelines, and Goal 7 to protect the
such as a toilet bowl or tank. The final 26, which established requirements for privacy of individuals who are subject
rule permits licensees and other entities securing a location that is not a to Part 26.
to use colors other than blue. However, designated collection site but will be Section 26.87(f)(4) requires the
the final rule prohibits use of a yellow used for a specimen collection(s). The collector, once he or she is in possession
coloring agent because it precludes the final rule requires either an individual of the donor’s specimen, to inspect the
collector’s ability to determine whether to guard access to a public rest room area in which the specimen donation
a donor had diluted the specimen with while the collection is occurring or the occurred for any evidence of a
water from a source of standing water in posting of a sign to ensure that no subversion attempt by the donor. This
the stall or room in which the donor unauthorized personnel enter the area paragraph amends the fifth and sixth
provides a specimen. The relaxation during the collection. The former rule sentences of former Section 2.4(g)(10) in
does not affect the accuracy of drug tests required only the posting of a sign. Appendix A to Part 26 that described
but gives FFD programs increased However, stationing an individual to the required sequence of actions during
flexibility in the choice of coloring guard access is at least as effective. The a specimen collection and specified that
agents. The agency made this change in final rule permits an individual to guard a donor is permitted to flush the toilet
response to stakeholder requests during access to the collection area in response after a specimen donation. The final
the public meetings discussed in the to stakeholder requests for this rule eliminates the option for the donor
preamble to the proposed rule and to flexibility during the public meetings to flush the toilet and directs the
meet Goal 5 of this rulemaking to discussed in the preamble to the collector to instruct the donor not to
improve Part 26 by eliminating or proposed rule. This change meets Goal flush the toilet. The change reduces the
modifying unnecessary requirements. 5 of this rulemaking to improve Part 26 possibility that a donor could dispose of
Section 26.87(e)(2) retains the second by eliminating or modifying evidence of a subversion attempt by
sentence of former Section 2.4(g)(1) in unnecessary requirements. flushing it down the toilet. Section
Appendix A to Part 26, which requires Section 26.87(f)(2) retains the third 26.87(f)(4) directs the collector to
sources of standing water to be secured, sentence of former Section 2.4(g)(10) in inspect the toilet bowl and area once he
but shortens it without changing the Appendix A to Part 26 that requires or she receives the specimen from the
intended meaning of the requirement. using a water-coloring agent, if possible, donor. The final rule adds these
The agency made this change to to deter a possible dilution or provisions to reduce the opportunities
improve clarity in the language of the adulteration attempt when a collection for a donor to subvert the testing process
rule. must occur at a location other than the at a location that is not a designated
The final rule adds § 26.87(e)(3) to licensee’s or other entity’s designated collection site to meet Goal 3 of this
require that chemicals or products that collection site. rulemaking to improve the effectiveness
could be used to adulterate a urine Section 26.87(f)(3) retains the of FFD programs. The requirements also
specimen must be secured or removed requirement in the second sentence of meet Goal 1 to update and enhance the
from the collection site. The paragraph former Section 2.4(g)(10) that the consistency of Part 26 with advances in
also requires the collector to inspect the collector must be the same gender as the other relevant Federal rules and
enclosure to ensure that no potential donor in the exceptional event of a guidelines.

adulterants are available before the specimen collection occurring at a Section 26.87(f)(5) amends the
donor enters the stall or enclosure. The location other than the FFD program’s portions of former Section 2.4(c)(2) in
agency intends these requirements to designated collection site. However, if a Appendix A to Part 26 that defined
prevent possible donor attempts to collector of the same gender is requirements for maintaining control of
specimens that are not collected at a the former rule with respect to the collector to positively identify the donor
designated collection site. The final rule actions that the ‘‘appropriate authority’’ before beginning a collection. This
permits an ‘‘authorized individual,’’ must take in these circumstances has section specifies the types of photo
including, for example, a security officer led some FFD programs to interpret this identification that the licensee or other
or hospital medical technician, to provision as requiring the imposition of entity may accept to establish a donor’s
maintain physical custody and control the sanctions for a ‘‘refusal to test’’ on identity.
of specimens, rather than only the an individual who fails to appear, Section 26.89(b)(2) amends the
collector, as the former rule required. including situations in which there is portion of former Section 2.4(g)(2) in
The licensee or other entity must clear evidence that the individual had Appendix A to Part 26 that directed the
designate the ‘‘authorized individual’’ not been informed that he or she was collector to stop the collection if the
and ensure that he or she is instructed required to appear for testing or was individual cannot be positively
in his or her responsibilities for otherwise not at fault for the failure. identified. The amended provision
maintaining custody and control of the This was not the NRC’s intent. directs the collector to proceed with the
specimen. The authorized individual’s Therefore, under this new provision, collection and inform FFD program
custody of the specimen must be when informed that an individual who management that the donor did not
documented on the custody-and-control was selected for testing has not present acceptable photo identification.
form to ensure that the individual may appeared at the required time, FFD This paragraph requires FFD
be located should any subsequent program management must ensure that management to take the necessary steps
questions arise with respect to the the circumstances are investigated and to determine whether the lack of
collection in a review under § 26.39 or determine whether the individual’s identification is an attempt to subvert
legal proceedings. This change absence or tardiness represents an the testing process. However, the
continues to ensure specimen integrity attempt to avoid testing and, therefore, provision retains the former
and security, but responds to industry subvert the testing process. The final requirement for the collector to delay
experience, as described by stakeholders rule requires the licensee or other entity the collection until the individual can
at the public meetings discussed in the to impose the sanctions specified in be identified if it is a pre-access test.
preamble to the proposed rule. The § 26.75(b) for a refusal to test only if the The NRC has made these changes for
stakeholders reported that it is investigation identifies evidence that several reasons.
sometimes difficult in unusual the individual’s failure to appear for First, lessons learned from
circumstances, such as the hospital testing was a subversion attempt. If the implementing the former rule have
setting, for the collector to maintain investigation does not identify evidence indicated that the large majority of
physical custody of the specimen until of a subversion attempt, the final rule failures to present acceptable
it is prepared for transfer, storage, or prohibits the licensee or other entity identification result from
shipping. Therefore, the NRC made this from imposing sanctions and requires miscommunication or other errors that
change to meet Goal 5 of this testing the individual at the earliest are easily resolved. However, stopping
rulemaking, to improve Part 26 by reasonable and practical opportunity or delaying the specimen collection may
eliminating or modifying unnecessary after the individual is located. The NRC alter test results (e.g., if an individual
requirements, while also continuing to has added these more detailed has consumed alcohol, the individual’s
meet Goal 7 to protect the privacy and requirements to strengthen the rule’s alcohol test result would show a lower
other rights (including due process) of effectiveness in preventing subversion BAC after a delay or may not be
individuals who are subject to Part 26. by ensuring that a failure to appear for detected if testing is not conducted).
testing is investigated to increase the Therefore, collecting the specimens first
Section 26.89 Preparing To Collect and then resolving the individual’s
likelihood of detecting a willful attempt
Specimens for Testing identity ensures that test results are
to avoid testing. In addition, the
This added section describes the requirements prevent an individual available and accurate from donors who
preliminary steps that the collector and from being subject to a permanent are currently authorized and whose
donor must take before specimens will denial of authorization, as required identity the licensee or other entity has
be collected for drug and alcohol under § 26.75(b), if the individual’s previously confirmed. Therefore, this
testing. This section reorganizes and failure to appear is determined to be change meets Goal 3 of this rulemaking
amends portions of the former outside of the individual’s control or to improve the effectiveness and
Appendix A to Part 26, and adds several otherwise not a result of a willful efficiency of FFD programs.
new requirements. The final rule attempt to avoid testing. The agency has Second, the former requirement to
presents these requirements in a new made these changes to meet Goal 3 of stop the collection without investigating
section to facilitate locating them within this rulemaking to improve the the reasons that the individual is unable
the final rule to meet Goal 6 of this effectiveness of FFD programs, and Goal to present acceptable identification does
rulemaking to improve clarity in the 7 to protect the privacy and other rights not ensure that an attempt by an
organization of the rule. (including due process) of individuals individual to subvert the testing process
Section 26.89(a) provides more who are subject to Part 26. is detected. For example, an individual
detailed requirements than those Section 26.89(b) reorganizes and who has engaged in substance abuse
contained in former Section 2.4(g)(3) in expands former Section 2.4(g)(2) in could delay specimen collection by
Appendix A to Part 26 for actions to be Appendix A to Part 26, which required claiming to have ‘‘forgotten’’ his or her
taken if an individual does not appear the collector to ensure that an photo identification in his or her car or
for testing. The former rule required the individual who arrives at the collection locker. Permitting the individual to
collector to contact an ‘‘appropriate site for testing is positively identified. leave the collection site to obtain his or
authority’’ to determine the actions to The final rule adds more detailed her identification provides an
take if a donor does not appear for requirements for the reasons discussed opportunity for the individual to obtain
testing. At the public meetings with respect to each requirement. an adulterant or substitute urine that he
discussed in the preamble to the Section 26.89(b)(1) retains the or she could then use to subvert the
proposed rule, some stakeholders requirement in former Section 2.4(g)(2) testing process. Steps that FFD program
indicated that the lack of specificity in in Appendix A to Part 26 for the management could take to investigate
the reasons that the individual did not privacy requirements of the Americans which improves the effectiveness and
present acceptable identification in this with Disabilities Act [Pub. L. 101–336, efficiency of FFD programs, consistent
instance could include assigning a July 26, 1990], the final rule eliminates with Goal 3 of this rulemaking.
security officer to accompany the the requirement to list medications prior This section also requires the
individual to his or her car or locker to to specimen collection and testing. The collector to inform the donor that a
verify the individual’s claim, as well as final rule requires donors to provide failure to cooperate in the specimen
to ensure that the individual does not medication information to the MRO collection process is considered a
have the opportunity to bring an only in the event of positive, refusal to test and may result in a
adulterant or substitute urine back to adulterated, substituted, or invalid permanent denial of authorization
the collection site. Therefore, the new confirmatory validity and/or drug test under § 26.75(b). In response to public
requirement strengthens the result to enhance their rights to privacy comment, the final rule adds examples
effectiveness of FFD programs in under the rule. This revised requirement to those in the proposed rule describing
detecting attempts to subvert the testing is also consistent with the procedures of behavior that may be determined to be
process. other Federal agencies and meets Goal a refusal to test. In addition to leaving
The final rule modifies the proposed 1 of this rulemaking to update and the collection site before the collection
rule to permit an individual’s enhance the consistency of Part 26 with is complete, the final rule adds behaving
supervisor, except for pre-access tests, advances in other relevant Federal rules in a confrontational manner that
to positively identify an individual who and guidelines. disrupts the testing process; admitting
appears for testing without acceptable Section 26.89(b)(4) also adds a to the collector that the donor has
photo identification. The NRC made this requirement for the collector to explain substituted, diluted, or adulterated the
change in response to a public the testing procedure to the donor. specimen; or the collector finds that the
comment, which noted that under many Former Section 2.2(d)(3) in Appendix A donor has a device, such as a prosthetic
FFD programs, supervisors are trusted to to Part 26 required providing appliance, the purpose of which is to
notify donors that they have been individuals who are subject to testing interfere with providing an actual urine
selected for random testing, and, with standard written instructions specimen. Other examples could
therefore, it is reasonable to trust setting forth their responsibilities. include a donor refusing to permit the
supervisors also to verify a donor’s However, the NRC is aware that collector to examine the contents of the
identity. The change increases the individuals typically receive these donor’s pockets or the donor refusing to
consistency of Part 26 with access instructions as part of the training that wash his or her hands when directed by
authorization requirements established is required under former § 26.21 [Policy the collector. The final rule does not
in 10 CFR 73.56, as supplemented by communications and awareness provide an exhaustive list of behaviors
orders to nuclear power plant licensees training] rather than at the collection that comprise a refusal to test because
dated January 7, 2003 (Goal 4 of this site before starting the specimen they are too numerous to list. However,
rulemaking). collection process. This was not the the NRC has added these examples for
Section 26.89(b)(3) retains the former intent of Section 2.2(d)(3) in Appendix increased clarity in the rule. Informing
requirement to delay the specimen A to Part 26. Rather than retaining and donors of the potential consequences of
collection until the individual presents clarifying the former provision for failing to cooperate in the collection
acceptable identification if it is a pre- standard written instructions that some process, in advance, is consistent with
access test, at the request of individuals may have difficulty Goal 7 of this rulemaking to protect the
stakeholders during the public meetings comprehending, the final rule adopts privacy and other rights (including due
discussed in the preamble to the the related practices of other Federal process) of individuals who are subject
proposed rule. The stakeholders noted agencies, which require the collector to to Part 26. The requirements of this
that the former requirement to delay explain the testing procedure to the section also meet Goal 1 to improve the
pre-access testing until the individual donor. This change ensures that consistency of NRC requirements with
presents acceptable photo identification individuals are informed of the testing those of other Federal agencies.
does not present a risk to public health process in which they must participate Section 26.89(d) retains the last two
and safety or the common defense and and their responsibilities. It also meets sentences of former Section 2.4(e) in
security from a possible subversion Goal 7 of this rulemaking to protect the Appendix A to Part 26. These
attempt because the individual does not privacy and other rights (including due provisions require the collector to
yet have access to sensitive information, process) of individuals who are subject conduct only one urine specimen
radiological materials, or safety systems to Part 26, and Goal 1, by enhancing the collection at a time and define the point
and equipment. Furthermore, consistency of Part 26 with the at which the collection process ends,
stakeholders noted that retaining the requirements of other Federal agencies. which is when the donor has left the
former provision saves licensees and The NRC added § 26.89(c) to ensure collection site. The NRC has retained
other entities from the expense that the donor is aware of his or her these provisions in this paragraph
associated with collecting and testing a responsibilities to cooperate with the because they relate to the topic of this
specimen from the wrong individual. specimen collection process. This section, which is preparing for
Therefore, the NRC believes it is paragraph responds to reports from specimen collections, to ensure that
reasonable to retain the former stakeholders at the public meetings collectors are aware of this requirement
requirement as it relates to pre-access discussed in the preamble to the before they begin collecting any
tests. proposed rule that some donors have specimens. The change improves the
Section 26.89(b)(4) updates former attempted to obstruct or delay the organizational clarity of the rule.
Section 2.4(g)(4) and 2.4(g)(23)(ii) in collection process on the basis that the
Appendix A to Part 26, in which, before former rule implied, but did not Section 26.91 Acceptable Devices for
Conducting Initial and Confirmatory
any specimens are collected, donors explicitly state, the donor’s

were required to list the prescription responsibility to cooperate with the Tests for Alcohol and Methods of Use
and over-the-counter medications they collection process. Therefore, the new This added section amends
had used within the 30 days before provision eliminates that basis for requirements in the former rule that
testing. To be consistent with the obstructing or delaying collections, addressed alcohol testing devices and
methods of use. The requirements in the amendments) when conducting alcohol test results as well as permit the
former rule that are related to this topic confirmatory alcohol tests, and permits accurate identification of any test results
appeared in former § 26.24(g) and licensees and other entities to use these that may have been affected by
Sections 2.4(g)(18) and 2.7(o)(3)(ii) in EBTs for conducting initial alcohol instrument malfunctions that are
Appendix A to Part 26. This section tests. The EBTs that are listed without discovered later through additional
combines these requirements, amends an asterisk incorporate many quality assurance checks. The EBT
the former requirements, and adds improvements in EBT technology and capabilities listed in § 26.91(c)(4) and
others. The final rule groups these have been shown to accurately detect (c)(5) ensure that test results will be
requirements in one section to meet BACs at the 0.02 percent level. accurate by requiring collectors to verify
Goal 6 of this rulemaking to improve Therefore, they are the appropriate before each test that the instrument is
clarity in the organization of the rule. instruments to use for confirmatory functioning properly and there will be
The agency added § 26.91(a) testing at the revised alcohol cutoff no carryover effects from previous
[Acceptable alcohol screening devices] levels specified in § 26.103 testing. With respect to the proposed
to permit the use of alcohol screening [Determining a confirmed positive test rule, the final rule revises the language
devices (ASDs) for initial testing and result for alcohol]. of proposed § 26.91(c)(6) to clarify that
establish requirements for the ASDs that Further, because these EBTs have EBTs must have the capability to
may be used. Acceptable ASDs include been shown to provide valid, reliable, support a calibration check using an
alcohol saliva analysis devices and and legally defensible results in other external standard in response to public
breath testing devices that are listed on Federal programs that also require comments that the intended meaning of
the most recent version of NHTSA’s workplace alcohol testing, the new the proposed provision was unclear.
Conforming Products List (CPL) for requirement to use these EBTs permits
Commenters were unfamiliar with the
ASDs (66 FR 22639; May 4, 2001, and two additional changes to the alcohol
meaning of the term, ‘‘external
subsequent amendments). Former testing procedures contained in former
calibration check,’’ and stated that the
Section 2.7(o)(3)(ii) in Appendix A to Section 2.4(g)(18) in Appendix A to Part
proposed provision implied that the
Part 26 limited FFD programs to using 26: (1) Collecting only one breath
EBT itself must be capable of
only evidential-grade breath testing specimen for the initial alcohol test and
performing an external calibration check
devices. However, permitting FFD one for the confirmatory test in
to be acceptable for testing under this
programs to use ASDs listed on §§ 26.95(c) and 26.101(c), rather than
part. This was not the NRC’s intent. As
NHTSA’s CPL for initial alcohol testing the two specimens that were required
is consistent with other Federal for each test under the former rule; and discussed with respect to § 26.91(e)(1),
agencies’ procedures for workplace (2) conducting both the initial and EBT manufacturers must submit a
alcohol testing. Therefore, the change confirmatory tests (if a confirmatory test quality assurance plan to NHTSA that,
meets Goal 1 of this rulemaking to is required) using the same EBT in among other attributes, specifies the
update and enhance the consistency of § 26.101(d). As discussed further with minimum frequency with which the
Part 26 with advances in other relevant respect to §§ 26.95(c) and 26.101(c) and EBT must be subject to an external
Federal rules and guidelines. (d), these changes to the former alcohol calibration check. An external
Further, permitting the use of some testing requirements improve the calibration check simulates delivering a
ASDs for initial alcohol testing provides efficiency of alcohol testing while breath sample with a known alcohol
increased flexibility in conducting continuing to provide valid, reliable, concentration to the EBT to verify that
initial alcohol tests. Licensees and other and legally defensible results that are the EBT is reading within acceptable
entities may find that, over time, it is necessary to protect donor’s rights limits. The external standards used for
less expensive to use a particular ASD under workplace alcohol testing the calibration checks are typically
than to continue using EBTs for all programs. The use of these improved either wet bath (i.e., a solution of
initial alcohol tests. The option to use EBTs is similarly required for ethanol in water) or dry gas (i.e., a
alcohol saliva analysis devices also may confirmatory alcohol testing and mixture of pressurized gas, usually
reduce the burden of alcohol testing for permitted for initial testing under 49 ethanol in nitrogen) and are delivered to
some donors, such as individuals who CFR Part 40. Therefore, this change the EBT through a regulator or other
have impaired lung functioning. The meets Goal 1 of this rulemaking to device that simulates a human breath
final rule’s permission to use ASDs that update and enhance the consistency of exhalation. Calibrating devices may be
are listed on NHTSA’s CPL for ASDs for Part 26 with advances in other relevant included in an EBT ‘‘kit’’ or sold
initial alcohol testing meets Goal 5 of Federal rules and guidelines; Goal 3 to separately. Section 26.91(c)(6) of the
this rulemaking to improve Part 26 by improve the efficiency of FFD programs; final rule clarifies that EBTs used for
eliminating or modifying unnecessary and Goal 5 to improve Part 26 by confirmatory alcohol testing must be
requirements by increasing FFD eliminating or modifying unnecessary capable of being calibrated using
programs’ flexibility in administering requirements. external standards, rather than implying
initial alcohol tests. The NRC added § 26.91(c) [EBT that the EBTs must be self-calibrating
Section 26.91(b) [Acceptable capabilities] to specify the required with external standards. The
evidential breath testing devices] capabilities of the EBTs that licensees capabilities specified in § 26.91(c)(4)
amends former Section 2.7(o)(3)(ii) in and other entities may use for initial through (c)(6) improve the effectiveness
Appendix A to Part 26 and establishes alcohol testing and must use for and efficiency of confirmatory alcohol
new requirements for the EBTs that confirmatory alcohol tests. The EBT testing by limiting the need to cancel
licensees and other entities must use for capabilities listed in § 26.91(c)(1) test results due to instrument errors, as
confirmatory alcohol breath testing. The through (c)(3) are necessary to ensure required under § 26.91(e)(3). Using EBTs
new section requires licensees and other that a confirmatory alcohol test result that have the required capabilities for
entities to use EBTs that are listed on can be uniquely associated with the confirmatory alcohol tests protects
the most recent version of NHTSA’s CPL instrument used, the time of testing, and donors’ rights to accurate test results,
for evidential breath testing devices the donor. These capabilities are provides greater assurance that test
without an asterisk (67 FR 62091; necessary to establish an unimpeachable results will withstand any legal
October 3, 2002, and subsequent chain of custody for confirmatory challenges, and improves FFD
programs’ abilities to identify tests that assurance plan to ensure that the ASD perform calibration checks using
instrument errors may have affected. will not provide false negative test external standards at the manufacturer’s
Therefore, these requirements meet Goal results from improper storage or use. As recommended intervals, at a minimum.
3 of this rulemaking to improve the discussed with respect to § 26.91(d), the These calibration intervals take into
effectiveness and efficiency of FFD new provision is necessary to maintain account factors such as frequency of
programs. the effectiveness of FFD programs that use, environmental conditions (e.g.,
The NRC added § 26.91(d) [Quality rely on ASDs for initial alcohol testing. temperature, humidity, altitude), and
assurance and quality control of ASDs] The NRC added § 26.91(d)(2) to type of operation (e.g., stationary or
to establish quality assurance and prohibit licensees and other entities mobile). Therefore, this provision is
quality control requirements for ASDs. from using an ASD that fails the quality intended to ensure that the EBT will not
These requirements are necessary to control checks that are specified in the provide false test results from improper
ensure that initial tests that are most recent version of the storage or use.
conducted using an ASD do not yield manufacturer’s quality assurance plan Section 26.91(e)(2) adds a
false negative test results. If an ASD or that has passed its expiration date. requirement for licensees and other
provides a false negative test result, the This prohibition is necessary to ensure entities to use only calibration devices
test would not detect a donor who has that test results from using the ASD are appearing on NHTSA’s CPL for
an alcohol concentration that exceeds accurate both to protect public health ‘‘Calibrating Units for Breath Alcohol
the cutoff levels established in this part, and safety and donors’ rights to accurate Tests’’ when conducting external
and the donor may be permitted to test results under the rule. calibration checks. This requirement is
perform duties while impaired, The NRC added § 26.91(d)(3) to necessary to ensure that the calibrating
potentially creating an unacceptable risk require licensees and other entities to units used by licensees and other
to public health and safety or the follow the device use and care entities meet minimum standards and
common defense and security. The final requirements that are specified in provide accurate results.
rule continues to require confirmatory § 26.91(e) for any ASD that tests breath The final rule adds § 26.91(e)(3) to
testing if initial alcohol test results are specimens. The agency added this address circumstances in which an EBT
positive, so false positive test results requirement because some ASDs test fails an external calibration check. This
from an ASD lead to confirmatory specimens of oral fluids while others section requires the licensee or other
testing, which provides accurate test test breath specimens, and some ASDs entity to take the EBT out of service and
results. False positive test results from that test breath specimens also appear prohibits its use until it has been
initial testing reduce the efficiency of on NHTSA’s CPL for evidential breath repaired and passes an external
FFD programs and inconvenience testing devices (67 FR 62091: October 3, calibration check. An EBT that has
donors by causing them to be subject to 2002, and subsequent amendments). failed an external calibration check
unnecessary confirmatory testing, but Those ASDs that do test breath must be taken out of service to avoid
do not pose any risks to public health specimens and are used for inaccurate reporting of breath alcohol
and safety or the common defense and confirmatory testing have more detailed test results that could result either in the
security. However, confirmatory testing quality assurance and quality control imposition of sanctions on a donor who
is not required if the result of an initial provisions because their results must be has not abused alcohol or the failure to
alcohol test result is negative. Therefore, legally defensible. identify a donor who has.
the quality assurance and quality Section 26.91(e) [Quality assurance The NRC moved and amended the
control requirements contained in this and quality control of EBTs] establishes requirement in proposed § 26.91(e)(3) to
paragraph are necessary to maintain the new quality assurance and quality cancel any positive confirmatory
effectiveness of FFD programs, which is control requirements for EBTs. The new alcohol test results that were obtained
Goal 3 of this rulemaking. requirements are consistent with those from an EBT that fails an external
The agency added § 26.91(d)(1) to of other Federal agencies that require calibration check and also to cancel the
require FFD programs to implement the workplace alcohol testing and, results of any tests that were conducted
most recent version of the quality therefore, update and enhance the with that EBT subsequent to its last
assurance plan that a manufacturer has consistency of Part 26 with advances in successful external calibration check.
submitted to NHTSA for any ASD that other relevant Federal rules and The final rule retains this requirement
the licensee or other entity uses for guidelines. in § 26.91(e)(4)(i), but presents it as one
initial alcohol testing. To obtain NHTSA Section 26.91(e)(1) adds a of two options licensees and other
approval for an ASD, the manufacturer requirement that licensees and other entities must implement if an EBT fails
of the device must submit a quality entities must implement the most recent an external calibration check. The final
assurance plan that (1) specifies the version of the manufacturer’s rule adds a second option for handling
methods that must be used for quality instructions for the use and care of the circumstances in which an EBT fails an
control checks, (2) the temperatures at EBT consistent with the quality external calibration check in
which the ASD must be stored and assurance plan submitted to NHTSA for § 26.91(e)(4)(ii). This new section
used, (3) the shelf life of the device, (4) the EBT, including the required permits licensees and other entities to
environmental conditions (e.g., frequency for conducting calibration conduct an external calibration check of
temperature, altitude, humidity) that checks using external standards the EBT after each positive confirmatory
may affect the ASD’s performance, (5) (‘‘external calibration checks’’). An EBT alcohol test result. If the EBT fails the
instructions for its use and care, (6) the manufacturer is required to submit to check, the provision requires the
time period after specimen collection NHTSA a quality assurance plan that collector to cancel the donor’s test result
within which the device must be read, addresses methods used to perform and perform another initial and
where applicable, and (7) the manner in external calibration checks on the EBT, confirmatory alcohol test, if necessary,
which the reading is made. This the tolerances within which the EBT is using a different EBT. The requirements
paragraph requires licensees and other regarded as being in proper calibration, to cancel tests from an EBT that has
entities who intend to use an ASD to and the intervals at which these checks failed an external calibration check are
obtain and implement the most recent must be performed. The final rule necessary to protect donors’ right to
version of the manufacturer’s quality requires licensees and other entities to accurate testing under the rule because
positive test results from an EBT that subject to adverse consequences for a under the former rule and document
has failed an external calibration check false positive test result because the that the information is provided.
are questionable and donors should not malfunction will be detected before the Providing more detailed requirements
be subject to sanctions on the basis of licensee or other entity imposes any for the 15-minute waiting period
these test results. sanctions. The NRC has added this improves the effectiveness and
The NRC added § 26.91(e)(4)(ii) in provision to meet Goal 7 of the efficiency of the alcohol testing process
response to a public comment on rulemaking to protect donors’ privacy by reducing false positive test results
proposed § 26.91(e)(3). The commenter and other rights (including due process) that are due to residual mouth alcohol
stated that canceling donors’ positive under the rule. or other substances that could
confirmatory test results from an EBT The final rule renumbers as potentially trigger a false positive result.
that fails an external calibration check § 26.91(e)(5) the provision contained in Section 26.93(a)(1) retains the former
may not adequately protect donors’ § 26.91(e)(4) of the proposed rule. This requirement for the collector to ask the
rights under the rule, if a licensee or section requires an EBT manufacturer or donor about behaviors such as eating
other entity performs external a maintenance representative or other and drinking that may have occurred
calibration checks at the manufacturers’ individual who is certified by the within the 15 minutes before an alcohol
recommended intervals. The commenter manufacturer, a State health agency, or test and adds a requirement for the
noted that most EBT manufacturers’ other appropriate State agency to collector to advise the donor to avoid
recommended intervals for conducting inspect, maintain, and calibrate the these activities during the collection
external calibration checks are 1 month, EBT. This new provision ensures that process. Section 26.93(a)(2) permits
which could result in several canceled qualified personnel perform inspection, alcohol testing to proceed if the donor
tests, if an EBT has yielded false maintenance, and calibration of EBTs states that none of the activities listed in
positive test results that are only (1) to ensure that the EBTs used in Part § 26.93(a)(1) has occurred, while
discovered when the EBT fails the 26 programs continue to provide § 26.93(a)(3) retains the former
monthly check. However, if the licensee accurate test results, and (2) because the requirement for a 15-minute waiting
or other entity has already imposed experience of other Federal agencies period before a donor may be tested if
sanctions on a donor for a positive that require workplace alcohol testing he or she had engaged in the activities
confirmatory alcohol test result from the has demonstrated that such stringent listed in § 26.93(a)(1). Section
EBT, the donor will experience the EBT inspection, maintenance, and 26.93(a)(4) adds a requirement for the
adverse consequences of those calibration requirements are necessary collector to explain that it is to the
sanctions, which may include job loss, to withstand legal challenges to alcohol donor’s benefit to avoid the activities
before the licensee or other entity test results. The final rule adds ‘‘or other listed in § 26.93(a)(1) during the
identifies the instrument malfunction individual who is certified’’ to the collection process. Section 26.93(a)(5)
and cancels the donor’s confirmed proposed provision because some adds a requirement for the collector to
positive test result. licensees and other entities may choose explain to the donor that initial and
The NRC considered several options to obtain the required certification for confirmatory alcohol tests will be
to address this concern, including their FFD program personnel or other conducted at the end of the waiting
requiring more frequent external employees, and the NRC does not period regardless of whether the donor
calibration checks, but could not intend to prohibit this practice. has engaged in any of the activities
identify a technical basis for
Section 26.93 Preparing for Alcohol listed in § 26.93(a)(1). Section
establishing schedules that would be
Testing 26.93(a)(6) adds a requirement for the
more appropriate for every EBT on the
This added section expands on former collector to document that he or she has
NHTSA list than those recommended by
the EBT manufacturers. Further, the Section 2.4(g)(18) in Appendix A to Part communicated the instructions to the
agency recognizes that canceling tests 26, which specified procedures for donor. The additional requirements for
imposes a burden on licensees and other alcohol testing. The final rule provides the collector to communicate with the
entities as well as on donors and more detailed procedures than the donor about the potential effects on test
expects that licensees and other entities former paragraph to increase the results of the activities listed in
will likely choose to conduct external consistency of these procedures with § 26.93(a)(1) ensure that donors clearly
calibration checks more often than those of other Federal workplace understand the reasons for avoiding
recommended by the EBT alcohol testing programs as well as those activities and the potential
manufacturers to avoid canceling consistency among the alcohol testing consequences of engaging in them to
multiple tests. Therefore, the final rule procedures of Part 26 programs. The protect their rights to accurate test
retains the proposed requirement as an agency added more detailed results under the rule. The requirement
option in § 26.91(e)(4)(i), but adds a requirements for the reasons discussed for the collector to document that the
second option for handling in Section IV.B. instructions were communicated to the
circumstances in which an EBT fails an Section 26.93(a) contains more donor ensures that the collector does
external calibration check in detailed procedures for implementing not inadvertently omit the instructions
§ 26.91(e)(4)(ii). Under the latter the requirement in the first sentence of and, therefore, improves the legal
provision, it is unnecessary for a former Section 2.4(g)(18) in Appendix defensibility of the collection
licensee or other entity to cancel any A. That provision instructed collectors procedure, should a donor challenge it.
previous donors’ confirmed positive to delay alcohol breath testing for 15 The final rule adds § 26.93(b) to
alcohol test results from using the EBT minutes if the donor has engaged in any require collectors to minimize delays in
because the licensee or other entity will of the activities listed (e.g., smoking, administering for-cause drug and
perform the external calibration check regurgitation of stomach contents from alcohol tests and complete alcohol
after every positive confirmatory test vomiting). Section 26.93(a)(1) through testing before collecting a specimen for
result and no other donors will have (a)(6) requires the collector to provide drug testing. These requirements
been affected by false positive test the donor with more detailed decrease the likelihood that a donor’s
results from an EBT that fails the check. information about mouth alcohol and test results will fall below the program’s
Under this option, a donor will not be the testing process than was required cutoff levels as a result of metabolic
processes over time, which could of the test result. Delays in conducting intended to increase donor confidence
prevent the detection of proscribed the test increase the possibility that the in the integrity of the testing process by
alcohol consumption and drug use. donor may inadvertently engage in a ensuring that both the donor and the
Delays between the time at which a behavior that could result in the collector have access to the same
donor reports for testing and the time at presence of mouth alcohol as well as information about the donor’s test
which testing occurs continue to be permit the donor’s metabolism to lower result. The requirement is consistent
permitted for tests conducted under the alcohol concentration in the with Goal 7 of this rulemaking to protect
conditions other than for cause, specimen if the donor has consumed the privacy and other rights (including
because, in contrast to for-cause testing, alcohol. However, the stakeholders due process) of individuals who are
there is no reason to believe that an noted that when preparing for outages, subject to Part 26, by ensuring that
individual may have used drugs or in which it is sometimes necessary to donors are aware of the information
alcohol in violation of the FFD policy. test large numbers of individuals, used by the collector to determine
Therefore, there is no basis for a concern collectors often provide the instructions whether an alcohol test result is positive
that metabolic processes may cause in § 26.93 to groups of donors at the or negative.
inaccurate test results. The new same time and it is not feasible to test Section 26.95(b)(5) requires the
provision is consistent with the related each one immediately after providing collector to ensure that the test result
regulations of other Federal agencies. the instructions. Therefore, the final record can be associated with the donor
rule adds the phrase, ‘‘as soon as and is maintained securely, consistent
Section 26.95 Conducting an Initial with the many provisions throughout
reasonably practical,’’ to permit
Test for Alcohol Using a Breath the former and final rules that the chain
reasonable delays in testing associated
Specimen of custody must be maintained for
with outage planning.
Section 26.95 replaces portions of Section 26.95(b)(1) permits the donor specimens and the associated
former Section 2.4(g)(18) in Appendix A to select a mouthpiece to be used for his documentation of test results. Sections
to Part 26 that specified procedures for or her test, at the collector’s discretion. 26.129 [Assuring specimen security,
conducting an initial test for alcohol. The rule does not require the collector chain of custody, and preservation] and
Collectors follow the procedures in this to permit the donor to select the 26.159 [Assuring specimen security,
section when using ASDs that test mouthpiece. However, this practice may chain of custody, and preservation]
breath specimens and EBTs. The new increase the donor’s confidence in the establish similar requirements for urine
section increases the consistency of Part integrity of the testing process by specimens at licensee testing facilities
26 with the procedures of other Federal assuring the donor that the selection of and HHS-certified laboratories,
agencies for workplace alcohol testing. the mouthpiece is random if he or she respectively.
Consistent with other agencies’ is concerned that a collector may The NRC has added § 26.95(c) to
procedures, the final rule eliminates the attempt to subvert the testing process by require the collection of only one breath
requirement in former Section 2.4(g)(18) selecting a mouthpiece that had been specimen for the initial test unless
in Appendix A to Part 26 for collecting contaminated with alcohol or other problems in the collection require
a second breath specimen for the initial means of tampering with the testing repetition of the collection. Problems in
alcohol test. The experience of other device. The NRC is not aware of any the collection may include, but are not
Federal agencies indicates that the instances in Part 26 programs in which limited to, device malfunctions or a
former Part 26 requirement for two a donor has accused a collector of donor’s inability to provide an adequate
breath specimens is unnecessary to altering an alcohol testing device. breath specimen on the first try. If a
obtain a valid, reliable, and legally However, the experience of other repeat collection is required, the
defensible test result if the procedures Federal agencies who similarly require collector must rely on the result from
specified in the new section are workplace alcohol testing indicates that the first successful collection in
followed. Therefore, the final rule taking steps to reduce potential donor determining the need for confirmatory
amends the former procedures to reduce concerns about the integrity of the alcohol testing. If the procedures
the burden on FFD programs and donors testing process increases donors’ specified in this paragraph are followed,
that is associated with collecting two willingness to participate in the testing relying on one breath specimen for the
breath specimens for the initial alcohol procedures and reduces the potential for initial test, rather than the two required
test, while continuing to ensure that legal challenges. in the former rule, increases the
breath alcohol testing provides accurate In § 26.95(b)(2), the NRC has added a consistency of Part 26 collection
results. requirement for the collector to open the procedures with those of other Federal
The agency added § 26.95(a) to mouthpiece packaging and insert it into agencies, in accordance with Goal 1 of
require the collector to start breath the device in view of the donor for the this rulemaking. The new requirement
testing as soon as reasonably practical same reason described with respect to also reduces the time required for breath
after the donor indicates that he or she § 26.95(b)(1). specimen collections without
has not engaged in any activities that Section 26.95(b)(3) requires the donor compromising the accuracy, validity, or
may result in the presence of mouth to blow into the mouthpiece for at least reliability of the test results. Therefore,
alcohol or after the 15-minute waiting 6 seconds in order to obtain an adequate the provision also meets Goal 3 to
period, if required. The final rule adds breath sample. The NRC deleted the improve the efficiency of FFD programs.
the phrase, ‘‘as soon as reasonably requirement to obtain the specimen
practical,’’ to this paragraph in response from the end of the breath exhalation in Section 26.97 Conducting an Initial
to stakeholder comments at the public former Section 2.4(g)(18) in Appendix A Test for Alcohol Using a Specimen of
meetings discussed in the preamble to to Part 26 because it is unnecessary, Oral Fluids
the proposed rule. The intent of the based on improvements to breath-testing The NRC added this section to
provision is for the collector to conduct technology. establish requirements for conducting
the initial alcohol test as soon as the Section 26.95(b)(4) requires the initial alcohol tests using an ASD for
individual has received the instructions collector to show the test result to the testing oral fluids specimens. The final
specified in § 26.93 [Preparing for donor. This requirement is consistent rule permits licensees and other entities
alcohol testing] to ensure the accuracy with current industry practices and is to rely on ASDs that test oral fluids for
the reasons discussed with respect to control if the first attempt fails. The test result. This paragraph also requires
§ 26.83(a). The procedures for final rule requires the second device to the collector to record the test result and
conducting alcohol testing of oral fluids have been under the collector’s control document that an ASD was used to
with an ASD incorporate the related to ensure that the donor or another ensure that the information is available,
requirements from 49 CFR Part 40 and individual has no opportunity to should any questions arise with respect
have been added to the final rule to substitute the new device with another to the collection procedure in a review
ensure that initial alcohol tests of oral that has been altered to provide a false conducted under § 26.39 or legal
fluids provide accurate and legally negative test result. This provision is proceedings.
defensible test results. necessary to protect the integrity of the To protect collectors and donors from
The agency has added § 26.97(a) to collection process. any possible biohazards, the final rule
specify the procedures that the collector Section 26.97(b)(2) requires the adds § 26.97(e) to prohibit the reuse of
must follow in using an ASD for testing collector to record the reason for the any devices, swabs, gloves, and other
oral fluids. new test. This requirement ensures that materials used in collecting oral fluids.
Section 26.97(a)(1) requires the the information is available, should any
collector to check the expiration date on Section 26.99 Determining the Need
questions arise with respect to the
the device and show it to the donor. for a Confirmatory Test for Alcohol
collection procedure in a review
Because some devices degrade during conducted under § 26.39 or legal Section 26.99 amends the
storage, this step is necessary to assure proceedings. requirements in former § 26.24(g) and
both the donor and the collector that the Section 26.97(b)(3) requires the the portion of Section 2.7(e)(1) in
device can be expected to function collector to offer the donor the choice of Appendix A to Part 26 that addressed
properly. using the device or having the collector cutoff levels for alcohol testing. The
Section 26.97(a)(2) requires the use it, unless the collector concludes final rule amends the former
collector to open an individually that the donor was responsible for the requirements for consistency with a new
wrapped or sealed package containing new test needing to be conducted. The approach to determining positive
the device in the presence of the donor final rule requires the collector to offer alcohol test results in § 26.103. The NRC
for the reasons discussed with respect to the donor the choice of using the device adopted the new approach because
§ 26.95(b)(1). for the reasons discussed with respect to some licensees have not taken
Section 26.97(a)(3) requires the § 26.95(b)(1). The requirement for the appropriate action when a donor has
collector to offer the donor a choice of collector to use the device if he or she obtained alcohol test results just below
using the device or having the collector concludes that the donor was the 0.04 percent BAC cutoff level after
use it. If the donor chooses to use the responsible for the second test needing the donor has been at work for several
device, the collector must provide to be conducted enhances the efficiency hours. A BAC below 0.04 percent after
instructions for its proper use. The final of the collection procedure by ensuring the donor has been at work for several
rule requires the collector to offer the that the second collection is conducted hours allows very little doubt that the
donor the choice of using the device to properly. donor has had an unacceptably high
increase the donor’s confidence in the Section 26.97(b)(4) requires the BAC, and has probably been impaired,
integrity of the testing process, as collector to repeat the collection at some time during the work period.
discussed with respect to § 26.95(b)(1). procedures outlined in § 26.97(a) for the Therefore, the final rule establishes new
Section 26.97(a)(4) requires the second collection. cutoff levels for alcohol testing in
collector to gather oral fluids in the If the second collection attempt fails, §§ 26.99 and 26.103 that take into
proper manner if the donor chooses not § 26.97(c) directs the collector to use an account the average rate at which
to use the device, or in cases in which EBT to perform the initial alcohol test individuals metabolize alcohol over
a second test is necessary because the instead. The final rule requires the time. In § 26.99(a), the agency decreased
device failed to activate. In addition, the collector to use an EBT to perform the the cutoff level for the initial alcohol
collector is required to wear single-use initial test after two failed attempts at test result from 0.04 to 0.02 percent BAC
examination or similar gloves while testing oral fluids specimens to ensure and requires a confirmatory alcohol test
doing so and change them following that a valid test result is obtained to if a donor’s initial test result is 0.02
each test. Section 26.97(a)(5) requires enhance the efficiency of the collection percent BAC or higher. In addition,
the collector to follow the procedure by changing the method used § 26.99(b) requires the collector to
manufacturer’s instructions to ensure to conduct the test. record the time at which the initial
that the device has activated. The NRC If the specimen collection using the alcohol test result is obtained, so that
has added the requirements in these ASD for testing oral fluids is successful, the length of time during which the
sections to ensure that the collection is § 26.97(d) instructs the collector to donor has been in a work status can be
properly conducted. The requirement to follow the device manufacturer’s calculated to determine whether a
use single-use examination gloves instructions for reading the result and confirmatory test result is positive, in
ensures that the collector and donor are show the result to the donor. The final accordance with § 26.103. These
protected from possible infection from rule prohibits the collector from reading changes to the initial alcohol test cutoff
exposure to body fluids. the result sooner than instructed by the level and testing procedure are
The NRC added § 26.97(b) to specify device manufacturer because some necessary to support the provisions of
the procedures that the collector must devices require several minutes after § 26.103, which require the collector to
follow if the first attempt to conduct the specimen collection to provide an declare an alcohol test as positive if the
test using the ASD fails for any reason, accurate result, but no more than 15 donor’s confirmatory test result is 0.03
including, but not limited to, the ASD minutes in all cases. The requirement percent or higher after the donor has
failing to activate or because the device for the collector to show the test result been on duty for 1 hour, or 0.02 percent
is dropped on the floor. to the donor is intended to increase or higher after the donor has been on
Section 26.97(b)(1) requires the donor confidence in the integrity of the duty for 2 hours. The revised lower
collector to discard the device and testing process by ensuring that both the cutoff level for the initial test of 0.02
conduct another test using a new device donor and the collector have access to percent BAC permits licensees and
that has been under the collector’s the same information about the donor’s other entities to identify donors who
have had a BAC of 0.04 percent or Section 26.101(b)(3) requires the confirmatory alcohol test than used for
higher while in a work status, and to collector to take the EBT out of service initial alcohol testing. The final rule
initiate confirmatory testing for those if a second air blank test reading is permits the use of the same EBT for both
individuals. above 0.00. This step is necessary initial and confirmatory alcohol testing,
because a reading above 0.00 on an air instead of requiring the use of two
Section 26.101 Conducting a blank test indicates that the EBT is not different EBTs. The licensee or other
Confirmatory Test for Alcohol functioning properly and may provide entity must obtain one breath specimen
The NRC added this section to inaccurate test results. for initial alcohol testing and one for
provide detailed procedures for The NRC has added § 26.101(b)(4) confirmatory testing, if necessary, but is
conducting confirmatory breath alcohol through (b)(7) to specify requirements permitted to conduct both tests using
tests. These procedures incorporate the for handling the EBT’s mouthpiece; the same EBT. The NRC has made this
related requirements from 49 CFR Part reading the test number displayed on change because improvements in EBT
40, which the NRC has added to the the EBT; blowing into the EBT; and technology assure that valid and reliable
final rule to ensure that confirmatory showing, recording, and documenting test results may be obtained from a
breath alcohol tests provide accurate the result displayed on the EBT, single EBT if the specimen collection
and legally defensible test results when respectively. The need for these steps is and quality assurance procedures in this
using the EBTs that are required in the same as for those discussed with part are followed. Reducing the number
§ 26.91(b) [Acceptable evidential breath respect to the related steps in § 26.95 of breath specimens required for alcohol
testing devices] and relying on one [Conducting an initial test for alcohol testing not only reduces the costs
breath specimen for confirmatory using a breath specimen]. However, the associated with alcohol testing, but also
testing, as is required in § 26.91(c). final rule does not permit the donor to reduces the burden on donors that the
Section 26.101(a) requires licensees insert the mouthpiece into the EBT for collection process imposes. Use of the
and other entities to conduct the the confirmatory test because it is same EBT for initial and confirmatory
confirmatory test as soon as possible necessary to ensure that the testing is consistent with the procedures
following the initial alcohol test, and in confirmatory test is conducted strictly of other Federal agencies for workplace
all cases, no later than 30 minutes after in accordance with the proper alcohol testing.
the initial test. The final rule adds this procedures to produce a result that
meets evidential standards. Meeting Section 26.103 Determining a
requirement to reduce the possibility Confirmed Positive Test Result for
that alcohol metabolism will cause a evidential standards is necessary if any
questions arise with respect to the Alcohol
confirmatory test to provide a result
collection procedure in a review Section 26.103 amends the cutoff
falling below the applicable cutoff level.
conducted under § 26.39 or legal level for determining whether a
Former Section 2.4(g)(18) in Appendix confirmatory alcohol test result is
proceedings.
A to Part 26 did not require conducting positive, as specified in former
Section 26.101(c) requires that only
a confirmatory test as soon as possible § 26.24(g) and Section 2.7(f)(2) in
one breath specimen must be collected
after obtaining a positive initial alcohol for the confirmatory alcohol test, unless Appendix A to Part 26. This section
test result, although licensees follow problems in the collection require that establishes new cutoff levels that take
this practice. However, the agency had the collection be repeated. If a repeat into account the length of time the
added a 30-minute limit because some collection is required, the collector must donor has been in a work status for the
FFD program personnel may be tested rely on the result from the first reasons discussed with respect to
under DOT procedures, as permitted in successful collection in determining the § 26.99 [Determining the need for a
§ 26.31(b)(2), and an EBT that is suitable confirmatory test result. As discussed confirmatory test for alcohol]. Section
for confirmatory testing may not be under § 26.95(c), if the specified 26.103(a)(1) retains the 0.04 percent
immediately available at the collection procedures are followed, relying on one BAC in former § 26.24(g) and Section
site, such that transport to another breath specimen for the initial test 2.7(f)(2) in Appendix A to Part 26 as the
collection site is required. The 30- rather than the two required in the cutoff level for a confirmed positive
minute interim period is unnecessary at former rule increases the consistency of alcohol test result at any time regardless
licensees’ and other entities’ collection Part 26 collection procedures with those of the length of time the donor has been
sites because licensees’ and other of other Federal agencies. This also in a work status. Sections 26.103(a)(2)
entities’ collection sites must have the reduces the time required for breath and (a)(3) establish new cutoff levels for
capability to conduct confirmatory tests specimen collections without positive alcohol test results that are
with an EBT, as required under compromising the accuracy, validity, or above the 0.02 percent BAC cutoff level
§ 26.87(a). Therefore, except in these reliability of the test results. This on the initial test and do not meet or
unusual circumstances, licensees and section also prohibits licensees and exceed the 0.04 percent BAC cutoff level
other entities are expected to continue other entities from combining or on confirmatory testing but indicate that
their current practice of conducting the averaging results from more than one the donor had a BAC of 0.04 percent or
confirmatory test immediately after a test in order to arrive at the greater while in a work status or
donor’s initial test result is determined confirmatory test result. These consumed alcohol while on duty. The
to be positive. calculations, required by former Section cutoff levels and time periods in
The NRC added § 26.101(b) to specify 2.4(g)(18) in Appendix A to Part 26, are § 26.103(a)(2) and (a)(3) are based on the
procedures for conducting a no longer necessary because of the average rate at which normal metabolic
confirmatory alcohol test. mandatory use of the EBTs specified in processes reduce an individual’s BAC
Sections 26.101(b)(1) and (b)(2) § 26.91(b). The change meets Goal 3 of over time, which is about 0.01 percent
require the collector to conduct an air this rulemaking to improve the BAC per hour. Therefore, a donor whose
blank before beginning the confirmatory efficiency of FFD programs. BAC is measured as 0.03 percent after
test and verify that the air blank reading Section 26.101(d) amends the portion the donor has been in a work status for
is 0.00. These steps are necessary to of former Section 2.4(g)(18) in Appendix 1 hour would have had a BAC of
ensure that the EBT is functioning A of Part 26 that required using a approximately 0.04 percent when he or
properly before the test begins. different EBT to conduct the she reported for work an hour ago.
Through the same metabolic processes, specimen for drug testing. For testing, then the collector must secure
a donor whose BAC is measured as 0.02 organizational clarity, this section the item and continue with the
percent after he or she has been in a reorganizes the requirements in former collection. The agency added these
work status for 2 hours would also have Section 2.4(g)(5) through (g)(7) in requirements to meet Goal 1 of this
had a BAC of approximately 0.04 Appendix A to Part 26 by separating rulemaking to update and enhance the
percent when he or she reported for alcohol and urine specimen collection consistency of Part 26 with advances in
work 2 hours ago. These changes procedures into separate sections of the other relevant Federal rules and
improve the effectiveness of FFD final rule. The section also establishes guidelines, as well as Goal 3 to improve
programs by ensuring that confirmatory several new requirements that the the effectiveness of FFD programs, by
alcohol testing identifies donors who agency has added to meet Goal 1 of this improving the ability of the collector to
have been impaired from alcohol use rulemaking to update and enhance the identify attempts to subvert the drug
while on duty and, therefore, may have consistency of Part 26 with advances in testing process. Adding the requirement
posed a risk to public health and safety. other relevant Federal rules and for the donor to permit the collector to
The NRC added § 26.103(b) to guidelines. make this examination ensures that
strengthen FFD programs by requiring Section 26.105(a) revises former donors understand that they must
licensees and other entities to address Section 2.4(g)(5) in Appendix A to Part cooperate with the examination.
circumstances in which a donor’s 26. The final rule retains the former Section 26.105(c) retains former
confirmatory alcohol test result is requirement for the donor to remove any Section 2.4(g)(6) in Appendix A to Part
greater than 0.01 percent BAC when the unnecessary outer garments and 26, which required the individual to be
individual has been in a work status for belongings that might conceal items or instructed to wash his or her hands
3 hours or more, but his or her BAC falls substances that could be used to tamper prior to urination. The final rule makes
below the cutoff levels in § 26.103(a). with a urine, breath, or blood specimen. two minor editorial changes to the
The final rule requires the collector to However, the final rule eliminates the former provision for clarity in the
declare the test as negative because references to blood and breath language of the final rule. The final rule
NHTSA has not thoroughly evaluated specimens in the former paragraph clarifies that the collector is to instruct
some of the EBTs that licensees and because the final rule no longer permits the donor to wash and dry his or her
other entities are permitted to use for donors to request blood testing for hands and replaces the term
confirmatory alcohol testing under the alcohol. This paragraph also eliminates ‘‘individual’’ with the term ‘‘donor.’’
final rule for accurately estimating BAC reference to breath specimens because Section 26.105(d) retains former
levels below 0.02 percent. However, if the final rule presents requirements Section 2.4(g)(7) in Appendix A to Part
an individual has an alcohol test result related to preparing for alcohol testing 26 and requires the donor to remain in
above 0.01 percent BAC and has been in in a separate section (§ 26.93) for the presence of the collection site
a work status for 3 hours or more, the organizational clarity. person and not to have access to any
test result provides a reason to believe The NRC added § 26.105(b) to require source of water or other materials that
that the individual has been impaired the donor to empty his or her pockets could be used to tamper with the
while on duty. Therefore, the provision and display the items contained in specimen. The final rule makes two
requires the licensee or other entity, them. The new requirement for the minor editorial changes to the former
after testing, to ensure that the donor’s collector to examine the articles in the provision for clarity in the language of
alcohol use is evaluated, a donor’s pockets increases the likelihood the rule. The final rule replaces the term
determination of fitness is performed, of detecting items (e.g., a vial of ‘‘collection site person’’ with the
and the determination of fitness powdered urine, bleach, a portable simpler term ‘‘collector’’ and the term
indicates that the donor is fit to safely heating unit, a false penis or any other ‘‘individual’’ with the term ‘‘donor.’’
and competently perform his or her tube or device that may be used to The NRC added § 26.105(e) to permit
duties before the individual is permitted replicate the function of urinary the donor, at the collector’s discretion,
to perform the duties that require him excretion) that could be used to to select the specimen collection
or her to be subject to this part. This adulterate or substitute the specimen in container that he or she will use.
change strengthens the effectiveness of a subversion attempt. The rule requires Permitting the donor to select the
FFD programs by ensuring that the the collector to use his or her judgment collection kit is not required. However,
alcohol use of individuals who may in determining whether an item found this practice may increase the donor’s
have been impaired when reporting for in the donor’s pockets indicates a clear confidence in the integrity of the testing
duty is assessed to determine whether intent to attempt to subvert the testing process by assuring the donor that the
such individuals’ alcohol use is process. For example, whereas a selection of the collection kit is random
problematic and may pose a future risk container of urine found in a donor’s if he or she is concerned that a collector
to public health and safety and the pocket would be clear evidence of an may attempt to subvert the testing
common defense and security. intent to subvert the testing process, a process by selecting a kit that had been
The NRC has deleted former Section container of eye drops, which could be contaminated with a substance that
2.4(g)(19) in Appendix A to Part 26, used to adulterate the specimen, would, would produce a positive, adulterated,
which established requirements for in most cases, be unlikely to indicate an substituted, or invalid test result in
collecting a blood specimen for alcohol intent to subvert the testing process. order to entrap the donor. The
testing, in its entirety because the final Should the collector identify an item importance of providing assurance to
rule no longer permits blood testing for that indicates a possible intent to the donor regarding the integrity of the
alcohol, at the donor’s discretion, for the subvert the testing process, this section collection process is discussed with
reasons discussed with respect to requires him or her to contact the FFD respect to § 26.95(b)(1). This paragraph
§ 26.83(a). program manager or MRO in order to also prohibits the donor from taking
obtain direction regarding the need for collection kit materials (such as the
Section 26.105 Preparing for Urine a directly observed collection. If the specimen label) other than the
Collection collector identifies an item that could be collection container, into the private
This section is added to describe the used to tamper with the specimen, but area used for urination. This prohibition
preliminary steps for collecting a urine does not indicate an intent to subvert ensures that a donor could not tamper
with the other collection kit materials specimen temperature range specified in the procedures implemented by other
and thereby disrupt the chain of custody § 26.111(b). Federal agencies in accordance with
for the urine specimen. Section 26.107(a)(1) further amends Goal 1 of this rulemaking.
This section is consistent with the former Section 2.4(g)(8) in Appendix A Section 26.107(b) amends former
related requirements of other Federal to Part 26. The former provision stated Section 2.4(g)(9) in Appendix A to Part
agencies and so meets Goal 1 of this that the individual may provide his or 26. The former provision required the
rulemaking to update and enhance the her urine specimen in the privacy of a collector to note any unusual behavior
consistency of Part 26 with advances in stall or otherwise partitioned area that or appearance in the permanent record
other relevant Federal rules and protects individual privacy. For clarity, book and on the custody-and-control
guidelines, as well as Goal 3 to improve this paragraph replaces ‘‘may’’ in the form. This section clarifies the intent of
the effectiveness of FFD programs, by former rule with ‘‘shall’’ to indicate that the former requirement, which raised
improving the ability of the collector to the area in which the donor will urinate implementation questions from
identify attempts to subvert the drug must provide for individual privacy. licensees, by specifying that the
testing process. The final rule adds the The final rule also adds an exception to collector must pay careful attention to
new provision requiring the donor to the former requirement for privacy in the donor during the collection process
permit the collector to make this the case of a directly observed so that the collector can note any
examination in response to stakeholder collection. The agency made this change conduct that may indicate an attempt to
requests at the public meetings for greater accuracy in the rule language substitute or tamper with the specimen.
discussed in the preamble to the because the requirement for individual This section also provides examples of
proposed rule to ensure that donors privacy does not apply in the case of a the types of behavior that may indicate
understand that they must cooperate directly observed collection, as a subversion attempt and requires the
with the examination. discussed with respect to § 26.115. collector to contact FFD program
The NRC added § 26.107(a)(2) to management if he or she observes such
Section 26.107 Collecting a Urine further emphasize the requirement in behavior. This section requires FFD
Specimen former Section 2.4(g)(8) in Appendix A program management to determine
to Part 26 that donors must be afforded whether a directly observed collection is
Section 26.107 amends former Section
individual privacy when providing a necessary under § 26.115.
2.4(g)(8), (g)(9), and (g)(12) in Appendix
urine specimen. The new paragraph The NRC added § 26.107(c) to specify
A to Part 26 to update the rule’s urine
requires that, unless the specimen is to the actions to be taken by the collector
specimen collection procedures and
be collected under direct observation, and donor to complete the specimen
incorporate advances in other relevant
no one other than the donor may go into collection procedure. The first sentence
Federal rules and guidelines, consistent the private area in which the donor will of § 26.107(c) retains the instruction in
with Goal 1 of this rulemaking. urinate. Although the NRC is not aware former Section 2.4(g)(12) in Appendix A
The NRC added § 26.107(a)(1) to of any instances in Part 26 programs in to Part 26 that prohibits the donor from
specify the instructions that the which the former requirement for washing his or her hands until the
collector is required to provide to the individual privacy has been specimen has been delivered to the
donor. This paragraph requires the compromised, the experience of other collector. This paragraph also adds a
collector to instruct the donor to go into Federal agencies has indicated that such requirement for the collector to inspect
the room or stall used for urination, emphasis is necessary. the private area for any evidence of a
provide a specimen of the quantity that Section 26.107(a)(3) permits the subversion attempt prior to flushing the
the licensee or other entity has collector to set a reasonable time limit toilet. This additional requirement is
predetermined, refrain from flushing the for the donor to void. Rather than consistent with existing industry
toilet, and return with the specimen as establishing a specific time limit, the practices and the procedures of other
soon as the donor has completed the final rule permits the collector to rely on Federal agencies. It is intended to
void. The final rule requires the his or her professional judgment in increase the likelihood of detecting
collector to provide these instructions to order to ensure that individuals who subversion attempts if the donor leaves
the donor so that the donor understands may experience difficulty in voiding any physical evidence in the toilet bowl
his or her responsibilities with respect have sufficient time to provide a or private area where the donor voided,
to the urine collection procedure. In specimen while also permitting which could include, but is not limited
addition, the instructions are necessary collectors to prevent donors from to, an empty vial that contains an
to implement other provisions of the disrupting the testing process by taking adulterant, powdered urine spilled on
final rule. For example, the quantity of an unduly long time to provide a the floor, or the remains of an adulterant
urine that the collector instructs the specimen. In § 26.85(a), the rule in the toilet bowel.
donor to provide is based on the specifies new training and qualification
requirements of the licensee’s or other requirements to ensure that collectors Section 26.109 Urine Specimen
entity’s drug testing program, as are able to exercise professional Quantity
discussed with respect to § 26.109 judgment appropriately. At the public Section 26.109 amends former Section
[Urine specimen quantity]. The collector meetings discussed in the preamble to 2.4(g)(11) in Appendix A to Part 26. The
instructs the donor not to flush the toilet the proposed rule, stakeholders reported former provision established 60
so that the collector may inspect the incidents in which donors appeared to milliliters (mL) as the minimum
private area in which the donor voided be attempting to disrupt the testing quantity of urine that an FFD program
after receiving the specimen, as process by spending an unduly long must collect from donors and the
discussed with respect to § 26.109(c). time providing a specimen and procedures to be followed if a donor is
The collector must instruct the donor to challenged the collector’s authority to unable to provide the specified quantity.
return with the specimen as soon as the set a time limit. The new paragraph The final rule reduces to 30 mL the
donor has completed the void in order clarifies that collectors have the basic quantity of urine to be collected.
to minimize the possibility that the authority to set a reasonable time limit Section 26.109(a) introduces a new
urine specimen cools and its for voiding. In addition, this paragraph term ‘‘the predetermined quantity.’’ The
temperature falls below the acceptable increases the consistency of Part 26 with licensee or other entity establishes a
predetermined quantity of urine that testing for additional drugs beyond The final rule adds § 26.109(b) to
each donor is requested to provide, those specified in § 26.31(d)(1), then the establish the actions that the collector
depending on the characteristics of the predetermined quantity for this testing must take if a donor provides a
licensee’s or other entity’s testing program is 45 mL (30 mL for basic specimen that is less than the 30-mL
program. The final rule requires the testing + 15 mL for the split specimen). basic quantity. NRC staff discussions
predetermined quantity to include at The predetermined quantity must be with representatives of HHS-certified
least 30 mL of urine, but licensees and larger than 45 mL if the testing program laboratories indicated that 30 mL is
other entities may request a larger also includes initial tests at a licensee sufficient to meet the NRC’s primary
quantity of urine if— testing facility and testing for additional objectives of detecting drug use and
The specimen will be initially tested drugs. subversion attempts through initial
at a licensee testing facility; Section 26.109(a) also permits validity and drug testing, and for
Testing will be conducted for licensees and other entities to include in confirmatory validity and drug tests, if
additional drugs beyond those required the predetermined quantity the required, at an HHS-certified laboratory
in § 26.31(d)(1); additional amount of urine that is for the panel of drugs for which testing
Split specimen procedures will be necessary to support testing for is required in § 26.31(d)(1). The 30-mL
followed; or additional drugs beyond those specified quantity also ensures that sufficient
The licensee’s or other entity’s in § 26.31(d)(1). Licensees and other urine is available for retesting the
program includes some combination of entities must consult with the HHS- specimen for validity and for drugs and
these characteristics. certified laboratories they use to identify drug metabolites, should the donor
The NRC has reduced the 60-mL the quantity of urine required to test for request such retesting, as permitted in
quantity that was required in former the additional drugs. For example, if the
Section 2.4(g)(11) in Appendix A to Part § 26.165(b). Therefore, the 30-mL basic
licensee’s or other entity’s testing quantity is necessary to achieve the
26 to 30 mL to decrease the burden on program does not include initial tests at
donors, while ensuring that a sufficient NRC’s drug-testing objectives, although
a licensee testing facility and does not it is insufficient to permit testing for
quantity of urine is available to follow split specimen procedures, then
complete initial validity and drug tests, additional drugs, initial testing at
the predetermined quantity for that licensee testing facilities, or splitting the
confirmatory validity and drug tests (if testing program consists of the 30-mL
required), and any retests that may be specimen, which this part does not
basic quantity plus the additional require.
requested by the donor and authorized amount of urine needed to test for
by the MRO under § 26.165(b). NRC staff additional drugs. As another example, if Section 26.109(b)(1) amends the
discussions with representatives of a licensee’s or other entity’s testing portions of former Section 2.4(g)(11) in
HHS-certified laboratories indicated that program includes initial tests at a Appendix A to Part 26 that prescribed
advances in testing technologies allow licensee testing facility, follows split collector actions if a donor provides an
for these minimum testing and retesting specimen procedures, and tests for insufficient specimen. The final rule
procedures to be completed on a 30-mL additional drugs, then the requires the collector to ‘‘encourage’’ the
specimen. Therefore, a 60-mL specimen predetermined quantity consists of the donor to drink a reasonable amount of
is no longer necessary to achieve the 30-mL basic quantity plus 15 mL for the liquid in order to provide a specimen of
NRC’s minimum objectives of split specimen plus the additional at least 30 mL, rather than ‘‘allow’’ the
conducting validity and drug tests on amount required by the licensee testing donor to drink additional liquid as
each specimen for the five classes of facility and HHS-certified laboratory to required under the former rule. The
drugs specified in § 26.31(d)(1), as well test for the additional drugs. NRC made this change to enhance the
as retesting of the specimen, if required. Section 26.109(a) also permits efficiency of FFD programs, consistent
Section 26.109(a) also specifies the licensees and other entities to include in with Goal 3 of this rulemaking, by
additional quantity of urine, above the the predetermined quantity the potentially reducing the time required
basic 30 mL, to be collected when the additional amount of urine that is to obtain a specimen of the required
testing program follows split specimen necessary to perform initial validity and quantity from the donor and, thereby, to
procedures. The rule requires licensees drug tests at the licensee testing facility, complete the collection, should the
and other entities to collect an if initial tests are performed there. For donor choose to comply. However, this
additional 15 mL for transfer into Bottle example, one licensee testing program paragraph establishes a limit on the
B of a split specimen for storage and currently requires an additional 10 mL amount of liquid that the individual is
possible testing. (As discussed with of urine for initial testing at the licensee permitted to consume to avoid the
respect to § 26.113(b), the final rule testing facility, but does not test for potential for ‘‘water intoxication,’’
replaces the terms, ‘‘primary specimen’’ other drugs or follow split specimen which is a physical response to
and ‘‘split specimen,’’ in the former rule procedures. In this program, the consuming too many liquids that may
with the terms, ‘‘Bottle A’’ and ‘‘Bottle predetermined quantity that collectors cause harm to the donor. Although the
B,’’ for clarity in the language of the rule must request the donor to provide is 40 limit of 24 ounces of water over a 3-hour
and consistency with the terminology mL. As another example, if a licensee’s period in the proposed rule is the same
used by other Federal agencies.) This or other entity’s testing program limit imposed in the HHS Guidelines,
additional 15 mL is sufficient to permit includes initial tests at the licensee the NRC raised the limit in the final rule
the HHS-certified laboratory to conduct testing facility, does not test for to 40 ounces over a 3-hour period for
validity and drug tests of the specimen additional drugs, and follows: split consistency with the DOT limit, in
in Bottle B, at the donor’s request, and specimen procedures, the response to public comment. This limit
is consistent with the quantity required predetermined quantity may be 55 mL continues to be conservative to ensure
in the related provisions of other (30 mL for basic testing + 15 mL for the that individuals who may have a
Federal agencies. Therefore, if a split specimen + 10 mL for initial medical condition that makes them
licensee’s or other entity’s testing testing at the licensee testing facility). If more subject to water intoxication, such
program follows split specimen this program also tests for additional as some forms of renal disease, or who
procedures, but does not include initial drugs, the predetermined quantity may are taking some medications, would not
tests at the licensee testing facility or be larger than 55 mL. be placed at risk. The final rule retains
the former requirement in Section with respect to § 26.119. Requirements observed donor conduct or specimen
2.4(g)(11) in Appendix A to Part 26 to for implementing ‘‘shy bladder’’ characteristics that indicate there is a
collect successive specimens in separate procedures are contained in that reason to believe that the donor may
containers. section. have altered the specimen, the NRC’s
The NRC added § 26.109(b)(2) to The NRC added § 26.109(b)(4) to interest in assuring that the testing
require the collector to end the establish additional requirements for process is not subverted takes
specimen collection process as soon as specimen collections when a donor precedence over the donor’s ability to
the donor provides a specimen of at provides a specimen of less than 30 mL. request retesting of the specimen. Any
least 30 mL in a subsequent attempt. This section eliminates the
requirement in former Section 2.4(g)(11) results of validity testing that confirm
This requirement reduces the burden on
in Appendix A to Part 26 to combine that the specimen was adulterated or
donors who may have some difficulty
providing a urine specimen while successive specimens from a donor in substituted, in combination with the
meeting the NRC’s objectives of order to obtain a specimen of 60 mL. collector’s observations, provide clear
obtaining a specimen of sufficient size The final rule prohibits the practice of evidence that a donor has tampered
to support initial and confirmatory combining specimens to ensure that with the specimen and thereby
validity and drug testing, as well as successive specimens neither attempted to subvert the testing process.
retesting of the specimen. contaminate nor dilute a specimen that This section also amends former
Section 26.109(b)(2) also specifies that will be tested. In addition, the Section 2.4(g)(17) in Appendix A to Part
the licensee or other entity may not prohibition increases the consistency of 26. The former provision required a
impose any sanctions if a donor Part 26 with the related requirements of directly observed collection whenever
provides a subsequent specimen that is other Federal agencies (Goal 1 of this there is a reason to believe that a donor
less than the licensee’s or other entity’s rulemaking). has or may attempt to alter a specimen.
predetermined quantity, as long as the Section 26.109(b)(4) also requires the
collector to discard any specimens of The amended provision requires the
specimen quantity is at least 30 mL.
less than 30 mL unless there is reason collector to contact FFD program
Imposing sanctions for failing to provide
sufficient urine to support initial testing to believe that a specimen may have management to determine whether a
at the licensee’s testing facility, split been altered. Examples of reasons to directly observed collection is required,
specimen procedures, or testing for believe that a donor may have attempted but does not require a directly observed
additional drugs is inappropriate, to alter the specimen may include, but collection in every circumstance. At the
because a specimen of at least 30 mL is are not limited to: (1) Observation of public meetings discussed in the
sufficient to meet the NRC’s objectives powder (that could be an adulterant or preamble to the proposed rule, the
and, therefore, could not be considered powdered urine) spilled in the private stakeholders requested flexibility in the
a refusal to test. area in which the donor urinated or on decision to collect another specimen
Section 26.109(b)(2) also requires the the donor’s clothing; (2) unexpected under direct observation. They noted
collector to forward a subsequent sounds from the private area while the that numerous instances have occurred
specimen that is greater than 30 mL, but donor should be voiding, such as the in which a collector identified
less than the licensee’s or other entity’s sound of something being unwrapped or incontrovertible evidence that the donor
predetermined quantity, to the HHS- dropping to the floor; (3) observation intended to or had tampered with a
certified laboratory for testing, rather that the donor’s pocket appears to specimen and that, in such cases, drug
than permit the specimen to be tested at contain an item that was not visible testing would not provide additional
the licensee testing facility. This before the donor entered the private area information that justifies the costs
provision is necessary to ensure that a (that the donor may have previously had
associated with conducting a directly
sufficient quantity of urine is available taped to his body); and (4) an unusual
observed collection and testing the
for validity and drug testing and color or lack of clarity in the urine
retesting at the HHS-certified laboratory, specimen. The final rule requires the additional specimen. The NRC believes
if required, consistent with the NRC’s collector to discard specimens of less that the presence of drugs and drug
objectives. However, if the subsequent than 30 mL when there is no reason to metabolites in a specimen that is
specimen is equal to or greater than the believe that the specimens have been collected under direct observation
licensee’s or other entity’s subject to tampering because they are establishes a clear motive for an alleged
predetermined quantity, the licensee or not used for testing and there is no attempt to tamper with a specimen and
other entity is permitted to follow the reason to retain them. adds further evidence supporting the
FFD program’s normal testing If the collector suspects that a imposition of sanctions on the donor for
procedures. Following normal testing specimen has been altered and the attempting to subvert the testing
procedures in this instance is suspect specimen is equal to or greater process. However, the NRC believes that
permissible because there is sufficient than 15 mL, the rule requires the such additional evidence is unnecessary
urine to implement the FFD program’s collector to forward the suspect when there is incontrovertible evidence
testing procedures (e.g., split specimen specimen to the HHS-certified that the donor intends to or has
procedures, testing for additional drugs, laboratory for testing, consistent with attempted to tamper with a specimen.
initial testing at a licensee testing former Section 2.4(g)(16) in Appendix A Therefore, the final rule permits FFD
facility), while continuing to ensure that to Part 26. NRC staff discussions with program management to determine
sufficient urine is available for testing representatives of HHS-certified whether an additional specimen
and retesting at the HHS-certified laboratories indicate that 15 mL is the collection under direct observation must
laboratory, if required. minimum quantity necessary for HHS- be conducted. The agency has made this
The agency added § 26.109(b)(3) to certified laboratories to perform the
change to meet Goal 3 of this
require the implementation of ‘‘shy initial and confirmatory (if necessary)

rulemaking to improve the efficiency of
bladder’’ procedures if a donor is unable validity and drug testing required in this
to provide a 30-mL specimen within 3 part, although it is insufficient to FFD programs, by reducing the number
hours of the initial attempt to provide a support retesting of the specimen at the of directly observed collections required
specimen, for the reasons discussed donor’s request. When the collector has under the rule.
Section 26.111 Checking the of body temperature. In addition, the could, at their discretion, continue this
Acceptability of the Urine Specimen final rule deletes § 26.111(b) in the practice. Instead, the new provision
Section 26.111 amends former proposed rule entirely and has requires the collector to contact the FFD
requirements for assessing specimen renumbered the paragraphs in this program manager, if the collector has a
validity at the collection site, which section accordingly. The NRC has made reason to believe the donor has
appeared in Section 2.4(g)(13) through these changes in response to public attempted to subvert the testing process
(g)(17) in Appendix A to Part 26. In comments, which reported that DOT’s based on observed donor behavior, the
general, the NRC has made changes in experience indicates that there are often specimen temperature, unusual
this section to meet Goal 1 of this discrepancies when comparing the specimen characteristics, or other
rulemaking to update and enhance the temperature provided by a specimen observations. The FFD program
consistency of Part 26 with advances in container temperature strip and that manager, at his or her discretion, may
other relevant Federal rules and provided by a device that measures consult with the MRO to determine
body temperature. Further, with the whether the collector’s observations
guidelines. In addition, the NRC
increase in the range of acceptable provide sufficient evidence that a
changed the heading of this section from
specimen temperatures, as discussed subversion attempt has occurred to
‘‘Checking the validity of the urine
with respect to § 26.111(a), a warrant the imposition of sanctions. If
specimen’’ in the proposed rule to
measurement of body temperature is the MRO and/or FFD program manager
‘‘Checking the acceptability of the urine
less useful to counter a reason to believe determine that a subversion attempt has
specimen,’’ in response to a public
that the donor has altered the specimen occurred on the basis of the collector’s
comment which noted that
(e.g., humans who have a body observations, the final rule permits the
‘‘acceptability’’ more accurately
temperature at or below 90°F would be licensee or other entity to impose the
characterizes the purpose of the
suffering from severe hypothermia). sanctions for a subversion attempt in
requirements in this section. Therefore, eliminating the opportunity § 26.75(b) without conducting a directly
Section 26.111(a) amends former
for a donor to provide a measure of body observed collection. However, at the
Section 2.4(g)(13) in Appendix A to Part
temperature in this paragraph meets FFD program manager’s or the MRO’s
26. The former provision required the
Goal 5 of this rulemaking to improve discretion, a second specimen may be
collector to measure the temperature of
Part 26 by eliminating or modifying collected under direct observation. The
the specimen immediately after the
unnecessary requirements. rule permits a second specimen to be
urine specimen is collected. The new Section 26.111(b) amends former collected under direct observation to
provision requires the collector to Section 2.4(g)(15) in Appendix A to Part provide further information to assist the
measure the temperature of any 26. The former provision required the MRO in determining whether or not a
specimen that is 15 mL or more. The collector to inspect the specimen’s subversion attempt has occurred. For
final rule does not mandate measuring color, determine whether there were any example, positive drug test results from
the temperature of smaller specimens signs of contaminants, and record any a second specimen that is collected
because the collector is required to unusual findings in the permanent under direct observation provide
discard them, as discussed with respect record book. The final rule amends this additional evidence that the donor
to § 26.109(b)(4). This paragraph also provision by deleting reference to the attempted to tamper with his or her first
replaces former Section 2.4(g)(14) in permanent record book and requiring specimen to hide drug use. The NRC has
Appendix A to Part 26, which the collector to use the custody-and- made this change in response to
established the acceptable specimen control form to record this information. stakeholder requests, for the reasons
temperature range and required The NRC has made this change because discussed with respect to proposed
conducting a second specimen the final rule no longer requires § 26.109(b)(4).
collection under direct observation if a collection sites to maintain a permanent The NRC also added permission in
specimen’s temperature falls outside the record book, consistent with the § 26.111(c) for a donor to volunteer to
acceptable range. The final rule elimination of the requirement to submit another specimen under direct
increases the range of acceptable maintain a permanent record book in observation to counter any reason to
specimen temperatures from 90.5°F– the HHS Guidelines. The final rule also believe that he or she may have altered
99.8°F in the former provision to 90°F– makes minor editorial revisions to the the first specimen. The agency added
100°F for consistency with the former provision by incorporating the this permission in response to a public
temperature range specified in the HHS related language from the HHS comment suggesting this change and
Guidelines. The wider acceptable Guidelines. The agency made these because it is consistent with Goal 7 of
temperature range provides increased changes to meet Goal 1 of this the rulemaking to protect donor’s rights
protection against false low or false high rulemaking to update and enhance the (including due process) under the rule.
temperature readings and, therefore, consistency of Part 26 with the Section 26.111(d) replaces and revises
protects donors from the imposition of regulations of other Federal agencies. former Section 2.4(g)(16) in Appendix A
sanctions based on inaccurate specimen Section 26.111(c) replaces and to Part 26. The former provision
temperature readings. The portion of amends the first sentence of former required forwarding all urine specimens
former Section 2.4(g)(14) that specified Section 2.4(g)(14) in Appendix A to Part that are suspected of being adulterated
collector actions if there is a reason to 26. The former provision required a or diluted to the HHS-certified
believe that the individual may have second specimen to be collected under laboratory for testing. The final rule
tampered with the specimen has been direct observation if the temperature of adds a third reason, suspicion that a
moved to § 26.111(d) for organizational the first specimen submitted by a donor specimen has been substituted, for
clarity. fell outside of the acceptable specimen forwarding a specimen to the HHS-
In response to a public comment, the temperature range. The final rule certified laboratory. As discussed with
final rule eliminates the requirement in eliminates the requirement for a second respect to § 26.31(d)(3)(i), substitution
§ 26.111(a), which appeared in both the specimen collection under direct entails replacing a valid urine specimen
former and proposed rules, for the observation if the specimen temperature with a drug-free specimen. The NRC has
collector to offer the donor an falls outside of the required range, made this change for consistency with
opportunity to provide a measurement although licensees and other entities the addition of substitution to the final
rule as another method of attempting to Section 26.113(a) of the final rule sufficient quantity for conducting all of
subvert the testing process for which revises the same provision in the the testing that may be required under
licensees and other entities are required proposed rule, in that the NRC has this part and 15 mL is sufficient for
to impose sanctions, as discussed with deleted the phrase ‘‘who are subject to conducting testing of the specimen in
respect to § 26.75(b). This paragraph this part’’ to provide additional clarity Bottle B.
also adds a provision that specifically to the language of the rule, in response In response to public comment, the
prohibits testing any suspect specimen to public comment. The NRC deleted NRC has revised this paragraph in the
at a licensee testing facility to (1) limit this phrase because not all of the final rule to more clearly specify that
the potential for specimen degradation licensees and entities who are subject to the specimen in Bottle A must be used
during the time period required to Part 26 are required to meet the for drug and validity testing even if
conduct testing at the licensee testing requirements of this section. there is less than 15 mL of urine
facility; (2) decrease the time required to For organizational clarity, the NRC available for Bottle B. The agency added
obtain confirmatory validity test results has added § 26.113(b) to group together this clarification to the final rule
if the specimen, in fact, has been in one paragraph the steps that the because, in the experience of other
altered; and (3) ensure that a sufficient collector and donor must follow for the Federal agencies, some collection sites
quantity of urine is available for split specimen collection procedure. have discarded any specimen of less
conducting validity tests at more than These steps were embedded in former than 45 mL and conducted another
one HHS-certified laboratory if, for Section 2.4(g)(20) and portions of collection to obtain a sufficient amount
example, the specimen contains a new Section 2.7(j) in Appendix A to Part 26. of urine to fill both Bottles A and B.
adulterant or an adulterant that the The final rule also replaces the Following this practice would reduce
licensee’s or other entity’s primary terminology used in the former rule that the efficiency of FFD programs and
laboratory is not capable of identifying referred to the split specimen as an unnecessarily increase the burden on
(see § 26.161(g)). Only suspect ‘‘aliquot,’’ and uses the terms, ‘‘Bottle donors who are subject to testing. The
specimens of 15 mL or more must be A’’ and ‘‘Bottle B,’’ to refer to the final rule incorporates this clarification
sent for testing, rather than all primary and split specimen, from the HHS Guidelines to ensure that
specimens. The final rule establishes respectively. The agency made these Part 26 programs do not adopt this
this lower limit on specimen quantity to changes for increased clarity in the inefficient and burdensome practice.
ensure that there is sufficient urine language of the rule and consistency Section 26.113(b)(3) retains the
available for the HHS-certified with the terminology used in other portion of former Section 2.4(g)(20) in
laboratory to conduct all of the validity relevant Federal rules and guidelines. Appendix A to Part 26 that requires the
and drug tests on the specimen that are In response to a public comment, the donor to observe the process of splitting
required under this part. In response to NRC revised proposed § 26.113(b)(1) to the specimens and maintain visual
a comment, this paragraph of the final delete the option of using a specimen contact with the specimen bottles until
rule also adds a requirement to send bottle to collect a urine specimen to they are sealed and prepared for storage
specimens of 15 mL or more, collected eliminate the possibility of problems or shipping.
under direct observation in accordance arising from collecting urine in two The NRC added § 26.113(c) to
with § 26.111(c), to an HHS-certified different types of containers. The final establish priorities for using the
laboratory for initial and confirmatory rule retains the requirement for the specimen that has been collected. The
testing. collector to instruct the donor to void paragraph permits the licensee testing
Section 26.111(e) requires collectors into a specimen container to clarify that facility to test aliquots of the specimen
and the HHS-certified laboratory to the donor is not required to divide a at a licensee testing facility or to test for
preserve as much of a suspect specimen specimen into Bottle A and Bottle B additional drugs beyond those required
as possible. The NRC has added this while urinating. This paragraph under § 26.31(d)(1), but only if the
requirement to provide increased incorporates the related provision in the donor has provided a specimen of at
assurance that a sufficient quantity of HHS Guidelines. least the predetermined quantity, as
urine is available to support further Section 26.113(b)(2) amends the discussed with respect to § 26.109. As
testing, in the event that further testing portions of former Section 2.7(j) in discussed with respect to § 26.113(b)(2),
of the specimen is necessary, and to Appendix A to Part 26 that specified the the final rule requires the collector first
enhance the consistency of Part 26 with amount of urine to be poured into the to ensure that 30 mL of urine is
the related provisions of other Federal split specimen bottles. The rule replaces available for Bottle A and 15 mL for
agencies. the implied requirements in the second Bottle B. If the donor has provided more
The agency also added § 26.111(f) to and third sentences of Section 2.4(j), than 45 mL of urine and the additional
inform donors and collectors of the which referred to the split specimens as amount is sufficient to support testing at
characteristics of a specimen that is ‘‘halves’’ of the specimen that was the licensee testing facility, testing for
acceptable for testing at an HHS- collected, with updated requirements additional drugs, or both, the final rule
certified laboratory. This paragraph that are consistent with those permits the remaining amount of urine
incorporates the related provision from established in § 26.109 and the related to be subject to such testing. However,
the HHS Guidelines. provisions in the HHS Guidelines. This if the donor has provided only 45 mL
paragraph requires the collector to of urine, the final rule requires that the
Section 26.113 Splitting the Urine ensure that Bottle A contains 30 mL and 15 mL of urine that remains after 30 mL
Specimen that Bottle B contains a minimum of 15 has been retained for Bottle A must be
Section 26.113 updates former mL of urine. As discussed with respect used for Bottle B rather than to conduct
Sections 2.4(g)(20) and 2.7(j) in to § 26.109, advances in urine testing testing at the licensee testing facility or
Appendix A to Part 26. This section technologies since the agency first testing for additional drugs. The final
amends collection site procedures for promulgated Part 26 permit a reduction rule establishes this priority because the
split specimens in the former rule and in the quantity of urine that must be FFD program has established the
groups them together in one section collected from donors in order to expectation among donors in this
within the final rule for organizational conduct the testing this part requires. instance that the FFD program will
clarity. Therefore, 30 mL of urine is now a follow split specimen procedures and
that Bottle B will be available for believe that a donor may dilute, medical explanation for the result.’’ The
retesting at the donor’s request. substitute, adulterate, or otherwise alter NRC made this change for consistency
Reserving the 15 mL of urine for Bottle a specimen, and that warrant the with the addition of more detailed
B is also consistent with the principle invasion of individual privacy requirements for validity testing
that is established in the last sentences associated with a directly observed throughout the final rule, as discussed
of §§ 26.135(b) and 26.165(a)(4) that collection. with respect to § 26.31(d)(3)(i). Section
control over testing of the specimen Section 26.115(a)(1) amends former 26.161 [Cutoff levels for validity testing]
contained in Bottle B resides with the Section 2.4(f)(2) in Appendix A to Part specifies the cutoff concentrations and
donor. 26, which stated that a directly observed specimen characteristics that require the
collection may be performed if the last HHS-laboratory to report a specimen as
Section 26.115 Collecting a Urine urine specimen provided by the donor substituted, adulterated, or invalid.
Specimen Under Direct Observation yielded specific gravity and creatinine Section 26.185 [Determining a fitness-
Section 26.115 groups together in one concentration results that were for-duty policy violation] specifies the
section the former rule’s requirements inconsistent with normal human urine. requirements for the MRO’s review of
that apply to collecting a urine The new paragraph amends the former these test results.
specimen under direct observation. The provision in several ways. Section 26.115(a)(2) combines and
NRC has made this organizational First, the final rule eliminates the updates former Sections 2.4(f)(1) and
change because requirements that limitation in the former paragraph that 2.4(g)(14) in Appendix A to Part 26. The
address this topic were dispersed a specimen may be collected under former provisions stated that the
throughout the former rule. This section direct observation if ‘‘the last urine presentation of a specimen that falls
also incorporates more detailed specimen’’ provided by the individual outside of the required temperature
procedures for collecting specimens yielded specific gravity and creatinine range is sufficient grounds to conduct a
under direct observation that are based concentration results that are directly observed collection. The new
on related requirements from other inconsistent with normal human urine. paragraph retains the requirement in
relevant Federal rules and guidelines. The final rule permits a directly former Section 2.4(f)(1) in Appendix A
More detailed procedures are necessary observed collection if the donor had to Part 26, which specified that a
because devices and techniques to presented a specimen with directly observed collection may be
subvert the testing process have been characteristics that are inconsistent with conducted at any time the specimen’s
developed since Part 26 was first normal human urine ‘‘at this or a temperature falls outside of the required
published that are difficult to detect in previous collection.’’ The change is temperature range. However, the final
many collection circumstances, consistent with § 26.75(b), which rule deletes the provisions of the
including under direct observation, requires that an individual who has proposed rule that addressed measuring
such as a false penis or other realistic subverted or attempted to subvert any the donor’s body temperature for the
urine delivery device containing a test conducted under Part 26 must be reasons discussed with respect to
substitute urine specimen and heating subject to a permanent denial of § 26.111(a).
element that may be used to replicate authorization. Because § 26.75(b) Section 26.115(a)(3) updates former
urination. Therefore, the agency has requires permanent denial of Section 2.4(f)(3) in Appendix A to Part
made these changes to increase the authorization to a donor who has 26. The former provision permitted a
likelihood of detecting attempts to engaged in a subversion attempt, directly observed collection if a
subvert the testing process and increase individuals whose last specimen had collector observed donor conduct that
the effectiveness of directly observed characteristics that are inconsistent with clearly and unequivocally demonstrates
collections in assuring that a valid normal human urine are not subject to an attempt by the donor to substitute the
specimen is obtained from the donor. further testing under the rule. However, specimen. The final rule adds references
Section 26.115(a) amends and instances may arise in which a licensee to attempts to dilute and adulterate a
combines former Section 2.4(f), or other entity is aware that an specimen, in addition to substitution, as
2.4(g)(17), and (g)(25) in Appendix A to individual engaged in a subversion behaviors that demonstrate a subversion
Part 26. The former provisions attempt under a drug testing program attempt, consistent with the NRC’s
established requirements for collecting a that the NRC does not regulate. If the heightened concern in the final rule for
urine specimen under direct licensee or other entity is considering ensuring specimen validity, as
observation. This paragraph of the final granting authorization under Part 26 to discussed with respect to
rule assigns responsibility for approving the individual, then a directly observed § 26.31(d)(3)(i). As discussed with
a directly observed collection to the collection is warranted to ensure that respect to § 26.107(b), donor conduct
MRO or FFD program manager, rather the donor does not have an opportunity that clearly and unequivocally
than a ‘‘higher level supervisor’’ of the to tamper with the specimen and, demonstrates an attempt to alter a
collector, as stated in former Section therefore, that drug test results will be specimen may include, but is not
2.4(b)(25) in Appendix A to Part 26. accurate. The amended language of the limited to, possession of a urine
This change ensures that an individual new provision permits collecting a specimen before the collection has
who is thoroughly knowledgeable of the specimen under direct observation in occurred; possession of a vial, or vials,
requirements of this part, and the these circumstances. filled with chemicals that are
emphasis that the NRC places on Second, the final rule updates the subsequently determined to be urine or
maintaining the individual privacy of former provision by replacing the an adulterant; possession of a heating
donors, makes the decision to conduct specific gravity and creatinine element; or evidence that the coloring
a directly observed collection. The concentration values in the former agent used by the licensee or other
change is also consistent with revised paragraph with references to a urine entity in a source of standing water at
requirements in the HHS Guidelines specimen that ‘‘the HHS-certified the collection site (see § 26.87(e)(1))
related to who may authorize a directly laboratory reported as being substituted, discolors the specimen.
observed collection. adulterated, or invalid to the MRO and Section 26.115(a)(4) updates former
The final rule also lists the the MRO reported to the licensee or Section 2.4(f)(4) in Appendix A to Part
circumstances that constitute a reason to other entity that there is no adequate 26. The former provision permitted
directly observed collections if a donor individual had attempted to subvert the of other relevant Federal rules and
had previously been determined to have testing process. Therefore, conducting guidelines.
engaged in substance abuse and the the directly observed collection as soon Section 26.115(e) retains and
specimen was being collected as part of as reasonably practical ensures that test combines the former requirements in
a rehabilitation program and/or pre- results from the specimen provide Sections 1.2, 2.4(b), 2.4(g)(14), (g)(17),
access testing following a confirmed relevant and useful information. The and (g)(25) in Appendix A to Part 26.
positive test result. This paragraph requirement is also consistent with These provisions required that the
updates the former requirement by those of other relevant Federal rules and individual who observes the specimen
adding a cross-reference to § 26.69 guidelines. collection must be of the same gender as
[Authorization with potentially The agency added § 26.115(c) to the donor. Consistent with the former
disqualifying fitness-for-duty require the collector to inform the donor requirements, the final rule permits
information], which establishes of the reason(s) for the directly observed another individual of the same gender to
requirements for granting or collection so that the donor is aware of serve as the observer if a qualified urine
maintaining the authorization of an the nature of the concern that has collector of the same gender is not
individual about whom potentially initiated a directly observed collection. available as long as the observer
disqualifying FFD information has been The final rule includes this requirement receives the instructions specified in
discovered or disclosed. Several for two reasons: (1) knowing the reason § 26.115(f). The final rule combines the
provisions in § 26.69 permit or require for a directly observed collection may former requirements in this paragraph
directly observed collections, including increase a donor’s willingness to for organizational clarity.
§ 26.69(b)(5), which requires specimens cooperate in the procedure in order to The NRC added § 26.115(f) to specify
to be collected under direct observation counter the reason to believe that the the procedures that must be followed in
for pre-access drug testing of conducting a directly observed
donor has or may attempt to alter the
individuals who have been subject to collection by either a qualified collector
specimen, and (2) informing the donor
sanctions under the rule. For or an individual of the same gender who
of the reason for a directly observed
organizational clarity, this paragraph may serve as the observer. These more
collection meets Goal 7 of this
replaces the former requirement with a detailed procedures are necessary
rulemaking to protect the privacy and
cross-reference to § 26.69, rather than because devices and techniques to
other rights (including due process) of
repeat the applicable requirements in subvert the testing process have been
individuals who are subject to Part 26
this section. developed since Part 26 was first
by ensuring that the donor is aware of
published that can be used under direct
Section 26.115(b) amends the the concern that has initiated the
observation without detection.
requirement in former Section 2.4(g)(25) collection. This paragraph also meets Therefore, the agency made these
in Appendix A to Part 26 that the Goal 1 of this rulemaking by improving changes to increase the likelihood of
collector must obtain permission from a consistency with the requirements of detecting attempts to subvert the testing
‘‘higher level supervisor’’ before other relevant Federal rules and process and, thereby, increase the
conducting a directly observed guidelines. effectiveness of directly observed
collection, as discussed with respect to The NRC added § 26.115(d) to collections in assuring that a valid
§ 26.115(a). The NRC has added the establish recordkeeping requirements specimen is obtained from the donor.
second sentence of this paragraph to related to the directly observed The NRC added § 26.115(f)(1) to
require that, once the decision has been collection. This provision requires the specify that the observer must instruct
made to conduct a directly observed collector to record on the specimen’s the donor to adjust his or her clothing
collection based on a reason to believe custody-and-control form that the to ensure that the area of the donor’s
that the donor may alter a specimen, the specimen was collected under direct body between the waist and knees is
collection must occur as soon as observation and the reason(s) for the exposed. This requirement ensures that
reasonably practical. Although the NRC directly observed collection. This the observer is able to detect the use of
is not aware of any occasions in Part 26 requirement ensures that the HHS- an anatomically correct urine delivery
programs in which a directly observed certified laboratory and the MRO have device.
collection has been unreasonably this information available when the The agency added § 26.115(f)(2) to
delayed, the new requirement ensures specimen is tested and the MRO specify the action to be observed during
that test results from the directly conducts his or her review of the test the collection. This paragraph is
observed collection provide information results, as is required under § 26.185. consistent with the requirements of
about the presence or absence of drugs This information is important in an other Federal agencies and is intended
and drug metabolites in the donor’s MRO’s decision to request the to ensure that the urine specimen is
urine. If a collection is delayed for a day laboratory to test a specimen that obtained from the donor’s body.
or more, metabolism may cause the appeared to have been diluted, as The rule adds § 26.115(f)(3) to
concentration of drugs and drug permitted under § 26.185(g)(2), in order prohibit an observer who is not the
metabolites in the donor’s urine, if any to compare the results from testing the collector from touching the specimen
are present, to fall below the cutoff dilute specimen with those obtained container. The new provision is
levels established in this part or by the from testing the specimen that was consistent with the related requirements
FFD program and, therefore, not be collected under direct observation. of other Federal agencies and is
detected by testing. Positive, Positive, adulterated, substituted, or intended to protect the observer from
adulterated, substituted, or invalid test invalid test results from the dilute any potential claims by a donor that the
results from a specimen collected under specimen and the presence of the same observer had altered the specimen.
direct observation provide evidence to drugs or drug metabolites in the The new § 26.115(f)(4) requires the
support a conclusion that the individual specimen collected under direct collector to record the observer’s name
had attempted to subvert the testing observation provide evidence that the on the custody-and-control form if the
process in order to mask drug abuse, donor diluted the first specimen in an observer is not the collector. This
whereas negative test results may attempt to mask drug use. This section mandate is consistent with the related
counter the reason to believe that the is also consistent with the requirements requirements of other Federal agencies
and is intended to ensure that the may be required to call in the donor and the procedures for sealing and preparing
observer’s identity is documented a collector to perform the directly the specimen (and aliquots, if
should future questions arise regarding observed collection, if the donor and applicable) for transfer are performed.
the collection. collectors are not on site when the Section 26.117(c) retains the meaning
The NRC added § 26.115(g) to clarify oversight is identified. This requirement of former Section 2.4(g)(22) in Appendix
that a donor’s refusal to participate in increases consistency with the related A to Part 26. This provision establishes
the directly observed collection requirements of other Federal agencies requirements for labeling and sealing
constitutes a refusal to test and, and is intended to provide instructions the specimen(s), but the final rule splits
therefore, is considered to be an act to for correcting an oversight that the the former requirement into several
subvert the testing process under former rule did not address. sentences for increased clarity in the
§ 26.75(b). Former Section 2.4(j) in language of the provision.
Appendix A to Part 26 required the Section 26.117 Preparing Urine For organizational clarity, § 26.117(d)
collector to inform the MRO, and the Specimens for Storage and Shipping retains and combines former Section
MRO to inform licensee management, if A new § 26.117 reorganizes and 2.4(g)(23) and 2.4(g)(23)(i) in Appendix
a donor failed to cooperate with the presents together in one section former A to Part 26. These provisions required
specimen collection process, including, requirements for safeguarding the donor to certify that the specimen
but not limited, to a refusal to provide specimens and preparing them for was collected from him or her.
a complete specimen, complete transfer from the collection site to the However, the final rule deletes former
paperwork, or initial the specimen licensee’s testing facility or the HHS- Section 2.4(g)(23)(ii), which required
bottles. The former requirement did not certified laboratory for testing. The NRC the donor to have an opportunity to list
specifically mention that a refusal to made this organizational change on the custody-and-control form any
participate in a directly observed because requirements that address these medications he or she had taken within
collection is also an instance of a failure topics were dispersed throughout the the past 30 days for the reasons
to cooperate. In addition, the former former rule and grouping them together discussed with respect to § 26.89(b)(3).
rule did not require the licensee or other in a single section in the final rule The final rule deletes former Section
entity to impose sanctions on a donor makes them easier to locate. 2.4(g)(24) in Appendix A to Part 26,
for refusing to be tested. Therefore, the Section 26.117(a) amends former which required the collector to enter
final rule adds a provision that both Section 2.4(g)(20) in Appendix A to Part into the permanent record book all
clarifies the NRC’s original intent by 26, which required the donor and information identifying the specimen.
stating that a refusal to participate in a collector to maintain visual contact with The agency eliminated this requirement
directly observed collection constitutes specimens until they were sealed and because the final rule no longer requires
a refusal to test and updates the former labeled. The final rule eliminates collection sites to maintain a permanent
requirement by adding a cross-reference reference to blood specimens because record book, consistent with the
to the sanction of permanent denial of donors are no longer permitted to elimination of the requirement to
authorization that is required under request blood testing for alcohol under maintain a permanent record book in
§ 26.75(b). the final rule, as discussed with respect the HHS Guidelines. Collection sites are
The agency added § 26.115(h) to to § 26.83(a). The new paragraph also permitted to use other means of tracking
specify the actions that a collector must amends the requirements in the second specimen identity, including, but not
take if a directly observed collection sentence of the former provision. For limited to, bar coding.
was required but not performed. The organizational clarity, the final rule Section 26.117(e) amends former
collector must report the omission to the moves to § 26.113 [Splitting the urine Section 2.4(g)(26) in Appendix A to Part
FFD program manager or designee, who specimen] procedural requirements for 26. The former provision required the
ensures that a directly observed observing the splitting of a specimen collector to complete the chain-of-
collection is immediately performed. and sealing the split specimen bottles. custody forms for both the aliquot and
Although the concentrations of any However, this provision broadens the the split sample and certify proper
drugs, drug metabolites, or blood former requirement, which addressed completion of the collection. The final
alcohol in the donor’s specimens may only split specimens, to require the rule eliminates reference to the aliquot
fall below the cutoff levels that are donor to observe the transfer of any and split sample in the former section
specified in this part or in the licensee’s specimen or aliquot that the collector to clarify the intent of this requirement,
or other entity’s FFD policy if several transfers to a second container and the which is that the collector must
days have elapsed since the directly sealing of the container(s). This complete the appropriate chain-of-
observed collection should have requirement is necessary because some custody forms for all of the sealed
occurred, testing a specimen collected FFD programs who operate licensee specimen and aliquot containers, not
several days later increases the testing facilities may transfer an aliquot simply those resulting from a split
likelihood of detecting any subsequent of the urine specimen to a second specimen procedure. For example, if an
drug or alcohol use. In addition, the container for initial testing at the FFD program follows split specimen
metabolites from using some drugs, licensee testing facility, while procedures and conducts initial testing
such as marijuana, linger in an preserving the primary specimen in the at a licensee testing facility, the donor’s
individual’s body. Therefore, first or another container. The final rule urine specimen may be divided into
conducting a directly observed requires the donor to observe these Bottle A, Bottle B, and another container
collection may result in detecting these actions to ensure that the specimen or that would be used for tests at the
metabolites. However, because elapsed aliquot(s) that are transferred belong to licensee testing facility. This section
time reduces the concentrations of the donor and that the identity and retains the former requirement for the
drugs, drug metabolites, or alcohol in integrity of the specimen are collector to certify proper completion of
the donor’s specimens, the final rule maintained. the collection.

requires a directly observed collection Section 26.117(b) retains former Section 26.117(f) amends former
to be performed immediately. This Section 2.4(g)(21) in Appendix A to Part Section 2.4(g)(27) in Appendix A to Part
section uses the term ‘‘immediately’’ to 26. This provision requires the donor 26. The former provision stated that the
indicate that the licensee or other entity and collector to remain present while specimens and chain-of-custody forms
‘‘are now ready for transfer’’ and must which specimens were transferred However, the final rule continues to
be appropriately safeguarded if they are offsite (e.g., shipping specimens that test require licensees and other entities to
not immediately prepared for shipment. as ‘‘presumptive positive’’ on initial protect specimens from any conditions
The final rule replaces the first sentence testing at the licensee testing facility, that could cause specimen degradation.
of the former provision, which stated special processing of suspect Collection site personnel are required to
that the specimens and forms are ready specimens), because they are redundant refrigerate specimens that are not
for transfer, with a requirement for the with other portions of the final rule. For transferred or shipped to the licensee
collector to package the specimens and organizational clarity, the rule moves testing facility or the HHS-certified
forms for transfer to the HHS-certified new requirements related to transferring laboratory within 24 hours of collection.
laboratory or licensee testing facility. specimens from a licensee testing The final rule also requires that any
This change improves the clarity in the facility to an HHS-certified laboratory specimens that may have been
rule’s language because it is necessary for further testing to § 26.129(g) in substituted or adulterated must be
for the collector to package the Subpart F. The final rule also eliminates refrigerated as soon as they are collected
specimens and chain-of-custody forms the third sentence of the former section, because some adulterants may interfere
for transfer before they are ready to be which required the collector to sign and with drug testing results unless the
transferred. This section retains the date the tape used to seal the container. specimen is refrigerated. The final rule
second sentence of the former provision. The NRC eliminated this requirement establishes a time limit of 2 business
Section 26.117(g) retains former because licensees and other entities now days for receipt of specimens at the
Section 2.4(g)(28) in Appendix A to Part transfer specimens using courier licensee testing facility or HHS-certified
26. This provision requires the collector services who offer other means of laboratory after shipment from the
to maintain control of the specimens tracking the sender and the date that a collection site to further protect against
and custody documents and ensure they container of specimens is shipped. potential specimen degradation.
are secure, if he or she must leave the Program experience has shown these Section 26.117(k) amends the portions
workstation or collection site for any other means to be equally effective. This of former Section 2.4(h) in Appendix A
reason. The final rule makes minor new section retains the intended to Part 26 that required a specimen’s
editorial changes to some of the meaning of the former requirements for custody-and-control form to identify
terminology used in the former section the collector to place the specimens in every individual in the chain of
for consistency with the terminology a second container that minimizes the custody. The final rule does not require
used throughout the final rule, as possibility of damage during shipment couriers to meet the requirements in
discussed with respect to § 26.5 and seal them so that tampering will be former Section 2.4(h), which stated that
[Definitions], but retains the intended detected. At the request of stakeholders each time a specimen is handled or
meaning of the former requirements. during the public meetings discussed in transferred, the date and purpose of the
Section 26.117(h) retains the transfer must be documented on the
the preamble to the proposed rule, the
requirements in former Section 2.4(c)(2) chain-of-custody form and every
final rule adds shipping bags to the
in Appendix A to Part 26 related to individual in the chain of custody must
former set of examples of acceptable
maintaining specimen security until the be identified. Couriers are not required
shipping containers that protect the
specimens are sent from the collection to meet these requirements because
specimens from damage. Also at the
site to the licensee testing facility or the custody-and-control forms for
request of stakeholders, the final rule
HHS-certified laboratory for testing. For individual specimens are packaged
deletes the last sentence of the former
organizational clarity, the NRC moved inside the shipping container, where
section, which required the collector to
the former paragraph to this section of they are inaccessible to couriers, so that
ensure that chain-of-custody documents
the final rule because requirements for it is impractical to expect them to sign
maintaining specimen security apply at were attached to the container used to
the forms when handling the specimen
this point in the specimen collection ship the specimens to the licensee
shipping containers. This new
process. Likewise, the agency has testing facility or laboratory. The
paragraph codifies licensees’ and other
moved the portion of the former section stakeholders requested this change
entities’ practice of relying on courier
that applies to situations in which it is because their practice is to seal a
services’ normal package tracking
impractical to maintain continuous specimen’s custody-and-control
systems to maintain accountability for
physical security of a collection site to documentation inside the shipping specimen shipping containers, which is
§ 26.87(f)(5) because § 26.87(f) addresses container to ensure that it cannot be consistent with the HHS Guidelines and
those circumstances. altered. The NRC endorses this practice standard forensic practices. The final
Section 26.117(i) updates the as providing greater protection for rule also eliminates the former
specimen packaging requirements in donors and, therefore, adopts this requirement, contained in the last
former Section 2.7(i) in Appendix A to change. sentence of Section 2.4(h) in Appendix
Part 26 by replacing the former section Section 26.117(j) amends and A to Part 26, to minimize the number of
with the related provision from the HHS combines the first sentence of former persons handling specimens because
Guidelines. For organizational clarity, Section 2.4(i) in Appendix A to Part 26 this requirement cannot be enforced.
the rule moves § 26.117(j) to the first with the requirements applicable to the
sentence of the former section, which short-term storage of specimens at Section 26.119 Determining ‘‘Shy’’
directs collection site personnel to collection sites in former Section 2.7(c) Bladder
arrange to transfer the specimens to the in Appendix A to Part 26. The NRC The agency has adapted a new
licensee testing facility or HHS-certified moved to this section the first sentence § 26.119 from the DOT Procedures at 49
laboratory. Section 26.117(j) addresses of former Section 2.4(i) in Appendix A CFR 40.193 [What happens when an
transfer and storage requirements, while to Part 26 for the reasons discussed with employee does not provide a sufficient
§ 26.117(i) addresses packaging respect to § 26.117(i). Under this amount of urine for a drug test?] to
requirements. This section also section, as a result of advances in testing specify procedures for determining
eliminates the initial phrases in the technologies, the rule no longer requires whether a donor who does not provide
second sentence of the former provision, short-term refrigerated storage of a urine specimen of 30 mL within the
which listed the conditions under specimens within 6 hours of collection. 3 hours that is permitted for a specimen
collection is refusing to test or has a These requirements for the physician The agency added § 26.119(d) to
medical reason for being unable to who performs the evaluation to be define the physical and psychological
provide the required 30 mL specimen. qualified in the relevant medical issues conditions that constitute a medical
This new section responds to ensure that the results of the evaluation condition that could have precluded the
stakeholder requests during public are valid. donor from providing a 30-mL specimen
meetings discussed in the preamble to This section also requires that the as well as to provide examples of
the proposed rule. The stakeholders evaluation must be completed within 5 conditions that do not constitute a
reported that some donors have had calendar days of the unsuccessful legitimate medical condition. Legitimate
difficulty providing the minimum 60 collection. The agency has established medical conditions include an
mL of urine required in former Section the time limit of 5 calendar days as a ascertainable physiological condition
2.4(g)(11) for medical reasons, but the trade off between the need to provide (e.g., a urinary system dysfunction) or a
former rule did not establish procedures the donor with sufficient time to locate medically documented pre-existing
for handling such circumstances. As a a qualified physician, obtain an psychological disorder that precluded
result, some FFD programs have appointment, and for the physician to the donor from providing a 30-mL
adopted the DOT ‘‘shy bladder’’ complete the evaluation (i.e, the donor’s specimen. Unsupported assertions of
procedures, but stakeholders preferred right to due process), and the public’s ‘‘situational anxiety’’ or dehydration are
that the final rule incorporate the interest in a rapid determination of examples of conditions that could not
requirements to (1) clarify that the NRC whether the donor had attempted to be considered legitimate medical
accepts the procedures, (2) inform subvert the testing process by refusing conditions. The final rule adds this
donors of the procedures that they are to provide a sufficient specimen. DOT’s section to provide necessary guidance to
required to follow if they have medical experience indicates that 5 days is the evaluating physician.
reasons for being unable to provide a sufficient to complete the evaluation. The final rule adds § 26.119(e) to
sufficient quantity of urine for testing, The final rule adds § 26.119(b) to require the evaluating physician to
(3) enhance consistency among Part 26 specify the information that the MRO provide a written statement of his or her
programs, and (4) enhance the must provide to the physician who is findings and conclusion from the
consistency of Part 26 procedures with selected to perform the evaluation if the evaluation. By implication, if the MRO
the procedures that collectors must MRO does not perform it. Sections performs the evaluation, the MRO
follow when conducting tests under 26.119(b)(1) and (b)(2) require the MRO provides this written statement. The
DOT requirements. The NRC expects to inform the physician that the donor
written statement is necessary to
that fewer donors will be subject to ‘‘shy was required to take a drug test under
communicate the results of the
bladder’’ problems under the final rule Part 26 but was unable to provide a
evaluation and create a record of it,
sufficient quantity of urine for testing
because § 26.109 reduces the minimum should any question arise later with
and explain the potential consequences
quantity of urine required from 60 mL respect to the determination.
to the donor for a refusal to test. These
in the former rule to 30 mL. However, This section also requires that the
requirements ensure that the evaluating
because some donors’ medical problems physician must provide only the
physician understands the context in
may also interfere with their ability to information that is necessary to support
which he or she is being asked to
provide 30 mL of urine, the final rule the physician’s conclusion. The NRC
perform the evaluation. Section
incorporates the DOT procedures. These has added this requirement to protect
26.119(b)(3) also requires the MRO to
procedures are intended to protect the the donor’s privacy by ensuring that the
inform the physician that he or she must
due process rights of individuals who physician documents only the medical
agree to follow the procedures specified
are subject to Part 26. That is, this in § 26.119(c) through (f) if he or she information that is necessary to support
section establishes procedures for performs the evaluation. This the determination.
ensuring that there is a legitimate requirement ensures that the physician The NRC added § 26.119(f) to require
medical reason that a donor was or is understands and consents to follow the the physician to inform the MRO, in the
unable to provide a urine specimen of procedures specified in this section. written statement, whether any medical
the required quantity so that the The NRC added § 26.119(c) to condition that may be identified also
licensee or other entity has a medical describe the conclusions that the precludes the donor from providing
basis for not imposing sanctions on the physician must provide to the MRO specimens of 30 mL or more in future
individual. In addition, the MRO is following the evaluation. Under collections. This information is
authorized to devise alternative § 26.119(c)(1), the physician may necessary for the MRO to determine
methods of drug testing, if it appears determine that a medical condition has, whether to implement alternative
that the donor’s medical problem or with a high degree of probability methods of drug testing for the donor,
prevents him or her from being able to could have, precluded the donor from as required under § 26.119(g)(3).
provide sufficient urine for drug testing providing the required quantity of urine. The agency added § 26.119(g) to
in future tests. Or, under § 26.119(c)(2), the physician prescribe the actions that the MRO must
The agency has added § 26.119(a) to may determine that there is an take based on the results of the
require that a licensed physician, who inadequate basis for determining that a evaluation, as follows:
has appropriate expertise in the medical medical condition has, or with a high Section 26.119(g)(1) requires the MRO
issues raised by the donor’s failure to degree of probability could have, to determine that the donor did not
provide a sufficient specimen, must precluded the donor from providing a violate the FFD policy, if the physician
evaluate a donor who was unable to sufficient quantity of urine. The final concluded that a medical condition
provide a urine specimen of at least 30 rule limits the physician’s conclusions could account for the insufficient
mL. The rule permits the MRO to to one of these two alternatives to specimen and the MRO concurred with
perform the evaluation if the MRO ensure that the results of the evaluation that conclusion. In this instance, the
possesses the appropriate expertise. If are relevant to and useful for licensee or other entity does not impose
not, the rule requires the MRO to review determining whether sanctions must be sanctions on the donor because the
the qualifications of the physician and imposed on the donor for a refusal to donor had not violated the FFD policy
agree to the selection of that physician. test. by refusing to test.
Section 26.119(g)(2) requires the MRO adulterated, substituted, dilute, or individuals’ qualifications. The final
to determine that the donor had refused invalid. The new term used for these rule makes minor changes in the former
to be tested by failing to provide a validity testing results is ‘‘questionable provision to improve consistency with
sufficient specimen, if the physician validity.’’ The NRC has added a amended language in the related portion
concluded that a medical condition definition for ‘‘questionable validity’’ to of the HHS Guidelines.
could not account for the insufficient § 26.5 [Definitions]. Adding the term Section 26.125(b) amends former
specimen. In this instance, the licensee ‘‘questionable validity’’ addresses the Section 2.6(b) in Appendix A to Part 26.
or other entity imposes the sanction of commenters’ concern and improves the This provision required laboratory
a permanent denial of authorization for clarity of the final rule to meet Goal 6 technicians and nontechnical staff to
an attempt to subvert the testing of this rulemaking. The NRC retained have the necessary training and skills
process, as required under § 26.75(b). the use of ‘‘positive’’ to refer to results for the tasks assigned to them. The final
Section 26.119(g)(3) requires the MRO from initial testing for drugs that rule retains the former provision and
to devise an alternative method of indicate the presence of a prohibited adds another. The final rule requires
collecting specimens for drug testing, if drug in the specimen. laboratory technicians who perform
the donor’s medical condition, over the urine specimen testing to demonstrate
long-term, consistently prevents the Section 26.121 Purpose proficiency in operating the instruments
donor from providing urine specimens The NRC added § 26.121 to provide and tests used at the licensee testing
of 30 mL or more. For example, the an overview of the contents of the facility. The NRC added this proficiency
provision permits the MRO to direct the proposed subpart, consistent with Goal requirement to ensure that technicians
collection and testing of alternate 6 of this rulemaking to improve clarity are capable of correctly using the
specimens, including, but not limited in the organization and language of the instruments and tests that the licensee
to, hair, or other bodily fluids, if, in the final rule. testing facility has selected for validity
MRO’s professional judgment, the Section 26.123 Testing Facility
and drug testing. This change is
collection and analysis of these alternate necessary for several reasons. First, the
Capabilities
specimens is scientifically defensible final rule adds new requirements for
and forensically sound. The section Section 26.123 amends the second licensee testing facilities to conduct
grants flexibility to the MRO in sentence of former Section 2.7(l)(2) in validity testing, and the instruments and
exercising his or her professional Appendix A to Part 26 as it related to tests that the technicians will use are
judgment in determining an alternative the capabilities of licensee testing likely to differ from those previously
method of conducting drug testing, facilities. The final rule retains the used at licensee testing facilities.
rather than establishing detailed former requirement for licensee testing Therefore, additional training and
requirements that may not appropriately facilities to be capable of performing proficiency testing is required to ensure
address the range of possible medical initial tests for each drug and drug that validity testing is conducted
conditions that could arise. metabolite for which testing is properly. Second, the final rule permits
conducted by the FFD program and licensees and other entities to rely on
Subpart F—Licensee Testing Facilities adds a requirement for licensee testing drug test results from testing that was
In this subpart, the final rule replaces facilities to have the capability to performed by another Part 26 program
two terms used in the proposed rule in perform either validity screening tests, to a greater extent than the former rule.
response to public comments. These initial validity tests, or both. The agency Therefore, it is necessary to ensure that
language changes affect numerous moved the first sentence of former all drug testing performed under Part
sections within Subpart F. First, one Section 2.7(l)(2), which established 26, including tests performed at licensee
public comment addressed a proposed requirements for the capabilities of testing facilities, meets minimum
provision in § 26.137(b) [Performance HHS-certified laboratories, to Subpart G standards. The requirement for
testing and quality control requirements [Laboratories Certified by the technicians to demonstrate proficiency,
for validity screening tests] that Department of Health and Human then, contributes to meeting this goal.
permitted licensee testing facilities to Services]. The NRC deleted the last Third, the experience of other Federal
use validity screening tests approved by sentence of the former paragraph, which agencies has shown that requirements
the U.S. Food and Drug Administration permitted the testing of breath for technicians to demonstrate
(FDA). The NRC has eliminated both the specimens for alcohol at the collection proficiency assist in any litigation that
requirement and the use of the term site, because the final rule addresses may occur with respect to urine test
‘‘device’’ with respect to validity alcohol testing in Subpart E [Collecting results.
screening testing because the FDA is not Specimens for Testing]. The NRC made With respect to the proposed rule and
responsible for approving validity these changes to the former provision to in response to a public comment that
screening devices. The final rule has meet Goal 6 of this rulemaking to proficiency documentation
replaced the term ‘‘device’’ in ‘‘validity improve organizational clarity in the requirements were missing from the
screening device’’ with the term ‘‘test’’ final rule. proposed rule in several locations, the
throughout Subpart F. Second, several final rule adds a requirement for
public comments addressed the use of Section 26.125 Licensee Testing licensee testing facilities to document
the term ‘‘non-negative’’ to refer to drug Facility Personnel the proficiency of its technicians.
and validity test results and requested Section 26.125 amends former Section Although proposed § 26.125(c) required
that the NRC eliminate the term from 2.6 in Appendix A to Part 26 [Licensee licensee testing facility personnel files
the final rule and instead use a more testing facility personnel], as follows: to include documentation of training
familiar term such as ‘‘positive’’ test Section 26.125(a) retains former and experience and the results of tests
result. Throughout Subpart F, the NRC Section 2.6(a) in Appendix A to Part 26. that establish employee competency for
has replaced the term ‘‘non-negative’’ This provision requires each licensee the position he or she holds, the final
with a new term to address validity testing facility to have one or more rule adds a requirement for
screening and initial validity testing individuals who are responsible for the documentation of proficiency in
results from a licensee testing facility day-to-day operations of the facility and § 26.125(b) to further clarify that this
that indicate that a specimen may be establishes requirements for those documentation is required and
specifically applies to laboratory reference to procedures for specimen portions of the former provision to other
technicians who perform urine drug collections in this paragraph because subparts of the rule that address related
testing. The NRC made this change to procedural requirements for specimen topics to improve clarity in the
meet Goal 6 of this rulemaking to collections are addressed in Subpart E. organization and language of the final
improve clarity in the organization and Section 26.127(b) amends and rule, as follows: The agency relocated
language of the rule. combines portions of the requirements the last two sentences of former Section
Section 26.125(c) amends former in the first sentence of former Section 2.7(o)(1) in Appendix A to Part 26,
Section 2.6(c) in Appendix A to Part 26. 2.4(d) and 2.7(a)(2) in Appendix A to which addressed requirements for
The provision establishes recordkeeping Part 26 related to the content and retaining copies of superceded
requirements for the personnel files of implementation of specimen chain-of- procedures, to § 26.715(a) of Subpart N
licensee testing facility staff. The final custody procedures. The final rule [Recordkeeping and Reporting
rule, with respect to the proposed rule, retains the portions of the former Requirements], and the final rule moves
further clarifies the intent of the provisions that required licensee testing procedural requirements for HHS-
licensee testing facility personnel facilities to develop, implement, and certified laboratories to § 26.157(b) in
competency requirements by specifying maintain written chain-of-custody Subpart G.
that personnel must be proficient in procedures to maintain control and Section 26.127(d) amends former
conducting testing using the most recent accountability of specimens from Section 2.7(o)(3)(iii) in Appendix A to
instructions from instrument and test receipt through completion of testing Part 26. This provision required
manufacturers. In addition, in response and reporting of results, during storage procedures for the setup and normal
to comments received on the and shipping to the HHS-certified operation of testing instruments, a
elimination of the former provision in laboratory, and continuing until final schedule for checking critical operating
Section 2.5(f) in Appendix A to Part 26 disposition of the specimens. For characteristics for all instruments,
that required licensees and other organizational clarity, the NRC moved tolerance limits for acceptable function
entities to maintain color blindness the former requirements related to HHS- checks, and instructions for major
testing records in files for licensee certified laboratories to § 26.157(b) in troubleshooting and repair. The final
testing facility personnel, the final rule Subpart G. The final rule also removes rule extends the former requirements to
reinstates the requirement. The final references to custody-and-control non-instrumented tests (such as some
rule retains the color blindness testing procedures for blood specimens because validity screening tests, if the licensee
recordkeeping requirement because donors no longer have the option to testing facility uses these tests),
some validity screening and initial request blood testing for alcohol, as
consistent with the addition of
validity tests require laboratory testing discussed with respect to § 26.83(a).
requirements to conduct validity testing
facility personnel to visually evaluate Section 26.127(c) retains the portions
of former Section 2.7(o)(1) in Appendix throughout the final rule. The final rule
the color of the assay to determine the
A to Part 26 that addressed the required also makes three organizational changes
test result. Retaining records of color
content of procedures for licensee to the former provision. The final rule
blindness testing is necessary to
testing facilities and amends the former presents the required topics of the
demonstrate licensee testing facility
requirements. The final rule retains the procedures in a list format in
personnel competency.
portions of the former provision that § 26.127(d)(1)–(d)(3) to clarify that each
Section 26.127 Procedures required licensee testing facilities to topic stands on its own. The NRC
Section 26.127 combines, reorganizes, develop and maintain procedures to relocated the former requirement to
and amends requirements for specify all of the elements of the testing maintain records of preventative
procedures that were interspersed process, including, but not limited to, maintenance to § 26.715(b)(10) in
throughout Appendix A to Part 26, the principles of each test and the Subpart N. And, the NRC has moved the
including requirements in former preparation of reagents, standards, and former requirements that applied to
Sections 2.2 [General administration of controls. The final rule presents the HHS-certified laboratories to § 26.157(d)
testing] and 2.7 [Laboratory and testing required topics of the procedures in a in Subpart G. These changes improve
facility analysis procedures]. These list format in § 26.127(c)(1)–(c)(12) to clarity in the organization of the rule,
changes improve clarity in the clarify that each topic stands on its own consistent with Goal 6 of this
organization of the final rule by and to meet Goal 6 of this rulemaking rulemaking.
grouping procedural requirements for to improve clarity in the organization of Section 26.127(e) reorganizes and
licensee testing facilities in one section, the rule. amends former Section 2.7(o)(4) in
consistent with Goal 6 of this Section 26.127(c) also amends former Appendix A to Part 26. The former
rulemaking. Section 2.7(o)(1) in Appendix A to Part provision required corrective actions to
Section 26.127(a) makes minor 26 in several ways. First, the final rule be documented if systems are out of
editorial changes to the first sentence of eliminates the former requirement for acceptable limits or errors are detected.
former Section 2.2 in Appendix A to the procedures to be maintained in a The final rule extends the former
Part 26. The former provision required laboratory manual as unnecessarily requirement to validity screening tests if
licensee testing facilities and HHS- restrictive. The final rule permits the licensee testing facility uses these
certified laboratories to have detailed licensee testing facilities to use other tests, consistent with the addition of
procedures for conducting testing. The means to maintain their procedures. requirements to conduct validity testing
final rule deletes the reference to blood Second, the agency has added a throughout the final rule. The final rule,
samples in the former provision because requirement for the development, with respect to the proposed rule, also
donors no longer have the option to implementation, and maintenance of adds the term ‘‘instrumented’’ to clarify
request blood testing for alcohol, as written standard operating procedures that a licensee testing facility must
discussed with respect to § 26.83(a). For for all laboratory instruments and develop and implement procedures for
organizational clarity, the final rule validity screening tests, consistent with remedial actions on testing facility
moves the reference to HHS-certified the addition of requirements to conduct equipment, instruments, and tests. The
laboratories to § 26.157(a) in Subpart G. validity testing throughout the final NRC has moved the requirements in the
The final rule also deletes the former rule. Third, the final rule moves two former paragraph that applied to HHS-
certified laboratories to § 26.157(e) in rejected for testing by the HHS-certified personnel to correct any systematic
Subpart G for organizational clarity. laboratory (if the specimen must be weaknesses in specimen custody-and-
subject to additional testing) when flaws control procedures that may be
Section 26.129 Assuring Specimen
can be corrected. For example, if the identified in the investigation, such as
Security, Chain of Custody, and
collector’s signature is missing on the inadequate safeguarding of specimen
Preservation
custody-and-control form, licensee shipping containers.
Section 26.129 has been added to testing facility personnel will work with Section 26.129(b)(1)(ii) adds a
group together in one section the collection site personnel to attempt to prohibition on testing of any specimen
requirements of the final rule that apply identify the collector and obtain a if the licensee or other entity has reason
to licensee testing facilities with respect memorandum for the record from the to believe that the specimen was subject
to the safeguarding of specimen collector if possible. This requirement to tampering or altered in a manner as
identity, integrity, and security. The reduces the potential burden on donors to affect specimen identity and integrity.
NRC made this organizational change who may otherwise be required to In this circumstance, the MRO will
because requirements that addressed submit additional specimens to replace cancel testing of the specimen or any
these topics were dispersed throughout those for which the chain of custody test results for the specimen, and
the former rule. Grouping them together could not be confirmed. The final rule, require the licensee or other entity to
in a single section makes them easier to with respect to the proposed rule, adds retest the donor who submitted the
locate within the final rule and meets a provision that specifies the procedures original specimen. The final rule, with
Goal 6 of this rulemaking to improve to be followed by licensee testing respect to the proposed rule, adds an
clarity in the language and organization facility personnel to correct custody- exception for split specimen collections
of the rule. and-control form errors that are in response to a public comment that
Section 26.129(a) retains the first four identified after the specimen collection requested additional clarification of the
sentences of former Section 2.7(a)(1) in proposed rule’s requirements for
process has been completed and the
Appendix A to Part 26. The provision cancelling tests. For a split specimen
donor has departed from the collection
requires licensee testing facilities to be collection, if the tamper-evident seal
site. This addition is based on a
secure and accessible only to authorized remains intact on either Bottle A or
comment received on the proposed rule
personnel. The final rule moves the Bottle B of the specimen and the bottle
requesting the addition of these
requirements in the former provision contains at least 15 mL of urine, the
procedures. The requirements also
that applied to HHS-certified final rule requires the licensee testing
improve the efficiency of FFD programs
laboratories to § 26.159(a). The final rule facility to forward the intact specimen
by avoiding the need to conduct
moves the last sentence of the former to the HHS-certified laboratory and
additional specimen collections when
paragraph, which established prohibits any testing at the licensee
recordkeeping requirements, to discrepancies can be corrected. The
additional provision meets Goal 7 of testing facility. This new provision
§ 26.715(b)(13) in Subpart N. The NRC serves to eliminate unnecessary
made these changes for organizational this rulemaking to protect the privacy
and other rights (including due process) additional specimen collections, thereby
clarity. meeting Goal 3 of this rulemaking to
Section 26.129(b) amends former of individuals who are subject to Part
26, as well as Goal 1 of this rulemaking, improve the effectiveness and efficiency
Section 2.7(b)(1) in Appendix A to Part of FFD programs.
26. This provision established to update and enhance the consistency
The NRC added § 26.129(b)(2) in the
requirements for receiving specimens at of Part 26 with advances in other
final rule, with respect to the proposed
the licensee testing facility and assuring relevant Federal rules and guidelines.
rule, to include specific instances that
their integrity and identity. For Section 26.129(b)(1) adds would require the cancellation of the
organizational clarity, the final rule requirements for licensee testing facility testing of a donor’s urine specimen.
moves the former requirements related personnel to report to management any This change has been made in response
to HHS-certified laboratories to indications of specimen tampering to a public comment that requested the
§ 26.159(b) in Subpart G. The final rule, within 8 hours of the discovery. This NRC to add information in the final rule
with respect to the proposed rule, adds provision also requires licensee or other to describe the actions that must be
§ 26.129(b)(1) and (b)(2) to improve the entity management personnel to initiate taken if the integrity of a specimen is in
clarity of the organization of the rule. an investigation to determine whether question. Adding this information to the
The NRC has also added several tampering has occurred. Section final rule meets Goal 7 of this
requirements to the former provision, as 26.129(b)(i) requires management to rulemaking to protect the privacy and
follows: take corrective actions if tampering is other rights (including due process) of
In § 26.129(b), the final rule retains confirmed. The final rule adds these individuals who are subject to Part 26,
the requirement for licensee testing requirements because some licensees as well as Goal 1 to improve the
facility personnel to inspect specimens did not investigate or take corrective consistency of NRC requirements with
received for testing to determine actions in response to indications of those of other Federal agencies. The
whether there is any evidence of tampering with specimens under the provisions are modeled on similar
tampering with the specimens and to former rule. The appropriate corrective requirements in the DOT’s drug testing
ensure that the custody-and-control actions that management personnel program.
documents are correct. With respect to would take depend on the nature of the Although the NRC is not aware of any
the proposed rule, the final rule adds a tampering identified as a result of the instances when these circumstances
requirement for licensee testing facility investigation. For example, if the have arisen in Part 26 programs, the
personnel to attempt to resolve any investigation indicated that the experience of other Federal agencies
discrepancies in the information on tampering was an attempt to subvert the indicates that specimen tampering is
specimen bottles or on the testing process and the persons involved possible. Therefore, the requirements in
accompanying custody-and-control were identified, management personnel § 26.129(b) are necessary to ensure that
forms to ensure the identity and would impose the sanctions in donors are not subject to sanctions for
integrity of specimens and prevent § 26.75(b) for a subversion attempt. This positive, adulterated, substituted, or
specimens from being unnecessarily provision also requires management invalid test results from a specimen that
may not have been theirs. These 26. This provision required licensee The final rule also adds a requirement
changes meet Goal 7 of this rulemaking testing facility personnel to maintain for refrigerating any specimen (and the
to protect the privacy and other rights and document the chain of custody for associated Bottle B specimen if a split
(including due process) of individuals specimens and aliquots. The final rule specimen collection is performed) that
who are subject to Part 26 and ensure incorporates the simpler language of the yields a questionable validity test result
that the individuals are afforded related provision from the HHS from validity screening or initial
accurate and consistent testing. These Guidelines while retaining the intent of validity testing. Refrigerating these
requirements are also consistent with the former provision. The final rule specimens is necessary because some
the requirements of other Federal relocates the requirements in the former adulterants have been shown to
agencies. section that were related to HHS- interfere with drug test results more
Section 26.129(c) amends former certified laboratories to § 26.159(d) and rapidly if the specimen remains at room
Section 2.7(b)(2) in Appendix A to Part (e) in Subpart G to improve temperature.
26. This provision established organizational clarity. The final rule also updates the
requirements for chain-of-custody Section 26.129(e) amends the first terminology used in the former
procedures for specimens and aliquots sentence of former Section 2.7(d) in paragraph to be consistent with the new
at licensee testing facilities. The final Appendix A to Part 26 [Specimen terminology adopted throughout the
rule moves the requirements in the processing]. That sentence required final rule for referring to split
former paragraph that were related to specimens that test as ‘‘presumptive specimens. Therefore, in the final rule,
HHS-certified laboratories to Subpart G positive’’ at the licensee testing facility the licensee testing facility continues to
to improve organizational clarity. to be shipped to the HHS-certified be responsible for protecting from
The section incorporates two laboratory for further testing. The final degradation the primary specimen
additional changes to the former rule replaces the term ‘‘presumptive (Bottle A) and the specimen in Bottle B
provision at the request of stakeholders positive’’ with terms to describe the of a split specimen if the FFD program
at the public meetings discussed in specific test results, as appropriate (i.e., follows split specimen procedures. The
Section I.D. The stakeholders requested ‘‘positive,’’ ‘‘questionable validity’’) in rule also requires the licensee testing
that the NRC permit licensee testing order to address validity testing results, facility to refrigerate any specimen that
facilities to use methods other than a consistent with the addition of yields a positive test result or a
custody-and-control form to maintain requirements to conduct validity testing questionable validity test result. This
the chain of custody for aliquots of a throughout the final rule, as discussed includes the specimen in Bottle B
specimen that are tested at the licensee with respect to § 26.31(d)(3)(i). For associated with any aliquot that yields
testing facility. The NRC incorporated organizational clarity, the agency has a positive or questionable validity test
this change because methods other than moved the requirements in former result at the licensee testing facility. The
a custody-and-control form, such as the Section 2.7(d) in Appendix A to Part 26 NRC made these changes in the
use of bar coding, have been shown to that related to quality control terminology of the paragraph to improve
be equally effective at tracking the chain procedures for testing at licensee testing clarity in the language of the final rule.
of custody for an aliquot at licensee facilities and HHS-certified laboratories The final rule separates former
testing facilities. Adding this flexibility to § 26.137 [Quality assurance and Section 2.4(i) in Appendix A to Part 26
is consistent with Goal 5 of this quality control] and § 26.167 [Quality [Transportation to laboratory or testing
rulemaking to improve Part 26 by assurance and quality control] of the facility] into two paragraphs, § 26.129(g)
eliminating or modifying unnecessary final rule, respectively. and (h), for organizational clarity and
requirements. Section 26.129(f) clarifies and revises amends the former provision for the
The stakeholders also requested that former Section 2.7(c) in Appendix A to reasons previously discussed with
the section specify the conditions under Part 26 [Short term refrigerated storage], respect to § 26.117(i) and (k). Section
which specimens and aliquots may be as it related to refrigerating urine 26.129(g) and (h), which repeats the
discarded because the former rule did specimens to protect them from requirements for packaging and
not address discarding of negative degradation. For organizational clarity, shipping specimens contained in
specimens. Therefore, the final rule the final rule moves the former § 26.117(i) and (k) of Subpart E, applies
permits licensee testing facilities to requirements that applied to HHS- these requirements to packaging and
discard specimens and aliquots as soon certified laboratories to § 26.159(h) in shipping specimens from licensee
as practical after validity screening or Subpart G. The final rule restates testing facilities to HHS-certified
initial validity tests have demonstrated portions of the former provision and laboratories. The basis for these
that the specimen is valid and initial adds a performance standard regarding requirements is discussed with respect
test results for drugs and drug ‘‘appropriate and prudent actions’’ to to § 26.117(i) and (k).
metabolites are negative. The minimize specimen degradation. For the
clarification codifies licensee practices. reasons discussed with respect to Section 26.131 Cutoff Levels for
This permission has no impact on § 26.117(j), the final rule no longer Validity Screening and Initial Validity
donors’ rights under the final rule requires all specimens to be refrigerated Tests
because donors are not at risk of within 6 hours after collection, but adds The NRC has added § 26.131 to
management actions or sanctions as a a requirement that any specimen that establish cutoff levels for validity
result of negative test results and, has not been tested within 24 hours of screening and initial validity tests that
therefore, do not need the licensee receipt at the licensee testing facility are conducted at licensee testing
testing facility to retain the specimen for must be refrigerated. The final rule facilities. The procedures, substances,
additional testing for review or litigation continues to require the licensee or and cutoff levels for initial validity
purposes. The change has been made to other entity to refrigerate any specimen testing in this section incorporate
meet Goal 6 of this rulemaking to (and the associated Bottle B for that related requirements from the HHS
improve clarity in the language of the specimen if the FFD program follows Guidelines (69 FR 19643; April 13,
final rule. split specimen procedures) that yields a 2004). The validity screening test
Section 26.129(d) updates former positive test result from initial drug requirements have been adapted, in
Section 2.7(a)(2) in Appendix A to Part testing at the licensee testing facility. large part, from the HHS proposed
revision to the Guidelines that was also As discussed in Section IV.C, the levels for validity screening and initial
published in the Federal Register on primary distinction between validity validity testing than the cutoff levels
April 13, 2004 (69 FR 19673). screening tests and initial validity tests established in this provision. This
In contrast to the requirements for is that validity screening tests may be prohibition is necessary to decrease the
initial validity testing in the HHS performed using non-instrumented risk of obtaining false adulterated,
Guidelines, the final rule does not devices, such as dipsticks, whereas substituted, or invalid test results and
permit licensee testing facilities to initial validity tests generally rely on ensures that donors are not subject to
evaluate the specific gravity of any more complex instrumented testing sanctions on the basis of inaccurate test
specimens. To determine if a specimen technologies. The final rule permits results.
is dilute or substituted, specific gravity licensee testing facilities to perform Section 26.131(b)(1)–(b)(8) specifies
testing is required. If the creatinine validity screening tests before the criteria for determining whether the
concentration of a specimen is less than performing initial validity tests but does licensee testing facility must forward a
20 mg/dL, the final rule requires the not require them to do so because specimen to an HHS-certified laboratory
licensee testing facility to forward the validity screening tests are unnecessary for further validity testing. These
specimen to the HHS-certified if the licensee testing facility performs criteria are incorporated from the HHS
laboratory to complete the testing, initial validity testing. Licensees and Guidelines. With respect to the
where the specimen’s specific gravity other entities may choose to conduct proposed rule, the agency modified the
will be measured. The final rule differs validity screening tests, followed by requirements in the final rule in
from the HHS Guidelines in this initial validity testing of any specimens response to public comments received
provision because the costs of the that are identified to be of questionable on the proposed specimen pH and
instruments (i.e., refractometers) that are validity as a result of validity screening, nitrite levels. Specifically, the
required in the Guidelines for potentially to reduce the number of commenters identified that the
measuring specific gravity are high. donor specimens that must be proposed rule did not include pH and
Some licensee testing facilities are forwarded to the HHS-certified nitrite levels that would permit the
currently measuring the specific gravity laboratory. In addition, the rule permits licensee testing facility to detect a
of specimens. However, the cutoff levels licensee testing facilities to choose specimen that meets the criteria for an
established in the Guidelines require whether to conduct validity screening invalid test result in the HHS
more sensitive measurement and tests or initial validity testing for each Guidelines. Therefore, § 26.131(b)(2) in
type of validity testing that is required the final rule establishes a pH level of
licensee testing facilities would be
under the rule. For example, a licensee less than 4.5, rather than a pH level of
required to purchase new equipment in
or other entity may choose to use less than 3.0 in the proposed rule, as
order to test at the new HHS specific
dipsticks (a validity screening test) to one criterion for determining that a
gravity cutoff levels. Therefore, the final
evaluate a specimen’s creatinine specimen requires additional validity
rule requires licensee testing facilities to
concentration and only a pH meter (a testing. The NRC also revised the nitrite
transfer all specimens with creatinine
method for conducting initial validity concentration from equal to or greater
concentrations less than 20 mg/dL to an
testing) without first performing a than 500 micrograms (mcg) per mL in
HHS-certified laboratory to complete the
validity screening test for pH to evaluate proposed § 26.131(b)(3) to equal to or
initial testing process and does not
the specimen’s pH. The NRC is greater than 200 mcg/mL in the final
include cutoff levels for specific gravity rule. These changes to the pH and
permitting flexibility in the means
or quality control requirements for nitrite criteria in the final rule are
licensee testing facilities use to conduct
measuring specific gravity. consistent with the current HHS
specimen validity testing to meet Goal
Section 26.131(a) has been added to 3 of this rulemaking to enhance the Guidelines and meet Goal 1 of this
require licensee testing facilities to efficiency and effectiveness of FFD rulemaking to update and enhance the
perform either validity screening tests, programs. consistency of Part 26 with advances in
initial validity tests, or both. Consistent Section 26.131(b) requires licensee other relevant Federal rules and
with related requirements for further testing facilities to test each urine guidelines. By ensuring detection of
testing of a specimen at an HHS- specimen for creatinine concentration, specimens that may be invalid, these
certified laboratory when initial drug pH, and the presence of one or more changes also meet Goal 3 of this
testing at the licensee testing facility oxidizing adulterants, such as nitrite or rulemaking to improve the effectiveness
yields a positive test result, the final bleach. Abnormal creatinine and efficiency of FFD programs.
rule also requires licensee testing concentrations, abnormal pH values, or
facilities to forward specimens that Section 26.133 Cutoff Levels for Drugs
the possible presence of an oxidizing
yield a questionable validity screening and Drug Metabolites
adulterant indicate that a donor may
or initial validity test result to an HHS- have altered the specimen (e.g., Section 26.133 replaces former
certified laboratory for further testing. adulterated the specimen or substituted Section 2.7(e)(1) in Appendix A to Part
Further testing at an HHS-certified another substance in place of the 26. That section established cutoff levels
laboratory is necessary because licensee donor’s urine) in an attempt to subvert for initial testing for drugs and drug
testing facilities do not have the the testing process. The final rule metabolites. Section 26.133 replaces and
sophisticated testing instruments permits licensees and other entities to amends some cutoff levels for initial
required for conducting confirmatory choose the oxidizing adulterant(s) for tests for drugs and drug metabolites in
testing that are required under the HHS which testing will be conducted. The former Section 2.7(e)(1) in Appendix A
Guidelines. In addition, further testing requirements in this paragraph are to Part 26 to be consistent with the HHS
at an HHS-certified laboratory provides consistent with the related requirements cutoff levels for the same substances.
an independent check on test results in the HHS Guidelines. The NRC has decreased the initial test
from licensee testing facilities that is Because validity testing is complex cutoff level for marijuana metabolites
necessary to ensure that donors are and the methods for testing are from 100 nanograms (ng) per milliliter
afforded accurate and consistent testing relatively new, the second sentence of (mL) to 50 ng/mL. Current immunoassay
under this part, consistent with Goal 7 § 26.131(b) prohibits an FFD program techniques can now reliably detect the
of this rulemaking. from establishing more stringent cutoff presence of marijuana metabolites at
this cutoff level. As discussed in Section Section 2.7(j) in Appendix A to Part 26. HHS-certified laboratory for testing on
IV.B, this change strengthens the The final rule revises the terminology the same day of the donor request. The
effectiveness of FFD programs by used in these sentences (e.g., ‘‘Bottle A’’ final rule, with respect to the proposed
increasing the likelihood of detecting rather than ‘‘primary specimen,’’ ‘‘Bottle rule, references the provisions in
marijuana use. B’’ rather than ‘‘split specimen,’’ § 26.165(b) pertaining to the time period
The final rule increases the initial test ‘‘positive or of questionable validity’’ (1 business day) within which licensee
cutoff level for opiate metabolites from rather than ‘‘presumptive positive’’) to testing facilities must forward a
300 ng/mL in the former rule to 2,000 be consistent with terminology used in specimen to a second HHS-certified
ng/mL. The change in the cutoff level other parts of the regulation without laboratory following the donor request.
for opiate metabolites substantially amending the meaning of the sentences. This change responds to stakeholder
reduces the number of positive opiate The final rule deletes the requirement in feedback provided during the public
test results that are reported to MROs by the third sentence of former Section meetings discussed in Section IV.D. The
HHS-certified laboratories that MROs 2.7(j) to seal the split specimen prior to stakeholders reported that
ultimately verify as negative. placing it in secure storage because implementing the former same-day
The final rule retains the permission Bottles A and B have already been requirement was often difficult for a
in the former rule for licensees and sealed at the collection site, as required number of reasons, including, for
other entities to establish more stringent under § 26.113(b)(3). The final rule adds example, communication delays among
cutoff levels for initial drug tests, a requirement to forward the Bottle A donors, MROs, and FFD program
subject to the requirements specified in specimen to an HHS-certified laboratory personnel, particularly on weekends
§ 26.31(d)(3)(iii), for the reasons if the licensee testing facility obtains a and holidays, and the time required to
discussed with respect to that questionable validity test result. This identify a second laboratory with the
paragraph. requirement is consistent with the appropriate capability to test the split
The final rule eliminates the former addition of requirements to conduct specimen, depending on the nature of
requirement for licensees and other validity testing throughout the final the non-negative test result. The final
entities to report drug test results for rule, as discussed with respect to rule alleviates some of these logistical
both the cutoff levels in the former rule § 26.31(d)(3)(i). With respect to the difficulties (e.g., logistical problems
and any more stringent cutoff levels proposed rule, the final rule adds a associated with weekends and holidays)
they applied. The NRC in the former requirement that Bottle B specimens while continuing to provide the donor
rule required FFD programs to report must remain in secure storage under the with timely test results. Therefore, the
test results for the cutoff levels specified requirements in § 26.159(i) if the NRC made this change to meet Goal 5
in this part, when the licensee was licensee testing facility retains Bottle B of this rulemaking to improve Part 26 by
applying more stringent cutoff levels, specimens rather than sending the eliminating or modifying unnecessary
because it provided means for the NRC specimens to the HHS-certified requirements.
to monitor licensees’ implementation of laboratory with Bottle A specimens.
the permission to use more stringent Section 26.135(b) amends the Section 26.135(c) amends former
cutoff levels. The final rule eliminates requirements in former Section 2.7(j) in Section 2.7(c) in Appendix A to Part 26
this requirement because Appendix A to Part 26 related to donor that applied to storing specimens at
§ 26.31(d)(3)(iii)(C) requires a qualified requests for testing of the specimen in licensee testing facilities. The NRC has
forensic toxicologist to certify the Bottle B. The final rule adds adulterated amended some of the terminology used
scientific and technical validity of the or substituted validity test results as a in the former provision for consistency
licensee’s or other entity’s testing basis for a donor request for testing the with the terminology changes made
process at any lower cutoff levels. specimen in Bottle B consistent with the throughout the rule. For example, the
Therefore, the reporting requirement is addition of requirements to conduct provision replaces the term ‘‘split
no longer needed to ensure licensee validity testing throughout the final specimen’’ with the term ‘‘Bottle B.’’ In
testing facility performance in this area. rule, as discussed with respect to addition, the final rule imposes the
Eliminating this requirement meets Goal § 26.31(d)(3)(i). The final rule, with requirements for long-term frozen
5 of this rulemaking to improve Part 26 respect to the proposed rule, imposes a storage of split specimens in former
by eliminating or modifying requirement on the MRO to ensure that Section 2.7(h) in Appendix A to Part 26
unnecessary requirements. Bottle B is forwarded to a second HHS- on licensees and other entities who
certified laboratory that did not test the choose to retain Bottle B of a split
Section 26.135 Split Specimens specimen at the licensee testing facility
specimen in Bottle A, at the request of
The NRC has added § 26.135 to the donor, and to follow the procedures rather than forwarding it with Bottle A
reorganize and amend the requirements specified in § 26.165(b). In addition, the to the HHS-certified laboratory when
contained in former Section 2.7(j) in NRC eliminated the procedures for additional testing at the HHS-certified
Appendix A to Part 26 that related to donor requests for testing the specimen laboratory is required. The final rule
licensee testing facility handling of split in Bottle B that were included in this requires licensees and other entities to
specimens. The requirements in this provision in the proposed rule because ensure that Bottle B of any specimen
section apply only to FFD programs that they were incomplete and partially that the MRO has confirmed to be
follow split specimen collection redundant with the related provision in positive, adulterated, substituted, or
procedures. The NRC has divided the § 26.165(b). The NRC made these invalid is retained in long-term frozen
former provision into separate changes to meet Goal 6 of this storage for at least 1 year. The final rule,
paragraphs in this section to indicate rulemaking to improve clarity in the with respect to the proposed rule,
that each requirement stands on its own. organization and language of the rule. includes a requirement that licensee
This change has been made to meet Goal The final rule eliminates the testing facilities who retain Bottle B
6 of this rulemaking to improve clarity requirement in the fourth sentence of specimens must ensure that proper
in the organization and language of the former Section 2.7(j) in Appendix A to specimen storage conditions (i.e., frozen
final rule. Part 26 that required the licensee testing storage) are maintained during extended
Section 26.135(a) amends the second, facility or HHS-certified laboratory to power outages. This change is based on
third, and fourth sentences of former forward the split specimen to another comments received on the proposed
rule noting the oversight. The final rule testing at the licensee testing facility, that identified an adulterant that the
is consistent with former Section 2.7(c) consistent with the addition of HHS-certified laboratory could not
in Appendix A to Part 26, which requirements to conduct validity testing identify because the laboratory did not
required licensee testing facilities to throughout the proposed rule, as also test for the adulterant in their
have emergency power equipment discussed with respect to proposed validity testing panel. If this was the
available in case of a prolonged power § 26.31(d)(3)(i). case, a specimen with a questionable
failure. The final rule extends the Section 26.137(b) [Performance validity result from a licensee testing
former requirement to apply to Bottle B testing and quality control requirements facility would be tested by the HHS-
of any specimen that has yielded for validity screening tests] establishes certified laboratory and the specimen
adulterated, substituted, or invalid new requirements for performance would receive a negative or invalid
validity test results, consistent with the testing and quality control of validity validity test result, creating conflicting
addition of requirements to conduct screening testing at the licensee testing results. The final rule resolves this
validity testing throughout the final facility. This section permits licensee inconsistency.
rule, as discussed with respect to testing facilities to use validity In addition, the final rule eliminates
§ 26.31(d)(3)(i). The final rule moves the screening tests to determine whether a the term, ‘‘non-instrumented devices,’’
portions of former Section 2.7(h) in specimen is valid or must be subject to that was used in proposed
Appendix A to Part 26 that applied to further validity testing. However, any § 26.137(b)(1). By eliminating the
HHS-certified laboratories to § 26.159(i) specific validity screening test that a specific reference to non-instrumented
in subpart G to improve the licensee testing facility chooses to use tests and by revising the definition of
organizational clarity of the final rule. (e.g., a validity screening test for ‘‘validity screening test’’ in § 26.5, the
creatinine concentration, a validity NRC is permitting licensee testing
Section 26.137 Quality Assurance and screening test for pH, a validity facilities to use instrumented tests, in
Quality Control screening test for oxidizing adulterants) addition to non-instrumented tests, to
The NRC has added § 26.137 to must meet the stringent performance perform validity screening testing. The
amend former Section 2.8 in Appendix testing requirements in this section. The NRC made this change in response to a
A to Part 26 [Quality assurance and requirements in this section are based public comment. The commenter
quality control] . This section adds on requirements that were proposed by suggested that the proposed requirement
quality control requirements for HHS in a Notice of Proposed Revisions that limited licensee testing facilities to
performing validity screening tests, to the Mandatory Guidelines dated using only non-instrumented devices to
initial validity tests, and initial tests for April 13, 2004 (69 FR 19673). However, perform validity screening tests was
drugs and drug metabolites at the in response to detailed public comments unduly restrictive. Specifically, the
licensee testing facility, for the reasons on the proposed rule and further commenter stated that instrumented
discussed with respect to each technical analyses, the NRC has revised tests could successfully meet the
paragraph. The final rule incorporates several of the proposed HHS performance testing requirements (e.g.,
the related requirements from the HHS requirements that were incorporated in pH testing) for some validity screening
Guidelines to meet, in part, Goal 1 of this section in the proposed rule, as tests described in proposed
this rulemaking to update and enhance discussed with respect to each provision § 26.137(b)(1). The inclusion of
the consistency of Part 26 with advances the NRC has changed. instrumented tests for validity screening
in other relevant Federal rules and Section 26.137(b)(1) permits licensee testing meets Goal 3 of this rulemaking
guidelines. The NRC has relocated the testing facilities to use validity to improve the effectiveness and
portions of former Section 2.8 in screening tests to determine whether a efficiency of FFD programs.
Appendix A to Part 26 that established specimen is valid or must be subject to In § 26.137(b)(1)(i) of the final rule,
requirements for HHS-certified further validity testing. However, under the NRC permits licensee testing
laboratories to § 26.167 in Subpart G of § 26.137(b)(1)(i) and (ii), the NRC facilities to use validity screening tests
the final rule for organizational clarity. requires licensee testing facilities to use that are identified, by lot number, on the
The agency has made many changes in only validity screening tests that either SAMHSA list of point-of-collection tests
this section with respect to the proposed have been placed on the SAMHSA list approved for use in the Federal
rule in response to detailed technical of point-of-collection testing devices Workplace Drug Testing Program, as
comments the NRC received on the that are certified for use in the Federal published in the Federal Register. The
proposed rule. The performance testing Workplace Drug Testing Program as NRC is aware that SAMHSA has yet to
and quality control requirements in the published in the Federal Register, or publish a list of approved point-of-
final rule are consistent, in large part, that meet the performance testing collection tests but added this
with those required for initial testing at criteria set forth in § 26.137(b)(1)(ii) for permission so that licensee testing
the HHS-certified laboratories. the reasons discussed with respect to facilities may rely on that list when it
Section § 26.137(a) [Quality assurance that provision. With respect to the is available. With respect to the
program] amends former Section 2.8(a) proposed rule, § 26.137(b)(1) in the final proposed rule, the final rule has
in Appendix A to Part 26, which rule includes a new provision to address removed the requirement that validity
required licensee testing facilities and an unintentional omission in the screening tests must be cleared by the
HHS-certified laboratories to have a proposed rule. Specifically, the NRC has FDA in response to a public comment.
quality assurance program for all added a requirement that licensee The NRC eliminated the proposed
aspects of the testing process. The NRC testing facilities must use an HHS- requirement because, as the commenter
moved the former requirements related certified laboratory that has the pointed out, the FDA is not responsible
to HHS-certified laboratories to capabilities to confirm the presence of for clearing specimen validity point-of-
§ 26.167(a) in Subpart G to improve any adulterant for which the licensee collection tests. The final rule also
organizational clarity. The final rule testing facility conducts validity clarifies the proposed provision by
extends the former requirements for screening tests. The inclusion of this adding the requirement that licensee
licensee testing facilities to have a provision is necessary because, as testing facilities may only use validity
quality assurance program and proposed, a licensee testing facility screening tests from ‘‘lots’’ (i.e., batches
procedures for drug testing to validity could have used a validity screening test or groups of tests that are manufactured
from the same original materials) that agrees with the commenters and has performance test samples that the
are identified on the SAMHSA list when revised the proposed rule to require licensee testing facility must submit is
it is available. The NRC added this manufacturers to perform and document less. For example, if a licensee or other
clarification because SAMHSA approval validation studies in § 26.137(b)(1)(ii)(D) entity chooses to use a validity
will apply to all validity screening tests of the final rule. The final rule also screening test only for determining
from the same lot but may not apply to requires licensees and others entities creatinine concentration, the total
other lots of the test that do not meet that intend to use validity screening number of performance samples that the
SAMHSA’s criteria for approval. tests to submit performance testing licensee testing facility must submit for
Because SAMHSA has yet to publish samples to the validity screening test testing is 18 samples divided into three
a list of approved validity screening manufacturer in § 26.137(b)(1)(ii)(E) of sets. The NRC believes that the revised
tests, the NRC has added the final rule. This change ensures that performance testing sample
§ 26.137(b)(1)(ii) to permit licensee the evaluation of a validity screening requirements reduce the burden on
testing facilities to use validity test is conducted by an individual(s) licensees and other entities imposed by
screening tests that meet the stringent endorsed by the manufacturer. If an these performance testing requirements
performance testing requirements individual with limited training were while ensuring that the validity
established in this section. Adding these used to conduct the tests, the screening tests provide accurate and
requirements to the final rule permits manufacturer may have a reason to consistent test results.
licensee testing facilities to conduct the question the test results obtained by the The agency has also relocated and
required performance testing and begin licensee testing facility or the HHS- revised the requirements in proposed
using any validity screening tests that certified laboratory. The NRC believes § 26.137(b)(1)(ii)(B) and (b)(1)(ii)(C).
meet the criteria before SAMHSA’s list that the validity screening test These proposed provisions established
is published. The NRC is aware that the manufacturer is best qualified to requirements for the formulation of
performance testing requirements in demonstrate the effectiveness of each performance testing samples and criteria
§ 26.137(b)(1)(ii) are stringent and that test because the manufacturer is the for licensees and other entities to apply
few, if any, validity screening devices entity with the greatest knowledge of when evaluating performance testing
are yet available that meet them. correct testing procedures. results, respectively. The final rule
However, because individuals may be combines these requirements in
Another public comment received on
subject to a temporary administrative § 26.137(b)(1)(ii)(E) and presents them
proposed § 26.137(b)(1)(ii)(A) stated that
withdrawal of authorization on the basis in the rule in the sequence in which
of a positive initial drug test result for the requirement to test 100 validity licensees and other entities would
marijuana or cocaine from a specimen screening devices was overly implement them for organizational
that yields negative test results from burdensome. The NRC agrees with the clarity. The NRC has also made other
validity screening (see proposed commenter, has revised the changes to the provisions in proposed
§ 26.75(i)), it is critical that any validity requirement, and relocated the amended § 26.137(b)(1)(ii) to address a public
screening tests used in Part 26 programs provision to § 26.137(b)(1)(ii)(E). The comment that stated that the
provide accurate results. The proposed new § 26.137(b)(1)(ii)(E) requires a performance testing standards in the
performance testing requirements are licensee or other entity to submit three proposed rule were unduly prescriptive
necessary to protect donors from consecutive sets (at least 6 samples in and should instead be performance
inaccurate results and ensure that each set) of performance testing samples based. The NRC agrees with the
specimens of questionable validity are to the validity screening test commenter and has further revised the
detected. manufacturer for performance testing performance testing provisions in
The final rule eliminates the proposed before the licensee testing facility begins proposed § 26.137(b) as is subsequently
provision in § 26.137(b)(1)(ii)(A) that using a validity screening to test donor discussed with respect to each provision
required a licensee testing facility or specimens. Therefore, the final rule in the final rule.
HHS-certified laboratory to conduct requires the licensee or other entity to Section 26.137(b)(1)(ii)(A) of the final
performance testing of 100 validity submit a minium of 18 samples for each rule specifies that a validity screening
screening devices from all currently validity screening test to be used by a test that a licensee testing facility
available manufactured lots of the licensee or other entity. If a licensee or intends to use to conduct creatinine
device to ensure that the devices met other entity chooses to use validity testing must be able to detect whether
the performance testing criteria in screening tests to conduct all of the a specimen’s creatinine concentration is
proposed § 26.137(b)(1)(ii)(C) before the validity testing required by this subpart less than 20 mg/dL. This provision
licensee testing facility began using the (e.g., creatinine, pH, and oxidizing replaces the portions of proposed
validity screening test. The NRC adulterants), the total minimum number § 26.137(b)(1)(ii)(B) and (b)(4) that
eliminated proposed of performance test samples that a established the required creatinine
§ 26.137(b)(1)(ii)(A) to address public licensee testing facility must submit to measurement capabilities of validity
comments received suggesting that meet the minimum performance testing screening devices. The NRC revised the
licensee testing facilities and HHS- requirements in the final rule is 72 provision in response to a public
certified laboratories may not have the samples (18 samples for a creatinine test comment received on proposed
experience or expertise to conduct divided into three sets, 18 samples for § 26.137(b)(4) that stated that tests
performance testing of validity pH testing at levels equal to or less than currently available that could be used
screening devices. The commenters 4.5 divided into three sets, 18 samples for validity screening testing for
suggested that the NRC should instead for pH testing at levels equal to or creatinine cannot distinguish creatinine
consider requiring the manufacturer of greater than 9 divided into three sets, concentrations in the proposed ranges of
the validity screening tests to perform and 18 samples for an oxidant test 5–20 and 1–5 mg/dL. The commenter
and document validation studies of the divided into three sets). If a licensee or noted that current validity screening
validity screening tests as well as other entity chooses to use a validity tests, at best, can detect creatinine
conduct tests of performance testing screening test for only one of the types concentration at a cutoff of 20 mg/dL.
samples that licensee testing facilities of validity testing required in this Because the rule does not require
submit to the manufacturer. The NRC subpart, the total number of licensee testing facilities to determine
whether a specimen meets the criteria from 650 mcg/mL to 800 mcg/mL would to suppliers and use by licensee testing
for substitution or dilution, which not identify specimens that meet the facilities.
depend on the results of specific gravity invalid specimen testing criteria in the As discussed with respect to proposed
testing in addition to lower creatinine HHS Guidelines (i.e., nitrite § 26.137(b)(1)(ii)(A), the NRC has
concentrations, the NRC agrees with the concentration equal to or greater than revised the performance testing
commenter that the proposed creatinine 200 mcg/mL). The NRC agrees with the requirements in proposed
testing to lower concentrations is commenter and has revised the oxidant § 26.137(b)(1)(ii)(A)–(b)(1)(ii)(C). In
unnecessary. A validity screening test measurement requirements for validity addition to the changes to performance
that can detect creatinine concentration screening tests to detect nitrite testing requirements previously
at a cutoff of 20 mg/dL is adequate for concentration at a cutoff of 200 mcg/mL discussed, the final rule revises the
a licensee testing facility to determine in § 26.137(b)(1)(ii)(C) of the final rule. portion of proposed § 26.137(b)(1)(ii)(C)
that a specimen is of questionable For completeness, the final rule also that established the percentage of total
validity and requires further testing at includes performance testing criteria for performance test samples that validity
an HHS-certified laboratory. This screening tests must correctly identify
additional oxidant tests (i.e., chromium,
revision avoids imposing an when licensees and other entities
halogen) that a licensee testing facility
unnecessary burden on licensee testing submit performance testing samples to
could perform to meet the requirements
facilities while ensuring that the the manufacturer. In
for testing for oxidizing adulterants in § 26.137(b)(1)(ii)(E), the NRC has
validity screening test will support the
§ 26.131(b). Therefore, these changes increased this required percentage from
creatinine concentration cutoff at 20
improve the clarity of the performance 80 percent in the proposed rule to 90
mg/dL established in § 26.131(b)(1).
Section 26.137(b)(1)(ii)(B) of the final testing requirements in this section and percent in the final rule. The more
rule specifies that a validity screening the consistency of the final rule with the rigorous criterion for validity screening
test that a licensee testing facility HHS Guidelines. tests increases consistency among the
intends to use to conduct pH testing At the suggestion of a commenter, the rule’s criteria for licensee testing facility
must be able to identify specimens with NRC has added § 26.137(b)(1)(ii)(D) to drug testing performance and criteria in
pH of less than 4.5 and pH equal to or the final rule. This provision requires the HHS Guidelines for HHS-certified
greater than 9. This provision replaces the manufacturer of a validity screening laboratory drug and validity testing
the portions of proposed test to conduct and document validation performance. The NRC has made this
§ 26.137(b)(1)(ii)(B) and (b)(4) that studies demonstrating the performance revision in the final rule to ensure that
established the required pH characteristics of the validity screening validity screening tests perform
measurement capabilities of validity test around the cutoff levels established accurately and reliably and that each
screening devices. Proposed in this subpart. The commenter FFD program effectively evaluates the
§ 26.137(b)(1)(ii)(B) and (b)(4) would suggested that the majority of the validity of urine specimens.
have required pH validity screening burden of demonstrating the Section 26.137(b)(1)(iii) revises
tests to be capable of detecting pH in the performance capabilities of validity proposed § 26.137(b)(1)(iii) to further
ranges of 1–3 and 10–12. However, the screening tests should rest with the reduce the performance testing burden
NRC received two comments noting that manufacturer rather than with licensees on licensees and other entities who use
the proposed pH ranges would not and other entities or HHS-certified validity screening tests. The proposed
permit the licensee testing facility to laboratories, as required by several rule would have required licensees and
detect a specimen that meets the criteria other entities to ensure the continued
provisions of the proposed rule. The
for an invalid test result in the HHS effectiveness of any validity screening
NRC agrees with the commenter and
Guidelines (i.e., pH less than 4.5 or tests it is using, after they have been
believes that the manufacturer of each
equal or greater than 9). Therefore, this placed in service, by conducting or
validity screening test is the most
change addresses the issue raised by the requesting the HHS-certified laboratory
appropriate entity to demonstrate the
commenter and ensures that the validity to conduct performance testing of 50
performance characteristics of the devices on a nominal annual frequency.
screening test will support the pH
validity screening tests before a licensee Consistent with other changes to the
cutoffs established in § 26.131(b)(2) as
or other entity begins using a test in an performance testing requirements in
revised in the final rule.
Section 26.137(b)(1)(ii)(C) of the final FFD program. The NRC believes it is § 26.137(b), the final rule requires the
rule specifies the required performance necessary to establish requirements validity screening tests’ manufacturers
capabilities for a validity screening test similar to those that exist for other types to conduct this followup performance
that a licensee testing facility intends to of testing performed by licensee testing testing rather than licensee testing
use to conduct testing for oxidizing facilities and HHS-certified laboratories. facilities or HHS-certified laboratories as
adulterants. This provision replaces the Both the former and final rules require proposed. In addition, the final rule
portions of proposed licensee testing facilities and HHS- eliminates the specific requirement for
§ 26.137(b)(1)(ii)(B) and (b)(4) that certified laboratories to validate their testing of 50 devices annually and
established the required oxidizing analytical methods before conducting replaces it with a performance-based
adulterant measurement capabilities of drug testing of donor specimens. The standard in response to a public
validity screening devices. Proposed requirement for manufacturers to comment suggesting that the specificity
§ 26.137(b)(1)(ii)(B) and (b)(4) would validate their validity screening tests in the proposed provision was
have required oxidizing adulterant before providing them to licensee unnecessarily burdensome. The final
validity screening tests to be capable of testing facilities is essentially parallel to rule does not specify the number of
detecting nitrite in the ranges of 250 these requirements for licensee testing performance testing samples to be tested
mcg/mL to 400 mcg/mL and from 650 facilities and HHS-certified laboratories. by the manufacturer using validity
mcg/mL to 800 mcg/mL. However, one The NRC believes the validation screening tests from the lot in use by the
commenter on the proposed rule noted requirement is necessary to ensure that licensee testing facility. The final rule
that the proposed nitrite concentrations the manufacturer has verified the instead requires the manufacturer to test
for performance testing samples ranging performance characteristics of the performance testing samples that are
from 250 mcg/mL to 400 mcg/mL and validity screening test before shipment formulated around the cutoff levels for
validity testing in this subpart. The NRC donor specimens in any 8-hour period manually), it is impractical to impose
believes this standard is adequate to must consist of one sample that is similar requirements for calibrators,
determine whether validity screening certified as negative and one that is controls and blind quality control
tests in each lot are continuing to formulated to appropriately challenge testing each time a single validity
provide accurate and consistent test each type of validity screening test to be screening test is performed. Therefore,
results and avoids imposing conducted (e.g., certified to contain an the NRC added this provision to ensure,
unnecessarily restrictive requirements. oxidizing adulterant, to have creatinine without imposing unrealistic
The NRC has eliminated proposed below 20 ng/mL). For example, the final requirements, that validity screening
§ 26.137(b)(1)(iv) from the final rule. rule requires that if a licensee testing tests continue to perform reliably during
That provision required licensees and facility is using a validity screening test any 8-hour period in which the validity
other entities to ensure that the to determine the nitrite concentration of screening tests are used and to increase
manufacturer of a validity screening test a specimen, licensee testing facility consistency among quality control
that is used by the licensee testing personnel must use a certified quality requirements for validity screening and
facility informs the licensee or other control sample containing nitrite. This initial validity and drug testing in this
entity of any changes to the device that requirement is necessary to verify that section.
may require additional performance and the validity screening tests to be used The NRC has moved the requirements
to conduct additional performance are functioning properly and that in proposed § 26.137(b)(2) that
testing if recommended by the MRO or licensee testing facility personnel are addressed the steps that licensee testing
HHS-certified laboratory. This provision able to conduct the tests appropriately, facilities must take if a validity
is no longer necessary because the as discussed with respect to screening tests fails to perform correctly
revised performance testing § 26.137(b)(2). The final rule replaces when testing quality control samples.
requirements in the final rule are the term ‘‘non-negative’’ in the proposed For organizational clarity, the NRC
focused on each lot of validity screening rule, which was used to describe the relocated the proposed provisions to
tests the licensee testing facility intends quality control samples that licensees § 26.137(f) in the final rule because
to use. Because manufacturers cannot and other entities must use, with a § 26.137(f) establishes requirements
make changes to a validity screening requirement that the quality control related to the topic of the proposed
test after a lot of the tests has been samples must be formulated to provisions, errors in testing.
produced, information about changes to challenge each validity screening test Section 26.137(b)(3) requires licensee
the tests in that lot and additional around the cutoffs for initial validity testing facility personnel to submit 1 out
performance testing are not required. testing specified in this subpart. The of every 10 donor specimens that yield
Section 26.137(b)(2) establishes NRC made this change to improve the negative results using validity screening
quality control requirements that clarity in the language of the rule, as
tests to an HHS-certified laboratory.
licensee testing facility personnel must This requirement is necessary to detect
discussed with respect to § 26.5.
implement at the beginning of any 8- false negative test results from validity
hour period when validity screening The final rule, with respect to the screening tests. A false negative test
tests will be performed and while proposed rule, adds a provision to result in this instance is a result from a
conducting validity screening testing. require validity screening tests to be validity screening test indicating that
With respect to the proposed rule, the challenged by licensee testing facility the specimen is valid when, in fact,
NRC has revised the quality control personnel after screening every 10 validity testing at the HHS-certified
requirements that were in § 26.137(b)(2) donor specimens in § 26.137(b)(2)(ii). laboratory identifies the specimen as
in the proposed rule and relocated them Specifically, this provision requires the adulterated, substituted, or invalid.
to § 26.137(b)(2)(i). The agency made licensee testing facility to test at least 1 Assessing the validity screening test’s
this change because the final rule adds quality control sample after testing rate of false negative test results is
a new § 26.137(b)(2)(ii) and it is every 10 donor specimens during an 8- necessary because false negative results
necessary to group the related hour testing period and requires the from a validity screening test could
requirements together for organizational quality control sample to be formulated mean that some attempts to subvert the
clarity in the final rule. to challenge the validity screening testing process may not be detected. For
In response to a public comment, the test(s) in use around the cutoffs example, if an individual had
agency has revised § 26.137(b)(2) in the specified in Subpart F. The NRC has adulterated his or her specimen and it
final rule to require that the licensee added this provision to enhance the was not detected because of a faulty
testing facility personnel who will be or consistency of quality control device, the licensee or other entity
are performing validity screening testing procedures for conducting validity would have no reason to terminate the
must implement the quality control screening testing with quality control individual’s authorization. As a result,
requirements in this section. The procedures for conducting initial an individual who has demonstrated
commenter reasoned that because some validity and drug testing at licensee that he or she is not trustworthy and
validity screening tests have visually testing facilities. As discussed with reliable would be permitted to perform
read endpoints, the test result must be respect to § 26.137(d) and (e), the NRC duties under this part and may pose a
interpreted by the tester. Therefore, it is requires licensee testing facilities to test risk to public health and safety and the
necessary to verify that each tester is calibrators, controls, and blind quality common defense and security.
able to interpret the quality control control samples during each analytical With respect to the proposed rule, the
samples correctly before conducting run of initial validity and drug testing NRC has moved the requirements in
tests on donor specimens and during the conducted at the licensee testing facility proposed § 26.137(b)(3) that addressed
testing process. The NRC agrees with (See § 26.5 for a discussion of the term, the steps that licensee testing facilities
this comment and made the appropriate ‘‘analytical run’’) to monitor the must take if the HHS-certified
change in the final rule. accuracy of testing. However, because it laboratory’s results indicate that the
Section 26.137(b)(2)(i) revises may not be possible to conduct validity validity screening test provided a false
portions of proposed § 26.137(b)(2) and screening tests in batches (i.e., the tester negative result. For organizational
requires that the quality control samples may have to insert a dipstick into an clarity, the NRC relocated the proposed
to be tested before beginning to test aliquot of each donor’s specimen provisions to § 26.137(f) in the final rule
because § 26.137(f) establishes in § 26.91(d) and meets Goal 3 of this required calibrators and controls for
requirements related to the topic of the rulemaking to improve the effectiveness initial pH testing, based on the type of
proposed provisions, errors in testing. and efficiency of FFD programs. testing instrument used and whether a
The NRC notifications required in The NRC has deleted proposed pH validity screening test has been
§ 26.137(b)(2)and (b)(3) are necessary § 26.137(b)(5) and (b)(6) from the final performed.
because false negative results from a rule and replaced these provisions with Section 26.137(d)(3) establishes
validity screening test indicate the the performance testing requirements in quality control requirements for
laboratory testing process may not be § 26.137(b)(1)(ii) for the reasons performing initial tests for oxidizing
successfully detecting donor attempts to discussed with respect to that section. adulterants, including nitrite, and
subvert the testing process through The NRC added § 26.137(c) [Validity § 26.137(d)(4) establishes quality control
specimen adulteration or substitution. screening test results] to specify the requirements for performing initial tests
For example, if an individual had actions that the licensee testing facility for ‘‘other’’ adulterants at the licensee
adulterated his or her specimen and it must take if a donor’s specimen yields testing facility.
was not detected because of a faulty test, questionable results from validity Section 26.137(d)(5) requires that one
the licensee or other entity would have screening testing. If a specimen has a of the quality control samples included
no reason to terminate the individual’s questionable validity screening test in each analytical run must appear to be
authorization. As a result, an individual result, the final rule requires a donor specimen to laboratory analysts.
who has demonstrated that he or she is instrumented initial validity testing The final rule retains the related
not trustworthy and reliable would be either at the licensee testing facility or requirement in the last paragraph of
permitted to perform duties under this the HHS-certified laboratory. This Section 2.8(c)(3) in Appendix A to Part
part and may pose a risk to public provision is consistent with the rule’s 26 and amends the provision to be
health and safety and the common requirements for transferring to the consistent with the same requirement in
defense and security. The NRC will use HHS-certified laboratory specimens the HHS Guidelines. With respect to the
the information to ensure that HHS is with initial positive drug test results proposed rule, the NRC relocated this
notified of the test failure as well as from testing at a licensee testing facility. requirement from proposed
inform other licensees and entities who Further testing of a specimen of § 26.137(e)(7) to § 26.137(d)(5) in the
may also be using the test of the false questionable validity is necessary to final rule to clarify that the requirement
negative results to prevent additional protect donors from inaccurate test to test one blind quality control sample
testing errors. Therefore, the results, as well as provide assurance in each analytical run applies to initial
notifications are necessary to protect that specimens of questionable validity validity test runs as well as to initial
donors from inaccurate test results, to are detected using the more drug testing if the licensee testing
ensure that specimens of questionable sophisticated technologies required for facility does not conduct initial validity
validity are detected, and to ensure that instrumented initial validity testing in and drug testing concurrently. However,
any problems with a test are detected the HHS Guidelines and the final rule. if a licensee testing facility conducts
and corrected as soon as possible. The final rule, with respect to the initial validity and drug testing of
In response to public comments, the proposed rule, eliminates the term specimens concurrently, the NRC
NRC has eliminated proposed ‘‘non-negative’’ from the heading of the intends that the licensee testing facility
§ 26.137(b)(4) that required validity provision for the reasons discussed with would include only one blind
screening tests to be capable of respect to § 26.5 related to the performance test sample in the
measuring a specimen’s creatinine elimination of this term throughout the analytical run to meet this requirement
concentration to 1 decimal place. final rule. as well as the same requirement in
Specificity below 20 mg/dL is The agency added § 26.137(d) § 26.137(e)(6)(v) for drug testing runs.
unnecessary because NRC is not [Quality control requirements for The NRC made these changes to meet
requiring licensee testing facilities to performing initial validity tests] to Goal 6 of this rulemaking to improve
conduct the tests for specific gravity that specify the required methods for clarity in the organization of the rule.
are necessary for reporting substituted, performing initial validity tests at a The NRC also added § 26.137(d)(6) in
dilute, or invalid validity test results, as licensee testing facility that are the final rule to require licensee testing
discussed with respect to necessary to ensure that initial validity facilities to send 1 out of 10 specimens
§ 26.137(b)(1)(ii)(A). This change testing at the licensee testing facility that test negative on initial validity tests
reflects the current capabilities of provides accurate results. The to an HHS-certified laboratory for initial
validity screening tests and supports the requirements in this paragraph and, if necessary, confirmatory validity
intent of the NRC that licensee testing incorporate the related requirements in testing. The NRC added this
facilities need only be able to identify the HHS Guidelines as revised on April requirement in response to public
whether a specimen has a creatinine 13, 2004 (69 FR 19644). The paragraph comments noting inconsistencies in the
concentration of less than 20 mg/dL and has been added to meet Goal 1 of this proposed rule’s quality control
therefore requires additional testing at rulemaking to update and enhance the requirements for validity screening,
an HHS-certified laboratory. consistency of Part 26 with advances in initial validity testing, and initial drug
The NRC has added a new other relevant Federal rules and testing, and for the reasons discussed
§ 26.137(b)(4) in the final rule to guidelines. with respect to the addition of a similar
establish requirements for storing Section 26.137(d)(1) requires licensee requirement applicable to validity
validity screening tests and requires testing facilities to measure creatinine screening testing in § 26.137(b)(3).
licensee testing facilities to maintain the concentration to 1 decimal place and Adding this provision ensures that
tests consistent with the manufacturer’s establishes requirements for the controls licensee testing facilities can assess their
storage specifications. Storing the tests to be used in initial tests for creatinine rates of false negative initial validity test
as required by the manufacturer’s concentration. results and therefore meets Goal 3 of

instructions is necessary to ensure that Section 26.137(d)(2) establishes this rulemaking to improve the
the tests continue to function optimally. quality control requirements for effectiveness of FFD programs.
This requirement is consistent with the performing initial pH tests. Sections Section 26.137(e) [Quality control
quality control requirements for ASDs 26.137(d)(2)(i)–(d)(2)(v) specify the requirements for initial drug tests]
amends and combines portions of licensee testing facility or pool them The paragraph uses the term
former Section 2.7(d), 2.7(e)(1), and and use these specimens as quality ‘‘analytical run’’ rather than the former
2.8(b) in Appendix A to Part 26. The control specimens, if the specimens are term ‘‘test run’’ to reflect changes in
former provisions established quality certified as negative and valid by an testing technologies that some licensee
control requirements for performing HHS-certified laboratory. This provision testing facilities have adopted since the
initial tests for drugs and drug incorporates the related provision from former rule was published.
metabolites at licensee testing facilities. the HHS Guidelines to meet Goal 1 of Requirements for blind performance and
The final rule groups together in one this rulemaking to update and enhance other quality control testing in the
paragraph the requirements that were the consistency of Part 26 with advances former rule were based on the
dispersed throughout the former rule to in other relevant Federal rules and assumption that specimens would be
meet Goal 6 of this rulemaking to guidelines. With respect to the proposed tested in batches. However, many
improve clarity in the organization of rule, the final rule adds a sentence licensee testing facilities now conduct
the final rule. prohibiting licensee testing facilities continuous testing, and no longer test
Section 26.137(e)(1) amends the first from retaining any information linking specimens in batches. Therefore, the
sentence of former Section 2.7(e)(1) in donors to specimens pooled for use in final rule uses the term, ‘‘analytical
Appendix A to Part 26 but retains the the internal quality control program. run,’’ to refer to both batch and
intent of the former provision as it The agency added this prohibition in continuous processing, as defined in
applies to licensee testing facilities. This response to a public comment § 26.5. This change has been made to
provision retains the former requesting this addition. This change meet Goal 6 of this rulemaking to
requirement that licensee testing meets Goal 7 of this rulemaking to improve clarity in the language of the
facilities may use only immunoassay protect the privacy and other rights final rule.
tests that meet the requirements of the (including due process) of individuals The former rule did not establish a
Food and Drug Administration for who are subject to Part 26. number or percentage of negative
commercial distribution. The NRC has Section 26.137(e)(3) permits licensee specimens that licensee testing facilities
moved the requirements in the former testing facilities to conduct multiple were required to submit to the HHS-
provision related to initial drug testing tests of a single specimen for the same certified laboratory for performance
at HHS-certified laboratories to drug or drug class. The NRC has revised testing, which raised implementation
§ 26.167(d)(1) of Subpart G of the final § 26.137(e)(3) in the final rule, with questions from licensees who have
rule to improve organizational clarity in respect to the proposed rule, to include wanted to know how many specimens
the rule. a more precise description of when must be submitted. Therefore, to clarify
In addition, § 26.137(e)(1) prohibits the former requirement to ‘‘submit a
multiple initial drug tests on a specimen
licensee testing facilities from relying on sampling of specimens,’’ the final rule
(also know as rescreening) are
drug test results from any tests they may requires licensee testing facilities to
permitted. The NRC added this
use to perform validity screening tests. forward at least one specimen that
information in the final rule in response
The NRC added this prohibition because yields negative drug test results from
several non-instrumented devices are to a comment received on the proposed
each analytical run to the HHS-certified
available that combine tests for the provision requesting the addition. The
laboratory for performance testing. The
presence of drugs and drug metabolites requirements in the provision are
final rule also establishes five percent of
in a urine specimen with tests for other consistent with a similar provision in
the specimens tested in each analytical
attributes of a urine specimen, such as the HHS Guidelines and, therefore, meet
run as the percentage of negative
creatinine concentration. The final rule Goal 1 of this rulemaking to update and
specimens that the licensee testing
permits licensee testing facilities to use enhance the consistency of Part 26 with facility must submit to the HHS-
such combination tests as validity advances in other relevant Federal rules certified laboratory for testing, except if
screening tests if the tests meet the and guidelines. five percent of an analytical run is a
requirements of § 26.137(b)(1). However, Section 26.137(e)(4) amends the first number less than one specimen. In the
the drug testing capabilities of these sentence of former Section 2.8(b) in latter case, the licensee testing facility
tests are not yet sufficiently accurate Appendix A to Part 26. The former submits at least one negative specimen
and sensitive to be used in Part 26 sentence stated that licensee testing from the analytical run. This
programs, in which licensees and other facilities are not required to assess their requirement ensures the ongoing
entities are permitted to false positive rates in drug testing. The evaluation of the accuracy of the
administratively withdraw an final rule retains the intent of the former licensee testing facility’s initial drug
individual’s authorization on the basis requirement, but the NRC has updated testing without imposing a large
of positive initial drug test results for the terminology in the provision to use performance testing burden.
marijuana and cocaine metabolites. The the new terms that are used throughout The NRC has moved the last sentence
NRC may consider accepting the use of the final rule, e.g., ‘‘initial’’ rather than of the former paragraph, which
initial drug test results from non- ‘‘screening,’’ as discussed with respect addressed performance testing of breath
instrumented tests in a future to § 26.5. analysis equipment for alcohol testing,
rulemaking, when HHS publishes a final Section 26.137(e)(5) amends the to § 26.91(e) in Subpart E because that
revision to the Mandatory Guidelines second sentence of former Section 2.8(b) subpart of the final rule addresses
that establishes requirements for their in Appendix A to Part 26. This quality control requirements for alcohol
use in Federal workplace drug testing provision required licensee testing testing. The NRC made this change to
programs. At this time, however, the facilities to submit specimens that yield meet Goal 6 of this rulemaking to
final rule retains the former prohibition negative results from initial testing to improve clarity in the organization of
on using such tests for drug testing at the HHS-certified laboratory as a quality the final rule.
licensee testing facilities. control check on the licensee testing Section 26.137(e)(6) amends the
The NRC added § 26.137(e)(2) to facility’s drug testing process. The requirements of former Section 2.8(c) in
require licensee testing facilities to paragraph retains the intent of the Appendix A to Part 26 and applies them
either discard specimens that yield former provision but makes several to licensee testing facilities. The NRC is
negative results from initial tests at the changes to the specific requirements. applying requirements for quality
controls to initial drug testing at distribution of quality control samples ensure that carryover does not
licensee testing facilities to provide among the drugs and metabolites for contaminate the testing of a donor’s
greater assurance that initial drug tests which the FFD program tests. This specimen and to document the
performed by these facilities provide provision clarifies the former rule and procedures. The final rule extends this
accurate results. The increased increases the internal consistency of this requirement to licensee testing facilities
performance testing requirements in the subpart. Additionally, this provision because it is a standard forensic practice
final rule are necessary because the final provides for enhanced monitoring of the that is necessary to ensure the integrity
rule permits licensees and other entities effectiveness of the licensee testing of the testing process.
to rely on test results from other Part 26 facilities’ drug testing procedures to The NRC has added § 26.137(f) [Errors
programs to a greater extent that the meet Goal 3 of this rulemaking to in testing] to require licensees and other
former rule. Therefore, it is necessary to improve the effectiveness of FFD entities who maintain testing facilities
ensure that any tests performed at programs. to investigate any errors or
licensee testing facilities meet minimum The NRC has added § 26.137(e)(6)(i)– unsatisfactory performance of the
standards. This change meets Goal 3 of (e)(6)(iii) to describe the required testing process, identify the cause(s) of
this rulemaking to improve the characteristics of the quality control the adverse conditions, and correct
effectiveness of FFD programs. samples that the licensee testing facility them. The final rule requires the
The final rule, with respect to the must include in each analytical run of licensee or other entity to document the
proposed rule, moves the provision in specimen testing. These provisions investigation and any corrective actions
proposed § 26.137(e)(7) to § 26.137(e)(6) require each analytical run to include at taken. The provision requires licensees
in the final rule to improve least one negative quality control and other entities to investigate any
organizational clarity. The NRC made sample as well as quality control testing errors or unsatisfactory
this change to address a public samples targeted at 25 percent above the performance identified throughout the
comment received on the proposed rule cutoff and at 25 percent below the cutoff testing process or during the review
that noted that because the second level for each drug and drug metabolite process that are required under § 26.91
sentence in proposed § 26.137(e)(7) for which testing is conducted. The final [Review process for fitness-for-duty
discussed a quality control sample rule, with respect to the proposed rule, policy violations]. The NRC intended, in
requirement, the provision would be revises the requirement that a quality the original rule, that testing or process
more appropriately located in control sample must be targeted at 75 errors discovered in any part of the
§ 26.137(e)(6) which describes the percent of the cutoff level and instead, program, including through the review
quality control sample requirements for the final rule requires the calibrator to process, be investigated as an
each analytical run. be targeted at 25 percent below the unsatisfactory performance of a test.
Section 26.137(e)(6) establishes cutoff level. This change was made to This provision clarifies that intent.
requirements for the number of quality improve the clarity of the language of Thorough investigation and reporting of
control samples to be included in each the final rule without changing the such test results will continue to assist
analytical run at the licensee testing intent of the provision. These the NRC, the licensees, HHS, and the
facility. The final rule requires that a requirements are consistent with the HHS-certified laboratories in preventing
minimum of 10 percent of the current HHS Guidelines for processing future occurrences.
specimens in each analytical run must quality control samples during initial The NRC has reorganized the
be quality control samples. For example, drug testing. requirements in proposed § 26.137(f)
if an analytical run consists of 50 donor With respect to the proposed rule, the into a list format in § 26.137(f)(1)–(f)(5)
specimens, an additional 5 quality final rule has added § 26.137(e)(6)(iv) in the final rule to improve the
control samples would be included in and § 26.137(e)(6)(v) to further enhance organizational clarity of the rule and
the analytical run for a total of 55 quality control requirements for initial added new requirements to this section
specimens tested in the run. The drug testing at licensee testing facilities. for the reasons discussed with respect to
licensee testing facility will not send the In response to a public comment, the each provision.
quality control samples to the HHS- NRC added § 26.137(e)(6)(iv) to require Section 26.137(f)(1) requires,
certified laboratory for confirmatory that each analytical run has a sufficient whenever possible, that the
testing, but use them for internal quality number of calibrators to ensure linearity investigation of testing or processing
control purposes only. The of the assay. This additional provision errors must determine relevant facts and
requirements in this paragraph is consistent with the related identify the root cause(s) of the error.
incorporate the related requirements in requirement in the HHS Guidelines. Section 26.137(f)(2) requires the
the HHS Guidelines and meet Goal 1 of Section 26.137(e)(6)(v) requires that one licensee testing facility to take action to
this rulemaking, which is to update and sample must appear to be a donor correct the cause of any error or
enhance the consistency of Part 26 with sample to the laboratory analysts. This unsatisfactory performance within the
advances in other relevant Federal rules requirement was previously embedded licensee testing facility’s control.
and guidelines. in § 26.137(e)(7) of the proposed rule, The NRC has added § 26.137(f)(3) to
The final rule also requires licensee and the NRC moved the requirement to the final rule, with respect to the
testing facilities to ensure that quality § 26.137(e)(6)(v) of the final rule in proposed rule, to address instances
control samples that are positive for response to a comment received that when testing of a quality control sample
each drug and metabolite for which the noted this move would enhance at a licensee testing facility yields a false
FFD program conducts testing are organizational clarity in the rule. The negative test result. This provision
included in at least one analytical run NRC agrees with the commenter. requires the licensee testing facility to
in each quarter of the calendar year. The Section 26.137(e)(7) extends to forward all donor specimens from the
NRC added this provision at the request licensee testing facilities the analytical run in which the error is
of comments received addressing requirement in the third sentence of the detected to the HHS-certified laboratory
inconsistences within the proposed last paragraph of former Section 2.8(c) for additional testing. This requirement
rule. The proposed rule required quality in Appendix A to Part 26. That is necessary to ensure that licensees and
control samples for each type of validity provision required HHS-certified other entities do not permit individuals
test, but failed to specify the required laboratories to implement procedures to who may have altered a specimen or
used prohibited drugs to be granted or final rule to enhance consistency of the most laboratories prepared their own
maintain authorization to have the types rule’s requirements for addressing errors standards and controls. In the ensuing
of access or perform the duties that in testing at licensee testing facilities years, the number and variety of sources
require them to be subject to the rule. with those required for addressing for materials used in performance
Additional testing at the HHS-certified errors in testing at HHS-certified testing have increased. This provision
laboratory of the donor specimens laboratories and in response to public updates the former requirements to refer
included in the analytical run during comments received on the proposed to several of the alternatives, including,
which the error is identified ensures rule mentioning the inconsistencies. but not limited to, pure drug reference
that public health and safety and the This requirement is consistent with materials, stock standard solutions from
common defense and security are not standard forensic practices and meets other laboratories, and standard
placed at risk because initial validity or Goal 1 of this rulemaking to update and solutions obtained from commercial
drug test results from the licensee enhance the consistency of Part 26 with manufacturers. The requirements in this
testing facility failed to identify an advances in other relevant Federal rules paragraph incorporate the related
individual who has attempted to subvert and guidelines. requirements in the HHS Guidelines
the testing process or engaged in The NRC has added § 26.137(f)(4) to and meet Goal 1 of this rulemaking to
substance abuse. In addition, testing of address instances where testing update and enhance the consistency of
these specimens at the HHS-certified conducted at an HHS-certified Part 26 with advances in other relevant
laboratory may also provide the licensee laboratory identifies a specimen that Federal rules and guidelines.
testing facility with additional yielded a false negative test result from
the licensee testing facility. To evaluate Section 26.139 Reporting Initial
information regarding the cause(s) and Validity and Drug Test Results
extent of condition that resulted in the whether tests at a licensee testing
error. The NRC added this requirement facility may be providing false negative The NRC has added § 26.139 to
to the final rule to enhance consistency test results, § 26.137(b)(3), (d)(6), and combine requirements related to the
of the rule’s requirements for addressing (e)(5) require the licensee testing facility reporting and management of test
errors in testing at licensee testing to submit some donor specimens that results from the licensee testing facility
facilities with those required for yield negative test results to an HHS- that were interspersed throughout
addressing errors in testing at HHS- certified laboratory for additional former Appendix A to Part 26. The
certified laboratories and in response to testing. If, after confirmatory testing by agency made this change to meet Goal
the HHS-certified laboratory, a donor 6 of this rulemaking to improve clarity
public comments received on the
specimen yields positive, substituted, in the organization of the final rule, by
proposed rule noting the
adulterated, or invalid results, grouping related requirements together
inconsistencies. This requirement is
§ 26.137(f)(4) mandates that the licensee in a single section.
consistent with standard forensic Section 26.139(a) amends former
practices and meets Goal 1 of this testing facility must take corrective
action(s) before resuming testing for the Section 2.7(g)(2) in Appendix A to Part
rulemaking to update and enhance the 26. That provision established
consistency of Part 26 with advances in drug(s), drug metabolite(s),
adulterant(s), or other specimen requirements for the manner in which
other relevant Federal rules and HHS-certified laboratories and licensee
guidelines. characteristics (i.e., creatinine, pH)
associated with the donor specimen(s) testing facilities must report test results
Section § 26.137(f)(3) also requires the that yielded the false negative result(s). to licensee management. The final rule
licensee testing facility to implement Additionally, § 26.137(f)(4) permits the amends the former provision by moving
corrective actions before resuming licensee or other entity to re-collect and the former requirements that were
testing of donor specimens. For test specimens from any donor whose related to reporting test results from
example, if testing of a certified-positive test results from initial testing at the HHS-certified laboratories to § 26.169(b)
quality control sample at the licensee licensee testing facility may have been of Subpart G for organizational clarity.
testing facility yields false negative test inaccurate. The NRC added this The final rule also deletes the former
results for opiates, this provision provision to the final rule for the same reference to ‘‘special processing’’ and
requires the licensee testing facility to reasons discussed with respect to replaces it with reference to validity test
stop testing donor specimens for opiates § 26.137(f)(3). results, consistent with the addition of
until the cause(s) of the false negative Section 26.137(f)(5) requires the requirements to conduct validity testing
test are identified and corrected. licensee or other entity to document the throughout the final rule, as discussed
Similarly, if a quality control sample investigation and any corrective actions with respect to § 26.31(d)(3)(i). The NRC
that has been certified to contain an taken for consistency with Criterion XVI made these changes to improve clarity
adulterant at a concentration above the in Appendix B to 10 CFR Part 50. in the language and organization of the
cutoff levels established in Subpart F for Section 26.137(g) [Accuracy] retains rule consistent with Goal 6 of this
validity screening or initial validity former Section 2.7(o)(3)(i) in Appendix rulemaking.
testing yields a false negative test result, A to Part 26 as it applied to licensee With respect to the proposed rule, the
this provision requires the licensee testing facilities. This provision requires final rule eliminates use of the term
testing facility to stop testing for that checking the instruments used in testing ‘‘non-negative’’ in § 26.139(a) for the
adulterant until the cause(s) of the false for accuracy. The final rule moves the reasons discussed with respect to § 26.5
negative test result are identified and former requirement as it relates to HHS- for eliminating this term throughout the
corrected. This requirement is necessary certified laboratories to § 26.167(h) in proposed rule. Eliminating the term
to prevent additional errors in testing Subpart G for organizational clarity. ‘‘non-negative’’ and replacing it with
that could permit individuals who may Section 26.137(h) [Calibrators and terms to describe specific results of drug
have altered a specimen or used controls] updates former Section and validity testing (e.g., ‘‘positive,’’
prohibited drugs to be granted or 2.7(o)(2) in Appendix A to Part 26, ‘‘adulterated’’), necessitates splitting the
maintain authorization to have the types which established requirements for the last sentence of proposed § 26.139(a)
of access or perform the duties that standards and quality control samples into two sentences for clarity. Therefore,
require them to be subject to the rule. used for performance testing. At the the final rule prohibits licensee testing
The NRC added this requirement to the time the original paragraph was written, facilities from reporting to licensee or
other entity management any positive testing facility to prepare a monthly forensic toxicologist to certify the
drug test results from initial drug testing report of test results with a requirement scientific and technical suitability of the
at the licensee testing facility, except as for the licensee testing facility to licensee’s or other entity’s testing
permitted under § 26.75(h). The final summarize the data annually in the FFD process at any lower cutoff levels.
rule also prohibits licensee testing program performance report required Therefore, the testing and reporting
facilities from reporting to licensee or under § 26.717(b) of the final rule. requirements in the former rule are no
other entity management any validity Experience implementing the former longer needed to monitor licensee
screening and initial validity test results requirement for a monthly statistical testing facility performance in this area.
that indicate a specimen is of summary has indicated that the monthly The final rule continues to require
questionable validity and any positive summary has not been as useful to licensee testing facilities to report test
initial drug test results from specimens licensees for ongoing monitoring of results (and the cutoff levels used) from
that are of questionable validity. The testing program effectiveness as other
NRC made these changes to improve testing for additional drugs and drug
mechanisms that licensees have
clarity in the language of the rule, metabolites, beyond those specified in
developed. Therefore, the final rule
consistent with Goal 6 of this § 26.31(b)(1).
replaces the monthly reporting
rulemaking. requirement in former Section 2.7(g)(6) Section 26.139(f) has been added to
Section 26.139(b) amends the last in Appendix A to Part 26 with a require FFD program management to
sentence of former § 26.24(d)(1), which requirement in § 26.139(f) of the final monitor the ongoing effectiveness of the
specified the individuals to whom rule for FFD program management to licensee testing facility testing program.
results of initial tests from the licensee monitor the ongoing effectiveness of the The final rule provides examples of the
testing facility may be released. The licensee testing facility testing program. types of information and possible
NRC added the MRO’s staff to the list of This change meets Goal 5 of this program performance indicators that
individuals who are permitted to have rulemaking to improve Part 26 by licensees and other entities may use for
access to the results of initial tests eliminating or modifying unnecessary program monitoring. The final rule also
performed at the licensee testing facility requirements. The NRC has moved the requires FFD program management to
consistent with the addition of this job requirements in the former paragraph
role to the final rule. Individuals who make adjustments to the testing program
that addressed summary reports from in response to information gained from
are serving as MRO staff members HHS-certified laboratories to § 26.169(k)
require access to initial test results from the ongoing monitoring. These
of Subpart G for organizational clarity. requirements replace the monthly
a licensee’s testing facility in the course With respect to the proposed rule, the
of performing their administrative summary report required under former
agency changed the cross-reference to Section 2.7(g)(7) in Appendix A to Part
duties for the MRO. Additionally, with FFD program performance reporting
respect to the proposed rule, the final 26 to strengthen FFD programs by
requirements in § 26.217(b) in the
rule permits an SAE to access initial test ensuring that licensees monitor licensee
proposed rule to § 26.717(b) in the final
results when appropriate consistent rule to reflect the changes the NRC has testing facility performance on an
with the addition of this job role to the made in the organization of the final ongoing basis and correct any
final rule. Omitting the SAE from this rule. weaknesses as they are identified. The
provision was an unintended oversight paragraph is also consistent with the
in the proposed rule which the NRC has Section 26.139(e) amends former
NRC’s performance-based approach to
corrected in the final rule. Section 2.7(g)(7) in Appendix A to Part
26. That provision required licensee regulation. This change meets Goal 3 of
Section 26.139(c) amends former this rulemaking to improve the
Section 2.7(o)(5) in Appendix A to Part testing facilities and HHS-certified
laboratories to report test results for effectiveness of FFD programs, as
26. The NRC has moved the discussed in Section IV.B.
requirements in the former paragraph both the cutoff levels specified in Part
that addressed the availability of 26 and any more stringent cutoff levels Subpart G—Laboratories Certified by the
personnel to testify in proceedings used by the FFD program. The NRC has Department of Health and Human
related to drug test results from an HHS- relocated the former requirement related Services
certified laboratory to § 26.153(f)(2) of to HHS-certified laboratories to
Subpart G for organizational clarity. The § 26.169(c) of Subpart G for Section 26.151 Purpose
final rule moves the former requirement organizational clarity. The final rule
requires licensees and other entities The NRC has added § 26.151 to
for licensee testing facility personnel to
who operate testing facilities, and have introduce the purpose of the subpart,
be available to testify at any proceedings
with respect to breath analysis test adopted more stringent cutoff levels for which is to establish requirements for
results to § 26.85(d) [Personnel available initial tests for drugs and drug the HHS-certified laboratories that
to testify at proceedings] because the metabolites than those specified in licensees and other entities must use for
collection site and not the licensee § 26.133 [Cutoff levels for drugs and testing urine specimens for validity and
testing facility is typically responsible drug metabolites], to conduct tests and the presence of drugs and drug
for quality control of alcohol testing report test results based only on their metabolites. Adding this paragraph
equipment. The agency made these more stringent cutoff levels. The basis meets Goal 6 of this rulemaking to
changes for organizational clarity in the for the former requirement to conduct improve clarity in the organization and
rule, consistent with Goal 6 of this tests and report test results for the cutoff language of the rule. The majority of the
rulemaking. levels specified in this part, when the requirements in this subpart are based
Section 26.139(d) amends the licensee is using more stringent cutoff on the former requirements in Appendix
portions of former Section 2.7(g)(6) in levels, was a method by which the NRC A to Part 26, as they relate to HHS-
Appendix A to Part 26 that applied to monitored licensee implementation of certified laboratories. However, the rule
the summary report that licensee testing the permission to use more stringent substantially updates the former
facilities must provide to FFD program cutoff levels. The final rule eliminates requirements to be consistent with the
management. The NRC has replaced the this requirement, because HHS Guidelines.
former requirement for the licensee § 26.31(d)(3)(iii)(C) requires a qualified
Section 26.153 Using Certified validity testing to the rule, as discussed Section 26.153(e) amends the third
Laboratories for Testing Urine with respect to § 26.31(d)(3)(i). The sentence of former Section 2.7(m) in
Specimens second sentence of former Section Appendix A to Part 26. That sentence
The NRC added § 26.153 to group into 2.7(l)(2) in Appendix A to Part 26, required licensees to conduct an
one section requirements related to the which established requirements for the inspection and evaluation of a
use of HHS-certified laboratories by capabilities of licensee testing facilities, laboratory’s drug testing operations
licensees and other entities who are has been moved to § 26.123 of Subpart before using the laboratory’s services.
subject to the rule. F [Licensee Testing Facilities] for Some licensees have incorrectly
Section 26.153(a) combines and organizational clarity. The agency interpreted the former regulation as
updates former requirements for deleted the last sentence of the former requiring licensee employees to perform
licensees and other entities to use HHS- paragraph, which permitted the testing the pre-award inspection and
certified laboratories for initial and of breath specimens for alcohol at the evaluation. In many cases, however,
confirmatory drug testing of urine collection site, because the rule appropriately qualified licensee
specimens. The paragraph relocates and addresses alcohol testing in Subpart E employees may not be available to
combines former § 26.24(f) and former [Collecting Specimens for Testing]. perform the inspection and evaluation,
Sections 1.1(3) and 4.1(a) in Appendix These organizational changes to the and the use of contracted experts may
A to Part 26. These provisions required former paragraph have been made to be necessary to achieve the NRC’s
licensees and other entities to use HHS- meet Goal 6 of this rulemaking to intent. The paragraph revises the former
certified laboratories for drug testing. improve clarity in the organization and requirement to indicate that licensees
language of the rule. and other entities are responsible ‘‘to
The NRC made this change to eliminate
Section 26.153(c) amends the first ensure’’ that the inspection and
redundancies in the former rule and
sentence of former Section 2.7(k) in evaluation is performed, in order to
improve organizational clarity. The Appendix A to Part 26. The former clearly indicate that the use of expert
paragraph updates the former citations provision prohibited HHS-certified contractors is acceptable. In addition,
for the HHS Guidelines because the laboratories from subcontracting unless the rule clarifies that the pre-award
guidelines have been amended several authorized by the licensee. The rule inspection and evaluation must be
times since the former rule was extends this restriction to performed by qualified individuals.
published. In addition, the provision subcontracting for specimen validity Section 26.153(e) also permits a
provides current contact information for testing for consistency with the addition licensee or other entity to begin using
obtaining information about the of requirements to perform validity the services of another HHS-certified
certification status of HHS-certified testing to the rule, as discussed with laboratory immediately, without a pre-
laboratories because the contact respect to § 26.31(d)(3)(i). The second award evaluation and inspection, in the
information has changed since the sentence of former Section 2.7(k) has event that the licensee’s or other entity’s
former rule was published. The been deleted from the paragraph for primary laboratory loses its certification.
paragraph also adds a requirement for several reasons: First, the requirement to To be considered acceptable, the rule
licensees and other entities to use HHS- have the capability to test for marijuana, requires that the replacement laboratory
certified laboratories for initial and cocaine, opiates, phencyclidine, and must be in use by another Part 26
confirmatory validity testing, consistent amphetamines has been deleted because program. The rule adds this provision to
with the addition of urine specimen it is redundant with § 26.31(d)(1). The ensure that testing can continue, in the
validity testing requirements to the rule, requirement to be capable of testing event that the HHS-certified laboratory
as discussed with respect to whole blood has been deleted because on whom a licensee or other entity
§ 26.31(d)(3)(i). The rule also updates the rule no longer permits donors to relies loses its certification, as some
the cross-reference to former § 26.24(d), request confirmatory alcohol testing of licensees have experienced. Related
which permitted licensee testing blood for the reasons discussed with requirements for auditing the
facilities to conduct initial drug tests, to respect to § 26.83(a). Finally, the replacement laboratory are specified in
reference the related provision in the requirement for laboratories to be § 26.41(g)(5).
final rule, § 26.31(d)(3)(ii). capable of using gas chromatography/ The agency added § 26.153(f) to
Section 26.153(b) amends the first mass spectrometry (GC/MS) has been require that licensees’ and other entities’
sentence of former Section 2.7(l)(2) in eliminated because HHS-certified contracts with HHS-certified
Appendix A to Part 26. The former laboratories would be permitted to use laboratories must require the
provision required HHS-certified other methods of confirmatory testing, laboratories to implement the applicable
laboratories to have the capability, at the consistent with related revisions to the requirements of this part. Because the
same laboratory premises, of performing HHS Guidelines. NRC does not regulate HHS-certified
initial and confirmatory tests for any Section 26.153(d) amends former laboratories, this revision would ensure
drug and drug metabolite for which Section 4.1(b) in Appendix A to Part 26, that the agency has a legal basis for
service is offered and confirmatory which required licensees and C/Vs to requiring HHS-certified laboratories to
testing of blood for alcohol use only HHS-certified laboratories who comply with this part when conducting
concentrations. The former requirement agree to follow the same rigorous testing for licensees and other entities.
for HHS-certified laboratories to be testing, quality control, and chain-of- Section 26.153(f)(1) retains the
capable of conducting confirmatory custody procedures when testing for requirement in former Section 2.7(l)(1)
alcohol testing of blood has been more stringent cutoff levels, additional in Appendix A to Part 26. The former
deleted for the reasons discussed with drugs to those for which testing required requirement stated that HHS-certified
respect to § 26.83(a). The paragraph under Part 26, and blood. The final rule laboratories must comply with
adds a requirement for HHS-certified eliminates reference to testing for blood applicable State licensor requirements.
laboratories to have the capability to in this provision because the rule no The final rule replaces the term ‘‘HHS-
perform both initial validity and longer permits donors to request certified laboratories’’ with the term
confirmatory validity tests at the same confirmatory alcohol testing of blood for ‘‘laboratory facilities’’ to clarify that
premises for consistency with the the reasons discussed with respect to State requirements apply to laboratory
addition of requirements to perform § 26.83(a). facilities rather than to the HHS-
certified laboratory as a corporate entity. The NRC added § 26.153(f)(5) to Section 26.155(a) [Day-to-day
The clarification is necessary because clarify that HHS-certified laboratories management of the HHS-certified
some HHS-certified laboratories are must avoid relationships with a laboratory] amends former Section
operated by large national corporations licensee’s or other entity’s MRO(s) that 2.5(a)(1) in Appendix A to Part 26,
with facilities in several different States, may be construed as a potential conflict which required the HHS-certified
and only the facilities in a specific State of interest. The final rule, with respect laboratory to have a qualified individual
are required to meet the requirements of to the proposed rule, adds a reference to to assume responsibility for day-to-day
that State. The NRC made this change provisions added in the final rule at management of the HHS-certified
for clarity in the language of the rule as § 26.183(b) to specify specific conflict of laboratory. Specifically, the paragraph
well as consistency with the HHS interest relationships. The NRC added replaces the term ‘‘qualified individual’’
Guidelines. the provisions in § 26.183(b) in response with the term ‘‘responsible person’’ for
Section 26.153(f)(2) amends former to a comment on the proposed rule consistency with terminology that other
Section 2.7(o)(5) in Appendix A to Part requesting the NRC to consider using Federal agencies use to refer to this job
26. The former regulation required HHS- the examples of MRO conflict of interest role. The final rule retains the majority
certified laboratories to make available relationships specified in DOT’s drug of Section 2.5(a)(2) in Appendix A to
qualified personnel to testify in and alcohol testing regulations. The Part 26 and establishes qualification
proceedings based on urinalysis results paragraph responds to the experiences requirements for the responsible person.
reported by the laboratory. The NRC of other Federal agencies regarding The provisions in § 26.155(a)(1)(i)–
moved the reference to licensee testing apparent conflicts of interest involving (a)(1)(iv) retain former Section
facilities to § 26.139(c) in Subpart F for laboratories and MROs. Although the 2.5(a)(2)(i)–(a)(2)(iv) in Appendix A to
organizational clarity. The requirement NRC is not aware of any situations of Part 26, with minor grammatical
for qualified personnel to be available to this type in Part 26 programs, the changes that are consistent with similar
testify in proceedings related to breath integrity of the MRO function is changes to the related provisions in the
analysis results has been moved to sufficiently important that incorporating HHS Guidelines.
§ 26.85(d) in Subpart E for this requirement is warranted to prevent Section 26.155(a)(2) and (a)(3)
organizational clarity and because potential conflict of interest concerns. establishes minimum day-to-day
responsibility for testifying with respect The paragraph is consistent with the management responsibilities of the
to breath analysis results resides with related provision in the HHS responsible person and retains former
the licensee’s or other entity’s collection Guidelines. Section 2.5(a)(4) and (a)(5) in Appendix
site personnel. A to Part 26.
Section 26.153(f)(6) amends the
Section 26.153(f)(3) updates former Section 26.155(a)(4) retains former
requirements in the first two sentences
Section 3.1 in Appendix A to Part 26, Section 2.5(a)(5) in Appendix A to Part
which required HHS-certified of former Section 2.7(m) in Appendix A 26, which relates to the responsible
laboratories to protect donors’ records. to Part 26, which required HHS-certified person’s responsibility to maintain the
The former requirement for licensee laboratories to permit the NRC, HHS-certified laboratory procedures in a
testing facilities to protect donors’ licensees, and other entities to conduct manual. With respect to the proposed
records has been subsumed within the inspections at any time, including rule, the final rule includes a provision
second sentence of § 26.37(a) for unannounced inspections. The rule that HHS-certified laboratories’
organizational clarity. The cross- deletes, for organizational clarity, the procedures be maintained in a manual
reference to former § 26.29 has been existing references to collection site of standard operating procedures. The
updated to reference § 26.39 in the final services and licensee testing facilities, proposed rule eliminated the former
rule. which are covered under Subpart F. The requirement in Section 2.5(a)(5) to
Section 26.153(f)(4) updates former paragraph also deletes reference to provide flexibility to HHS-certified
Section 3.2 in Appendix A to Part 26. confirmatory testing of blood specimens laboratories in how laboratory operating
Specifically, the rule adds a reference to for alcohol because HHS-certified procedures were maintained. However,
Sec. 503 of Pub. L. 100–71 to document laboratories are no longer testing blood based on a comment received on the
the basis for this requirement. The specimens for alcohol, as discussed proposed rule, the NRC has reinstituted
paragraph adds a requirement for a with respect to § 26.83(a). the former requirement that laboratory
donor to have access to records relating A new § 26.153(g) requires licensees procedures be maintained in a manual
to his or her validity test results for and other entities to provide a to improve consistency with the HHS
consistency with the addition of validity memorandum for the record to the HHS- Guidelines, meeting Goal 1 of this
testing requirements to the rule, as certified laboratories that they use to rulemaking. The paragraph retains the
discussed with respect to document why the licensee or other former requirements in the second and
§ 26.31(d)(3)(i). The paragraph deletes entity is using a non-Federal custody- third sentences of Section 2.5(a)(5) in
the former reference to records related and-control form. Under the HHS Appendix A to Part 26, and requires the
to alcohol test results because the final Guidelines, laboratories may reject any responsible person to review, sign, and
rule will no longer require HHS- specimen that is submitted for testing date the procedures when they are first
certified laboratories to be capable of with a non-Federal custody-and-control placed in use, changed, or a new
testing blood specimens for alcohol, as form unless the licensee or other entity individual assumes responsibility for
discussed with respect to § 26.83(a). provides a memorandum for the record. management of the laboratory. The
With respect to the proposed rule, the The paragraph is necessary to prevent responsible person must also maintain
NRC has added a phrase to the licensee and other entity specimens copies of the procedures. The final rule
provision to clarify that a donor’s from being rejected. updates the former cross-reference to
designated representative is also Section 2.7(o) in Appendix A to Part 26
Section 26.155 Laboratory Personnel
permitted to have access to records to reference § 26.157, consistent with

relating to the donor’s validity test Section 26.155 updates former the organizational changes made to the
results. The NRC made this change in Section 2.5 in Appendix A to Part 26 to rule.
response to a public comment be consistent with revisions to the HHS Section 26.155(a)(5) and (a)(6) retains
requesting the clarification. Guidelines. former Section 2.5(a)(6) and (a)(7) in
Appendix A to Part 26. These laboratories into a single section to the rule that address related topics. The
provisions define the responsible improve organizational clarity in the NRC relocated requirements for licensee
person’s responsibilities with respect to rule. testing facility procedures to § 26.127(c)
maintaining a quality assurance In § 26.157(a), the agency has made in Subpart F. In addition, the rule
program and taking remedial actions to minor editorial changes to the first moves the last two sentences of former
maintain satisfactory laboratory sentence of former Section 2.2 in Section 2.7(o)(1), which specify records
operations. Appendix A to Part 26, but retains the retention requirements, to § 26.715(b)(4)
Section 26.155(b) [Certifying scientist] former requirement for HHS-certified of Subpart N [Recordkeeping and
amends former Section 2.5(b) in laboratories to have detailed procedures Reporting Requirements].
Appendix A to Part 26 to be consistent for conducting testing. The rule deletes Section 26.157(d) amends former
with changes made to the related the former reference to blood samples Section 2.7(o)(3)(iii) in Appendix A to
requirement in the HHS Guidelines. because donors no longer have the Part 26. The final (and former) provision
Consistent with the HHS Guidelines, the option to request blood testing for requires procedures for the setup and
rule provides more detailed alcohol, as discussed with respect to normal operation of testing instruments;
requirements with respect to the § 26.83(a). Reference to licensee testing a schedule for checking critical
individual who certifies test results at facilities has been moved to § 26.127(a) operating characteristics for all
the HHS-certified laboratory before they in Subpart F for organizational clarity. instruments; tolerance limits for
are transmitted to the licensee or other The rule also deletes reference to acceptable function checks; and
entity’s MRO. procedures for specimen collections, instructions for major troubleshooting
In § 26.155(b)(1), a new job title, because the NRC relocated procedural and repair. The rule makes three
‘‘certifying scientist,’’ replaces the term requirements for specimen collections changes to the former provision for
‘‘qualified individual(s)’’ in the first to Subpart E in the final rule. organizational clarity. The paragraph
sentence of former Section 2.5(b) in Section 26.157(b) combines and presents the required topics of the
Appendix A to Part 26 for consistency amends portions of the requirements in procedures in a list format in
with a related change in the HHS the first sentence of former Sections § 26.157(d)(1)–(d)(3) to clarify that each
Guidelines. The final rule, with respect 2.4(d) and 2.7(a)(2) in Appendix A to topic stands on its own. The former
to the proposed rule, replaces the phrase Part 26 related to the content and requirement to maintain records of
‘‘attest the validity of’’ with ‘‘certify’’ implementation of specimen chain-of- preventative maintenance has been
test results, as this is a more accurate custody procedures. The regulation relocated to § 26.715(b)(10) in Subpart
description of the responsibilities of a retains the portions of the former N. And, the rule moves the former
certifying scientist. The NRC made this paragraphs that required HHS-certified requirements that apply to licensee
change in response to a comment laboratories to develop, implement, and testing facilities to § 26.127(d) in
received on the proposed rule. Section maintain written chain-of-custody Subpart F.
26.155(b)(2) specifies the required procedures to maintain control and Section 26.157(e) amends former
qualifications of individuals who serve accountability of specimens from Section 2.7(o)(4) in Appendix A to Part
as certifying scientists. Section receipt through completion of testing 26, but continues to require documented
26.155(b)(3) permits laboratories to use and reporting of results, during storage corrective actions if systems are out of
more than one certifying scientist with and shipping to another HHS-certified acceptable limits or errors are detected.
differing responsibilities. laboratory, and continuing until final The requirements in the former
Section 26.155(c) [Day-to-day disposition of the specimens. The paragraph that apply to licensee testing
operations and supervision of analysts] former requirements related to licensee facilities have been moved to § 26.127(e)
retains former Section 2.5(c) in testing facilities have been moved to in Subpart F for organizational clarity.
Appendix A to Part 26. The rule makes § 26.127(b) in Subpart F for
Section 26.159 Assuring Specimen
minor language changes to the former organizational clarity. The rule also
Security, Chain of Custody, and
paragraph to increase the consistency of removes references to custody-and-
Preservation
the language in this provision with that control procedures for blood specimens
of the related provision in the HHS because donors no longer have the The NRC added § 26.159 to present in
Guidelines. option to request blood testing for one section the requirements of the rule
Section 26.155(d) [Other personnel] alcohol, as discussed with respect to that apply to HHS-certified laboratories
and (e) [Training] retains former Section § 26.83(a). with respect to the safeguarding of
2.5(d) and (e) in Appendix A to Part 26, The NRC has amended the portions of specimen identity, integrity, and
respectively. former Section 2.7(o)(1) in Appendix A security. This organizational change
Section 26.155(f) [Files] updates to Part 26 that address the required consolidates requirements that were
former Section 2.5(f) in Appendix A to content of procedures for HHS-certified dispersed throughout the former rule.
Part 26. The revisions are consistent laboratories. Section 26.157(c) retains Section 26.159(a) amends former
with related requirements in the HHS the portions of the former provision that Section 2.7(a)(1) in Appendix A to Part
Guidelines. required laboratories to develop and 26. This provision retains the first three
maintain written procedures to specify sentences of former Section 2.7(a)(1) in
Section 26.157 Procedures all of the elements of the testing process, Appendix A to Part 26, which required
Section 26.157 reorganizes and including, but not limited to, the HHS-certified laboratories to be secure
amends requirements for HHS-certified principles of each test and the and accessible only to authorized
laboratories’ procedures. The preparation of reagents, standards, and personnel. For organizational clarity,
requirements for procedures were controls. The paragraph presents the the NRC moved the requirements that
interspersed throughout former required topics of the procedures in a apply to licensee testing facilities to
Appendix A to Part 26, including list format in § 26.157(c)(1) through § 26.129(a) in Subpart F. The last
requirements contained in former (c)(12) to clarify that each topic stands sentence of the former paragraph, which
Sections 2.2 and 2.7 in Appendix A to on its own. For organizational clarity, establishes recordkeeping requirements,
Part 26. The NRC has combined two portions of the former provision has been moved to § 26.715(b)(13) in
procedural requirements for the have been moved to other subparts of Subpart N. In addition, the NRC has
revised the last sentence of the former licensee testing facility has retained the and 3.1 in Appendix A to Part 26, which
paragraph to increase clarity in the specimen in Bottle B and it is intact, the require the laboratory to maintain the
requirement and expands the list of rule requires the licensee testing facility original specimen and custody-and-
persons who are authorized to have to forward the intact specimen for control form in secure storage at the
access to the laboratory to include testing to the HHS-certified laboratory. HHS-certified laboratory. The NRC
representatives of the Secretary of HHS The NRC added this provision to the made these changes to reduce
and emergency responders. This change final rule in response to public redundancies and improve the
increases the consistency of Part 26 with comments on the related provision in organizational clarity of the rule.
the related provision in the HHS the proposed rule. The commenters Section 26.159(d) and (e) updates the
Guidelines. requested the NRC to include this portions of former Section 2.7(a)(2) in
Section 26.159(b) amends former provision from DOT’s procedures. The Appendix A to Part 26 that established
Section 2.7(b)(1) in Appendix A to Part NRC agreed with the commenters’ requirements for HHS-certified
26. That provision established suggestion because eliminating the laboratory personnel to maintain and
requirements for receiving specimens at recollection when an intact specimen is document the chain of custody for
the HHS-certified laboratory and available reduces the burden on donors specimens and aliquots, by replacing
assuring their integrity and identity. The that a recollection would impose. the former paragraph with two related
final rule makes several organizational The final rule, with respect to the provisions from the HHS Guidelines.
changes to the former rule by dividing proposed rule, establishes a new Paragraph (d) in this section requires the
the provision into paragraphs section, § 26.159(b)(2) to specify the laboratory’s internal custody-and-
§ 26.159(b)(1) and (b)(2) for increased exclusive grounds requiring an MRO to control form to allow for identification
organizational clarity. cancel a test. The NRC added this of the donor, documentation of the
Section 26.159(b)(1) retains the former section in response to public comments testing process and transfers of custody
requirement for the HHS-certified received on the proposed rule that of the specimen. The agency added the
laboratory to report evidence of requested this clarification. Section phrase, ‘‘within the laboratory,’’ to
tampering to licensees’ or other entities’ 26.159(b)(2)(i) requires the MRO to paragraph (e) of this section to clarify
management within 24 hours of cancel a test if the custody and control that the requirement to document each
discovery, as well as the requirement for form does not contain information to instance of handling and transfer of
the laboratory to document any identify the specimen collector and the specimens applies to internal laboratory
evidence of tampering on the collection site cannot provide activities and does not apply to transfers
specimen’s custody-and-control form. conclusive evidence of the collector’s involving couriers. For organizational
The rule moves the former requirements identity. Section 26.159(b)(2)(ii) clarity, the rule relocates the
related to licensee testing facilities to requires the MRO to cancel a test if the requirements in the former paragraph
§ 26.129(b) in Subpart F for identification numbers on the specimen that are related to licensee testing
organizational clarity. With respect to bottle seal(s) do not match the facilities to § 26.129(d) and (e) in
the proposed rule, the final rule adds identification numbers on the custody- Subpart F.
several requirements to the provision. and-control form. Section Section 26.159(f) and (g) separates
The NRC has renumbered as 26.159(b)(2)(iii) requires the MRO to former Section 2.4(i) in Appendix A to
§ 26.159(b)(1)(i), but retained without cancel a test if a specimen bottle seal is Part 26 into two paragraphs, for the
change, the portion of proposed broken or shows evidence of tampering reasons discussed with respect to the
§ 26.159(b)(1) that required licensee or and an intact specimen, as specified in similar provisions of § 26.117(i) and (k)
other entity management personnel to paragraph (b)(1)(ii) of this section, does and § 26.129(g) and (h). The paragraphs
ensure that an investigation is initiated not exist. Section 26.159(b)(2)(iv) repeat the requirements for packaging
if any indications of specimen requires the MRO to cancel a test if the and shipping positive, adulterated,
tampering are identified, and take specimen appears to have leaked out of substituted, or invalid specimens that
corrective actions if tampering is its sealed bottle and there is less than 15 have been presented in § 26.117(i) and
confirmed. The appropriate corrective mL remaining, and an intact specimen, (k) of Subpart E and § 26.129(g) and (h)
actions will depend on the nature of the as specified in paragraph (b)(1)(ii) of in Subpart F, but apply them to
tampering identified as a result of the this section, does not exist. Section packaging and shipping specimens from
investigation. For example, if the 26.159(b)(2)(v) requires the MRO to one HHS-certified laboratory to another.
investigation indicates that the cancel a test if the provisions of The bases for these requirements are
tampering was an attempt to subvert the § 26.165(f)(2) apply. The NRC discussed with respect to § 26.117(i) and
testing process and the persons involved incorporated these requirements from (k). With respect to the proposed rule,
are identified, the rule requires licensee the related DOT procedures. the final rule clarifies § 26.159(f) to
and other entity management personnel Section 26.159(c) updates and ensure that a copy of the custody-and-
to impose the sanctions in § 26.75(b) for combines former Section 2.7(b)(2) in control form, rather than the original
a subversion attempt. Appendix A to Part 26 with portions of custody-and-control form, is included
Section 26.159(b)(1)(ii) requires the former Sections 2.7(n) and 3.1 in with an aliquot of a single specimen or
licensee and other entity to collect Appendix A to Part 26. These Bottle B of a split specimen that is
another specimen as soon as possible, if regulations in the former rule transferred to a second HHS-certified
the licensee or other entity has reason established requirements for chain-of- laboratory for testing. The NRC made
to question the integrity and identity of custody procedures for specimens and this change in response to a public
a specimen. With respect to the aliquots at licensee testing facilities and comment on this provision that noted
proposed rule, the final rule eliminates HHS-certified laboratories. For the proposed provision was inconsistent
the need to collect another specimen if organizational clarity, the NRC has with the related requirement in the HHS
a split specimen collection was relocated the requirements in the former Guidelines.
performed, either the Bottle A or Bottle paragraphs that are related to licensee Section 26.159(h) replaces former
B seal remains intact, and the intact testing facilities to § 26.129(c) in Section 2.7(c) in Appendix A to Part 26.
specimen contains at least 15 mL of Subpart F. The final rule retains the The former provision established
urine. If this circumstance arises and the requirements in former Sections 2.7(n) requirements for refrigerating urine
specimens at the HHS-certified comment received on the proposed rule. (b)(5) establishes requirements for initial
laboratory and licensee testing facility to This addition meets Goal 7 of this validity tests that HHS-certified
protect them from degradation. The rule rulemaking to protect the privacy and laboratories must conduct on a primary
replaces the former paragraph with the other rights (including due process) of specimen. The primary specimen is
simplified language of the related individuals who are subject to Part 26. either a single specimen submitted by
provision in the HHS Guidelines. The an FFD program that does not follow
Section 26.161 Cutoff Levels for
NRC moved the requirements related to split specimen procedures, or the
Validity Testing
short-term refrigerated storage at specimen contained in Bottle A of a
licensee testing facilities to § 26.129(f) A new § 26.161 establishes maximum split specimen. For initial validity tests
in Subpart F for organizational clarity. cutoff levels and methods for of each specimen, HHS-certified
The final rule, with respect to the conducting specimen validity testing at laboratories will determine the
proposed rule, adds the Fahrenheit HHS-certified laboratories, consistent creatinine concentration of each
temperature level that is equivalent to with the addition of requirements to specimen under § 26.161(b)(1). If the
the Celsius temperature level included conduct validity testing throughout the creatinine concentration is less than 20
in the proposed rule to improve the rule, as discussed with respect to mg/dL, the laboratory will determine
clarity of the final rule. § 26.31(d)(3)(i). The rule incorporates the specimen’s specific gravity under
In § 26.159(i), the NRC amends former these requirements from the HHS § 26.161(b)(2). Section 26.161(b)(3)
Section 2.7(h) in Appendix A to Part 26. Guidelines as revised on April 13, 2004, requires the laboratory to determine
The former requirement established (69 FR 19644) to meet, in part, Goal 1 each specimen’s pH. Section
requirements for long-term frozen of this rulemaking to update and 26.161(b)(4) requires the laboratory to
storage of positive urine specimens at enhance the consistency of Part 26 with test the specimen for the presence of
HHS-certified laboratories and licensee advances in other relevant Federal rules oxidizing adulterants, and § 26.161(b)(5)
testing facilities. For organizational and guidelines. This section prohibits requires additional validity testing,
clarity, the NRC moved the licensee and other entities from using depending on the characteristics of the
requirements related to long-term more stringent validity test cutoff levels specimen.
storage of specimens by licensee testing to ensure consistency among licensees With respect to the proposed rule, the
facilities to § 26.135(c) in Subpart F. The and other entities and reduce the final rule deletes proposed
rule adds requirements for storing likelihood of false adulterated, § 26.161(b)(2). The proposed paragraph
specimens that yield adulterated, substituted, or invalid test results, and specified the results from initial validity
substituted, or invalid test results from ensure that donors are not subject to testing that would indicate the need for
specimen validity testing, consistent sanctions on the basis of inaccurate test the HHS-certified laboratory to conduct
with the addition of requirements to results. The prohibition supports Goal 7 confirmatory validity testing. The NRC
conduct validity testing throughout the of this rulemaking to protect the privacy deleted this paragraph in the final rule
rule, as discussed with respect to and other rights (including due process) because the criteria it contained
§ 26.31(d)(3)(i). The NRC has eliminated of individuals who are subject to Part repeated the criteria embedded in
the reference to ‘‘administrative or 26. § 26.161(c)–(f). In addition, the HHS
disciplinary proceedings’’ in the first The NRC added § 26.161(a) to specify Guidelines do not include these criteria
sentence of the former paragraph that HHS-certified laboratories must separately. Therefore, this revision
because there are other circumstances in conduct initial and, if necessary, increases the consistency of Part 26 with
which it may be necessary to have a confirmatory validity testing using two the related provisions in the HHS
specimen available for retesting, different aliquots of a urine specimen. Guidelines.
including, but not limited to, retesting This provision incorporates the related The final rule adds § 26.161(c) to
an aliquot of an invalid specimen at a provision from the HHS Guidelines. establish criteria for HHS-certified
second HHS-certified laboratory under With respect to the proposed rule, the laboratories to apply in determining
§ 26.161(g). The rule also updates the final rule revises the provision to clarify whether to report to a licensee’s or other
terminology used in the former that confirmatory testing of a second entity’s MRO that a specimen is
paragraph by adding a reference to aliquot is required if initial validity test adulterated. Section 26.161(c)(1)
‘‘Bottle B’’ of a split specimen. As results indicate that the specimen may through (c)(8) specifies results from
discussed with respect to § 26.5 be adulterated, substitute, dilute, or initial and confirmatory validity testing
[Definitions], these changes in invalid. The final rule also adds a that indicate that a specimen is
terminology are intended to improve requirement that licensees and other adulterated. The paragraphs also specify
clarity in the language of the rule. entities must ensure that the HHS- the appropriate testing devices and
The NRC added § 26.159(j) to certified laboratory is capable of instruments to be used for initial and
incorporate related changes to the HHS conducting, and conducts, confirmatory confirmatory validity tests. In general,
Guidelines. The final rule permits the testing for at least one oxidizing the paragraphs require the HHS-certified
HHS-certified laboratory to discard adulterant and any other adulterants for laboratory to report to the MRO that a
negative specimens. This paragraph also which the licensee’s or other entity’s urine specimen is adulterated if it meets
permits laboratories to pool specimens FFD program conducts testing. The any one of the following criteria: (1) It
that are certified to be negative for drugs agency made these changes in response is confirmed to contain a substance that
and drug metabolites and valid, as well to public comments and to improve should not be present at all in normal
as use them as quality control samples, clarity in the language of the rule. human urine; (2) it is confirmed to
as permitted under the HHS Guidelines. The agency added § 26.161(b) to contain a substance which, although it
With respect to the proposed rule, the establish requirements and cutoff levels could be present in normal human
final rule prohibits the laboratory from for initial validity tests to be performed urine, is found to be at a concentration
retaining any information linking at HHS-certified laboratories. With that appears to be inconsistent with
donors to specimens that are pooled for respect to the proposed rule, the final human physiology; or (3) it presents an
use in the laboratory’s internal quality rule renumbers these paragraphs to acid/base balance (pH) that appears to
control program. The NRC added this improve the organization and clarity of be inconsistent with human life. The
prohibition in response to a public the rule. Section 26.161(b)(1) through paragraphs address several substances
that some donors have used to try to interfere with the chemistry of some of Section 26.163(a) [Initial drug testing]
defeat drug tests through ‘‘in vitro’’ the initial tests). However, it was also amends former Section 2.7(e) in
contamination (i.e., adding the recognized that many of these problem Appendix A to Part 26. When
substance to a urine specimen). These specimens actually contained an determining whether to report to the
adulterants include substances that adulterant that the laboratory could not MRO that a specimen is positive for
create a urine pH inconsistent with specifically identify with ‘‘scientific drug(s) or drug metabolite(s),
human life, oxidizing adulterants, certainty’’ which is the requirement for § 26.163(a)(1) requires HHS-certified
chromium (VI), halogens, reporting a specimen as adulterated. laboratories to apply the same cutoff
glutaraldehyde, pyridine, and Therefore, the HHS adopted the term levels that licensee testing facilities are
surfactants. These substances, when ‘‘invalid specimen’’ to mean that the required to use in § 26.133, except if the
either placed into an already voided laboratory has determined that valid test FFD program specifies more stringent
urine specimen or used in place of a results cannot be obtained from a cutoff levels or the specimen is dilute,
urine specimen, generally either attempt specimen or an unknown substance as discussed further in § 26.163(a)(2).
to defeat the chemistry of the test or interfered with the confirmatory test. The paragraph reiterates the former
destroy a drug that is present. The NRC The rule adopts the term ‘‘invalid permission for licensees and other
recognizes that this list will be updated specimen’’ with the same meaning. entities to establish lower cutoff levels.
and/or modified as new substances and The rule adds § 26.161(g) to address In addition, § 26.163(a)(1) decreases the
formulas are introduced, and methods circumstances in which an HHS- initial test cutoff level for marijuana
to detect them have been developed and certified laboratory suspects that a metabolites from 100 nanograms (ng)
implemented by HHS-certified specimen is adulterated but cannot per milliliter (mL) to 50 ng/mL and
laboratories. Section 26.161(c)(8) identify the adulterant. The paragraph increases the initial test cutoff level for
recognizes that new adulterants will be permits the laboratory to transfer the opiate metabolites from 300 ng/mL to
found and, therefore, requires HHS- specimen to a second HHS-certified 2,000 ng/mL for the reasons discussed
certified laboratories to use appropriate laboratory for additional testing, if the with respect to § 26.133. The changes
testing methods when conducting initial first HHS-certified laboratory cannot are consistent with the HHS cutoff
and confirmatory testing for new identify a possible adulterant in the levels for the same substances.
adulterants for which cutoff levels and specimen using their standard testing A new § 26.163(a)(2) establishes
criteria have not yet been established. technologies and the licensee’s or other requirements and criteria for the initial
Section 26.161(d) and (e) establishes entity’s MRO concurs with the
cutoff levels and criteria for a drug testing of any specimen that
additional testing. Personnel at the first confirmatory validity testing indicates is
determination by the laboratory that a
HHS-certified laboratory will consult dilute. Although there are many
specimen has been substituted or is
with the licensee’s or other entity’s legitimate reasons that a donor may
dilute, respectively. In § 26.161(d), the
MRO to determine whether to transfer provide a urine specimen that is dilute,
HHS-certified laboratory will report to
the specimen to a second laboratory for dilution is also a method used to
the MRO that a specimen is substituted
additional testing. subvert the testing process. Dilution of
if it contains less than 2 mg/dL of
creatinine and the specific gravity is less The agency added § 26.161(h) to a specimen decreases the concentration
than or equal to 1.0010 or equal to or prohibit licensees and other entities of any drugs or drug metabolites in the
greater than 1.0200. These low from requiring an HHS-certified specimen. Dilution may decrease the
creatinine concentrations combined laboratory to apply validity testing concentration sufficiently that applying
with the highly skewed specific gravity cutoff levels and criteria that are more the cutoff levels specified in this part,
values indicate that the specimen is not stringent than those specified in this or a licensee’s or other entity’s more
human urine. In § 26.161(e), the HHS- proposed section. Because validity stringent cutoff levels, would provide
certified laboratory is required to report testing is complex and the methods for false negative drug test results.
to the MRO that a specimen is dilute if testing are relatively new, the rule does Therefore, the rule adds special testing
the creatinine concentration is equal to not permit an FFD program to establish procedures and criteria for determining
or greater than 2 mg/dL but less than 20 more stringent cutoff levels for validity which dilute specimens must be subject
mg/dL and the specimen specific gravity testing. The prohibition is necessary to to confirmatory drug testing. With
is greater than 1.0010 but less than decrease the risk of obtaining false respect to the proposed rule, the NRC
1.0030. adulterated, substituted, or invalid test has eliminated the optional provision
The NRC added § 26.161(f)(1) through results and ensure that donors are not for FFD programs to test specimens with
(f)(12) to establish the criteria that HHS- subject to sanctions on the basis of initial validity test results that indicate
certified laboratories apply when inaccurate test results. a specimen is dilute using FDA
determining that a specimen is invalid. approved kits for the lowest
Section 26.163 Cutoff Levels for Drugs
In 1998, HHS established criteria for concentration levels marketed for the
and Drug Metabolites
what were termed ‘‘unsuitable’’ technologies being used to conduct
specimens (Program Document 35, Section 26.163 groups together in one initial testing of specimens for drug or
September 28, 1998). An unsuitable section, for organizational clarity, the drug metabolites. This change is based
specimen was defined as one that requirements for conducting initial and on a comment received on the proposed
contained an interfering substance but confirmatory tests for drugs and drug provision. Instead, the NRC is adopting
the laboratory could not determine the metabolites at HHS-certified the procedure proposed by the
nature of the substance with scientific laboratories. The section also updates commenter. That is, for dilute
certainty. In these circumstances, the requirements related to cutoff levels for specimens, the final rule permits an
laboratory could not achieve a ‘‘valid’’ drugs and drug metabolites in the FFD program to request the HHS-
test result. The HHS recognized that in former rule to meet Goal 1 of this certified laboratory to conduct
some cases, an interfering substance rulemaking to update and enhance the confirmatory testing of dilute specimens
could be a legitimately ingested consistency of Part 26 with advances in at the confirmatory assay’s LOD for a
medication (some non-steroidal anti- other relevant Federal rules and drug or drug class, if the response to the
inflammatory drugs have been known to guidelines. initial drug test for any drug class for
which testing is performed is within 50 number of changes to the former 2.7(f)(1) in Appendix A to Part 26 that
percent of the cutoff calibrator level. paragraph. the HHS-certified laboratory uses to
The NRC agrees that the commenter’s The agency has moved former Section determine that a confirmatory drug test
approach is consistent with the intent of 2.7(f)(1) in Appendix A to Part 26 to result is positive. The rule increases the
the proposed provision, while reducing § 26.169(b)(1) of the final rule. Former confirmatory test cutoff levels for
the burden on HHS-certified Section 2.7(f)(1) required the HHS- morphine and codeine to 2,000 ng/mL.
laboratories imposed by the proposed certified laboratory to report to the MRO This change in the cutoff level for opiate
requirements. This special processing of that test results are negative for any metabolites substantially reduces the
dilute specimens increases the specimens that yield negative test number of positive opiate test results
likelihood that any drugs and drug results when they are subjected to that are reported to MROs by HHS-
metabolites in the specimen will be confirmatory testing. The NRC moved certified laboratories that MROs
detected. Therefore, this requirement this requirement to § 26.169(b)(1) for ultimately verify as negative and is
meets Goal 3 of this rulemaking to organizational clarity because § 26.169 consistent with the opiate cutoff levels
improve the effectiveness of FFD addresses the topic of reporting test contained in the HHS Guidelines.
programs, by increasing the likelihood results by the HHS-certified laboratory Section 26.163(b)(1) also amends two
that testing of dilute specimens will to the MRO. of the testing procedures in former
reveal drug use if the donor had engaged The NRC has also eliminated the Section 2.7(f) in Appendix A to Part 26.
in substance abuse. requirement in former Section 2.7(f)(1) The rule amends former Section 2.7(f)(5)
As discussed with respect to § 26.133, in Appendix A to Part 26 that the in Appendix A to Part 26, which
the final rule eliminates the requirement laboratory must conduct confirmatory required the laboratory to test for 6-
in the last sentence of former Section testing using both the maximum cutoff acetylmorphine (6–AM) if a specimen
2.7(e)(1) of Appendix A to Part 26 for values established in Part 26 as well as tests positive for opiates on the initial
HHS-certified laboratories to report drug any more stringent cutoff levels adopted drug test. The rule requires the HHS-
test results for both the cutoff levels in by the licensee’s or other entity’s FFD certified laboratory to test for 6–AM, if
the rule and any more stringent cutoff program. The former requirement to test results for morphine are at or above
levels that the licensee or other entity conduct testing for the cutoff levels the 2,000 ng/mL opiate cutoff levels,
may establish. The basis for the former specified in this part, when the licensee and establishes a cutoff level of 10 ng/
requirement to report test results for the is using more stringent cutoff levels, mL for determining that a specimen is
cutoff levels specified in this part, when was a means by which the NRC positive for 6–AM. In addition,
the licensee is using more stringent monitored implementation of the § 26.163(b)(1) adds a requirement that a
cutoff levels, was a means by which the permission to use more stringent cutoff specimen must also contain
NRC monitored implementation of the levels. The rule eliminates this amphetamine at a concentration equal
permission to use more stringent cutoff requirement, because to or greater than 200 ng/mL in order for
levels. The rule eliminates this § 26.31(d)(3)(iii)(C) requires a qualified the HHS-certified laboratory to report to
requirement, because forensic toxicologist to certify the the MRO that the specimen has yielded
§ 26.31(d)(3)(iii)(C) requires a qualified scientific and technical validity of any a positive test result for
forensic toxicologist to certify the testing at lower cutoff levels. Therefore, methamphetamine. These changes are
scientific and technical validity of any the requirement to test at both cutoff consistent with the related provisions in
testing at lower cutoff levels. Therefore, levels is no longer needed to assure the HHS Guidelines.
the former reporting requirement is no laboratory performance in this area. Section 26.163(b)(1) updates the
longer needed to ensure laboratory For organizational clarity, the NRC terminology used in former Section
performance in this area. Eliminating has moved the first sentence of former 2.7(f)(1) in Appendix A to Part 26. As
this requirement meets Goal 5 of this Section 2.7(f)(2) in Appendix A to Part discussed with respect to § 26.5, the
rulemaking to improve Part 26 by 26 that required the laboratory to use final rule replaces the term
eliminating or modifying unnecessary GC/MS techniques for confirmatory ‘‘presumptive positive’’ with the phrase
requirements. testing to § 26.167(e)(1) in the final rule. ‘‘positive on an initial drug test’’ to
The rule also eliminates former Section 26.167(e)(1) addresses quality increase clarity in the language of the
Section 2.7(e)(2) in Appendix A to Part control requirements for conducting rule.
26. The former provision stated that the confirmatory drug tests. A new § 26.163(b)(2) amends the
list of substances and cutoff levels The rule eliminates former Section second sentence of former Section
contained in Appendix A to Part 26 2.7(f)(3) in Appendix A to Part 26. The 2.7(f)(2) in Appendix A to Part 26. The
were subject to change by the NRC. At former provision required HHS-certified former sentence required the HHS-
the time the former rule was published, laboratories to use GC analysis of blood certified laboratory to document drug
the NRC expected to be able to amend specimens in testing for alcohol. The and drug metabolite concentrations that
the list of substances and cutoff levels final rule also eliminates the exceed the linear region of the standard
in the former rule without additional confirmatory alcohol cutoff level in curve in the laboratory record. The rule
rulemaking. However, the NRC has former Section 2.7(f)(1) in Appendix A replaces the former sentence with a
determined that rulemaking is required to Part 26. The NRC eliminated these paragraph that incorporates the related
to make such changes. Therefore, the provisions because the rule no longer provision from the HHS Guidelines. The
rule deletes this paragraph because it is permits donors to request confirmatory HHS Guidelines permit the laboratory to
unnecessary. testing of a blood specimen for alcohol, dilute an aliquot of the specimen to
The final rule replaces former Section as discussed with respect to § 26.83(a). obtain an accurate quantitative result
2.7(f) in Appendix A to Part 26 with In addition, the rule eliminates former when the concentration is above the
§ 26.163(b) [Confirmatory drug testing]. Section 2.7(f)(4) in Appendix A to Part upper limit of the linear range. This
The former provision established cutoff 26 for the same reasons discussed with change has been made to meet Goal 1
levels and requirements related to respect to former Section 2.7(e)(2) in of this rulemaking to update and
confirmatory testing for drugs and drug Appendix A to Part 26. enhance the consistency of Part 26 with
metabolites at the HHS-certified Section 26.163(b)(1) amends several advances in other relevant Federal rules
laboratory. The rule also makes a of the cutoff levels in former Section and guidelines.
Section 26.165 Testing Split validity’’ to refer to the results of testing additional testing of an aliquot from a
Specimens and Retesting Single at the licensee testing facility. The single specimen or testing of Bottle B by
Specimens agency made this change to improve the a second HHS-certified laboratory. This
Section 26.165 reorganizes and clarity of the rule’s language. permission is consistent with related
Section 26.165(a)(3) retains the provisions in the HHS Guidelines and
amends the requirements formerly
authorization in the second sentence of amends the requirements in former
found in § 26.24(f), and Section 2.7(i)
former Section 2.7(j) in Appendix A to Section 2.7(j) in Appendix A to Part 26
and (j) in Appendix A to Part 26 that
Part 26 for licensee testing facilities to that pertained to donor requests to test
related to testing split specimens and
retain custody of the split specimen in the specimen in Bottle B. The final rule
retesting specimens at HHS-certified
Bottle B or forward it with Bottle A to permits donors to request retesting of an
laboratories. For organizational clarity,
the HHS-certified laboratory for storage aliquot of a single specimen by a second
the final rule groups the requirements
until testing of Bottle A is completed. HHS-certified laboratory to protect
together in a single section to make
The final rule also retains the former donors’ rights to retesting under FFD
them easier to locate in the rule. The authorization for the specimens in programs that do not follow split
section also adds several new Bottle A and Bottle B to be discarded if specimen procedures. The rule adds
requirements. test results from the HHS-certified confirmed adulterated and substituted
Section 26.165(a) [Testing split
laboratory are negative. With respect to validity test results as bases for a donor
specimens] combines and amends
the proposed rule, the final rule makes request for testing the specimen in
former § 26.24(f) and Section 2.7(j) in minor editorial changes to this Bottle B or retesting an aliquot of a
Appendix A to Part 26. Those provision to increase the clarity of the single specimen, consistent with the
provisions established requirements for language. In addition, the final rule adds addition of requirements to conduct
HHS-certified laboratories when testing cross-references to § 26.135(a) and (c). validity testing throughout the rule, as
split specimens. The final rule uses the These provisions contain requirements discussed with respect to
terms ‘‘Bottle A’’ and ‘‘Bottle B’’ to refer for storing Bottle B of a split specimen § 26.31(d)(3)(i). However, in order to
to the primary and split specimens, at a licensee testing facility, if the have sufficient urine to support
respectively, for consistency with the licensee testing facility chooses to retain retesting, the paragraph applies only if
updated terminology used throughout Bottle B rather than forwarding it with the donor had originally submitted a
the rule. The rule also requires Bottle A to the HHS-certified laboratory. specimen of 30 mL or more in a single
specimen validity testing, consistent The NRC made these changes to specimen, or a specimen in Bottle A.
with the addition of requirements to improve clarity in the language of the Specimens that the HHS-certified
conduct validity testing throughout the rule and in response to a public laboratory determines to be invalid are
rule, as discussed with respect to comment requesting the clarifications. not eligible for retesting because of the
§ 26.31(d)(3)(i). The NRC added § 26.165(b) [Donor risk of damage to laboratory equipment
Section 26.165(a)(1) retains the request to MRO for a retest of a single that some invalid specimens may pose
portions of former Section 2.7(j) in specimen or testing Bottle B of a split and because retesting the specimen
Appendix A to Part 26 that required the specimen] to permit donors to request would not provide useful information.
HHS-certified laboratory to analyze the retesting of an aliquot from a single The procedures for requesting and
primary specimen of a split specimen. specimen, if the FFD program does not conducting the retest of a single
The former requirements related to follow split specimen procedures, and specimen are consistent with those for
licensee testing facilities in this section testing of Bottle B if the program follows requesting and conducting tests on the
have been moved to § 26.135 in Subpart split specimen procedures. This specimen in Bottle B of a split specimen
F for organizational clarity. This paragraph assures that donors who are in the final rule.
paragraph retains the former subject to a program that does not Section 26.165(b)(2) adds a
requirement that the primary specimen follow split specimen procedures have requirement for the MRO to inform the
(Bottle A) must be subject to initial the right to request additional testing. donor that he or she may, within 3
testing by the HHS-certified laboratory, With respect to the proposed rule, the business days of notification by the
and confirmatory testing, if the results final rule combines and reorganizes the MRO of a confirmed positive,
of initial testing indicate that the provisions in proposed § 26.165(b) adulterated, or substituted test result,
specimen is positive. The final rule adds pertaining to a donor’s request for request a retest of an aliquot of a single
a requirement for HHS-certified retesting a single specimen with those specimen or, as appropriate, Bottle B of
laboratories also to conduct initial and, in proposed § 26.165(c) pertaining to a a split specimen. The NRC also added
if necessary, confirmatory validity donor’s request for testing of Bottle B of a requirement that the donor must
testing of the specimen in Bottle A of a a split specimen. The agency made request retesting an aliquot of a single
split specimen. these changes in response to a public specimen or testing the Bottle B
Section 26.165(a)(2) retains the comment. The commenter noted that specimen within 3 business days after
portion of the second sentence of former the separate paragraphs in the proposed notification by the MRO that a single
§ 26.24(f) that required the HHS- rule contained redundant requirements specimen or the specimen in Bottle A of
certified laboratory to perform initial and that separating the requirements a split specimen has yielded positive,
and confirmatory tests, if required, on into two paragraphs was inconsistent adulterated, or substituted test results.
the primary specimen in Bottle A, even with the related provisions in the HHS Since 1994, the HHS Guidelines have
if a licensee testing facility conducted Guidelines. Therefore, the NRC also allowed up to 72 hours for a donor to
initial testing on an aliquot of the changed the title of this section from make this request, so this change
specimen. The NRC moved the former ‘‘Donor request to MRO for a retest of a increases the consistency of Part 26 with
requirement to this section for single specimen’’ in the proposed rule the HHS Guidelines. This provision
organizational clarity. With respect to to ‘‘Donor request to MRO for a retest of combines proposed § 26.165(a)(4) and
the proposed rule, the final rule replaces a single specimen or testing of Bottle B (b)(1) into one paragraph for the reasons
the term ‘‘non-negative’’ in the proposed of a split specimen’’ in the final rule. discussed with respect to § 26.165(b).
rule with the more specific terms Section 26.165(b)(1) assures that The final rule, with respect to the
‘‘positive’’ and ‘‘of questionable donors may request through the MRO proposed rule, includes a new
requirement that the MRO must provide has added a new provision that permits requirement for forwarding Bottle B in
the donor with specific contact a donor to present to the MRO evidence former Section 2.7(j) of Appendix A to
information and have the ability to supporting the inability of the donor to Part 26 has often been difficult for a
verify the time the donor’s call was make a timely request for retesting of a number of reasons. These reasons
received by the MRO’s office if single specimen or the testing of the included communication delays among
telephone notifications for retesting are Bottle B specimen after the 3-business- donors, MROs, the HHS-certified
the preferred method of the MRO’s day period permitted has elapsed. For laboratory, and FFD program personnel,
office. The NRC added this provision in example, a donor may have been particularly on weekends, holidays, and
response to a public comment received severely ill when informed of a the time required to identify a second
on the proposed rule that requested the confirmed positive, adulterated, or HHS-certified laboratory with the
addition to further protect donors’ rights substituted test result and was unable to appropriate capability to test the
under the rule. The requirement is contact the MRO to make the request specimen, depending on the nature of
consistent with related requirements in because of hospitalization. On the basis the positive test result. The change
the DOT’s drug and alcohol testing of the information the donor presents, alleviates some types of logistical
procedures and, therefore, meets Goal 1 the MRO will make the sole problems associated with weekends and
of the this rulemaking to enhance the determination whether the holidays while continuing to provide
consistency of Part 26 with the related circumstances described unavoidably the donor with timely test results. This
regulations of other Federal agencies. prevented the donor from making a change meets Goal 5 of this rulemaking
In § 26.165(b)(2) of the final rule, the timely request. If the MRO makes this to improve Part 26 by eliminating or
NRC has modified the requirement in determination, he or she will direct a modifying unnecessary requirements.
proposed § 26.165(a)(4) that a donor retest of an aliquot of a single specimen The final rule renumbers proposed
must inform the MRO in writing of his or testing of Bottle B of a split specimen § 26.165(a)(5) as § 26.165(b)(5) for the
or her request to conduct testing of an by a second HHS-certified laboratory, as reasons discussed with respect to
aliquot of the single specimen or the if a timely request was made. The NRC § 26.165(b).
specimen contained in Bottle B at a added this provision in response to Section 26.165(b)(6) retains the last
second HHS-certified laboratory. This public comments on the proposed rule, sentence of former Section 2.7(j) in
change is based on public comments and has incorporated the related Appendix A to Part 26. This provision
received on the proposed rule which requirement in the DOTs’ procedures. requires the second HHS-certified
stated that requiring a donor to make a The added provision protects donors’ laboratory to provide quantitative test
written request for additional specimen rights to fair and consistent testing results from Bottle B to the MRO, who
testing would be unduly restrictive procedures under the rule, consistent provides them to the donor. The rule
given that other Federal agencies permit with Goal 7 of this rulemaking, and adopts the simpler language from the
the donor to make these requests meets Goal 1 to update and enhance the related provision in the HHS
verbally. The NRC agrees that a donor consistency of Part 26 with advances in Guidelines, consistent with Goal 6 of
should be provided with as much other relevant Federal rules and this rulemaking to improve clarity in the
flexibility as possible, while ensuring guidelines. language of the rule. This provision also
the request is made in a secure and extends the former requirement to apply
accurate manner. Therefore, the final Section 26.165(b)(5) requires the to communicating results from retesting
rule permits the donor to make his or MRO, in response to a donor’s timely an aliquot of a single specimen,
her request for additional testing request for a retest of an aliquot of a consistent with the explicit permission
verbally to the MRO or in writing. This single specimen or testing of Bottle B of the NRC has added for a donor to
change meets Goal 1 of this rulemaking a split specimen, to ensure that either request retesting of a single specimen if
to update and enhance the consistency the HHS-certified laboratory forwards the FFD program does not follow split
of Part 26 with advances in other an aliquot of a single specimen, or the specimen procedures. With respect to
relevant Federal drug and alcohol HHS-certified laboratory or licensee the proposed rule, § 26.165(b)(6)
testing programs. testing facility forwards Bottle B of a combines the redundant requirements
Section 26.165(b)(3) combines into split specimen, as appropriate, to a in proposed § 26.165(a)(6) and (c)(4) for
one paragraph the requirements that second HHS-certified laboratory that did the reasons discussed with respect to
were contained in the last sentences of not test the specimen in Bottle A. This § 26.165(b).
proposed § 26.165(a)(4) and (b)(1) for paragraph amends the requirement in Section 26.165(c) [Retesting a
the reasons discussed with respect to the fourth sentence of former Section specimen for drugs] amends former
§ 26.165(b). The final rule requires 2.7(j) in Appendix A to Part 26, which Section 2.7(i) in Appendix A to Part 26,
permission from the donor for testing required that the split specimen must be which specified that retesting of a
Bottle B of a split specimen or retesting forwarded to another HHS-certified specimen is not subject to cutoff
an aliquot of a single specimen and laboratory for testing on the same day of requirements. This paragraph updates
prohibits the MRO, NRC, or any other the donor request. The final rule and expands the former requirements
entity from requiring additional tests of requires the licensee testing facility or for retesting a single specimen or Bottle
a donor’s specimen without his or her HHS-certified laboratory, as applicable, B of a split specimen for drugs and drug
permission. These limitations are to forward Bottle B of a split specimen metabolites to be consistent with the
consistent with the principle or the aliquot of a single specimen to a related provisions in the HHS
established in § 26.31(d)(6) that affirms second laboratory as soon as reasonably Guidelines, as follows:
the donor’s right to retain control over practical and not more than 1 business The NRC added § 26.165(c)(1) to
his or her specimen. Therefore, adding day following the day of the donor’s require the second HHS-certified
this provision meets Goal 7 of this request. The NRC amended the former laboratory to use the laboratory’s
rulemaking to protect the privacy and provision to respond to stakeholder confirmatory test for the drug or drug
other rights (including due process) of comments during the public meetings metabolite for which the specimen
individuals who are subject to Part 26. discussed in Section I.D. The tested positive at the first laboratory.
In § 26.165(b)(4) of the final rule, with stakeholders indicated that The second HHS-certified laboratory
respect to the proposed rule, the NRC implementing the ‘‘same-day’’ will not conduct initial tests, or tests for
other drugs or drug metabolites, retesting for adulterants to conducting adulterated, or substituted test result
consistent with the related requirements confirmatory testing only for the from the first HHS-certified laboratory
in the HHS Guidelines. With respect to adulterant(s) identified by the first that tested the specimen as a violation
the proposed rule, for completeness, the laboratory. This limitation is consistent of the licensee’s or other entity’s FFD
final rule adds a reference to conducting with limitations on retesting specimens policy and the donor requests a retest of
confirmatory tests on specimens that the for drugs and drug metabolites in the a single specimen or testing of the
first laboratory confirmed to be positive related requirements of the HHS specimen in Bottle B. This provision
and dilute as a result of the special Guidelines. With respect to the requires the licensee or other entity to
analysis permitted in § 26.169(a)(2). In proposed rule, the final rule, when take the same actions in response to the
addition, in response to a public discussing confirmatory validity testing confirmed positive, adulterated, or
comment, the final rule eliminates the in § 26.165(d), replaces the phrase substituted test result(s) from the first
reference to the second laboratory’s ‘‘appropriate confirmatory test’’ with HHS-certified laboratory, as explained
‘‘standard’’ confirmatory drug test in the ‘‘required confirmatory test’’ in response in § 26.75(i), in response to a positive
proposed provision because HHS- to a comment received on the proposed drug test result for marijuana or cocaine
certified laboratories do not have rule. The commenter noted that the from initial testing at a licensee testing
‘‘standard’’ confirmatory drug tests. The confirmatory testing requirements in facility. That is, § 26.165(f)(1) requires
NRC made this change to enhance § 26.161(d) are ‘‘required’’ rather than the licensee or other entity to
clarity in the language of the rule. ‘‘appropriate,’’ and the NRC concurs. administratively withdraw the donor’s
Section 26.165(c)(2) amends former The agency made this change to authorization until the test results from
Section 2.7(i) in Appendix A to Part 26, enhance the consistency of the final rule the second HHS-certified laboratory
which specified that retesting of a with the HHS Guidelines and improve have been reported to and reviewed by
specimen is not subject to cutoff clarity in the language of the rule. the MRO. If the test results from the
requirements. The paragraph retains the The NRC added § 26.165(e) [Retesting second laboratory reconfirm any
requirement for the second HHS- a specimen for substitution] to positive, adulterated, or substituted test
certified laboratory to provide data incorporate related requirements in the results from the first HHS-certified
sufficient to confirm the presence of the HHS Guidelines for performing retests laboratory, the rule requires the licensee
drug(s) or drug metabolite(s) and adds on substituted specimens at a second or other entity to impose the appropriate
permission to test the specimen at the HHS-certified laboratory. The rule limits sanctions that are specified in subpart D
assay’s LOD. This addition ensures that retesting for specimen substitution to for any positive, adulterated, or
the second laboratory’s testing is as conducting confirmatory testing only for substituted results that were confirmed
sensitive to the presence of the drug(s) creatinine and specific gravity. This by the second laboratory. If the test
or drug metabolite(s) as is scientifically limitation is consistent with limitations results from the second laboratory do
and legally defensible. on retesting specimens for drugs and not reconfirm the positive, adulterated,
The NRC has added § 26.165(c)(3) to drug metabolites and the related or substituted test results from the first
require the second laboratory, if requirements in the HHS Guidelines. laboratory, the rule (1) prohibits the
retesting fails to confirm the presence of With respect to the proposed rule, the licensee or other entity from imposing
the drug(s) or drug metabolite(s) final rule eliminates the second any sanctions on the individual; (2)
identified by the first HHS-certified sentence of the proposed provision in requires the licensee or other entity to
laboratory, to attempt to determine the response to a public comment that eliminate any records of the first
reason why it could not reconfirm the noted it was inconsistent with the
confirmed positive, adulterated, or
drug test results from the first related provision in the HHS
substituted results; and (3) requires the
laboratory. The provision requires the Guidelines.
second laboratory to conduct specimen Section 26.165(f) [Management licensee or other entity to inform the
validity testing if the second laboratory actions and sanctions] has been added donor, in writing, that the records have
fails to reconfirm the first laboratory’s to specify the management actions that been expunged and that he or she need
findings, consistent with the related licensees and other entities must take not disclose the temporary
requirements in the HHS Guidelines. when a donor requests a retest of a administrative action to any other
Section 26.165(c)(4) retains the single specimen or testing of Bottle B of licensee or entity. These requirements
requirement in the last sentence of a split specimen. The NRC added this protect public health and safety and the
former Section 2.7(j) in Appendix A to paragraph to establish the requirements common defense and security by
Part 26 that requires the second for management actions and sanctions ensuring that an individual whose
laboratory to report the test results of when an individual has had a confirmed fitness for duty is questionable does not
testing a split specimen to the MRO. positive, adulterated, or substituted test perform any duties or have the types of
The rule extends this requirement to result and requests a retest of a single access that require the individual to be
reporting results from retesting an specimen or Bottle B of a split subject to this part, while serving to
aliquot of a single specimen, consistent specimen. This section responds to protect the privacy rights of individuals
with the explicit permission the rule stakeholder comments at the public who are subject to Part 26 and ensure
adds in § 26.165(b) for a donor to meetings discussed in Section I.D. The that the individuals are afforded
request retesting of a single specimen if stakeholders noted that the former rule accurate and consistent testing.
the FFD program does not follow split did not address required management The NRC added § 26.165(f)(2) to
specimen procedures. The requirement actions when an individual has had a address the unlikely circumstances in
is consistent with the related confirmed positive test result and which a donor requests retesting of a
requirements in the HHS Guidelines. requests a retest of a single specimen or single specimen or testing Bottle B of a
The NRC added § 26.165(d) [Retesting Bottle B of a split specimen. Therefore, split specimen, but the testing cannot be
a specimen for adulterants] to the NRC added this section to establish performed because the single specimen
incorporate related requirements in the such requirements. or Bottle B is no longer available due to
HHS Guidelines for performing retests The agency added § 26.165(f)(1) to causes that are outside of the donor’s
for adulterants at a second HHS- address circumstances in which the control. These causes could include, but
certified laboratory. The final rule limits MRO has confirmed a positive, are not limited to, an insufficient
quantity of urine in the single specimen consistency with related provisions in Appendix A to Part 26 that required
to permit retesting, either Bottle B or the the HHS Guidelines, and adds new HHS-certified laboratories to use
aliquot of a single specimen is lost in requirements for validity testing, appropriate calibrators and controls for
transit to the second HHS-certified consistent with the addition of initial and confirmatory drug testing.
laboratory, or Bottle B has been requirements to conduct validity testing The rule adds a requirement to include
misplaced. This provision requires the throughout the rule, as discussed with appropriate calibrators and controls for
MRO to cancel the original test result, respect to § 26.31(d)(3)(i). initial and confirmatory validity testing,
prohibits the licensee or other entity Section 26.167(a) [Quality assurance consistent with the addition of
from imposing any sanctions on the program] amends and combines former requirements to conduct validity testing
donor, and requires the licensee or other Section 2.8(a) and the last two sentences throughout the rule, as discussed with
entity to ensure that any records are of Section 2.8(d) in Appendix A to Part respect to § 26.31(d)(3)(i). The NRC has
expunged that could link the donor to 26, which required HHS-certified added more detailed requirements for
the original positive, adulterated, or laboratories and licensee testing calibrators and controls to this section
substituted test result and the facilities to have quality assurance than were contained in the former
administrative action required under programs. For increased clarity in the section for consistency with the HHS
§ 26.165(f)(1). The final rule, with language of the rule, the rule replaces Guidelines. The final rule presents these
respect to the proposed rule, adds the the term ‘‘specimen acquisition’’ with requirements in separate paragraphs
requirement that the MRO must direct the term ‘‘specimen accessioning’’ in the that address each type of test to be
the licensee or other entity to collect a first sentence of former Section 2.8(a), performed by the HHS-certified
second specimen under direct which is the more accurate term. The laboratory for organizational clarity.
observation as soon as reasonably rule also adds a requirement for the The NRC added § 26.167(c) [Quality
practical. The paragraph requires a quality assurance program to encompass control requirements for performing
second collection as soon as reasonably the certification of calibrators and initial and confirmatory validity tests] to
practical because other provisions of the controls to ensure that calibrators and establish quality control requirements
regulation (see Subpart C) require controls are accurate. This requirement for performing initial and confirmatory
negative test results in order for the is consistent with the related provision validity tests at an HHS-certified
licensee or other entity to grant or in the HHS Guidelines. laboratory. The quality control
maintain the donor’s authorization. The In addition, the rule moves to
requirements for validity tests in this
NRC made this change in response to § 26.167(a) and amends the
paragraph incorporate the related
public comments received on the requirements in the last two sentences
provisions of the HHS Guidelines.
proposed rule and to increase the of former Section 2.8(d) in Appendix A
The final rule adds § 26.167(c)(1)
consistency of Part 26 with the related to Part 26, which required that the
linearity and precision of testing [Requirements for performing creatinine
requirements in the HHS Guidelines. tests] to require HHS-certified
The last sentence of § 26.165(f)(2) methods used must be periodically
documented as well as the procedures laboratories to measure creatinine
requires the licensee or other entity to
to ensure that carryover does not concentration to 1 decimal place on
impose the appropriate sanctions, as
contaminate a donor’s specimen. The initial and confirmatory creatinine tests
specified in Subpart D, if the results of
rule updates these requirements for and to establish requirements for the
testing the specimen from a second
consistency with the HHS Guidelines quality control samples to be used in
collection are positive, adulterated, or
substituted and confirmed by the MRO and requires that (1) the performance initial and confirmatory tests for
to be an FFD policy violation. However, characteristics (e.g., accuracy, precision, creatinine concentration.
the rule prohibits the licensee or other LOD, limit of quantitation (LOQ), Section 26.167(c)(2) [Requirements for
entity from considering the results of specificity) for each test must be performing specific gravity tests]
testing the original specimen when validated and documented; (2) establishes the required characteristics
imposing sanctions because the donor validation of procedures must document of the refractometers that HHS-certified
was (inadvertently) denied his or her that carryover does not affect the laboratories must use to measure
right to due process in this case. donor’s specimen results, and (3) the specific gravity and the characteristics
The new requirements in § 26.165(f) laboratory must periodically re-verify of the quality control samples to be used
are generally consistent with the related the analytical procedures. The NRC for initial and confirmatory tests for a
requirements in the HHS Guidelines. relocated the updated requirements to specimen’s specific gravity.
The differences from the HHS § 26.167(a) for organizational clarity Section 26.167(c)(3) [Requirements for
Guidelines’ requirements in the rule are because they are aspects of the performing pH tests] establishes quality
variations in the terminology used to laboratory’s quality assurance program. control requirements for performing
adapt the language for the NRC’s The NRC has moved the requirements initial and confirmatory pH tests.
purposes and the addition of cross- in former Section 2.8(a) in Appendix A Section 26.167(c)(3)(ii) through (c)(3)(vi)
references to other portions of the rule. to Part 26 that applied to licensee specifies the required calibrators and
testing facilities to § 26.137(a) [Quality controls for pH testing, based on the
Section 26.167 Quality Assurance and assurance program] in Subpart F. type of testing instrument used and
Quality Control Section 26.167(a) retains the second whether the laboratory has performed a
Section 26.167 updates former sentence of former Section 2.8(a). The pH validity screening test. In response
Section 2.8 in Appendix A to Part 26 NRC also relocated the quality control to a public comment on the proposed
[Quality assurance and quality control], requirements for initial tests at licensee rule, the NRC relocated the
which established quality assurance and testing facilities in former Section 2.8(b) requirements for calibrators and
quality control requirements for drug in Appendix A to Part 26 to § 26.137 in controls for an initial colorimetric pH
testing at HHS-certified laboratories. Subpart F. The NRC made these changes test from § 26.167(c)(3)(ii) in the
This section provides more detailed for organizational clarity in the rule. proposed rule to § 26.167(c)(3)(vi) in the
requirements for the quality assurance Section 26.167(b) [Calibrators and final rule. The agency made this change
and quality control programs of HHS- controls required] retains the portions of to increase consistency between the
certified laboratories to improve former Section 2.8(c) and (d) in organization of Part 26 and the
organization of the related requirements section in response to a public of the proposed provision into separate
in the HHS Guidelines. comment. The requirements and paragraphs and renumbers the second
The NRC has added three additional example in this paragraph are consistent sentence of proposed § 26.167(e)(2) as
paragraphs related to quality control of with a similar provision in the HHS § 26.167(e)(3) for organizational clarity,
initial and confirmatory validity testing: Guidelines. in response to a public comment.
§ 26.167(c)(4) [Requirements for Section 26.167(d)(3)(i)–(d)(3)(v) Section 26.167(e)(3)(i) through
performing oxidizing adulterant tests], updates former Section 2.8(c) in (e)(3)(iv) amends the requirements for
§ 26.167(c)(5) [Requirements for Appendix A to Part 26. The former quality control samples in former
performing nitrite tests], and section required HHS-certified Section 2.8(d) in Appendix A to Part 26.
§ 26.167(c)(6) [Requirements for laboratories to include quality control The final rule, with respect to the
performing ‘‘other’’ adulterant tests]. samples in each analytical run of proposed rule, makes minor language
These paragraphs establish quality specimens for initial drug testing. clarifications in this paragraph. Section
control requirements for performing Section 26.167(d)(3)(i)–(d)(3)(v) 26.167(e)(3)(i) and (e)(3)(ii) retains the
initial and confirmatory tests for specifies the number and characteristics former requirements for laboratories to
oxidizing adulterants, among which of the quality control samples to be include blank samples and samples that
nitrites are one example, and for ‘‘other’’ included in each analytical run of contain known standards in each
adulterants. The added paragraphs are specimens. With respect to the proposed analytical run. The requirements adopt
consistent with the related requirements rule, the final rule contains minor the simpler language from the related
in the HHS Guidelines. With respect to language clarifications. These provisions in the HHS Guidelines to
the proposed rule, the agency made requirements are identical to those improve clarity in the language of the
minor editorial changes to these contained in § 26.137(e)(6) and (e)(7) for rule. For consistency with the related
provisions in response to public initial drug tests at licensee testing requirements in the HHS Guidelines,
comments to improve the clarity of the facilities and have been added for the paragraph provides more detailed
requirements. For example, the NRC consistency with the related provisions requirements for ‘‘positive controls with
implemented one commenter’s in the HHS Guidelines. the drug or metabolite at or near the
suggestion to add cross-references in In addition, in response to a public threshold’’ than in former Section
§ 26.167(c)(4)(i) and (c)(4)(ii) to the comment on the organization of this 2.8(d)(1) in Appendix A to Part 26. The
specific provisions in § 26.161 that section, the final rule, with respect to rule requires, in § 26.167(e)(3)(iii), at
establish the cutoff criteria for oxidizing the proposed rule, moves proposed least one control fortified with a drug or
adulterants to clarify the adulterant § 26.167(d)(3)(v) to § 26.167(d)(4) to drug metabolite targeted at 25 percent
concentrations that calibrators must improve organizational clarity. Section above the cutoff and, in
contain. 26.167(d)(4) requires that 10 percent of § 26.167(e)(3)(iv), at least one calibrator
Section 26.167(d) [Quality control the specimens in each analytical run or control that is targeted at or below 40
requirements for initial drug tests] must be quality control samples. percent of the cutoff.
amends and combines portions of Proposed § 26.167(e) [Quality control The NRC moved the requirements in
former Sections 2.7(d) and (e)(1), and requirements for performing proposed § 26.167(f) [Blind performance
2.8(c) in Appendix A to Part 26. The confirmatory drug tests] updates and testing] to a new section in the final
former sections established quality combines portions of former Sections rule, § 26.168 [Blind performance
control requirements for performing 2.7(f)(2) and 2.8(d) in Appendix A to testing]. The agency made this change
initial tests for drugs and drug Part 26. The former sections addressed because licensees and other entities,
metabolites at HHS-certified quality control requirements for rather than HHS-certified laboratories,
laboratories. For organizational clarity, performing confirmatory drug tests. In are primarily responsible for
the final rule groups together these general, the changes the NRC has made implementing these requirements.
related requirements that were to the former requirements are made for Therefore, presenting requirements for
dispersed throughout the former rule. In organizational clarity in the final rule licensees’ and other entities’ blind
addition, the NRC has amended a and to incorporate the related performance testing of HHS-certified
number of the former requirements, as provisions in the HHS Guidelines. laboratories in a separate section makes
follows: Section 26.167(e)(1) amends former them easier to locate in the final rule
Section 26.167(d)(1) updates the first Section 2.7(f)(2) in Appendix A to Part and meets Goal 6 to improve clarity in
sentence of former Section 2.7(e)(1) in 26. The former provision required that the organization of the rule.
Appendix A to Part 26 but retains the confirmatory drug tests must be With respect to the proposed rule, the
intent of the former provision as it performed using GC/MS testing. The final rule renumbers proposed
applies to HHS-certified laboratories. final rule permits HHS-certified § 26.167(g) [Errors in testing] as
This section requires laboratories to use laboratories to use other techniques for § 26.167(f). This section amends former
only immunoassay tests that meet the confirmatory drug testing that the HHS Section 2.8(e)(4) through (e)(6) in
requirements of the Food and Drug Guidelines approve for use in Federal Appendix A to Part 26, and imposes
Administration for commercial workplace drug testing programs. requirements on licensees, other
distribution. The requirements in the The NRC added § 26.167(e)(2) to entities, and HHS-certified laboratories
former paragraph related to initial drug update Section 2.8(d) in Appendix A to related to unsatisfactory performance,
testing at licensee testing facilities have Part 26 by establishing a requirement for including false positive and false
been moved to § 26.137(e)(1) of Subpart the percentage of quality control negative test results from the HHS-
F to improve organizational clarity in samples that HHS-certified laboratories certified laboratory. This paragraph
the rule. must include in each analytical run for requires the licensee or other entity to
Section 26.167(d)(2) permits HHS- confirmatory testing. The former rule ensure that the HHS-certified laboratory
certified laboratories to conduct did not specify a percentage. The NRC investigates any conditions that may
multiple tests of a single specimen for added this requirement for consistency adversely reflect on the testing process.
the same drug or drug class. The final with the HHS Guidelines. With respect Notably, the rule no longer requires the
rule, with respect to the proposed rule, to the proposed rule, the final rule licensee to perform the investigation,
includes an example to clarify this separates the first and second sentences but rather to ‘‘ensure’’ that the
laboratory completes an investigation. § 26.31(d)(3)(i). The rule deletes the last to this new section because presenting
The NRC made this change because sentence of the former paragraph them in a separate section makes them
licensees and other entities do not because it addressed the responsibilities easier to locate in the final rule. The
typically retain personnel with the of the HHS and is not relevant to the final rule also provides more detailed
expertise required to investigate the NRC or the licensees and other entities requirements for the formulation of
complex technologies and processes who are subject to Part 26. The blind performance test samples that
involved in testing at HHS-certified paragraph retains the other provisions of licensees and other entities use to obtain
laboratories. The agency has moved the former Section 2.8(e)(6), but adopts the HHS-certified laboratory performance
requirements for reporting and simpler language of the related data and revises the number,
documentation of the investigation, provision in the HHS Guidelines for composition, and percentages of blind
which formerly appeared in Section increased clarity in the language of the samples that licensees and other entities
2.8(e)(4) in Appendix A to Part 26, to rule. With respect to the proposed rule, must submit to the HHS-certified
§§ 26.715(b)(8) and 26.719(c) in Subpart the final rule replaces the term laboratories. The NRC made these
N of the final rule for organizational ‘‘certifying scientist’’ in the third changes in response to detailed public
clarity. sentence of the proposed provision with comments that addressed these issues.
Section 26.167(f)(1) explicitly states the accurate term ‘‘responsible person’’ The NRC added § 26.168(a) to require
the requirements that were implied in in response to a public comment which licensees and other entities to submit
former Section 2.8(e)(4) in Appendix A noted the use of the incorrect term in blind performance test samples to the
to Part 26 that the investigation must the proposed rule. HHS-certified laboratories with whom
identify the root cause(s) of any Section 26.167(g) [Accuracy] retains they contract for drug testing services.
unsatisfactory performance and the former Section 2.7(o)(3)(i) in Appendix To improve clarity in the language of
HHS-certified laboratory must take A to Part 26 with minor editorial the rule, the NRC added this provision
corrective actions. The rule expands revisions. The agency relocated the to make explicit the same requirement
these requirements to include the former paragraph to § 26.167(g) because that was implied in former Section
licensee or other entity, as well as the it relates to quality control of the HHS- 2.8(e) of Appendix A to Part 26.
HHS-certified laboratory, depending on certified laboratory’s drug testing Section 26.168(a)(1) amends the
the causes identified and the extent to processes. The NRC made this change to portion of former Section 2.8(e)(2) in
which the causes are within each meet Goal 6 of this rulemaking to Appendix A to Part 26 that established
entity’s control. The NRC revised the improve clarity in the organization and the percentages and numbers of blind
former requirement to recognize that language of the rule. performance test samples that licensees
some testing errors are not attributable Section 26.167(h) [Calibrators and and other entities must submit to the
to the HHS-certified laboratory. controls] updates former Section HHS-certified laboratory during the first
Section 26.167(f)(2) amends former 2.7(o)(2) in Appendix A to Part 26. At 90 days of any initial contract with the
Section 2.8(e)(5) in Appendix A to Part the time the original paragraph was HHS-certified laboratory. The final rule
26. This provision required the licensee written, most laboratories prepared their decreases the percentage of blind
to notify the NRC if a false positive error own standards and controls. In the performance test samples that licensees
occurred on a blind performance test ensuing years, the number and variety and other entities must submit to the
sample and the error was determined to of sources for materials used in HHS-certified laboratory during the
be administrative. The final rule performance testing has increased. The initial 90-day period of any contract (not
requires the licensee or other entity, and final rule updates former requirements including rewritten or renewed
the HHS-certified laboratory, to take to refer to several of the alternatives, contracts). Specifically, the rule reduces
corrective actions for any false positive including, but not limited to pure drug the percentage from 50 percent to 20
errors in blind performance testing, in reference materials, stock standard percent of the total number of
response to the findings of the solutions from other laboratories, and specimens submitted in the 90-day
investigation that would be required in standard solutions obtained from period, up to a maximum of 100 blind
this section. The rule continues to commercial manufacturers. The samples, rather than a maximum of 500
authorize licensees and other entities to requirements in this paragraph samples as specified in the former rule.
require the laboratory to review and re- incorporate the related requirements in This decrease in the blind performance
analyze previously tested specimens, if the HHS Guidelines and meet Goal 1 of testing rate increases the consistency of
the investigation indicates that the error this rulemaking to update and enhance Part 26 with related provisions in the
could have been systematic. The rule the consistency of Part 26 with advances HHS Guidelines. In addition, since the
also deletes reference to administrative in other relevant Federal rules and NRC published the former rule, the
errors, which appeared in former guidelines. The labeling requirements in number and size of Federal agencies
Section 2.8(e)(5), so that any type of the second sentence of former Section who conduct drug testing has
errors falls under the requirements of 2.7(o)(2) have been retained without substantially increased. These agencies
the paragraph. The NRC moved the change. are also required to submit blind
reporting requirement in former Section performance test samples under the
2.8(e)(5) to § 26.719(c)(2) in Subpart N Section 26.168 Blind Performance HHS Guidelines. As a result, especially
for organizational clarity. Testing with respect to the issue of correctly
Section 26.167(f)(3) amends former Section 26.168 updates and expands identifying negative specimens, the
Section 2.8(e)(6) in Appendix A to Part former Section 2.8(e) in Appendix A to burden on Part 26 programs to conduct
26. This section addressed false positive Part 26 [Licensee blind performance test performance tests of the HHS-certified
errors resulting from technical or procedures]. The former paragraph laboratories can be reduced without
methodological errors by the laboratory. established requirements for licensees affecting the likelihood that errors in
The rule incorporates reference to and other entities to conduct blind testing will be detected.
validity testing, consistent with the performance testing of HHS-certified The regulation also adds a
addition of requirements to conduct laboratories. With respect to the requirement for licensees and other
validity testing throughout the rule, as proposed rule, the final rule has moved entities to submit a minimum of 30
previously discussed with respect to the requirements in proposed § 26.167(f) blind performance test samples in the
initial 90-day period. The agency has percent of all blind samples submitted rule replaces the proposed requirement
established this minimum to address to HHS-certified laboratories must be for positive samples to be spiked to
Part 26 programs who submit only a positive for one or more drugs per between 60 and 80 percent of the initial
small number of specimens to HHS- sample will ensure that all licensees, cutoff levels used by the licensee or
certified laboratories for testing each including those who will only send the other entity with a cross-reference to the
quarter. For example, for a very small minimum number of blind samples more detailed requirements for positive
program, 20 percent of the number of required under this rule, will submit blind performance test samples in
specimens submitted in the initial 90- several samples for each drug being § 26.168(g)(2), as discussed with respect
day period could be less than one blind tested. This change will permit to that section.
performance test sample. Establishing a licensees and other entities to better The NRC has added § 26.168(d) to
minimum number of samples will monitor and make more informed require licensees and other entities to
provide assurance that the HHS- decisions regarding their HHS- submit approximately 10 percent of all
certified laboratories used by these Part laboratories’ performance. Under the blind performance test samples as false
26 programs are providing accurate test previous ‘‘80 percent negative’’ rule, negative challenge samples to the HHS-
results. licensees who submitted only the 40 certified laboratory according to the
Section 26.168(a)(2) amends the minimum blind samples required would requirements established in
portion of former Section 2.8(e)(2) in nominally receive two results per year § 26.168(g)(3). The NRC has added this
Appendix A to Part 26 that addressed on three drugs (which were chosen by provision in response to public
ongoing blind performance testing after the licensee or other entity). This comments on proposed § 26.167(f) that
the first 90 days of an initial contract requirement provided licensees with blind samples containing drugs or drug
with an HHS-certified laboratory. The scant information to determine metabolites at a concentration 20
rule decreases the rate at which independently, as required by rule, percent above the cutoff levels would
licensees and other entities must submit whether the HHS-certified laboratory frequently yield false negative test
blind performance test samples to an was meeting the licensee or other entity results and, therefore, unfairly challenge
HHS-certified laboratory in each quarter contract provisions with the HHS- HHS-certified laboratories. False
after the initial 90-day period from 10 certified laboratory. Under the revised negatives occur when drug levels that
percent in the former rule to one section, assuming a reasonable are positive but close to the initial drug
percent, or a total of 10 samples, distribution, even those licensees and test cutoff level may actually be
whichever is greater. The rule also other entities who submit only the reported as negative. Assuming that an
decreases the maximum number of minimum 40 required blind samples a initial negative drug test has an error
samples to be submitted per quarter year will receive results from marijuana rate of one percent (one percent false
from 250 to 100 samples. The rationale blind performance test samples at least negatives) and all HHS-certified
for these changes is the same as 8 times a year, from cocaine text laboratories perform equally, then over
discussed with respect to § 26.168(a)(1). samples at least 7 times a year, from time, for every 100 people who have
The NRC added § 26.168(a)(3) to recently used drugs and been tested by
amphetamines and opiate test samples
require licensees and other entities to licensees and other entities, one person
at least 3 times a year, and from PCP test
submit blind performance test samples will not be identified as having a
samples at least 2 times a year. The
to the HHS-certified laboratory at a positive test result for one or more drugs
NRC’s increased emphasis on testing for
frequency that is similar to the on the basis of the initial test alone.
marijuana and cocaine and the
frequency for other specimens. This Recent research [Cone et al., 2003]
reduction in testing for PCP in
change enhances the consistency of Part strongly suggests that the issue of false
§ 26.168(b)(1) and (2) reflect the fact that
26 with the HHS Guidelines. negatives may be significantly greater
Section 26.168(b) amends and among all FFD programs, marijuana and
than previously understood. The NRC
expands former Section 2.8(e)(3) in cocaine have resulted in the largest
recognizes that false negatives will
Appendix A to Part 26, which required number of confirmed positive drug tests
occur within its drug testing guidelines,
that 80 percent of the blind samples and PCP the least number of confirmed
but intends to minimize them as much
submitted by the licensee or other entity positive drug tests, as reported in the
as is reasonably possible within
each quarter to the HHS-certified NRC’s ‘‘Summary of FFD Performance
scientific constraints and practical
laboratory must be ‘‘blank’’ (i.e., Reports’’, from 1990 through 2005. limitations of resources. Therefore, the
certified to contain no drugs or drug Therefore, the NRC has made these NRC has established the requirements
metabolites). With respect to the changes to meet Goal 3 of this for the characteristics of false negative
proposed rule, the NRC has rulemaking to enhance the effectiveness challenge samples under the final rule
substantially changed the requirements and efficiency of the rule. to present a fair test to HHS-certified
in proposed § 26.167(f)(3) in response to Section 26.168(c) limits the laboratories because they are targeted at
extensive comments on the proposed submission of positive blind specimens clearly above the range of
blind performance test sample performance test samples to the HHS- laboratory controls yet below the
provisions. In the final rule, § 26.168(b) certified laboratory to samples standard cutoff levels.
now requires that approximately 60 containing only those drugs for which Section 26.168(e) requires licensees
percent of all blind performance test the licensee or other entity tests and and other entities to submit
samples that licensees and other entities requires that the blind samples sent to approximately 20 percent of all blind
send to the HHS-certified laboratory HHS-certified laboratories must be samples as adulterated, diluted, or
must be positive for one or more of the formulated according to the substituted and formulated according to
drugs for which the licensee or other requirements established in the requirements established in
entity tests, and that all drugs for which § 26.168(g)(2). This provision updates § 26.168(g)(4)–(g)(6). The NRC added
the licensee or other entity tests must be former Section 2.8(e)(3) in Appendix A this provision for consistency with the
submitted to the HHS certified to Part 26, which also limited addition of requirements to conduct
laboratory at least once a quarter except performance testing to only those drugs validity testing throughout the proposed
as indicated in § 26.168(b)(1) and (2). included in the licensee’s panel. With rule, as discussed with respect to
The requirement that approximately 60 respect to the proposed rule, the final proposed § 26.31(d)(3)(i). This
performance testing is necessary to was first promulgated. Also, these specimens and hold false negatives to a
challenge the accuracy of the HHS- agencies are required to submit negative minimum. The NRC recognizes that
certified laboratories’ specimen validity blind performance test samples at a rate these issues are routinely scrutinized
testing. With respect to the proposed of 80 percent under the HHS and evaluated by the HHS Laboratory
rule at proposed § 26.167(f)(3), the final Guidelines. Therefore, the previous Certification Program (LCP), but is
rule increases the proportion of blind need for Part 26 programs to so mindful that the LCP challenges are not
samples that licensees and other entities extensively challenge the HHS-certified blind to the HHS-certified laboratories.
must submit to challenge the laboratories’ false positive rates is Because of its over-arching interest in
laboratories’ specimen validity testing. reduced. making the Part 26 drug testing program
The NRC made this change in response The NRC has added formulation as rigorous as possible, as evidenced by
to public comments on the proposed standards for the blind performance test the detail of Subparts F and G, the NRC
rule and the NRC’s concern that validity samples that licensees and other entities believes that a more aggressive licensee
test results are accurate. The must use in § 26.168(g). The final rule and other entity blind challenge to the
requirements elaborated in this section revises proposed § 26.167(f)(5)(i) in HHS-certified laboratories in these area
protect public health and safety and the response to detailed public comments adds an important independent
common defense and security by on the scientific and technical dimension to ensuring licensee and
increasing the effectiveness of FFD suitability of the proposed standards in other entity confidence in the overall
programs (Goal 3 of this rulemaking) in achieving the NRC’s objective of drug testing program.
ensuring that an individual whose ensuring that the performance testing Section 26.168(h) has been added to
fitness for duty is questionable does not required under this rule ensures that establish additional detailed
perform duties or have the types of test results from HHS-certified requirements for the blind performance
access that require the individual to be laboratories are accurate. test samples that licensees and other
subject to this part. The agency added § 26.168(g)(1) to entities must submit to the HHS-
require that negative blind performance certified laboratories and to ensure the
The final rule substantially decreases test samples may not contain a consistency and effectiveness of the
the percentage of negative blind measurable amount of a target drug or blind performance testing process.
performance test samples that licensees analyte, and must be confirmed by Section 26.168(h)(1) requires the
were required to submit to HHS- immunoassay and confirmatory testing. supplier of the blind samples to certify
certified laboratories in former Section Section 26.168(g)(2) requires that that all blind specimen batches are
2.8(e)(3) of Appendix A, as retained in positive blind performance test samples confirmed by an HHS-certified
proposed § 26.168(f). The former and must contain drug or analyte laboratory prior to being put into service
proposed provision required 80 percent concentrations between 150 and 200 and to remove blind specimen batches
of blind samples to be negative. The percent of the initial cutoff levels and be from service after they have been open
final rule revises this percentage to 10 certified by immunoassay and for 6 months. Section 26.168(h)(2)
percent. The NRC made this change in confirmatory testing to contain one or requires the supplier to provide an
response to public comments on the more drug(s) or drug metabolites. expiration date for each sample. Section
proposed rule and because the NRC Section 26.168(g)(3) requires that false 26.168(h)(3) requires the supplier to
believes that carryover effects (i.e., a negative challenge samples must monitor each open batch on a bi-
positive sample contaminates a negative contain target drug or analyte monthly (i.e., every two months) basis
sample because of improper laboratory concentrations between 130 and 155 to ensure that the remaining batch does
equipment cleaning), while a concern percent of the initial cutoff values. not fall below the criteria in this section.
during the early years of drug testing, Section 26.168(g)(4) requires that an These requirements are based on related
are not an issue in current HHS-certified adulterated blind performance test provisions in the HHS Guidelines and
laboratories based on current specimen sample must have a pH of less than or DOT’s procedures for drug and alcohol
testing practices. The agency also equal to 2, or greater than or equal to 12, testing. The NRC added these
believes that it is more appropriate to or nitrite or other oxidant concentration requirements in response to a public
challenge the drug and validity testing equal to or greater than 500 mcg/mL) comment on the proposed rule
capabilities of HHS-certified using either a nitrite colorimetric test or requesting the NRC to clarify the
laboratories and therefore, is increasing a general oxidant colorimetric test. requirements in proposed § 26.167(f)(5).
the percentage of positive, adulterated, Section 26.168(g)(5) requires that a The NRC added § 26.168(i) to provide
substituted, dilute, and invalid dilute blind performance test sample specific requirements for ensuring that
specimens submitted as blind must contain a creatinine concentration blind performance test samples are
performance test samples in each that is equal to or greater than 5 mg/dL indistinguishable to laboratory
quarter of testing. With regard to the but less than 20 mg/dL, and the specific personnel from a donor’s specimen in
issue of correctly identifying negative gravity must be greater than 1.0010 but response to a public comment on
specimens (i.e., ensuring that less than 1.0030. Section 26.168(g)(6) proposed § 26.167(f)(5). These
laboratories do not report false positive requires that a substituted blind requirements are based on the related
test results), the NRC is confidant that performance test sample must contain DOT procedures.
the 10 percent negative sample less than 2 mg/dL of creatinine and the Section 26.168(i)(1) requires the
requirement in the final rule will specific gravity must be less than or licensee or other entity to ship blind
provide adequate oversight regarding equal to 1.0010, or equal to or greater performance test samples to the HHS-
false positive test results due to than 1.0200. certified laboratory in the same way
carryover and other related issues. The NRC has made these changes in donors’ specimens are sent to the
Another reason that the NRC is § 26.168(b)–(g) to increase the ability of laboratory. This provision provides
decreasing the required percentage of licensees and other entities to greater assurance than the former rule
negative samples in the final rule is that independently monitor the ability of that personnel at the HHS-certified
the number and size of Federal agencies their HHS-certified laboratories to laboratories will not be aware that the
who conduct drug testing has consistently identify positive, specimen they are handling is a blind
substantially increased since Part 26 adulterated, dilute, and substituted performance test sample. The NRC
added this provision to increase the specimens sent to the laboratory by the substituted, or invalid test result from
effectiveness of blind performance licensee or other entity until the testing of the specimen. The regulation
testing under the rule. laboratory completes testing of all of the requires the laboratory to report any
Section 26.168(i)(2) specifies the specimens in the group. The prohibition positive test results, as well as any
information that must be entered on the in the former rule was based on a adulterated, substituted, or invalid
custody-and-control form accompanying concern for maintaining control of validity test results from the same
the blind performance test sample. This specimen identity. However, new specimen. This change is necessary
information is necessary to ensure that technologies for identifying specimens because sanctions for the different test
the MRO is aware that the specimen is and aliquots (such as bar codes on results differ under § 26.75. Reporting
a blind performance test sample. specimen labels matched to bar codes multiple test results for a single
Section 26.168(i)(3) requires licensees on aliquots and the associated custody- specimen is consistent with related
and other entities to submit split and-control forms) have reduced the requirements in the HHS Guidelines.
samples where applicable. This likelihood that specimen identity may Section 26.169(c)(2) updates former
provision is necessary to ensure that the be lost, and, therefore, have Section 2.7(g)(3) in Appendix A to Part
FFD program submits blind substantially reduced the need for the 26, which permitted the MRO routinely
performance test samples that appear to requirement in the former rule. to obtain quantitative test results from
be normal specimens that the laboratory Section 26.169(b) amends portions of the HHS-certified laboratory. This
may receive from a donor. former Section 2.7(f)(2) in Appendix A paragraph incorporates the first two
Section 26.169 Reporting Results to Part 26 by eliminating the sentences of proposed § 26.169(d).
requirement for the HHS-certified Specifically, the final rule revises the
This section contains requirements for laboratory to conduct tests for drugs and first sentence of former Section 2.7(g)(3)
HHS-certified laboratories’ reporting of drug metabolites using both the cutoff by stating that the HHS-certified
test results to the licensee’s or other levels specified in this part and any laboratory shall provide quantitative test
entity’s MRO. The final rule in § 26.169 more stringent cutoff levels specified by results for a positive confirmatory drug
updates former Section 2.7(g) in the FFD program. If the FFD program test result to the MRO on request. The
Appendix A to Part 26. The rule updates specifies cutoff levels that are more paragraph clarifies the former
the former requirements for consistency stringent than those specified in this requirement by stating that the MRO’s
with the HHS Guidelines. In addition, part, the final rule requires the request may be either a general request
the rule adds requirements for reporting laboratory only to conduct testing using covering all such results or a specific
the results of validity testing, consistent those more stringent cutoff levels, and case-by-case request. The changes to
with the addition of requirements to only to report results from those tests to this paragraph are consistent with the
conduct validity testing throughout the the MRO. The NRC made this change for related provisions in the HHS
rule, as discussed with respect to the reasons discussed with respect to Guidelines. The final rule also moves
§ 26.31(d)(3)(i). With respect to the § 26.31(d)(1)(i)(D). This provision was the requirement that was contained in
proposed rule, the NRC has made § 26.169(c) in the proposed rule. proposed § 26.169(g) to this paragraph
several organizational changes to Section 26.169(c) (§ 26.169(b) in the for organizational clarity. Therefore, this
improve clarity by presenting the proposed rule) establishes requirements provision of the final rule requires the
provisions in the order that is more for the laboratory’s reporting of validity HHS-certified laboratory to routinely
consistent with the order in which HHS- test results. This provision amends report to the MRO, whether requested or
certified laboratories, licensees, and former Section 2.7(g)(2) in Appendix A not, quantitative values for confirmatory
other entities will implement them, to Part 26, which established opiate test results for morphine or
consistent with Goal 6 of this requirements for the manner in which codeine that are equal to or greater than
rulemaking. HHS-certified laboratories and licensee 15,000 ng/mL. The rule adds this
Section 26.169(a) amends former testing facilities must report test results requirement for consistency with the
Section 2.7(g)(1) in Appendix A to Part to licensee management. The NRC has related provision in the HHS Guidelines
26, which established a time-limit on moved the requirements in the former and because the MRO is not required to
the HHS-certified laboratory’s reporting paragraph that are related to reporting perform an assessment for clinical signs
of test results to the MRO and test results from the licensee testing of opiate abuse in this instance, as
requirements for the processing and facility to § 26.139(a) of Subpart F for discussed with respect to § 26.185(j)(1).
content of the report. The NRC has organizational clarity. The final rule The reference to test results from blood
retained the requirement for the deletes the former reference to ‘‘special specimens in former Section 2.7(g)(3) in
laboratory to report results to the MRO processing’’ and replaces it with Appendix A to Part 26 has been deleted
within 5 business days of receiving the reference to validity test results, for the reasons discussed with respect to
specimen at the laboratory. Under the consistent with the addition of § 26.83(a).
final rule, the HHS-certified laboratory’s requirements to conduct validity testing In response to public comments on
‘‘certifying scientist,’’ rather than the throughout the final rule, as discussed the proposed rule, the NRC has added
laboratory’s ‘‘responsible individual,’’ with respect to § 26.31(d)(3)(i). In § 26.169(c)(3) to require the HHS-
certifies the test results. This change has addition, the final rule makes minor certified laboratory to report to the MRO
been made for consistency with the changes in terminology, such as numerical values supporting an
updated term used to refer to this referring to a ‘‘drug or drug metabolite,’’ adulterated or substituted test result.
individual, as discussed with respect to rather than a ‘‘substance,’’ for clarity in The final rule also adds instructions for
§ 26.155(b). The rule adds a reference to the rule language. the laboratory’s report to the MRO if a
validity test results, consistent with the The NRC has renumbered proposed specimen’s numerical values for
addition of requirements to conduct § 26.169(e) as § 26.169(c)(1) in the final creatinine are below the LOD. The NRC
validity testing throughout the proposed rule. The NRC added this provision to added this provision for consistency
rule, as discussed with respect to require the HHS-certified laboratory to with the HHS Guidelines.
§ 26.31(d)(3)(i). The final rule deletes report all test results for a single Section 26.169(c)(4) requires the HHS-
the former prohibition on reporting test specimen, if the laboratory obtains more certified laboratory to contact the MRO
results for any specimen in a group of than one positive, adulterated, after the HHS-certified laboratory has
determined that a specimen has an characterizes these relationships the cutoff levels specified in this part,
invalid result, but before reporting out without changing the intent of the if the FFD program uses more stringent
the test result, to determine whether former provision. cutoff levels, for the reasons discussed
testing by a second HHS-certified Section 26.169(f) updates former with respect to § 26.169(b). The rule
laboratory would be useful. The rule Section 2.7(g)(5) in Appendix A to Part adds a requirement to report initial and
permits the laboratory’s contact with the 26, which established requirements for confirmatory test results for additional
MRO to occur using electronic means, transmitting chain-of-custody drugs (if the FFD program tests for
such as telephone, fax, and e-mail. If no documentation with test results to the additional drugs), as well as a
further testing is necessary, the final MRO. The rule permits HHS-certified requirement to report the number of
rule requires the laboratory to report the laboratories to use various means to specimens with confirmed positive 6–
invalid result to the MRO. These transmit test results to the MRO, AM test results. (The rule includes
reporting requirements have been added including transmittal of a computer- testing for 6–AM, because the presence
for consistency with the related generated electronic report for negative of 6–AM in a specimen uniquely
provisions in the HHS Guidelines. This test results. However, for positive, identifies heroin use.) In addition, the
provision retains the portions of adulterated, substituted, or invalid test rule adds requirements to report the
proposed § 26.169(d) that pertained to results, the rule requires the laboratory results of validity testing. The NRC has
reporting invalid test results but the to transmit a legible image or copy of made these changes to conform to other
final rule presents them in a separate the completed custody-and-control form changes in the rule, as discussed with
paragraph to improve organizational to the MRO. The change has been made respect to §§ 26.717(b)(2), 26.185(j)(1),
clarity. for consistency with the related and 26.31(d)(3)(i). With respect to the
Section 26.169(c)(5) establishes provision in the HHS Guidelines. This proposed rule, the NRC has added
requirements for the HHS-certified provision contains the requirements in requirements for the laboratory to report
laboratory in reporting drug, metabolite, § 26.169(i) of the proposed rule. whether a specimen that has been
or adulterant concentrations that exceed Section 26.169(g) further amends reported as positive and dilute was
normal testing ranges. This provision former Section 2.7(g)(5) in Appendix A subject to the special analyses permitted
updates the last sentence of former to Part 26. The paragraph continues to under § 26.163(a)(2) and the number of
Section 2.7(f)(2) in Appendix A to Part require that the HHS-certified laboratory specimens reported as rejected for
26 for consistency with the HHS must retain the original custody-and- testing. The NRC added these reporting
Guidelines. This provision appeared in control form for any positive, requirements in response to public
the proposed rule as the third sentence adulterated, substituted, or invalid comment noting that the NRC will
of proposed § 26.169(d). specimens. However, the paragraph require this information to maintain
Section 26.169(d) retains the portion assigns responsibility for certifying the adequate oversight of FFD programs and
of former Section 2.7(g)(3) in Appendix test results to the laboratory’s certifying for consistency with related provisions
to Part 26 that prohibited the MRO from scientist, rather than to ‘‘the individual in the HHS Guidelines. This
disclosing quantitative results to a responsible for day-to-day management requirement appeared as proposed
licensee or other entity and extends it to of the laboratory or the individual § 26.169(k) in the proposed rule.
MRO staff for clarity in the language of responsible for attesting to the validity
the rule. This provision requires the of the test reports.’’ The change has been Subpart H—Determining Fitness-for-
MRO to only report whether the made for consistency with the updated Duty Policy Violations and Determining
specimen was positive (and for which terminology used to refer to this Fitness
analyte), adulterated, substituted, dilute, individual in the HHS Guidelines, as Throughout this subpart, the final rule
invalid, or negative, except as permitted discussed with respect to § 26.155(b). makes minor clarifications to the
under § 26.37(b). This provision This provision was § 26.169(j) in the proposed rule because of public
appeared as the fourth and fifth proposed rule. comment, to accommodate conforming
sentences of proposed § 26.169(f). Section 26.169(h) combines and changes, and to meet Goal 6 of this
Section 26.169(e), which was amends former Section 2.7(g)(6) and rulemaking to improve clarity in the
§ 26.169(h) in the proposed rule, (g)(7) in Appendix A to Part 26, which organization and language of the rule.
amends former Section 2.7(g)(4) in required the laboratory to submit a For example, the final rule eliminates
Appendix A to Part 26, which monthly statistical summary of drug test the term ‘‘non-negative,’’ which was
established requirements for the results to the licensee or other entity. used in proposed Subpart H in many
electronic transmission of test results The rule reduces the required frequency places and replaces it with the terms
from the HHS-certified laboratory to the of the statistical summary report from ‘‘positive, adulterated, substituted,
MRO. Specifically, the rule clarifies that monthly to annually in order to reduce dilute, or invalid,’’ as appropriate, for
the licensee or other entity is the burden on licensees, other entities, the reasons discussed with respect to
responsible for assuring the security of and their laboratories. The requirement § 26.5 [Definitions]. Also, in § 26.185,
data transmissions from the laboratory for annual reporting makes the reporting the final rule adds the term
to the MRO, rather than only the HHS- time consistent with the NRC’s need for ‘‘confirmatory’’ when referring to test
certified laboratory, as specified in the the information as it relates to the NRC’s results that have been reported to the
former requirement. This change inspection schedule and the annual FFD MRO by the HHS-certified laboratory
responds to stakeholder comments at program performance report that is and deletes the ambiguous term
the public meetings discussed in required under § 26.717, for the reasons ‘‘referral’’ when referring to a physician.
Section V. The stakeholders accurately discussed with respect to that section. The final rule also uses ‘‘business days’’
noted that licensees and other entities The rule also deletes the existing instead of only ‘‘days’’ to be consistent
are responsible to the NRC for ensuring reference to blood specimens because with other provisions in the rule.
the security of their HHS-certified the option for donors to request blood The final rule also makes more
laboratories’ data storage and testing for alcohol has been eliminated substantive changes to the proposed
transmission systems through their from the rule, as discussed with respect rule in this subpart because of public
contracts with and audits of the to § 26.83(a). The rule also deletes the comment or to improve clarity in the
laboratories. This revision accurately requirement to report drug test results at organization and language of the rule.
The substantive changes in this subpart ensures that an MRO is able to perform rulemaking to update and enhance the
can be found in §§ 26.183(b), (d), (d)(1), his or her function appropriately under consistency of Part 26 with advances in
and (d)(2)(iv); 26.185(g), (g)(2), (g)(5), this part. In addition, the provision adds other Federal rules and guidelines and
(h)(1), and (i)(1); 26.187(a) and (f); and a requirement that within 2 years Goal 6 of the rulemaking to improve
26.189(a) and (c). These changes are following the date on which this rule is clarity in the rule language.
discussed in detail below. However, published in the Federal Register, the Section 26.183(c) [Responsibilities] of
other than the changes mentioned MRO must pass an MRO certification the final rule reorganizes and updates
above, the final rule adopts the examination. The requirement increases the requirements in former § 26.3, as
provisions of this subpart as proposed, consistency in the performance of the well as former Sections 1.2, 2.4(j),
without change. MRO function among FFD programs 2.7(d), and 2.9(a) and (b) in Appendix
because licensees and other entities are A to Part 26 to specify the
Section 26.181 Purpose
permitted to accept test results and the responsibilities of the MRO in Part 26
Section 26.181 of the final rule results of determinations of fitness programs. This provision reorganizes
describes the purpose of Subpart H, conducted by other licensees and the former provisions and combines
which is to establish requirements for entities who are subject to the FFD rule. them. In addition, the NRC has revised
MRO reviews of positive, adulterated, The 2-year implementation date the terminology to be consistent with
substituted, dilute or invalid provides MROs who are not currently that used throughout the FFD rule.
confirmatory drug test results and for certified with an opportunity to pass the These changes meet Goal 6 of this
making determinations of fitness. This required examination. With the rulemaking to improve clarity in the
section provides an overview of the exception of the first sentence of this organization and language of the rule.
contents of the subpart, consistent with provision that specifically relates to the
Goal 6 of this rulemaking to improve Section 26.183(c) retains the
MRO function under Part 26, these MRO requirement in former Section 2.9(a) in
clarity in the organization and language qualification requirements are
of the rule. Appendix A to Part 26 for the MRO to
consistent with those of other Federal review positive confirmatory drug test
Section 26.183 Medical Review Officer agencies. results from the HHS-certified
Section 26.183(b) [Relationships] of
The NRC has added § 26.183 to the laboratory. The provision also adds a
the final rule establishes requirements
final rule to present requirements requirement for the MRO to review
related to the relationships that are
related to the qualifications, adulterated, substituted, or invalid
permitted or prohibited between the
relationships, staff, and responsibilities MRO, the licensee or other entity, and results from confirmatory validity
of the MRO. Grouping these HHS-certified laboratories. The first testing, consistent with the addition of
requirements together in a single section sentence of this provision retains the requirements to conduct validity testing
meets Goal 6 of this rulemaking to portion of the first sentence of former throughout the rule, as discussed with
improve clarity in the organization and Section 2.9(b) in Appendix A to Part 26 respect to § 26.31(d)(3)(i). If a licensee’s
language of the rule. that permitted the MRO to be an or other entity’s FFD program elects to
Section 26.183(a) [Qualifications] of employee of a licensee or other entity, conduct the special analyses of dilute
the final rule combines and amends the or a contractor. The NRC has added specimens permitted in § 26.163(a)(2),
requirements in former § 26.3 requirements to prohibit the MRO from the MRO also is required to review
[Definitions] and Section 1.2 of being an employee or agent of, or have those results. This provision also
Appendix A to Part 26, as well as any financial interest in, a laboratory or requires the MRO to identify evidence
portions of former Section 2.9(b) in a contracted operator of a licensee of subversion of the testing process,
Appendix A to Part 26. The provision testing facility for whom the MRO identify issues or problems associated
reorganizes the former requirements to reviews drug testing results for the with the collection and testing of
eliminate redundancies and group in licensee or other entity. The NRC has specimens, and work with FFD program
one paragraph the related provisions in added this prohibition based upon the management to ensure the overall
the former rule. These changes meet experiences of other Federal agencies effectiveness of the FFD program. The
Goal 6 of this rulemaking to improve and to be consistent with the related final rule adds these responsibilities to
clarity in the organization and language provision in the HHS Guidelines, clarify that the MRO carries
of the rule. consistent with Goal 1 of the rulemaking programmatic responsibilities within a
The provision amends portions of the to update and enhance the consistency licensee’s or other entity’s FFD program,
former requirements related to MRO of Part 26 with advances in other in addition to responsibility for
qualifications. It continues to provide relevant Federal rules and guidelines. reviewing drug and specimen validity
that the MRO must be a licensed With respect to the proposed rule, the test results. These additional
physician, but clarifies that the MRO final rule adds the last sentence of responsibilities strengthen the
may hold either a Doctor of Medicine or § 26.183(b) and paragraphs (b)(1) effectiveness of FFD programs by
Doctor of Osteopathy degree for through (b)(6) to provide some examples ensuring that the MRO’s expertise is
consistency with the related regulations of relationships between laboratories brought to bear in the management of
of other Federal agencies. The provision and MROs that create conflicts of FFD programs. This provision also
adds a requirement that the MRO must interest. The NRC has included these increases the consistency of the MROs’
be knowledgeable of Part 26 and the examples in response to a public responsibilities under Part 26 with the
FFD policies and procedures of the comment requesting more clarification responsibilities of MROs in the drug and
licensees and other entities for whom regarding such conflict-of-interest alcohol testing programs of other
the MRO provides services. The relationships. The basis for these Federal agencies. Therefore, the changes
requirements of this part and the examples is 49 CFR Part 40, meet Goal 1 of this rulemaking to
policies and procedures of various Part ‘‘Procedures for Department of update and enhance the consistency of
26 FFD programs may differ from those Transportation Workplace Drug and Part 26 with advances in other relevant
of other workplace drug and alcohol Alcohol Testing Programs’’ (65 FR Federal rules and guidelines and Goal 3
testing programs for which an MRO 41944; August 9, 2001). Adding these to improve the effectiveness and
provides services. This provision examples meets Goal 1 of this efficiency of FFD programs.
Section 26.183(c)(1) retains and from the HHS-certified laboratory, members at all times. Direction of staff
updates the former definitions of the perform some administrative functions activities need not occur face-to-face on
term ‘‘Medical Review Officer’’ for MROs that permit them to view an all-day, every-day basis. Also, the
contained in former § 26.3 and Sections donors’ private medical information, definition of directing, specifically the
1.2 and 2.9(b) in Appendix A to Part 26. and often have contact with donors. The phrase ‘‘directly involved in the
This provision continues to require the NRC is not aware of any instances when execution of the work activity,’’ does
MRO to examine alternate medical individuals who serve as MRO staff not require the MRO to be on site when
explanations for any positive drug test have compromised the confidentiality of giving direction to individuals who are
results. It also adds a requirement to donors’ test results, medical performing MRO staff functions. For
examine alternate medical explanations information, or otherwise acted example, the MRO must be directly
for adulterated, substituted, invalid, or, improperly in Part 26 programs. involved in the work of onsite licensee
at the licensee’s or other entity’s However, this provision adopts MRO staff, even if that direct
discretion, dilute test results report by requirements related to the MRO staff involvement occurs by telephone.
the HHS-certified laboratory. The function from the regulations of other Direction may also take place through
provision also retains the former Federal agencies who similarly permit using a variety of electronic
provision that the MRO may interview MRO staff to provide administrative communications.
the donor and review the donor’s support to MROs to ensure that donors’ However, this provision requires that
medical history and any other relevant medical information is handled with the the MRO’s direction of staff must be
biomedical factors, and review all highest concern for individual privacy. meaningful. Meaningful direction
medical records that the donor may The requirement also ensures that involves personal oversight of staff
make available to the MRO. In addition information related to positive, members’ work; providing input to their
to the responsible use of legally adulterated, substituted, invalid, or performance evaluation; line authority
prescribed medication, this provision dilute test results is not released to over the staff for decisions, direction,
requires the MRO to consider a licensee or other entity management and control; and regular contact and
documented condition or disease state personnel unless the MRO has oversight concerning drug testing
and the demonstrated physiology of the determined that a donor has violated the program matters. This provision also
donor in determining whether a FFD policy. These changes meet Goal 1 requires that the MRO’s direction and
positive, adulterated, substituted, or of this rulemaking to update and control of the staff members cannot be
invalid test result is an FFD policy enhance the consistency of Part 26 with superseded by or delegated to anyone
violation. The provision requires the advances in other relevant Federal rules else with respect to the review of
MRO to consider the latter factors and guidelines and Goal 7 to protect the negative tests and other functions that
because they may cause some privacy and due process rights of staff members perform for the MRO. In
adulterated, substituted, invalid, or individuals who are subject to Part 26. addition, the provision requires that
dilute validity test results. These With respect to the proposed rule, the MROs must personally review a
changes are necessary for consistency final rule adds another sentence to confirmed positive drug test result that
with the addition of requirements to § 26.183(d) to clarify that employees of is received from the HHS-certified
conduct validity testing throughout the a licensee or other entity who serve laboratory, as well an adulterated,
rule, as discussed with respect to MRO staff functions may also perform substituted, invalid, or dilute result.
§ 26.31(d)(3)(i). The changes also other duties for the licensee or other This requirement is consistent with the
increase the consistency of Part 26 with entity and need not be under the addition of requirements to conduct
advances in other relevant Federal rules direction of the MRO while performing validity testing throughout the rule, as
and guidelines, which is Goal 1 of this those other duties. The final rule also discussed with respect to
rulemaking. clarifies § 26.183(d)(1) to reflect this § 26.31(d)(3)(i).
Section 26.183(c)(2) retains the intent and specify that individuals who Section 26.183(d)(1)(i) requires that
meaning of the last sentence of former serve MRO staff functions need only to MRO staff duties must be independent
Section 2.9(b) in Appendix A to Part 26, be under the direction of the MRO while from any other activity or interest of the
but adds minor editorial revisions for performing those functions. The NRC licensee or other entity. The rule has
consistency with the terminology used has added these changes to specify added this requirement because, in
throughout the rule. For example, the NRC’s intent in response to a public contrast to other Federal agencies’
rule replaces the term ‘‘split samples’’ in comment that requested clarification on regulations, Part 26 permits employees
the former rule with the term ‘‘split this issue. of licensees and other entities to
specimens.’’ The NRC has made these The NRC has added § 26.183(d)(1) perform MRO staff activities for MROs
changes to meet Goal 6 of this [Direction of MRO staff activities] to who work off site and are not physically
rulemaking to improve clarity in the require an MRO to be directly present to supervise the staff. These
organization and language of the rule. responsible for the administrative, circumstances may provide greater
The NRC has added § 26.183(d) [MRO technical, and professional activities of opportunities for inadvertent
staff] to the final rule to establish individuals who perform MRO staff compromise of the independence of the
requirements related to individuals who duties. As discussed with respect to MRO function than situations when the
provide routine administrative support § 26.5, directing means the exercise of MRO and his or her staff are physically
functions to MROs, whether the control over a work activity by an co-located, such as the inadvertent
individuals are employees of the individual who is directly involved in release of positive, adulterated,
licensee or other entity, employees of the execution of the activity and either substituted, or invalid test results before
the MRO, or employees of an makes technical decisions for that the MRO has discussed the results with
organization with whom the licensee or activity without subsequent technical the donor. Therefore, the NRC believes
other entity contracts for MRO services. review, or is ultimately responsible for that the requirement is necessary to
This provision adds requirements the correct performance of that work protect the integrity of the MRO
related to MRO staff because these activity. The NRC does not intend to function and donors’ privacy, consistent
individuals have access to drug test mandate that MROs must share the with Goal 7 of this rulemaking to protect
results that are forwarded to an MRO same physical space with all their staff the privacy and other rights (including
due process) of individuals who are results. The provision also prohibits include assisting the licensee or other
subject to Part 26. MRO staff from requesting or reviewing entity in determining whether a donor
The NRC has added § 26.183(d)(ii) to medical information from donors has attempted to subvert the testing
the final rule to further specify the related to any positive, adulterated, process. These responsibilities may
MRO’s responsibilities for directing substituted, dilute, or invalid test include, but are not limited to,
MRO staff. These responsibilities results. reviewing positive, adulterated,
include, but are not limited to, ensuring Section 26.183(d)(2)(iv) prohibits substituted, dilute, or invalid test results
that the procedures that must be MRO staff from reporting or discussing and authorizing the testing at an HHS-
followed by MRO staff meet the positive, adulterated, substituted, certified laboratory of any suspicious
regulations of this part and HHS and invalid, or dilute test results received substance discovered in a donor’s
professional standards of practice. The from the HHS-certified laboratory with pockets that could be used to adulterate
MRO must also ensure that personal any individuals other than the MRO and or substitute a urine specimen. The
information about the donor is other MRO staff. The provisions are change meets Goal 3 of the rulemaking
maintained confidentially with the necessary to protect donor as it relates to improving the
highest regard for individual privacy. confidentiality and the integrity of the effectiveness of FFD programs and is
These requirements meet Goal 7 of this MRO review process, consistent with consistent with the NRC’s increased
rulemaking to protect the privacy and Goal 7 of this rulemaking to protect concern with potential subversion of the
other rights (including due process) of privacy and other rights (including due testing process, as discussed with
individuals who are subject to Part 26. process) of individuals who are subject respect to § 26.31(d)(3)(i). This
The NRC has also added to Part 26. At the same time, the provision also deletes the former
§ 26.183(d)(1)(iii) to prohibit the MRO provision permits licensees and other reference to ‘‘nuclear power plant
from delegating his or her entities to realize the cost efficiencies worker’’ and replaces it with
responsibilities for directing MRO staff associated with the MRO delegating ‘‘individual’’ because persons other than
activities to any individual or entity, some tasks to staff, consistent with Goal nuclear power plant workers are subject
other than another MRO. Although the 3 of this rulemaking to increase the to the requirement. In addition, this
NRC is unaware of any instances when effectiveness and efficiency of Part 26 provision eliminates the former
the MRO function has been programs. With respect to the proposed requirement for the MRO to review
compromised by MRO staff in Part 26 rule, the NRC has clarified this blood test results from the HHS-certified
programs, the experience of other provision to specify that the MRO staff laboratory because the rule no longer
Federal agencies has indicated that clear may not report or discuss positive, permits donors to request testing of a
limits on who may direct MRO staff adulterated, substituted, dilute, or blood specimen for alcohol, as
activities are advisable to maintain the invalid test results received from the discussed with respect to § 26.83(a).
independence and integrity of the MRO HHS-certified laboratory with any However, the provision retains the
function. Therefore, § 26.183(d)(1)(iii) individuals other than the MRO and former requirement that the MRO must
establishes these clear limits and is other MRO staff before those results complete the review of any positive,
consistent with Goal 3 of this have been reviewed and confirmed by adulterated, substituted, invalid, and, at
rulemaking to improve the effectiveness the MRO. The final rule also adds the licensee’s or other entity’s
of the FFD program. limitations on with whom the MRO staff discretion, dilute test results before
The NRC has added § 26.183(d)(2) can discuss confirmed positive, transmitting results to a licensee’s or
[MRO staff responsibilities] to specify adulterated, substituted or invalid test other entity’s designated representative.
the duties that MRO staff may and may results, as well as limitations on With regard to the proposed rule, the
not perform. The provisions are also discussion of quantitative test results NRC received a public comment stating
based on the experience of other Federal and any personal medical information. that the MRO should not be required to
agencies, which has indicated that clear The NRC believes that only the MRO is determine whether a donor has violated
limits on MRO staff duties are necessary qualified to answer questions from FFD the FFD policy because MRO expertise
to protect donor confidentiality and the program personnel about the basis for is exclusively medical. The NRC
integrity of the MRO process. Therefore, his or her decisions and the proper believes that an MRO has the medical
this addition is consistent with Goal 1 interpretation of test results from the expertise and detailed knowledge of
of this rulemaking to update and HHS lab. These changes are consistent possible alternate medical explanations
enhance the consistency of Part 26 with with Goal 6 of this rulemaking to that is essential to the review process.
advances in other relevant Federal rules improve clarity in the language of the Therefore, the NRC maintains that the
and guidelines. Section 26.183(d)(2)(i) rule. MRO is required to determine whether
permits MRO staff to receive results a donor has violated the FFD policy.
from the HHS-certified laboratory and to Section 26.185 Determining a Fitness- Section 26.185(b) [Reporting of initial
review and report negative test results to for-Duty Policy Violation test results prohibited] of the final rule
the licensee’s or other entity’s Section 26.185 of the final rule retains the intent of the requirement in
designated reviewing official under the contains requirements related to the the last sentence of former Section 2.9(a)
MRO’s direction. Section MRO’s determination that a positive, in Appendix A to Part 26. Specifically,
26.183(d)(2)(ii) permits MRO staff to adulterated, substituted, invalid, or this provision continues to prohibit the
review the custody-and-control forms dilute test result constitutes an FFD MRO from communicating to licensees
for specimens that the laboratory reports policy violation. and other entities any positive,
as positive, adulterated, substituted, Section 26.185(a) [MRO review adulterated, substituted, dilute, or
invalid, or dilute, and to correct errors. required] of the final rule amends invalid initial test results reported by
However, the MRO is required to review portions of former Section 2.9(a) in the HHS-certified laboratory before
and approve the corrections. Section Appendix A to Part 26. The former confirmatory testing has been completed
26.183(d)(2)(iii) prohibits staff from section established requirements for the and the MRO has conducted his or her
conducting interviews with donors to MRO’s review of test results from the review. However, this provision extends
discuss positive, adulterated, HHS-certified laboratory. The final rule the prohibition to MRO staff, consistent
substituted, invalid, or dilute test expands the MRO’s responsibilities to with Goal 7 of this rulemaking and the
addition of requirements related to MRO policy violation with the MRO, as other relevant Federal rules and
staff in § 26.183(d), as discussed with specified in § 26.185(d)(1); guidelines.
respect to that provision. (2) The donor fails to contact the MRO The NRC has added § 26.185(f)
Section 26.185(c) [Discussion with the within one business day after being through (i) to the final rule to establish
donor] of the final rule amends former contacted by the licensee or other entity, requirements for the MRO’s review of
Section 2.9(c) in Appendix A to Part 26. or an MRO staff member, as specified in validity test results. The NRC has added
This provision continues to require the § 26.185(d)(2); and these paragraphs for consistency with
MRO to discuss a positive confirmatory (3) The MRO is unable to contact the the addition of requirements to conduct
drug test result with the donor before donor after making a reasonable effort to validity testing throughout the rule, as
determining that the FFD policy had do so as specified in § 26.185(d)(2). discussed with respect to § 26.31(d)(3)(i)
been violated. This provision adds a These provisions provide more to meet Goal 3 of this rulemaking to
requirement for the MRO to discuss detailed guidance than the first sentence increase the effectiveness and efficiency
adulterated, substituted, dilute or of former Section 2.9(c) in Appendix A of Part 26 programs.
invalid confirmatory validity test results to Part 26 in response to many questions Section 26.185(f) [Review of invalid
with the donor as part of the review that have arisen regarding specimens] clarifies the MRO’s
process, consistent with the addition of implementation of the requirement for responsibilities if the HHS-certified
requirements to conduct validity testing MROs to discuss test results with the laboratory reports that a specimen is
donor. The revisions also respond to invalid. This provision is consistent
throughout the rule, as discussed with
stakeholders’ requests during the public with related provisions in the HHS
respect to § 26.31(d)(3)(i). This
meetings discussed in Section I.D. In Guidelines and is necessary because
provision also adds a reference to ‘‘other
questions to the NRC staff and during MRO actions in response to an invalid
occurrence’’ to address circumstances
the public meetings, licensees have specimen are not specified in the former
when the donor may have engaged in a
pointed out that the former rule made rule. Section 26.185(f) provides the
subversion attempt that would be
no provision for these circumstances MRO with the following several
detected through other means,
that do occasionally arise. Therefore, alternative courses of action if a
including, but not limited to, the
these provisions address these specimen is declared to be invalid by
specimen collection process in Subpart
circumstances. The NRC believes that the laboratory:
E [Collecting Specimens for Testing]. these provisions give the donor Section 26.185(f)(1) requires the MRO
This provision eliminates the former adequate opportunity to be contacted, to consult with the HHS-certified
requirement for the MRO to contact the consistent with Goal 7 of this laboratory to determine whether
EAP. Under this provision, referral to rulemaking to protect the rights of additional testing by another HHS-
the EAP is at the licensee’s or other individuals subject to Part 26, while certified laboratory may be useful for
entity’s discretion, as documented in allowing licensees to make ‘‘reasonable completing testing of the specimen.
FFD procedures. The NRC has efforts’’ to contact the donor; thus Another laboratory may use different
eliminated the former requirement meeting Goal 3 of this rulemaking as it testing methods that could provide more
because most licensees terminate the relates to improving efficiency in the definitive test results regarding the
employment of individuals who have a FFD program. invalid specimen, such as the ability to
confirmed positive, adulterated, or For the same reasons, § 26.185(e) identify a new adulterant or obtain valid
substituted drug test result. It is [Additional opportunity for discussion] drug test results despite the presence of
inappropriate to require licensees and of the final rule specifies procedures for an interfering substance in the
other entities to provide EAP services to addressing a circumstance when the specimen. If the MRO and laboratory
persons they will no longer employ. If donor was unable to be contacted by the agree that additional testing would be
a licensee or other entity plans to MRO to discuss a positive, adulterated, useful, the MRO shall direct the
consider granting authorization to the substituted, dilute, or invalid test result, laboratory to forward an aliquot of the
individual after his or her authorization or other occurrence. This provision specimen to a second HHS-certified
has been terminated unfavorably for the permits the donor to present laboratory for further testing.
FFD policy violation, this provision information to the MRO documenting Section 26.185(f)(2) requires the MRO
requires the licensee or other entity to the circumstances that unavoidably to contact the donor to determine
meet the applicable requirements of prevented the donor from being whether there is an acceptable medical
§ 26.69 [Authorization with potentially contacted by or from contacting the explanation for the invalid result if the
disqualifying fitness-for-duty MRO, and permits the MRO to reopen MRO and HHS-certified laboratory agree
information]. The NRC has made these the procedure for determining whether that testing at a second laboratory would
changes in the paragraph for the donor had violated the FFD policy. not be useful. If the MRO determines
consistency with other changes to the This provision also permits the MRO to that there is an acceptable medical
regulation and to meet Goal 3 of the modify the initial determination based explanation for the invalid result, the
rulemaking as it relates to increasing on the information that the donor MRO would report to the licensee or
efficiency in FFD programs. provides. other entity that no FFD policy violation
The NRC has added § 26.185(d) The requirements in § 26.185(d) and had occurred, but that a negative test
[Donor unavailability] to the final rule (e) incorporate the related requirements result had not been obtained. Because
to clarify the circumstances when the in 49 CFR Part 40, ‘‘Procedures for the specimen did not yield negative test
MRO may confirm a positive, Department of Transportation results, the licensee or other entity
adulterated, substituted, dilute, or Workplace Drug and Alcohol Testing could not use the invalid test result in
invalid test result, or other occurrence, Programs’’ (65 FR 41944; August 9, the decision to grant or deny
as an FFD policy violation without 2001). Therefore, in addition to authorization. However, this provision
having first discussed the test result or responding to implementation questions also requires the MRO to assess whether
occurrence with the donor. These from licensees and stakeholder requests, the medical condition would similarly
circumstances include when— the provisions meet Goal 1 of this affect a second specimen collection. If
(1) The donor expressly declines the rulemaking to update and enhance the the MRO determines that the medical
opportunity to discuss the possible FFD consistency of Part 26 with advances in condition is temporary and would not
affect a second specimen, he or she Section 26.185(g)(1) requires the MRO § 26.185(g)(2). These circumstances are
would direct the licensee or other entity to confirm a drug-positive FFD violation the same as those specified in
to collect another specimen from the for a dilute specimen in which drugs or § 26.115(a)(1) through (a)(3). The final
donor. The licensee or other entity drug metabolites are detected, if the rule clarifies this provision of the
would then rely upon the results of the MRO determines that there is no proposed rule by specifying that these
second test to make an authorization legitimate medical explanation for the circumstances must be considered by
decision. This provision does not presence of the drugs or metabolites in the MRO, if applicable, and are not the
require the second specimen to be the specimen. The final rule amends the exclusive grounds to believe the donor
collected under direct observation in proposed rule by clarifying that a may have diluted the specimen in a
this situation because there is no reason clinical examination is one of the subversion attempt. This NRC has made
to believe that the individual may have criteria that must be met before the this change in response to public
attempted to subvert the testing process. MRO can confirm a drug-positive FFD comment and to meet Goal 6 of this
If the MRO determines that the medical violation, consistent with Goal 6 of this rulemaking to improve clarity in the
condition would likely affect the rulemaking to improve clarity in the organization and language of the rule.
validity of further urine specimens, the organization and language of the Section 26.185(g)(3) clarifies that the
MRO may authorize an alternative rulemaking. There are many legitimate MRO may also require the additional
method for drug testing. At this time, reasons for submitting a dilute testing of a dilute specimen that is
the NRC declines to specify the specimen, which is the basis for permitted in § 26.185(g)(2) if the
alternative methods that the MRO may omitting the submission of a dilute specimen was collected under direct
authorize, which may include, but are specimen as one type of subversion observation. This provision adds this
not limited to, testing of alternate attempt for which a permanent denial of permission for consistency with the
specimens, such as hair, oral fluids, or authorization is required in § 26.75(b). related provisions in the FFD rule.
sweat. The NRC leaves the selection of Although neither the submission of a Section 26.185(g)(4) requires the MRO
an alternative method to the dilute specimen nor the presence of to determine whether there is clinical
professional judgement of the MRO. drugs or drug metabolites in a dilute evidence of the illegal use of opiates or
This provision also prohibits licensees specimen establishes that the donor has if opiates other than 6–AM at any
and other entities from taking attempted to subvert the testing process concentration are detected in a dilute
management actions or imposing without additional evidence of specimen before the MRO verifies that
sanctions on the basis of an invalid test subversion, the presence of drugs or the donor has violated the FFD policy.
result from a medical condition because metabolites in a dilute specimen This provision does not require an
no FFD violation would have occurred. without a legitimate medical evaluation for clinical evidence of
Section 26.185(f)(3) requires the MRO explanation is a sufficient basis for the illegal use of opiates for 6–AM because
to direct the licensee or other entity to MRO to confirm that the donor has its presence in a specimen is proof of
collect another specimen under direct violated the FFD policy. heroin use. However, the provision does
The final rule modifies and clarifies
observation, if testing by another not establish cutoff levels below and
§ 26.185(g)(2) of the former and
laboratory would not be useful in above which an evaluation for clinical
proposed rules. This provision specifies
obtaining a valid result and the donor evidence of illegal opiate use is not
the conditions that must be met in order
did not provide an acceptable medical required (in contrast to those contained
for the MRO to determine whether the
explanation for the invalid specimen. in paragraph (j) of this section) because
positive and dilute specimen is a refusal
The invasion of privacy associated with the concentration of opiates in a dilute
to test. These conditions include
a directly observed collection is specimen does not bear any known
when—
warranted in this situation because the (1) The HHS-certified laboratory relationship to the concentration of
invalid specimen may be the result of a conducts the special analysis of dilute opiates in vivo (i.e., in the donor’s
subversion attempt. This provision specimens permitted in 26.163(a)(2) and body). For similar reasons, this
requires the licensee or other entity to the results show the presence of drugs provision also requires an evaluation for
rely on the test results from the directly or drug metabolites in the specimen; clinical evidence of abuse before the
observed collection in authorization (2) The MRO determines there is no MRO determines that the donor has
decision-making because the result from legitimate medical explanation for the violated the FFD policy when drugs or
the invalid specimen would be neither presence of drugs or drug metabolites in drug metabolites are detected in a dilute
negative nor positive, adulterated, the specimen; and specimen, indicating that the donor has
substituted, or invalid, and could not (3) a clinical examination has been used prescription or over-the-counter
meet the requirements for granting conducted in accordance with this medications.
authorization to an individual in section. The NRC has added § 26.185(g)(5) to
Subpart C [Granting and Maintaining The provision also specifies when the the final rule, with respect to the
Authorization] or serve as the basis for MRO shall determine that drug test proposed rule, to specify the
imposing the sanctions specified in results are positive and the donor has circumstances under which MRO
Subpart D [Management Actions and violated FFD policy. These changes are review is not required. This change is
Sanctions]. consistent with the changes the NRC has consistent with related provisions in the
The NRC has added § 26.185(g) made to procedures for processing HHS guidelines.
[Review of dilute specimens] to the final dilute specimens, as discussed in The NRC has added § 26.185(h)
rule to establish requirements for the § 26.163(a)(2). [Review of substituted specimens] to the
MRO’s review of positive confirmatory Section 26.185(g)(2)(i) through final rule to establish requirements for
drug test results from dilute specimens. (g)(2)(iii) defines the circumstances that the MRO review of substituted test
The NRC has added this paragraph may constitute a reason to believe that results. These provisions have been
because reviewing test results from a a donor may have attempted to subvert added because MRO actions in
dilute specimen is complex and MRO the testing process and provide a determining an FFD policy violation for
actions in response to a dilute specimen sufficient basis for the MRO to require a substituted specimen are consistent
are not addressed in the former rule. the additional testing permitted in with the related provisions in the HHS
Guidelines and are not addressed in the that the specimen is adulterated. If the change because, in the experience of
former rule. donor provides an acceptable medical other Federal programs, such
Section 26.185(h)(1) requires the MRO explanation, § 26.185(j)(3) requires the concentrations without a legitimate
to contact the donor to determine MRO to report that no FFD policy medical explanation can only indicate
whether there is a legitimate medical violation had occurred. These substance abuse. In addition, the rule
reason for the substituted result. This requirements are consistent with the prohibits the MRO from considering
provision requires the MRO to give the related provisions in the HHS consumption of food products as a
donor the opportunity to provide Guidelines. legitimate medical explanation for the
legitimate medical evidence, within 5 Section 26.185(j) [Review for opiates, specimen having morphine or codeine
business days of being contacted by the prescription and over-the-counter concentrations at or above 15,000 ng/mL
MRO, that he or she produced the medications] of the final rule amends because food consumption could not
specimen for which the HHS-certified former Section 2.9(d) in Appendix A to result in a concentration at this level.
laboratory reported a substituted result. Part 26. It addresses circumstances that Section 26.185(j)(2) retains the last
The final rule, with respect to the have arisen since Part 26 was first sentence of former Section 2.9(d) in
proposed rule, specifies that a qualified published and about which licensees Appendix A to Part 26. This provision
and experienced physician, as verified have sought guidance from the NRC. requires the MRO to determine whether
by the MRO, shall submit the medical These changes are consistent with Goal there is clinical evidence of abuse of
evidence. The NRC has made this 3 of the rulemaking to improve the these substances or their derivatives, in
change because after publishing the effectiveness of FFD programs. The addition to the positive confirmatory
proposed rule, it recognized the need for paragraph amends the former test result.
additional clarity in this provision to requirements in Section 2.9(d) in The NRC has added § 26.185(j)(3) to
specify the NRC’s intent. This provision Appendix A to Part 26 and adds others, the final rule to provide greater
also provides examples of donor claims as follows: consistency in MRO determinations
that the MRO may not consider to be Section 26.185(j)(1) incorporates related to a donor’s use of another
legitimate medical explanations, updated requirements from the HHS person’s prescription medication. The
including, but not limited to, race, Guidelines related to the MRO’s review NRC is aware that MROs in different
gender, body weight, and dietary of a positive drug test result for opiates. FFD programs have varied in their
factors. The rule revises but retains the meaning determinations as to whether the use of
Section 26.185(h)(2) directs the MRO of the requirement for the MRO to another person’s prescription
to report to the licensee or other entity determine that there is clinical evidence medication is an FFD policy violation.
that the specimen was substituted if the of illegal use of opiates, which appeared The paragraph clarifies the NRC’s intent
MRO determines that there is no in former Section 2.9(d) in Appendix A with respect to these circumstances. In
acceptable medical explanation for the to Part 26. Because some licensees and the final rule, if a donor claims, and the
substituted test result. other entities rely on MROs who work MRO confirms, that a positive,
Section 26.185(h)(3) directs the MRO off site and are not available to conduct adulterated, substituted, or invalid drug
to report to the licensee or other entity the required assessment, the rule test result is due to the unauthorized
that no FFD policy violation has permits the MRO to designate another use of another person’s prescription
occurred if the MRO determines that the licensed physician who has knowledge medication, the rule requires the MRO
donor has provided an acceptable of the clinical signs of drug abuse to to evaluate or ensure that the donor is
medical explanation for the substituted conduct the evaluation. This change evaluated for clinical evidence of abuse.
test result. ensures that the clinical assessment is If no clinical evidence of abuse is
Section 26.185(i) [Review of performed by a qualified physician identified, the MRO shall report to the
adulterated specimens] of the final rule while reducing unnecessary burden by licensee or other entity that a violation
establishes requirements for the MRO’s permitting FFD programs to continue to of the FFD policy regarding misuse of a
review of adulterated test results. This rely on off site MROs. Therefore, the prescription medication had occurred. If
provision has been added because MRO change meets Goal 5 of this rulemaking clinical evidence of abuse is identified,
actions in determining an FFD policy to improve Part 26 by eliminating or the MRO will confirm that the test
violation for an adulterated specimen modifying unnecessary requirements. results are positive for the drug or
are not addressed in the former rule. This provision eliminates the metabolites detected.
Section 26.185(i)(1) requires the MRO to examples of clinical signs of opiate The NRC has added § 26.185(j)(4) to
contact the donor and offer him or her abuse in former Section 2.9(d) in the final rule to assure greater
the opportunity to provide an Appendix A to Part 26 because these consistency in MRO determinations
acceptable medical explanation for the signs are addressed as part of the related to a donor’s use of a prescription
adulterated result within 5 business training that MROs must obtain in order or over-the-counter medication that the
days after the donor produced the to pass the comprehensive certification donor obtained legally in a foreign
adulterated result. The final rule, with examination required in § 26.183(a) country. Again, the NRC is aware that
respect to the proposed rule, specifies [Qualifications]. The rule retains the MROs in different FFD programs have
that a qualified and experienced provision in former Section 2.9(d) that varied in their determinations as to
physician, as verified by the MRO, shall permits the MRO to omit the evaluation whether the use of medications legally
submit the medical evidence. The NRC for clinical evidence of abuse if the obtained in a foreign county is an FFD
has made this change because after laboratory identifies 6–AM in the policy violation. The paragraph clarifies
publishing the proposed rule, it specimen. However, the rule adds the NRC’s intent with respect to these
recognized the need for additional permission for the MRO to omit the circumstances. At the licensee’s or other
clarity in this provision to specify the evaluation if the morphine or codeine entity’s discretion and in accordance
NRC’s intent. If the MRO determines concentration in the specimen is equal with the FFD policy and procedures, the
that there is no legitimate acceptable to or greater than 15,000 ng/mL without rule permits the MRO to confirm a test
medical explanation for the adulterated a legitimate medical explanation for the result as negative if there is a legitimate
result, § 26.185(i)(2) requires the MRO presence of opiates at or above this medical use for the medication that the
to report to the licensee or other entity concentration. The NRC has made this donor obtained legally in a foreign
country and the donor has used it (2) The drug or other substance has no specimen (Bottle B) if there is any
properly for its intended medical currently accepted medical use in question about the accuracy or scientific
purpose. The rule prohibits the MRO treatment in the United States; and validity of a drug test result in order to
from confirming a test result as negative (3) There is a lack of accepted safety determine whether the FFD policy has
if the drug used has no legitimate for use of the drug or other substance been violated. The final rule retains the
medical purpose, including, but not under medical supervision. provisions in former Section 2.9(e) that
limited to phencyclidine and heroin. The prohibition is primarily intended permitted a donor to request a retest of
The NRC has added § 26.185(j)(5) to to address the medical use of marijuana, an aliquot of a single specimen or a split
prohibit the MRO from considering the which some States permit, as well as the specimen if the FFD program follows
consumption of food products, use of certain hallucinogenic drugs. split specimen procedures. However,
supplements, and other preparations Although some have argued that the use the final rule updates the former
that are available over-the-counter as a of such drugs under State laws may not requirement for consistency with the
legitimate medical explanation for the adversely reflect on an individual’s terminology used throughout the final
specimen having drugs or drug trustworthiness and reliability, the rule (e.g., ‘‘Bottle B’’ to refer to a split
metabolites above the cutoff levels requirement is necessary to ensure that specimen), as discussed with respect to
specified in § 26.163, including, but not individuals who are subject to this part § 26.5. The final rule also includes a
limited to hemp products and coca leaf can be trusted and relied upon to requirement that the retesting must be
tea. In so doing, the rule provides comply with Part 26 requirements and conducted at a second HHS-certified
guidance concerning a potential are not impaired from using these drugs laboratory that did not conduct the
subversion technique that has become when performing duties that require original tests. The requirement that
an issue for several licensees (i.e., them to be subject to this part. retesting must be performed at a second
Section 26.185(k) [Results consistent HHS-certified laboratory ensures the
claims of ingestion of hemp food
with legitimate drug use] of the final independence of the second testing and
products as the basis for a positive
rule amends former Section 2.9(f) in provide additional protection of donors’
marijuana test). Ingestion of food
Appendix A to Part 26. The former due process rights under the rule. In
products containing hemp seeds or
provision instructed the MRO to report addition, the requirement increases the
extracts has produced marijuana
to the licensee that a drug test result is consistency of Part 26 with related
positive test results even though the negative if, after review, the MRO
seller claimed that the seeds or extracts provisions in the HHS Guidelines,
determines that there is a legitimate consistent with Goal 1 of the rulemaking
were sterilized to remove the THC medical explanation for the positive test
metabolite. The NRC endorses the to update and enhance the consistency
result and that use of the substance of Part 26 with advances in other
Federal policy in this matter that was identified through testing in the manner
published by the DOT, with the Federal rules and guidelines.
and at the dosage prescribed does not The proposed rule required the donor
concurrence of the Departments of reflect a lack of reliability and is to request the retest in writing in order
Justice and Health and Human Services unlikely to create on-the-job to ensure donors’ control over the
and the Office of National Drug Control impairment. However, the former specimen and rights to privacy under
Policy. MROs must never accept an provision did not provide instructions § 26.135(b). However, the final rule
assertion of consumption of a hemp for MRO action in the case of an eliminates the provision that the donor’s
food product as a basis for confirming individual whose drug use is legitimate authorization for re-testing must be in
that a marijuana test is negative. but may cause impairment on duty. writing. This change is in response to
Consuming a hemp food product is not Therefore, if the MRO determines that a public comment stating that obtaining a
a legitimate medical explanation for a risk exists, the final rule requires that a written request poses an unnecessary
prohibited substance or metabolite in an determination of fitness must be logistical burden on the donor and the
individual’s specimen. When a performed. Because the MRO MRO and that verbal requests are and
specimen is positive for THC, the only determined that the drug test result was have been sufficient in the past.
legitimate medical explanation for its negative, the licensee or other entity Therefore, the NRC has made this
presence is a prescription for marinol. shall not impose sanctions on the change, consistent with other Federal
Under § 26.29(a)(6) and (a)(7), individual. However, the results of the regulations and Goal 1 of this
individuals who are subject to Part 26 determination of fitness may indicate a rulemaking to update and enhance the
receive training in order to be able to need to establish controls and consistency of Part 26 with advances in
avoid ingesting substances that could conditions on the individual’s other relevant Federal rules and
result in positive drug test results, such performance of certain duties in order to guidelines.
as over-the-counter medications, food ensure that any impairment from the Section 26.185(m) [Results
products, supplements, and other drug use does not result in adverse scientifically insufficient] of the final
preparations. impacts on public health and safety or rule amends the first sentence of the
The NRC has added § 26.185(j)(6) to the common defense and security. By former Section 2.9(g) in Appendix A to
the final rule to prohibit the MRO from providing greater assurance that Part 26. This provision permits the MRO
accepting the use of any drugs that are individuals who are subject to the rule to determine that a positive, adulterated,
listed in Schedule I of section 202 of the are fit to safely and competently substituted or invalid test result is
Controlled Substances Act [21 U.S.C. perform their duties, the provision scientifically insufficient for further
812] as a legitimate medical explanation meets Goal 3 of this rulemaking to action. The final rule instructs the MRO
for a positive confirmatory drug test improve the effectiveness of FFD to report that the drug or validity test
result, even if the drug may be legally programs. result is not an FFD policy violation in
prescribed and used under State law. Section 26.185(l) [Retesting these circumstances, but that a negative
Drugs that are listed in Schedule I of authorized] of the final rule amends test result was not obtained. The NRC
section 202 of the Controlled Substances former Section 2.9(e) in Appendix A to has made this change for consistency
Act have the following characteristics: Part 26. This provision permits the MRO with other changes in the rule related to
(1) The drug or other substance has a to authorize retesting of an aliquot of a invalid test results (see § 26.185(f)). A
high potential for abuse; specimen or the analysis of any split test result that the MRO determines to
be scientifically insufficient for further Part 26 with advances in other relevant the former phrase, ‘‘initial presumptive
action (as well as an invalid test result) Federal rules and guidelines. positive screening test result,’’ with the
could not be a basis for a licensee or The NRC has added § 26.185(o) [Re- phrase, ‘‘initial positive, adulterated or
other entity to grant or deny authorization after a first violation] to substituted test result,’’ for consistency
authorization or impose sanctions the final rule. This provision addresses with the terminology used throughout
because it would be neither a negative the MRO’s review of drug test results the rule (see § 26.5). This provision also
nor positive, adulterated, or substituted following a first violation of the FFD requires the MRO to report his or her
test result. Therefore, the change meets policy based on a confirmed positive determination that a test result is an
Goal 6 of this rulemaking to improve drug test result. The former rule did not FFD policy violation in writing to the
clarity in the language of the rule. The require the MRO to evaluate whether licensee or other entity and in a manner
NRC has changed some of the drug test results in these instances that ensures the confidentiality of the
terminology used in the former indicated subsequent drug use after a information. The NRC has made these
paragraph in the final rule for first confirmed positive drug test result, changes for consistency with the related
consistency with the terminology used and MROs from different FFD programs provisions in the HHS Guidelines,
throughout the final rule (e.g., have implemented different policies. consistent with Goal 1 of this
‘‘samples’’ is changed to ‘‘specimens’’). Specifically, the final rule requires the rulemaking.
The final rule also makes the following MRO to determine whether subsequent
drug test results indicate further drug Section 26.187 Substance Abuse
changes to this provision:
The final rule also adds a statement to use since the first positive drug test Expert
the former paragraph to indicate that the result was obtained. For example, The NRC has added § 26.187 to the
MRO is neither expected nor required to because marijuana metabolites are fat- final rule. This section establishes
request retesting of the specimen unless, soluble and may be released slowly over minimum requirements for a new
in the sole opinion of the MRO, such an extended period of time, a second position within FFD programs, the
retesting is warranted. The final rule positive test result for marijuana from a ‘‘substance abuse expert’’ (SAE). These
includes this statement because, in the test that is performed within several added provisions meet Goal 3 of the
experience of other Federal agencies, weeks after a first confirmed positive rulemaking to improve the effectiveness
some MROs have been pressured by the test result for marijuana may not, in fact, and efficiency of FFD programs.
organization to whom they provide indicate further marijuana use. The NRC has added § 26.187(a)
services to request retesting of Therefore, in this case, the provision [Implementation] to the final rule. This
specimens that the MRO has confirmed prohibits the MRO from determining provision requires SAEs to meet the
to be positive, adulterated, substituted, that a second FFD policy violation for requirements of this section within 2
or invalid. Although the NRC is not marijuana had occurred if the years of the date on which the final rule
aware of any such instances in Part 26 quantitative results from confirmatory is published in the Federal Register.
programs, the rule clarifies that the testing of the second specimen are The NRC has imposed the 2-year period
MRO alone is authorized to request positive for marijuana metabolites, but in order to ensure that professionals
retesting to further protect the at a concentration that is inconsistent who may currently be performing
independence of the MRO function. with additional marijuana use since the determinations of fitness, but who do
In addition, the NRC has moved the first positive, adulterated, substituted, not meet these proposed requirements,
last sentence of former Section 2.9(g), or invalid test result was obtained. If the have the time necessary to obtain the
which contained records retention MRO concludes that the concentration required credentials, knowledge, and
requirements, to § 26.215(b)(11) of of marijuana metabolites identified by qualification training. With respect to
Subpart N [Recordkeeping and confirmatory testing is inconsistent with the proposed rule, the final rule adds a
Reporting Requirements] of the final further marijuana use since the first sentence that allows an MRO who meets
rule. The NRC has moved this provision positive test result, the MRO would the requirements of this section to serve
to group it with other records retention declare the test result as negative, even as both an MRO and as an SAE. The
requirements in the rule for if the quantitative test result exceeds the NRC has made this change in response
organizational clarity. 15 ng/mL confirmatory cutoff level to a public comment suggesting that
Section 26.185(n) [Evaluating results specified in this part or a licensee’s or allowing the MRO, if qualified, the
from a second laboratory] establishes other entity’s more stringent cutoff option to function as the SAE would
new requirements for the MRO’s level. The provision prevents avoid any unnecessary financial burden
determination of an FFD policy individuals from being subject to a 5- for licensees that have an MRO that can
violation based on a retest of a single year denial of authorization for a second make SAE determinations.
specimen or a test of the specimen in confirmed positive drug test result The NRC has added § 26.187(b)
Bottle B of a split specimen. This under § 26.75(e), when the donor has [Credentials] to the final rule to
provision specifies that the test result(s) not engaged in further drug use, establish the credentials required for an
from the second HHS-certified consistent with Goal 7 of this individual to serve as an SAE under this
laboratory supersede the confirmatory rulemaking to protect the privacy and part. The rule requires that the SAE
test results provided by the HHS- other rights (including due process must possess the extensive education,
certified laboratory that performed the rights) of individuals who are subject to training, and supervised clinical
original testing of the specimen. The Part 26. experience that are prerequisites for
final rule incorporates these Section 26.185(p) [Time to complete obtaining the professional credentials
requirements from the HHS Guidelines MRO review] of the final rule amends listed in § 26.187(b)(1) through (b)(5).
because the former rule did not address former § 26.24(e). This provision Further, § 26.187(c) through (e) requires
MRO actions in response to test results requires the MRO to complete his or her an SAE to possess additional knowledge
from a second laboratory. Therefore, the review of test results and notify and experience directly related to
provision is consistent with the related management of the results of his or her substance abuse disorders and the
provisions in the HHS Guidelines and review within 10 business days after an requirements of this part.
meets Goal 1 of this rulemaking to initial positive, adulterated or The NRC has added § 26.187(c) [Basic
update and enhance the consistency of substituted test result. The rule replaces knowledge] and (d) [Qualification
training] to the final rule to establish the assessment of the SAE’s understanding individual may be impaired as a result
specific areas of expertise and training of the material presented in the of the use of prescription or over-the-
that are required for an individual to continuing education activities in order counter medications or alcohol. Related
serve as an SAE under this part. The to ensure that the SAE learned the provisions in § 26.77 [Management
knowledge and training requirements in material. These continuing education actions regarding possible impairment]
these two paragraphs are necessary to requirements are necessary to ensure require the licensee or other entity to
ensure that SAEs possess the knowledge that SAEs maintain updated knowledge rely upon the results of the SAE’s
and clinical experience required to and skills to continue performing the determination of fitness when
perform the SAE function effectively in SAE function effectively under this part. determining whether an individual may
a Part 26 program. The NRC has added § 26.187(f) perform duties that require the
Section 26.187(c) requires SAEs to [Documentation] to the final rule to individual to be subject to this part.
possess the following types of specify the records that the SAE must Therefore, the NRC has added the
knowledge: (1) Knowledge of and maintain in order to demonstrate that he paragraph for consistency with other
clinical experience in the diagnosis and or she meets the requirements of this related provisions in the rule.
treatment of alcohol and controlled- section. The SAE is required to provide The NRC has added § 26.187(g)(2) to
substance abuse disorders, in the documentation, as requested, to the final rule to require the SAE to act
§ 26.187(c)(1); (2) knowledge of the SAE NRC representatives, and to licensees or as a referral source to assist an
function as it relates to individuals who other entities who rely on the SAE’s individual’s entry into an appropriate
perform the duties that require an services. Licensees and other entities treatment or education program. The
individual to be subject to this part, in who intend to rely upon a provision also prohibits the SAE from
§ 26.187(c)(2); and (3) knowledge of this determination of fitness that is made by engaging in any activities that could
part and any changes to its an SAE under another FFD program are create the appearance of a conflict of
requirements, in § 26.187(c)(3). also required to have access to this interest. Section 26.187(g)(2)(i) prohibits
Section 26.187(d) establishes the documentation. These requirements are the SAE from referring an individual to
topical areas in which an SAE must be necessary to ensure that licensees and any organization with whom the SAE
trained. The qualification training other entities, and the NRC, have access has a financial relationship, including
requirements include training in the to the documentation required to verify the SAE’s private practice, to avoid
following areas: (1) The background, that the SAE’s knowledge, training, and creating the appearance of a conflict of
rationale, and scope of this part, in practice meet the requirements of this interest. However, § 26.187(g)(2)(ii)(A)
§ 26.187(d)(1); (2) key drug and alcohol part. The final rule, with respect to the through (g)(2)(ii)(D) specifies
testing requirements of this part, in proposed rule, adds a cross-reference to circumstances in which the prohibition
§ 26.187(d)(2) and (d)(3), respectively; ensure that this provision is consistent in § 26.187(g)(2)(i) does not apply. In
(3) SAE qualifications and prohibitions, with the protection of information general, the rule permits the SAE to
in § 26.187(d)(4); (4) the role of the SAE requirements in § 26.37 of this part. refer an individual to an entity with
in making determinations of fitness, and The NRC has added § 26.187(g) whom the SAE has a financial
developing treatment recommendations [Responsibilities and prohibitions] to relationship in situations where
and followup testing plans, in the final rule to specify the treatment and educational resources
§ 26.187(d)(5); (5) procedures for responsibilities of SAEs within a may be limited by cost considerations or
consulting and communicating with licensee’s or other entity’s FFD program geographical availability. These
licensee or other entity officials and the and their limitations. provisions are necessary to ensure that
MRO, in § 26.187(d)(6); (6) reporting Section 26.187(g)(1) specifies at least the SAE’s determinations are not
and recordkeeping requirements of this three circumstances in which the SAE is influenced by financial gain and that
part as they related to the SAE function, responsible for making a determination individuals who are subject to the rule
in § 26.187(d)(7); and (7) appropriate of fitness under the rule. In and the public can have confidence in
methods for addressing issues that SAEs § 26.187(g)(1)(i), an SAE may be called the integrity and independence of the
confront in carrying out their duties upon to make a determination of fitness SAE function in Part 26 programs.
under this part, in § 26.187(d)(8). regarding an applicant for authorization
The NRC has added § 26.187(e) when the self-disclosure, the suitable Section 26.189 Determination of
[Continuing education] to the final rule inquiry, or other sources of information Fitness
to ensure that SAEs maintain the identify potentially disqualifying FFD The NRC has added § 26.189 to the
knowledge and skills required to information about the applicant. In final rule to present in one section and
perform the SAE function. The § 26.187(g)(1)(ii), an SAE may be called amend former requirements related to
paragraph requires SAEs to complete at upon to make a determination of fitness the determination that an individual is
least 12 continuing professional when an individual has violated the fit to safely and competently perform
education hours relevant to performing substance abuse provisions of a the duties that require individuals to be
the SAE function during each 3-year licensee’s or other entity’s FFD policy, subject to this part.
period following completion of initial including, but not limited to a first The final rule replaces the terms
qualification training. Section confirmed positive drug test result. ‘‘medical assurance’’ and ‘‘medical
26.187(e)(1) describes the topics that Related provisions in § 26.69 require the determination of fitness’’ used in
must be covered in the continuing licensee or other entity to rely upon the various sections of the former rule (e.g.,
education training, to include, but not results of the SAE’s determination of § 26.27(a)(3), (b)(2) and (b)(4)) with the
limited to, new drug and alcohol testing fitness when making a decision to grant term ‘‘determination of fitness’’ as
technologies, and any rule or maintain an individual’s defined in this section. The NRC has
interpretations or new guidance, rule authorization and implement any made this change in terminology
changes, or other developments in SAE recommendations from the SAE for because the rule permits healthcare
practice under this part since the SAE treatment and followup testing. In professionals other than licensed
completed the qualification training § 26.187(g)(1)(iii), an SAE may be called physicians to conduct determinations of
requirements in § 26.187(d). Section upon to make a determination of fitness fitness, as discussed with respect to
26.187(e)(2) requires documented when there is a concern that an § 26.187 [Substance abuse expert].
Therefore, the change meets Goal 6 of developing treatment plans are reserved performed before an individual is
this rulemaking to improve clarity in the for healthcare professionals who have granted authorization following an
organization and language of the rule. met the specific training, clinical unfavorable termination or denial of
The NRC has added § 26.189(a) to the experience, and knowledge authorization for a violation of a
final rule. The first sentence of the requirements for an SAE under § 26.187 licensee’s or other entity’s FFD policy.
paragraph defines the term for the reasons discussed with respect to Section 26.189(b)(3) reiterates the
‘‘determination of fitness.’’ This term that section. requirement in § 26.69(c) [Granting
refers to the process entered when there The final rule also prohibits authorization with other potentially
are indications that an individual may healthcare professionals who may disqualifying FFD information] that a
be in violation of the licensee’s or other conduct a determination of fitness for a determination of fitness must be
entity’s FFD policy or is otherwise Part 26 program from addressing fitness performed before an individual is
unable to safely and competently issues that are outside of their specific granted authorization when potentially
perform his or her duties. The final rule areas of expertise, consistent with the disqualifying FFD information is
amends this definition as it was ethical standards of healthcare identified that has not been previously
proposed, due to public comment, to professionals’ disciplines as well as addressed and resolved under the
clarify the intent of the provision. State laws. The rule adds this requirements of this subpart.
In general, the final rule requires that prohibition to clarify that the ethical Section 26.189(b)(4) addresses other
professionals who perform standards and State laws also apply to circumstances in which a determination
determinations of fitness must be making determinations of fitness under of fitness may be required. For example,
qualified and possess the requisite Part 26 because a determination of a determination of fitness may be
clinical experience, as verified by the fitness conducted by a professional who necessary if an FFD concern has been
licensee or other entity, to assess the is not qualified to address the specific raised regarding another individual, as
specific fitness issues presented by an fitness issue would be of questionable required in § 26.27(c)(4), and if a
individual whose fitness may be validity. Therefore, the prohibition is licensee’s or other entity’s reviewing
questionable. The approach to necessary to meet Goal 3 of this official requires one, under § 26.69(c)(3)
designating the healthcare professionals rulemaking to improve the effectiveness and (d)(2).
who may conduct a determination of and efficiency of FFD programs, as well The NRC has added § 26.189(c) to the
fitness focuses on the appropriateness of as Goal 7 to protect the privacy and final rule to establish requirements for
the professional’s expertise for other rights (including due process a determination of fitness that is
addressing the subject individual’s rights) of individuals who are subject to conducted ‘‘for cause.’’ Specifically,
fitness issue, rather than on the Part 26. § 26.189(c) requires that a determination
professional’s organizational affiliation Section 26.189(b)(1) through (b)(4) of of fitness that is conducted for cause
[see the discussion of § 26.69(b)(4)] or the final rule lists and presents together must be conducted through face-to-face
whether the individual is a licensed the circumstances in which a interaction. With respect to the
physician. Therefore, § 26.189(a)(1) determination of fitness must be proposed rule, the final rule clarifies
through (a)(5) provides examples of the performed, as required in other sections that a face-to-face interaction is required
healthcare professionals who are of the rule. Although this paragraph is only when there is observed behavior or
qualified to address various fitness redundant with other sections of the a physical condition. This provision
issues that may arise in a FFD program. rule, these circumstances are listed in ensures that the professional who is
When a decision must be made to one paragraph to meet Goal 6 of this performing the determination has
determine whether an individual may rulemaking to improve clarity in the available all of the sensory information
be granted or maintain authorization organization and language of the rule, that may be required for the assessment,
and a substance abuse disorder is by grouping related requirements such as the smell of alcohol or the
involved, only professionals who meet together in the order in which they individual’s physical appearance. The
the requirements to serve as an SAE are would apply to licensees’ and other NRC does not require a for-cause
permitted to make determinations of entities’ FFD processes. determination of fitness to be conducted
fitness under § 26.189(a)(1). The final Section 26.189(b)(1) reiterates the under this section if there is an absence
rule permits other healthcare requirement in former Section 2.9(f) in of physical or sensory information (i.e.,
professionals to perform determinations Appendix A to Part 26 and § 26.185(k) based solely on receiving information
of fitness that involve assessing and of the final rule that a determination of that an individual is engaging in
diagnosing impairment from causes fitness must be performed when there is substance abuse). The immediacy of the
other than substance abuse, such as a medical explanation for a positive, decision limits the amount of
clinical psychologists in § 26.189(a)(2), adulterated, substituted, or invalid test information that can be gathered and
psychiatrists in § 26.189(a)(3), result, but a potential for impairment made available to the professional by
physicians in § 26.189(a)(4), or an MRO exists. For example, legitimate use of others. The provision does not require
in § 26.189(a)(5), consistent with their some psychotropic medications or that determinations of fitness for other
professional qualifications. The final medications for pain relief may cause purposes be conducted face-to-face.
rule also permits other licensed and impairment in some individuals and it These other purposes may include, but
certified professionals who are not may be necessary to limit the types of are not limited to, the determination of
listed in the paragraph, such as tasks the individual performs until the fitness that is required when an
registered nurses or physicians’ medication is no longer necessary or the applicant for authorization has self-
assistants who have the appropriate person adjusts to its effects. disclosed potentially disqualifying FFD
training and qualifications, to perform a Section 26.189(b)(2) reiterates information. Determinations of fitness
determination of fitness regarding requirements in former § 26.27(b)(1) and in these other circumstances would
specific fitness issues that are within (b)(4) and § 26.69(b) [Authorization after focus primarily on historical, rather
their areas of expertise. However, the a first confirmed positive drug or than immediate, information. In these
critical tasks of assessing the presence of alcohol test result or a 5-year denial of cases, the professional would have
a substance abuse disorder, providing authorization] of the final rule that a access to information that could be
input to authorization decisions, and determination of fitness must be gathered by others about the individual,
and no time urgency would be involved individual may be referred to the EAP (3) With the exception of NRC orders
in the evaluation. Therefore, NRC has for assistance. limiting the work hours of security
added the paragraph to meet Goal 3 of The NRC has added § 26.189(d) to the personnel, the former NRC regulatory
this rulemaking to improve the final rule to prohibit licensees and other framework did not include consistent
effectiveness and efficiency of FFD entities from seeking a second requirements to prevent worker fatigue
programs. This provision also requires a determination of fitness if a from adversely impacting safe
face-to-face assessment in some determination of fitness under Part 26 operations and the former requirements
circumstances where electronic means has already been performed by a are difficult to readily and efficiently
of communication could not provide the qualified professional who is employed enforce.
requisite information for the evaluation. by or under contract to the licensee or (4) Reviews of nuclear power plant
It also permits other means of other entity. The paragraph also requires licensees’ controls on work hours have
conducting the assessment when those that the professional who made the repeatedly identified practices that are
means provide increased flexibility to initial determination must be inconsistent with the NRC Policy on
licensees and other entities while responsible for modifications to the Worker Fatigue, including excessive
continuing to achieve the goal of the initial determination based on new or work hours and the overuse of work
evaluation. additional information. However, if the hour limit deviations.
Section 26.189(c)(1) through (c)(2) (5) The former regulatory framework
initial professional is no longer
specifies the required outcomes of a for was comprised of requirements that
available, then the licensee or other
cause determination of fitness. The final were inadequate and incomplete for
entity is required to assist in arranging
rule provides an increased level of effective fatigue management.
for consultation between a new (6) Ensuring effective management of
detail in these requirements to increase professional and the professional who is worker fatigue through rulemaking
consistency in implementing the for no longer employed by or under substantially enhances the effectiveness
cause determination of fitness process contract to the licensee or other entity. of FFD programs (i.e., the new
among FFD programs for the reasons The paragraph is necessary to ensure requirements are cost-justified safety
discussed with respect to § 26.187. consistency and continuity in the enhancements) and,
Section 26.189(c)(1) requires that, if treatment of an individual who may be (7) Preventing the fatigue of workers
there is neither conclusive evidence of undergoing treatment, aftercare, and in safety-critical positions through
an FFD policy violation nor a significant followup testing. Therefore, this regulation is consistent with practices in
basis for concern that the individual addition meets Goal 3 of the rulemaking foreign countries and other industries in
may be impaired while on duty, then to improve the effectiveness and the United States.
the individual must be determined to be efficiency of FFD programs. The requirements in the final rule also
fit for duty. The licensee or other entity apply to C/Vs who implement FFD
shall permit the individual to perform Subpart I—Managing Fatigue
programs or program elements, to the
the duties that require the individual to Section 26.201 Applicability extent that nuclear power plant
be subject to this part. licensees rely upon those C/V FFD
Section 26.189(c)(2) requires that, if Section 26.201 specifies the licensees
programs or program elements to meet
there is no conclusive evidence of an and other entities to whom the
the requirements of this part. This final
FFD policy violation, but there is a requirements in Subpart I apply. This
rule provision permits a licensee to rely
significant basis for concern that the section replaces, with limited editorial
on the fatigue management program of
individual may be impaired while on changes, § 26.195 of the proposed rule.
a C/V, which is consistent with former
duty, then the individual must be Subpart I applies to licensees who are
§ 26.23(a), so long as the C/V relies on
determined to be unfit for duty. Such a authorized to operate a nuclear power
licensee-approved FFD programs and
determination does not constitute a reactor (under § 50.57 [Issuance of
program elements, as retained in § 26.3
violation of Part 26 or the licensee’s or operating license] of this chapter) and
[Scope].
other entity’s FFD policy. Therefore, no holders of a combined license after the Subpart I does not apply to the
sanctions shall be applied. Examples of Commission has made the finding under materials licensees who are otherwise
circumstances in which an individual § 52.103(g) [Operation under a subject to Part 26 (see § 26.3) for two
may be determined to be unfit under combined license] of this chapter, as reasons. First, NRC analyses indicate
this paragraph could include a specified in § 26.3(a), and licensees and that significant offsite radiological
temporary illness, such as a severe other entities specified in § 26.3(c) at the exposure is not a realistic accident
migraine headache, or transitory but time the licensee or other entity receives consequence at a materials facility that
severe stress in a personal relationship. special nuclear material in the form of is subject to Part 26 regulations because
These circumstances may impact an fuel assemblies. Also, Subpart I applies of the nature of the radioactive materials
individual’s ability to work safely for a to Contractors/Vendors (C/Vs) who that are involved and the multiple
short period, but would have no implement FFD programs or program layers of controls that NRC regulations
implications for the individual’s overall elements upon which these licensees require. Second, no analysis has been
fitness to perform the duties that require rely, as specified in § 26.3(d). As done to date to determine if there is
the individual to be subject to this part. discussed in Section IV.D, the final rule evidence of excessive overtime use by
In addition, the final rule requires the requires nuclear power plant licensees the materials licensees. Therefore, at
professional who conducts the to implement the requirements in this time, the final rule does not impose
determination of fitness to consult with Subpart I for the following reasons: the requirements of Subpart I on
the licensee’s or other entity’s (1) Fatigue and decreased alertness materials licensees. However,
management personnel to identify and can substantively degrade an requirements to prevent fatigue from
individual’s ability to safely and
implement any necessary limitations on adversely affecting the job performance

the impaired individual’s activities to competently perform his or her duties. of security personnel at materials
ensure that the individual’s condition (2) Conditions that contribute to facilities provide a substantial
would not affect workplace or public worker fatigue are prevalent in the U.S. enhancement to the security of these
health and safety. If appropriate, the nuclear power industry. facilities. In SRM–COMSECY–04–0037,
‘‘Staff Requirements: Fitness-For-Duty The final rule requires each licensee to Procedures are necessary to ensure that
Orders to Address Fatigue of Nuclear incorporate the fatigue management licensees’ fatigue management programs
Facility Security Force Personnel,’’ policy statement into the written FFD are properly and consistently
dated September 1, 2004, the policy that is required under § 26.27(b) implemented. This section replaces
Commission determined that FFD [Policy]. As discussed with respect to § 26.197(b) of the proposed rule with
program enhancements related to the § 26.27(b), the final rule requires the limited editorial changes.
fatigue of security force personnel at policy statement to be clear, concise, Section 26.203(b)(1) requires licensees
independent spent fuel storage and readily available, in its most current to develop, implement, and maintain
installations, decommissioning reactors, form, to all individuals who are subject procedures that describe the process
Category I fuel cycle facilities, gaseous to the policy. that an individual subject to the
diffusion plants, and the natural The NRC’s past experience with licensee’s FFD program should follow
uranium conversion facility should be worker fatigue, such as that documented when reporting to a supervisor that he
pursued as a separate rulemaking in NRC Regulatory Issue Summary (RIS) or she is unfit for duty because of
activity with additional stakeholder 2002–007, ‘‘Clarification of NRC fatigue (i.e., he or she makes a self-
interactions. Requirements Applicable to Worker declaration). In RIS 2002–007, the NRC
Fatigue and Self-Declarations of Fitness- noted that self-declaration is an
Section 26.203 General Provisions For-Duty,’’ dated May 10, 2002 (referred important adjunct to behavioral
Section 26.203 establishes fatigue to in this document as RIS 2002–007), observation in meeting the requirements
management requirements for licensees’ indicates that a need exists for of the performance objective in former
FFD programs. This section replaces individuals to clearly understand their § 26.10(b) (as retained in § 26.23(c)),
§ 26.197 of the proposed rule with own fatigue management which is ‘‘to provide reasonable
limited editorial changes. These responsibilities, as well as those of the measures for the early detection of
editorial changes include the addition of licensee. These responsibilities include persons who are not fit to perform the
recordkeeping requirements under the individual’s duty to report FFD duties that require them to be subject to
§ 26.197(d) and the removal of collective concerns, including concerns related to this part.’’ Because individuals are the
work hour requirements from the impact of fatigue on the individual’s first line of defense against the potential
§ 26.197(e)(2) of the proposed rule. The ability to safely and competently for fatigue-related impairment to
general provisions in this section perform his or her duties, as well as adversely affect their job performance, it
establish requirements for licensees’ concerns related to others, and the is essential that all individuals who are
fatigue management policies, licensee’s obligation to assess such subject to a licensee’s FFD program
procedures, training, examinations, fatigue-related FFD concerns. Further, understand when and how to make a
recordkeeping, and reporting. The the final rule does not prohibit licensees self-declaration that they are unfit for
NRC’s objective in establishing these from imposing sanctions on individuals duty. Individuals must also understand
general provisions is to facilitate who fail to comply with the portions of how the licensee’s response to a
integrating fatigue management into the licensees’ fatigue management worker’s self-declaration will differ from
licensees’ FFD programs, as discussed policies that assign certain a licensee’s response to an individual’s
in Section IV.D. responsibilities to individuals. For general statement of fatigue (e.g.,
Section 26.203(a) [Policy] requires example, a licensee may impose casually commenting to a co-worker,
each licensee to have a written policy sanctions on an individual who fails to ‘‘I’m really tired today’’), if the
statement that describes its seek recommended treatment for a sleep individual does not express a concern
management’s expectations and disorder that, as part of a determination that is specific to his or her FFD (e.g.,
methods for managing fatigue to ensure of fitness performed in accordance with formally stating to a supervisor, ‘‘I am
that fatigue does not adversely affect § 26.189 [Determination of fitness], a too tired right now to check these valve
any individual’s ability to safely and healthcare professional has determined lineups accurately’’).
competently perform his or her duties. is adversely affecting the individual’s Section 26.203(b)(1)(i) requires the
This section replaces § 26.197(a) of the job performance and potentially could licensee’s self-declaration procedure to
proposed rule with limited editorial be medically resolved. The final rule describe the responsibilities and rights
changes. The policy required in this does not establish minimum sanctions of individuals and licensees and the
section will apply to all individuals for specific failures to comply with such actions they must take with respect to
subject to the licensee’s FFD program fatigue management requirements an individual’s self-declaration of
and not just those individuals subject to because the reasons that an individual fatigue. The licensee’s self-declaration
the work hour requirements presented may report to work in a fatigued state procedure may explain the employees’
in § 26.205 [Work hours], which are varied and often highly personal. right to know what is going to happen
contains the revised work hour Rather, the NRC prefers to permit to them if they self-declare, including
requirements presented in proposed licensees and the appropriate healthcare any sanctions that may be imposed on
§ 26.199. The NRC considers the professionals to respond to such them. The procedure may also describe
responsibility for ensuring that each circumstances on a case-by-case basis. the employees’ right to privacy
individual is fit to safely and However, to protect an individual’s regarding the causes for the self-
competently perform his or her duties to rights under the rule, it is necessary for declaration. This section ensures that all
be shared between the licensee and the a licensee’s fatigue management policies parties involved in the self-declaration
individuals who perform duties on the to communicate any sanctions that the process understand the process and
licensee’s behalf. Therefore, the final licensee may impose on an individual responsibilities and the extent and
rule requires each licensee’s FFD policy for failing to comply with the policy’s limitations of their rights related to self-
to delineate the licensee’s fatigue requirements. declaration. The NRC has considered
management policy. Thus, individuals Section 26.203(b) [Procedures] industry experience with individuals
who are subject to this policy will be requires each licensee to develop, refusing to report to work on the basis
aware of and can comply with the implement, and maintain procedures to that they were too tired. The NRC
fatigue management requirements for carry out the fatigue management policy concluded that detailed procedures are
which they will be held accountable. that § 26.203(a) [Policy] requires. necessary to specify (1) the individual’s
responsibility to be available at work for which the individual disagrees with the new process or specify the required
a fatigue assessment, which must be licensee’s determination either that the characteristics of the licensees’
conducted face-to-face under § 26.211(b) individual is capable of performing process(es).
for the reasons discussed with respect to work safely (with appropriate controls Section 26.203(b)(2) requires licensees
that section, (2) the individual’s and conditions, if necessary) or that the to develop, implement, and maintain
responsibility to cooperate with the individual cannot safely be permitted to procedures that describe the process for
fatigue assessment process by providing perform the duties listed in § 26.205(a) implementing the work hour
the necessary information (see the [Individuals subject to work hour requirements in § 26.205. For example,
discussion of § 26.211(c)(2)), and (3) the controls] because of fatigue. For the procedures will detail individual
licensee’s responsibility for conducting example, the licensee’s procedure may and organizational responsibilities and
a fatigue assessment in response to an refer an individual who disagrees with requirements, including items such as
individual’s self-declaration, as required the outcome of the fatigue assessment to scheduling, tracking and calculating
under § 26.211(a)(2), to determine the bargaining unit to initiate a work hours, granting waivers from the
whether, and under what controls and grievance process, the employee individual work hour requirements,
conditions if any, the individual is concerns program, or the corrective reviewing the implementation of the
permitted or required to work. Section action program. work hour requirements, documenting
26.211 [Fatigue assessments] retains The final rule adds this requirement the results of the reviews, and
with, limited editorial changes, the for several reasons. First, in RIS 2002– implementing any necessary corrective
requirements in proposed § 26.201 007, the NRC documented concerns actions. These procedures are necessary
[Applicability]. associated with past instances of self- to ensure that individuals understand
Section 26.203(b)(1)(ii) requires the declaration. These instances indicate the work hour requirements to which
licensee’s self-declaration procedure to the need for licensees to describe the they are subject and that licensees
describe requirements for establishing processes to be followed if an individual consistently implement the work hour
controls and conditions under which an disagrees with the results of a fatigue requirements in § 26.205 as the NRC
individual is permitted or required to assessment following a self-declaration. intends.
perform work after that individual In addition, at the public meetings Section 26.203(b)(3) requires licensees
declares that he or she is not fit for duty discussed in the preamble to the to develop, implement, and maintain
as a result of fatigue. This portion of the proposed rule, several stakeholders procedures that describe the process(es)
procedure ensures correct and asked the NRC to add this provision to they will follow in conducting a fatigue
consistent implementation of the the final rule to ensure that individuals assessment, as required under
requirements in § 26.211(b), which have recourse if they disagree with the § 26.211(a). These procedures will
states that a supervisor or staff member results of a fatigue assessment establish the methods by which the
of the FFD program must conduct the conducted in response to a self- licensee will determine whether an
fatigue assessment and determine declaration. Some of the stakeholders individual is fatigued, whether the
whether, and under what conditions, an expressed a concern for the potential individual will be permitted or required
individual who has self-declared can be impact on public health and safety if an to perform work, and whether controls
returned to duty. For example, the individual is convinced that he or she and conditions are necessary for the
licensee’s procedure will provide is too fatigued to perform work safely, individual to be able to perform work
guidance on establishing appropriate but the licensee requires the individual safely and competently. The licensee’s
controls and conditions under which an to work. Other stakeholders expressed procedure will address fatigue
individual could be permitted or concerns that an individual may assessments that are conducted
directed to return to work after experience adverse employment and following an individual’s self-
declaring that he or she is unfit because financial consequences if he or she is declaration or an event, for cause, or to
of fatigue. Controls and conditions will prevented from working because of reassess an individual after returning
include, but will not be limited to, (1) fatigue. the individual to work despite a self-
controls on the type of work to be The NRC agrees that licensee policies declaration of fatigue (the situations in
performed (e.g., physical or mental, and procedures related to implementing which the final rule requires licensees
tedious or stimulating, individual or the requirements of this subpart must to conduct fatigue assessments are
group, risk-significant or not), (2) the address these potential issues to protect discussed in § 26.211(a)). Because of the
required level of supervision the rights of individuals subject to the potentially subjective and personal
(continuous or intermittent) and other rule. However, the final rule does not nature of the fatigue assessment task
oversight (e.g., peer checks, establish specific requirements for the and the potential for conflict and
independent verifications, quality process(es) to be followed in such sanctions (e.g., if an individual is found
assurance reviews, and operability instances for two reasons, (1) licensees to have been asleep while on duty),
checks), and (3) the need to implement have already implemented a number of comprehensive procedures are
fatigue countermeasures (e.g., naps, rest processes for addressing similar safety necessary to ensure consistent
breaks). The purpose of the controls and and employment issues that provide implementation of the fatigue
conditions is to mitigate the risks to appropriate mechanisms for resolving assessment requirements in § 26.211.
public health and safety or the common fatigue-related issues, and (2) the wide Therefore, the NRC expects these
defense and security that a fatigue- variety of possible issues that may arise procedures to describe measures to
induced human error could pose, as limits the ability of a single mechanism ensure that fatigue assessments (1) are
discussed in Section IV.D. established in the final rule to performed by properly trained
Section 26.203(b)(1)(iii) requires appropriately address them all. personnel, (2) are free of bias, (3)
licensee procedures to describe the Therefore, the final rule requires methodically address the factors that
processes to be followed if an individual licensees to have procedures for commonly contribute to fatigue, (4) are
disagrees with the results of a fatigue addressing situations in which an based on complete and accurate
assessment conducted in response to the individual who has self-declared information, (5) protect the privacy of
individual’s self-declaration. These disagrees with the outcome of a fatigue the individuals being assessed, (6)
procedures will address situations in assessment, but it does not require a recognize the fact that an individual can
be fatigued and unfit for duty even However, individuals who are subject to for facilities that offered such training to
though he or she has not exceeded the Subpart I should also have a working- their employees, and 2.9 percent for
work hour limits, (7) are thoroughly level knowledge of specific, fatigue- those offering the training to employees
documented, and (8) are reviewed, as related topics that may facilitate and their family members (Circadian
required by § 26.205(e)(1)(iii). These personal decisions and actions that are Technologies, Inc., 2004).
procedures are necessary to implement consistent with the objective of Section 26.203(c)(2) requires FFD
the requirements in this subpart and preventing, detecting, and mitigating the training and examinations to ensure that
protect the privacy rights and other adverse effects of fatigue on worker job individuals who are subject to Subpart
rights of individuals, consistent with performance. Individual workers I have the ability to identify symptoms
Goal 7 of this rulemaking. typically do not possess these KAs of worker fatigue and contributors to
Section 26.203(b)(4) requires licensees without training (Folkard and Tucker, decreased alertness in the workplace.
to develop, implement, and maintain 2003; Knauth and Hornberger, 2003; Examples of topics that are related to
procedures that describe the Monk, 2000). Therefore, the final rule this KA will include, but are not limited
disciplinary actions they may impose on requires licensee FFD training and to, (1) behavioral symptoms of fatigue
individuals, if any, following a fatigue testing programs to address the topics (e.g., yawning, red eyes, prolonged or
assessment (e.g., termination or leave specified in § 26.203(c)(1) and (c)(2). excessive blinking, irritability), (2) task
without pay) and the conditions and Section 26.203(c)(1) requires FFD conditions that may contribute to
considerations for imposing those training and examinations to ensure that degraded alertness and increased fatigue
disciplinary actions. In the final rule, individuals who are subject to Subpart
(e.g., repetitive tasks, tasks with high
the NRC revised § 26.203(b)(4) to cognitive or attentional demands, tasks
I understand the contributors to worker
replace the word ‘‘sanctions’’ with the that require the individual to be
fatigue, circadian variations in alertness
words ‘‘disciplinary actions’’ to avoid sedentary, tasks that limit social
and performance, indications and risk
confusion that might develop from the interaction), and (3) environmental
factors for common sleep disorders,
multiple meanings of the word conditions that may contribute to
shiftwork strategies for obtaining
‘‘sanctions.’’ During the public meetings degraded alertness and increased
adequate rest, and the effective use of
discussed in the preamble to the worker fatigue (e.g., high heat and
fatigue countermeasures. Examples of
proposed rule, several industry humidity, low lighting, and low-
topics that licensee training and
representatives indicated that licensees frequency noise/white noise). Requiring
examinations will address that are
may rely upon the results of a fatigue individuals to be trained on this KA is
assessment as the basis for determining related to this KA will include, but are necessary to ensure that an individual is
that an individual has not met not limited to, (1) the principal factors able to determine when it is appropriate
management expectations for that influence worker fatigue, (2) to self-declare that he or she is unfit for
maintaining his or her FFD. Although knowledge that a worker’s ability to duty because of fatigue, as permitted
the NRC neither endorses nor prohibits perform and remain alert is influenced under § 26.209 [Self-declarations] and
the imposition of disciplinary actions in by physiological changes that follow a § 26.211(a)(2), and to determine when it
cases of fatigue, clear communication daily pattern, (3) the time periods is appropriate to report an FFD concern
regarding possible disciplinary actions during which workers are most likely to about another individual who, based on
and the considerations for taking those exhibit degraded alertness and behavioral observations, is exhibiting
disciplinary actions is necessary for performance, (4) the principal indications of fatigue, as required under
individuals to meet their responsibility symptoms of common sleep disorders § 26.33 [Behavioral observation].
for self-declaration without (e.g., sleep apnea and insomnia) and the Section 26.203(d) [Recordkeeping]
unwarranted fear of potential outcomes. conditions that can contribute to their establishes recordkeeping requirements
For this reason, procedures are onset, (5) the methods for optimizing related to the implementation of
necessary to ensure that licensees fully sleep periods on a shiftwork schedule, Subpart I. This section includes, with
disclose the conditions under which and (6) how to safely and effectively revisions, the requirements presented in
disciplinary actions will be considered; counteract fatigue with measures such § 26.197(d) of the proposed rule.
the nature of the possible disciplinary as caffeine and strategic napping. Specifically, § 26.203(d)(1), which
actions; and the process for Knowledge of these topics is necessary retains § 26.197(d)(1) of the proposed
administering and imposing the to ensure that individuals are able to (1) rule without change, requires licensees
disciplinary actions, including self-manage fatigue that is caused by to retain records of the number of hours
management’s expectations and the shiftwork and factors other than work worked by individuals who are subject
individual’s right to a review of the hours, (2) take actions to maintain their to the work hour requirements
determination that he or she has alertness at work, and (3) recognize and established in § 26.205. Section
violated the FFD policy, as required seek treatment for sleep disorders that 26.203(d)(2) requires licensees to retain
under § 26.39 [Review process for might be creating or exacerbating their records of shift schedules and shift
fitness-for-duty policy violations]. own fatigue. In addition, training in cycles of individuals who are subject to
Section 26.203(c) [Training and methods for coping with the challenges the work hour requirements established
examinations] establishes fatigue-related of shiftwork may contribute to a more in § 26.205. The NRC added this
training and examination requirements stable workforce by reducing worker requirement to the final rule. Section
in addition to those required under turnover. A Circadian Technologies, Inc. 26.203(d)(3) through (d)(5) retains the
§ 26.29(a) [Training content] and (b) survey of 550 facilities in the United requirements in proposed § 26.197(d)(2)
[Comprehensive examination]. This States and Canada found that turnover through (d)(4) without changes.
section retains without change the at facilities with operations extending Specifically, § 26.203(d)(3) requires
requirement in § 26.197(c) of the beyond 7 a.m. to 7 p.m. averaged 10 licensees to retain records of the number
proposed rule. Several of the knowledge percent in 2003, compared with 3.4 of, and the bases for, waivers they have
and abilities (KAs) requirements listed percent in all U.S. companies. Facilities granted, § 26.203(d)(4) requires
in § 26.29(a) ensure that individuals are offering no training on specific coping licensees to retain documentation of the
familiar with a licensee’s or other strategies had an average turnover rate work hour reviews that are required
entity’s fatigue policies and procedures. of 11.4 percent, compared to 7.6 percent under § 26.205(e)(3) and (e)(4), and
§ 26.203(d)(5) requires retaining deleted from the rule because they will The NRC expects that the information
documentation of any fatigue not provide new or unique information provided by licensees in response to the
assessments licensees conduct. The to the NRC, are unnecessary to protect annual reporting requirements in
NRC removed the proposed public health and safety, are Subpart I will facilitate NRC oversight of
§ 26.197(d)(5) from the final rule unnecessary to facilitate NRC oversight the implementation of the requirements
because the NRC eliminated the of the revised rule, and are unduly through the following means:
collective work hour requirements. The burdensome. In choosing to retain • Consistency, efficiency, and
final rule establishes these reporting requirements for waiver use, continuity of NRC oversight—
recordkeeping requirements for four the NRC considered several aspects of Information provided through the
reasons: (1) These records are necessary the work hour requirements in the final annual FFD program performance
to ensure that documentation of the rule. First, the NRC established the work reports concerning fatigue management
licensee’s fatigue management program hour limits in the final rule at levels will enable the NRC to achieve a higher
is retained and available for NRC such that the potential for fatigue is level of consistency and efficiency in
inspectors to verify that licensees are substantive for individuals working in the oversight of the implementation of
complying with the work hour excess of those limits. Second, the rule the requirements in Subpart I and in the
requirements and waiver and fatigue permits licensees to authorize waivers enforcement of those requirements.
assessment provisions, (2) the of the limits only for circumstances in Without the reporting requirements, the
documentation is necessary for a review which the additional work hours are NRC’s inspection of licensee FFD
process under § 26.39 or in legal necessary to prevent or mitigate a programs would likely be limited to
proceedings related to a determination condition adverse to safety or security. individual inspectors evaluating
that an individual has violated the Finally, the rule only requires a waiver licensee fatigue management for a
fatigue provisions of an FFD policy, (3) if the individual is operating or sample of workers at a site for a limited
the documentation is necessary to maintaining an SSC that a risk-informed time period. These assessments would
perform the trending and self- evaluation process has shown to be necessarily be conducted without the
assessments that § 26.205(e) [Reviews] important to the protection of public benefit of broader contextual
requires; and (4) the documentation is health and safety or if the individual is information of the site and industry
necessary to meet the reporting performing specified functions that are normative information that would be
requirements in § 26.203(e) [Reporting]. essential to an effective response to a available through the annual reports. In
To ensure that the records remain fire, plant emergency, or contrast, the annual reports will help
available for NRC inspections and the implementation of the site security plan. ensure a common perspective and
review process or legal proceedings, the As a result, information concerning maintain consistency among inspectors
final rule requires licensees to retain licensee use of waivers indicates (1) the conducting the oversight process. In
these records for 3 years or until the number of hours worked on risk- addition, the annual reports can
completion of any related legal significant activities by individuals at enhance the efficiency of the NRC
proceedings, whichever is later. increased potential for impairment, and inspection process by providing
Section 26.203(e) [Reporting] requires (2) how often a licensee must mitigate information necessary to allow the
licensees to report to the NRC certain or prevent a condition adverse to safety agency to focus inspection resources on
data related to their fatigue management while using individuals at increased duty groups (e.g., security or
programs as part of the annual FFD potential for impairment. The NRC
maintenance) or issues (e.g., self-
program performance report, which declaration) that may warrant review.
considers this unique information, not
§ 26.717 [Fitness-for-duty program The reports will enable the NRC to be
otherwise reported, to be relevant to the
performance data] requires. This better focused in preparing for the
agency’s mission.
requirement replaces, with revisions, inspection, reduce the burden of onsite
§ 26.197(e) of the proposed rule. This The NRC similarly considered the inspection hours, and potentially reduce
section is revised to specify that reports need to retain reporting requirements the total number of hours required for
are required in a standard format. The regarding fatigue assessment and any a baseline inspection. Furthermore, the
final rule requires licensees to include management actions in response to the annual reporting will also help to
the following information in the annual fatigue assessments. The NRC achieve a more complete and
report: (1) Information on the number of concluded that the fatigue assessment continuous assessment of licensee
waivers granted from work hour information that would have been performance because the NRC intends to
requirements in the previous calendar reported under the proposed rule conduct the baseline inspection of FFD
year, and (2) a summary of corrective requirements are more the purview of a programs only once every 2 years.
actions, if any, resulting from the licensee’s corrective action program, • Evaluation of rule implementation
analyses of these data, including fatigue and would have been more detailed for lessons learned—Although the NRC
assessments. This section does not than the program performance data for and stakeholders have made extensive
retain the requirements in the proposed drug and alcohol testing required under efforts to ensure clear and enforceable
§ 26.197(e)(2) for the reporting of § 26.717(c) of the final rule. requirements that are effective and
information pertaining to the control of Accordingly, the final rule requires practical for the management of worker
collective work hours because the final licensees to report a summary of fatigue, the rule introduces the potential
rule does not include collective work corrective actions, if any, resulting from for unintended consequences and
hour limits. In addition, this section the licensee’s analysis of waiver and lessons learned. In addition, changes in
does not retain the proposed rule fatigue assessment data. As a the size and composition of the nuclear
requirement for licensees to report a consequence, the required reports will industry may have unforeseen
summary of instances of fatigue provide information that will focus implications for site staffing and fatigue
assessments that the licensee more on licensee performance in management. The NRC expects that the
conducted. managing worker fatigue and will site-specific and normative information
The NRC considered comments that enable the NRC to review licensee obtained through the annual reports can
the requirements for including fatigue reporting of waivers in the context of provide important insights regarding
management information should be associated corrective actions. opportunities to amend the rule to
improve its effectiveness or reduce Section IV.D of this document have suggesting that the agency
unnecessary burden. The NRC notes demonstrated that worker fatigue can underestimated the number of clerical
that such information was the basis for produce levels of impairment that are and management hours associated with
reducing the random testing rate for comparable to blood alcohol this requirement and has taken these
drugs and alcohol required in the final concentrations above the levels comments into consideration in
rule. permitted by this rule. Furthermore, estimating the burden of the reporting
• Consistent interpretation of waiver given the frequency of worker concerns requirements in § 26.203(e) of the final
criterion—The final rule provides regarding fatigue and the work rule. Nevertheless, the NRC considers
licensees the discretion to use waivers scheduling practices that are common the burden associated with the annual
to exceed the work hour limits, thereby during outages, the incidence of reporting requirements to be justified for
allowing levels of work hours that could impairment from fatigue is likely to be the reasons described in this and the
adversely affect worker FFD. The greater than the very low incidence of preceding paragraphs.
principal basis for allowing waivers is to drug and alcohol use that is detected The NRC also considered comments
reduce the additional staffing burden through testing. The NRC therefore that the reporting requirement ignores
that licensees would otherwise incur if considers the reporting of information significant duplication in licensee
waivers were not available to address pertaining to licensee management of efforts. The NRC agrees that § 26.205(e)
exigent circumstances. The annual worker fatigue to be consistent with (1) of the final rule requires licensees to
reporting of waiver use will enable the the requirements for reporting periodically review and assess the
NRC to ensure that licensees use this information pertaining to drug and effectiveness of the work hour controls
discretion in a manner consistent with alcohol testing, (2) the performance and that the licensee’s corrective action
the objectives of the rule and not as a objective of this rulemaking for program, which is routinely inspected
means to compensate for a lack of licensees to implement a comprehensive by the NRC, will document and trend
adequate staffing. Furthermore, FFD program, and (3) the NRC’s belief these reviews. However, as noted
although the use of waivers is limited to that the management of worker fatigue previously, the NRC considers the
conditions when the work hours are is no less important to worker FFD than annual reports to be a limited burden
‘‘necessary to prevent or mitigate a the effective detection and deterrence of that will enable the NRC to provide
condition adverse to safety or security,’’ drug and alcohol use. more effective and consistent oversight
the NRC recognizes the potential for • Public confidence—Public interest and achieve other objectives for the
licensees to develop different groups such as the UCS and the Project effective implementation of the
interpretations regarding this criterion. on Government Oversight have requirements in Subpart I.
Some industry commenters on the commented at public meetings that Section 26.203(e)(1) requires licensees
proposed rule took exception to the relevant information regarding worker to provide the NRC with an annual
NRC’s characterization of high levels of fatigue is withheld to either protect summary of all instances during the
waiver use at some sites as abuse. These alleger identity or, in the case of previous calendar year in which the
commenters suggested that differences security personnel, plant security. In licensee waived each of the work hour
in licensee waiver practices could be addition, several public media articles controls specified in § 26.205(d)(1) and
attributed to the policy being subject to have been published during the past 2 (d)(2) for each of the duties listed in
a number of interpretations during the years reporting instances of guards § 26.4(a)(1) through (a)(5). This section
many years that it has been in effect. sleeping and guards fearing revises the requirements in proposed
Regardless of the cause of the repercussions for refusing forced and § 26.197(e)(1). The agency revised this
differences in licensee use of work hour excessive overtime. Information reporting requirement in response to
control waivers, the NRC considers it submitted by licensees in the annual comments that the required information
prudent to address, through rulemaking, reports will be publicly available and would not provide a meaningful
the lessons learned from past will reassure public stakeholders that indication of licensee performance in
implementation of the policy and the NRC is appropriately cognizant of managing work hours because a number
provide a level of oversight through the licensee actions regarding fatigue of valid conditions may warrant waivers
annual reporting requirement that will management and that the NRC’s of work hour controls.
ensure consistent implementation of the oversight of these activities is Section 26.203(e)(1) revises the
waiver criteria in the future. transparent to all stakeholders. reporting requirements in proposed rule
In addition to the reasons cited in the • The burden is limited and justified— § 26.197(e)(1) to clarify that licensees
preceding paragraphs explaining the Section 26.203(e) requires licensees to are required to report the number of
need for reporting requirements to report information concerning waivers for each work hour requirement
ensure the effective and efficient management of worker fatigue as part of and not the sum total of all waivers for
oversight of the implementation of the the annual FFD program report. As a all work hour requirements. For
rule, the NRC considers the reporting result, the burden associated with this example, if the licensee permits an
requirements to be justified and reporting requirement is an incremental operator to work 18 hours in a 24-hour
beneficial for the following additional change to the reporting requirement for period three times in a year, another
reasons: drug and alcohol testing. In addition, operator to work 80 hours in a 7-day
• Consistency with Part 26 the fatigue management information period, and another operator to take a
requirements and performance required by § 26.203(e) is largely rest break of only 6 hours between
objective—The final rule retains the information that licensees will have shifts, then the licensee will report that
requirement that licensees report the already generated to demonstrate it granted three waivers of
results of drug and alcohol testing and compliance with other provisions of § 26.205(d)(1)(i), one waiver of
the performance objective for reasonable Subpart I. As a result, the burden § 26.205(d)(1)(iii), and one waiver of
assurance that individuals are not associated with the report will be § 26.205(d)(2)(i), for the operations
impaired from any cause (§§ 26.719 largely associated with compiling the group that year. This clarification
[Reporting requirements] and 26.23(b) of information in an appropriate form and ensures that the waiver information is
the final rule, respectively). In addition, reviewing that compilation. The NRC reported at a level of detail that will
several studies discussed in detail in has reviewed the public comments enable the NRC to know which limits
are most frequently exceeded and requirement the NRC considered and (d)(5)(i) was waived for individuals
therefore better understand the specific comments that the use of waivers working on outage activities. The
scheduling challenges to licensee should be considered in context. differences between § 26.205(e)(1)(i) and
management of worker fatigue. Through its review of authorized (e)(ii) in the work hour requirements
Section 26.203(e)(1) also requires waivers from the work hour limits in specified reflects whether requirements
licensees to include only those waivers plant technical specifications, the NRC are applicable to outage activities.
under which work was actually has found that waivers are most Section 26.203(e)(1)(iii) requires
performed in the annual report. This frequently associated with outage licensees to report a summary that
section contains requirements presented activities. Accordingly, the NRC has shows the distribution of waiver use
in § 26.197(e)(1)(i) of the proposed rule. revised the final rule to require among the individuals within each
The final rule retains this provision of licensees to report whether a waiver of category of individuals § 26.4(a)
the proposed rule because it may the work hour requirements in § 26.205 identifies. This summary will show, for
sometimes be unnecessary for was associated with an outage activity. example, how many individuals
individuals to work the extended hours This revision will enable the NRC to received only one waiver during the
for which a licensee planned when better understand a site’s changes in reporting period, how many individuals
granting a waiver. Licensees may waiver use over time and understand received two waivers, how many
anticipate that it will be necessary to why certain annual reports for a given received three waivers, and so on. This
waive one or more of the work hour site may indicate a heightened level of reporting requirement enables the NRC
controls listed in § 26.205(d)(1) and waiver use relative to the site’s other to determine the extent to which
(d)(2) in order to complete a task and so reports. waivers are concentrated among a few
will implement the process specified in The NRC recognizes that outages are individuals or distributed more broadly
§ 26.207 [Waivers and exceptions] for not the only cause of waivers; however, within a group of individuals who
granting waivers. However, on some the agency expects that most other perform the same duties. The NRC
occasions, the work will be finished causes of waiver use will be for incorporated this requirement in the
sooner than the licensee anticipated substantially shorter periods of time or final rule in response to comments that
with the result that the waiver was involve smaller groups of workers and the rule should also require licensees to
granted but no one was required to work that these other conditions would not report the number of workers covered
an extended work period. The final rule have a substantive effect on overall under § 26.199(a) of the proposed rule to
requires licensees to exclude waivers waiver use. For unique causes that may provide an appropriate context for the
under which no work was performed have more substantive effects (e.g., annual reporting of waivers. The NRC
from the annual report because this licensee response to hurricanes), the understood that the intent of this
circumstance provides no meaningful NRC is likely to be aware of or able to comment was to provide a basis for
information about the licensee’s identify these conditions if they were to evaluating the number of waivers from
management of fatigue during extended significantly affect waiver use. the work hour controls relative to the
work periods. Furthermore, the NRC intends to number of individuals subject to those
Section 26.203(e)(1) further specifies consider waiver use in conjunction with controls. The NRC chose not to require
that licensees shall report all waivers the reported fatigue assessment licensees to report the number of
granted for each of the work hour information. Therefore, the agency will individuals covered under § 26.4(a) of
controls in § 26.205(d)(1) through (d)(5) be able to determine whether waiver use the final rule because that number will
for those instances in which a single may be associated with the incidence of vary throughout the course of the
extended work period required a waiver fatigue assessments conducted for reporting period, particularly when the
of more than one work hour control. cause, following events, or in response reporting period includes a unit outage.
This section contains the requirements to self-declarations by individuals In addition, the NRC believes that the
presented in § 26.197(e)(1)(ii) of the asserting that they are not able to safely required distribution of waivers more
proposed rule. For example, if an and competently perform their duties effectively provides context to the
individual works 12 hours on day 1 and because of fatigue. The NRC notes that waiver use by indicating if the waivers
on day 2 the licensee needs the the frequency of waiver use (i.e., how were concentrated among individuals
individual to work more than 16 hours often individuals exceed the work hour performing a certain duty and if the
to resolve a condition adverse to safety, limits while performing functions waiver use in a duty group was
the licensee would need to authorize important to safety and security) associated with relatively few
and report a waiver of § 26.205(d)(1)(i), indicates the potential for worker individuals or distributed among many
for exceeding 16 hours in a 24-hour fatigue to affect the performance of these individuals.
period, and (d)(1)(ii), for exceeding 26 functions, regardless of whether a The waiver data that licensees are
hours in a 48-hour period. Although this waiver is the result of an activity required to report to the NRC under
example included only one work associated with an outage or a cause that § 26.203(e)(1)(i) through (e)(1)(iii) are
period, both waivers are required and is beyond the licensee’s control. important because waivers represent
must be reported because the potential Section 26.203(e)(1)(i) requires ‘‘assumed risk.’’ As discussed in Section
for fatigue results not only from the licensees to report the number of IV.D, fatigued workers experience
length of the workday (e.g., exceeding instances in which each work hour impaired cognitive functioning,
16 hours of work in a 24-hour period) control specified in § 26.205(d)(1)(i) including difficulties in decisionmaking
but also the cumulative effect of prior through (d)(1)(iii), (d)(2)(i) and (d)(2)(ii), and maintaining attention. If a licensee
work (e.g., exceeding 26 hours of work and (d)(3)(i) through (d)(3)(iv) was permits an individual to work extended
in a 48-hour period). waived for individuals not working on hours that cause the individual to
Section 26.203(e)(1)(i) and (e)(1)(ii) outage activities. Section 26.203(e)(1)(ii) become fatigued, the individual may
requires licensees to report whether requires licensees to report the number experience momentary lapses in
work hour controls are waived for of instances in which each work hour attention or degraded decisionmaking
individuals working on normal plant control specified in § 26.205(d)(1)(i) from fatigue. These performance
operations or working on outage through (d)(1)(iii), (d)(2)(i) and (d)(2)(ii), degradations can be mitigated by
activities. In establishing this (d)(3)(i) through (d)(3)(iv), and (d)(4) establishing controls and conditions
under which the individual is permitted reporting of corrective actions required specified in § 26.4(a)(1) through (a)(5)
to work, as required under § 26.211(e). in § 26.203(e)(2) provides important must be subject to work hour controls.
However, controls and conditions can information concerning the The duties specified in § 26.4(a)(1)
reduce, but not eliminate, the potential effectiveness of fatigue management at a through (a)(5) are the same as the duties
risks from fatigue-induced errors. The licensee site. The reports permit the that were specified in § 26.199(a)(1)
more often that a licensee permits NRC to (1) efficiently monitor the through (a)(5) of the proposed rule.
individuals to exceed work hour limits, ongoing effectiveness of licensees’ Rather than list the duties in § 26.205(a),
the more risk from fatigue-induced fatigue management programs by the final rule references § 26.4(a) which
errors a licensee is assuming. The risk providing interpretable data, (2) provides a consolidated list of
of fatigue-induced errors increases efficiently allocate inspection resources, individuals subject to the requirements
further when an individual is permitted (3) track the effectiveness of the of Part 26.
to exceed more than one of the work requirements of Subpart I in controlling Section 26.205(a) requires that
hour limits contained in the fatigue of nuclear power plant individuals identified in § 26.4(a)(1)
§ 26.205(d)(1)(i) through (d)(1)(iii) workers, (4) assess whether the (i.e., individuals who operate or provide
because of the potential for the objectives of the final rule are being onsite direction of the operation of
combined effects of both acute and achieved, and (5) determine whether systems and components that ‘‘a risk
cumulative fatigue. Any waivers from any further changes to the requirements informed evaluation process has shown
the rest breaks that are required under are necessary to ensure that worker to be significant to public health and
§ 26.205(d)(2) or the minimum day off fatigue is managed consistent with the safety’’) must be subject to the work
requirements of § 26.205(d)(3) through intent of the provisions. hour requirements in this section. To
(d)(5) will also contribute to the Section 26.203(f) [Audits] requires the implement the work hour requirements,
accumulation of a sleep deficit, licensee to audit the management of nuclear power plant licensees are
especially when inadequate rest breaks worker fatigue as part of the overall FFD required to delineate the operations
are combined with long work hours. program audits required in § 26.41 personnel who are subject to the work
Repeated and continual use of waivers [Audits and corrective action]. This hour requirements, on the basis of the
may indicate a staffing or other section does not add a new requirement, risk significance of the safety SSCs
programmatic weakness at a site that but is included in Subpart I for clarity. being operated. At a minimum, this
warrants additional inspection must include personnel who are
Section 26.205 Work Hours
resources. Therefore, the NRC considers performing activities on SSCs that are
the number of waivers granted from the The NRC substantively revised determined to be significant to public
work hour limits to be a key element in § 26.199 of the proposed rule in health and safety. To delineate the
evaluating FFD program performance. response to public comments. The scope of the operations duty group,
Section 26.203(e)(2) requires that revised provisions are in § 26.205 of the licensees can use, for example, the risk-
licensees include in the annual report final rule and establish controls on the significance determination process and
the reporting of corrective actions work hours of select individuals who criteria that they currently employ to
resulting from the analyses of waiver are subject to nuclear power plant meet the requirements of § 50.65(a)(4) of
and fatigue assessment data. The NRC licensees’ FFD programs, as follows. this chapter for assessing and managing
considers the reporting of a summary of Section 26.205(a) [Individuals subject the risk associated with maintenance
corrective actions to be consistent with to work hour controls] establishes the activities. The work hour requirements
the requirement of § 26.717 for reporting scope of individuals who are subject to of § 26.205 would typically apply to
of drug and alcohol test results. For the work hour requirements in § 26.205. individuals who are operating or
example, the NRC views the number of These individuals are subject to the directing, while on site, the operation of
for-cause drug and alcohol tests that a work hour requirements, in addition to SSCs that are included within the scope
licensee conducts each year to be one the training, behavioral observation, and of an assessment required by
indicator of the health of the licensee’s self-declaration requirements of Subpart § 50.65(a)(4). Therefore, the work hour
behavioral observation program and its I that apply to all individuals who are requirements would apply to the
effectiveness in meeting the rule’s subject to nuclear power plant licensees’ individuals who most directly affect the
performance objective identified in FFD programs. In determining the scope operation of those SSCs most important
§ 26.23(c) to provide for the early of personnel who are subject to the work to the protection of public health and
detection of individuals who are not fit hour controls, the NRC considered the safety. Controlling the work hours of
to perform the duties that require them burdens on individuals and licensees these individuals would achieve the
to be subject to this part. The NRC associated with the practical control of NRC’s objective to minimize the
similarly views the reporting of work hours in conjunction with the potential for fatigue-related errors in
corrective actions resulting from the potential for individuals’ work activities operating these risk-significant SSCs.
analyses of these data, including fatigue to affect public health and safety or the Licensed operators who perform the
assessments, to be another indicator of common defense and security if their duties specified in § 26.4(a)(1) are
the health of the licensee’s behavioral performance is degraded by fatigue. The responsible for correctly performing
observation and self-declaration NRC also considered the nature of these actions that are necessary for the safe
processes with respect to fatigue. individuals’ work activities and work operation of nuclear power plants and
Annual reports, which will include the environments relative to their potential the mitigation of accidents at these
distribution of waiver use among to induce or exacerbate fatigue (e.g., facilities. These responsibilities include
individuals performing the same duties, whether the work is monotonous or the monitoring the plant for off-normal
will enable NRC to determine the extent environment is not stimulating), the risk conditions and taking appropriate
to which waivers are concentrated significance of the work, and the actions to prevent these conditions from
among a few individuals or distributed potential for other controls to prevent or challenging the reactor core, safety
broadly among individuals within each mitigate the consequences of a fatigue- systems, and fission product barriers.
category specified in § 26.4. related error. As a result of these The importance of licensed operator
Collectively, the reporting of waivers deliberations, the rule requires that actions to the protection of public
required in § 26.203(e)(1) and the individuals who perform the duties health and safety is reflected in the 10
CFR Part 55, ‘‘Operators’ Licenses,’’ work hours of operations personnel, gas, oxygen deficiency) that may be
requirements that are applicable to these considered together with the risk immediately dangerous to life and
individuals, including specific significance of the activities performed health could be present. In these
licensing, examination and testing, by operators, indicates the need for circumstances, health physics
requalification, and FFD requirements. more readily enforceable work hour technicians (HPTs) support necessary
In addition to performing actions that limits for operators whose job duties are plant staff actions to assess conditions,
are necessary for accident mitigation, important to protect public health and perform search and rescue missions,
operator actions, if performed safety. and take timely mitigation actions (e.g.,
incorrectly, can be accident initiators. Further, the work hour requirements local manual operations by operators).
Section IV.D discussed the effects of in § 26.205 also apply to individuals The overall success of responding safely
fatigue on decisionmaking, risk-taking, who direct risk-significant operations on and appropriately to emergencies and
communications, and other key skills. site. These individuals include the protection of public health and
Fatigued operators have an increased management on shift, such as shift safety depends, in part, on the ability of
potential to commit errors, raising the operations management or special HPTs to safely and competently perform
probability of component failures, outage managers, if those individuals their emergency response duties.
system misalignments, and incorrect provide direction to operators. Similarly, NUREG–0654, Revision 1,
execution of accident mitigation Individuals to whom the work hour ‘‘Criteria for Preparation and Evaluation
strategies. Operator actions are highly requirements apply also include of Radiological Emergency Response
dependent on cognitive skills (e.g., engineers who provide onsite technical Plans and Preparedness in Support of
attention, decisionmaking) that are direction to operations, such as test Nuclear Power Plants,’’ issued March
susceptible to fatigue, and operators are directors or reactor engineers. These 2002, identifies the need for an on-shift
frequently exposed to conditions that individuals perform tasks that are often chemistry/radiochemistry emergency
can induce fatigue (e.g., long work highly dependent on cognitive skills response capability. An on-shift
hours, shiftwork). The NRC highlighted (e.g., problem-solving, decisionmaking, chemistry technician(s) provides an
this concern in 1982 by issuing its communications) and are susceptible to important component for a successful
Policy on Worker Fatigue. The Policy fatigue-induced errors, as described in response at the onset of a radiological
specifically addressed the need for Section IV.D. Incorrect technical emergency. The independent and timely
‘‘controls to prevent situations where direction provided to operators can actions of the chemistry technician(s) in
fatigue could reduce the ability of significantly challenge licensed response to a radiological event can
operating personnel to keep the reactor operators and increase the possibility of provide key information for assessing
in a safe condition.’’ errors or events, particularly when the core status and estimating the source
direction is provided by an individual term of a potential release. By providing
Despite the NRC’s Policy on Worker who supervises the operators or an defense-in-depth support for operations
Fatigue and subsequent technical individual who the operator reasonably personnel, chemistry technicians also
specifications to limit operator work expects to have specialized technical assist with offsite dose calculations and
hours, an NRC staff review of technical knowledge of the system or component ancillary radiological protection tasks,
specification implementation from being operated. such as sampling spaces for toxic gases
1997–99 found that a significant Section 26.205(a) requires that or explosive mixtures. Chemistry
percentage of licensed and non-licensed individuals identified in § 26.4(a)(2) technicians may also be needed to
operators worked more than 600 hours (i.e., individuals who perform health conduct analyses for the detection of
of overtime in a year (Attachment 1 to physics or chemistry duties that are hydrogen and oxygen gas concentrations
SECY–01–0113, ‘‘Rulemaking Plan: required of the onsite emergency in both the reactor coolant and the
Fatigue of Workers at Nuclear Power response organization minimum shift containment atmosphere. These
Plants’’). This level of overtime is two complement) must be subject to the analyses support severe accident
to three times the level that is permitted work hour requirements of this section. management decisions with respect to
for operations personnel at some foreign Although § 26.207(d) [Plant minimizing radiological release
nuclear plants and twice the level emergencies] exempts licensees from potential. As a consequence, ensuring
recommended by a 1985 expert panel applying the work hour controls during that chemistry technicians are able to
(NUREG/CR–4248). In addition, the declared emergencies, the intent of this safely and competently perform their
NRC staff has noted that some licensees provision is to provide reasonable emergency response duties is essential
appeared to be abusing the authority to assurance that the work schedules of to the overall success of responding
permit deviations from the technical these individuals during non-emergency safely and appropriately to emergencies
specification limits on working hours, conditions ensure that fatigue does not and to the protection of public health
including deviations for operators. For compromise their abilities to safely and and safety.
example, data provided by NEI on competently perform their duties should Section 26.205(a) requires that
August 29, 2000, from J. W. Davis, NEI, an emergency occur. NUREG–1465, individuals identified in § 26.4(a)(3)
to G.T. Tracy (ADAMS Accession No. ‘‘Accident Source Terms for Light-Water (i.e., individuals who are performing the
ML003746495), indicated that during a Nuclear Power Plants,’’ concluded that duties of a fire brigade member who is
sample of 37 refueling outages significant fission product releases from responsible for understanding the
conducted in 1999, licensees authorized the bulk of the fuel can occur within effects of fire and fire suppressants on
more than 1,800 deviations for licensed 30–60 minutes after the onset of an safe shutdown capability) must be
operators and more than 1,100 accident. As a function of the accident subject to the work hour requirements of
deviations for non-licensed operators. and its severity, certain areas within the this section. The work hour
This frequency of deviations is plant, while predictable and benign requirements are applicable to the
inconsistent with the intent of the during normal operations, could present members of the fire brigade who are
NRC’s Policy on Worker Fatigue that elevated levels of airborne/external responsible for providing the control
deviations should be authorized only for radiation levels (greater that 300 Rad/ room operators and fire brigade leader
‘‘very unusual circumstances.’’ The hour). Additionally, industrial hazards with information that is critical to
failure of some licensees to limit the (e.g., explosive mixtures, smoke, toxic implementing a fire mitigation strategy
to maintain safe shutdown capability for mitigate the fire effects, or the effects of employ to meet the requirements of
the reactor. Attachment 1 to SECY–99– suppressant activities, on critical § 50.65(a)(4) for assessing and managing
140, ‘‘Recommendation for Reactor Fire equipment. As a consequence, ensuring the risk associated with maintenance
Protection Inspections,’’ dated May 20, that fire brigade members, who are activities. As a consequence, the work
1999, states that ‘‘based on IPEEE responsible for understanding the hour requirements of § 26.205 would
results, fire events are important effects of fire and fire suppressants on typically apply to individuals who are
contributors to the reported core damage safe-shutdown capability, are able to maintaining or directing on site the
frequency (CDF) for a majority of plants. safely and competently perform their maintenance of SSCs that are included
The reported CDF contribution from fire duties is essential to the overall success within the scope of an assessment
events can, in some cases, approach (or of the fire mitigation strategy and the required by § 50.65(a)(4). Therefore, the
even exceed) that from internal events.’’ protection of public health and safety. work hour requirements would apply to
Fire brigade members must retain their In addition, the NRC periodically the individuals who most directly affect
cognitive abilities to be able to grants exemptions from the the maintenance of SSCs that are most
determine the best way to suppress a requirements of Appendix R [Fire important to the protection of public
fire to prevent additional damage to Protection Program for Nuclear Power health and safety, which would achieve
safety-related equipment, evaluate Facilities Operating Prior to January 1, the NRC’s objective to minimize the
equipment affected by a fire to report to 1979] to 10 CFR Part 50, ‘‘Domestic potential for fatigue-related errors in
control room operators concerning Licensing of Production and Utilization maintaining these risk-significant SSCs.
equipment availability, make decisions Facilities,’’ based on protection of the Nuclear power plant maintenance
concerning smoke ventilation to prevent levels of defense in depth listed in personnel perform tasks that are often
the fire effects from affecting other plant Section II(A) of Appendix R to Part 50, highly dependent on cognitive skills
operations, and coordinate fire brigade which are ‘‘To prevent fires from (e.g., the ability to comprehend oral and
activities with control room operators. starting; to detect, rapidly control, and written instructions, problem-solving,
extinguish promptly those fires that do communication) that are susceptible to
As discussed in Section IV.D, fatigue
occur; to provide protection for fatigue, as described in Section IV.D.
can substantially degrade an
structures, systems, and components These tasks may require extensive
individual’s decisionmaking and
important to safety so that a fire that is physical effort in high heat, humidity,
communication abilities, cause an
not promptly extinguished by the fire and noise conditions that can exacerbate
individual to take more risks, and suppression activities will not prevent fatigue. In addition, maintenance
maintain faulty diagnoses throughout an the safe shutdown of the plant.’’ personnel are subject to the work
event. The abilities to make accurate Granting these exemptions is often scheduling conditions of round-the-
and conservative decisions, predicated on effective manual clock operations and emergent work
communicate effectively, and accurately suppression of the fire by the fire conditions that also can exacerbate
diagnose events are key to the duties of brigade. Therefore, it is necessary to fatigue (e.g., long work hours,
the fire brigade members who are ensure that fire brigade members who unscheduled overtime, shiftwork).
responsible for providing the control are responsible for understanding the Compared to rested workers, fatigued
room operators and fire brigade leader effects of fire and fire suppressants on maintenance personnel would have a
with information that is critical to safe-shutdown capability remain rested higher probability of (1) taking longer to
implementing a fire mitigation strategy so that they are able to safely and complete maintenance activities or
to maintain the safe-shutdown competently perform their duties in using non-conservative work practices,
capability for the reactor. Degradations plant events involving a fire. (2) making errors that would increase
of these abilities could have significant Section 26.205(a) requires that the risk of failure of the affected SSCs
consequences on the outcome of an individuals identified in § 26.4(a)(4) to perform their functions or operate for
event involving a fire. For instance, a (i.e., individuals who are performing their required mission time during post-
fatigued individual could incorrectly maintenance or the onsite directing of maintenance testing, thus delaying their
decide to vent smoke or toxic gas to an maintenance of systems, structures, or return to unrestricted service, and (3)
area required for alternate shutdown, components that ‘‘a risk informed making errors that could introduce
which could prevent or impair access to evaluation process has shown to be latent defects that may not be readily
equipment needed for safe shutdown of significant to public health and safety’’) detected by post-maintenance testing,
the plant. In addition, a fatigued worker must be subject to the work hour but that may cause degraded reliability
could incorrectly apply the wrong fire requirements in this section. Section (i.e., degraded performance or failure of
suppressant, which could affect 26.5 [Definitions] includes a definition the SSCs at a later time). Collectively,
additional equipment in the plant. of ‘‘maintenance’’ to clarify the scope of the effects of fatigue on the performance
Further, impaired decisionmaking could individuals described by § 26.4(a)(4). To of maintenance personnel have the
lead a worker to fail to properly control implement this requirement, licensees potential to decrease the availability and
flooding, which could impact other are required to delineate the reliability of SSCs that are important to
needed equipment, or to incorrectly maintenance personnel, as well as the the protection of public health and
determine whether an area contains personnel who direct maintenance on safety. Therefore, the rule requires these
critical equipment and improperly site, who would be subject to the work maintenance personnel to be subject to
apply a suppressant in that area. hour controls on the basis of the risk the work hour requirements to ensure
Impaired communications could also significance of the SSCs that they that fatigue does not compromise their
lead to incomplete disclosure of maintain. At a minimum, this must abilities to safely and competently
information to licensed operators in the include personnel who maintain SSCs perform their duties relative to the
control room, which could adversely that are determined to be significant to maintenance of these SSCs.
impact the decisionmaking of those public health and safety. To delineate The work hour requirements also
operators. If information known to the the scope of the maintenance job duty apply to those who direct risk-
impaired fire brigade member is not group, licensees can use, for example, significant maintenance on site. For
properly communicated, operators may the risk-significance determination example, these individuals include
not initiate appropriate actions to process and criteria that they currently maintenance supervisors who provide
direction to maintenance technicians duties are largely dependent on which there are no reasonable
and engineers who provide onsite maintaining vigilance, and vigilance opportunities or accommodations
technical direction to maintenance tasks are among the most susceptible to appropriate for restorative sleep. The
crews, during key outage maintenance degradation from fatigue (Rosekind, rule also details the periods excluded
activities. These individuals perform 1997; Monk and Carrier, 2003). Finally, from the calculation.
tasks that are often highly dependent on unlike operators, security forces lack The rule specifically does not limit
cognitive skills (e.g., problem solving, automated backup systems that can work hours to hours that are assigned to
decisionmaking, communications) that prevent or mitigate the consequences of an individual by the licensee, that are
are susceptible to fatigue, as discussed an error caused by fatigue. For these worked on site, or that are worked as
in Section IV.D. Incorrect technical reasons, and in light of the excessive part of a scheduled shift, but does
direction provided to maintenance hours that some security force personnel require licensees to include hours
technicians can significantly challenge were required to work following the during which an individual performs
maintenance technicians and increase elevated threat condition(s) in effect duties for the licensee. The rule defines
the possibility of errors or events, after the terrorist attacks of September hours worked in this broad manner
particularly when that direction is 11, 2001, the Commission issued orders because the NRC is aware that some
provided by an individual who for Compensatory Measures Related to licensees permit individuals to perform
supervises them or an individual who Fitness-for-Duty Enhancements duties on behalf of the licensee from
the maintenance technician reasonably Applicable to Nuclear Facility Security offsite locations and during periods
expects to have specialized technical Force Personnel on April 23, 2003. The when the individual is not assigned to
knowledge of the system or component security force personnel who are subject a shift or scheduled by the licensee to
being maintained. to work hour controls in the orders are be working on site. For example,
the same individuals who are subject to because of the large amount of
Section 26.205(a) requires that
the work hour requirements in this administrative work that is frequently
individuals identified in § 26.4(a)(5)
section. assigned to individuals in the shift
(i.e., individuals who are performing the
Section 26.205(b) [Calculating work manager role, some shift managers stay
duties of an armed security force officer,
hours] specifies the time periods that at work to review and act upon
alarm station operator, response team
licensees shall include when calculating administrative matters after the end of
leader, or watchperson at a nuclear
the work hours of the individuals listed their scheduled shifts in order to
power plant) must be subject to the in § 26.205(a) for the purposes of this complete the reviews and meet
work hour requirements of this section. subpart. This requirement replaces, with deadlines. Anecdotal reports from these
Individuals who perform these duties editorial and substantive modifications, individuals have indicated that they
are the members of licensees’ security the requirements presented in may work for 3–4 hours after going off
forces who are responsible for § 26.199(b) of the proposed rule. The shift to manage their workload, with the
implementing the licensees’ physical editorial changes are renumbering and result that the hours they have available
security plans. To ensure that these reorganization of the requirements for for personal obligations and sleep are
individuals are able to meet their clarity. The substantive change is the reduced. Many licensees operate
responsibilities for maintaining the deletion of the provisions concerning multiple sites and at times send
common defense and security, it is the calculation of collective work hours personnel to other sites for short periods
necessary to ensure that they are not as a conforming change resulting from to fill in or to extend expertise. This
subject to fatigue, which could reduce the deletion of the collective work hour time away from their normal duty site
their alertness and ability to perform the controls as described with respect to must be included when calculating
critical job duties of identifying and § 26.205(d)(3). work hours. If the rule limited the
promptly responding to plant security The NRC’s Policy on Worker Fatigue calculation of work hours to only those
threats. Security personnel are the only established guidelines for the control of hours that an individual is paid by the
individuals at nuclear power plants who work hours but did not define the licensee, works on shift, works on site,
are entrusted with the authority to apply concept of ‘‘work hours’’ or establish and/or is scheduled to be working by
deadly force. Decisions regarding the criteria for calculating them. As a the licensee, many individuals may
use of deadly force are not amenable to consequence, licensees have continue to be permitted to work
many of the work controls (e.g., peer inconsistently defined and calculated excessive hours, thereby becoming
checks, independent verification, post- work hours when implementing the fatigued. Therefore, § 26.205(b)
maintenance testing) that are Policy through their technical [Calculating work hours] requires
implemented for other personnel specifications and administrative licensees to include these work hours in
actions at a nuclear plant to ensure procedures. This inconsistency has their work hour calculations.
correct and reliable performance. In contributed to some licensees Section 26.205(b)(1) [shift turnover]
contrast to most other nuclear power permitting individuals to work excludes the time periods during which
plant job duty groups, security excessive hours that caused them to an individual participates in shift
personnel are typically deployed in a become fatigued. Therefore, the rule turnover from the calculation of the
configuration in which some members defines work hours and requirements individual’s work hours. Section
of the security force have very for calculating them, as well as certain 26.199(b)(1) of the proposed rule
infrequent contact with other members specific periods that may be excluded defined the specific shift turnover
or with other plant personnel. A lack of from the calculation to ensure activities that licensees may exclude
social contact can exacerbate the effects consistent implementation of the work from their work hour calculations. The
of fatigue on individuals’ abilities to hour controls established in § 26.205(d) final rule defines shift turnover as only
remain alert (Horne, 1988). In addition, [Work hour controls]. those activities that are necessary to
these deployment positions can be fixed The rule requires licensees to safely transfer information and
posts where very little physical activity calculate work hours as the amount of responsibilities between two or more
is required, further promoting an time that an individual performs duties individuals between shifts. Shift
atmosphere in which fatigue could for a licensee, including all within-shift turnover is a vital activity, but it also
transition into sleep. Many security break times and rest periods during contributes to the length of the workday,
and therefore, to worker fatigue. The Section 26.205(b)(2) [Within shift calculations, rather than the 84 hours
NRC understands that shift turnovers break and rest periods] permits that the individuals are actually at work.
routinely add approximately 30 minutes licensees to exclude within-shift breaks The discussion of § 26.205(d)(1)(iii)
to the length of a shift and typically no and rest periods from their work hour details the basis for limiting individuals
more than 2–2.5 hours to the length of calculations if the individual has both a to 72 work hours per week.
a typical work week. Stakeholder reasonable opportunity and Although breaks without sleep have
comments during the public meetings accommodations for restorative sleep. some fatigue mitigation value (Tucker,
described in the preamble to the The rule permits licensees to exclude Folkard, and Macdonald, 2003), the
proposed rule highlighted the breaks from the accounting of work benefits are principally limited to short-
importance of this activity for hours only when the exclusion can be term improvements in vigilance. Horne
communicating plant status information justified on the basis that the break (1988), Mitler and Miller (1996), and
between work crews and expressed substantively mitigates fatigue. The Dinges, et al. (1997) have pointed out
concern that including turnover time in exclusion allows workers to be that the only non-pharmacological cure
work hour calculations could cause scheduled for round-the-clock duties for fatigue is sleep. The duration of
indirect pressure on individuals to (e.g., dedicated fire brigades) during within-shift break times is normally
abbreviate shift turnovers in order to which they are on site and available to insufficient to allow a worker to obtain
ensure that work hour limits would not respond as needed but the licensee sleep and, consequently, these periods
be violated. This pressure could provides sleeping accommodations and add to the total amount of time an
compromise the quality of shift the individuals are allowed periods of individual remains awake while at
turnovers and have unintended adverse time to obtain restorative sleep. This work. Time since awakening is a
safety consequences, such as omitting exclusion also permits licensees to make principal determinant of worker fatigue
important equipment or maintenance use of strategic napping, a well-proven (Folkard and Akerstedt, 1992; NTSB,
status information. Although some fatigue countermeasure (McCallum, et 1994; Akerstedt, 2004) and performance
stakeholders believe that turnover is al., 2003; Petrie, et al., 2004; Rosekind, generally declines as a function of the
part of the workday and, therefore, et al., 1994, 1995; Dinges, et al., 1988; amount of time that an individual
should be included in the calculation of Kemper, 2001; Schweitzer, et al., 1992; remains awake (Dawson and Reid,
hours worked, the NRC concluded that Sallinen, et al., 1998), without requiring 1997). Because within-shift breaks and
the benefit of including turnover for the nap period to be included in work rest periods provide only short-term
managing worker fatigue would be hour calculations. mitigation of fatigue (Kruger, 2002;
outweighed by the potential adverse The exclusion is limited to that Baker, et al., 1990), the rule requires
consequence on the quality of shift portion of a break or rest period that licensees to include short breaks in the
turnovers. provides a reasonable opportunity for calculation of work hours.
restorative sleep. For example, a 15- Section 26.205(b)(3) [Beginning or
The exclusion of shift turnover from minute coffee break would not provide resuming duties subject to work hour
work hour calculations is consistent a reasonable opportunity for restorative controls] permits licensees to assign
with current requirements in most sleep. The rule limits the exclusion to individuals, who are qualified to
licensee technical specifications for the the amount of time the individual has perform the duties listed in § 26.4(a), to
control of work hours for personnel available to actually sleep and does not duties other than those listed § 26.4(a),
performing safety-related functions and include transit time to and from the without controlling their work hours in
with GL 82–12, ‘‘Nuclear Power Plant sleep accommodations. The term accordance with the work hour controls
Staff Working Hours,’’ dated June 15, ‘‘restorative sleep’’ means an amount of contained in § 26.205(d). However, if
1982. For example, most technical sleep that mitigates fatigue, which is these individuals are assigned or
specifications state, ‘‘An individual generally considered to be a minimum returned to performing any duties that
should not be permitted to work more of approximately 30 minutes (Buxton, et are listed in § 26.4(a) during the
than 16 hours in any 24-hour period, al., 2002; McCallum, et al., 2003; calculation period, the rule requires the
nor more than 24 hours in any 48-hour Sallinen, 1998; Rosekind, 1995). licensee to include all of the hours that
period, nor more than 72 hours in any The final rule also requires that they worked when calculating their
7-day period, all excluding shift individuals must have reasonable work hours and to subject the
turnover time’’ (see SECY–01–0113, accommodations available for sleep in individual to the work hour controls in
Attachment 1, Table 2). However, the order to exclude the break period from § 26.205(d). For example, if a licensed
final rule more clearly describes the the calculation of the individual’s work operator was assigned to training for an
activities that may be included in hours. Reasonable accommodations entire calculation period, then his or her
turnover and the activities that may not would include a sleep surface (e.g., bed, work hours would not be subject to
be included. This provision addresses recliner) in a darkened, quiet room § 26.205(d) for that period because he or
the NRC concerns arising from (Priest, 2000). she would not be performing any of the
observations that some licensees have The degree of specificity in this duties listed in § 26.4(a). However, if the
occasionally excluded 2 or more hours section is necessary because some same individual were assigned to
from calculated work hours on the basis licensees currently exclude within-shift training for only a portion of the
that the individuals were engaged in breaks from the calculation of work calculation period and performed the
‘‘turnover.’’ To ensure that turnover is hours required by their technical duties listed in § 26.4(a) during the
not hurried, the rule does not establish specifications. Excluding break periods remainder of the calculation period, all
a time limit for an acceptable turnover from the calculation of work hours can of his or her hours, including those
period. However, by clearly delineating add up to as many as 12 hours over the worked while assigned to training,
the activities that licensees may course of a week, which permits would be included in the calculation of
consider to be turnover activities, the individuals to work an additional 12- the individual’s work hours as if the
rule reduces the potential for hour shift. As a consequence, licensees individual were performing operations
individuals and/or licensees to use the may assign seven consecutive 12-hour duties for the entire calculation period.
shift turnover exclusion to perform shifts to individuals, but only include Licensees would be required to count
other work activities. 72 hours in their work hour the hours that the individual worked
performing other duties if an individual the collective work hours of certain job 6748 (Baker, et al., 1990), and in
begins performing the duties listed in duty groups that would have been technical reports, such as, NUREG/CR–
§ 26.4(a) during the calculation period subject to the collective work hour 4248 and the Office of Technology
because the individual’s level of fatigue limits in proposed § 26.199(f). The final Assessment’s report, ‘‘Biological
is largely dependent on the total number rule does not include these Rhythms: Implications for the Worker’’
of hours he or she has worked, requirements because the NRC (Liskowsky, 1991). For example, the
regardless of where the work was eliminated the concept of collective EPRI guidelines address issues related
performed or the nature of the work work hours in the final rule, as to the sequencing of day, evening, and
itself. Therefore, including the hours discussed in § 26.205(d)(3) of this night shifts and the use of break periods
worked performing other duties would section-by-section analysis. Therefore, between shifts to optimize the ability of
provide assurance that fatigue would to conform with other changes in the personnel to obtain adequate sleep and
not compromise that individual’s ability final rule, § 26.205(b) does not include effectively transition from one shift to
to safely and competently perform the those aspects related to calculating another. Although research provides
duties that are specified in § 26.4(a). collective work hours. clear evidence of the importance of
Section 26.205(b)(4) [Unannounced Section 26.205(c) [Work hours these factors in developing schedules
emergency preparedness exercise and scheduling] requires licensees to that support effective fatigue
drills] allows licensees to exclude schedule the work hours of individuals management, the NRC also recognizes
certain time associated with who are subject to this section in a that the complexity of effectively
unannounced emergency preparedness manner that is consistent with the addressing and integrating each of these
exercises and drills from the calculation objective of preventing impairment from factors in work scheduling decisions
of an individual’s work hours. Only the fatigue resulting from the duration, precludes a prescriptive requirement.
time an individual works unscheduled frequency, or sequencing of successive Therefore, § 26.205(c) establishes a non-
work hours for the purpose of shifts. This section retains the prescriptive, performance-based
participating in the actual conduct of an requirement presented in § 26.199(c) of requirement.
unannounced emergency preparedness the proposed rule. The NRC intends for Stakeholder interactions have
exercise or drill can be excluded. This the maximum work hour and minimum interpreted this requirement as a
exclusion is incorporated in the final break and day off requirements performance-based approach in that
rule in response to stakeholder specified in § 26.205(d) to apply to licensees’ fatigue management
comments that adjusting work infrequent, temporary circumstances performance could be assessed in terms
schedules in anticipation of an and not be considered guidelines or of adherence to the schedules developed
unscheduled exercise or drill would limits for routine work scheduling. In in response to § 26.205(c). Although the
negate the element of surprise for the addition, the work hour controls in NRC had intended this requirement to
individuals. The nature of such drills is § 26.205(d) do not address several be limited to the development of work
that they are relatively infrequent and elements of routine schedules that can schedules, the NRC acknowledges the
short in duration. Therefore, they would significantly affect worker fatigue, such benefit of implementing this provision
not have a major impact on individual as shift length, the number of as a performance-based requirement
fatigue and any impact would be offset consecutive shifts, the duration of applicable to licensee control of the
by the potential contribution to safety. breaks between blocks of shifts, and the actual hours worked by individuals
Section 26.205(b)(5) [Incidental duties direction of shift rotation. Therefore, performing the duties specified in
performed off site] allows licensees to § 26.205(c) requires licensees to § 26.4(a)(1) through (a)(5) and adopts
exclude from the calculation of an schedule personnel consistent with this interpretation for the final rule. As
individual’s work hours unscheduled preventing impairment from fatigue a consequence, this provision of the
work performed off site (e.g., technical from these scheduling factors. final rule requires the work hours of
assistance provided by telephone from The rule requires licensees to address individuals subject to the requirements
an individual’s home) provided the total scheduling factors because human of this section to be controlled in a
duration of the work does not exceed a alertness and the propensity to sleep manner that prevents impairment from
nominal 30 minutes during any single vary markedly through the course of a fatigue resulting from elements of
break period. For the purposes of 24-hour period. These variations are routine schedules that can significantly
compliance with the minimum break referred to as circadian rhythms and are affect worker fatigue, such as shift
requirements of § 26.205(d)(2) and the the result of changes in physiology length, the number of consecutive shifts,
minimum day off requirements of brought about by a circadian clock or the duration of breaks between blocks of
§ 26.205(d)(3) through (d)(5), such oscillator inside the human brain that is shifts, and the direction of shift rotation.
duties do not constitute work periods or outside the control of the individual. Section 26.205(d) [Work hour
work shifts. The final rule includes this Work may be scheduled, and the controls] requires licensees to establish
exclusion in response to stakeholder consequent timing of periods of sleep work hour controls for individuals who
comments regarding the necessity of and wakefulness, in a manner that are subject to the requirements of
obtaining expert advice or details on either facilitates an individual’s § 26.205. The provision requires
recent operating experience that may adaptation to the work schedule or licensees to establish controls that limit
not have been included in a turnover challenges the individual’s ability to get work periods and provide for breaks
and the burden that would be imposed adequate rest. Therefore, the duration, that are of sufficient length to allow the
by resetting the clock to account for the frequency, and sequencing of shifts, individual to obtain restorative rest.
disruption in a break period. The particularly for personnel who work This requirement replaces § 26.199(d) of
nominal 30-minute reduction in the rotating shifts, are critical elements of the proposed rule, with limited editorial
break period is not expected to have a fatigue management. Section IV.D also changes.
detrimental impact on the individual’s discusses the effects of circadian Section 26.205(d)(1) establishes work
overall fatigue level and would be offset rhythms on worker fatigue. The hour limits for consecutive, rolling
by the potential contribution to safety. importance of these elements for fatigue periods of 24 and 48 hours and 7 days.
Proposed § 26.199(b)(2) would have management is reflected in guidelines The majority of licensees have
established requirements for calculating for work scheduling, such as EPRI NP– incorporated the work hour controls
from the NRC’s Policy on Worker The section permits an individual to turning over work could contribute to
Fatigue, as disseminated by GL 82–12, work no more than 26 work hours in a errors. In addition, licensees commonly
into either their technical specifications 48-hour period; by contrast, GL 82–12 use waivers to exceed the 24-hours of
or administrative procedures. The limits individuals’ work hours to 24 work in any 48-hour period limit for
Policy (including the bases for the work hours in any 48-hour period. This short durations. As a result, the NRC
individual requirements) has been in change accommodates the fact that most concluded that the relaxation will
place for over 20 years and was the licensee sites are now routinely working principally reduce the paperwork
subject of a substantive review 12-hour shifts, rather than 8-hour shifts, burden, rather than increase the hours
documented in Attachment 1 to SECY– as was the case when the NRC that individuals would have actually
01–0113. The work hour limits from GL published GL 82–12. At that time, the worked under the proposed rule.
82–12 also were the subject of basis for the 24-hour limit was to permit Accordingly, the relaxation provides a
substantial stakeholder comments a worker to work one 16-hour double substantive reduction in burden with a
during the public meetings described in shift, followed by an 8-hour break, and limited net effect on human
the preamble of the proposed rule. In then start another 8-hour shift at the performance reliability.
developing the requirements in this worker’s normal starting time, but only Section 26.205(d)(1)(iii) limits the
section, the NRC staff considered the in very unusual circumstances. With the number of hours an individual may
information gained through these majority of plants now routinely work in any 7-day period. This section
stakeholder interactions. working 12-hour shifts, the rule retains without change the requirement
Section 26.205(d)(1)(i) limits the increases the maximum work hours in presented in § 26.199(d)(1)(iii) of the
number of hours that an individual may a 48-hour period from 24 to 26 hours to proposed rule. The requirement limits
work in any 24-hour period. The section decrease the burden on licensees by an individual to working no more than
permits individuals to work no more accommodating situations in which a 72 hours in any 7-day period. This limit
than 16 hours in any 24-hour period. worker’s relief is delayed or similar is identical to the related limit specified
This provision retains without change circumstances. For example, a 12-hour in GL 82–12. Attachment 1 to SECY–01–
the requirement in § 26.199(d)(1)(i) of shift worker is able to work up to 14 0113 provides the basis for this limit,
the proposed rule. This limit is identical hours in one day and still return to work which is summarized in this section. In
to that specified in GL 82–12. at his or her normal time the next day, the absence of the break and day off
Attachment 1 to SECY–01–0113 but can only work 12 hours that day. In requirements in § 26.205(d)(2) and
provides the basis for this limit, which the extreme, the 26-hour limit permits (d)(3), respectively, the limit would
is summarized as follows. Studies have an individual to work up to 16 hours permit a worker to work six 12-hour
shown that task performance declines one day, followed by a minimum 10- shifts per week continuously. Studies
after 12 hours on a task (Folkard, 1997; hour break, as required in have shown that longer work schedules
Dawson and Reid, 1997; Rosa, 1991). § 26.205(d)(2)(i). The individual is then cause fatigue (Colquhoun, 1996; Rosa,
Other studies have shown that the limited to 10 hours of work over the 1995). Human reliability analysis
relative risk of having an accident next 22 hours. experts have recommended that the
increases dramatically after 9 When developing this requirement, NRC set ‘‘a maximum of 60 hours in any
consecutive hours on the job (Hanecke, which effectively relaxes by 2 hours the 7-day period and a maximum of 100
et al., 1998; Colquhoun, et al., 1996; NRC’s policy guideline in GL 82–12 for hours in any 14-day period,’’ noting
U.S. DOT, 49 CFR Parts 350, et al., the maximum hours individuals should studies indicating that fatigue from long
Proposed Rule, May 2, 2000, 65 FR work in 48 hours, the NRC considered: work hours can result in personnel
25544). Further, nine experts who met (1) The burden associated with granting developing their own subjective
in 1984 to develop recommendations for a waiver for the additional 2 hours; (2) standards of what is important in their
NUREG/CR–4248 recommended a the increased stringency of the criteria jobs (NUREG/CR–1278, ‘‘Handbook on
maximum of 12 work hours per day. for granting a waiver of the work hour Human Reliability Analysis with
Therefore, in originally developing its limits in § 26.207 relative to those in Emphasis on Nuclear Power Plant
Policy on Worker Fatigue, the NRC had plant technical specifications; and (3) Applications’’). Further, NUREG/CR–
planned a 12-hour maximum limit, but the increased potential for worker 4248 recommends a limit of 60 hours of
revised it to 16 hours in response to fatigue and fatigue-related errors that work in a 7-day period. However, in its
practical concerns raised by the may accrue from working 26 hours in a Policy on Worker Fatigue, the NRC
industry that the 12-hour limit required 48-hour period versus working 24 hours established a 72-hour maximum limit
personnel who worked 8-hour shifts to in that same period. based on the expectation that
split shifts when they work overtime. The increase of 2 additional work individuals would work up to this limit
Those practical concerns remain valid, hours during a 48-hour period will on an infrequent and temporary basis.
and the final rule retains a 16-hour likely contribute to some increase in The rule codifies this expectation, in
limit. fatigue and fatigue-related errors, part, through § 26.205(d)(3), which
Although the rule permits 16-hour particularly when these hours come at requires licensees to ensure a minimum
shifts, other work hour limits in the rule the end of a work period of 12 or more number of days off per week, averaged
would effectively limit the number of hours or coincide with a decrease in an over a shift cycle, for individuals who
16-hour shifts that licensees could individual’s circadian level of alertness, are subject to the work hour controls.
assign. The NRC’s response to a as might be expected at the end of a 12- The rule effectively prevents an
comment from PROS on this issue is hour day shift. However, because the individual from consistently working
discussed in the preamble to the revised criteria for granting a waiver of six 12-hour shifts in a week.
proposed rule. the work hour limits in § 26.207 are Section 26.205(d)(2) requires
Section 26.205(d)(1)(ii) limits the expected to substantially reduce the licensees to provide adequate rest
number of hours that an individual may number of waivers that are granted, the breaks for individuals who are
work in any 48-hour period. This licensee will have to either delay or turn performing the duties listed in § 26.4(a).
provision retains without change the over any work that the individual is This section contains, with substantial
requirement presented in performing when it is necessary for him revisions, the requirements presented in
§ 26.199(d)(1)(ii) of the proposed rule. or her to go off shift. Either delaying or § 26.199(d)(2) of the proposed rule.
Although § 26.205(d)(2) retains without and administrative procedures that are during which a full 7 hours of sleep was
change the requirement presented in based on GL 82–12 require a minimum obtained) through the 7 partial sleep
proposed rule § 26.199(d)(2)(i) for a 10- 8-hour break between work periods. restriction days, the research subjects’
hour break, the final rule revises the 24- Section 26.205(d)(2)(i) increases the sleepiness and performance became
hour break requirement proposed in minimum break period from 8 hours to progressively worse and these effects
§ 26.199(d)(2)(ii) and replaces the 48- 10 hours to provide greater assurance achieved a high level of statistical
hour break requirement proposed in that individuals have an adequate significance. The Dinges, et al. study
§ 26.199(d)(2)(iii) with an alternative opportunity to obtain the 7–8 hours of also concluded that ‘‘recovery from
break requirement. The following sleep that is recommended by most these deficits appeared to require two
section-by-section discussion of experts in work scheduling and fatigue. full nights of sleep.’’
§ 26.205(d)(2) and (d)(3) provides a When considering shift turnover and The importance of adequate sleep and
rationale for these specific changes. commute times, which do not provide the need to provide adequate
Section 26.205(d)(2) is necessary to individuals with opportunities for rest opportunity for sleep in work schedules
ensure that licensees provide and recovery, a nominal rest break of 8 are reflected in studies (e.g., Kecklund
individuals with sufficient time off hours actually leaves the individual and Akerstedt, 1995; Wylie, et al., 1996),
between work periods (shifts) to permit with approximately 6 hours available to guidelines (Pratt, 2003; Baker, et al.,
them to recuperate from fatigue and meet personal needs, including sleep (8 1990), handbooks (Tepas and Monk,
provide reasonable assurance that acute hours off-duty minus an average 1.5- 1987), and the panel recommendations
and cumulative fatigue do not hour round-trip commute minus an of sleep and fatigue experts (e.g.,
compromise the abilities of these average 0.5 hours spent in shift NUREG/CR–4248). An EPRI/NEI Work
individuals to safely and competently turnover, equaling 6 hours available for Hours Task Force white paper,
perform their duties. Acute fatigue personal needs). However, individuals ‘‘Managing Fatigue in the Nuclear
results from excessive cognitive work, typically also require 0.5 hours for Energy Industry: Challenges and
especially if an individual is missing preparing (or buying) and eating at least Opportunities’’ (ADAMS Accession No.
significant amounts of sleep, and is one meal off-shift and 0.5 hours for ML0221740179), also notes the
readily relieved by obtaining adequate personal hygiene, which leaves, at best importance of providing an opportunity
rest and sleep. Cumulative fatigue (i.e., assuming no social or domestic for at least 8 hours of sleep. The report,
results from receiving inadequate commitments that day), a total of 5 prepared by Mark Rosekind, states that
amounts or poor quality sleep for hours available for sleep. By contrast, ‘‘the strongest and most extensive data
successive days. An extensive body of the 10-hour break ensures that demonstrate that sleep is a critical factor
research has shown that a lack of individuals generally have 7 hours in promoting alertness and performance
adequate days off and extended available each day for sleep, which is in subsequent wakefulness. Data clearly
workdays result in a cumulative sleep close to the 7–8 hours of sleep needed show that acute and cumulative sleep
debt and performance impairment by adults in the United States (National loss degrade subsequent alertness and
(Williamson and Feyer, 2000; Tucker, Sleep Foundation, 2001; Monk, et al., performance. Therefore, any ‘hours of
1999; Colquhoun, 1996; Baker, et al., 2000; Rosekind, et al., 1997; Rosa, service’ policy should emphasize the
1994; Webb and Agnew,1974; U.S. DOT 1995). provision of an appropriate sleep
(65 FR 25546, May 2, 2000)). opportunity prior to duty.’’ More
Section 26.205(d)(2) defines a rest The scientific literature provides specifically, human reliability analysis
break as an interval of time that falls strong evidence of the negative effects experts have recommended that the
between successive work periods during on performance and alertness of a week NRC require ‘‘a break of at least 12
which the individual does not perform when sleep is restricted to 5 hours per hours between all work periods’’
any duties for the licensee. For example, day. Dinges, et al., 1997, and Belenky, (NUREG/CR–1278). Similarly, a panel of
individuals would not perform work- et al., 2003, who have headed key sleep and fatigue experts criticized a
related duties during rest breaks such as laboratories in the field of sleep DOT requirement for an 8-hour break for
completing paperwork reviews, deprivation (the University of motor carriers as inadequate because 8
mandatory reading, or required self- Pennsylvania and the Walter Reed Army hours of off-duty time does not translate
study. Rest breaks could include periods Institute of Research, respectively), have into 8 hours of sleep. The DOT has since
during which an individual is ‘‘on-call’’ conducted studies in this area. Belenky, amended its regulations for motor
because actual demands on an et al. (2003) clearly demonstrates that carriers to require 10-hour rest breaks
individual’s time while he or she is on- limiting sleep to 5 hours per night leads (68 FR 22456–22517, April 28, 2003).
call would be infrequent and of limited to significant impairment in both Although a longer minimum rest
duration, such as answering a phone alertness and actual performance, which break requirement would provide
call. However, if an individual who is builds up over the week, when greater assurance that individuals have
‘‘on-call’’ is ‘‘called-in’’ to report to the compared to the alertness and adequate opportunities for sleep, the 10-
site, the licensee would be required to performance of individuals who obtain hour break requirement provides
include the hours that the individual 7 hours of sleep per night. The adequate opportunity for rest when used
worked as work hours, not as break difference was found to be significant infrequently, as is expected given other
time, because the individual would be on all days during which sleep was requirements in this rule. For example,
performing duties on behalf of the restricted to 5 hours. Compared to the § 26.205(d)(1)(ii) limits individuals to
licensee while on site. research subjects’ performance after two working 26 hours in any 48-hour period.
Section 26.205(d)(2)(i) requires baseline nights during which they Although licensees could use routine
licensees to provide a 10-hour break obtained 7 hours of sleep, the subjects’ 10-hour breaks in conjunction with
between successive work periods, but performance after nights during which atypical shift durations (e.g., alternating
permits 8-hour breaks in limited they were restricted to 5 hours of sleep 12- and 14-hour shifts), the practical
circumstances in which a shorter break showed more than twice as many lapses implications of these schedules, such as
is necessary for a crew’s scheduled (extra slow responses). Dinges, et al. varied start times, make their use
transition between work schedules. (1997) obtained similar results. From improbable. As a consequence, the 10-
Current licensee technical specifications the second baseline day (the last day hour break requirement is sufficient to
assure adequate rest during infrequent maintain reliable human performance. restriction is widely practiced—people
circumstances in which individuals For example, Belenky, et al. (2003) have the subjective impression they
work extended hours (e.g., more hours found that the performance of subjects have adapted to it because they do not
than their typical 8-,10-, or 12-hour whose sleep periods were restricted to feel particularly sleepy.’’ However,
shift) and that rest opportunities will 7 hours per night over 7 consecutive results of the Van Dongen study also
typically vary between 12 and 16 hours days increasingly degraded as the demonstrated that the performance of
in duration. number of sleep-restricted days subjects in that study continued to
The minimum 10-hour break duration increased. Van Dongen, et al. (2003) degrade as the number of consecutive
also accommodates most scheduling similarly found that the performance of restricted sleep periods increased over a
circumstances for the common shift subjects whose sleep was limited to 8- 2-week period, including the
durations that are currently in use in the hours per night also declined over a 2- performance of subjects who were
industry. A notable exception is that the week period. The only subjects in these permitted 6- and 8-hour sleep periods.
10-hour break requirement could studies who did not show any Section 26.199(d)(2)(ii) of the
potentially prevent an individual who performance decrements were those proposed rule would have established a
has worked 16 hours straight (e.g., two who were permitted 9-hour sleep requirement for a minimum 24-hour
consecutive 8-hour shifts) from periods in the Van Dongen study. These break in any 7-day period. The NRC
returning to duty at the start of his or results clearly demonstrate that revised the maximum number of days
her next regularly scheduled shift. individuals require more rest than a 10- between the breaks in response to
However, the 10-hour break requirement hour break provides over time to stakeholder comments that the proposed
appropriately prevents the individual prevent performance degradation from requirement would have substantially
from working in this circumstance cumulative fatigue, including that reduced licensee flexibility in
because the potential for degraded job which accrues from a series of days of scheduling 8-hour shifts. Stakeholders
performance resulting from fatigue mild sleep restriction (e.g., 7 hours per noted that many licensees currently use
would be substantial given the night). Recent changes in the DOT 8-hour schedules that include periods of
individual’s continuous hours of work regulations for the work hours of 7 consecutive days. In revising the
and limited opportunity to sleep. commercial truck drivers also reflect the proposed requirement, the NRC
Section 26.205(d)(2)(i) permits need for longer breaks to mitigate considered that, although the final rule
licensees to schedule a minimum 8-hour fatigue. On April 28, 2003, the DOT allows more consecutive days for 8-hour
break in only one circumstance: if the 8- published final regulations (68 FR and 10-hour shifts, the final rule allows
hour break is necessary to accommodate 22456–22517) for hours-of-service for licensees the flexibility to more readily
a crew’s scheduled transition between drivers of motor carriers, which optimize 8-hour shift schedules to
work schedules. During the public amended 49 CFR Parts 385, 390, and
meetings described in the preamble of minimize the transitions between day,
395. These regulations require a evening, and night shifts that can lead
the proposed rule, the NRC received
minimum 34-hour break after any to worker fatigue. Although this
comments that a 10-hour break
period of 8 consecutive days with no relaxation also allows more consecutive
requirement would occasionally
more than 70 hours on duty. The intent shifts for individuals on 10-hour shifts,
interfere with a transition from 12-hour
of this 34-hour break is to provide for individuals on 10-hour shifts typically
shifts to 8-hour shifts. This transition
two consecutive sleep periods. do not work a rotating schedule and
typically occurs at the end of an outage
for individuals who normally work an Further, a 10-hour break provides an thereby do not experience the
8-hour shift, but work a 12-hour shift opportunity for 7 hours of sleep only if disruption of their circadian cycle that
during outages. Although the exception one assumes the minimal times for exacerbates the cumulative fatigue
provides individuals with less time for meals, hygiene, and commuting effects of consecutive work shifts. The
recovery, the shorter break is limited to described with respect to final rule also provides flexibility to
one break occurring on a very restricted § 26.205(d)(2)(i), with no other daily accommodate other practical
frequency. Therefore, the permission for living obligations. These assumptions considerations such as scheduling
an 8-hour break for the specific are realistic only for unusual training on a Monday through Friday
circumstances of a shift transition circumstances and limited periods of basis and allows a contingency day in
provides scheduling flexibility with time during which individuals may be 8-hour shift schedules that includes a
minimal potential to adversely affect an able to temporarily defer their other series of seven consecutive 8-hour shifts
individual’s ability to safely and obligations. As the number of as part of the routine shift cycle.
competently perform his or her duties. consecutive days increases in which The final rule also revises the
Section 26.205(d)(2)(ii) replaces and individuals have only a 10-hour break minimum duration of the break period
revises § 26.199(d)(2)(ii) of the proposed available to meet these other from 24 hours, as specified in
rule which would have required a obligations, the pressure on individuals § 26.199(d)(2)(ii) of the proposed rule, to
minimum 24-hour break in any rolling to restrict sleep time in order to meet a minimum 34-hour break. The revision
7-day period. Section 26.205(d)(2)(ii) of these other obligations increases. In more clearly states the NRC’s intent to
the final rule requires a minimum 34- addition, after a series of moderately require a periodic ‘‘day off’’ in which
hour break in any rolling 9-day period. restricted sleep periods (i.e., 6 hours per individuals have the opportunity for
This provision requires a periodic long night), individuals’ subjective feelings two consecutive sleep periods without
duration break thereby preventing an of sleepiness stabilize and they report an intervening work period. The 34-
excessive number of consecutive work feeling only mild sleepiness (Van hour break duration provides
shifts that would not otherwise be Dongen, et al., 2003), which may further opportunity for two consecutive sleep
prevented by the requirements of encourage individuals to restrict their periods without an intervening work
§ 26.205 of this rule. sleep periods in order to meet daily period, supports use of forward rotating
Break periods longer than the living obligations. Van Dongen, et al. and fixed shifts, and allows for the
minimum 10 hours between shifts noted ‘‘the lack of reports of intense possibility that individuals may work 26
required by § 26.205(d)(2)(i) are feelings of sleepiness during chronic hours in a 48-hour period contiguous to
necessary on a regular basis in order to sleep restriction may explain why sleep the break.
Given these considerations, the NRC proposed in § 26.199(d)(2)(iii) with [Collective work hour limits], which
concluded that § 26.205(d)(2)(ii) of the alternative requirements that ensure that would have required licensees to
final rule provides a level of assurance each worker receives a minimum control the collective work hours of
of worker FFD relative to fatigue that is number of days off per week, on each group of individuals performing
comparable to that which would have average, while the plant is operating or the duties subject to the work hour
been achieved through the requirement receives a minimum number of days off requirements and ensure that the
in § 26.199(d)(2)(ii) of the proposed rule. in each consecutive 15-day period of a collective work hours of each job duty
The provision for a 34-hour break in any plant outage. Security personnel subject group would not have exceeded an
rolling 9-day period serves both to to the requirements of § 26.205 are also average of 48 hours per person per week
prevent and mitigate cumulative fatigue. subject to requirements for minimum in any averaging period. Section
The 34-hour break periods will not only days off in 15-day periods during 26.205(d)(3), by requiring a minimum
provide some opportunity for recovery security system outages and increased number of days off, indirectly limits
sleep, but also time that individuals threat conditions. These alternative average weekly work hours to levels
need to meet the many daily living extended break requirements are in comparable to those that would have
obligations that they cannot otherwise § 26.205(d)(3) through (d)(5) of the final been permitted by the collective work
readily meet. Without such long break rule and are addressed in the section-by- hour limits of the proposed rule.
opportunities, individuals must either section analysis applicable to those Consequently, § 26.205(d)(3) of the final
forego activities that can be important to requirements. In adopting the rule performs the same function as the
general mental and physical fitness (e.g., alternative requirement for the final requirements of proposed § 26.199(f),
family interactions, exercise, recreation, rule, the NRC considered that, whereas providing reasonable assurance that the
doctor appointments) or sacrifice sleep the alternative requirements assured FFD of individuals subject to the work
and increase their sleep debt (Presser, that workers subject to the requirement hour requirements is not impaired by
2000), resulting in impairment on the would receive a minimum number of cumulative fatigue. As described with
job. days off, which would serve to limit the respect to § 26.205(d)(2), this
Section 26.205(d)(2) of the final rule potential for cumulative fatigue, the requirement also addresses an objective
does not retain the requirement for a requirements would not assure that any of the 48-hour break requirement of the
minimum 48-hour break in any rolling of the days off would be consecutive, as proposed rule by limiting the potential
14-day period as would have been would have been required by the for the cumulative fatigue of individuals
required by § 26.199(d)(2)(iii) of the minimum 48-hour break requirement of while the plant is operating. The
proposed rule. The NRC received many proposed § 26.199(d)(2)(iii). In provision does not require that days off
stakeholder comments in opposition to proposing the 48-hour break be provided consecutively, as would
the 48-hour break requirement. One requirement, the NRC cited several have been required by proposed
commenter stated that fixed break studies that demonstrate the benefits of § 26.199(d)(2)(iii), but rather allows
requirements and collective work hour consecutive days off, noting that one licensees discretion, within the
restrictions will lead to significant night of unrestricted sleep is not constraints of the other work hour limit
safety implications and could affect a sufficient to fully recover from the and break requirements, in distributing
licensee’s ability to restore inoperable cumulative fatigue that can result from days off throughout the shift cycle. As
equipment in a timely manner. This restricted sleep and extended work a consequence, § 26.205(d)(3), like
view was echoed by many other hours. However, the NRC also proposed § 26.199(d)(2)(iii), is intended
commenters. Another commenter found
considered that the minimum day off to ensure that individuals receive
fault with focusing on days off without
requirements would, in effect, limit sufficient days off on a periodic basis to
considering the number of hours
each individual’s average number of prevent cumulative fatigue.
worked in a particular day and the
work hours and the average number of The minimum day off requirements of
breaks between work periods. In
consecutive work shifts between days § 26.205(d)(3) will ensure that licensees
addition, many commenters raised the
off, thereby reducing the potential for manage during periods of normal plant
issue of work schedule disruption as a
cumulative fatigue. As a consequence, operation the potential for cumulative
result of the 48-hour break requirement.
the final rule’s requirements reduce the fatigue (i.e., fatigue from successive
They asserted that, for workers on the
need for consecutive days off to prevent weeks of overwork or inadequate rest) to
night shift, having one day off provides
an additional rest period and allows the or mitigate fatigue. The NRC also adversely affect the abilities of
worker to maintain a consistent pattern expects that common scheduling individuals to perform functions that
of work and sleep habits, which reduces constraints and worker preferences will are important to maintaining the safety
the risk of accidents on the job. Two cause licensees to schedule days off in and security of the plant. The
days off, however, may interfere with succession. In addition, the NRC requirements prevent excessive use of
his or her sleep cycle, and as a result, considered that the alternative the maximum work hours and
the individual would have to readjust to requirements of § 26.205(d)(3) and (d)(4) minimum rest breaks that are permitted
the night shift after the 2-day break. of the final rule provides licensees under § 26.205(d)(1) and (d)(2). In
According to the commenters, some greater flexibility in meeting scheduling addition, proactively controlling work
workers have stated that having 2 days demands and minimizing circadian hours to ensure individuals receive a
off is worse than having no days off. disruption for workers. minimum weekly average number of
They also argued that a 1-day break in Section 26.205(d)(3) requires days off while the plant is operating is
any 7-day period is more than adequate individuals subject to the requirements likely to reduce the need for licensees
when combined with other rule of § 26.205 to have a minimum average to grant waivers of the work hour
provisions to address cumulative number of days off per week. The requirements in § 26.205(d)(1) and
fatigue. Thus, commenters requested specific number of days off depends (d)(2). Individuals will be better rested
that the 48-hour break requirement upon the length of shifts in the work and less susceptible to cumulative
during outage periods be deleted. schedule of the individual. This fatigue from the increased work hours
In response to stakeholder comments, requirement replaces the requirements that are common during outages and
the NRC replaced the requirement presented in proposed § 26.199(f) that are necessary to augment security
staffing during increased threat stakeholder comments regarding instances the NRC did not adopt the
conditions. Therefore, the minimum day differences among individuals in their specific minimum number of days off
off requirement is essential for limiting abilities and desires to work overtime. that NEI proposed in its comments,
cumulative fatigue and augments other The proposed rule would have § 26.205(d)(3) establishes requirements
important elements of licensees’ fatigue permitted a group of workers who similar to those proposed by NEI by
management programs. perform similar duties to average 48 requiring each individual subject to the
Requiring a minimum number of days hours of work over a period not to requirements of § 26.205 to have a
off that results in a maximum average exceed 13 weeks. Because the proposed minimum average numbers of days off
work week of approximately 48–54 limit would have been imposed on a job per week.
hours per week helps to ensure that duty group’s average number of work Section 26.205(d)(3) defines, for the
licensees meet a fundamental objective hours during an averaging period, purposes of Subpart I, the term day off
of the NRC’s Policy on Worker Fatigue. licensees would have been able to as a calendar day in which an
The Policy, promulgated in GL 82–12, is distribute overtime among their workers individual does not start a work shift.
intended to ensure that there are a based on their assessment of The definition ensures consistent
sufficient number of operating individuals’ abilities and desires to licensee implementation of the
personnel available to ‘‘maintain work overtime. Stakeholder comments requirements in § 26.205(d)(3). In
adequate shift coverage without routine on the proposed requirement for developing the definition, the NRC
heavy use of overtime.’’ Routine collective work hour controls raised considered the alternative of defining
overtime can cause cumulative fatigue, several concerns. the requirements of § 26.205(d)(3) in
thereby degrading workers’ abilities to Some stakeholders expressed the terms of 24-hour break periods. A
safely and competently perform their concern that the collective work hour stakeholder at the March 29, 2006,
tasks. Section 26.205(d)(3) establishes controls were not an effective means for public meeting concerning this
requirements that are expected to result addressing fatigue. One stakeholder rulemaking noted that the number of 24-
in maximum average work weeks in the expressed the concern that the hour breaks in a schedule could be
range of 48–54 hours, thereby ensuring collective work hour controls would readily influenced by the number of
that work hours approaching the limits allow licensees to force individuals to rotations between shifts and therefore
in § 26.205(d)(1) and NRC’s Policy on work overtime. Another stakeholder could encourage scheduling practices
Worker Fatigue are the exception and expressed the opinion that collective that achieved compliance with the
not routine. work hour controls are not an effective requirement through schedules that
The minimum day off requirements of means to address the known were adverse to the circadian
§ 26.205(d)(3) also address, in part, the physiological fatigue risks contributed adjustment of workers. As defined in
cumulative fatigue concerns reported by by individual operators. Other the final rule, use of the term day off
security personnel in the months stakeholders expressed the concern that does not encourage such adverse
following the terrorist attacks of licensees may be able to manipulate the scheduling practices and results in
September 11, 2001. These individuals collective work hour calculations. Other requirements that establish uniform
questioned their readiness and ability to commenters asserted that the collective limits for all schedule designs. In
perform their required job duties work hour controls were unnecessary to addition, the definition enables workers
because of the adverse effects of mitigate the effects of cumulative fatigue and schedulers to readily determine the
cumulative fatigue. The NRC reviewed and that the controls would limit the number of days off in a schedule
the actual hours worked by security flexibility to increase work hours in a without the need to calculate the
personnel and determined that, in the job-duty group based on operational duration of break periods.
vast majority of cases, individual work needs. These commenters stated that Section 26.205(d)(3)(i) through
hours did not exceed the guidelines other rule provisions, such as the work (d)(3)(iv) specifies the minimum
specified in the NRC’s Policy on Worker schedule, individual work hour limits, number of days off for each individual
Fatigue. However, the review confirmed and individual break requirements, as subject to the requirements of § 26.205
that individuals had been working up to well as the provisions concerning in terms of a minimum number of days
60 hours per week for extended periods. fatigue assessments and the self- off per week, averaged over the shift
Individual concerns regarding their declaration process adequately address cycle. The requirements in this section
FFD, in light of work schedules that did cumulative fatigue. thereby allow the number of days off for
not exceed the specific guidelines of the Although the NRC acknowledges that an individual to vary from week to
policy, as well as relevant technical Subpart I provisions concerning fatigue week, but mandate that over the
research supporting the basis for assessment and self-declaration are duration of the shift cycle, the average
cumulative fatigue, led the NRC to important for the detection of number of days off per week meets the
conclude that the work hour guidelines cumulative fatigue, these provisions, specified minimum. Section
of the Policy are inadequate for like the individual work hour limit and 26.205(d)(3) requires that, for the
addressing cumulative fatigue. The NRC break requirements of the proposed rule, purposes of calculating the average
obtained additional support for this do not adequately address the number of days off required in this
conclusion following a review of worker prevention of cumulative fatigue. section, the duration of a shift cycle may
fatigue concerns and work hours during Accordingly, the final rule addresses the not exceed 6 weeks. This maximum
a long-term outage at the Davis Besse comments on the limitations of the duration of a shift cycle limits the
nuclear plant (NRC Inspection Report collective work hour requirements by period over which licensees are
05000346/2004003, dated March 31, replacing the requirements of § 26.199(f) permitted to average the number of days
2004, ADAMS Accession No. of the proposed rule with the minimum off and thereby limits the potential for
ML040910335). day off requirements in § 26.205(d)(3) of cumulative fatigue by preventing an
Through public interactions during the final rule. The minimum day off excessive number of consecutive weeks
the development of order EA–03–038, requirements were largely derived from in which individuals may be working
the NRC developed a collective work a work hour control proposal submitted the maximum hours allowed by
hour requirement, rather than a limit on by NEI as a comment on the proposed § 26.205(d)(1) while having only the
individual work hours, in response to rulemaking. Although in several minimum breaks required by
§ 26.205(d)(2). The 6-week maximum for should not be approved for an entire collected work scheduling data for
shift cycles also corresponds to the crew, noting that this individual security personnel at all nuclear power
longest shift cycle commonly used in maximum on overtime should not be a plants following the events of
the U.S. nuclear industry. group norm. Work schedules that meet September 11, 2001, as part of the
Section 26.205(d)(3)(i) requires the minimum day off requirements will process of evaluating the need to require
individuals who are working 8-hour result in levels of individual work hours licensees to implement compensatory
shift schedules to have at least 1 day off that are typically in the middle of the measures to address security personnel
per week, averaged over the shift cycle. range of work hours defined by the fatigue. The NRC’s analysis, as
This minimum day off requirement maximum routine scheduling limits and described in letters from the NRC to
allows an average of 48 hours of work maximum individual overtime. The licensees (e.g., ADAMS Accession No.
per week, assuming individuals receive expert panel further recommended that ML031880257), indicated that at some
the minimum number of days off with the NRC authorize no more than 400 of the sites (31 percent), security
no work shifts extended beyond 8 hours of overtime in a year. A limit of personnel worked more than 55 hours
hours. This requirement is therefore 400 hours of overtime annually is very per week and at a few sites (11 percent)
generally consistent with the 48-hour similar to a 48-hour average (i.e., 52 they worked 60 hours or more per week.
collective work hour requirement of weeks × 8 hours = 416 hours). The data also indicated that at the
§ 26.199(f) of the proposed rule, though In addition to considering the majority of the sites (58 percent)
it imposes the requirement on an opinions of experts in work scheduling security personnel typically worked 50
individual rather than a group basis. and fatigue, the NRC staff also hours per week or less. The NRC also
This requirement is also consistent with considered the opinions of individuals reviewed work hours data collected by
the NEI proposal for an average of 1 day who work in nuclear power plants. NEI (ADAMS Accession No.
off per week, averaged over a shift cycle, These opinions were expressed in ML003746495) and found that, although
for predominantly 8-hour shift surveys conducted by PROS and EPRI. individual sites varied substantially, the
schedules. In 2002, PROS surveyed the attitudes average annual overtime for licensed
In developing requirements to address of its members towards work hours and operators was 375 hours and 361 hours
cumulative fatigue, the NRC considered the development of a proposed rule for non-licensed operators. These
several types and sources of concerning fatigue of workers at nuclear findings suggest that an average work
information, including (1) past power plants (ADAMS Accession No. week of approximately 48 hours is an
recommendations from experts and ML05270310). One of the survey achievable objective for operations
expert panels on work scheduling and questions was, ‘‘What is your personal personnel as well, although it was not
maintaining worker alertness in the tolerance for overtime?’’ The responses a current practice at a small fraction of
nuclear industry, (2) surveys of nuclear indicated that 75 percent of the nuclear power plants.
power plant workers on their desire and respondents had a ‘‘tolerance’’ for up to The minimum day off requirements
ability to work overtime, (3) data on the 350 hours per year. Only 13 percent are comparable to, though less
amount of overtime worked by security expressed a tolerance for more than 350 restrictive than, limits on workers in
personnel, and (4) the requirements and hours of overtime. other industries within the United
practices in other industries. The work conducted in the States and the limits imposed by other
EPRI NP–6748 (Baker, et al., 1990) development of EPRI NP–6748 also countries that regulate overtime for
and NUREG/CR–4248 are two of the included a survey of operators. The nuclear power plant workers. The NRC
most comprehensive documents on results were consistent with the PROS staff noted that several other countries
worker fatigue in the U.S. nuclear survey, indicating that the amount of address cumulative fatigue of nuclear
industry. Like the collective work hour overtime that operators wanted to work power plant personnel through
limits of the proposed rule, the ranged from 100 to 400 hours per year. individual monthly and/or annual work
minimum average number of days off A survey of nuclear power plant hours limits on overtime. These limits,
requirement is a new concept developed personnel in the United Kingdom summarized in Table 6 of Attachment 1
to meet the rule’s objectives while also yielded similar results. to SECY–01–0113, are generally more
addressing stakeholders’ unique A minimum day off requirement will restrictive than the minimum day off
circumstances and specific concerns. As limit individuals to approximately 400 requirements because they directly limit
a consequence, neither of the to 500 hours of overtime in a year. hours of work, rather than work days,
documents provides specific guidelines Therefore, the minimum day off and permit fewer hours of work (e.g.,
for establishing collective work hour requirements permit levels of overtime Finland limits overtime to 250 hours per
limits. Nevertheless, the documents while the plant is operating that are at year). Table 5 of Attachment 1 to SECY–
contain information and guidelines the upper extreme of the number of 01–0113 includes a summary of limits
relevant to this requirement. overtime hours for which nuclear power on work hours in other industries in the
Collectively, the shift scheduling plant personnel have expressed a United States.
guidelines of EPRI NP–6748 and tolerance. In addition, the minimum day The NRC also considered the
NUREG/CR–4248 suggest a maximum off requirements are less restrictive than requirements of the European Union
routine work schedule of 44–46 hours the limit implied by worker opinions (EU) Working Times Directive (WTD)
per week. This maximum includes an because the minimum day off (Council Directive, 1993). The WTD
assumed turnover time of 30 minutes requirements of § 26.205(d)(3) would establishes requirements concerning the
per shift. The NRC also considered the not apply during the first 60 days of working hours of workers across various
recommendations of experts concerning plant outages, and for security industries in EU member nations. The
the use of overtime. The expert panel personnel, during the first 60 days of WTD establishes a requirement that
that developed the guidelines for plant outages, security system outages, ‘‘workers cannot be forced to work more
NUREG/CR–4248 also addressed or increased threat conditions. than 48 hours per week averaged over
overtime use and recommended an Together with expert and worker 17 weeks.’’
individual limit of 213 hours per month, opinions, the NRC considered industry Moreover, the amount of overtime
including shift turnover time. The practices concerning the use of overtime permitted by the minimum day off
expert panel emphasized that overtime for security personnel. The NRC requirements would be greater than the
amount used in most continuous than the requirement for 8-hour (a)(5), the duties described in
operations. Circadian Technologies, schedules, 10-hour schedules are not § 26.4(a)(4) involve fewer and less
Inc., a consulting firm that is expert in typically used for rotating shift prolonged periods of sedentary
fatigue management, regularly surveys schedules. As a consequence, the activities, which can contribute to
U.S. and Canadian companies individuals on those schedules are less degraded alertness, and monitoring
conducting 24/7 operations. Its 2000 likely to experience the disruption of activities, which are particularly
survey of 550 major companies their circadian cycles that is caused by susceptible to degraded vigilance.
indicates that shift workers at 89 rotating shifts and therefore better able Section 26.205(d)(3)(v) of the rule
percent of the companies surveyed to cope with the additional work hours. requires that licensees ensure that
averaged less than 400 hours of Section 26.205(d)(3)(iii) requires that individuals who are working 12-hour
overtime per year (Circadian individuals performing the duties shifts and performing the security duties
Technologies, Inc., 2000). Circadian described in § 26.4(a)(1) through (a)(3) described in § 26.4(a)(5) have a
Technologies, Inc., noted that the have at least 2.5 days off per week minimum of 3 days off per week,
average overtime for workers in averaged over a shift cycle and averaged over a shift cycle. This
extended operations in the United individuals described in § 26.4(a)(4) requirement limits the security
States was 12.6 percent above the have at least 2 days off per week, personnel who are subject to this
standard work week in the first 8 averaged over a shift cycle. In requirement to an average work week of
months of 2003, with utilities averaging developing this requirement, the NRC 48 hours. In developing this
14.9 percent (Circadian Technologies, considered NEI’s proposal to require a requirement the NRC considered the
Inc., 2003). minimum of 2 days off per week for all technical basis described with respect to
Therefore, the minimum day off individuals working 12-hour shifts § 26.205(d)(3) and public comment on
requirements establish appropriate subject to the work hour requirements, the collective work hour controls of the
limits on work schedules while the except security personnel. For proposed rule. The NRC also considered
plant is operating. The requirements individuals performing the duties its experience with implementing the
would ensure that individuals subject to described in § 26.4(a)(1) through (a)(3), group work hour controls that were
the work hour requirements of § 26.205 the NRC judged 2 days off per week to required for security personnel by the
have sufficient days off to prevent be insufficient for routine scheduling of compensatory measures of order EA–
fatigue. The minimum day off 12-hour shifts because it would allow an 03–038. The NRC has generally found
requirements will indirectly permit average work week of 60 hours, which that licensees have implemented work
levels of overtime at the upper extreme the NRC expects would lead to hour controls consistent with the
desired by most nuclear power plant cumulative fatigue. Furthermore, such a requirements of the compensatory
workers while limiting overtime to requirement would ensure substantially measures. However, the NRC has
levels comparable to those fewer days off than would be received a limited number of concerns
recommended by work scheduling and recommended by the scheduling from security personnel stating that they
fatigue experts. guidelines contained in EPRI NP–6748 are still experiencing excessive fatigue
Section 26.205(d)(3)(ii) requires that (Baker, et al., 1990) and NUREG/CR– leading to the perception that the
individuals who are working 10-hour 4248. requirements have not been fully
shift schedules have at least 2 days off In developing § 26.205(d)(3)(iii), the protective of all security personnel. The
per week, averaged over a shift cycle. NRC also considered the effect of NRC also notes that it has received
Individuals working schedules that scheduled training weeks on the overall numerous reports of inattentive security
meet the minimum day off requirements work hours of operations personnel. personnel at U.S. nuclear powerplants
of this section would therefore be Operators have 1 week of requalification within the last 2 years. In addition, the
working, on average, five 10-hour shifts training in most shift cycles. The NRC considered the critical importance
(50 hours) per week. In developing this training week typically consists of four of mental alertness and maintaining
requirement the NRC considered the 9-hour days or five 8-hour days. As a vigilance to the effective performance of
NEI proposal for a minimum of 1 day off consequence, § 26.205(d)(3)(iii) has the security personnel and the unique
per week average for 10-hour shift effect of limiting covered operations challenges of security duties and work
schedules. The NRC concluded that personnel to an average work week environments to meeting these needs
such a limit would allow excessive ranging from 48.8 hours to 52 hours, in (see the section-by-section analysis of
work hours (i.e., an average of 60 hours most shift cycles (i.e., when the shift § 26.205(a) for a more detailed
per week) for routine scheduling, thus cycle contains a training week). The discussion of the relationship between
creating the potential for cumulative specific number of hours depends on security duties and fatigue). Given these
fatigue. The NRC would not expect such the number of weeks in the shift cycle considerations, the NRC concluded that
a limit for long-term work hour control and the training week schedule. This it is appropriate to establish more
to prevent fatigue concerns such as estimate also assumes that individuals stringent work hour requirements for
those reported by security personnel do not work longer than their scheduled security personnel than other
working on the order of 60 hours per 12-hour shift. individuals subject to the requirements
week in the months following the Section 26.205(d)(3)(iv) of the rule of § 26.205. Accordingly,
terrorist attacks of September 11, 2001. requires that licensees ensure that § 26.205(d)(3)(iv) requires a minimum of
The section-by-section analysis for individuals who are working 12-hour 3 days off per week, averaged over a
§ 26.205(d)(3)(i) addresses in detail the shifts while performing the maintenance shift cycle, for individuals working 12-
basis for minimum day off requirements duties described in § 26.4(a)(4) have a hour shifts who are performing the
that effectively limit work schedules to minimum of at least 2 days off per week, security duties described in § 26.4(a)(5).
work weeks averaging approximately 48 averaged over a shift cycle. For Section 26.205(d)(4) provides a
hours per week. Section 26.205(d)(3)(i) individuals described in § 26.4(a)(4) the limited exception from the minimum
would permit an average work schedule NRC judged 2 days off per week to be day off requirements in § 26.205(d)(3)
of approximately 50 hours. Although sufficient for routine scheduling of 12- for individuals performing the duties
this requirement for 10-hour schedules hour shifts. Relative to the duties specified in § 26.4(a)(1) through (a)(4)
would allow 2 more hours per week described in § 26.4(a)(1)–(a)(3) and (i.e., certain operations, chemistry,
health physics, fire brigade, and the NRC has never defined the term frequency of outages, by duration, the
maintenance personnel). The exception ‘‘temporary basis’’ as used in the Policy. NRC found that it would be necessary
from the minimum day off requirements As a result, licensees have relied on this to increase the exclusion period
is available during the first 60 days of phrase in the guidelines to permit substantially to address a marginal
a unit outage while a subject individual extended work hours for periods number of additional outages of longer
is working on outage activities. In these ranging from a few days to more than a lengths. Many comments on the
circumstances, § 26.205(d)(4) requires year. Industry experience with proposed rule recommended that the 8-
licensees to ensure that individuals conditions such as sustained plant week exclusion period be increased to a
specified in § 26.4(a)(1) through (a)(3) shutdowns and the increased work 10-week exclusion period. This increase
have a minimum of 3 days off in each hours of security personnel following in the exclusion period would
successive (i.e., non-rolling) 15-day the terrorist attacks of September 11, substantially increase the period of time
period and that individuals specified in 2001, have demonstrated the need for that an individual would be working
§ 26.4(a)(4) (maintenance personnel) the NRC to establish clearer and more with reduced recovery time. During the
have at least 1 day off in any 7-day readily enforceable requirements exclusion period, individuals are
period. If at any time during a unit limiting the sustained use of extended permitted to work up to 72 hours in a
outage an individual performs duties work hours. 7-day period and are assured of just 3
specified in § 26.4(a)(1) through (a)(4) Differences between individuals, job days off in each 15-day period.
on or for a unit that is not disconnected demands, and work-rest schedules can Individuals who work 12-hour shifts,
from the electrical grid, the individual each have a substantial effect on the which is common during outages, will
is subject to the minimum day off period of time that an individual can average up to 67.2 hours per week,
requirements of § 26.205(d)(3) while the work without compromising his or her which represents 160 percent of their
individual is performing those duties, ability to safely and competently normally scheduled hours with less
except as permitted by § 26.205(d)(6). perform duties. As a result, studies of than half of their normally scheduled
After the first 60 days of a unit outage, work scheduling and fatigue provide days off for recovery, for a period of up
regardless of whether the individual is insights into the potential for to 2 months. Extending the outage
working on unit outage activities, the cumulative fatigue of workers, but do exclusion period to prolong these
individual is again subject to the not provide a direct basis for conditions would substantively increase
minimum day off requirements of establishing the maximum acceptable the potential for cumulative fatigue and
§ 26.205(d)(3), except as permitted by period for excluding plant outage work fatigue-related personnel errors.
§ 26.205(d)(6). hours from the collective work hour Therefore, the NRC did not adopt the
The minimum day off requirements in controls. In setting the maximum recommendation to increase the
§ 26.205(d)(3) address the long-term duration of the exclusion period, the duration of the exclusion period in the
control of work hours while permitting NRC considered that, by the end of 60 final rule.
the occasional use of extended work days of work at the limits permitted by
hours for short duration circumstances § 26.205(d)(1) and (d)(2), individuals The NRC also received several
such as equipment failure, personnel who are performing the duties specified comments on the proposed rule which
illness, or attrition. The requirements in in § 26.4(a)(1) through (a)(4) will have recommended that the NRC eliminate
§ 26.205(d)(4) address the control of (1) worked 576 hours, including more the exclusion for outage periods. In an
work hours for unique plant conditions than 200 hours of overtime, and (2) early phase of developing the work hour
(i.e., unit outages) which require missed as many as 17 normally requirements in Subpart I, the NRC
extended work hours for a more scheduled days off. The loss of the 17 considered establishing a set of uniform
sustained period of time. In developing normally scheduled days off represents requirements that would be applicable
the minimum day off requirements of a 60-percent reduction in the time regardless of whether a unit was
§ 26.205(d)(4), the NRC considered available to recover and prevent operating or shut down. However, as
several factors, including current policy, cumulative fatigue. Further, with each noted with respect to § 26.205(d)(4), the
the bases for the policy, lessons learned passing week of increased work hours NRC recognizes that individuals are
from the policy implementation, and and decreased time off, deferring daily capable of working with limited rest
public comment on the proposed rule. living obligations becomes increasingly without degraded performance for short
The NRC’s Policy on Worker Fatigue difficult, causing increased pressure on periods of time. As a consequence, the
provides guidelines for controlling work individuals to reduce their sleep time in NRC considers it appropriate to allow
hours, ‘‘on a temporary basis,’’ during order to meet the demands of both work flexibility within the work hour
periods requiring substantial overtime. and daily life, resulting in an increased requirements to accommodate limited
The Policy reflects the NRC’s potential for cumulative fatigue. periods of more intensive work
recognition that outages are unique, In addition to considering the schedules, such as unit outages.
relatively short term, and involve levels potential for cumulative fatigue, the However, the NRC limits this flexibility
of activity that are substantially higher NRC considered current industry data to infrequent circumstances, such as
than most non-outage operating periods. on the duration of unit outages in unit outages, to limit the potential for
The policy also reflects the NRC’s determining whether the cost to cumulative fatigue. Further, the NRC
understanding that, although licensees imposed by limiting the considered the substantial cost to
individuals are capable of working with exclusion period to 60 days is justified licensees for meeting the requirements
limited rest without degraded in terms of the benefit. The average applicable to periods of plant operation
performance for short periods of time, outage duration, as indicated by outage through either increasing staffing (to
research has shown that the ability to data from 2000–2002, is approximately minimize outage durations) or
sustain performance without adequate 39 days (Information System on increasing outage durations to
rest is clearly limited (Knauth and Occupational Exposure Database, accommodate a less intensive work
Hornberger, 2003; Pilcher and Huffcutt, ADAMS Accession No. ML050190016). schedule. Given these considerations,
1996; Van Dongen, et al., 2003), as Eighty-nine percent of plant outages the NRC concluded that a limited period
discussed in Section IV.D. However, as during this period were less than 8 of less restrictive work hour
noted in SECY–01–0113, Attachment 1, weeks in duration. In reviewing the requirements, as included in the final
rule, is better justified by the costs and attracting qualified supplemental requirements of § 26.205(d)(3).
benefits. workers is challenging in the entire However, whereas § 26.205(d)(3) is
The 60-day exclusion period that commercial reactor industry, that for principally applicable to extended
§ 26.205(d)(4) permits from the many supplemental workers the periods while a unit is operating,
minimum day off requirements of availability of overtime is a key factor in § 26.205(d)(4) is applicable to periods of
§ 26.205(d)(3) replaces the 8-week where they decide to work, and that the limited duration during unit outages. As
exclusion period that proposed industry has already experienced cases a consequence, the specific limits and
§ 26.199(f) would have permitted from where individuals have left during an details of these requirements differ to
the collective work hour limits. The outage to go to a job that offered more accommodate these different plant
discussion with respect to § 26.205(d)(3) overtime. The final rule partially conditions and periods of applicability.
presents the issues the NRC considered addresses these comments by requiring In its development of § 26.205(d)(4),
in deciding to replace the collective that maintenance personnel have at the NRC considered industry work
work hour limits with minimum day off least 1 day off in any 7-day period scheduling practices during outages and
requirements. The NRC revised the instead of the requirement for at least 3 the applicability of other proposed
maximum duration of the permitted days off in each successive (i.e., requirements during these periods. In
exclusion period to a duration that is nonrolling) 15-day period. The NRC SECY–01–0113 and NRC staff reviews of
comparable to the 8-week (56-day) notes that critical maintenance tasks records of deviations from technical
period of the proposed rule, but better performed by individuals within the specification work hour controls from
conforms with the minimum day off scope of § 26.4(a)(4) are subject to 2003 and 2004, the most common
requirements in § 26.205(d)(4) and quality assurance and corrective action deviation identified was to permit
(d)(5). For most categories of programs and that these programs are individuals to work more than 72 hours
individuals, the final rule establishes subject to NRC inspection. In addition, in 7 days, frequently by working more
minimum day off requirements in terms post-maintenance testing provides than six consecutive 12-hour days.
of 15-day periods, rather than weeks, as additional assurances of equipment These reviews also indicated that this
the proposed rule would have required. performance. practice was used extensively at a
As a consequence, the NRC revised the As described with respect to number of sites. Industry comments at
maximum duration of the exclusion § 26.205(d)(2), the NRC received many the public meetings described in the
period to 60 days (4 × 15) to encompass stakeholder comments on the proposed preamble to the proposed rule also
four complete periods of time. rule regarding the 48-hour break confirmed the NRC observation that
Section 26.205(d)(4) requires requirement. Several commenters some licensees were scheduling outages
licensees to ensure that individuals asserted that, for workers on the night with several weeks of 12-hour shifts
performing the duties specified in shift, having 1 day off provides an with no scheduled days off. The NRC
§ 26.4(a)(1) through (a)(3) have at least 3 additional rest period and allows the also considered industry comments
days off in each successive (i.e., non- worker to maintain a consistent pattern submitted during the public comment
rolling) 15-day period during the first 60 of work and sleep habits, which reduces period that asserted 1 day off in 7 is
days of a unit outage and that the risk of accidents on the job. adequate for maintaining worker
individuals specified in § 26.4(a)(4) However, two days off may interfere performance and that offering schedules
(maintenance personnel) have at least 1 with his or her sleep cycle and, as a that included these levels of overtime is
day off in any 7-day period. This result, the individual would have to necessary to attract supplemental outage
requirement replaces, in part, proposed readjust to the night shift after the 2-day workers. The minimum day off
§ 26.199(d)(2)(ii), which would have break. The NRC acknowledges that these requirement of § 26.205(d)(4) is the one
required that these individuals have a concerns may be particularly applicable requirement of this final rule that
minimum 24-hour break in any 7-day during outage periods when it is prevents individuals who perform the
period. This requirement also replaces, common for licensees to schedule many duties listed in § 26.4(a)(1) through
in part, proposed § 26.199(d)(2)(iii), individuals on a fixed night shift for the (a)(3) from working 72 hours per week
which would have required that these duration of an outage. The final rule for the entire first 8 weeks of a unit
individuals have a minimum 48-hour addresses this concern by providing outage. In addition, the minimum day
break in any 14-day period, except licensees increased flexibility in the off requirement of § 26.205(d)(4) is the
during the first 14 days of an outage. distribution of the days off. As a one requirement of this final rule that
The NRC is replacing these consequence, licensees may schedule prevents individuals from performing
requirements with § 26.205(d)(4) in single days off to limit circadian the duties listed in § 26.4(a)(4) with no
response to public comment (see the disruption for workers on the night scheduled days off for the entire first 8
discussion of public comment with shift. Alternatively, they may provide weeks of a unit outage. In this regard,
respect to § 26.205(d)(2)(i) and (d)(3)). the days off in consolidated blocks to the NRC notes that the duties listed in
The combined effect of § 26.199(d)(2)(ii) provide extended breaks of 2 or more § 26.4(a)(1) through (a)(4) are those the
and (d)(2)(iii) of the proposed rule consecutive unrestricted sleep periods NRC considers most important for
would have been to require 2 days off which are important to reducing fatigue management because of their
in the first 2 weeks of the outage and 3 cumulative fatigue. relationship to the protection of public
days off in each subsequent 14-day The objective of the requirement in health and safety. In particular, these
period. Section 26.205(d)(4) establishes § 26.205(d)(4) is to ensure that duties include operating and
a requirement that is similar to, though individuals performing the duties maintaining systems and components
more flexible and less complex than, the described in § 26.4(a)(1) through (a)(4) that a risk-informed process has shown
requirements it replaces. have sufficient periodic long-duration to be significant to public health and
The NRC also received stakeholder breaks to prevent cumulative fatigue safety.
comments on the proposed rule which from degrading their ability to safely As described with respect to
recommended that the NRC eliminate and competently perform their duties. § 26.205(d)(2)(ii), break periods longer
the minimum day off requirements for The minimum day off requirement in than the minimum 10 hours required by
outage periods. In additions, the NRC § 26.205(d)(4) serves the same general § 26.205(d)(2)(i) are necessary on a
received comments asserting that function as the minimum day off regular basis to maintain reliable human
performance. A 10-hour break provides § 26.205(d)(4), the minimum day off individuals only 2 days off in a 15-day
an adequate opportunity to sleep requirement of this section replaces, in block but would be required to provide
(approximately 7 hours for most part, the 48-hour break requirement of those individuals 4 days off in the
individuals) only if one assumes the the proposed rule, and is the single subsequent 15-day block). This option
minimal times for meals, hygiene, and requirement that prevents individuals would have required fewer days off for
commuting, as described with respect to responsible for performing risk- outages of less than 15 days and
§ 26.205(d)(2)(i), with no other daily significant duties from working provided additional scheduling
living obligations. During unit outages, extended periods of 72-hour work flexibility for longer outages. At the
work schedules of 12-hour shifts and weeks or extended periods with no days March 29, 2006 public stakeholder
limited days off are common. As the off. meeting regarding this rulemaking the
ratio of 12-hour work shifts to days off The NRC further considered that some staff discussed the potential of a graded
increases, the pressure on individuals to transient personnel include licensee approach and solicited stakeholder
restrict sleep time in order to meet daily employees and long-term C/Vs. Many of comment. Only one licensee
living obligations that cannot be these individuals may move from site to representative stated that a graded
deferred increases. Without periodic site within a fleet during plant outage approach may provide useful flexibility.
days off, individuals must either forego periods. For large fleets, some The NRC subsequently considered the
activities that can be important to individuals may work much of the increased potential for cumulative
general mental and physical fitness (e.g., spring and fall outage seasons under fatigue that would result from deferring
family interactions, exercise, recreation, only the work hour limits and break days off, the increased complexity of the
doctor appointments) or sacrifice sleep requirements applicable to unit outage rule and scheduling to meet the
and increase their sleep debt (Presser, periods. For these individuals, the requirements, the minimal stakeholder
2000). Such sleep restriction will minimum day off requirement of interest in a graded approach, and
compound the effect of the long (12- § 26.205(d)(4) is the single requirement determined that the option for deferring
hour) work shift resulting in impairment that will prevent such individuals from a required day off to a subsequent 15-
on the job. performing risk-significant duties while day block was not warranted.
The NRC also considered ways to working with no days off for substantial Section 26.205(d)(5) requires that
prevent and mitigate cumulative fatigue portions of a year. during the first 60 days of unit outages,
in roving outage crews and other In developing the minimum day off security system outages, and increased
transient workers who predominantly requirements for the final rule, the NRC threat conditions, licensees control the
work during plant outages in the considered scheduling practices during hours worked by individuals performing
development of this requirement. outages and determined that it could not the security duties specified in
During the stakeholder meetings practically extend the same approach § 26.4(a)(5) in accordance with the
discussed in the preamble to the used in § 26.205(d)(3) because the requirements in § 26.205(d)(5)(i) and
proposed rule, many stakeholders requirements of this section are based (d)(5)(ii). The effect of this section is to
expressed a strong desire for transient on shift cycles which provide a defined provide a 60-day exception from the
workers to be subject to work hour period to which the average day off minimum day off requirements in
controls. One stakeholder observed that requirement will apply. The length of 26.205(d)(3) for these plant conditions.
assuring transient outage workers are outages and increased threat conditions After the first 60 days of these periods,
not impaired by fatigue is particularly is variable and therefore does not these individuals are again subject to
important because these individuals provide a consistent averaging period. the minimum day off requirements of
typically do not have the extensive The NRC further considered § 26.205(d)(3), except as permitted by
training in methods for maintaining establishing a requirement of a § 26.205(d)(6). The purpose of this
reliable human performance that is minimum of 3 days off in any 14-day exception is to allow licensees the
provided to permanent plant personnel. period for individuals specified in flexibility provided by the less stringent
During development of the proposed § 26.4(a)(1) through (a)(3) because that day off requirements of § 26.205(d)(5)(i)
rule, the NRC staff considered would have been similar to the and (d)(5)(ii) to provide the increased
establishing long-term work hour requirements it would have replaced. level of security staffing that is required
controls. However, collective work hour However, the NRC ultimately by these unique circumstances. The
controls would not be effective because determined that 3 days off within a 15- requirements in § 26.205(d)(5)(i) and
these individuals typically work during day period provides licensees (d)(5)(ii) provide the restrictions
outages when the collective work hour scheduling flexibility (e.g., establishing necessary to prevent and mitigate
controls would not be applicable or a schedule comprising a repeating series excessive cumulative fatigue during
practical. The NRC staff then considered of 4 work shifts followed by 1 day off). these periods.
individual long-term (quarterly and As a consequence, the rule allows Section 26.205(d)(5)(i) provides an
yearly) work hour limits for transient licensees the option to establish a exception from the minimum day off
workers. However, industry schedule that is predictable, a requirements of § 26.205(d)(3) for
representatives strongly objected characteristic desired by schedulers and personnel performing the duties
because these transient workers move workers, and that both mitigates and described in § 26.4(a)(5) during unit
from one licensee to another, and the prevents cumulative fatigue by outages or unplanned security system
burden of obtaining work hour including periodic rest breaks. outage. The requirement limits this
information for all of these individuals During the development of the final exception period to 60 days from the
from other licensees would be extremely rule the NRC also considered a graded beginning of the outage and requires
high. In part because of the practical approach to the minimum day off that individuals performing the security
difficulties of controlling long-term requirements for outages. Specifically, duties identified in § 26.4(a)(5) during
work hours for transient individuals, the the staff considered an option which this period have a minimum of 4 days
NRC developed the 48-hour break would have allowed licensees to defer 1 off in each non-rolling 15-day period.
requirement as a replacement for long- of the 3 required days off in a 15-day This requirement replaces the collective
term work hour limits for transient block to the subsequent 15-day block work hour limit of 60 work hours per
individuals. As noted with respect to (i.e., licensees could provide person per week that § 26.199(f)(2)(i) of
the proposed rule would have required Since September 11, 2001, the NRC and would also provide more flexibility.
for these individuals during the first 8 has received several reports of nuclear The 60-hour limit of the proposed rule
weeks of a unit outage or a planned security officers found asleep while on would have ensured that security force
security system outage. duty. In addition, the NRC received personnel who work a 12-hour shift
Section 26.205(d)(5) permits licensees numerous allegations from nuclear receive, on average, 2 days off in every
to meet the minimum day off security officers that certain licensees 7-day period, thereby reducing the
requirements of § 26.205(d)(5)(i) as an have required them to work excessive potential for cumulative fatigue.
exception to the more stringent amounts of overtime over long periods As discussed with respect to
minimum day off requirements in as a result of the post-September 11 § 26.205(d)(3), stakeholder comments on
§ 26.205(d)(3). The rule permits this threat environment. The nuclear the proposed rule expressed a range of
exception for a limited duration, 60 security officers questioned their concerns regarding the need for, and
days to accommodate the short-term readiness and ability to perform their effectiveness of, collective work hour
demand for increased work hours required job duties because of fatigue controls. As a consequence, the NRC
associated with these outages while and stated that they feared reprisal if replaced the collective work hour limits
limiting cumulative fatigue. Therefore, they refused to work assigned overtime. of the proposed rule with the minimum
the requirement provides reasonable The NRC received similar information day off requirements outlined in
assurance that security personnel will from newspaper articles and from § 26.205(d)(3) through (d)(5). More
remain capable of safely and interactions with public stakeholder specifically, the requirement for a
competently responding to a security groups. For example, the Project on minimum of 4 days off in each 15-day
incident or an increased security threat Government Oversight (POGO) issued a period of the first 60 days of an outage
condition, should one occur during or report entitled, ‘‘Nuclear Power Plant required in § 26.205(d)(5)(i) establishes
shortly after a period of increased work Security: Voices from Inside the a requirement in the final rule that is
hours. Fences,’’ and submitted this report to comparable to the 60-hour collective
The basis for limiting the duration of the NRC staff (ADAMS Accession No. work hour limit of the proposed rule,
the exception from the requirements of ML031670987). POGO interviewed while addressing stakeholder comments
§ 26.205(d)(3) during unit outages is more than 20 nuclear security officers regarding the importance of addressing
described with respect to § 26.205(d)(4). protecting 24 nuclear reactors (at 13 worker fatigue on an individual basis.
In addition to establishing a minimum plants) to obtain material for its report. Although § 26.205(d)(5)(i) does not
day off requirement for personnel POGO reported that the security officers directly limit work hours, the
performing the security duties identified who were interviewed said, ‘‘Their requirement has the effect of limiting
in § 26.4(a)(5) during the first 60 days of plants are heavily relying on increased individuals to an average work week of
a unit outage, § 26.205(d)(5) establishes overtime of the existing guard force 61.6 hours, assuming no work shifts
minimum day off requirements for these exceed 12 hours. The NRC established
* * *. These guards raised serious
individuals for the first 60 days of a the minimum day off requirement in
concerns about the inability to remain
planned security system outage. terms of 15-day periods to establish
alert.’’ After reviewing the work hours
Planned security system outages are requirements for security personnel in
and FFD concerns of security personnel
typically of very short duration relative time periods consistent with the
subsequent to September 11, 2001, the
to unit outages and the NRC does not minimum day off requirements for other
NRC issued Order EA–03–038 to limit
expect that planned security system personnel to simplify licensee
the work hours of security personnel
outages will exceed 60 days. However, implementation of the requirements of
and ensure that they remain capable of
the rule establishes the 60-day limit for this section.
safely and competently performing their
planned security system outages to For several reasons, control of work
simplify implementation of the rule by duties. The order requires compensatory hours for security personnel must be
applying identical exclusion periods for measures for limiting work hours to a more stringent than for other
all outages and increased threat collective work hour average of 48 hours individuals who are subject to the work
conditions. Additionally, the ability of per person per week during normal hour controls. First, security personnel
security personnel to perform their operations, as well as limiting work are the only individuals at nuclear
duties safely and competently during hours to an average of 60 hours per powerplants who are entrusted with the
these outage and increased threat week for planned plant outages and authority to apply deadly force.
conditions is based on the length of time planned security system outages. Decisions regarding the use of deadly
individuals work additional hours, not Ensuring that work schedules force are not amenable to many of the
on the nature of the site condition. incorporate adequate break periods is an work controls (e.g., peer checks,
Section 26.205(d)(5)(i) replaces, in important mitigation strategy for independent verification, post-
part, the requirements limiting work cumulative fatigue. The need for maintenance testing) that are
hours of security personnel established periodic long breaks was discussed with implemented for other personnel
by order EA–03–038 with alternative respect to § 26.205(d)(2) and (d)(3). The actions at a nuclear plant to ensure
requirements that will achieve the same NRC’s initial concept for compensatory correct and reliable performance.
objective. Collectively, the requirements measures to prevent fatigue of security Second, unlike most other work groups,
in Subpart I more effectively achieve the personnel from the long work hours of security personnel are typically
objectives of the compensatory outages included a feature that required deployed in a configuration in which
measures and therefore the NRC intends a 48-hour break in any 7-day period for some members of the security force have
to revoke order EA–03–038 following periods of increased work hours that very infrequent contact with other
implementation of this rule. This exceeded 45 days (ADAMS Accession members of the security force or with
requirement limits, with the exception No. ML030300470). Through other plant personnel. A lack of social
specified in § 26.205(d)(6), the stakeholder interactions during interaction can exacerbate the effects of
maximum duration of the outage development of the order, the NRC fatigue on individuals’ abilities to
requirements to 60 days instead of the concluded that a 60-hour collective remain alert (Horne, 1988). Third, these
120-day period order EA–03–038 work hour limit would be an effective deployment positions can be fixed posts
permits. alternative to meet the same objective where very little physical activity is
required, further promoting an 03–038 provides an exception from the security] provides a means for extending
atmosphere in which fatigue could collective work hour limits in the the proposed 60-day exception period,
transition into sleep. Fourth, many compensatory measures for these as discussed with respect to that
security duties are largely dependent on conditions for a period of up to 120 provision.
maintaining vigilance. Vigilance tasks days. Section 26.205(d)(5)(ii) establishes Proposed § 26.199(f)(2)(iv) would
are among the most susceptible to a more stringent exception period. have clarified the instances in which
degradation from fatigue (Rosekind, Unplanned security system outages security personnel would be subject to
1997; Monk and Carrier, 2003). Finally, and increased threat conditions require a collective work hour limit for certain
unlike operators, security forces lack extensive increases in security force instances in which multiple plant
automated backup systems that can labor in terms of compensatory conditions exist. The NRC has not
prevent or mitigate the consequences of measures. These increases can make it retained this provision for the final rule
an error caused by fatigue. very difficult to maintain work hour because § 26.205(d)(ii), in conjunction
Consistent with the requirements of controls during these periods, especially with the definition of increased threat
the proposed rule, the final rule because licensees are unable to plan in condition as described in § 26.5,
requirement differs from that in Order advance for these circumstances. adequately addresses the applicability
EA–03–038 by establishing more Although the increased work hours of the work hour requirements for
stringent work hour requirements for increase the potential for cumulative circumstances in which multiple plant
unplanned plant outages than for fatigue, other fatigue management conditions (e.g., a unit outage and
increased threat conditions. Order EA– requirements, including the work hours increased threat condition) occur
03–038 currently does not impose controls in § 26.205(d)(1) and (d)(2), simultaneously. Specifically,
collective work hour limits for provide reasonable assurance of guard § 26.205(d)(ii) states that during the first
unplanned plant outages. As discussed readiness during the exception period. 60 days of an unplanned security
in the preceding paragraph, security Therefore, the benefit to plant security system outage or increased threat
duties are particularly susceptible to of ensuring adequate staffing during condition, licensees need not meet the
fatigue. Therefore, the NRC considers such unplanned conditions outweighs requirements of either § 26.205(d)(3) or
that the minimum day off requirement the potential for excessive worker (d)(5)(i). As a consequence, should an
for security personnel should only be fatigue. unplanned security system outage or
waived in cases in which (1) licensees Staffing to a level necessary to meet increased threat condition occur at any
would be unable to sufficiently plan for the minimum day off requirements of time during a unit outage, security
the increased security demands, and (2) § 26.205(d)(3) during unplanned personnel subject to the work hour
the increased potential for fatigue- security system outages or increased requirements would not be required to
induced errors is outweighed by the threat conditions would not be practical meet the minimum day off requirements
need for a higher complement of because it would require licensees to of § 26.205(d)(3) or (d)(5)(i) during the
security personnel on shift to maintain maintain security staffing in numbers first 60 days of the unplanned security
the common defense and security. In the that would be excessive for the vast system outage or increased threat
case of unplanned plant outages, majority of circumstances. Limiting condition.
although licensees would be unable to periods of extended work hours for Proposed § 26.199(f)(2)(iv) would
sufficiently plan for the increased security personnel to 60 days aligns the have also clarified the applicability of
security demands that typically exception period for security personnel the collective work hour controls to
accompany plant outages, licensees can with the exception period for other instances in which a threat level
control the demands on the work hours personnel subject to the work hour increases and then decreases. In the
of security personnel by controlling the requirements, simplifying the rule and final rule, the NRC has defined an
outage activities (e.g., maintenance) that its implementation. Further, the cost to increased threat condition in § 26.5 as
create the increased demand for security licensees of the compensatory measures ‘‘an increase in protective measure
personnel. As a consequence, work required to address security system level, relative to the lowest level
hours that may compromise the FFD of outages is significant, and most security applicable to the site during the
security personnel, such as those that systems are modular. Therefore, an previous 60 days, as promulgated by an
would be permitted in the absence of unplanned security system outage is NRC advisory.’’ Accordingly, any time a
the minimum day off requirements of unlikely to exceed 60 days. Outages of threat level changes, whether by
§ 26.205(d)(5)(i), cannot be justified. The this duration have been uncommon. increasing or decreasing, the
economic benefit gained by licensees Therefore, reducing the exclusion determination of whether a site is in an
cannot justify the increased potential for period from 120 days to 60 days is not increased threat condition, for purposes
fatigue-induced errors. likely to have a practical impact on of applying the work hour requirements
Section 26.205(d)(5)(ii) provides an licensees. of Subpart I, is made by comparing the
exception from the minimum day off The Department of Homeland current threat level with the lowest level
requirements for security personnel for Security has refined its threat system to applicable to the site during the
the first 60 days of an unplanned compartmentalize increases in threat previous 60 days.
security system outage or an increased conditions for individual business Proposed § 26.199(f)(2)(v) would have
threat condition. This requirement sectors and regions of the country. In clarified the applicability of the
replaces proposed § 26.199(f)(2)(iii), addition, since the inception of the collective work hour limits for security
which would have provided an system, the threat level has not been personnel during multiple consecutive
exception to the collective work hour increased for any period that exceeded and concurrent plant conditions. The
limits for security personnel for the first 6 weeks. An event that would cause NRC has not retained this provision for
8 weeks of an unplanned security NRC-regulated sites to maintain the final rule because the requirements
system outage or an increased threat increased protective measures for a in § 26.205(d)(5) and (d)(7), in
condition. The exception allowed by period of more than 60 days would conjunction with the definition of
§ 26.205(d)(5)(ii) is consistent with likely mean a significant domestic increased threat condition as described
compensatory measures required by attack had occurred. In this event, in § 26.5, adequately define the
Order EA–03–038. However, Order EA– § 26.207(c) [Common defense and requirements applicable to multiple
consecutive and concurrent plant weeks 5 and 6 of a 10-week outage, an circumstances. The NRC has not
conditions. In the case of multiple individual may work 42-hour work retained this provision for the final rule
consecutive increases in threat weeks because of reduced demand for because the requirements in
conditions, § 26.205(d)(ii) would permit his or her skills during those weeks of § 26.205(d)(3) and (d)(6), and § 26.207
a 60-day exception from the minimum the outage. That individual would then adequately define the requirements
day off requirements, with the 60 days be eligible to work an additional 2 applicable to these circumstances.
beginning with each increase. As weeks beyond the 60-day exception The objective of proposed
described in the preceding paragraph, period under the minimum day off § 26.199(f)(3) would have been to
should the threat level decrease, the requirements applicable to the first 60 establish a regulatory framework that
determination of which work hour days of an outage. The NRC added this accommodated circumstances beyond
requirements are applicable (i.e., provision to the final rule partly in the reasonable control of licensees,
whether the increased threat level response to public comment on the while ensuring that licensees continue
exception applies) depends upon a proposed rule that the exception for to provide reasonable assurance that the
comparison of the current threat level to outage periods should be extended to 10 effects of fatigue and degraded alertness
the lowest level applicable in the weeks. As described with respect to on individuals’ abilities to safely and
previous 60 days. § 26.205(d)(4), the NRC does not believe competently perform their duties are
Proposed § 26.199(f)(2)(vi) would it is appropriate to extend the outage managed commensurate with
have established requirements exception period to 10 weeks without maintaining public health and safety.
controlling the exception period from restriction because of the increased The requirements of the final rule
the collective work hour controls when potential for cumulative fatigue when provide licensees the flexibility to
a threat condition decreases during an individuals work at the limits accommodate these circumstances in a
unplanned security system outage or established by § 26.205(d)(4) for manner that is consistent with
increased threat condition. In these extended periods of time. However, reasonable assurance of worker FFD.
circumstances, the proposed rule would during public meetings on the proposed Section 26.205(d)(3) establishes
have established the beginning of the rule, stakeholders also commented that minimum day off requirements that
exception period based upon the date during extended outages individuals do accommodate variation in workload
upon which the current threat condition not always work an outage schedule for because it does not require a minimum
was last entered as a result of a threat the entire outage but may have periods number of days off each week but
condition increase. The NRC has not of reduced activity that provide
retained this provision for the final rule requires licensees to ensure that
opportunity for individuals to recover individuals have an average number of
because the requirement in from cumulative fatigue. The break
§ 26.205(d)(5) in conjunction with the days off over the duration of a shift
requirements exception allowed by cycle of up to 6 weeks. As a
definition of increased threat condition § 26.205(d)(6) acknowledges this
as described in § 26.5, adequately define consequence, individuals are able to
circumstance. The provision work up to 72 hours in a week, to the
the requirements. For example, if the accommodates longer outages without
threat level increases at the beginning of extent that they are still able to meet the
increasing the risk of worker fatigue by minimum days off requirement for the
week 1, increases again at the beginning allowing licensees to extend the outage
of week 3, and then decreases in week shift cycle. For example, individuals on
exception, and therefore the reduced 12-hour shifts can work 72 hours per
5 to the level of week 1, the beginning requirements applicable to outages, by
of the maximum 60-day exception week for 2 weeks, and still have enough
taking credit for these periods of days off to work an average of 45 hours
period would be the beginning of week
reduced work hours. As a result, this per week for the remaining 4 weeks of
1 because the definition of increased
requirement also provides licensees the a 6-week cycle. Section 26.205(d)(3) also
threat condition is based upon an
flexibility of planning outages longer accommodates circumstances that may
increase from the lowest level of
than the normal 60-day exception require increased work hours for more
protective measures in the past 60 days.
period by incorporating periods of extended periods of time. Again, as an
The requirements ensure that the
reduced work hours appropriate to example, § 26.205(d)(3)(iii) requires an
duration of the exception period is no
maintaining worker FFD over an average of 2.5 days off per week for
longer than necessary based upon the
extended duration outage. In addition, individuals performing the job duties
current threat level, thereby providing
licensees with the flexibility to respond this provision also applies to increased specified in § 26.4(a)(1) through (a)(4).
to increased threat conditions while threat conditions and provides a Individuals can meet this requirement
minimizing the potential for cumulative mechanism for a limited extension of while working an average of 54 hours
fatigue of security personnel. As a the reduced requirements applicable to per week. This limit is comparable to
consequence, § 26.205(d)(5), in scheduling individuals performing the limit that would have been required
conjunction with the definition of security functions during increased by § 26.199(f)(3)(ii) of the proposed rule,
increased threat condition in § 26.5, threat conditions. which would have restricted the
establishes requirements applicable to Proposed § 26.199(f)(3) would have exception allowed by § 26.199(f)(3) to a
changes in threat conditions that are permitted the collective work hours of group collective work hour average of
consistent with the work hour controls any job duty group specified in not more than 54 hours per person per
order EA–03–038 requires. proposed § 26.199(a) to exceed an week. Section 26.205(d)(6) can also
Section 26.205(d)(6) permits licensees average of 48 hours per week in one accommodate limited unplanned
to extend the 60-day exception periods averaging period if all of the conditions extensions of an outage beyond the 60-
in § 26.205(d)(4) and (d)(5) for each specified in § 26.199(f)(3)(i) through day exception period, provided
individual in 7-day increments for each (f)(3)(iii) of the proposed rule were met. individuals have periods of reduced
non-overlapping 7-day period in which The criteria in proposed § 26.199(f)(3)(i) work hours that qualify for the 7-day
the individual has worked not more through (f)(3)(iii) would have permitted extensions. Such circumstances may
than 48 hours during the unit or licensees to control work hours to a arise if unexpected complications in an
security system outage or increased higher collective work hour limit under outage task occur that cause the work to
threat condition. For example, during certain occasional, short-term exigent be deferred until later in the outage,
leaving the assigned work crew with a close succession. The final rule does not subsequent outages could be affected if
reduced period of activity. retain these requirements. the outage extension affects the ability
The NRC also notes that the work A comment on the proposed rule of individuals to have 2 weeks of
hour limits of Subpart I are only noted that several companies own and reduced work hours before the
applicable to a limited scope of operate reactors at multiple sites and it subsequent outage.
personnel and therefore not all exigent is common for these companies to Given the limited scope of individuals
circumstances would necessarily develop outage work groups and deploy that would benefit from the
involve individuals or duties subject to these work groups to outages in close requirements in proposed § 26.199(g)
these controls. In addition, should the succession at their sites. Another and the potential for substantial adverse
circumstances require increased work comment noted that recruiting qualified impacts on licensee’s ability to plan and
hours by individuals who perform the supplemental workers to support conduct outages, the NRC has not
duties specified in § 26.5(a)(1) through outages is challenging for the entire retained these requirements in the final
(a)(5), the provisions of § 26.207 address commercial reactor industry and that for rule. However, the NRC notes that the
waivers of the work hour requirements many supplemental workers the final rule includes other provisions that
when necessary to prevent or mitigate availability of overtime is a key factor in will reduce the potential for cumulative
conditions adverse to safety and provide where they decide to work. This fatigue from successive outages,
exceptions from the requirements when comment further stated that the industry including more stringent work hour
necessary to ensure common defense has already experienced cases where controls, requirements for a process
and security and allow adequate staffing individuals have left during an outage through which individuals may self-
during declared plant emergencies. for employment that offered more declare if they believe they are not fit for
Proposed § 26.199(f)(4) would have overtime. duty because of fatigue, and
prohibited licensees from repeatedly In determining to eliminate the requirements for training in fatigue
permitting the collective work hours of requirements pertaining to successive management.
any job duty group to exceed an average plant outages the NRC concluded that Section 26.205(e) [Reviews] has been
of 48 hours per person per week. The although reduced work hours between added to require licensees to
final rule does not retain this successive outages would reduce the periodically self-assess their
requirement because the NRC has potential for cumulative fatigue, the performance with respect to controlling
deleted collective work hour control NRC expects that in many cases the work hours of those individuals who
requirements from the final rule. As a transient workers would have days off perform the job duties specified in
consequence, a limit on repeatedly between outages as they travel between proposed § 26.4(a). This section replaces
exceeding the collective work hour limit nuclear power plant sites or wait for the with substantive changes the
is not necessary for the final rule. beginning of the next outage. As a requirements in § 26.199(j) of the
Proposed § 26.199(f)(5) would have result, a rule requirement for reduced proposed rule. The NRC revised the
permitted licensees to exceed any work hours between successive outages review requirements to eliminate
collective work hour limit of proposed would provide no or limited additional reviews related to the collective work
§ 26.199(f) if the licensee submitted and benefit in these circumstances. The NRC hour limits that were deleted from the
obtained advance approval of a written also considered the limited applicability final rule and to add a review
request to the NRC that included the of the requirement, i.e., the requirement requirement for the implementation of
information in proposed § 26.199(f)(5)(i) would have been limited to instances in the requirements in § 26.205(d)(3).
through (f)(5)(iii). The primary objective which individuals worked successive Work hour controls in proposed
of this provision was to provide a outages for the same licensee. As a § 26.205(d) would provide licensees
regulatory framework for addressing result, the requirement would have with substantial flexibility in
unique and infrequent circumstances, provided a benefit for only a limited controlling work hours. Accordingly,
such as steam generator replacements or scope of individuals in these periodic self-assessments are needed for
other extended outages, that would be circumstances. The NRC also the licensee to maintain reasonable
difficult to manage within the collective considered the increased challenge assurance that they are implementing
work hour controls of § 26.199(f) of the licensees would face in retaining crews the specific work hour control
proposed rule. As described with of supplemental workers between provisions of § 26.205(d) consistent with
respect to § 26.205(d)(6), § 26.205(d)(6) outages if these workers were required the general performance objective in
provides a mechanism in the final rule to take a full 2 weeks off between § 26.23(e). In addition, it is necessary for
for licensees to establish work hour outages. The NRC further considered the self-assessments to be scheduled in
schedules for extended outages without that licensees could have alternatively a manner that ensures corrective action,
the need for NRC approval of a written complied with the requirement by if necessary.
request and therefore allows licensees to employing supplemental workers for a 2 Outages and increased threat
directly and more simply address the week period at the conclusion of an conditions increase the risk of human
circumstances that would have initial outage or the beginning of a error as a result of higher workload, the
otherwise been handled through the successive outage at the levels performance of more complex and
process that proposed § 26.199(f)(5) applicable to an operating plant. The infrequent tasks, and the pressure to
would have required. NRC acknowledges that such a practice meet schedular goals. Therefore, it is
Proposed § 26.199(g) [Successive would likely extend outages and the particularly important to include those
plant outages] would have established reduced work hours could cause some periods of time in any assessment of the
requirements for the control of work individuals to seek alternative effectiveness of a licensee’s work hour
hours during unit and security system employment. In addition, the NRC controls. Accordingly, licensees are
outages that follow a preceding outage considered the potential for the required to conduct a review once per
by less than 2 weeks. The objective of successive outage requirements to calendar year. If any plant or security
the proposed requirements would have adversely affect outage schedules. system outages or increased threat
been to limit the potential for Specifically, if a planned outage must be conditions occurred since the licensee
cumulative fatigue that could result extended due to unforeseen completed the most recent review, the
from working successive outages in complications, the schedule for licensee shall include in the review an
evaluation of the control of work hours Section 26.205(e)(1)(iii) requires that the specific requirements and
during the outages or increased threat the licensee assessments include performance objectives of Part 26.
conditions. Licensees shall complete the individuals who were assessed for Accordingly, licensees are required to
review within 30 days of the end of the fatigue in accordance with § 26.211 maintain the documentation that is
review period. during the review period. This section necessary for NRC reviews of licensees’
Section 26.205(e)(1) requires licensees requires licensees to evaluate whether compliance with the work hour controls
to review the actual work hours and these individuals’ abilities to safely and within the licensees’ existing corrective
performance of individuals who are competently perform their duties had action programs. The requirement is in
subject to this section for consistency actually been compromised. An keeping with the existing requirements
with the requirements of § 26.205(c), so individual who has been assessed for in 10 CFR Part 50 Appendix B, Criterion
that licensees can determine if they are fatigue may be working above his or her XVII, ‘‘Quality Assurance Records,’’ and
scheduling individuals with the tolerance for overtime, and it would be Criterion XVI, ‘‘Corrective Action.’’ The
objective of preventing impairment from necessary for licensees to fully evaluate NRC will use the documentation during
fatigue due to the duration, frequency, the individual’s overall performance. site inspections as a means of assuring
or sequencing of successive shifts. This The requirement is necessary to ensure compliance with the regulations. The
review is consistent with the that licensee fatigue assessments are corrective actions and trending would
performance-based approach in consistent with worker performance and be indicative of a licensee’s performance
§ 26.205(c). are providing an effective basis for in managing the fatigue of its workers
Section 26.205(e)(1)(i) requires the licensee fatigue management decisions. who are subject to the requirements of
licensees to assess individuals whose Section 26.205(e)(2) requires licensees this part. Irregularities in the corrective
actual hours worked during the review to review each individual’s hours action process may indicate a
period exceeded an average of 54 hours worked and the waivers under which programmatic weakness that might
per week in any shift cycle while the work was performed to assess staffing trigger further inspection activities. The
individuals’ work hours are subject to adequacy for all of the jobs that are NRC considers the additional
subject to the work hour controls of recordkeeping burden for documenting
the requirements of § 26.205(d)(3).
§ 26.205. The minimum day off this information under the existing
Individuals that average more than 54
requirements of § 26.205(d)(3) through corrective action program to be
hours over a shift cycle have a
(d)(5) provide assurance that licensees outweighed by the NRC’s need to ensure
substantial number of extended work
are managing cumulative fatigue at a that licensees are complying with the
days, or have received minimal days off,
gross level, and an indication of requirements and maintaining effective
or both. Although the objective of the
whether staffing is adequate to support fatigue management programs.
minimum day off requirements of
the objectives of the rule. However,
§ 26.205(d)(3) is a maximum average Section 26.207 Waivers and
there is a potential that individuals with
work week of 48 hours, the Exceptions
specialized skills may work a
requirements do not prevent individuals disproportionate number of hours and, Section 26.207 permits licensees to
from exceeding an average of 54 hours consequently, may be more susceptible authorize waivers from the work hour
per week. The requirement is necessary to fatigue than others. Accordingly, requirements in § 26.205(d)(1) through
to ensure that licensees fully evaluate § 26.205(e)(2) requires licensees to (d)(5)(i) for conditions that meet the two
the work hours and performance of review work hours and waivers of the criteria specified in this section. Section
these individuals. Several studies have work hour controls to provide assurance 26.207 contains the revised
indicated a tendency for individuals to that fatigue is properly managed for all requirements in proposed § 26.199(d)(3)
underestimate their levels of fatigue jobs. and 26.199(h) and (i) of the proposed
(Wylie, et al., 1996; Dinges, 1995; Section 26.205(e)(3) requires licensees rule. The final rule consolidates these
Rosekind and Schwartz, 1988). This to document the methods used to requirements into a single section to
tendency may cause an individual to conduct their reviews and the results of improve the organization of Subpart I.
fail to recognize that his or her ability the reviews. The NRC will use the Although the provisions are
to perform is degraded. The final rule documentation during site inspections renumbered, the NRC made only limited
requires licensees to independently as a means of assuring compliance with changes to the requirements for the final
evaluate the performance of these the regulations. The methods and rule.
individuals to determine whether their results of the reviews are indicative of Section 26.207(a) permits licensees to
abilities to safely and competently a licensee’s performance in managing grant a waiver of the work hour controls
perform their duties had actually been the fatigue of its workers who are in § 26.205(d)(1) through (d)(5)(i).
compromised. subject to the requirements of this Exceeding the individual work hour
Section 26.205(e)(1)(ii) requires that section. Irregularities in the review limits is justified for limited
licensee assessments include process may indicate a programmatic circumstances in which compliance
individuals who were granted more weakness that might trigger further with the work hour requirements could
than one waiver during the review inspection activities. The NRC considers have immediate adverse consequences
period. This provision requires the additional recordkeeping burden for for the protection of public health and
licensees to assess the work hours and documenting this information to be safety or the common defense and
performance of these individuals to outweighed by the NRC’s need to ensure security. Limited use of waivers is also
ensure that licensees adequately that licensees are complying with the consistent with the Commission’s
evaluate whether an individual’s proposed requirements of this section position stated in the NRC’s Policy on
abilities to safely and competently and maintaining effective fatigue Worker Fatigue. However, as specified
perform their duties had actually been management programs. in § 26.207(a)(2), which contains the
compromised while working under a Section 26.205(e)(4) requires licensees requirements in proposed
waiver. This requirement is necessary to to record, trend, and correct, under the § 26.199(d)(3)(ii), the NRC expects a
ensure that licensees’ use of waivers did licensee’s corrective action program, licensee to grant waivers only to address
not result in degraded worker fitness- any problems identified in maintaining circumstances that it cannot reasonably
for-duty. control of work hours consistent with control.
Section 26.207(a)(1)(i) requires an considerable stakeholder comment and guidelines. Accordingly,

operations shift manager to determine discussion during the public meetings § 26.207(a)(1)(i) permits senior site
that the waiver is necessary to mitigate described in the preamble to the managers with the signature authority of
or prevent a condition adverse to safety, proposed rule. Industry representatives operations shift supervisors to make the
or a security shift manager to determine stated that the criterion is overly safety determinations that are required
that the waiver is necessary to maintain restrictive because it would prohibit the to grant waivers and senior site
site security, or a site senior-level granting of waivers for conditions that managers with the signature authority of
manager with requisite signature could be cost beneficial to the licensee security shift supervisors to make the
authority to make either determination. without a substantive decrease in safety. security determinations required to
This section establishes one of two However, the potential for worker grant waivers.
criteria in the final rule for granting a fatigue in conditions that require a Section 26.207(a)(1)(ii) establishes the
waiver from the individual work hours waiver is substantial (Baker, et al., 1994; second of two criteria for granting a
requirements. This section replaces Dawson and Reid, 1997; Stephens, 1995; waiver from the individual work hour
proposed § 26.199(d)(3)(i)(A), with Strohl, 1999). Therefore, the NRC does controls of § 26.205(d)(1) through
limited editorial revisions. not believe that licensees can reasonably (d)(5)(i). This section contains, with
The NRC’s Policy on Worker Fatigue justify the performance of risk- revision, the requirements in
recognized that ‘‘very unusual significant functions by individuals who § 26.199(d)(3)(i)(B) of the proposed rule.
circumstances may arise requiring have worked hours in excess of the Section 26.207(a)(1)(ii) requires that a
deviation from the above [work hour] limits on the basis that granting the supervisor, who is qualified to direct the
guidelines.’’ In SECY–01–0113, the NRC waiver will not have an adverse impact work to be performed by the individual
noted that the frequency of guideline on safety or security. The preamble to to whom the waiver will be granted and
deviations at a substantial proportion of the proposed rule details the NRC’s is trained in accordance with the
sites appeared to be inconsistent with decision not to incorporate industry’s requirements of §§ 26.29 [Training] and
the intent of the policy and that some comment on this provision. 26.203(c) [Training and examinations],
licensees abused the authority to grant must assess the individual face to face
Section 26.207(a)(1)(i) further requires
deviations from the work hour and be reasonably sure that the
that an operations shift manager or a
guidelines. Section 26.207(a)(1)(i) more individual will be able to safely and
senior-level site manager with requisite
clearly articulates the NRC’s competently perform his or her duties
signature authority must make the
expectations with respect to exceeding during the additional work period for
the work hour limits; licensees must determination that a waiver is necessary which the waiver is sought. These
limit the granting of waivers from the to mitigate or prevent a condition determinations require knowledge of the
work hour limits to circumstances in adverse to safety. Similarly, the final specific skills that are necessary to
which such a waiver is necessary to rule requires that a security shift perform the work and the conditions
prevent or mitigate a condition adverse manager, or a senior-level site manager under which the work will be
to safety or to maintain the security of with requisite signature authority, must performed in order to assess the
the plant. The criterion in the final rule make the determination that a waiver is potential for fatigue to adversely affect
limits waivers to conditions that are necessary to maintain the security of the the ability of an individual to safely and
infrequent while still permitting waivers facility. Operations shift managers and competently perform the work. This
that are necessary for safety or security. security shift managers have the knowledge is generally limited to
For example, § 26.207(a)(1)(i) permits a requisite knowledge and qualifications individuals who are qualified to direct
licensee to grant a waiver from a work to make the respective safety or security the work. The training required by
hour requirement if necessary to prevent determinations and making such §§ 26.29 and 26.203(c) provides the KAs
a condition adverse to safety, if determinations is consistent with the that are essential for a supervisor to
compliance with the work hour scope of duties currently performed by make valid assessments in this regard.
requirement will cause the licensee to individuals in these positions. The NRC Among other FFD topics, the training
violate other NRC requirements, such as considered industry stakeholder addresses the contributors to worker
the minimum onsite staffing comments during the public meetings fatigue and decreased alertness in the
requirements in 10 CFR 50.54(m), or if described in the preamble to the workplace, the potential adverse effects
a delay in the recovery of failed plant proposed rule, expressing concern that of fatigue on job performance, and the
equipment that is necessary for limiting the authority to approve effective use of fatigue countermeasures.
maintaining plant safety will occur. waivers to operations shift managers Accordingly, the training is necessary
Similarly, the NRC considers it and security shift managers could for individuals to perform these
appropriate to grant a waiver from the contribute to overburdening individuals assessments.
work hour requirements if necessary to in these positions and prevent The NRC revised the proposed rule to
prevent a condition adverse to safety or distributing the administrative burden account for the situation in which no
if compliance with the work hour of granting a waiver to other qualified supervisor qualified to direct the work
requirements would cause a forced individuals. The NRC also considered is on site. To address this circumstance,
reactor shutdown, power reduction, or other stakeholder comments concerning § 26.207(a)(1)(ii) of the final rule states
other similar action, as a result of the need to ensure that the individuals that a supervisor who is qualified to
exceeding a time limit for a technical making these determinations are not provide oversight of the work to be
specification limiting condition for unduly influenced by schedule performed by the individual can make
operation (LCO). LCOs require nuclear pressures. The NRC noted that some the assessment if he or she is trained in
power plant licensees to take certain licensees had delegated the authority to accordance with the requirements of
actions to maintain the plant in a safe authorize deviations to organizational §§ 26.29 and 26.203(c). Although this
condition under various conditions, levels that appeared to be inconsistent individual may be less familiar with the
including malfunctions of key safety with the guidelines in the NRC’s Policy details of how the work is to be
systems. on Worker Fatigue, which recommend performed, the exception prevents the
The criterion for granting waivers in that the plant manager or plant manager substantial burden of a licensee
§ 26.207(a)(1)(i) was the subject of designee authorize deviations from the requiring a supervisor who is qualified
to direct the work to report to the site the need for licensees to be able to focus IV.D, waivers should be used
to perform the assessment, as well as the assessment on information that is infrequently and only when necessary
preventing the potential fatigue of the readily available and could be verified. to protect the public. Licensees should
supervisor if called in during the night. Section 26.207(a)(1)(ii) further take all reasonable care to ensure the
Section 26.207(a)(1)(ii) further requires that the supervisory assessment use of waivers is minimized. Therefore,
requires that supervisors must perform for granting a waiver address the § 26.207(a)(2) prohibits the use of
the assessment face to face with the potential for fatigue-related waivers in lieu of adequate staffing or
individual to which the waiver will degradations in alertness and proper work planning, for example, but
apply. This requirement ensures that the performance to affect risk-significant would permit the use of waivers for
supervisor who is performing the functions and whether it is necessary to circumstances that the licensee could
assessment has the opportunity to establish controls and conditions under not have reasonably controlled, which
observe the individual’s appearance and which the individual is permitted to may include, but are not limited to,
behavior and note any indications of perform work. This requirement is equipment failures or a sudden increase
fatigue (e.g., decreased facial tone, consistent with the NRC’s Policy on in the personnel attrition rate.
rubbing of eyes, slowed speech). The Worker Fatigue, which states that ‘‘the Section 26.207(a)(3) requires that the
supervisor can also interact with the paramount consideration in such face-to-face supervisory assessment
individual to assess his or her ability to authorizations shall be that significant required by § 26.207(a)(1)(ii) be
continue to safely and competently reductions in the effectiveness of performed sufficiently close in time to
perform his or her duties during the operating personnel would be highly the period during which the individual
period for which the waiver will be unlikely.’’ However, § 26.207(a)(1)(ii) will be performing work under the
granted. requires the supervisor to identify any waiver to ensure that the assessment
Section 26.207(a)(1)(ii) also requires risk-significant functions that may be will provide a valid indication of the
that the supervisory assessment must compromised by worker fatigue, thereby potential for worker fatigue during the
address, at a minimum, the potential for focusing the assessment on worker extended work period. This section
acute and cumulative fatigue, activities that have the greatest impact contains the requirements presented in
considering the individual’s work on the protection of the public, § 26.199(d)(3)(iii) of the proposed rule.
history for at least the past 14 days, and considering the types of skills and This requirement is needed because
the potential for circadian degradations abilities that are most sensitive to worker alertness and the ability to
in alertness and performance, fatigue-related degradations. perform can change markedly over
considering the time of day for which Section 26.207(a)(1)(ii) also requires several hours (Baker, et al., 1990;
the waiver will be granted. The the supervisor to identify any additional Dawson and Reid, 1997; Frobert, 1997;
potential for acute fatigue can be controls and conditions that he or she Folkard and Monk, 1980; Rosa, 1995).
practically assessed by estimating the considers necessary to grant the These changes can be particularly
total number of continuous hours that individual a waiver from a work hour dramatic if fatigue from sustained
the individual will have worked by the control. For example, applicable wakefulness coincides with circadian
end of the work period for which the controls and conditions may include, periods of decreased alertness (Baker, et
waiver is being considered. The but are not limited to (1) peer review al., 1990; Gander, et al., 1998; Rosekind,
potential for cumulative fatigue can be and approval of assigned job tasks, (2) 1997; Folkard and Tucker, 2003; Carrier
practically assessed by reviewing the assignment of job tasks that are non- and Monk, 2000). Therefore, the final
individual’s work schedule during the repetitive in nature, (3) assignment of rule requires licensees to conduct
past 14 days to determine whether (1) job tasks that allow the individual to be supervisory assessments within a time
the individual had adequate physically active, and (4) provisions for period that provides reasonable
opportunity to obtain sufficient rest, additional rest breaks. The requirement assurance that the individual’s
considering the length and sequencing to consider establishing controls and condition will not substantively change
of break periods, (2) the available sleep conditions is necessary to ensure that before work is performed under the
periods occurred during the night or at licensees take steps to mitigate fatigue waiver.
other times when sleep quality may be from an extended work period and Section 26.207(a)(3) also establishes a
degraded, and (3) the potential exists for reduce the likelihood of fatigue-related period of 4 hours before the individual
transitions between shifts (e.g., from errors adversely affecting public health begins working under the waiver as the
days to nights) to have interfered with and safety or the common defense and period within which the supervisory
the individual’s ability to obtain security. assessment must be performed. In
adequate rest. The potential for Section 26.207(a)(2) requires establishing a maximum time period the
circadian degradations in alertness and licensees, to the extent practical, to NRC considered several factors.
performance can be practically assessed grant waivers only in circumstances that Conducting the assessment as close in
by considering the time of day or night could not have been reasonably time as practical to the period during
during which the work would be controlled. This section contains the which the individual will perform work
performed, as well as the times of day requirement presented in under the waiver will provide the
of the individual’s recent shift § 26.199(d)(3)(ii) of the proposed rule. greatest assurance of a valid assessment.
schedules. Section 26.207(a)(1)(ii) in This requirement is necessary because However, conducting the assessment
effect requires supervisors to address conditions for meeting the waiver immediately before the individual will
the three work schedule factors (i.e., criteria that are specified in begin performing work under the waiver
shift timing, shift duration, and speed of § 26.207(a)(1) could routinely result could, in some circumstances, cause the
rotation) that are generally considered to from inadequate staffing or work timing of assessments to conflict with
be the largest determinants of worker planning. Licensees have authorized the conduct of shift turnovers and other
fatigue (Akerstedt, 2004; McCallum, et deviations from their technical practical administrative and operational
al., 2003; Mallis, et al., 2002; Folkard specification limits on work hours for constraints. Additionally, assessments
and Monk, 1980; Rosa, 1995; Rosa, et such reasons in the past. However, for granting waivers from the longer
al., 1996). In determining the scope of because of the significant adverse effects term individual limits (e.g., the
the assessment, the NRC also considered of worker fatigue, as detailed in Section maximum number of work hours in 7
days) would be less sensitive to the minimum days off requirement because status. At the conclusion of the declared
specific timing of the assessment. these exercises can be fully planned and emergency, the rule would require
However, certain licensees have scheduled by licensees in advance in a licensees to again comply with the work
periodically authorized blanket manner that complies with the hour controls.
deviations from technical specification requirements. Nevertheless, the more
Section 26.209 Self-Declarations
work hour limits days and weeks in limited exception should provide
advance of the actual performance of the adequate flexibility to licensees given Section 26.209(a) retains, with limited
work. A maximum limit of 4 hours that (1) the final rule removes all editorial changes, the requirements
would address the need for an restrictions on group work hour controls presented in § 26.199(e) of the proposed
enforceable requirement that would for security personnel, and (2) the rule. Section 26.209(a) requires
provide reasonable assurance of valid exception applies to all security licensees to take immediate action in
assessments and would take into personnel working during affected shifts response to a self-declaration (as
account the relevant technical and (including staff that do not participate discussed with respect to § 26.203(b)(1))
practical considerations. An added in the exercise) even though the by an individual who is working under,
benefit of this requirement is that it minimum days off requirement applies or being considered for, a waiver from
would prevent the simultaneous to security personnel on an individual the work hour controls in § 26.205(d)(1)
granting of blanket waivers for large basis. In contrast, the group work hour through (d)(5)(i). Licensees are required
groups of individuals that do not take controls applied to security personnel to immediately stop the individual from
into account each individual’s level of collectively. During the limited performing any duties listed in § 26.4(a)
fatigue. exception period for these triennial unless the individual is required to
Section 26.207(a)(4) requires licensees (every 3 years) NRC-evaluated exercises, continue performing those duties under
to document the bases for granting the requirements in § 26.205(d)(1) and other requirements of 10 CFR Chapter I,
waivers from the individual work hour (d)(2) provide reasonable assurance that such as the minimum control room
controls of § 26.205(d). This section fatigue does not impair the ability of staffing requirements in 10 CFR
contains the requirement presented in these individuals to safely and 50.54(m). If other requirements make it
§ 26.199(d)(3)(iv) of the proposed rule. competently perform their duties. necessary for the individual to continue
This section requires licensees to Section 26.207(c) [Common defense working, this section requires the
document the circumstances that and security] provides a licensee relief licensee to immediately take action to
necessitate the waiver, a statement of from the work hour control relieve the individual. For example, the
the scope of work and time period for requirements of § 26.205(d) upon licensee should immediately begin a
which the waiver is approved, and the written notification from the NRC, for call-in procedure for another individual
bases for the determinations required by the purpose of assuring the common to fill the required position and remove
§ 26.207(a)(1). This documentation is defense and security for a period the the individual from duties as soon as
necessary to support NRC inspections of NRC defines. This section contains the relief becomes available.
compliance with requirements for requirements presented in § 26.199(h) of The final rule retains this requirement
granting waivers from the work hour the proposed rule. The exception of the proposed rule because correct
limits as well as for the licensee self- granted by this section provides performance of the duties specified in
assessments of the effectiveness of necessary relief from the requirements § 26.4(a) is critical to maintaining public
implementing work hour controls that of the work hour controls in cases of health and safety and the common
would be required under § 26.205(e). emergencies that are not otherwise defense and security. In addition, there
Section 26.207(b) [Force-on-force covered in this section, including war, is a significantly increased potential for
tactical exercises] of the final rule in which the increased risk from fatigue- fatigue-related errors when individuals
relieves licensees from the requirements induced errors would be outweighed by work more than the maximum work
of § 26.205(d)(3) by allowing them to the need to maintain the common hours or obtain less rest than the
exclude shifts worked by security defense and security. This section also minimum rest requirements of
personnel during the actual conduct of indicates that the NRC would provide § 26.205(d)(1) through (d)(5)(i).
NRC-evaluated force-on-force tactical such relief in writing. Individuals working extended hours
exercises when calculating the Section 26.207(d) [Plant emergencies] under a waiver will have a clear and
individual’s number of days off. This adds the potential to temporarily waive legitimate basis for a self-declaration of
provision is an addition to the the requirements of § 26.205(c) and (d) being unfit for duty because of fatigue.
requirements of the proposed rule and during declared emergencies, as defined Further, by self-declaring fatigue, the
is similar to a slightly different in the licensee’s emergency plan. This individual will effectively provide an
exception contained in Order EA–03–08 section contains the requirements assessment of his or her ability to
that applied to group work hour presented in § 26.199(i) of the proposed continue to safely and competently
controls. The NRC believes this rule. Plant emergencies are perform these critical duties. Several
provision is appropriate in order to extraordinary circumstances that may be studies indicate a tendency for
provide licensees flexibility in most effectively addressed through staff individuals to underestimate their level
accommodating the NRC-evaluated augmentation that can only be of fatigue (Wylie et al., 1996; Dinges,
tactical exercises, which are not under practically achieved through the use of 1995; Rosekind and Schwartz, 1988).
a licensee’s full control. For example, it work hours in excess of the limits of Therefore, it is very likely that an
allows licensees to use security § 26.205(c) and (d). The objective of the individual who makes a self-declaration
personnel on their normally scheduled temporary exemption is to ensure that of fatigue is potentially more impaired
days off to support the conduct of the the control of work hours and than he or she realizes.
exercise without violating the rule. The management of worker fatigue do not Section 26.209(a) does not require
exception in Order EA–03–08 also impede a licensee’s ability to use that licensees immediately relieve an
applied to other force-on-force tactical whatever staff resources may be individual who self-declares when it is
exercises (i.e., any not evaluated by the necessary to respond to a plant necessary for the individual to continue
NRC), but the NRC believes this is not emergency and ensure that the plant performing his or her duties under other
an appropriate exception for the reaches and maintains a safe and secure requirements of 10 CFR Chapter I. The
failure to meet minimum staffing or safety or the common defense and in fact, safely and competently perform
similar requirements will, in the security. their duties. Further, in situations in
majority of cases, have a greater Section 26.209(b)(2) requires licensees which a plant event requires drug or
potential to adversely affect public to permit or require an individual who alcohol testing as specified in § 26.31(c)
health and safety and the common has made a self-declaration to take a rest [Conditions for testing], this section
defense and security than permitting a break of at least 10 hours before the requires the licensee to conduct a
fatigued individual to continue individual returns to performing any fatigue assessment to determine whether
performing his or her duties for a duties listed in § 26.4(a). This section fatigue contributed to the event.
limited period of time. Further, in these contains, with limited editorial Work hour requirements are
circumstances, licensees can implement revisions, the requirements presented in necessary, but not sufficient, to manage
any fatigue mitigation strategies they § 26.199(e)(2) of the proposed rule. The worker fatigue effectively. Worker
deem necessary while the individual final rule includes this requirement to fatigue, and its effects on worker
remains on duty. Fatigue mitigation ensure that individuals who have self- alertness and performance, can result
measures in these circumstances declared are given an opportunity to from many causes in addition to work
include, but are not limited to, controls sleep before they are permitted to hours (e.g., stress, sleep disorders, daily
on the type of work that the individual resume performing any duties that have living obligations) (Rosa, 1995; Presser,
may perform until he or she is relieved the potential to adversely affect public 2000). Further, individuals differ
(e.g., physical or mental, tedious or health and safety or the common substantially in their ability to work for
stimulating, individual or group, risk- defense and security. Sleep is widely extended periods without performance
significant or not) and an increased considered the only non- degradation from fatigue (Gander, 1998;
level of supervision (continuous or pharmacological means of reducing Jansen et al., 2003; Van Dongen et al.,
intermittent) and other oversight (e.g., fatigue. As discussed with respect to 2004a; Van Dongen et al., 2004b). The
peer checks, independent verifications, § 26.205(d)(2)(i), a 10-hour rest break work hour requirements of § 26.205
quality assurance reviews, and generally allows individuals to obtain provide only partial assurance that
operability checks). the 7–8 hours of sleep that is individuals are not fatigued. Therefore,
Section 26.209(b) establishes the recommended by most experts for fatigue assessments are essential.
maintaining human performance Appropriately assessing fatigue is also
requirements for returning an individual
(National Sleep Foundation, 2001; important because workers who are
to duty following a self-declaration
Dinges et al., 1997; Belenky et al., 2003; experiencing either acute or cumulative
under the conditions described in
Akerstedt, 2003; Monk et al., 2000; fatigue may not be able to perform their
§ 26.209(a). These provisions allow the
Rosekind et al., 1997; Rosa, 1995). duties safely and competently, as
individual to be reassigned to duties Although one sleep period of 7–8 discussed in Section IV.D. A large body
that are not subject to work hour hours may be insufficient to ensure full of research demonstrates the negative
requirements, if the individual is fit for recovery from excessive fatigue, nothing effects of fatigue on individuals’
such duties, and requires that the in the final rule precludes an individual abilities to perform. The literature
individual have a break of at least 10 in this circumstance from making a includes studies comparing the effects
hours before returning to duties that are second self-declaration of fatigue if the of fatigue with those of alcohol
subject to the work hour requirements of individual believes that he or she intoxication. The effects of both
Subpart I. remains unable to safely and conditions can be expressed in the form
Section 26.209(b)(1) permits licensees competently perform his or her duties of performance decrements. Studies
to reassign an individual who has made following the rest break. Section I.B of have correlated hours of wakefulness
a self-declaration of fatigue to perform NRC RIS 2002–07 addressed the with equivalent blood alcohol
other duties than those specified in applicability of the protections of 10 concentrations showing that the
§ 26.4(a). This section contains with CFR 50.7, [Employee protection] to performance decrements resulting from
limited editorial revisions the workers who self-declare that they are fatigue are at least as severe as the
requirements presented in § 26.199(e)(1) unfit for duty as a result of fatigue. performance decrements observed when
of the proposed rule. The final rule individuals consume the legal limit of
includes this flexibility because, Section 26.211 Fatigue Assessments
alcohol (Dawson and Reid, 1997; Falleti
although an individual may not be fit to Section 26.211 requires licensees to et al., 2003). At the extreme, workers
perform the activities specified in conduct fatigue assessments under who have acute fatigue show symptoms
§ 26.4(a), he or she may be able to safely several conditions and contains, with that are similar to those of intoxication.
and competently perform other duties. limited editorial changes, the Speech is less precise, attention may be
Other duties can include, but are not requirements presented in proposed lacking, and normal body movements
limited to, tasks that require skills that § 26.201. The numbering and content of and posture may be absent. Therefore, it
are less susceptible to degradation from the paragraphs in § 26.211 remain is just as important for a worker to be
fatigue or do not have the potential to consistent with that of proposed assessed to determine if he or she is
adversely affect public health and safety § 26.201. These conditions, specified in unduly impaired from fatigue as it is for
or the common defense and security if § 26.211(a)(1) through (a)(4), include for the worker to be evaluated to determine
the individual commits fatigue-related cause, after a self-declaration, after an whether he or she is impaired from
errors. The final rule permits licensees event that requires post-event drug and consuming alcohol.
to reassign individuals who make a self- alcohol testing, and as a followup to The objective of the assessments
declaration of fatigue to other duties, if returning an individual to work after a required by § 26.211(a)(1) through (a)(4)
the results of a fatigue assessment (as self-declaration. The assessments are is for licensees to address instances of
required under § 26.211) indicate that necessary to determine whether worker fatigue appropriately, including
he or she is fit to perform them, because individuals who are observed to be in a those that are not prevented by the work
permitting the individual to remain at condition creating a reasonable hour requirements, regardless of the
work and continue performing such suspicion of impaired individual number of hours that the subject
duties will not have the potential to alertness or have indicated that they are individual has worked or rested. As
adversely impact public health and not fit for duty because of fatigue can, discussed with respect to § 26.211(c),
these assessments provide the basis for expressing concern with for-cause those whose fitness may be
subsequent management actions for assessments for work performed outside questionable, shall be removed from
fatigue management (e.g., relieving an of the protected area (PA). Although activities within the scope of this part,
individual of duties or requiring whether a worker is inside the PA is not and may be returned only after
additional fatigue mitigation actions). a criterion for being subject to Part 26 determined to be fit to safely and
Therefore, fatigue assessments are requirements, the NRC recognizes that competently perform activities within
important for effective fatigue napping is an effective means for the scope of this part.’’ A statement by
management because they provide the reducing worker fatigue. Therefore, an individual to his or her supervisor
basis for any short-term corrective § 26.211(a)(1) excludes napping during a that he or she is not fit to safely and
actions that may be necessary to ensure break period as a condition for which competently perform his or her duties
that individuals are able to safely and the final provision requires a for-cause because of fatigue is an indication that
competently perform their duties and fatigue assessment. the individual’s FFD is questionable,
any long-term corrective actions that Section 26.211(a)(1) also permits and that an assessment, or a rest break
may be necessary to address individual licensees to conduct a fatigue of at least 10 hours, is necessary before
or programmatic issues contributing to assessment, without drug and alcohol the individual may be returned to duty.
recurring instances of fatigue. testing, if the observed condition is Therefore, in circumstances in which an
Section 26.211(a)(1) specifies that impaired alertness with no other individual requests to be relieved of
licensees must perform a fatigue indication of possible substance abuse. duties because of fatigue and the
assessment, in addition to any other In developing the requirement related to individual is relieved of duties for at
testing that is required under §§ 26.31(c) for-cause fatigue assessments, the NRC least 10 hours, the final rule does not
and 26.77, if a worker is observed to be considered stakeholder comments require the licensee to conduct another
in a condition of impaired alertness and during the public meetings described in fatigue assessment before permitting the
there is a reasonable suspicion that he the preamble to the proposed rule. individual to return to duty, consistent
or she may not be fit to safely and Stakeholders expressed concern that with current industry practice.
competently perform his or her duties. testing for drugs and alcohol, in Providing a 10-hour break is consistent
The objective of the requirement is to addition to fatigue, when the only with § 26.205(d)(2)(i), which establishes
ensure that fatigue is considered, in apparent cause of impairment was required break times between work
addition to drugs or alcohol, as a cause decreased alertness, would cause periods, and is generally considered
for impaired alertness. As noted in stigma, burden, and reluctance to raise sufficient to address most acute fatigue
SECY–01–0113, approximately 80 FFD concerns that may result in for- conditions.
percent of all for-cause FFD tests cause testing. Accordingly, the As discussed with respect to
conducted annually yield negative requirement permits licensees to assess § 26.211(c), a fatigue assessment
results for drugs and alcohol. A fatigue only fatigue if there are no indications provides a basis for a licensee to
assessment will help to determine if of possible substance abuse. determine whether the individual is
fatigue was the cause for the perceived Section 26.211(a)(1) also permits able to safely and competently perform
impairment when testing does not licensees to conduct drug and alcohol his or her duties and what, if any,
support drugs or alcohol as the probable testing, without a fatigue assessment, subsequent management actions for
cause. when the licensee has reason to believe fatigue management are necessary (e.g.,
Common indications of impaired that the observed condition is not relieving an individual of duties or
alertness include yawning, red eyes, caused by fatigue. The NRC considered requiring additional fatigue mitigation
prolonged or excessive blinking, stakeholder comments at the public actions). As discussed with respect to
rubbing of the face with the hands, and meetings described in the preamble to § 26.203(b)(1)(ii), licensees are required
gross body movements to maintain the proposed rule that a requirement to to establish controls and conditions
alertness. Individuals may take perform a fatigue assessment when the under which an individual may be
substantially longer to complete routine licensee has a reasonable basis for permitted or required to perform work
tasks, exhibit difficultly processing believing that the condition is from after that individual declares that he or
written or oral communications, and causes other than fatigue is an undue she is not fit because of fatigue.
may become less talkative. At the burden. In many cases, an observed In developing the final requirement
extreme, workers who are experiencing condition may clearly relate to drugs or for fatigue assessments of individuals
acute fatigue have symptoms that are alcohol only (such as the smell of who have self-declared, the NRC
similar to those of intoxication. alcohol on an individual), and in such considered research on subjective
Individuals who are fatigued are more cases, a fatigue assessment will have no assessments of alertness. Self-
likely to complain of illness, pain, or benefit. declarations are generally based on an
discomfort. In addition to decreased Section 26.211(a)(2) requires licensees individual’s subjective evaluation of his
vigor, fatigued individuals may be more to conduct a fatigue assessment if an or her alertness. Studies have indicated
irritable, engage in inappropriate individual makes a self-declaration that that individuals often misjudge their
humor, exhibit less conservative he or she is not fit to safely and own fatigue, typically by
decisionmaking, and persevere in using competently perform his or her duties underestimating their level of fatigue
ineffective problem solutions (Horne, because of fatigue, except if the licensee and propensity for uncontrolled sleep
1988; Harrison and Horne, 2000; Dinges permits or requires the individual to episodes. This effect is widely
et al., 1997; Pilcher and Huffcutt, 1996; take a rest break of at least 10 hours. recognized by scientists who study
Belenky et al., 2003; Monk, 2003). Self-declarations provide assurance that sleep and fatigue. Rosekind, et al. (1997)
Section 26.211(a)(1) does not require instances of worker fatigue, including noted that ‘‘An important phenomenon,
licensees to conduct a fatigue those that are not prevented by the work highly relevant to operational
assessment if indications of impaired hour requirements in § 26.205, are environments, is that there is a
individual alertness are observed during appropriately addressed, regardless of discrepancy between subjective reports
an individual’s break period. The NRC the number of hours the individual has of sleepiness/alertness and
considered a comment from the IBEW at worked or rested. Former § 26.27(b)(1) physiological measures. In general,
a September 14, 2004, public meeting required that ‘‘impaired workers, or individuals will report higher levels of
alertness than indicated by future events. The assessment will also §§ 26.29 and 26.203(c), must conduct
physiological measures.’’ As a provide the basis for subsequent any fatigue assessment that is required
consequence, individuals who self- management actions for fatigue under § 26.211. Under § 26.211(c),
declare will tend to be more impaired management, as required by § 26.211(c) fatigue assessments provide the basis for
than they realize. An exception to this (e.g., relieving an individual of duties or subsequent actions for fatigue
tendency has been noted by Dinges, et requiring additional fatigue mitigation management (e.g., relieving an
al. (1988) who noted that naps can actions). Further, the fatigue assessment individual of duties or requiring
benefit the performance of those will provide insights concerning the additional fatigue mitigation actions). In
experiencing sleep loss, without that effectiveness of the licensee’s fatigue addition, the NRC recognizes that
benefit being apparent in subjective management program. fatigue assessments may be used by
measures. Therefore, it is not only Consistent with § 26.31(d)(5)(ii), the some licensees as a basis for imposing
important to assess self-declarations as requirement specifies that licensees may sanctions on individuals. Therefore, the
an indicator that an individual may not not delay necessary medical treatment authority to perform fatigue assessments
be able to safely and competently in order to conduct a fatigue assessment, should be limited to supervisors or staff
perform his or her duties, but also to if the event involved physical harm to members of the FFD program. The
consider factors in addition to a self- the individual. The NRC considers the training required by §§ 26.29 and
declaration as part of the fatigue immediate medical needs of the 26.203(c) provides the KAs that are
assessment. individual to be paramount. In these essential to a supervisor’s or FFD
Section 26.211(a)(2) also specifies that circumstances, it is reasonable to program staff member’s ability to make
licensees must perform fatigue presume that the individual has been valid assessments in this regard. Among
assessments for self-declarations made removed from duty and consequently other FFD program topics, the training
to an individual’s supervisor. The NRC the individual’s level of fatigue is addresses (1) the contributors to worker
considered stakeholder comments at irrelevant to the immediate protection of fatigue and decreased alertness in the
public meetings that the final rule public health and safety or the common workplace, (2) symptoms of worker
should be clear with respect to the defense and security. fatigue, (3) indications and risk factors
behavior that constitutes a self- Section 26.211(a)(4) requires licensees for common sleep disorders, and (4) the
declaration. For example, stakeholders to perform a followup fatigue effective use of fatigue countermeasures.
expressed concern that an individual’s assessment if an individual is returned Section 26.29(b) [Policy] also requires
off-hand remark to a co-worker that he to work after a break of fewer than 10 individuals to demonstrate successful
or she is groggy would be considered a hours following a fatigue assessment completion of the training by passing a
self-declaration under the final rule and, that was performed for cause or in comprehensive examination that
therefore, require a fatigue assessment response to a self-declaration. Although addresses the KAs.
in conditions that could be satisfactorily sleep periods of less than 8 hours (e.g., Section 26.211(b) further requires that
addressed through less formal naps) can mitigate some effects of supervisors or FFD program staff
processes. The NRC’s objective is not to fatigue, such sleep periods are typically members must perform the fatigue
supplant these normal processes for insufficient to provide complete assessment face to face with the subject
licensee workforce management, but to recovery from fatigue (McCallum, et al., individual. This requirement ensures
ensure that formal declarations of 2003; Dinges, et al., 1997; Totterdell, et that the individual performing the
fatigue are appropriately evaluated and al., 1995). As a consequence, the assessment has the opportunity to (1)
addressed. Therefore, the requirement objective of this provision is to ensure observe the subject individual’s
specifies that fatigue assessments must that, in circumstances of sleep periods appearance and behavior to note
be conducted for self-declarations of less than 8 hours (e.g., if a licensee indications of fatigue (e.g., decreased
concerning an individual’s ability to provides an individual an opportunity facial tone, rubbing of eyes, slowed
‘‘safely and competently perform his or for a nap rather than a 10-hour break), speech), (2) interact with the individual
her duties’’ and require that the self- the short rest break has provided to understand the individual’s self-
declaration must be made to the sufficient rest to mitigate the assessment of his or her ability to safely
individual’s supervisor. However, as individual’s fatigue and that the and competently perform his or her
discussed with respect to § 26.211(a)(1), individual is not still groggy from sleep duties, and (3) understand any factors in
a fatigue assessment must be performed inertia. Sleep inertia is the grogginess addition to the individual’s work
in response to an observed condition of that an individual experiences in the schedule that may have contributed to
impaired alertness. If, in the preceding transition from sleep to wakefulness fatigue.
example, the groggy individual remains that can temporarily affect an Section 26.211(b)(1) prohibits
on duty and is observed to exhibit individual’s ability to safely and individuals who observe another
impaired alertness, a fatigue assessment competently perform his or her duties individual exhibiting indications of
is required for cause in accordance with (Bruck and Pisani, 1999; Sallinen, et al., impaired alertness from performing the
§ 26.211(a)(1). 1998). Further, the assessment ensures for-cause fatigue assessment of that
Section 26.211(a)(3) specifies that that the individual is capable of individual. Without this prohibition, a
licensees must perform a fatigue performing his or her duties safely and single supervisor could potentially both
assessment after an event that requires competently during the upcoming work observe a worker exhibiting indications
drug or alcohol testing, as required in period. It also provides the information of impairment from fatigue and also
§ 26.31(c)(3). Section 26.31(c)(3)(i) necessary for the licensee to determine conduct the for-cause assessment of that
through (c)(3)(iii) specifies the events whether any controls or conditions must worker. In accordance with § 26.211(c),
and conditions requiring post-event be implemented during the work period fatigue assessments provide the basis for
drug and alcohol testing. A fatigue (Priest, 2000; Baker, et al., 1990; subsequent management actions for
assessment is also necessary in these Sallinen, 1998; Kruger, 2002). fatigue management. In addition, some
circumstances to determine whether Section 26.211(b) requires that either licensees may use fatigue assessments as
worker fatigue contributed to the event a supervisor or a staff member of the a basis for imposing sanctions on
and, if so, to identify the need for any FFD program, who is trained in individuals, if, for example, a licensee
corrective actions to prevent similar accordance with the requirements of believes that an individual has been
negligent in maintaining his or her FFD. assessments under the specified Section 26.211(c)(1)(ii) specifies the
Therefore, in the case of fatigue conditions. second criterion that fatigue
assessments that are conducted for Section 26.211(b)(2)(iii) prohibits assessments will address, cumulative
cause, an independent third party shall individuals from performing a post- fatigue. Cumulative fatigue also directly
perform the fatigue assessment to event fatigue assessment if they affects an individual’s ability to safely
provide reasonable assurance of an evaluated or approved a waiver of the and competently perform his or her
objective assessment. limits specified in § 26.205(d)(1) duties, as discussed in Section IV.D.
Section 26.211(b)(2) prohibits through (d)(5)(i) for any of the Licensees will assess the potential for
individuals from performing a post- individuals who were performing or cumulative fatigue by reviewing, at a
event fatigue assessment in those directing the work activities during minimum, (1) the individual’s work
circumstances specified in which the event occurred if the event schedule during the past 14 days to
§ 26.211(b)(2)(i) through (b)(2)(iii), in occurred while such individuals were assess whether the individual had
which a conflict of interest may be performing work under that waiver. adequate opportunity to obtain
present. An individual who has a This provision limits the potential for sufficient rest, considering the length
conflict of interest may not provide an bias in assessments that can result from and sequencing of break periods, (2)
objective assessment of the subject prior involvement in assessing the whether the available sleep periods
individual’s fatigue. This requirement individual or responsibility for the work occurred during the night or at other
provides assurance of an objective activities associated with the event. times when sleep quality may be
fatigue assessment by prohibiting Section 26.211(c) requires that fatigue degraded, (3) the potential for
individuals from performing the assessments must provide the transitions between shifts (e.g., from
assessment who were directly information necessary for management days to nights) to have interfered with
responsible for performing the work or decisions and actions in response to the the ability of the individual to obtain
assessing the individuals who were circumstance that initiated the adequate rest, and (4) other individual
involved in the event. assessment. This information is factors or information provided by the
Section 26.211(b)(2)(i) prohibits individual (such as any personal issues
necessary to determine the subject
individuals from performing a post- that may impact his or her ability to
individual’s ability to safely and
event fatigue assessment if they obtain adequate sleep). For cumulative
competently perform his or her duties,
performed or directed the work fatigue, the sleep medicine scientific
as well as any controls or conditions
activities during which the event establishment uses the concept of a
that must be implemented. Section
occurred. A supervisor who performed ‘‘sleep debt,’’ which is analogous to a
26.211(c) provides assurance that
some of the work activities during bank account becoming overdrawn, and
fatigue assessments include sufficient
which the event occurred may benefit is a measure of how much an
from either positive or negative results and appropriate information to support
a valid assessment of the individual individual’s sleep is being cumulatively
from a fatigue assessment of another
relative to fatigue and therefore an reduced from his or her everyday sleep
individual, depending on the
appropriate basis for management need. Many individuals build up a
circumstances. Similarly, a supervisor
decisions and actions. The criteria listed slight sleep debt during the working
who directed the work activities of an
in § 26.211(c)(1)(i) through (c)(1)(iii) week, dissipating it by ‘‘catch-up’’ sleep
individual may avoid an adverse action
specify the minimum considerations for on weekends (National Sleep
against himself or herself for the actions
fatigue assessments. Foundation, 2000; Monk, et al., 2001).
of a fatigued individual under his or her
In determining the scope of the Therefore, in evaluating cumulative
supervision if the supervisor
assessments, the NRC considered the fatigue, how much of a ‘‘sleep debt’’ the
erroneously assessed the individual as
not fatigued. Therefore, the final rule need for licensees to be able to focus the worker has accrued in the preceding
prohibits these individuals from assessment on information that is week needs to be evaluated. Dinges and
performing fatigue assessments under readily available and verifiable. Section colleagues (1997) noted a five- to seven-
the specified conditions. 26.211(c) requires the assessment to fold increase in the percentage of
Section 26.211(b)(2)(ii) prohibits address the three work schedule factors subjects noting a significant ‘‘illness,
individuals from performing a post- described in § 26.211(c)(1) through infection, pain, discomfort, worry or
event fatigue assessment if they (c)(3), which are generally considered to problem’’ in their daily logs as they
performed a fatigue assessment of the be the largest determinants of worker progressed from baseline through the 7
individuals who were performing or fatigue (Akerstedt, 2003, 2004; nights of restricted sleep. In addition to
directing the work activities during McCallum, et al., 2003; Mallis, et al., the expected decrements in vigor over
which the event occurred within 24 2002; Folkard and Monk, 1980; Rosa, the restricted sleep days, subjects’
hours before the event occurred. These 1995; Rosa, et al., 1996), as follows. ratings indicated increases in confusion-
individuals may have a conflict of Section 26.211(c)(1)(i) specifies the bewilderment, tension-anxiety, and total
interest. For example, if an individual first criterion that fatigue assessments mood disturbance.
previously self-declared fatigue, but a will address, acute fatigue. Acute fatigue Symptoms of cumulative fatigue are
fatigue assessment determined he or she directly affects an individual’s ability to in some ways similar to those of acute
was fit to continue work and an event safely and competently perform his or fatigue, but in other ways quite
subsequently occurred that required the her duties, as discussed in Section IV.D. different. The term ‘‘burnout’’ has been
subject individual to be assessed again, Licensees will assess the potential for used to describe workers experiencing
then the supervisor who performed the acute fatigue by estimating, at a cumulative fatigue. Similar to burnout
first assessment may avoid adverse minimum, the total number of from other sources, burnout from
action for the previous determination by continuous hours the individual has cumulative fatigue is often characterized
performing the post-event fatigue been awake, as well as considering other by a lack of initiative and/or creativity,
assessment and erroneously individual factors or information with the individual just ‘‘going through
determining that the individual was not provided by the individual (such as his the motions like a zombie’’ without
fatigued. The final rule prohibits these or her ability to obtain rest during break being actively engaged or involved in
individuals from performing fatigue periods). the job he or she is being asked to
perform. Harrison and Horne (2000) influence whether an individual has controls may not prevent an individual
advanced the view that the more had adequate opportunity to obtain from experiencing fatigue from one or
creative thought processes are those sufficient rest. However, individuals more of the many other factors that can
most likely to be impaired by the differ substantially in their ability to cause fatigue, some of which may not be
individual receiving insufficient adapt to various schedules (Monk and readily apparent to an employer.
amounts of the ‘‘core’’ sleep needed for Folkard, 1985). Therefore, individuals Workload and the type of work an
cognitive restitution. They note ‘‘[sleep can provide general information related individual performs, home stresses,
deprivation] presents particular to the quality and quantity of sleep that sleep disorders, and differences in an
difficulties for decisionmaking they actually obtained during this individual’s ability to work extended
involving the unexpected, innovation, period, which substantively improves hours or adapt to certain schedules can
revising plans, competing distraction the licensee’s assessment of the all substantively affect worker fatigue
and effective communication.’’ potential for cumulative fatigue. (Rosa, 1995; Totterdell, et al., 1995;
Section 26.211(c)(1)(iii) specifies the Licensees can practically assess the Knauth and Hornberger, 2003).
third criterion that fatigue assessments potential for circadian degradations in Although the NRC considered the
will address, circadian variations in alertness and performance by findings from studies of work hours and
alertness and performance. Section IV.D considering the time of day or night worker fatigue in developing the work
discusses the impact of such variations during which the work is or will be hours requirements of § 26.205(d)(1)
on an individual’s ability to safely and performed and whether the time period through (d)(5), it is neither practical nor
competently perform his or her duties. coincides with a circadian trough in possible to establish limits that will
Licensees can assess the potential for alertness for the individual. However, prevent fatigue for all individuals.
circadian degradations in alertness and individuals differ in the extent and rate Therefore, the final rule requires
performance by considering the time of at which they adapt to work during licensees to consider factors in addition
day or night during which the work was periods in which they would otherwise to work hours and rest breaks when
or will be performed and whether the be asleep (Folkard and Tucker, 2003; determining whether an individual is fit
time period coincides with a circadian Carrier and Monk, 2000) and can to safely and competently perform
variation through in the individual’s provide information (e.g., the timing of duties.
level of alertness. their sleep periods) that can better Section 26.211(e) requires that,
Section 26.211(c)(2) requires that inform a licensee’s assessment of the following a fatigue assessment, the
individuals must provide complete and potential for circadian degradations in licensee must decide whether the
accurate information that may be alertness. individual may perform duties without
required by the licensee to address the Section 26.211(c)(2) also limits a rest break, and, if so, whether controls
factors listed in § 26.20(c)(1) (i.e., acute licensees’ inquiries to only obtaining and conditions must be established
fatigue, cumulative fatigue, and information from the subject individual under which the individual may
circadian variations in alertness and that is necessary to assess the factors perform those duties. Examples of
performance). Although work hours are listed in § 26.211(c)(1). The fatigue controls and conditions include, but are
an important determinant of worker assessment will provide a valid basis for not limited to (1) a rest break, (2) peer
fatigue, many other factors can affect licensee decisions and actions for review and approval of assigned job
worker fatigue, not all of which may be fatigue management without undue tasks, (3) assignment of job tasks that are
readily apparent to a licensee. As a invasion of an individual’s privacy. For non-repetitive in nature, (4) assignment
consequence, individuals and licensees example, inquiries limited to the of job tasks that are simple in nature,
share the responsibility for effective amount, quality, and timing of sleep and and (5) assignment to duties that are not
assessment and management of fatigue general activity level of the individual important to the protection of public
which depends upon complete and can support an accurate fatigue health and safety or common defense
accurate communication between the assessment without the need for an and security. Section 26.211(e) also
individual and the licensee concerning individual to divulge personal details requires licensees to ensure that any
matters that may influence an about the reasons for missed sleep or controls and conditions that they
individual’s level of fatigue. For abnormal timings for sleep. Consistent determine to be necessary to return an
example, licensees may be able to with § 26.37 [Protection of information], individual to duty will be implemented.
estimate the total number of continuous licensees are required to keep any Section 26.211(f) requires that
hours that an individual has been awake information from the individual’s self- licensees document the results of any
through review of the individual’s work disclosures confidential. fatigue assessments that were
schedule and assumptions regarding Section 26.211(d) prohibits licensees performed, the circumstances that
typical waking times for individuals on from concluding that fatigue had not or necessitated the fatigue assessments,
that schedule. However, individuals can will not degrade the individual’s ability and any controls and conditions that
provide information to better to safely and competently perform his or were implemented. The documentation
approximate the number of hours they her duties solely on the basis that the is necessary for NRC inspectors to
have been continuously awake and individual’s work hours have not evaluate the fatigue assessment
facilitate a more accurate assessment of exceeded any of the limits specified in component of licensees’ FFD programs
acute fatigue. Additionally, individuals § 26.205(d)(1) or that the individual has and for the licensee to conduct the
may be able to provide information had the minimum rest breaks required reviews required under § 26.205(e). The
about their general level of work- and in § 26.205(d)(2) or the minimum days information that the final rule requires
non-work-related activities, as well as off required in 26.205(d)(3) through licensees to document will indicate how
opportunities for rest during the period (d)(5). The work hour controls of well a licensee’s fatigue mitigation
addressed in the fatigue assessment. § 26.205(d)(1) and (d)(2) provide program at a site is performing.
Licensees can practically assess the reasonable measures to prevent fatigue Section 26.211(g) requires that
potential for cumulative fatigue by resulting from excessive work hours. licensees prepare an annual summary
reviewing the individual’s work However, these controls address only for each nuclear power plant site of
schedule during the past 14 days to work hours and work schedules, and as instances of fatigue assessments that
identify schedule features that typically a consequence, compliance with these were conducted during the previous
calendar year for any individual in Subpart J of the proposed rule have proposed rule also did not specify the
identified in § 26.4(a) through (c). The been moved to Subpart N of the final individuals to whom the program would
NRC revised the reporting provisions in rule. This section is currently reserved. apply, thus making it applicable to the
§ 26.197(e)(3) of the proposed rule to entire new reactor construction
Subpart K—FFD Programs for
eliminate the requirement to include workforce. The proposed rule also did
Construction
information regarding fatigue not provide the option that is included
assessments in an annual report to the Section 26.401 General in § 26.401(a) of the final rule. The final
NRC. However, the NRC concluded that Section 26.401(a) provides that a rule provides greater flexibility to
the fatigue assessment information that licensee or other entity specified in licensees and other entities than either
would have been required in the annual § 26.3(c) may, at its discretion, establish, the former rule or the proposed rule by
report should be documented in an implement, and maintain an FFD giving them an option concerning the
annual summary available on site for program that meets the requirements of type of FFD program to apply. It also
NRC inspection. Specifically, Subpart K for those individuals who are clarifies and narrows the scope of the
§ 26.211(g)(1) requires that the summary specified in § 26.4(f). Alternatively, if an group to which Subpart K applies. This
include the conditions under which FFD program for those individuals that is consistent with Goal 6 of this
each fatigue assessment was conducted meets the requirements of Subpart K is rulemaking to improve clarity in the
(i.e., whether the assessment was not established, those individuals must organization and language of the rule.
conducted for cause, for a self- The former rule in § 26.2(c) imposed
be subject to an FFD program that meets
declaration, after an event, or as a FFD requirements on construction
the requirements of Subparts A
followup, as described in § 26.211(a)(1) permit holders ‘‘with a plant under
[Administrative Provisions] through H active construction’’ but did not define
through (a)(4)). As a result, the annual
[Determining Fitness-for-Duty Policy that term. The proposed rule in § 26.3(e)
reports will indicate the means by
Violations and Determining Fitness], N would have required an FFD program
which licensees are identifying
[Recordkeeping and Reporting for construction following NRC
potential instances of worker
Requirements], and O [Inspections, authorization to construct, and the Part
impairment from fatigue, including
Violations, and Penalties] of Part 26. 52 final rule made these changes to the
whether these instances are identified
The NRC recognizes that some new former § 26.2(c). However, the NRC
through plant events. Section
plants will be constructed near existing recognizes that there may be a period of
26.211(g)(2) requires that the annual
summaries include a statement for each nuclear power plants, and it may be time that elapses between the
fatigue assessment of whether or not the more efficient for the licensees of those authorization to construct and the
assessed individual was working on plants to extend their existing FFD commencement of specific construction
outage activities at the time of the self- programs to cover the individuals activities that have the potential to
declaration or condition resulting in the specified in § 26.4(f). Therefore, this affect public health and safety and the
fatigue assessment. The annual section of the final rule provides common defense and security when the
summaries will therefore show the licensees and other entities flexibility to nuclear power plant begins operations.
incidence of fatigue assessments during implement either the Subpart K program Therefore, the final rule clarifies that an
known periods of increased work hours or a program meeting all of the FFD program for construction is not
(i.e., outage periods) relative to other requirements of Subparts A through H, required until a licensee or other entity
times during the reporting period. N, and O. Subparts A through H, N, and begins ‘‘fabricating, erecting, integrating,
Section 26.211(g)(3) requires that the O include all elements of the FFD and testing safety- and security-related
annual summary indicate for each program that apply to operating nuclear SSCs, and the installation of their
fatigue assessment the category of duties power plant licensees, except fatigue foundations, including the placement of
that the individual was performing, if management requirements. This section concrete.’’
the individual was performing the meets Goal 3 of this rulemaking to In addition, the FFD program for
duties described in § 26.4(a)(1) through improve the effectiveness and efficiency construction in the final rule applies
(a)(5) at the time of the self-declaration of FFD programs. It also meets Goal 6 to only to construction activities that are
or condition resulting in the fatigue improve clarity in the organization and performed at the location where the new
assessment. Accordingly, the annual language of the rule. plant will be constructed and operated.
summaries will show the relative This section of the final rule differs in The NRC added this phrase to the
incidence of fatigue assessments for several respects from those sections of definition of construction activities in
each category of duties subject to the the former rule and the proposed rule § 26.5 of the final rule to clarify that any
work hour requirements of § 26.205 in that established the general applicability fabrication, integration, or testing of
addition to the incidence of fatigue requirements for FFD programs during safety- or security-related SSCs that is
assessments for individuals subject to construction. The former rule did not not performed within or near the
the FFD requirements of Part 26 but not specify the construction activities that licensee’s or other entity’s owner-
subject to the work hour controls of would be subject to the FFD program. controlled area in which the new plant
§ 26.205. Section 26.211(g)(4) requires Consequently, it applied to all workers will be operated would not be subject to
that the annual summaries include for performing any construction activities, Subpart K. For example, fabricating,
each fatigue assessment the whether or not the SSCs under integrating, and testing safety- or
management actions, if any, resulting construction could have an impact on security-related SSCs at a vendor’s or
from each fatigue assessment. The public health and safety or the common manufacturer’s facility that is located in
annual summaries will therefore show defense and security. In addition, it did another city, state, or country would not
the incidence of fatigue assessments that not provide a choice between applying be subject to Subpart K, whereas
warranted management actions, and the the FFD program in § 26.2(c) of the producing (i.e., ‘‘fabricating’’) the
nature of those actions. former rule or a complete Part 26 concrete to be used for the foundation
program to the new reactor construction of the reactor building in a facility
Subpart J—[Reserved] workforce (although the former § 26.2(c) located on the site where the nuclear
As a result of reorganization of the could have been interpreted as requiring power plant will be constructed and
proposed rule, the provisions contained a complete Part 26 program). The operated would be subject to Subpart K
(although the construction of the cement who are performing these other license, permit, or limited work
mixing facility would not). The NRC construction activities must be subject authorization application the particular
anticipates that the focus of the Subpart to the FFD program. Therefore, the final FFD requirements that are selected for
K program on construction activities rule also limits the scope of the implementation by licensees and other
performed at the location where the new requirements to cover only those entities. Subpart K provides licensees
plant will be constructed and operated individuals who are constructing (i.e., and other entities substantial flexibility
will lead licensees and other entities to fabricating, erecting, integrating, testing, in the design of the program to
ensure that the program covers all those and installing foundations of) these accommodate local circumstances and
individuals who perform construction specific SSCs. Thus, as one example of the logistical challenges associated with
activities within the footprint of the new a safety-related SSC, the rule requires construction. The NRC believes this
power reactor (e.g., the exterior individuals who are constructing the flexibility is necessary because it cannot
boundary of the reactor building once it containment structure that surrounds reasonably anticipate all of the
is completed) as well as the nearby areas the reactor to be subject to an FFD circumstances that may affect
where safety- and security-related SSCs program because the containment is implementation of an FFD program for
will be installed and operated when the relied on to mitigate the consequences construction (e.g., proximity to a
plant begins operations. of accidents that could result in licensee testing facility, proximity to a
The NRC considered whether the FFD potential offsite exposure. Similarly, population center that offers alternative
program for construction should also individuals who are constructing collection sites, stability in the
cover individuals who construct safety- security-related SSCs, such as the composition of the workforce at a
and security-related SSCs at a vendor’s central and secondary alarm stations, specific site, variations in the need for
or manufacturer’s facility that is physical barriers, communications an FFD program during different
geographically remote from the location systems, guard towers, surveillance and construction stages based on the
where the new plant will be operated. detection systems, or installing locks potential risks imposed by the
Because of the modular design of new and illumination systems, that will be construction activities at each stage)
reactors, many of the safety-related SSCs necessary to implement the physical and, therefore, could not develop
that will be relied on to protect public security and safeguards contingency prescriptive requirements that would be
health and safety will be fabricated by plans that are required under 10 CFR appropriate for all potential
vendor personnel at remote locations Part 73 also are subject to an FFD circumstances. However, because
and transported to the site for program for construction. Subpart K is not prescriptive and
installation and integration. Similarly, Section 26.401(b) provides that includes several new concepts (e.g., the
the small, complete nuclear reactors that licensees and other entities who intend fitness monitoring program, permission
may be constructed by manufacturing to implement an FFD program under to use specimens other than urine for
licensees under Part 52 will also be Subpart K shall submit a description of drug testing), the NRC believes that it is
constructed at remote locations and the FFD program and its necessary to verify that a licensee or
transported to the site for installation implementation as part of the license, other entity has understood the intent of
and integration. However, because of permit, or limited work authorization the Subpart K provisions and will
the complexity of the technical and application. The former rule and the implement a program that meets that
regulatory issues raised by imposing proposed rule did not contain a intent, including ensuring that any
FFD requirements on these entities, the reference to a limited work procedures used for testing specimens
staff has decided to defer adopting authorization application, because the other than urine for drugs will be
requirements for reactor manufacturing requirements in 10 CFR parts 50 and 52 scientifically sound and legally
facilities, which were included in the pertaining to limited work authorization defensible.
proposed rule, and has declined to had not yet been developed. The Requiring a Part 50 applicant to
impose a Subpart K program on reference to a limited work submit a description of its FFD program
modular fabrication facilities located at authorization application in § 26.401(b) for construction and its implementation
a distance from the site where the is consistent with Goal 6 of this is also consistent with the Part 52
nuclear power plant will be constructed rulemaking to improve clarity in the license application requirements. In the
and operated at this time. Although the organization and language of the rule. Part 52 rulemaking, the NRC
Part 52 final rule added manufacturing Licensees and other entities who implemented the Commission’s SRM–
licensees to the scope of Part 26, this intend to implement an FFD program SECY–02–0067, dated September 11,
final rule removes holders of for construction that meets all of the 2002, in which the Commission
manufacturing licenses from regulation requirements of Subparts A through H, disapproved the use of ITAAC for
under Part 26. N, and O are not required under Part 26 operational programs such as FFD as
The former rule and the proposed rule to submit a description of their FFD long as combined license applicants
also did not limit the applicability of the program and its implementation provide descriptions of the operational
FFD program to individuals who are because the details of the program are programs in their applications:
constructing only safety- or security- specified by 10 CFR Part 26, Subparts A [A]n ITAAC for a program should not be
related SSCs. However, the NRC through H, N, and O. necessary if the program and its
recognizes that there will be other Submittal of a description of the FFD implementation are fully described in the
construction work being performed at program and its implementation was not application and found to be acceptable by the
the location where a new plant will be required by § 26.2(c) of the former rule NRC at the COL stage. The burden is on the
constructed and operated that will not or § 26.3(e) of the proposed rule, but is applicant to provide the necessary and
have the potential to affect public health a logical and necessary component of sufficient programmatic information for
and safety or the common defense and Subpart K because of the flexibility that approval of the COL without ITAAC.
security when the nuclear power plant Subpart K provides in § 26.401(a) and This requirement to include
begins operations, such as constructing (d). The description of the FFD program descriptions of operational programs in
a building that will be used only for and its implementation will provide the combined license applications was
training or administration purposes. The information that the NRC needs to reiterated in the Commission’s SRM–
NRC does not intend that individuals enable it to review as a part of the SECY–04–0032, ‘‘Programmatic
Information Needed for Approval of a by the FFD program. This requirement that a clear, concise, written FFD policy
Combined License Application Without meets Goal 3 of the rulemaking to statement is provided to individuals
Inspections, Tests, Analyses, and improve the effectiveness and efficiency who are subject to the program. Section
Acceptance Criteria,’’ dated May 14, of FFD programs. 26.403(a) specifies that the policy
2004: Section 26.401(c) provides that statement must be written in sufficient
In this context, ‘‘fully described’’ should be nothing prohibits the licensees and detail to provide affected individuals
understood to mean that the program is other entities listed in § 26.3(c) from with information on the program’s
clearly and sufficiently described in terms of subjecting the individuals described in expectations of them and the
the scope and level of detail to allow a § 26.4(f) to an FFD program that meets consequences that may result from a
reasonable assurance finding of acceptability. all of the requirements of Part 26, or lack of adherence to the policy. Because
Required programs should always be program elements that meet all of the Subpart K does not require licensees
described at a functional level and at an applicable requirements of Part 26. This and other entities to provide site-
increased level of detail where
provision provides flexibility to specific FFD training to individuals, the
implementation choices could materially and
negatively affect the program effectiveness licensees and other entities to cover all FFD policy statement will be the
and acceptability. individuals with an FFD program that primary means for communicating
includes all the requirements of Part 26 information with respect to, for
Accordingly, Part 52 requires a or to adopt certain FFD requirements for example, the sanctions that are applied
combined license applicant to include a individuals described in § 26.4(f) from for confirmed positive, adulterated,
description of its FFD program and its Subpart K and certain FFD requirements substituted, or invalid test results, the
implementation, including the FFD from other subparts of Part 26, as long types of specimens and cutoff levels
program to be implemented during as the latter meet all of the applicable used in drug or alcohol testing, or the
construction. Similarly, § 26.401(b) requirements of Part 26. In either case, time periods within which an
requires license, permit, or LWA workers conducting preliminary work individual who has been selected for
applicants under Part 50 to submit a that does not involve building any random testing must report to the
description of their FFD programs safety-or security-related SSCs of a collection site, if the program includes
during construction and their facility are not required to be subject to random testing. Because of the likely
implementation. The NRC believes that an FFD program. This section allows large numbers and transient nature of
prior review of the description of the licensees and other entities, if they so construction workers involved in new
FFD program for construction and its choose, to include fatigue management reactor plant construction, requiring
implementation will be more efficient requirements under Subpart I in their each of them to be provided with a copy
than inspecting FFD programs for FFD programs for reactor construction. of the FFD policy statement is the most
construction because it will It also allows licensees to mingle effective and efficient means of ensuring
significantly reduce the inspection elements of the requirements of Subpart that each individual listed under
resources necessary to ensure proper K and program elements under Subparts § 26.4(f) is informed of the contents of
program implementation once A through H, N, and O, as long as the the policy. A clear and concise FFD
construction has begun. In addition, elements selected from Subparts A policy statement that is provided to
delaying an evaluation of the program through H, N, and O meet all of the individuals subject to the program will
until an inspection can be scheduled, requirements in Part 26 for that element. promote their awareness of the site-
which may occur after construction has Because neither the former rule nor the specific FFD policy to which they are
begun, could mean that an ineffective proposed rule included this provision, subject. This section satisfies Goal 3 of
FFD program may be in place during the final rule provides greater flexibility the rulemaking to improve the
early construction, when important than either the former rule or the effectiveness and efficiency of FFD
tasks are being performed and errors proposed rule. This section achieves programs, as well as Goal 7 to protect
resulting in faults could not be easily Goals 3 and 5 of the rulemaking to the privacy and other rights (including
detected and corrected (e.g., the pouring improve the effectiveness and efficiency due process) of individuals who are
of concrete). Finally, the emphasis on of FFD programs and to improve subject to the rule.
performance objectives in Subpart K, consistency between FFD requirements If a licensee or other entity chooses,
compared to the specific, prescriptive and access authorization requirements under § 26.401(d), to adopt FFD
requirements in the remainder of the established in 10 CFR 73.56, as elements from Subparts A through H, N,
rule, means that the Subpart K supplemented by orders to nuclear and O of Part 26, the requirements
requirements will be difficult to enforce power plant licensees dated January 7, established by those elements will need
without prior NRC knowledge of a 2003. to be documented in the FFD policy and
licensee’s FFD program secured through procedures, and in the FFD program
the description of the FFD program and Section 26.403 Written Policy and plan. Also, notice will need to be
its implementation. Procedures provided to the relevant workers falling
Consistent with the Part 52 final rule, Section 26.403 addresses the under the scope of the program, as
the NRC expects a Part 50 applicant’s requirements related to the FFD policy required by this section of the rule.
FFD program for construction and its for personnel listed in § 26.4(f) and the The final rule differs in several other
implementation to be ‘‘fully described,’’ requirements related to the procedures respects from the former rule and the
as explained by the Commission in for such FFD programs. These proposed rule. The former rule
SRM–SECY–04–0032. The applicant requirements are presented in separate contained a simple cross-reference to
should provide a description of the FFD sections to ensure that the requirements the section of the former rule pertaining
policy and procedures prepared by related to FFD policy and procedures to the requirement to adopt an FFD
licensees or other entities, including, are easy to locate within this section. policy and procedures in writing and
but not limited to, procedures for This is consistent with Goal 6 of this did not describe or circumscribe the
implementing either random testing or rulemaking to improve clarity in the requirement. Thus, the policy and
fitness monitoring and for performing organization and language of the rule. procedures requirement for FFD
drug and alcohol testing, and Section 26.403(a) requires FFD programs applicable to only the reactor
identification of the personnel covered programs under Subpart K to ensure construction workforce was the same as
the requirement for other FFD programs. Section 26.403(b)(3) requires the illicit drug within the month previous to
In contrast, the proposed rule did not procedures to describe the process to be the survey, while over 75 percent of the
contain any explicit cross-reference to followed if an individual’s behavior 18–24 age group and almost 55 percent
the requirement pertaining to FFD raises a concern regarding the possible of the over 25 group admitted to binge
program and procedures. However, the use, sale, or possession of illegal drugs drinking or heavy use of alcohol at least
program and procedures section could on or off site; the possible possession or once during the prior month. Because of
be interpreted to apply to FFD programs consumption of alcohol while the relatively small number of female
applicable to the reactor construction constructing safety-or security-related construction workers, the data pertain
workforce. The final rule both clarifies SSCs; or impairment from any cause only to male construction workers. A
and adds flexibility to the requirement which in any way could adversely affect study based on the results of the
for an FFD policy statement and FFD the individual’s ability to safely and SAMHSA NHSDA conducted in 1994
procedures for FFD programs for competently perform his or her duties. and in 1997 showed that in 1994 15.6
construction by explaining the limited The NRC considers the procedures percent of full-time construction
nature of the Subpart K FFD policy and specified in § 26.403(b)(1) to (b)(3) to be workers, ages 18–49, reported current
procedures and indicating that they the minimum set of procedures illicit drug use and 17.6 percent
need to be provided only to those necessary to implement an effective FFD reported heavy alcohol use, while in
persons subject to the Subpart K FFD program meeting the requirements of 1997 14.1 percent and 12.4 percent
program. This is consistent with Goal 6 Subpart K. Those sections clarify the reported such drug and alcohol use,
of this rulemaking to improve clarity in requirements in the former rule and the respectively. The report of the 2000
the organization and language of the proposed rule for FFD policy and SAMHSA NHSDA stated that ‘‘workers
rule. procedures by explaining what is meant in the construction and mining
Section 26.403(b) requires FFD by the requirements and limiting them industries reported the highest rates’’ of
programs under Subpart K to develop, to the listed topics. The section satisfies heavy alcohol use, illicit drug use,
implement, and maintain written Goal 3 of the rulemaking to improve the dependence on or abuse of alcohol, and
procedures that address the topics effectiveness and efficiency of FFD dependence on or abuse of illicit drugs
specified in section (b)(1) through (b)(3). programs, and Goal 6 of the rulemaking among full time workers aged 18
However, the procedures must address to improve clarity in the organization through 49 in the U.S. labor force.
a more limited set of topics than and language of the rule. As specified in SMHSA’s 2004 National Survey on Drug
specified in § 26.27 [Written policy and § 26.401(c), licensees and other entities Use and Health indicated that from
procedures], the section of Part 26 that are free to adopt procedures for other 2002–2004, past month illicit drug use
deals with policy and procedures for aspects of their FFD programs that are among full-time construction and
FFD programs generally. Thus, the final applicable to the individuals listed in extraction workers aged 18 to 64 was
rule reduces the scope of the FFD § 26.4(f). 15.1 percent, and past month heavy
procedures that are required for FFD alcohol use among this same group was
Section 26.405 Drug and Alcohol
programs applicable to the individuals 17.8 percent, which was the highest
Testing
listed in § 26.4(f), compared to the scope level among surveyed occupational
of the former rule and the proposed The former rule required reactor
construction permit holders to groups. Also, construction industry
rule. This section implements Goal 3 of groups, such as the Construction Safety
the rulemaking to improve the implement a chemical testing program,
including random tests. The proposed and Drug Abuse Executive Roundtable,
effectiveness and efficiency of FFD
rule made the requirement more also have concluded that ‘‘drug abuse
programs.
explicit, by requiring the continues to be widespread in the
Section 26.403(b)(1) requires the
written procedures to address the implementation of a drug and alcohol construction industry,’’ affecting up to
methods and techniques to be used in testing program, including random 25 percent of the workforce. Finally,
testing for drugs and alcohol, including testing, during construction. The final data collected annually through the FFD
procedures for protecting the privacy of rule requires pre-assignment, for-cause, program performance reports and
the individual who provides a post-accident, and followup testing, as evaluated by the NRC show a consistent
specimen, procedures for protecting the discussed with respect to § 26.405(c), pattern of substantially higher incidence
integrity of the specimen, and but does not require random testing of of detections of drugs and/or alcohol in
procedures for ensuring that the test all individuals who are constructing the population of short-term contractors,
results are valid and attributable to the safety- or security-related SSCs, as which includes construction workers
correct individual. discussed with respect to § 26.405(b), if who seek employment or are employed
Section 26.403(b)(2) requires the a licensee or other entity implements a during outages, who are given pre-
procedures to describe the immediate fitness monitoring program, as access, random, for-cause, and post-
and followup actions that must be taken discussed with respect to § 26.406. event drug and alcohol tests by the FFD
if an individual is determined to have: The NRC concludes that there is a programs of reactor licensees, compared
(1) Been involved in the use, sale, or strong empirical basis for requiring drug to long-term permanent employees at
possession of illegal drugs; (2) and alcohol testing for construction. reactors.
consumed alcohol to excess before or SAMHSA conducts annual surveys that To clarify that the drug and alcohol
while constructing safety-or security- investigate the prevalence, patterns, and testing requirements under Subpart K
related SSCs, as determined by a test consequences of alcohol and illegal drug are not intended to incorporate all of the
that accurately measures BAC; (3) use and abuse in the general U.S. requirements in Subparts C [Granting
attempted to subvert the testing process civilian population. Its National and Maintaining Authorization], E
by adulterating or diluting specimens Household Survey on Drug Abuse [Collecting Specimens for Testing], F
(in vivo or in vitro), substituting (NHSDA) covering the years 2000–2001, [Licensee Testing Facilities], and G
specimens, or by any other means; (4) for example, indicated that over 23 [Laboratories Certified by the
refused to provide a specimen for percent of male construction workers Department of Health and Human
testing; or (5) had legal action taken aged 18–24 and over 11 percent of those Services] of Part 26, but at the same time
relating to drug or alcohol use. 25 and older admitted to the use of an to ensure that the drug and alcohol
testing requirements of Subpart K are therefore available and eligible for contribute to the event. Post-accident
clear, the final rule clarifies the testing. Licensees and other entities may testing may involve more than one
proposed rule by substantially also need to develop programs to ensure individual, and should be conducted if
expanding the description of the that subcontractors who operate the event resulted in either: (i) A
program requirements in § 26.405. This independently also implement random significant illness or personal injury to
section meets Goal 3 of the rulemaking testing programs, and it will be the individual to be tested or another
to improve the effectiveness and necessary for licensees and other individual, which within 4 hours after
efficiency of FFD programs, and Goal 6 entities to conduct audits of the event is recordable under the U.S.
to improve clarity in the organization subcontractor programs. Section 26.405 Department of Labor standards
and language of the rule. provides licensees and other entities contained in 29 CFR 1904.7, and
Section 26.405(a) requires Subpart K flexibility to design their random testing subsequent amendments, and results in
FFD programs to provide a means to programs to address those problems. For death, days away from work, restricted
deter and detect substance abuse. The example, the final rule in Subpart K work, transfer to another job, medical
FFD programs must include drug and does not specify that random testing treatment beyond first aid, loss of
alcohol testing that complies with the must take place at times including consciousness, or other significant
requirements of § 26.405. The final rule weekends, backshifts, and holidays, and illness or injury as diagnosed by a
clarifies that if a licensee or other entity at various times during a shift because physician or other licensed health care
complies with the requirements of the construction schedule may not in all professional, even if it does not result in
§ 26.405 with respect to drug and cases include work during those death, days away from work, restricted
alcohol testing, it is not required to meet periods. The final rule also provides work or job transfer, medical treatment
the drug and alcohol testing flexibility for licensees and other beyond first aid, or loss of
requirements in the balance of Part 26. entities to determine the number of consciousness; or (ii) Significant
Section 26.405(b) specifies that if the random tests to be performed annually damage to any safety-related SSC of a
licensee or other entity elects to impose and the probability that a member of the facility that is required by the
random testing for drugs and alcohol on population that is subject to the FFD Commission’s rules and regulations to
individuals who are constructing safety- program will be selected for random be described in the site safety analysis
or security-related SSCs, the random testing. Because of the likely report or preliminary or final safety
testing must meet the requirements fluctuations in the numbers of reactor analysis report. Finally, (4) followup
specified in § 26.405(b)(1) through construction workers over the course of testing should be conducted as part of
(b)(4). Random testing must— a year, the NRC cannot specify that the a followup plan to verify an individual’s
(1) Be administered in a manner that
number of random tests performed continued abstinence from substance
provides reasonable assurance that
annually must be equal to at least 50 abuse.
individuals are unable to predict the
percent of the population that is subject The conditions that can lead to drug
time periods during which specimens
to the FFD program, as it does under and alcohol testing of an individual
will be collected.
(2) Require individuals who are § 26.31. Finally, Subpart K provides specified in § 26.405(c)(1) through (c)(4)
selected for random testing to report to licensees and other entities with the parallel generally the conditions listed
the collection site as soon as reasonably flexibility to adopt a fitness monitoring in § 26.31(c)(1) through (c)(4), with
practicable after notification, within the program under § 26.406 to detect and changes to reflect the different reasons
time period specified in the FFD deter substances abuse, rather than for testing individuals identified in
program policy. conducting random testing of § 26.4(f) under Subpart K and testing
(3) Ensure that all individuals in the individuals identified in § 26.4(f). individuals at an operating nuclear
population that is subject to testing on Section 26.405(c) specifies that the reactor under Part 26. Thus, pre-
a given day have an equal probability of individuals who are constructing safety- assignment testing is limited to those
being selected and tested. and security-related SSCs shall be individuals who will construct safety-or
(4) Provide that an individual subject to drug and alcohol testing security-related SSCs. Because the NRC
completing a test is immediately eligible under the following four conditions: (1) has concluded that there is no basis to
for another unannounced test. Before assignment to construct safety-or distinguish between for-cause testing
The random testing requirements in security-related SSCs; (2) When the under Subpart K and for-cause testing
Subpart K are considerably more licensee or other entity has adequate under Part 26 generally, the final rule in
flexible than the random testing cause, arising either in response to an Subpart K and § 26.31(c)(2) provide the
requirements in § 26.31 [Drug and individual’s observed behavior or same basis for for-cause testing.
alcohol testing]. These requirements physical condition indicating possible Similarly, § 26.405(c)(3)(i) requires post-
represent those elements of the random substance abuse or after the licensee or accident testing for exactly the same
testing requirements under § 26.31 that other entity has received credible significant illness and personal injury
the NRC has concluded are necessary information that an individual is situations as required under
and appropriate for random testing of engaging in substance abuse, as defined § 26.31(c)(3)(i). However, the Subpart K
individuals identified in § 26.4(f). They in § 26.5; (3) Following an accident in post-accident testing requirement that is
are intended to ensure randomness of which the individual was involved. triggered by property damage is limited
selection for testing but also take into Post-accident testing should be to damage to any safety-or security-
account the potentially difficult conducted as soon as practical after an related SSC of a facility. The NRC
logistical problems associated with event involving a human error that was recognizes that in the context of reactor
testing at such large and diverse committed by an individual specified in plant construction, damage incidents
locations. Licensees and other entities § 26.4(f), where the human error may can occur in a number of contexts that
who adopt random testing will need, in have caused or contributed to the are not related to the impairment or
particular, to develop a system for accident. The licensee or other entity is potential sabotage bases for FFD
tracking individuals who are subject to not required to test individuals who programs under Subpart K (e.g., vehicle
the random testing program to identify were affected by the event but whose accidents, injuries to persons not
when they are physically present and actions likely did not cause or working on safety-or security-related
SSCs). Followup testing under permit testing of oral fluids for drugs in protect the donor’s privacy and the
§ 26.405(c)(4) is defined exactly the FFD programs for other licensees and integrity of the specimen and
same as followup testing under entities who are subject to Part 26 implement stringent quality controls to
§ 26.31(c)(4). In the NRC’s view, the because the window of detection for ensure that test results are valid and
purpose of the testing, to verify an marijuana use when testing for oral attributable to the correct individual. At
individual’s continued abstinence from fluids is very short compared to the the licensee’s or other entity’s
substance abuse, is exactly the same in window of detection for marijuana use discretion, specimen collections and
both cases. These requirements meet when testing urine specimens, and the alcohol testing may be conducted at a
Goal 3 of the rulemaking to improve the NRC has a higher expectation that local hospital or other facility in
effectiveness and efficiency of FFD individuals will be trustworthy and accordance with the specimen
programs, and Goal 6 to improve clarity reliable, as demonstrated by the collection and alcohol testing
in the organization and language of the avoidance of substance abuse, for the requirements of 49 CFR Part 40,
rule. categories of individuals who are ‘‘Procedures for Department of
Section 26.405(d) specifies that, at a subject to Part 26 under the licensees’ Transportation Workplace Drug and
minimum, FFD programs under Subpart and entities’ FFD program for operating Alcohol Testing Programs’’ (65 FR
K shall test specimens for marijuana plants. However, the NRC believes that 41944; August 9, 2001), and subsequent
metabolite, cocaine metabolite, opiates oral fluids drug test results would be amendments. This section of the final
(codeine, morphine, 6-acetylmorphine), adequate to demonstrate that an rule is intended to provide licensees
amphetamines (amphetamine, individual who will be constructing and other entities with additional
methamphetamine), phencyclidine, safety- and security-related SSCs is not flexibility about the locations where
adulterants, and alcohol at the cutoff impaired that day from recent marijuana specimen collections and alcohol testing
levels specified in this part for testing use or the other substances for which may be carried out and to help ensure
the respective specimens, or comparable testing is required under § 26.405(d). that licensees will not be required,
cutoff level, if alternate specimens, such Permitting testing of alternate before construction can begin, to build
as oral fluids, are used for drug specimens under FFD programs for specimen collection and alcohol testing
screening. The list of substances for construction is consistent with Goal 3 of facilities at sites that are distant from a
which testing must be conducted under the rulemaking to improve the current licensee’s specimen collection
Subpart K exactly parallels the list in effectiveness and efficiency of FFD facilities for drug and alcohol testing.
§ 26.31(d)(1). The NRC considers this programs. This permission is also This provision is consistent with the
the minimum set of substances that an consistent with § 26.2(c) of the former former and proposed rules, which also
effective and adequate FFD program rule and § 26.3(e)(2) of the proposed did not require the construction of
must include for both construction and rule that required drug and alcohol specimen collection and alcohol testing
operation. However, this section does testing during construction, but did not facilities. This requirement meets Goal 3
not prohibit Subpart K programs from specify the specimens to be tested. of the rulemaking to improve the
testing for additional drugs, consistent Section 26.405(d) also requires that effectiveness and efficiency of FFD
with the permission in urine specimens collected for drug programs, and Goal 6 to improve clarity
§ 26.31(d)(1)(i)(A) for licensees and testing must be subject to validity in the organization and language of the
other entities who are implementing an testing. Although § 26.405(d) specifies rule.
FFD program for operating plants to test that urine specimens collected for drug
for additional drugs. testing must be subject to validity Section 26.405(f) specifies that testing
The NRC is not prohibiting drug testing and does not further elaborate on of urine specimens for drugs and
testing of specimens other than urine the validity testing requirement, the validity, except validity screening and
under Subpart K because it recognizes NRC considers the regulatory detail initial drug and validity tests that may
that there may be circumstances during found in § 26.31 to provide useful be performed by licensee testing
construction where waiting for the guidance to licensees and other entities facilities, must be performed in a
results of urine drug tests could on the agency’s expectations. However, laboratory that is certified by HHS for
unacceptably delay the assignment of Subpart K also provides flexibility to that purpose, consistent with its
individuals to construct safety-or licensees and other entities with respect standards and procedures for
security-related SSCs. For example, for to this requirement by not specifying certification. This section requires that
some construction activities or in some that they are required to meet the urine specimens collected for drug
locations, licensees and other entities standards of § 26.31. This section limits testing must be subject to initial validity
may rely on craftspersons from a local the requirement for validity testing to and drug testing by the laboratory
union hall and may not know in urine specimens because the final rule because means to attempt to adulterate
advance which specific individuals will does not prohibit the use of specimens or substitute a urine specimen are
be assigned to work on a particular day. other than urine for drug testing under readily available, but does not apply
If the union local does not offer pre- Subpart K and scientifically sound and these requirements to drug testing of
employment testing to its members, a legally defensible means of testing the other specimens for two reasons: (1)
licensee or other entity may elect to validity of other types of specimens are Some HHS-certified laboratories may
conduct an oral fluids drug screen, for not yet available for some alternate not have the capability to perform tests
example, that provides very rapid specimens. The requirements in this of alternate specimens, such as oral
results, as long as the collection section meet Goal 3 of the rulemaking fluids, or validity testing of alternate
procedures and testing of oral fluids to improve the effectiveness and specimens, and (2) means for attempting
meet the criteria established in efficiency of FFD programs, and Goal 6 to adulterate or substitute some
§ 26.405(e) by protecting the donor’s to improve clarity in the organization alternative specimens (e.g., oral fluids)
privacy and the integrity of the and language of the rule. are not readily available. However, any
specimen, and stringent quality controls Section 26.405(e) specifies that the initial drug test performed by a licensee
are implemented to ensure that test specimen collection and drug and or other entity subject to Subpart K,
results are valid and attributable to the alcohol testing procedures of FFD including tests of alternate specimens,
correct individual. The NRC does not programs under this subpart must must use an immunoassay that meets
the requirements of the Food and Drug Goal 6 to improve clarity in the SSCs, and impairment from any cause
Administration for commercial organization and language of the rule. that if left unattended may result in a
distribution. Urine specimens that yield risk to public health and safety or the
Section 26.406 Fitness Monitoring
positive, adulterated, substituted, or common defense and security. Both the
invalid initial validity or drug test Section 26.406(a) of Subpart K former rule and the proposed rule
results must be subject to confirmatory specifies that the requirements in included a cross-reference to the
testing by an HHS-certified laboratory, § 26.406 apply only if a licensee or other performance objectives standard. Thus,
except for invalid specimens that cannot entity does not elect to subject the § 26.406(b) of the final rule extends and
be tested. Alternate specimens that yield individuals specified in § 26.4(f) to clarifies the former and proposed rules.
positive drug test results must be subject random testing for drugs and alcohol Section 26.406(c) requires licensees
under § 26.405(b). The NRC considers and other entities to establish
to confirmatory testing by a laboratory
fitness monitoring of the individuals procedures that fitness monitors shall
that meets quality control requirements
who are constructing safety- and follow in response to the indications
that are at least as stringent as the
security-related SSCs, as specified in and actions specified in § 26.406(b) and
requirements those laboratories are § 26.406, to be a means of detecting and to train the monitors to implement the
required to meet for HHS-certification, deterring substance abuse that can program. Section 26.406(d) provides
such as the accreditation process of the function as effectively as random licensees and other entities with
American College of Pathologists. These testing, given the logistical and other significant flexibility in determining the
requirements constitute the general issues associated with random testing. number of individuals required to
administrative procedures that the NRC Daily monitoring of individuals by monitor fitness and the procedures they
considers necessary for drug testing. trained personnel provides a constant are required to follow, commensurate
Licensees and other entities would be source of information about their with the potential risk. Development of
allowed to conduct initial testing of fitness, in contrast to the sporadic fitness monitoring procedures and
urine or alternate specimens at a information provided by random testing training of monitors in those procedures
licensee testing facility, provided that during construction. Fitness monitoring as well as the licensee’s or other entity’s
the licensee testing facility staff can immediately detect situations where requirements for program
members possess the necessary training for-cause testing is required as well as implementation will ensure that fitness
and skills for the tasks assigned, the provide a degree of deterrence monitors know what is meant by the
staff’s qualifications are documented, comparable to the deterrence provided requirement and are informed about the
and adequate quality controls for testing by the potential for a random test. procedures for implementing this
are implemented. However, in parallel Subpart K gives a licensee or other requirement.
with § 26.31, Subpart K requires entity the flexibility to adopt either Section 26.406(d) requires licensees
licensees and other entities to use only random testing under § 26.405(b), or and other entities to ensure that the
HHS-certified laboratories to perform fitness monitoring under § 26.406, or to fitness of individuals who are
drug testing of urine specimens, except implement both if the licensee or other constructing safety- and security-related
if a licensee testing facility performs entity chooses. Neither the former rule SSCs is monitored effectively,
initial tests. This requirement is nor the proposed rule explicitly commensurate with the potential risk to
consistent with the former and proposed required fitness monitoring. However, public health and safety and the
rules, which also required the use of both listed the performance objective common defense and security imposed
only HHS-certified laboratories for standards section as one of the specific by the construction activity. To achieve
testing urine specimens for drugs. rule sections that an FFD program this objective, the rule requires licensees
applicable to individuals involved with and other entities to consider the
Section 26.405(g) requires FFD
the construction of a new reactor plant number and placement of monitors
programs under Subpart K to provide was required to satisfy. Attainment of required, the necessary ratio of monitors
for an MRO review of positive, the performance objectives clearly to individuals specified in § 26.4(f), and
adulterated, substituted, and invalid implied that licensees and other entities the frequency with which the
drug and validity test results from would undertake a program to deter individuals shall be monitored while
confirmatory testing to determine substance abuse and detect impairment. performing each construction activity.
whether the donor has violated the FFD Section 26.406(b) described below The NRC does not expect that the
policy, before reporting the results to contains a similar performance individuals designated as fitness
the individual designated by the objective. The requirement for fitness monitors will be dedicated solely to the
licensee or other entity to perform the monitoring in § 26.406, if a licensee or task of fitness monitoring. Licensees and
suitability and fitness evaluations other entity does not implement random other entities may assign fitness
required under § 26.419. This testing of individuals who construct monitoring responsibilities to first-line
requirement in Subpart K parallels the safety- and security-related SSCs, meets supervisors, security personnel, and
requirement in § 26.169 [Reporting Goal 3 of the rulemaking to improve the others who are performing other
results] of the final rule. This effectiveness and efficiency of FFD activities for the licensee or other entity
requirement is an integral component of programs and Goal 6 to improve clarity while monitoring the fitness of
all Federally-mandated drug and in the organization and language of the individuals who are constructing safety-
alcohol testing programs, and required rule. and security-related SSCs. In
by the Department of Health and Human Section 26.406(b) establishes the determining the number of such
Services Mandatory Guidelines for performance objective for a fitness monitors licensees and other entities
Federal Workplace Drug Testing monitoring program. It requires may need to consider how to ensure that
Programs. It is fully consistent with the licensees and other entities to equipment, walls, and other temporary
former and proposed rules, which also implement a program to deter substance or permanent barriers do not interfere
followed the HHS Guidelines. This abuse and detect indications of possible with the monitors’ abilities to maintain
requirement meets Goal 3 of the use, sale, or possession of illegal drugs, visual contact with individuals
rulemaking to improve the effectiveness use or possession of alcohol while performing the construction activity and
and efficiency of FFD programs, and constructing safety-or security-related whether monitoring will be conducted
continuously until completion of the Appendix B to Part 50; (3) based on a application of sanctions by specifying
construction activity, continuously only designation under § 26.406 by a licensee only that an FFD program applicable to
at critical points during a construction or other entity, monitors the fitness of individuals involved in the construction
activity, once at the beginning of a shift the individuals specified in § 26.4(f) of a new reactor plant should make
and again after a lunch break, or at a (and thus has also received fitness provision for the imposition of
frequency of every few hours on an monitoring training); (4) determines that sanctions but did not otherwise specify
irregular schedule. Licensees and other inspections, tests, and analyses, or parts the level or type of sanctions to be
entities thus have considerable thereof, required under 10 CFR Part 52 applied. The proposed rule, in
flexibility in designing their fitness have been successfully completed; (5) § 26.3(e)(3), included an identical
monitoring program. However, they supervises or manages the construction provision, also without specifying the
must ensure that the program meets the of safety-or security-related SSCs; or (6) level or type of sanctions to be included
performance objective stated in directs, as defined in § 26.5, or in the FFD program. By adding explicit
§ 26.406(b). This requirement is implements the licensee’s or other criteria for the types of FFD policy
consistent with the requirement in the entity’s access authorization program. violations to which sanctions shall be
former rule that FFD programs Because of their important oversight applied, the final rule clarifies the
pertaining to licensees actively responsibilities, these individuals will sanctions provision of the former and
constructing nuclear power plants be subject to an FFD program that meets proposed rules. This provision in the
satisfy former § 26.10(b), calling for the requirements for Subparts A through final rule adds flexibility because it does
measures for the early detection of H, N, and O of Subpart 26. In addition not require FFD programs under
persons who are not fit to perform to behavioral observation training, they Subpart K to implement the minimum
activities within the scope of Part 26. will be subject to random testing at the requirements for sanctions in § 26.75
50 percent annual rate and a suitable [Sanctions] or to apply the specific
Section 26.407 Behavioral Observation
inquiry/employment history check. procedures for conducting a
Section 26.407 provides that Neither the former rule nor the determination of fitness in § 26.189.
individuals in § 26.4(f) shall be subject proposed rule explicitly required Subpart K also allows licensees and
to behavioral observation while they are behavioral observation. However, both other entities the flexibility to assign
constructing safety- and security-related listed the performance objective individuals who violate the FFD policy
SSCs at the location where a nuclear standards section as one of the specific under Subpart K to other duties at the
power plant is under construction and rule sections that an FFD program site not covered by the FFD program,
will be operated. However, if these applicable to individuals involved with depending on the licensee’s assessment
individuals are subject to a fitness the construction of a new reactor plant of the violation and the other duties
monitoring program under § 26.406, was required to satisfy, and attainment involved.
they are not required to be subject to of the performance objectives clearly
behavioral observation under § 26.407. implied the use of behavioral Section 26.411 Protection of
Thus, this section provides licensees observation. The final rule clarifies the Information
and other entities with the flexibility of requirement and adds flexibility. This Section 26.411(a) requires FFD
subjecting the individuals specified in requirement is consistent with the programs that collect personal
§ 26.4(f) to either fitness monitoring requirement in the former rule that FFD information about an individual for the
under § 26.406 or to a combination of programs pertaining to licensees purpose of complying with Subpart K to
random drug and alcohol testing under actively constructing nuclear power establish and maintain a system of files
§ 26.405(b) and behavioral observation plants satisfy former § 26.10(b), calling and procedures to protect the personal
under § 26.407. for measures for the early detection of information. It also requires FFD
Behavioral observation is an persons who are not fit to perform programs to maintain and use such
important component of an FFD activities within the scope of Part 26. records with the highest regard for
program because it increases the Section 26.407 meets Goal 3, to improve individual privacy. This requirement
likelihood that the licensees and other the effectiveness and efficiency of FFD exactly parallels the requirement in
entities who are subject to the rule programs, and Goal 6 to improve clarity § 26.37 [Protection of information] of the
detect and appropriately address in the organization and language of the final rule pertaining to protection of
impairment and other adverse rule. information under Part 26 generally.
behaviors. The individuals listed under The NRC does not believe that any
§ 26.4(e) will be trained in behavioral Section 26.409 Sanctions lesser standard of protection can be
observation, because § 26.4(e) specifies Section 26.409 requires FFD programs justified for personal information
that they shall be subject to an FFD under Subpart K to establish sanctions collected under Subpart K than is
program that meets all of the for FFD policy violations that, at a required for personal information
requirements of Part 26, except Subparts minimum, prohibit the individuals collected under Part 26 generally. This
I and K, and such a program includes specified in § 26.4(f) from being section meets Goal 3 of this rulemaking
behavioral observation training. The assigned to or performing the duties to improve the effectiveness and
individuals who will perform the specified in that section until the efficiency of FFD programs, Goal 6 to
behavioral observation are specified licensee or other entity determines that improve clarity in the organization and
under § 26.4(e) as including any the individual’s behavior does not pose language of the rule, and Goal 7 to
individual whose duties for the a threat to public health and safety or protect the privacy of individuals.
licensees and other entities in § 26.3(c) the common defense and security. This The final Subpart K rule parallels the
require him or her to perform the section meets Goal 3 of this rulemaking requirements in the former rule and in
following activities at the location to improve the effectiveness and the proposed rule. Both included a
where the nuclear power plant will be efficiency of FFD programs and Goal 6 requirement that FFD programs
constructed and operated: (1) Serves as to improve clarity in the organization applicable to individuals involved with
a security officer under NRC and language of the rule. the construction of a new reactor plant
requirements; (2) performs quality The former rule provided for make provisions for the protection of
assurance activities, as specified in flexibility in the development and information. Section 26.411(a) provides
additional detail about the level of precisely parallels the requirement in program, including FFD program
protection (the highest regard for § 26.37, except for the differences noted, elements that C/Vs provide, and the
individual privacy) required of FFD because the NRC does not believe that FFD programs of C/Vs that are accepted
programs that maintain and use records any different procedures for handling by the licensee or other entity. This
of personal information. Thus, this final personal information can be justified for requirement parallels the audit
rule provides additional clarity, personal information collected under requirement in § 26.41(a) of the final
compared to the former rule or the Subpart K than are required for personal rule. The agency has not identified any
proposed rule, that the program should information collected under Part 26 circumstances relating to the reactor
achieve the necessary protection generally. construction workforce that would
through a system of files and support different auditing requirements
Section 26.413 Review Process
procedures. for Subpart K FFD programs than for
Section 26.413 requires FFD programs FFD programs under the other subparts
Section 26.411(b) requires licensees
under Subpart K to establish and of Part 26. The criterion to be applied
and other entities to obtain a signed
implement procedures for the review of for each audit program is that it must
consent that authorizes the disclosure of
a determination that an individual listed assure the continuing effectiveness of
the personal information collected and
in § 26.4(f) has violated the FFD policy. the FFD program. Although the former
maintained under Subpart K before
The procedure must provide for an rule did not contain a requirement for
disclosing the personal information,
objective and impartial review of the audits of the FFD programs for
except for disclosures to the individuals facts related to the determination that
and entities specified in § 26.37(b)(1) construction, the proposed rule referred
the individual has violated the FFD explicitly to § 26.41 [Audits and
through (b)(6), (b)(8), and persons policy. This requirement parallels the
deciding matters under review in corrective action] as one of the
one in § 26.39(a) of the final rule. requirements to be complied with by
§ 26.413 [Review process]. These Because the NRC recognizes that much
persons include the subject individual licensees authorized to construct a
of the construction workforce will be nuclear power plant. Thus, § 26.415
or his or her representative, when the transient and rapidly changing, it is
individual has designated the extends and clarifies the requirement in
leaving licensees and other entities the the proposed rule, meets Goal 3 of this
representative in writing for specified flexibility to adopt the additional review rulemaking to improve the effectiveness
FFD matters; assigned MROs and MRO procedures found in § 26.39(b) through and efficiency of FFD programs, and
staff; NRC representatives; appropriate (e), but is not mandating their adoption satisfies Goal 6 to improve clarity in the
law enforcement officials under court by including them in the review process organization and language of the rule.
order; a licensee’s or other entity’s requirements in § 26.413. This section Section 26.415(b) requires each
representatives who have a need to meets Goal 3 of this rulemaking to licensee and other entity who
access the information to perform improve the effectiveness and efficiency implements an FFD program under
assigned duties, including of FFD programs and Goal 6 to improve Subpart K to ensure that these programs
determinations of fitness, audits of FFD clarity in the organization and language are audited at a frequency that ensures
programs, and human resources of the rule. their continuing effectiveness and that
functions; the presiding officer in a The final rule is more explicit than corrective actions are taken to resolve
judicial or administrative proceeding the former rule, which specified only any problems identified. The section
that the subject individual initiates; and that the FFD program for the reactor also provides that licensees and entities
other persons pursuant to court order. construction workforce should make may conduct joint audits, or accept
The NRC did not include a reference to provisions for appeals procedures. The audits of C/Vs conducted by others, so
§ 26.37(b)(7) because it refers to persons proposed rule in § 26.3(e)(3) similarly long as the audit addresses the relevant
deciding matters under another section required FFD program for construction services of the C/V. The NRC expects
of Part 26 that Subpart K does not to make provisions for procedures for that in determining the frequency of
include. Instead, this section adds a new the objective and impartial review of audits, licensees and other entities will
reference to persons deciding matters authorization decisions. This final rule consider the frequency, nature, and
under review in § 26.413. The more clearly requires FFD programs severity of discovered problems, testing
requirement to obtain permission to under Subpart K to establish and errors, personnel or procedural changes,
release the personal information to implement procedures and more clearly previous audit findings, and lessons
individuals who are not specified in specifies that the procedures are for the learned. The requirement is intended to
§ 26.37(b)(1) through (b)(6), (b)(8), and review of the facts related to the promote performance-based rather than
persons deciding matters under review determination that an individual has compliance-based audit activities. By
in § 26.413 is necessary because violated the FFD policy. However, the allowing joint audits, the final rule
licensees have misinterpreted the basic requirement in this final rule is creates additional flexibility for Subpart
former requirement as prohibiting them the same as that in the former rule and K FFD programs.
from releasing the personal information the proposed rule. The requirement for Section 26.415(c) provides that
under any circumstances. In some an objective and impartial review licensees and other entities who
instances, such failures to release establishes the same criteria for the implement FFD programs under Subpart
information have inappropriately review as did the proposed rule, which K need not audit the HHS-certified
inhibited an individual’s ability to also mandated an impartial and laboratories or specimen collection and
obtain information that was necessary objective review. alcohol testing services that meet the
for a review or appeal of the licensee’s requirements of 49 CFR Part 40,
determination that the individual had Section 26.415 Audits ‘‘Procedures for Department of
violated the FFD policy. Therefore, the Section 26.415 establishes audit Transportation Workplace Drug and
final rule includes the explicit requirements for Subpart K FFD Alcohol Testing Programs’’ (65 FR
permission for licensees and other programs. Section 26.415(a) requires 41944, August 9, 2001) upon which
entities to release personal information licensees and other entities to ensure licensees and other entities may rely to
when an individual consents to the that audits are performed to assure the meet the drug and alcohol testing
release, in writing. This requirement continuing effectiveness of the FFD requirements of Subpart K. Because the
DOT conducts audits of collection sites requires annual program performance Section 26.23 of the proposed rule used
that the agency’s grantees use, the NRC reports for the FFD program. The former language similar to that in this final
has concluded that audits of those sites rule contained detailed reporting rule, requiring FFD programs to provide
when they are used by NRC licensees requirements similar to those in the reasonable assurance that individuals
and other entities are unnecessary. final rule. In addition, the NRC who are subject to Part 26 are
considers the reporting of acts that cast trustworthy and reliable, as
Section 26.417 Recordkeeping and
doubt on the integrity of the FFD demonstrated by the avoidance of
Reporting
program and any programmatic failure, substance abuse, and to provide
Section 26.417(a) of the final rule degradation, or discovered vulnerability reasonable assurance that individuals
provides that FFD programs shall ensure of the FFD program that may permit who are subject to Part 26 are not under
that records pertaining to the undetected drug or alcohol use or abuse the influence of any substance, legal or
administration of the program, which by individuals subject to Subpart K, as illegal, or mentally or physically
may be stored and archived well as annual program performance impaired from any cause, which in any
electronically, are maintained so that reports, to be clearly logical and way adversely impairs their ability to
they are available for NRC inspection necessary components of the program safely and competently perform their
purposes and for any legal proceedings and outgrowths of the recordkeeping duties.
resulting from the administration of the requirements.
program. This recordkeeping provision Subpart L—[Reserved]
provides more extensive detail than the Section 26.419 Suitability and Fitness
Evaluations Subpart M—[Reserved]
equivalent recordkeeping sections of the
former rule or the proposed rule, both Section 26.419 requires licensees and Subpart N—Recordkeeping and
of which provided only that the FFD other entities who implement FFD Reporting Requirements
program for the reactor construction programs under Subpart K to develop, As a result of the reorganization of the
workforce should make provisions for implement, and maintain procedures for proposed rule, the NRC has moved the
recordkeeping. This final rule provides evaluating whether to assign individuals provisions from Subpart J of the
notice that records may be stored and to the duties specified in § 26.4(f). These proposed rule to a new Subpart N of the
archived electronically, which clarifies procedures must provide reasonable final rule. The final rule includes minor
the requirement and provides flexibility assurance that such individuals are fit to clarifications of the language of the
to licensees and other entities. This rule safely and competently perform their proposed rule that are discussed with
also incorporates standard language duties and are trustworthy and reliable, respect to those sections. The NRC has
pertaining to the availability of records as demonstrated by the avoidance of also made more substantive changes to
for NRC inspection purposes and for substance abuse. This section provides the proposed rule in § 26.711(c) and (d).
any legal proceedings resulting from the flexibility for Subpart K programs to Otherwise, the provisions in this
administration of the program. These develop procedures for determining subpart have been adopted as proposed
provisions are inherent to the NRC’s suitability. The requirement that without change.
recordkeeping requirements. While licensees and other entities develop,
adding clarity, they do not significantly implement, and maintain procedures for Section 26.709 Applicability
change the recordkeeping requirement evaluating whether to assign individuals The NRC has added § 26.709 to the
from that in the former or proposed rule. to the duties specified in § 26.4(f) is final rule to specify the licensees and
Both the former rule and the proposed necessary to enable licensees and other other entities to whom the requirements
rule contained an explicit requirement entities to implement Subpart K. These of this subpart apply.
for recordkeeping by the FFD program procedures will allow licensees, other
Section 26.711 General Provisions
applicable to reactor construction entities, and the individuals who are
workers. This section meets Goal 3 of subject to the FFD program to know The NRC has added § 26.711 to the
this rulemaking to improve the who the Subpart K requirements cover. final rule to define general requirements
effectiveness and efficiency of FFD This section meets Goal 3 of this related to recordkeeping and reporting
programs, and Goal 6 to improve clarity rulemaking to improve the effectiveness under Part 26.
in the organization and language of the and efficiency of FFD programs, and Section 26.711(a) of the final rule
rule. Goal 6 to improve clarity in the establishes a requirement that licensees
Section 26.417(b) requires licensees organization and language of the rule. and other entities must maintain records
and other entities that implement FFD Although neither the former rule nor and submit certain reports to the NRC,
programs under Subpart K to make the the proposed rule contained an explicit consistent with Goal 6 of this
reports described in § 26.417(b)(1) and requirement for suitability and fitness rulemaking to improve clarity in the
(b)(2). Section 26.417(b)(1) requires evaluations, each contained a cross- organization and language of the rule. In
reports to the NRC Operations Center by reference to the general performance addition, this section requires that
telephone within 24 hours after the objectives sections of their respective licensees and other entities retain the
licensee or other entity discovers any rules (§ 26.10 of the former rule and records required under this part for
intentional act that casts doubt on the § 26.23 of the proposed rule). Section either the periods that are specified in
integrity of the FFD program and any 26.10 required the FFD programs Subpart N or for the life of the facility’s
programmatic failure, degradation, or applicable to reactor construction license, certificate, or other regulatory
discovered vulnerability of the FFD workers to provide reasonable assurance approval, if no records retention
program that may permit undetected that personnel would perform their requirement is specified. This general
drug or alcohol use or abuse by tasks in a reliable and trustworthy records retention requirement clarifies
individuals who are subject to Subpart manner and that they are not under the the language of the rule and is a
K. This provision also specifies that influence of any substance, legal or standard administrative provision that
these events must be reported under illegal, or mentally or physically is used in all other parts of 10 CFR that
Subpart K, rather than under the impaired from any cause, which in any contain substantive requirements
provisions of 10 CFR 73.71 [Reporting of way would affect their ability to safely applicable to licensees and applicants,
safeguards events]. Section 26.417(b)(2) and competently perform their duties. such as 10 CFR 50.71(c).
The NRC has added § 26.711(b) to the the changed or new information has and other rights (including due process)
final rule to permit records to be stored implications for adversely affecting an of individuals who are subject to Part 26
and archived electronically if the individual’s eligibility for authorization, and Goal 3 to improve the effectiveness
method used to create the electronic the final rule requires that the licensee and efficiency of FFD programs.
records (1) provides an accurate or other entity who discovers the Section 26.713(a)(1) amends former
representation of the original records, incorrect information or developed new § 26.71(a). Former § 26.71(a) required
(2) prevents the alteration of any information shall inform the reviewing licensees to retain records of the
archived information and/or data once it official of the updated information. The inquiries that licensees conduct in
has been committed to storage, and (3) NRC has added this provision to meet granting unescorted access to an
allows easy retrieval and re-creation of Goal 7 of this rulemaking to protect the individual for 5 years following the
the original records. This provision privacy and other rights (including due termination of such access
recognizes that most records are now process) of individuals who are subject authorizations. The final rule updates
stored electronically and must be to Part 26. This provision also meets the terminology used in the former
protected to ensure the integrity of the Goal 4 of this rulemaking to improve paragraph for consistency with the
data. The requirements are consistent consistency between this rule and revised language used throughout the
with related requirements in the access access authorization requirements rule. For example, the paragraph refers
authorization orders issued to nuclear established in 10 CFR 73.56, as to ‘‘self-disclosures,’’ ‘‘employment
power plant licensees dated January 7, supplemented by orders to nuclear histories,’’ ‘‘suitable inquiries,’’ and
2003. Therefore, these requirements power plant licensees dated January 7, ‘‘granting authorization,’’ but retains the
meet Goal 4 of this rulemaking to 2003. intent of the former paragraph. The NRC
improve consistency between FFD has made the changes in terminology for
Section 26.713 Recordkeeping the reasons discussed with respect to
requirements and access authorization
Requirements for Licensees and Other §§ 26.61 [Self-disclosure and
requirements established in 10 CFR
Entities employment history] and 26.63
73.56 [Personal access authorization
requirements for nuclear power plants], Section 26.713 of the final rule [Suitable inquiry]. In addition, the
as supplemented by orders to nuclear amends former § 26.71 [Recordkeeping agency has updated the former cross-
power plant licensees dated January 7, requirements]. Former § 26.71(d), which reference to § 26.27(a) to reflect the new
2003. established requirements for FFD organization of the rule.
In the final rule, the NRC has added program performance reports, is Section 26.713(a)(2) amends former
a new provision in § 26.711(c). This retained in § 26.717 [Fitness-for-duty § 26.71(b). Former § 26.71(b) required
provision requires licensees and other program performance data], a separate licensees to retain records that are
entities to inform individuals of the section that focuses only on those related to positive drug test results that
right to review and correct the records reports. Section 26.713 retains but the MRO has confirmed. The final rule
maintained about the individual under amends former § 26.71(a) through (c) revises the former requirement by
this part and imposes a requirement on and adds other requirements that are mandating that licensees and other
licensees and other entities to ensure interspersed throughout the former rule. entities retain records related to any
that the information they maintain and The NRC has made these changes to violation of the FFD policy, which
share with other licensees and entities meet Goal 6 of this rulemaking to includes confirmed positive drug and
is correct and complete. The NRC added improve clarity in the organization and alcohol test results. This change ensures
this provision to provide further language of the rule by grouping that licensees and other entities who
assurance that individuals who are recordkeeping requirements that apply may be considering granting
subject to an FFD program under this to licensees and other entities in one authorization to an individual who has
part are not unjustly or inaccurately section. previously violated any aspect of an
portrayed as having violated FFD Section 26.713(a) of the final rule FFD policy can obtain these records for
requirements in any written requires licensees and other entities to review as part of the authorization
documentation that licensees and other retain certain records related to decisionmaking process specified in
entities rely on when making authorization decisionmaking for at § 26.69 [Authorization with potentially
authorization decisions. This provision least 5 years after an individual’s disqualifying fitness-for-duty
meets Goal 7 of this rulemaking to authorization has been terminated or information].
protect the privacy and other rights denied, or until the completion of all The NRC has added § 26.713(a)(3) to
(including due process) of individuals related legal proceedings, whichever is the final rule to require licensees and
who are subject to Part 26. This later. The agency has added the other entities to retain records that are
provision is also meets Goal 4 of this requirement to retain records until the related to the granting and termination
rulemaking to improve consistency completion of all related legal of an individual’s authorization. This
between this rule and access proceedings at the suggestion of provision ensures that licensees and
authorization requirements established stakeholders during the public meetings other entities who may be considering
in 10 CFR 73.56, as supplemented by discussed in Section I.D. The granting authorization to an individual
orders to nuclear power plant licensees stakeholders noted that some legal under Subpart C [Granting and
dated January 7, 2003. proceedings involving records of the Maintaining Authorization] can
The NRC has also added § 26.711(d) type specified in the paragraph have determine which category of
to the final rule to require licensees and continued longer than the 5 years that authorization requirements in Subpart C
other entities to ensure that only correct the former rule required these records to applies to the individual, based upon
and complete information about be retained and that adding a the length of time that has elapsed since
individuals is retained and shared. This requirement in the final rule to retain the termination of the individual’s last
provision specifies that licensees and the records until all legal proceedings period of authorization and whether it
other entities shall correct or augment are complete protects an individual’s was terminated favorably. The new
shared information contained in the right to due process under the rule. This section discusses the categories of
records if this information changes or provision is consistent with Goal 7 of authorization requirements with respect
new information is developed. Also, if this rulemaking to protect the privacy to §§ 26.55 [Initial authorization], 26.57
[Authorization update], 26.59 expected working life of an individual, is consistent with Goal 7 of this
[Authorization reinstatement], and rather than on the period of the license. rulemaking to protect the privacy and
26.69. The termination of a license by the other rights (including due process) of
The NRC has added § 26.713(a)(4) to Commission does not mean that individuals who are subject to Part 26,
the final rule to require licensees and individuals whose authorizations were and Goal 3 to improve the effectiveness
other entities to retain records that are denied for 5 years or permanently and efficiency of FFD programs.
related to any determination of fitness denied under the licensee’ FFD program The NRC has added § 26.713(f) to the
that was conducted under § 26.189 would necessarily leave the industry. final rule to require licensees and other
[Determination of fitness]. The final Requiring retention of the records entities to retain records related to the
rule, with respect to the proposed rule, pertaining to those individuals ensures background investigations, credit and
clarifies that the records to be retained that the records of the 5-year and criminal history checks, and
include any recommendations for permanent denials are available, should psychological assessments of FFD
treatment and followup testing plans. the individual seek authorization from program personnel, conducted under
This provision ensures that licensees another licensee or other entity. This § 26.31(b)(1)(i), for the length of the
and other entities who may be amendment is consistent with Goal 7 of individual’s employment by or
considering granting authorization to an this rulemaking to protect the privacy contractual relationship with the
individual who has previously and other rights (including due process) licensee or other entity, or until the
undergone a determination of fitness of individuals who are subject to Part 26 completion of all related legal
can obtain these records for review as and Goal 3 to improve the effectiveness proceedings, whichever is later. This
part of the authorization and efficiency of FFD programs. requirement is consistent with the last
decisionmaking process specified in Section 26.713(d) of the final rule phrase of former Section 2.6(c) in
§ 26.69. In addition, if an individual replaces the recordkeeping requirement Appendix A to Part 26, which required
who is subject to followup testing and in former § 26.20 [Written policy and licensee testing facilities to retain
a treatment plan transfers to another procedures]. This paragraph requires personnel files that include
FFD program, the reviewing official and licensees and other entities to retain ‘‘appropriate data to support
SAE of the receiving FFD program, superseded FFD policies and determinations of honesty and integrity
which takes responsibility for procedures for at least 5 years, or until conducted in accordance with Section
implementing the testing and treatment completion of all legal proceedings 2.3 of this appendix.’’ The required
plans, are required to have access to this related to an FFD violation that may period during which these records must
information under § 26.69(e). have occurred under the policy and be maintained is based on the NRC’s
Section 26.713(b)(1) and (b)(2) of the procedures, whichever is later. The NRC need to have access to the records for
final rule requires licensees and other has increased the required period for inspection purposes and the potential
entities to retain records related to FFD retaining superseded materials from 3 to need for the records to remain available
training, examinations, audits, audit 5 years to ensure that the materials are if an individual, the NRC, a licensee, or
findings, and corrective actions for at available if subsequent licensees and another entity who is subject to this rule
least 3 years, or until the completion of other entities require the information in requires access to them in a legal or
all related legal proceedings, whichever making a determination of fitness. The regulatory proceeding. However, the
is later. These paragraphs retain the 3- requirement to retain the policy and final rule establishes a new limit on the
year recordkeeping requirements of the procedures related to any matter under period during which the records must
former rule in §§ 26.21(b) and 26.22(c) legal challenge until the matter is be retained in order to reduce the
for training records, and § 26.80(c) for resolved ensures that the materials burden associated with storing such
audit findings and corrective action remain available if an individual, the records indefinitely. This new provision
records. NRC, a licensee, or another entity who is consistent with Goal 7 of this
Section 26.713(c) of the final rule is subject to this rule require access to rulemaking to protect the privacy and
amends former § 26.71(c). Former them in a legal or regulatory proceeding. other rights (including due process) of
§ 26.71(c) required licensees to retain This provision is consistent with Goal 7 individuals who are subject to Part 26,
records related to any individual who of this rulemaking to protect the privacy and Goal 3 to improve the effectiveness
was made ineligible for authorization and other rights (including due process) and efficiency of FFD programs.
for 3 years or longer under former of individuals who are subject to Part The NRC has added § 26.713(g) to the
§ 26.27 [Management actions and 26, and Goal 3 to improve the final rule to require licensees and other
sanctions to be imposed] until the effectiveness and efficiency of FFD entities to retain records of the
Commission terminates each license programs. certification, provided by a qualified
under which the records were created. Section 26.713(e) of the final rule forensic toxicologist, as required under
However, the final rule requires amends the requirement in former § 26.31(d)(1)(i) and (d)(3)(iii)(C), of the
licensees and other entities to retain § 26.23(a) pertaining to the retention of scientific and technical suitability of
records concerning 5-year and written agreements for the provision of any assays and cutoff levels used for
permanent denials of authorization for FFD program services. This provision drug testing that this part does not
40 years or until, upon application, the requires licensees and other entities to address. This provision requires the
NRC determines that the records are no retain the written agreement for the life licensee or other entity to retain these
longer needed. The requirement to of the agreement (as in the former rule), records for the period of time during
retain records related to 5-year denials or until completion of all legal which the FFD program continues to
of authorization is consistent with the proceedings related to an FFD violation test for drugs for which this part does
more stringent sanctions established in that involved the services, whichever is not require testing, uses more stringent
§ 26.75(c), (d), and (e)(2), in which the later. This requirement ensures that the cutoff levels than those specified in this
NRC has eliminated the sanction of a 3- materials remain available should an part, or until the completion of all
year denial of authorization, as individual, the NRC, a licensee, or related legal proceedings, whichever is
discussed with respect to those another entity who is subject to the rule later. This new requirement ensures that
paragraphs. The 40-year retention require access to them in a legal or the NRC has access to the records for
requirement is based on the longest regulatory proceeding. This amendment inspection purposes and that the
records remain available if an assurance/quality control records; management actions; and the
individual, the NRC, a licensee, or superseded procedures; all test data; test information required under
another entity who is subject to this rule reports; records on performance testing; § 26.203(e)(1) and (e)(2). With respect to
requires access to them in a legal or records on testing errors or the proposed rule, the final rule clarifies
regulatory proceeding. This provision is unsatisfactory performance, and the § 26.717(b)(2) to be consistent with the
consistent with Goal 7 of this investigation and correction of the changes the NRC has made to
rulemaking to protect the privacy and errors or unsatisfactory performance; procedures for dilute specimens, as
other rights (including due process) of performance records on certification discussed with regard to § 26.163(a)(2).
individuals who are subject to Part 26, inspections; records on preventative This paragraph is identical to the
and Goal 3 to improve the effectiveness maintenance; records on negative test requirements of the former provision
and efficiency of FFD programs. results based on scientific insufficiency; with two exceptions: (1) the final rule
computer-generated data, printed or requires reporting the number of
Section 26.715 Recordkeeping
electronic copies of computer-generated subversion attempts by type, and (2)
Requirements for Collection Sites,
data; records of individuals accessing does not require a list of events reported
Licensee Testing Facilities, and
secured areas in licensee testing during the reporting period.
Laboratories Certified by The Concerning the first exception, the
facilities and HHS-certified laboratories;
Department of Health and Human final rule adds a requirement for
and records of EBT maintenance,
Services licensees and other entities to report the
inspection, and calibration. This listing
The NRC has added § 26.715 to the of records to be retained comes from number of subversion attempts by type.
final rule to group together in one provisions of the former rule in §§ 26.20 This new requirement is necessary to
section the recordkeeping requirements and 26.71(a) and Sections 2.7(a)(1), enable the NRC to monitor the ongoing
that apply to collection sites, licensee 2.7(f)(2), 2.7(g)(8), 2.7(n), 2.7(o)(1), integrity and effectiveness of FFD
testing facilities, and HHS-certified 2.7(o)(3), 2.8(e)(4), 2.9(g), and 3.1 of programs in detecting subversion
laboratories. Appendix A to Part 26. The final rule attempts, consistent with the NRC’s
Section 26.715(a) of the final rule groups them together in a single heightened concern with this issue, as
retains the requirement in former paragraph to make them easier to locate discussed with respect to
Section 2.7(n) in Appendix A to Part 26. within the rule, consistent with Goal 6 §§ 26.31(d)(3)(i) and 26.75(b). Although
This provision mandates that collection of this rulemaking to improve clarity in this information is available to NRC
sites, HHS-certified laboratories and the organization and language of the inspection personnel at each site, it
licensee testing facilities must maintain rule. would be costly and an inefficient use
documentation of all aspects of the of resources for inspectors to aggregate
testing process for at least two years. Section 26.717 Fitness-for-Duty and report it annually. Under the former
The final rule includes collection sites Program Performance Data rule, licensees typically reported
within this provision because licensee The NRC has added § 26.717 to the subversion attempts they detected under
testing facilities and collection sites may final rule to amend the requirements in the requirement to summarize ‘‘events
not be co-located, as was typically the former § 26.71(d) for collecting, reported’’ in former § 26.71(d).
case when the former rule was first compiling, and submitting FFD program Therefore, the NRC expects that the
published. This section retains the performance data to reduce the burden reporting requirement imposes minimal
provision in former Section 2.7(n) that on licensees and other entities and to additional burden. The agency has
the two-year period may be extended make the reporting time consistent with added this requirement to meet Goal 3
upon written notification by the NRC or the NRC’s need for the information. of the rulemaking to improve the
any licensee or other entity for whom Specifically, this paragraph requires effectiveness and efficiency of FFD
services are being provided. The final licensees and other entities to submit programs.
rule also adds a requirement to retain program performance data to the NRC Second, the final rule eliminates the
the documentation until completion of every 12 months, rather than every 6 former requirement to include the
all legal proceedings related to an FFD months. The NRC has made the number of events reported to the NRC
violation to ensure that the records additional conforming changes during the reporting period. The NRC
remain available if an individual, the described below to former § 26.71 for eliminated the former reporting
NRC, a licensee, or another entity who consistency with other revisions to the requirement because it has access to this
is subject to this rule requires access to rule. information through other avenues and
them in a legal or regulatory proceeding. Section 26.717(a) of the final rule reporting it twice is unnecessary.
This change is consistent with Goal 7 of retains the requirement in former Eliminating this requirement meets Goal
this rulemaking to protect the privacy § 26.71(d) that each FFD program 5 of the rulemaking to improve Part 26
and other rights (including due process) subject to Part 26 must collect and by eliminating or modifying
of individuals who are subject to Part compile FFD performance data. unnecessary requirements.
26, and Goal 3 to improve the Section 26.717(b)(1) through (b)(9) of The final rule also adds a requirement
effectiveness and efficiency of FFD the final rule amends the second in § 26.717(b)(9) that the FFD program
programs. sentence of former § 26.71(d). The performance data must include the
The NRC has added § 26.715(b)(1) provision specifies the FFD program information required under
through (b)(14) to the final rule to list in performance data that a licensee or § 26.203(e)(1) and (e)(2), which includes
a single paragraph the documents that other entity must report, including the (1) a summary of all instances during
collection sites, licensee testing random testing rate, the drugs for which the past calendar year when certain
facilities, and HHS-certified laboratories testing is conducted and their cutoff work hour controls were waived, and (2)
must retain. Specifically, those levels, workforce populations tested, a summary of corrective actions taken,
documents include personnel files of numbers of tests administered and resulting from the analysis of the data
individuals who are no longer working results, conditions under which the collected under § 26.203(e),
at a collection site, licensee testing tests were performed, substances respectively.
facility, or HHS-certified laboratory; on identified, number of subversion Section 26.717(c) of the final rule
chain-of-custody documents; quality attempts by type, summary of amends the portions of former § 26.71(d)
that required licensees and other this observation and, therefore, has other entities must report to the NRC
entities to analyze the FFD program eliminated the inaccurate phrase from (i.e., significant violations of the FFD
performance data semiannually. Instead, the final rule. The agency made this policy, significant FFD program failures,
this provision requires licensees and change to meet Goal 6 of the rulemaking and errors in drug and alcohol testing).
other entities to analyze FFD program relating to improving clarity in the The second sentence of the paragraph
performance data annually and retains language of the rule. retains the requirement in former
the requirement that actions must be Section 26.717(e) of the final rule § 26.73(c) that significant events must be
taken to correct program weaknesses. amends portions of former § 26.71(d). It reported under this section, rather than
NRC experience in reviewing FFD requires licensees and other entities to under the provisions of 10 CFR 73.71
program performance reports since it submit the annual summary to the NRC [Reporting of safeguards events].
first promulgated the rule has shown by March 1 of the following year, rather Section 26.719(b) of the final rule
that reporting twice per year is than the former requirement to provide reorganizes and amends former
unnecessary to ensure the continuing a semiannual summary within 60 days § 26.73(a)(1), (a)(2), and (b), consistent
effectiveness of FFD programs. of the end of each six-month reporting with Goal 6 of this rulemaking to
Therefore, the final rule relaxes the period. The agency made this change for improve clarity in the organization and
semiannual analysis and reporting consistency with the requirement in language of the rule. Paragraph
requirement, consistent with Goal 5 of § 26.717(c) to submit the report 26.719(b) retains the requirement in
the rulemaking to improve Part 26 by annually, as discussed with respect to former § 26.73(b) that notifications of
eliminating or modifying unnecessary that paragraph, and to meet Goal 5 of events must be made to the NRC
requirements. Furthermore, the the rulemaking to improve Part 26 by Operations Center within 24 hours of
provision requires licensees and other eliminating or modifying unnecessary their discovery. However, the final rule
entities to retain for 3 years records of requirements. presents this requirement at the
the data, analysis, and corrective actions Section 26.717(f) of the final rule beginning of the paragraph to clarify
taken, which is the same as the former retains the requirement in former that it applies to all of the events that
requirement in § 26.71(d). However, the § 26.71(d) that program performance are listed in the paragraph.
rule adds a requirement to retain the data may be submitted in a consolidated Section 26.719(b)(1) amends former
documentation until completion of any report as long as the data are reported § 26.73(a)(1). The former provision
legal proceedings related to an FFD separately for each site. required licensees to report the sale,
The NRC has added § 26.717(g) to the use, or possession of illegal drugs
violation to ensure that the records
final rule to require that C/Vs who within a protected area. The final rule
remain available if an individual, the
maintain an approved drug and alcohol adds a requirement for licensees and
NRC, a licensee, or another entity who
testing program must submit to the NRC other entities also to report the
is subject to this rule requires access to
the same program performance data that consumption or presence of alcohol in
them in a legal or regulatory proceeding.
are required from licensees and other a protected area. This change is
The agency has added this requirement
entities who are subject to the final rule, consistent with the NRC’s increased
to meet Goal 3 of the rulemaking to
either directly or via the licensee or concern with the adverse effects of
improve the effectiveness and efficiency
other entity to whom the C/V provides alcohol abuse on safe performance, as
of FFD programs.
services, ensuring that duplicate reports discussed with respect to § 26.75(e). The
Section 26.717(d) of the final rule are not provided to the NRC. This agency has made the change for
retains the last sentence of former requirement is necessary because the consistency with the performance
§ 26.71(d). The former provision final rule applies directly to C/Vs who objective in § 26.23(d), which is to
required any licensee who temporarily maintain licensee-approved programs, provide reasonable assurance that the
suspends an individual’s authorization rather than applying only to licensees workplaces subject to this part are free
or takes administrative actions on the under the former rule, as discussed with from the presence and effects of illegal
basis of an initial positive marijuana or respect to § 26.3(d). The agency has drugs and alcohol, as discussed with
cocaine drug test result (under the added this requirement to meet Goal 3 respect to that paragraph. This change
provisions of former § 26.24(d)) to report of the rulemaking to improve the also meets Goal 3 of the rulemaking to
the results in the annual summary by effectiveness and efficiency of FFD improve the effectiveness and efficiency
processing stage (i.e., initial testing at programs. of FFD programs, as the consumption or
the licensee testing facility, testing at presence of alcohol in a protected area
the HHS-certified laboratory, MRO Section 26.719 Reporting constitutes a significant programmatic
determination). The final rule continues Requirements failure in achieving this performance
to require that the report include the The NRC has added § 26.719 to the objective.
number of administrative actions taken final rule to replace former § 26.73 and Section 26.719(b)(2) amends former
against individuals for the reporting combines it with former Section § 26.73(a)(2). Former § 26.73(a)(2)
period. However, the agency has 2.8(e)(4), (e)(5), and (e)(6) in Appendix required licensees to report any acts by
eliminated the term ‘‘temporarily A to Part 26. The final rule groups into licensed operators and supervisory
suspend’’ from the provision and one section reporting requirements that personnel involving the sale, use, or
replaced it with the term are interspersed throughout the former possession of a controlled substance;
‘‘administratively withdraw rule to meet Goal 6 of this rulemaking resulting in confirmed positive test
authorization,’’ in response to to improve clarity in the organization results for such persons; involving the
stakeholder requests at the public and language of the rule. use of alcohol within the protected area;
meetings discussed in Section I.D. The The NRC added § 26.719(a) to the or resulting in a determination of
stakeholders noted that an individual is final rule to introduce the section, unfitness for scheduled work because of
either authorized to perform job duties consistent with Goal 6 of this the consumption of alcohol. The final
under Part 26 or not, and that the rulemaking to improve clarity in the rule expands the former reporting
concept of suspending an individual’s organization and language of the rule. requirement to include SSNM
authorization is conceptually This provision specifies the categories transporter personnel and FFD program
inconsistent. The NRC concurred with of significant events that licensees and personnel. The NRC has made this
change to ensure that it is informed of because transporter and FFD program Therefore, intentional acts that cast
events involving these individuals personnel typically do not work within doubt on the integrity of one FFD
because of the important roles they play a protected area. However, the NRC program may also indirectly affect the
in assuring public health and safety and maintains an interest in the integrity and effectiveness of other FFD
the common defense and security, in the consumption of alcohol by the programs. The NRC requires reporting of
former case, and the integrity of the FFD individuals listed in § 26.719(b)(2) these acts in order to monitor their
program, in the latter. The agency’s while they are performing the duties impacts and ensure that other FFD
change meets Goal 3 of the rulemaking specified in § 26.4 at any location. programs that may be affected are
to improve the effectiveness and Section 26.719(b)(3) establishes a new informed of the problem so that they
efficiency of FFD programs. requirement for licensees and other can take corrective actions, if necessary.
Section 26.719(b)(2)(i) retains former entities to report any intentional act that The agency has made this change to
§ 26.73(a)(2)(i). The provision requires casts doubt on the integrity of the FFD meet Goal 3 of the rulemaking to
licensees and other entities to report any program. Because of the wide array of improve the effectiveness and efficiency
acts by the subject individuals that possible acts that could fit this of FFD programs.
involve the use, sale, or possession of a definition and be of concern to the NRC, The NRC has added § 26.719(b)(4) to
controlled substance. the final rule does not specify the acts the final rule to require licensees and
Section 26.719(b)(2)(ii) combines and that licensees and other entities must other entities to report any
amends former § 26.73(a)(2)(ii) and report. However, such intentional acts programmatic failure, degradation, or
(a)(2)(iv). The former section required may include, but are not limited to: discovered vulnerability of an FFD
licensees and other entities to report any (1) Notifying individuals, outside of program that may permit undetected
confirmed positive test results for such the FFD program’s normal notification drug or alcohol use or abuse by
persons and any acts by the subject procedures, that they will be selected individuals within a protected area, or
individuals that result in a for random or followup testing on a by individuals who are assigned to
determination of unfitness for particular date or at a specific time so perform the duties that require them to
scheduled work because of the that the individuals have sufficient time be subject to the FFD program. In Item
consumption of alcohol, respectively. available to attempt to mask drug use 10.1 of NUREG–1385, ‘‘Fitness for Duty
The final rule amends the former by, for example, obtaining a substitute in the Nuclear Power Industry:
requirements by mandating that urine specimen or an adulterant, Responses to Implementation
licensees and other entities report any drinking large amounts of liquid in Questions,’’ the NRC emphasized that it
acts by the subject individuals that order to provide a dilute urine expects licensees to exercise prudent
result in a determination that the specimen, or leaving the site to avoid judgment in determining whether to
individual has violated the licensee’s or testing;
other entity’s FFD policy (including report unusual situations and that the
(2) Attempting to divert or tamper
subversion as defined in § 26.5 significant events the licensees must
with urine specimens that are being
[Definitions]). This change is consistent report are not limited to the examples
prepared for transfer to a licensee
with two other changes to the rule: (1) contained in the rule. However, the NRC
testing facility or HHS-certified
the addition of validity testing understands that licensees have not
laboratory by stealing the specimens,
requirements to the final rule, as reported many significant events that
substituting specimens in the package,
discussed with respect to would be useful for formulating public
or altering the specimens’ custody-and-
§ 26.31(d)(3)(i), and (2) the addition of policy or that the NRC should respond
control documentation;
new requirements in Subpart D (3) Attempting to tamper with testing to in a timely fashion because licensee
[Management Actions and Sanctions to instruments so that they provide false management decided not to do so unless
be Imposed] that impose the same negative test results; the rule specifically required this
sanctions for confirmed positive alcohol (4) Collusion by collection site reporting. Therefore, this final rule adds
test results as those required for personnel, an MRO, or MRO staff with § 26.719(b)(4) to clarify that significant
confirmed positive drug test results, as an individual who is subject to testing events and programmatic failures are
discussed with respect to § 26.75(e). to alter the individual’s test results; and not limited to those listed in § 26.719(b),
Therefore, the final rule requires (5) Attempts by information but include any programmatic failures
licensees and other entities to report technology personnel to alter the or weaknesses that potentially could
confirmed positive drug test results, any software that the FFD program uses to permit substance abuse to be
other acts to subvert or attempt to randomly select individuals for testing undetected. The agency has made this
subvert the testing process, and to ensure that specific individuals are change to meet Goal 3 of the rulemaking
confirmed positive alcohol test results not selected. to improve the effectiveness and
for these individuals. The intentional acts that this final efficiency of FFD programs.
Section 26.719(b)(2)(iii) amends rule requires licensees and other entities Section 26.719(c) of the final rule
former § 26.73(a)(2)(iii). The former to report could involve any aspect of the reorganizes and amends former
provision required licensees and other operations of the FFD program and the requirements for reporting errors in drug
entities to report any events involving testing process. and alcohol testing, consistent with
the consumption of alcohol within the The final rule adds this reporting Goal 6 of the rulemaking to improve
protected area by the subject requirement because of other changes to clarity in the organizational of the rule.
individuals. The final rule adds the the final rule that permit licensees and The final rule retains the former
requirement to report any acts involving other entities to rely on other Part 26 requirements for licensees and other
the consumption of alcohol while programs to a much greater extent than entities to investigate and take
performing the duties that require these under the former requirement. The final corrective actions for drug and alcohol
individuals to be subject to this part. rule permits licensees and other entities testing errors in §§ 26.137(f) and
This change is consistent with the to rely on testing performed by another 26.167(g) for licensee testing facilities
addition of SSNM transporters and FFD Part 26 program, FFD training, other and HHS-certified laboratories,
program personnel to this paragraph, as programs’ suitable inquiries and respectively, but moves the reporting
discussed with respect to § 26.719(b)(2), determinations of fitness, and audits. requirements to this section.
Section 26.719(c)(1) updates the The rule establishes a 24-hour time act, as discussed with respect to
portion of former § 2.8(e)(4) in limit because false positive test results § 26.137(c). Therefore, reporting of false
Appendix A to Part 26 that mandated would cause licensees and other entities positive errors is unnecessary to protect
that licensees and other entities must to impose sanctions on individuals who the interests of either donors or the
report within 30 days of completing an have not, in fact, abused drugs and/or public.
investigation any testing errors or attempted to subvert the testing process. The NRC has added § 26.719(d) to the
unsatisfactory performance in HHS may decertify a laboratory as a final rule to require licensees and other
performance testing at either a licensee result of false positive test results. The entities to document, trend, and correct
testing facility or an HHS-certified 24-hour time limit ensures that the NRC nonreportable FFD issues that identify
laboratory. This section amends the can quickly notify HHS of the problem programmatic weaknesses under the
former requirement by specifying that so that HHS may initiate the applicable licensee’s or other entity’s corrective
the report of the incident must describe steps required under its guidelines for action program. The final rule includes
the corrective actions taken or planned. such circumstances. In addition, the this requirement because some licensees
Although licensees and other entities NRC may use the information to inform have not documented, trended, or
have consistently described corrective other licensees and entities who rely on corrected programmatic weaknesses,
actions in such reports, the agency has the same HHS-certified laboratory of the while others have created separate
added this new requirement to meet problem, so that they may determine systems, with the result that corrective
Goal 6 of the rulemaking to improve whether to require the laboratory or a actions for FFD program weaknesses
clarity in the language of the rule. second laboratory to retest any have not been timely or effective.
In addition, this section adds cross- specimens a licensee or other entity has Therefore, the final rule adds these
references to other sections of the final submitted. The agency has established requirements for consistency with
rule that define processes that may also the 24-hour time limit to meet Goal 7 of Criterion XVI in Appendix B to 10 CFR
result in the identification of errors, the rulemaking to protect the privacy Part 50 [Domestic licensing of
including the reviews required under and other rights (including due process) production and utilization facilities]
§ 26.39 [Review process for fitness-for- of individuals who are subject to Part and to meet Goal 3 of this rulemaking
duty policy violations] and § 26.185 26. to improve the effectiveness and
[Determining a fitness-for-duty policy The NRC has added § 26.719(c)(3) to efficiency of FFD programs.
violation]. In the original rule, the NRC the final rule to require licensees and This section also requires licensees
intended that testing or process errors other entities to report any false and other entities to document, trend,
discovered in any part of the program, negative errors identified through and correct any programmatic
including these review processes, would quality assurance checks of validity weaknesses in a manner that protects
be investigated as an unsatisfactory screening tests within 24 hours of the individuals’ privacy. For example, this
performance of a test. Thorough discovery if the licensee or other entity section prohibits licensees and other
investigation and reporting of such test uses these tests for validity screening at entities from documenting a single
results will continue to assist the NRC, a licensee testing facility. This reporting confirmed positive, adulterated,
the licensees, HHS, and the HHS- requirement ensures that the NRC is substituted, or invalid drug test result in
certified laboratories in preventing aware of any testing failures, so that the corrective action program, because
future occurrences. Therefore, this other Part 26 programs that rely on the such documentation, along with other
change, consistent with Goal 6 of the tests may be informed of the error and cues in the work environment, may
rulemaking to improve clarity in the stop using them until the cause of the permit any individual who has access to
language of the rule, clarifies that the error is identified and the problem is the corrective action system easily to
requirement to investigate, correct, and resolved. Continued use of unreliable identify the donor. However, under the
report errors is not limited only to errors tests may permit attempts to subvert the final rule, the NRC expects licensees
identified through blind performance testing process to go undetected, with and other entities to document, trend,
testing in licensee testing facilities and the result that individuals who have analyze, and take corrective actions for
HHS-certified laboratories but also engaged in a subversion attempt may be an increase in the rate of confirmed
applies to errors identified through any granted or allowed to maintain positive, adulterated, substituted, or
means. authorization. The agency has added invalid test results in the aggregate if the
Section 26.719(c)(2) amends the this requirement to meet Goal 3 of the licensee or other entity determines that
portion of former Section 2.8(e)(5) in rulemaking to improve the effectiveness the increasing trend indicates
Appendix A to Part 26 that required and efficiency of FFD programs. programmatic weaknesses rather than
licensees to promptly notify the NRC if The final rule does not require improved effectiveness of the FFD
a false positive error occurs on a blind licensees and other entities to report program or some other factor. The
performance test sample. This section false positive errors identified through agency has added the requirement to
replaces the former requirement that the quality assurance checks of validity protect individuals’ privacy within the
report must be made ‘‘promptly’’ with screening tests for two reasons. First, corrective action program to meet Goal
one to report the false positive error other provisions of the rule prohibit 7 of this rulemaking to protect the
within 24 hours of the discovery. The licensees and other entities from taking privacy and other rights (including due
agency has made this change as a result management actions or imposing process) of individuals who are subject
of the public meetings discussed in sanctions on individuals on the basis of to Part 26.
Section I.D, during which the validity screening test results, as
stakeholders noted that the term discussed with respect to § 26.75(h). Subpart O—Inspections, Violations, and
‘‘promptly’’ is vague. Therefore, the Second, donors are protected from the Penalties
final rule clarifies the former adverse consequences of false positive As a result of the reorganization of the
requirement by establishing a 24-hour validity screening test results because proposed rule, the provisions contained
time limit for the notification, consistent these specimens are forwarded to an in Subpart K of the proposed rule have
with Goal 6 of this rulemaking to HHS-certified laboratory for initial and been moved to Subpart O of the final
improve clarity in the language of the confirmatory testing, if required, before rule. The NRC received no public
rule. a licensee or other entity is permitted to comment on Subpart O, and the final
rule adopts the provisions in Subpart O retains the requirements in former Public Document Room (PDR). The
as proposed without change. § 2626.91. NRC Public Document Room is located
The NRC added Subpart O to the final The NRC has deleted Appendix A to at 11555 Rockville Pike, Rockville,
Part 26 ‘‘Guidelines for Drug and Maryland.
rule to combine into one subpart former
Alcohol Testing Programs’’ in its
§§ 26.70 [Inspections], 26.90 entirety and has incorporated its Regulations.gov Web site (Web). The
[Violations], and 26.91 [Criminal requirements into Subparts E [Collecting federal government’s rulemaking portal
penalties], consistent with Goal 6 of the Specimens for Testing], F [Licensee is located at
rulemaking to improve clarity in the Testing Facilities], and G [Laboratories http://www.regulations.gov/.
organization of the rule, by grouping Certified by the Department of Health NRC’s Public Electronic Reading
related sections into one subpart. and Human Services]. Room (EPDR). The NRC’s electronic
Section 26.821 [Inspections] retains the public reading room is located at http://
requirements in former § 2626.70. VII. Availability of Documents
www.nrc.gov/reading-rm.html.
Section 26.823 [Violations] retains the The NRC is making the documents
identified below available to interested The NRC staff contact. David Diec,
requirements in former § 2626.90.
persons through one or more of the Mail Stop O–12D3, Washington, DC
Section 26.825 [Criminal penalties]
following methods as indicated. 20555–0001, 301–415–2834.
Document PDR Web EPDR NRC staff
Part 26 Derivation and Distribution Tables ................ X .................................................. ML080570421 .......................... X

Comments received ................................................... X NRC_2002_0002 ...................... .................................................. X
Analysis of comments received (when available) ...... X .................................................. X ............................................... X
Regulatory Analysis .................................................... X .................................................. ML080580135 .......................... X
VIII. Criminal Penalties directive, editorial changes have been process for self-declarations of fatigue
For the purpose of Section 223 of the made in these revisions to improve the by workers, and provide for rest breaks.
Atomic Energy Act (AEA), the organization and readability of the Further, the standard does not
Commission is amending 10 CFR Part former language of the paragraphs being adequately mitigate short-term fatigue,
26 under one or more of Sections 161b, revised. because it does not restrict deviations
161i, or 161o of the AEA. Willful XI. Voluntary Consensus Standards from the short-term limits to only those
violations of the rule are subject to unique instances necessary for the
criminal enforcement. The National Technology Transfer safety and security of the plant. The
and Advancement Act of 1995, Pub. L. standard only requires that exceptions
IX. Agreement State Compatibility
104–113, requires that Federal agencies be minimized and that they be approved
Under the ‘‘Policy Statement on use technical standards developed or by the plant manager or designee. The
Adequacy and Compatibility of adopted by voluntary consensus provisions in the standard are identical
Agreement State Programs’’ approved by standards bodies unless the use of such to those currently incorporated as
the Commission on June 30, 1997, and a standard is inconsistent with requirements in some nuclear power
published in the Federal Register on applicable law or otherwise impractical. plants’ technical specifications. Section
September 3, 1997 (62 FR 46517), this There are no consensus standards IV.D explains that enforcement of the
rule is classified as Compatibility regarding the methods for performing technical specification requirements is
Category ‘‘NRC.’’ Compatibility is not drug and alcohol testing, fatigue complicated by the fact that the
required for Category ‘‘NRC’’ assessments, or other aspects of FFD language is largely advisory, and key
regulations. The NRC program elements programs, that would apply to the terms have not been defined, with the
in this category are those that relate requirements imposed by this rule, with result that the requirements have been
directly to areas of regulation reserved the exception of short-term work hour interpreted inconsistently.
to the NRC by the Atomic Energy Act of limits for licensed operators, senior For the reasons noted above, the ANS
1954, as amended (AEA), or the operators, and the shift technical standard cannot be used in lieu of the
provisions of Title 10 of the Code of advisor. The NRC notes the inclusion of provisions of this rule to meet the
Federal Regulations. Although an these limits in a 1988 American Nuclear objective of comprehensive fatigue
Agreement State may not adopt program Society standard on administrative management.
elements reserved to the NRC, it may controls and quality assurance for the
wish to inform its licensees of certain operational phase of nuclear power XII. Finding of No Significant
requirements via a mechanism that is plants, ANSI/ANS–3.2–1998. Environmental Impact: Environmental
consistent with the particular States’s Assessment
administrative procedure laws but does The NRC does not believe that this
not confer regulatory authority on the standard is sufficient, as it does not The Commission has determined
State. apply to other categories of workers who under the National Environmental
would be subject to the provisions of Policy Act of 1969, as amended, and the
X. Plain Language this rule, such as maintenance, health Commission’s regulations in Subpart A
The Presidential memorandum dated physics, chemistry, fire brigade, and of 10 CFR Part 51, that this rule is not
June 1, 1998, entitled ‘‘Plain Language security force personnel. Additionally, a major Federal action significantly
in Government Writing’’ directed that the standard is insufficient because it affecting the quality of the human
the Government’s writing be in plain does not provide the comprehensive environment and, therefore, an
language. This memorandum was fatigue management approach that this environmental impact statement is not
published on June 10, 1998 (63 FR rule does, and lacks provisions to required. The basis for this
31883). In complying with this mitigate long-term fatigue, provide a determination reads as follows:
The final rule amends the NRC’s would adversely affect the environment. displays a currently valid OMB control
requirements for FFD programs which Therefore, there are no significant non- number.
are contained in 10 CFR Part 26 to radiological impacts associated with
XIV. Regulatory Analysis
address the following needs: (1) Update this action.
and enhance the consistency of 10 CFR The primary alternative to this action The NRC has prepared a final
Part 26 with advances in other relevant is the no action alternative. The no Regulatory Analysis on this regulation.
Federal rules and guidelines, including action alternative would result in The final regulatory analysis was
the HHS Guidelines and other Federal continued inconsistencies between FFD prepared under the NRC’s Regulatory
drug and alcohol testing programs (e.g., and access authorization requirements, Analysis Guidelines (RA Guidelines),
those required by DOT) that impose continued difficulties in NUREG/BR–0058, Revision 4, dated
similar requirements on the private implementation of the regulation due to September 2004. The Regulatory
sector; (2) strengthen the effectiveness of the current organization of the rule, Analysis consists of three parts. First, an
FFD programs at nuclear power plants continued use of less current aggregate analysis of the entire rule was
in ensuring against worker fatigue technologies and advances in testing performed. Second, a screening review
adversely affecting public health and and a continued lack of a for disaggregation was performed to
safety and the common defense and comprehensive fatigue management identify any individual provisions that
security by establishing clear and program. The no action alternative could impose costs disproportionate to
enforceable requirements for the would provide little or no safety, risk, the benefits attributable to each
management of worker fatigue; (3) or environmental benefit. provision. Finally, a separate analysis of
improve the effectiveness and efficiency the rule’s provisions addressing worker
No outside agencies or persons were
of FFD programs; (4) improve fatigue was performed. A description of
consulted, or outside sources used or
consistency between FFD requirements each of these three elements is
relied upon, in the preparation of this
and access authorization requirements discussed below. Single copies may be
environmental assessment. The NRC
established in 10 CFR 73.56, as obtained from the contact listed above
received no comments on this under the FOR FURTHER INFORMATION
supplemented by orders to nuclear environmental assessment.
power plant licensees dated January 7, CONTACT heading.
The determination of this
2003; (5) improve 10 CFR Part 26 by A. Aggregate Analysis
environmental assessment is that there
eliminating or modifying unnecessary
will be no significant environmental Consistent with the RA Guidelines, an
requirements; (6) improve clarity in the
impact from this action. aggregate analysis of the entire
organization and language of the rule;
and (7) protect the privacy rights and XIII. Paperwork Reduction Act rulemaking was performed. The
other rights (including due process) of Statement provisions of the rule relating to drug
individuals who are subject to 10 CFR and alcohol testing (and other general
The final rule contains new or FFD program requirements) are
Part 26.
It also grants, in part, a December 30, amended information collection estimated to result in net present value
1993, petition for rulemaking (PRM–26– requirements that are subject to the savings to industry of $129 million–
1) from Virginia Electric and Power Paperwork Reduction Act of 1995 (44 $204 million (using 7 percent and 3
Company (now Dominion Virginia U.S.C. 3501 et seq.). These requirements percent real discount rates), consisting
Power) which requested a relaxation in were approved by the Office of of $2 million in one-time costs and $10
required audit frequencies, and a Management and Budget, approval million in annual net savings. The
petition for rulemaking (PRM–26–2), number 3150–0146. worker fatigue portions of the final rule
dated December 28, 1999, from Barry The burden to the public for these are estimated to cost industry $439
Quigley, by establishing clear and information collections is estimated to million—$685 million net present value
enforceable requirements concerning average 1.5 hours per response, (using the 7 percent and 3 percent real
the management of worker fatigue. In including the time for reviewing discount rates, respectively), consisting
addition, the rule continues to apply to instructions, searching existing data of $12 million in one-time costs and $32
all personnel with unescorted access to sources, gathering and maintaining the million in annual net costs. The net
the protected area of a nuclear power data needed, and completing and present value of the entire rule,
plant, consistent with the Commission’s reviewing the information collection. including both the worker fatigue and
denial (SRM–SECY–04–0229) of an Send comments on any aspect of these drug and alcohol testing portions, is
exemption request by IBEW Local 1245 information collections, including estimated to be a cost to industry of
dated March 13, 1990, and renewed on suggestions for reducing the burden, to $310 million—$481 million (using 7
January 26 and December 6, 1993. the Records and FOIA/Privacy Services percent and 3 percent real discount
This rule does not significantly Branch (T–5 F52), U.S. Nuclear rates), which consists of $14 million in
increase the probability or consequences Regulatory Commission, Washington DC one-time costs and $22 million in
of an accident. No changes have been 20555–0001, or by Internet electronic annual costs. In addition, the rule is
made in the types or quantities of mail to INFOCOLLECTS@NRC.GOV; estimated to be a cost to the NRC of
radiological effluents that may be and to the Desk Officer, Office of $665,000—$1,025,000 net present value
released offsite, and there is no Information and Regulatory Affairs, (using 7 percent and 3 percent real
significant increase in public or NEOB–10202, (3150–0146), Office of discount rates), consisting of $28,000 in
occupational radiation exposure since Management and Budget, Washington, one-time costs and $47,000 in annual
there is no change to facility operations DC 20503. net costs.
that could create a new or affect a The NRC concludes that the costs of
Public Protection Notification
previously analyzed accident or release the rule are justified in view of the
path. The NRC may not conduct or sponsor, qualitative benefits evaluated in Section
With regard to non-radiological and a person is not required to respond 4.1.2 of the Regulatory Analysis. The
impacts, no changes have been made to to, a request for information or an basic analysis measures the incremental
non-radiological plant effluents and information collection requirement impacts of the rule relative to a baseline
there are no changes in activities that unless the requesting document that assumes full licensee compliance
with existing NRC requirements, this rule will not have a significant impacts because the gaseous diffusion
including current regulations and any economic impact on a substantial plants certified by the NRC are not
relevant orders or enforcement number of small entities. This rule currently authorized to possess formula
discretion. The aggregate analysis is affects only licensees authorized to quantities of strategic special nuclear
contained in Section 4.1 of the operate nuclear power reactors; material.
regulatory analysis. licensees authorized to possess, use, or
transport formula quantities of SSNM; B. Aggregate Backfit Analysis
B. Screening Review for Disaggregation
corporations who obtain certificates of The NRC performed an aggregate
The regulatory analysis also discusses compliance or approved compliance backfit analysis of all backfits consistent
the screening review for disaggregation plans under Part 76 involving formula with Section 4.3.2 of the RA Guidelines.
performed by the staff. The analysis was quantities of SSNM; combined license Because the changes associated with the
performed consistent with Section 4.3.2 holders; holders of construction rule are interrelated and deal with a
of the RA Guidelines to determine if permits; combined license and single subject area (FFD), the NRC
there are provisions whose costs are construction permit holders and followed its ordinary practice of
disproportionate to the benefits and combined license and construction
whose inclusion in the aggregate assessing the backfitting implications in
permit applicants with authorization to an aggregate manner, consistent with
analysis could obscure their impact, but construct; and C/Vs who implement
also responds to the Commission’s the RA Guidelines. The aggregate
FFD programs or program elements, to analysis is provided in Section 4.4.1 of
direction in SRM–01–0134 dated July the extent that licensees and other
23, 2001, that, ‘‘If there is a reasonable the Part 26 Regulatory Analysis. The
entities rely upon those C/V FFD aggregate analysis also includes a list of
indication that a change imposes costs programs or program elements to meet
disproportionate to the safety benefit all changes that constitute backfits, in
the requirements of Part 26. Those Exhibits 4–14 and 4–15 of the analysis.
attributable to that change, as part of the above do not fall within the scope of the
final rule package the Commission will Exhibit 4–16 of the analysis also
definition of ‘‘small entities’’ set forth in
perform an analysis of that change in includes a list of all changes that were
the Regulatory Flexibility Act, or the
addition to the aggregate analysis of the evaluated for potential cost
Size Standards established by the
entire rulemaking to determine whether implications, but were determined to
Nuclear Regulatory Commission (10
this change should be aggregated with not constitute backfits, as well as a list
CFR 2.810).
the other change for the purposes of the of the reasons those changes were
backfit analysis. That analysis will need XVI. Backfit Analysis determined to not constitute backfits. In
to show that the individual change is The rule constitutes backfitting as addition, the NRC prepared a
integral to achieving the purpose of the defined in 10 CFR 50.109(a)(1). The supplemental backfit analysis for the
rule, has costs that are justified in view NRC has performed a backfit analysis, as requirements in Subpart K of Part 26. A
of the benefits that would be provided described in § 50.109(c) [which applies summary of the results of the aggregate
or qualifies for one of the exceptions in to power reactors], § 70.76(b) [which analysis follows.
10 CFR § 50.109(a)(4).’’ These results are applies to formula quantity strategic The NRC determined the backfitting is
described in Sections 4.1.4.1 and 4.4.2 special nuclear material licensees], and justified under § 50.109(a)(3) and
of the regulatory analysis. § 76.76(b) [which applies to gaseous § 70.76(a)(3) because: (1) There is a
diffusion plants], consistent with the substantial increase in the overall level
C. Dissaggregation of Worker Fatigue NRC’s Regulatory Analysis Guidelines of protection afforded for the public
Provisions (RA Guidelines) in NUREG/BR–0058, health and safety or the common
Section 4.1.4.2 of the Regulatory Revision 4, dated September 2004. The defense and security to be derived from
Analysis summarizes the division of Backfit Analysis is included in the the backfitting; and (2) the costs of
costs and savings of the fatigue Regulatory Analysis. implementation and the annual costs
management portions of the rule, in are justified in view of this increase.
A. Consideration of Fuel Fabrication
comparison with the rest of the rule. The estimated cost of implementation
Facilities and Gaseous Diffusion Plants
The worker fatigue portions of the rule would be $14 million and the annual
are estimated to cost industry $439 The backfit provision of 10 CFR 70.76 net costs would be $42 million,
million—$685 million net present value applies to currently licensed fuel resulting in a net present value cost of
(using the 7 percent and 3 percent real fabrication facilities. Although gas $582 million–$911 million (using 7
discount rates, respectively), consisting centrifuge facilities are licensed under percent and 3 percent real discount
of $12 million in one-time costs and $32 Part 70, these facilities have not been rates, respectively).
million in annual net costs. The NRC considered in the analysis because NRC
has not granted authorization to possess In determining that the substantial
considers fatigue management to be an
formula quantities of SSNM at these increase standard is met, the NRC
integral and necessary aspect of FFD.
facilities. These facilities have been considered safety benefits qualitatively.
Fatigue was considered to be part of
considered in the aggregate backfit In this qualitative consideration, the
FFD under former § 26.10(a) and
analysis. The planned mixed-oxide fuel NRC determined that the FFD rule,
§ 26.20(a)(2). However, the NRC
fabrication facility also would be considered in the aggregate, constitutes
included a summary of the costs
licensed under Part 70, but has not yet a substantial increase in protection to
associated with the fatigue management
submitted a Part 26 program public health and safety by addressing
requirements in the aggregate as a
description. Therefore, the the following six key areas that have
courtesy to stakeholders in Section
consideration of the costs to the mixed- been identified as posing recurring and,
4.1.4.2 of the Regulatory Analysis.
oxide fuel fabrication facility in the in some cases, significant problems with
XV. Regulatory Flexibility Act respect to the effectiveness, integrity,
regulatory analysis is sufficient for

Certification consideration of the impacts to that and efficiency of FFD programs at
As required by the Regulatory facility. Although the backfit provision nuclear facilities.
Flexibility Act, as amended, 5 U.S.C. of 10 CFR 76.76 applies to gaseous 1. Subversion of the detection/testing
605(b), the Commission certifies that diffusion plants, there are no backfit process;
2. Regulatory efficiency between 10 operator alertness and performance in Carroll, R. J. (Ed.) (1999). Ocular measures of
CFR Part 26 and other related Federal nuclear power plants. EPRI Technical driver alertness: technical conference
rules and guidelines; Report NP–6748. CA: Palo Alto: Electric proceedings, April 26–27, 1999. FHWA–
3. Ineffective/unnecessary FFD Power Research Institute. MC–99–136. Washington DC: Federal
Baldwin, D.C. Jr. and Daugherty, S.R. (2004). Highway Administration Office of Motor
requirements; Sleep deprivation and fatigue in residency Carrier and Highway Safety.
4. Ambiguous or imprecise regulatory training: results of a national survey of Circadian Technologies Incorporated. (2004).
language in 10 CFR Part 26; first- and second-year residents. Sleep, 2004 shiftwork practices survey. Circadian
5. Technical developments; and 2004 March 15;27(2):217–23. Information, 125 Cambridge Park Drive,
6. FFD program integrity and Baldwin, D.C. Jr., Daugherty, S.R., Tsai, R. Cambridge MA.
protection of individual rights. and Scotti, M.J. Jr. (2003). A national Circadian Technologies Incorporated. (2003).
In addition to the six areas above, the survey of residents’ self-reported work Overtime in extended hours operations:
NRC noted in its analysis a significant hours: thinking beyond specialty. benefits, costs, risks and liabilities.
qualitative benefit in the management of Academic Medicine, Nov;78(11):1154–63. Circadian Information, 125 Cambridge Park
worker fatigue for key personnel at Balkin, T., Thorne, D., Sing, H., Thomas, M., Drive, Cambridge MA.
Redmond, D., Wesensten, N., Russo, M., Circadian Technologies Incorporated. (2000).
nuclear power plants. Williams, J., Hall, S., and Belenky, G. Shiftwork practices 2000: A summary of
C. Screening Review for Disaggregation (2000). Effects of sleep schedules on the annual managing 24x7 survey of 24-
commercial motor vehicle driver hour operations. Circadian Information,
The NRC also performed a screening performance. U.S. DOT Technical Report 125 Cambridge Park Drive, Cambridge MA.
review, consistent with Section 4.3.2 of No. DOT–MC–00–113. Washington, DC: Colquhoun, W., Costa, G., Folkard, S. and
the RA Guidelines, to determine if there Department of Transportation Federal Knauth, P. (1996). Shiftwork problems and
are provisions constituting backfits Motor Carrier Safety Administration. solutions. Frankfurt am Main: Peter Lang
whose costs are disproportionate to the Banderet, L.E., Stokes, J., Francesconi, R., GmbhH.
benefits and whose inclusion in the Kowal, D. and Naitoh, P. (1981). Artillery ‘‘Commentary on PROS Fatigue Survey
teams in simulated sustained combat: Results,’’ ML0705205540.
aggregate analysis could obscure their performance and other measures. In: L.C.
impact. The NRC identified 17 backfits Comperatore, C.A. and Krueger, G.P. (1990).
Johnson, D. Tepas, W. Colguhon, M. Circadian rhythm desynchronosis, jet lag,
with reasonable indications that the Colligan. Biological Rhythms, Sleep and shift lag, and coping strategies. In:
costs associated with the backfit may be Shift Work. Spectrum, New York, 459–477. Occupational Medicine: State of the Art
disproportional to the safety benefit Beal, J. and Rosekind, M. (Eds.) (1995). Reviews, 1990, Vol. 5, No. 2, pg. 323–341,
attributable to the change. The NRC Fatigue symposium proceedings,
Philadelphia, PA: Hanley and Belfus, Inc.
determined that all of the 17 backfits November 1–2, 1995. Washington, DC:
(1990). Also as USAARL Technical Report
National Transportation Safety Board.
were necessary to meet the objectives of Belenky, G.L., Wesensten, N.J., Thorne, D.,
No. 90–14. Fort Rucker, AL: U.S. Army
the rule. Therefore, the staff did not Aeromedical Research Laboratory,
Thomas, M., Sing, H., Redmond, D.P.,
disaggregate any of those individual September 1990. (DTIC No. AD: A228–
Russo, M.B. and Balkin, T. (2003). Patterns
provisions and perform a separate of performance gradation and restoration 787).
backfit analysis for each provision. A during sleep restriction and subsequent Council Directive. (1993). 93/104/EC of 23
recovery: a sleep dose-response study. November 1993 concerning certain aspects
detailed discussion of the screening of the organization of working time,
review, including the reasons why each Journal of Sleep Research, 12, 1–12.
Bobko, N., Karpenko, A., Gerasimov, A., and Official Journal of the European
of the 17 backfits were determined to be Communities L 307, 13/12/1993 P. 0018–
Chernyuk, V. (1998). The mental
necessary to meet the objectives of the performance of shiftworkers in nuclear and 00241.
rule is described in Section 4.4.2 of the heat power plants of Ukraine. In: Cone E.J., Sampson-Cone A.H., Darwin W.D.,
Regulatory Analysis. International Journal of Industrial Heustis, M.A., Oyler J.M. (2003). Urine
Ergonomics, 21, 333–340. testing for cocaine abuse: metabolic and
XVII. References excretion patterns following different
Bruck D. and Pisani D.L. (1999). The effects
Akerstedt, T. (2004). Predictions from the of sleep inertia on decision-making routes of administration and methods for
three-process model of alertness. Aviation, performance. Journal of Sleep Research, detection of false-negative results. Journal
Space and Environmental Medicine, 75(3), June;8(2):95–103. of Analytical Toxicology, Oct;27(7):386–
2, A75–A83. Buxton, S., Hartley, L. and Krueger, G.P. 401.
Akerstedt, T. (2003). Shift work and (2002). The health and safety hazards of Construction Safety and Drug Abuse
disturbed sleep/wakefulness. Occupational shift work: strategies to overcome them. Executive Roundtable, February 27, 2006,
Medicine, March;53(2):89–94. (Murdoch University Technical Report). http://www.avitarine.com/construction-
Akerstedt, T. (1995). Work hours, sleepiness Western Australia, Australia: Murdoch forum.cfm.
and the underlying mechanisms. Journal of University, Institute for Research in Safety Dawson D. and Campbell, S. (1991). Timed
Sleep Research, 4, 15–22. and Transport. Victoria Roads Technical exposure to bright light improves sleep and
Akerstedt, T. (1995). Work injuries and time Report No. 2002–05, October, 2002; Kew, alertness during simulated night shifts.
of day—national data. Shiftwork Victoria, Australia; ISBN No. 07–7311– Sleep, Dec;14(6):511–6.
International Newsletter, 12(1), 2. 9076–9. Dawson, D. and Reid, K. (1997). Fatigue,
Alluisi, E.A. and Morgan, B.B. (1982). Cabon, P., Bourgeois-Bougrine, S., Mollard, alcohol and performance impairment.
Sustained performance. In: E.E. Bilodeau R., Coblentz, A., and Speyer, J. (2003). Nature, 388:235.
(Ed.) Principles of Skill Acquisition. New Electronic pilot-activity monitor: a Department of Health and Human Services,
York: Academic Press. countermeasure against fatigue on long- Substance Abuse and Mental Health
Angus, R. and Heslegrave, R. (1985). Effects haul flights. Aviation, space, and Services Administration, ‘‘Guidance for
of sleep loss on sustained cognitive environmental medicine, June;74(6 Pt Reporting Specimen Validity Test Results,’’
performance during a command and 1):679–82. Program Document 35, September 28,
control simulation. Behavioral Research Carrier, J. and Monk, T. (2000). Circadian 1998.
Methods, Instruments and Computers, 17, rhythms of performance: New trends. Dinges, D.F., Pack, F., Williams, K., Gillen,
55–67. Chronobiology International, 17(6):719– K.A., Powell, J.W., Ott, G.E., Aptowicz, C.
Baker, K., Olson, J., and Morisseau, D. (1994). 732. and Pack, A.I. (1997). Cumulative
Work practices, fatigue, and nuclear power Carrier, J., Monk, T.H., Buysse, D., and sleepiness, mood disturbance, and
plant safety performance. Human Factors, Kupfer, D.J. (1997). Sleep and psychomotor vigilance performance
36(2), 244–257. morningness-eveningness in the ‘‘middle’’ decrements during a week of sleep
Baker, T.L., Campbell, S.C., Linder, K.D., and years of life (20–59 y). Journal of Sleep restricted to 4–5 hours per night. Sleep,
Moore-Ede, M.C. (1990). Control room Research, 6:230–237. 20:4, pp. 267–277.
Dinges, D.F. (1995). An overview of Fatigue in Transportation Conference. ‘‘Ltr. From NEI re: Plant Staff Working Hour
sleepiness and accidents. Journal of Sleep Australia: Femantle, Western Australia: Limits Survey,’’ August 29, 2000,
Research, 4, 4–14. Murdoch University Institute for Research ML003746495.
Dinges, D.F. (1992). Probing the limits of in Safety and Transport. Oxford, United Liskowsky, D.R. (Ed.) (1991). Biological
functional capability: The effects of sleep Kingdom: Elsevier Science, Ltd. rhythms: Implications for the worker.
loss on short-duration tasks. In: R.J. Hockey, G. (1970). Changes in attention OTA–BA–463. Washington, DC: U.S.
Broughton and R. Ogilvie (Eds.) Sleep, allocation in a multi-component task under Congress Office of Technology Assessment.
Arousal and Performance. Boston: sleep deprivation. British Journal of (ISBN 0–16–035497–8).
Birkhauser-Boston, Inc. Psychology, 61, 473–480. Lockley, S.W., Cronin, J.W., Evans, E.E.,
Dinges, D. F., Whitehouse, W. G., Orne, E. C. Horne, J. (1988). Why We Sleep: The Cade, B.E., Lee, C.J., Landrigen, C.P.,
and Orne, M. T. (1988). The benefits of a Functions of Sleep in Humans and Other Rothschild, J.M., Katz, J.T., Lilly, C.M.,
nap during prolonged work and Mammals. New York: Oxford University Stone, P.H., Aeschbach, D. and Czeisler,
wakefulness. Work and Stress, 2:139–153. Press. C.A. (2004). Effect of reducing interns’
‘‘Director’s Decision DD–01–05 Under 2.206 Horne, J. (1988). Sleep loss and ‘‘divergent’’ weekly work hours on sleep and
re Part 26 re Unescorted Access,’’ thinking ability. Sleep, December; attentional failures. New England Journal
November 26, 2001, ML013230169. 11(6):528–36. of Medicine, October 28, 2004, v351, n18,
Doran, S., Van Dongen, H., and Dinges, D.F. ‘‘IR 05000346–04–003, FirstEnergy Nuclear p1829–1837.
(2001). Sustained attention performance Operating Company, on 01/12/2004 to 02/ Lorist, M., Klein, M., Nieuwenhuis, S., De
during sleep deprivation: evidence of state 12/2004, Davis-Besse Nuclear Power Jong, R., Mulder, G., and Meijman T.
instability. Archive Itialiennes de Biologic. Station. Special Inspection,’’ March 31, (2000). Mental fatigue and task control:
Dorel, M., (1996). Human failure in the 2004, ML040910335. Planning and preparation.
control of nuclear power stations: temporal Jansen, N., Amelsvoort, L., Kristensen, T., Psychophysiology, September; 37(5):614–
logic of occurrence and alternating work Brandt, P., and Kant, I. (2003). Work 25.
times. In: Stanton, N., Human Factors in schedules and fatigue: A prospective Mallis, M., Mejdal, S., Nguyen, T., and
Nuclear Safety, London, Taylor & Francis cohort study. Occupational and Dinges, D. (2002). Summary of the key
Ltd. Environmental Medicine; 60 (Suppl 1):i47– features of seven biomathematical models
Falleti, M.G., Maruff, P., Collie, A., Darby, i53. of human fatigue and performance.
D.G. and McStephen, M. (2003). Kecklund, G., Akerstedt, T., Gillberg, M., and Aviation, Space, and Environmental
Qualitative similarities in cognitive Lowden, A. (1997). Task, shift and Medicine, Vol. 75 (No. 3, Section II,
impairment associated with 24h of sleepiness: A meta analysis. Stockholm, Supplement).
sustained wakefulness and blood alcohol Sweden: IPM and Karlinska Institute. Maloney, S. (1992). Evidence of circadian
concentration of 0.05%. Journal of Sleep Shiftwork International Newsletter
and extended shift effects on reactor
Research, Dec;12(4):265–74. 14(1):36.
transient frequency. In Transactions of the
Folkard S, and Tucker P. (2003). Shift work, Kemper, M. (2001). The role and
American Nuclear Society 1992 Annual
safety and productivity. Journal of effectiveness of napping on the work
Meeting, 65:512–513.
Occupational Medicine, Mar;53(2):95–101. performances of shift workers. Work,
‘‘Managing Fatigue in the Nuclear Energy
Folkard, S. (1997). Black times: temporal 16(2):153–157.
determinants of transport safety. Accident Knauth P, and Hornberger S. (2003). Industry: Challenges and Opportunities,’’
Analysis and Prevention, 29, 417–430. Preventive and compensatory measures for May 6, 2002, ML022750179.
Folkard S, Akerstedt T. (1992). A three- shift workers. Occupational Medicine, McCallum, M., Sandquist, T., Mitler, M., and
process model of the regulation of 2003 Mar; 53(2):109–16. Krueger, G.P. (2003). Commercial
alertness-sleepiness. In: Broughton R.J., Krueger, G.P. (1994). Fatigue, performance, transportation operator fatigue
Ogilvie R.D., (eds.) Sleep, arousal, and and medical error. Chapter 14, 311–326. In: management reference. (U.S. DOT
performance: a tribute to Bob Wilkinson. M.S. Bogner (Ed.), Human Error in Technical Report). Washington, DC: U.S.
Boston: Birkhauser; 1992, 11–26. Medicine. Northvale, NJ: Erlbaum Department of Transportation Research
‘‘FRN: General Notice Concerning 10 CFR Associates. and Special Programs Administration.
Part 26, Fitness for Duty Programs,’’ March Krueger, G.P. (1991). Sustained military [Seattle, WA: Battelle Transportation
10, 2006, ML060650535. performance in continuous operations: Research Center, Technical Report: OTA
Gander, P., Gregory, K., Miller, D., Graeber, Combatant fatigue, rest and sleep needs. Mp/DTRS56–01–T–003; July 2003].
R., Connell, L., and Rosekind, M. (1998). Pp. 255–277. Chapter 14 in R. Gal and A. ‘‘Memo to G. M. Tracy From: M. C. Nolan
Crew factors in flight operations: the initial D. Mangelsdorff (Eds.) Handbook of Subject: Summary of the January 23, 2003,
NASA-Ames field studies on fatigue. Military Psychology (1991). Chichester, Public Meeting to Discuss Draft Order
Aviation, Space, and Environmental UK: Wiley and Sons. Also as USAARL Regarding Worker Fatigue of Nuclear
Medicine, Vol. 69 (No. 9, Section II, Technical Report No. 91–19, U.S. Army Facility Security Force Personnel at
Supplement). Aeromedical Research Laboratory, Fort Nuclear Power Plants Attachments (3),’’
Hanecke, K., Tiedemann, S., Nachreiner, F. Rucker, AL, September 1991. (DTIC No. January 30, 2003, ML030300470.
and Grzech-Sukalo, H. (1998). Accident AD: A242–507). Miller, J.C. and Mitler, M.M. (1997).
risk as a function of time on task and time Krueger, G.P. (1989). Sustained work, fatigue, Predicting accident times. Ergonomics in
of day. Shiftwork International Newsletter. sleep loss and performance: A review of Design, 5, 13–18.
14(1) Abstracts from the XII International the issues. Work and Stress, 1989, 3(2) Mitler, M.M. and Miller, J.C. (1996). Methods
Symposium on Night and Shiftwork New 129–141. (Also as USAARL Tech Rep 89– of testing for sleepiness. Behavioral
Challenges for the Organization, June 23– 22). Fort Rucker, AL: U.S. Army Medicine, 21, 171–183.
27, 1997, Majvik, Finland. Aeromedical Research Laboratory, Monk, T.H. and Carrier, J. (2003). Shift
Harrison, Y. and Horne, J.A. (2000). The September 1989. (DTIC No. AD: A215– worker performance. Clinics in
impact of sleep deprivation on 234). Occupational and Environmental
decisionmaking: A review. Journal of Kryger, M.H., Roth, T., and Dement, W.C. Medicine, 2, 209–229.
Experimental Psychology: Applied, 6(3): (Eds.) (1994). Principles and practice of Monk, T.H. (2000). What can the
236–249. sleep medicine. Philadelphia, PA: W.B. chronobiologist do to help the shift
Harrison, Y. and Horne, J.A. (1998). Sleep Saunders. worker? Journal of Biological Rhythms,
loss impairs short and novel language tasks Landrigan, C.P., Rothschild, J.M., Cronin, 2000;15:86–94.
having a prefrontal focus. Journal of Sleep J.W., Kaushal, R., Burdick, E., Katz, J.T., Monk, T.H., Buysse, D.J., Rose, L.R., Hall,
Research, 7:95–100. Lilly, C.M., Stone, P.H., Lockley, S.W., J.A., Kupfer, D.J. (2000). The sleep of
Harrison, Y. and Horne, J.A. (1997). Sleep Bates, D.W. and Czeisler, C.A. (2004). healthy people—a diary study.
deprivation affects speech. Sleep. 20:871– Effect of reducing interns’ work hours on Chronobiology International, 2000 Jan;
877. serious medical errors in intensive care 17(1):49–60.
Hartley, L. (1998). Managing fatigue in units. New England Journal of Medicine, Monk, T.H., Moline, M.L., Graeber, R.C.
transportation: Proceedings of the 3rd October 28, 2004, v351, n18, p1838–1848. (1988). Inducing jet lag in the laboratory:
Patterns of adjustment to an acute shift in Conference Proceedings. Alexandria, VA: work shifts: how long does it take? The
routine. Aviat Space Environ Med. 1988 American Trucking Associations. ISBN: 0– Journal of Applied Psychology, February;
Aug; 59(8):703–10. 86587–516–2. 80(1):43–57.
Monk, T. and Folkard, S., (1985). Individual Rogers, W.C. (1996). Technical conference on Tucker, P., Smith, L., Macdonald, I., and
differences in shift work adjustment. In: enhancing commercial motor vehicle Folkard, S. (1999). Distribution of rest days
Hours of Work—Temporal Factors in Work driver vigilance, December 10–11, 1996. in 12-hour shift systems: Impacts on
Scheduling. John Wiley and Sons, Conference proceedings. Alexandria, VA: health, wellbeing, and on shift alertness.
Chichester and New York, 227–237. American Trucking Associations Occupational and Environmental
Morgan, B.B., Brown, B. R. and Alluisi, E.A. Foundation. Medicine, 56, 206–214.
(1974). Effects on sustained performance of Rosa, R.R., Harma, M., Pulli, K., Mulder, M. U.S. Department of Health and Human
48 hours of continuous work and sleep and Nasman, O. (1996). Rescheduling a Services, Substance Abuse and Mental
loss. Human Factors, 16, 406–414. three shift system at a steel rolling mill: Health Services Administration, Office of
National Center on Sleep Disorders Research Effects of a one hour delay of shift starting Applied Studies. Drug Use Among U.S.
(NCSDR) and the National Highway Traffic times on sleep and alertness in younger Workers: Prevalence & Trends by
Safety Administration, (1999). Drowsy and older workers. Occupational and Occupation and Industry Categories,
Driving and Automobile Crashes. Environmental Medicine, Oct; 53(10):677– ‘‘Percentage of Full-Time Workers, Age 18–
National Sleep Foundation (2003). Sleep in 85. 49, Reporting Current Illicit Drug and
America Poll: 2003. Washington DC, Rosa, R. (1995). Extended workshifts and Heavy Alcohol Use, by Occupational
http://www.sleepfoundation.org/polls/ excessive fatigue. Journal of Sleep Categories, 1994 and 1997.’’
2003SleepPollExecSumm.pdf. Research, 4(2), 51–56. U.S. Department of Health and Human
National Sleep Foundation (2000). Sleep in Rosa, R. (1991). Performance, alertness, and Services, Substance Abuse and Mental
America Poll: 2000. Washington DC, sleep after 3.5 years of 12 h shifts: A Health Services Administration, Office of
http://www.sleepfoundation.org/ follow-up study. Work and Stress, 5, 107– Applied Studies. National Household
publications/2000poll.cfm. 116. Survey on Drug Abuse, Illicit Drug Use
National Transportation Safety Board (1999). Rosekind, M., Neri, D., and Dinges, D. (1997). Among Construction Workers (2000–2001),
Evaluation of U.S. Department of Fatigue and duty time limitations—an Table 1B, ‘‘Age Groups: Percentages of Past
Transportation efforts in the 1990s to international review proceedings. The Month Users of Illicit Drugs Among Males
address operator fatigue. NTSB Safety Royal Aeronautical Society. 7, 1–14. ISBN Aged 18 or Older Who Reported
Report No. SR–99–01, May 1999. 1 85768 088 X. ‘Construction’ as Their Occupation,’’
Washington, DC: National Transportation Rosekind, M.R., Smith, R.M., Miller, D.L., Co http://www.oas.samhsa.gov/
Safety Board. PB99–917002. E.L., Gregory, K.B., Webbon, L.L., Gander, construction.htm.
P.H. and Lebacqz, J.V. (1995). Fatigue self- U.S. Department of Health and Human
National Transportation Safety Board (1994).
management strategies and reported fatigue Services, Substance Abuse and Mental
A Review of Flightcrew-Involved Major
in international pilots. Journal of Sleep Health Services Administration, Office of
Accidents of U.S. Air Carriers—1978
Research, Dec; 4(S2):62–66. Applied Studies. National Household
through 1990. NTSB Report No. SS–94–01/
Rosekind M.R., Gander, P.H., Miller, D.L., Survey on Drug Abuse, ‘‘Substance Use,
PB94–917001. Washington, DC, 1994.
Gregory, K.B., Smith, R.M., Weldon, K.J., Dependence or Abuse among Full-time
Pascoe, P., Rogers, A. and Spencer, M. (1995). Co, E.L., McNally, K.L. and Lebacqz, J.V. Workers,’’ September 2002, http://
Task loading and the development of (1994). Fatigue in operational settings: www.oas.samhsa.gov/2k2/workers/
fatigue at different times of day. Shiftwork Examples from the aviation environment. workers.pdf.
International Newsletter, 12(12):49. Human Factors, 1994 Jun; 36(2):327–38. U.S. Department of Health and Human
Petrie K.J., Powell D. and Broadbent E. ‘‘SECY–01–0113—Fatigue of Workers at Services, Substance Abuse and Mental
(2004). Fatigue self-management strategies Nuclear Power Plants,’’ ML010180224. Health Services Administration, Office of
and reported fatigue in international pilots. Sallinen, M., Harma, M., Akerstedt, T., Rosa, Applied Studies. Worker Substance Use
Ergonomics, April 15; 47(5):461–8. R. and Lillqvist, O. (1998). Promoting and Workplace Policies and Programs.
Pilcher J.J. and Huffcutt A.I. (1996). Effects of alertness with a short nap during a night National Survey on Drug Use and Health,
sleep deprivation on performance: A meta- shift. Journal of Sleep Research, 7, 240– Figure 3.1 ‘‘Past Month Illicit Drug Use
analysis. Sleep, May; 19(4):318–26. 247. among Full-Time Workers Aged 18 to 64,
Pratt, S. (2003). Work-related roadway Schellekens, J., Sijtsma, G.J., Vegter, E. and by Major Occupational Categories: 2002–
crashes—challenges and opportunities for Meijman, T.F. (2000). Immediate and 2004,’’ Figure 3.2, ‘‘Past Month Heavy
prevention. The National Institute for delayed after-effects of long lasting Alcohol Use among Full-Time Workers
Occupational Safety and Health mentally demanding work. Biological Aged 18 to 64, by Major Occupational
Publication No. 2003–119. Psychology, Vol. 53, No. 1, May 1, Categories: 2002–2004.’’ http://
Presser, H. (2000). Nonstandard work 2000:37–56. www.oas.samhsa.gov/work2k7/work.pdf.
schedules and marital instability. Journal Scott, A. (1990). Shiftwork. Occupational U.S. Department of Transportation. (1995).
of Marriage and the Family, 62, Feb: 93– Medicine: State of the Art Reviews, 1990, Sharing the knowledge: Department of
110. Vol. 5, No. 2. Philadelphia, PA: Hanley and Transportation Focus on Fatigue. (Program
Priest, D. (2000). War and Sleep. The Belfus, Inc. Description Pamphlet). Washington, DC:
Washington Post. Washington, DC. Strollo, P.J. Jr., Rogers, R.M. (1996). U.S. Department of Transportation.
November 19, 2000, W17. Obstructive sleep apnea. New England U.S. Nuclear Regulatory Commission,
Priest, B., Brichard, C., Aubert G., Liistro, G. Journal of Medicine. 334:99–104. ‘‘Criteria for Preparation and Evaluation of
and Rodenstein, D. (2001). Microsleep Summala, H., Hakkanen, H, Mikkola, T, and Radiological Emergency Response Plans
during a simplified maintenance of Sinkkonen, J. (1999). Task effects on and Preparedness in Support of Nuclear
wakefulness test. A validation study of the fatigue symptoms in overnight driving. Power Plants,’’ NUREG–0654, Rev. 1,
OSLER test. American Journal of Ergonomics, June; 42(6):798–806. March 2002.
Respiratory and Critical Care Medicine, Tepas, D. and Monk, T.H. (1987). Work U.S. Nuclear Regulatory Commission,
June; 163(7):1619–25. schedules. In: G. Salvendy. Handbook of ‘‘Accident Source Terms for Light-Water
‘‘Relaxation of the Order, Exercising Human Factors. John Wiley and Sons. 819– Nuclear Power Plants,’’ NUREG–1465,
Enforcement Discretion, and Extension of 894. February 1995.
the Time to Submit an Answer or Request Thomas, M. et al. (2000). Neural basis of U.S. Nuclear Regulatory Commission,
a Hearing Regarding Order EA–03–038, alertness and cognitive performance ‘‘Fitness for Duty in the Nuclear Power
Fitness-for-duty Enhancements for Nuclear impairments during sleepiness. In: Effects Industry: Responses to Implementation
Security Force Personnel,’’ July 10, 2003, of 24 h of sleep deprivation on waking Questions,’’ NUREG–1385, October 1989.
ML031880257. human regional brain activity. Journal of U.S. Nuclear Regulatory Commission,
Rogers, W.C. (Ed.). (1997). International Sleep Research. December; 9(4) 335. ‘‘Fitness for Duty in the Nuclear Power
conference on managing fatigue in Totterdell, P., Spelten, E., Smith, L., Barton, Industry: Responses to Public Comments,’’
transportation, April 29–30, 1997. J., and Folkard, S. (1995). Recovery from NUREG–1354, May 1989.
U.S. Nuclear Regulatory Commission, ‘‘The Register Notice (70 FR 50442), Dated 26.53 General provisions.
Human Performance Evaluation Process: A August 26, 2005 on 10 CFR Part 26, Fitness 26.55 Initial authorization.
Resource for Reviewing the Identification for Duty Programs,’’ October, 26, 2005, 26.57 Authorization update.
and Resolution of Human Performance ML052990048. 26.59 Authorization reinstatement.
Problems,’’ NUREG/CR–6751, April 2002. ‘‘12/15/2005 Revised Notice of Public 26.61 Self-disclosure and employment
U.S. Nuclear Regulatory Commission, Meeting with Nuclear Energy Institute to history.
‘‘Review of Findings for Human Error Obtain Clarifications on NEI’s Proposed 26.63 Suitable inquiry.
Contribution to Risk in Operating Events,’’ Alternative Approach to Work Hour 26.65 Pre-access drug and alcohol testing.
NUREG/CR–6753, August 2001. Portion of NRC Proposed 10 CFR Part 26, 26.67 Random drug and alcohol testing of
U.S. Nuclear Regulatory Commission, Fitness for Duty Programs,’’ December 6, individuals who have applied for
‘‘Recommendations for NRC Policy on 2005, ML053400002.
Shift Scheduling and Overtime at Nuclear authorization.
Power Plants,’’ NUREG/CR–4248, July Copies of publicly available reference 26.69 Authorization with potentially
1985. items are available for inspection and/ disqualifying fitness-for-duty
U.S. Nuclear Regulatory Commission, or copying for a fee in the NRC Public information.
‘‘Handbook on Human Reliability Analysis Document Room, One White Flint 26.71 Maintaining authorization.
with Emphasis on Nuclear Power Plant North, 11555 Rockville Pike, Room O- Subpart D—Management Actions and
Applications,’’ NUREG/CR–1278, August F21, Rockville, MD 20852–2738. Sanctions To Be Imposed
1983. Copyrighted materials may be viewed at
Van der Linden, D., Frese, M. and Sonnentag, 26.73 Applicability.
the NRC Public Document Room, but 26.75 Sanctions.
S. (2003). The impact of mental fatigue on
exploration in a complex computer task: may not be copied. 26.77 Management actions regarding
Rigidity and loss of systematic strategies. List of Subjects in 10 CFR Part 26 possible impairment.
Human Factors, 45:483–494.
Van Dongen, H.P., Maynard, M.D., Maislin, Alcohol abuse, Alcohol testing, Subpart E—Collecting Specimens for
G. and Dinges, D.F. (2004a). Systematic Appeals, Chemical testing, Drug abuse, Testing
interindividual differences in Drug testing, Employee assistance 26.81 Purpose and applicability.
neurobehavioral impairment from sleep programs, Fitness for duty, Management 26.83 Specimens to be collected.
loss: Evidence of trait-like differential actions, Nuclear power reactors, 26.85 Collector qualifications and
vulnerability. Sleep, 2004 May Protection of information, Reporting and responsibilities.
1:27(3):423–33. recordkeeping requirements. 26.87 Collection sites.
Van Dongen, H.P., Maislin, G. and Dinges, 26.89 Preparing to collect specimens for
D.F. (2004b). Dealing with inter-individual ■ For the reasons set out in the testing.
differences in temporal dynamics of fatigue preamble and under the authority of the 26.91 Acceptable devices for conducting
and performance: Importance and Atomic Energy Act of 1954, as amended; initial and confirmatory tests for alcohol
techniques. Aviation Space and the Energy Reorganization Act of 1974, and methods of use.
Environmental Medicine, 2004 March; 75(3 as amended; and 5 U.S.C. 552 and 553; 26.93 Preparing for alcohol testing.
Suppl.):A147–54.
Van Dongen, H., Maislin, G., Mullington, J.,
the NRC is revising 10 CFR Part 26. 26.95 Conducting an initial test for alcohol
and Dinges, D. (2003). The cumulative cost ■ 1. 10 CFR Part 26 is revised to read using a breath specimen.
of additional wakefulness: Dose-response as follows: 26.97 Conducting an initial test for alcohol
effects on neurobehavioral functions and using a specimen of oral fluids.
sleep physiology from chronic sleep PART 26—FITNESS FOR DUTY 26.99 Determining the need for a
restriction and total sleep deprivation. PROGRAMS confirmatory test for alcohol.
Sleep, March 15; 26(2):117–26. 26.101 Conducting a confirmatory test for
Webb, W.B. and Agnew, H.W. (1974). The Subpart A—Administrative Provisions alcohol.
effects of a chronic limitation of sleep Sec. 26.103 Determining a confirmed positive
length. Psychophysiology, 11, 265–274. 26.1 Purpose. test result for alcohol.
Williams, H.L., Lubin, A. and Goodnow, J.J. 26.3 Scope. 26.105 Preparing for urine collection.
(1959). Impaired performance with acute 26.4 FFD program applicability to 26.107 Collecting a urine specimen.
sleep loss. Psychological Monographs, No. categories of individuals. 26.109 Urine specimen quantity.
484, 73, 1–26. 26.5 Definitions. 26.111 Checking the acceptability of the
Williamson, A.M. and Feyer, A. (2000). 26.7 Interpretations. urine specimen.
Moderate sleep deprivation produces 26.8 Information collection requirements: 26.113 Splitting the urine specimen.
impairments in cognitive and motor OMB approval. 26.115 Collecting a urine specimen under
performance equivalent to legally 26.9 Specific exemptions. direct observation.
prescribed levels of alcohol intoxication. 26.11 Communications. 26.117 Preparing urine specimens for
Occupational and Environmental
Subpart B—Program Elements storage and shipping.
Medicine, 57, 649–655.
26.119 Determining ‘‘shy’’ bladder.
Wu, J.C., Gillin, J.C., Buchsbaum, M.S., 26.21 Fitness-for-duty program.
Hershey, T., Hazlett, E., Sicotte, N., and 26.23 Performance objectives. Subpart F—Licensee Testing Facilities
Bunney, W.E. (1991). The effect of sleep 26.25 [Reserved]
26.121 Purpose.
deprivation on cerebral glucose metabolic 26.27 Written policy and procedures.
26.123 Testing facility capabilities.
rate in normal humans assessed with 26.29 Training.
26.125 Licensee testing facility personnel.
positron emission tomography. Sleep, 26.31 Drug and alcohol testing.
156:1149–1158. 26.33 Behavioral observation. 26.127 Procedures.
‘‘9/21/2005 Notice of Public Meeting to 26.35 Employee assistance programs. 26.129 Assuring specimen security, chain
Solicit Comments on the Proposed Fitness- 26.37 Protection of information. of custody, and preservation.
for-Duty Rule and Discuss Industry Plans 26.39 Review process for fitness-for-duty 26.131 Cutoff levels for validity screening
for Developing Implementation Guidance policy violations. and initial validity tests.
for the Fatigue Management Provisions,’’ 26.41 Audits and corrective action. 26.133 Cutoff levels for drugs and drug
September 2, 2005, ML052420363. metabolites.
‘‘11/07/05 and 11/09/05 Notice Concerning Subpart C—Granting and Maintaining 26.135 Split specimens.
Offsite Public Meetings to Present Purposes Authorization 26.137 Quality assurance and quality
of Proposed Rule as Published in Federal 26.51 Applicability. control.
26.139 Reporting initial validity and drug Authority: Secs. 53, 81, 103, 104, 107, 161, systems, and components (SSCs) under
test results. 68 Stat. 930, 935, 936, 937, 948, as amended, the limited work authorization;
sec. 1701, 106 Stat. 2951, 2952, 2953 (42 (2) Combined license holders (under
Subpart G—Laboratories Certified by the U.S.C. 2073, 2111, 2112, 2133, 2134, 2137,
Department of Health and Human Services Part 52 of this chapter) before the
2201, 2297f); secs. 201, 202, 206, 88 Stat.
26.151 Purpose. 1242, 1244, 1246, as amended (42 U.S.C. Commission has made the finding under
26.153 Using certified laboratories for 5841, 5842, 5846). § 52.103(g);
testing urine specimens. (3) Construction permit applicants
26.155 Laboratory personnel. Subpart A—Administrative Provisions (under Part 50 of this chapter) who have
26.157 Procedures. been issued a limited work
26.159 Assuring specimen security, chain § 26.1 Purpose. authorization under § 50.10(e), if the
of custody, and preservation. This part prescribes requirements and limited work authorization authorizes
26.161 Cutoff levels for validity testing. standards for the establishment, the applicant to install the foundations,
26.163 Cutoff levels for drugs and drug implementation, and maintenance of
metabolites. including the placement of concrete, for
26.165 Testing split specimens and
fitness-for-duty (FFD) programs. safety- and security-related SSCs under
retesting single specimens. § 26.3 Scope.
the limited work authorization;
26.167 Quality assurance and quality (4) Construction permit holders
control.
(a) Licensees who are authorized to (under Part 50 of this chapter); and
26.168 Blind performance testing. operate a nuclear power reactor under (5) Early site permit holders who have
26.169 Reporting results. 10 CFR 50.57, and holders of a been issued a limited work
combined license under 10 CFR Part 52 authorization under § 50.10(e), if the
Subpart H—Determining Fitness-for-Duty
after the Commission has made the limited work authorization authorizes
Policy Violations and Determining Fitness
finding under 10 CFR 52.103(g) shall the early site permit holder to install the
26.181 Purpose. comply with the requirements of this
26.183 Medical review officer. foundations, including the placement of
part, except for subpart K of this part. concrete, for safety- and security-related
26.185 Determining a fitness-for-duty
policy violation. Licensees who receive their SSCs under the limited work
26.187 Substance abuse expert. authorization to operate a nuclear power authorization.
26.189 Determination of fitness. reactor under 10 CFR 50.57 after the (d) Contractor/vendors (C/Vs) who
date of publication of this final rule in implement FFD programs or program
Subpart I—Managing Fatigue.
the Federal Register and holders of a elements, to the extent that the licensees
26.201 Applicability. combined license under 10 CFR Part 52
26.203 General provisions. and other entities specified in
after the Commission has made the paragraphs (a) through (c) of this section
26.205 Work hours.
finding under 10 CFR 52.103(g) shall rely on those C/V FFD programs or
26.207 Waivers and exceptions.
26.209 Self-declarations. implement the FFD program before the program elements to meet the
26.211 Fatigue assessments. receipt of special nuclear material in the requirements of this part, shall comply
form of fuel assemblies. with the requirements of this part.
Subpart J—[Reserved] (b) Licensees who are authorized to (e) This part does not apply to either
Subpart K—FFD Programs for Construction possess, use, or transport formula spent fuel storage facility licensees or
26.401 General. quantities of strategic special nuclear non-power reactor licensees who
26.403 Written policy and procedures. material (SSNM) under Part 70 of this possess, use, or transport formula
26.405 Drug and alcohol testing. chapter, and any corporation, firm, quantities of irradiated SSNM.
26.406 Fitness monitoring. partnership, limited liability company,
26.407 Behavioral observation. association, or other organization who § 26.4 FFD program applicability to
26.409 Sanctions. obtains a certificate of compliance or an categories of individuals.
26.411 Protection of information. approved compliance plan under Part (a) All persons who are granted
26.413 Review process. 76 of this chapter, only if the entity unescorted access to nuclear power
26.415 Audits.
26.417 Recordkeeping and reporting.
elects to engage in activities involving reactor protected areas by the licensees
26.419 Suitability and fitness evaluations. formula quantities of SSNM shall in § 26.3(a) and, as applicable, (c) and
comply with the requirements of this perform the following duties shall be
Subpart L—[Reserved] part, except for subparts I and K of this subject to an FFD program that meets all
Subpart M—[Reserved] part. of the requirements of this part, except
(c) Before the receipt of special subpart K of this part:
Subpart N—Recordkeeping and Reporting nuclear material in the form of fuel (1) Operating or onsite directing of the
Requirements
assemblies, the following licensees and operation of systems and components
26.709 Applicability. other entities shall comply with the that a risk-informed evaluation process
26.711 General provisions. requirements of this part, except for has shown to be significant to public
26.713 Recordkeeping requirements for
licensees and other entities.
subpart I of this part; and, no later than health and safety;
§thnsp;26.715 Recordkeeping requirements the receipt of special nuclear material in (2) Performing health physics or
for collection sites, licensee testing the form of fuel assemblies, the chemistry duties required as a member
facilities, and laboratories certified by following licensees and other entities of the onsite emergency response
the Department of Health and Human shall comply with the requirements of organization minimum shift
Services. this part: complement;
§thnsp;26.717 Fitness-for-duty program (1) Combined license applicants (3) Performing the duties of a fire
performance data. (under Part 52 of this chapter) who have brigade member who is responsible for
§thnsp;26.719 Reporting requirements. been issued a limited work understanding the effects of fire and fire
Subpart O—Inspections, Violations, and authorization under § 50.10(e), if the suppressants on safe shutdown
Penalties limited work authorization authorizes capability;
§thnsp;26.821 Inspections. the applicant to install the foundations, (4) Performing maintenance or onsite
§thnsp;26.823 Violations. including the placement of concrete, for directing of the maintenance of SSCs
§thnsp;26.825 Criminal penalties. safety- and security-related structures, that a risk-informed evaluation process
has shown to be significant to public (2) Performs quality assurance, quality operations of the program, as defined by
health and safety; and control, or quality verification activities the procedures of the licensees and
(5) Performing security duties as an related to safety- or security-related other entities in § 26.3(a) through (c),
armed security force officer, alarm construction activities; and, as applicable, (d), and whose
station operator, response team leader, (3) Based on a designation under duties require them to have the
or watchperson, hereinafter referred to § 26.406 by a licensee or other entity, following types of access or perform the
as security personnel. monitors the fitness of the individuals following activities shall be subject to
(b) All persons who are granted specified in paragraph (f) of this section; an FFD program that meets all of the
unescorted access to nuclear power (4) Witnesses or determines requirements of this part, except
reactor protected areas by the licensees inspections, tests, and analyses subparts I and K of this part, and, at the
in § 26.3(a) and, as applicable, (c) and certification required under Part 52 of licensee’s or other entity’s discretion,
who do not perform the duties this chapter; subpart C of this part:
described in paragraph (a) of this (5) Supervises or manages the (1) All persons who can link test
section shall be subject to an FFD construction of safety- or security- results with the individual who was
program that meets all of the related SSCs; or tested before an FFD policy violation
requirements of this part, except (6) Directs, as defined in § 26.5, or determination is made, including, but
§§ 26.205 through 26.209 and subpart K implements the access authorization not limited to the MRO;
of this part. program, including— (2) All persons who make
(c) All persons who are required by a (i) Having access to the information determinations of fitness;
licensee in § 26.3(a) and, as applicable, used by the licensee or other entity to (3) All persons who make
(c) to physically report to the licensee’s make access authorization authorization decisions;
Technical Support Center or Emergency determinations, including information (4) All persons involved in selecting
Operations Facility by licensee stored in electronic format; or notifying individuals for testing; and
emergency plans and procedures shall (ii) Making access authorization (5) All persons involved in the
be subject to an FFD program that meets determinations; collection or onsite testing of
(iii) Issuing entry-control picture specimens.
all of the requirement of this part,
badges in accordance with access (h) Individuals who have applied for
except §§ 26.205 through 26.209 and
authorization determinations; authorization to have the types of access
subpart K of this part. (iv) Conducting background or perform the activities described in
(d) Any individual whose duties for investigations or psychological paragraphs (a) through (d) of this section
the licensees and other entities in assessments used by the licensee or shall be subject to §§ 26.31(c)(1),
§ 26.3(b) require him or her to have the other entity to make access 26.35(b), 26.37, 26.39, and the
following types of access or perform the authorization determinations, except applicable requirements of subparts C,
following activities shall be subject to that he or she shall be subject to and E through H of this part.
an FFD program that meets all of the behavioral observation only when he or (i) The following individuals are not
requirements of this part, except she is present at the location where the subject to an FFD program under this
subparts I and K of this part: nuclear power plant will be constructed part:
(1) All persons who are granted and operated, and licensees and other (1) Individuals who are not employed
unescorted access to Category IA entities may rely on a local hospital or by a licensee or other entity in this part,
material; other organization that meets the who do not routinely provide FFD
(2) All persons who create or have requirements of 49 CFR Part 40, program services to a licensee or other
access to procedures or records for ‘‘Procedures for Department of entity in this part, and whose normal
safeguarding SSNM; Transportation Workplace Drug and workplace is not at the licensee’s or
(3) All persons who measure Category Alcohol Testing Programs’’ (65 FR other entity’s facility, but who may be
IA material; 41944; August 9, 2001) to collect his or called on to provide an FFD program
(4) All persons who transport or her specimens for drug and alcohol service, including, but not limited to,
escort Category IA material; and testing; collecting specimens for drug and
(5) All persons who guard Category IA (v) Adjudicating reviews or appeals of alcohol testing, performing behavioral
material. access authorization determinations; observation, or providing input to a
(e) When construction activities (vi) Auditing the access authorization determination of fitness. Such
begin, any individual whose duties for program; or individuals may include, but are not
the licensees and other entities in (vii) Performing any of the activities limited to, hospital, employee assistance
§ 26.3(c) require him or her to have the or having any of the duties listed in program (EAP) or substance abuse
following types of access or perform the paragraph (e)(6) of this section for any treatment facility personnel, or other
following activities at the location C/V upon whom the licensee’s or other medical professionals;
where the nuclear power plant will be entity’s access authorization program (2) NRC employees, law enforcement
constructed and operated shall be will rely. personnel, or offsite emergency fire and
subject to an FFD program that meets all (f) Any individual who is constructing medical response personnel while
of the requirements of this part, except or directing the construction of safety- responding on site;
subparts I and K of this part: or security-related SSCs shall be subject (3) SSNM transporter personnel who
(1) Serves as security personnel to an FFD program that meets the are subject to U.S. Department of
required by the NRC, until the licensees requirements of subpart K of this part, Transportation drug and alcohol FFD
or other entities receive special nuclear unless the licensee or other entity programs that require random testing for
material in the form of fuel assemblies, subjects these individuals to an FFD drugs and alcohol; and
at which time individuals who serve as program that meets all of the (4) The FFD program personnel of a
security personnel required by the NRC requirements of this part, except for program that is regulated by another
must meet the requirements applicable subparts I and K of this part. Federal agency or State on which a
to security personnel in paragraph (a)(5) (g) All FFD program personnel who licensee or other entity relies to meet
of this section; are involved in the day-to-day the requirements of this part, as
permitted under §§ 26.4(j), 26.31(b)(2), conducted by any licensee testing handling and storage from the point of
and 26.405(e), if the FFD program facility or HHS-certified laboratory that specimen collection to final disposition
personnel are not employed by the continuously processes specimens, an of the specimen and its aliquots. ‘‘Chain
licensee or other entity and their normal analytical run is defined as no more of custody’’ and ‘‘custody and control’’
workplace is not at the licensee’s or than an 8-hour period. For a facility that are synonymous and may be used
other entity’s facility. analyzes specimens in batches, an interchangeably.
(j) Individuals who are subject to this analytical run is defined as a group of Circadian variation in alertness and
part and who are also subject to a specimens that are handled and tested performance means the increases and
program regulated by another Federal together. decreases in alertness and cognitive/
agency or State need be covered by only Authorization means that a licensee motor functioning caused by human
those elements of an FFD program that or other entity in § 26.3 has determined physiological processes (e.g., body
are not included in the Federal agency that an individual has met the temperature, release of hormones) that
or State program, as long as all of the requirements of this part to be granted vary on an approximately 24-hour cycle.
following conditions are met: or maintain the types of access or Collection site means a designated
(1) The individuals are subject to pre- perform the duties specified in § 26.4(a) place where individuals present
access (or pre-employment), random, through (e), and, at the licensee’s or themselves for the purpose of providing
for-cause, and post-event testing for the other entity’s discretion, § 26.4(f) or (g). a specimen of their urine, oral fluids,
drugs and drug metabolites specified in Best effort means documented actions and/or breath to be analyzed for the
§ 26.31(d)(1) at or below the cutoff that a licensee or other entity who is presence of drugs or alcohol.
levels specified in § 26.163(a)(1) for subject to subpart C of this part takes to Collector means a person who is
initial drug testing and in § 26.163(b)(1) obtain suitable inquiry and employment trained in the collection procedures of
for confirmatory drug testing; information in order to determine subpart E, instructs and assists a
(2) The individuals are subject to pre- whether an individual may be granted specimen donor at a collection site, and
access (or pre-employment), random, authorization, when the primary source receives and makes an initial
for-cause, and post-event testing for of information refuses or indicates an examination of the specimen(s)
alcohol at or below the cutoff levels inability or unwillingness to provide the provided by the donor.
specified in § 26.103(a) and breath information within 3 business days of Commission means the U.S. Nuclear
specimens are subject to confirmatory the request and the licensee or other Regulatory Commission (NRC) or its
testing, if required, with an EBT that entity relies on a secondary source to duly authorized representatives.
meets the requirements specified in meet the requirement. Confirmatory drug or alcohol test
§ 26.91; Blood alcohol concentration (BAC) means a second analytical procedure to
(3) Urine specimens are tested for means the mass of alcohol in a volume identify the presence of alcohol or a
validity and the presence of drugs and of blood. specific drug or drug metabolite in a
drug metabolites at a laboratory certified Calibrator means a solution of known specimen. The purpose of a
by the Department of Health and Human concentration which is used to define confirmatory test is to ensure the
Services (HHS); expected outcomes of a measurement reliability and accuracy of an initial test
(4) Training is provided to address the procedure or to compare the response result.
knowledge and abilities (KAs) listed in obtained with the response of a test Confirmatory validity test means a
§ 26.29(a)(1) through (a)(10); and specimen/sample. The concentration of second test performed on a different
(5) Provisions are made to ensure that the analyte of interest in the calibrator aliquot of the original urine specimen to
the testing agency or organization is known within limits ascertained further support a validity test result.
notifies the licensee or other entity during its preparation. Calibrators may Confirmed test result means a test
granting authorization of any FFD be used to establish a cutoff result that demonstrates that an
policy violation. concentration and/or a calibration curve individual has used drugs and/or
over a range of interest. alcohol in violation of the requirements
§ 26.5 Definitions. Category IA material means SSNM of this part or has attempted to subvert
Acute fatigue means fatigue from that is directly usable in the the testing process by submitting an
causes (e.g., restricted sleep, sustained manufacture of a nuclear explosive adulterated or substituted urine
wakefulness, task demands) occurring device, except if the material meets any specimen. For drugs, adulterants, and
within the past 24 hours. of the following criteria: substituted specimens, a confirmed test
Adulterated specimen means a urine (1) The dimensions are large enough result is determined by the Medical
specimen that has been altered, as (at least 2 meters in one dimension, Review Officer (MRO), after discussion
evidenced by test results showing either greater than 1 meter in each of two with the donor subsequent to the MRO’s
a substance that is not a normal dimensions, or greater than 25 receipt of a positive confirmatory drug
constituent of urine or showing an centimeters in each of three dimensions) test result from the HHS-certified
abnormal concentration of an to preclude hiding the item on an laboratory and/or a confirmatory
endogenous substance. individual; substituted or adulterated validity test
Alertness means the ability to remain (2) The total weight of an result from the HHS-certified laboratory
awake and sustain attention. encapsulated item of SSNM is such that for that donor. For alcohol, a confirmed
Aliquot means a portion of a it cannot be carried inconspicuously by test result is based on a positive
specimen that is used for testing. It is one person (i.e., at least 50 kilograms confirmatory alcohol test result from an
taken as a sample representing the gross weight); or evidential breath testing device (EBT)
whole specimen. (3) The quantity of SSNM (less than without MRO review of the test result.
Analytical run means the process of 0.05 formula kilograms) in each Constructing or construction activities
testing a group of urine specimens for container requires protracted diversions mean, for the purposes of this part, the
validity or for the presence of drugs to accumulate 5 formula kilograms. tasks involved in building a nuclear
and/or drug metabolites. For the Chain of custody means procedures to power plant that are performed at the
purposes of defining the periods within account for the integrity of each location where the nuclear power plant
which performance testing must be specimen or aliquot by tracking its will be constructed and operated. These
tasks include fabricating, erecting, class of material is sometimes referred Limit of detection (LOD) means the
integrating, and testing safety- and to as a Category I quantity of material. lowest concentration of an analyte that
security-related SSCs, and the HHS-certified laboratory means a an analytical procedure can reliably
installation of their foundations, laboratory that is certified to perform detect, which could be significantly
including the placement of concrete. urine drug testing under the Department lower than the established cutoff levels.
Contractor/vendor (C/V) means any of Health and Human Services Limit of quantitation (LOQ) means the
company, or any individual not Mandatory Guidelines for Federal lowest concentration of an analyte at
employed by a licensee or other entity Workplace Drug Testing Programs (the which the concentration of the analyte
specified in § 26.3(a) through (c), who is HHS Guidelines), which were published can be accurately determined under
providing work or services to a licensee in the Federal Register on April 11, defined conditions.
or other entity covered in § 26.3(a) 1988 (53 FR 11970), and as amended, Maintenance means, for the purposes
through (c), either by contract, purchase June 9, 1994 (59 FR 29908), November of § 26.4(a)(4), the following onsite
order, oral agreement, or other 13, 1998 (63 FR 63483), and April 13, maintenance activities: Modification,
arrangement. 2004 (69 FR 19643). surveillance, post-maintenance testing,
Control means a sample used to Illegal drug means, for the purposes of and corrective and preventive
monitor the status of an analysis to this regulation, any drug that is maintenance.
maintain its performance within included in Schedules I to V of section Medical Review Officer (MRO) means
predefined limits. 202 of the Controlled Substances Act a licensed physician who is responsible
[21 U.S.C. 812], but not when used for receiving laboratory results
Cumulative fatigue means the
pursuant to a valid prescription or when generated by a Part 26 drug testing
increase in fatigue over consecutive
used as otherwise authorized by law. program and who has the appropriate
sleep-wake periods resulting from
Increased threat condition means an medical training to properly interpret
inadequate rest.
increase in the protective measure level, and evaluate an individual’s drug and
Cutoff level means the concentration
relative to the lowest protective measure validity test results together with his or
or decision criteria established for
level applicable to the site during the her medical history and any other
designating and reporting a test result as
previous 60 days, as promulgated by an relevant biomedical information.
positive, of questionable validity Nominal means the limited flexibility
(referring to validity screening or initial NRC Advisory.
Initial drug test means a test to that is permitted in meeting a scheduled
validity test results from a licensee due date for completing a recurrent
testing facility), or adulterated, differentiate ‘‘negative’’ specimens from
those that require confirmatory drug activity that is required under this part,
substituted, dilute, or invalid (referring such as the nominal 12-month
to initial or confirmatory test results testing.
Initial validity test means a first test frequency required for FFD refresher
from an HHS-certified laboratory). training in § 26.29(c)(2) and the nominal
used to determine whether a specimen
Dilute specimen means a urine 12-month frequency required for certain
is adulterated, dilute, substituted, or
specimen with creatinine and specific audits in § 26.41(c)(1). Completing a
invalid, and may require confirmatory
gravity concentrations that are lower recurrent activity at a nominal
validity testing.
than expected for human urine. Invalid result means the result frequency means that the activity may
Directing means the exercise of reported by an HHS-certified laboratory be completed within a period that is 25
control over a work activity by an for a specimen that contains an percent longer or shorter than the period
individual who is directly involved in unidentified adulterant, contains an required in this part. The next
the execution of the work activity, and unidentified interfering substance, has scheduled due date would be no later
either makes technical decisions for that an abnormal physical characteristic, than the current scheduled due date
activity without subsequent technical contains inconsistent physiological plus the required frequency for
review, or is ultimately responsible for constituents, or has an endogenous completing the activity.
the correct performance of that work substance at an abnormal concentration Other entity means any corporation,
activity. that prevents the laboratory from firm, partnership, limited liability
Donor means the individual from completing testing or obtaining a valid company, association, C/V, or other
whom a specimen is collected. drug test result. organization who is subject to this part
Eight (8)-hour shift schedule means a Legal action means a formal action under § 26.3(a) through (c), but is not
schedule that averages not more than 9 taken by a law enforcement authority or licensed by the NRC.
hours per workday over the entire shift court of law, including an arrest, an Oxidizing adulterant means a
cycle. indictment, the filing of charges, a substance that acts alone or in
Employment action means a change conviction, or the mandated combination with other substances to
in job responsibilities or removal from implementation of a plan for substance oxidize drugs or drug metabolites to
a job, or the employer-mandated abuse treatment in order to avoid a prevent the detection of the drugs or
implementation of a plan for substance permanent record of an arrest or drug metabolites, or a substance that
abuse treatment in order to avoid a conviction, in response to any of the affects the reagents in either the initial
change in or removal from a job, following activities: or confirmatory drug test. Examples of
because of the individual’s use of drugs (1) The use, sale, or possession of these agents include, but are not limited
or alcohol. illegal drugs; to, nitrites, pyridinium chlorochromate,
Fatigue means the degradation in an (2) The abuse of legal drugs or chromium (VI), bleach, iodine/iodide,
individual’s cognitive and motor alcohol; or halogens, peroxidase, and peroxide.
functioning resulting from inadequate (3) The refusal to take a drug or Positive result means, for drug testing,
rest. alcohol test. the result reported by a licensee testing
Formula quantity means SSNM in any Licensee testing facility means a drug facility or HHS-certified laboratory
combination in a quantity of 5000 grams and specimen validity testing facility when a specimen contains a drug or
or more computed by the formula, that is operated by a licensee or other drug metabolite equal to or greater than
grams=(grams contained U–235)+2.5 entity who is subject to this part to the cutoff concentration. A result
(grams U–233+grams plutonium). This perform tests of urine specimens. reported by an HHS-certified laboratory
that a specimen contains a drug or drug following design basis events to ensure ultimately responsible for the correct
metabolite below the cutoff the integrity of the reactor coolant performance of that work activity.
concentration is also a positive result pressure boundary, the capability to Ten (10)-hour shift schedule means a
when the laboratory has conducted the shut down the reactor and maintain it schedule that averages more than 9
special analysis permitted in in a safe shutdown condition, or the hours, but not more than 11 hours, per
§ 26.163(a)(2). For alcohol testing, a capability to prevent or mitigate the workday over the entire shift cycle.
positive result means the result reported consequences of accidents that could Transporter means a general licensee,
by a collection site when the BAC result in potential offsite exposure under 10 CFR 70.20(a), who is
indicated by testing a specimen exceeds comparable to the guidelines in 10 CFR authorized to possess formula quantities
the cutoff concentrations established in 50.34(a)(1). of SSNM, in the regular course of
this part. Security-related SSCs mean, for the carriage for another or storage incident
Potentially disqualifying FFD purposes of this part, those structures, thereto, and includes the driver or
information means information systems, and components that the operator of any conveyance, and the
demonstrating that an individual has— licensee will rely on to implement the accompanying guards or escorts.
(1) Violated a licensee’s or other licensee’s physical security and Twelve (12)-hour shift schedule
entity’s FFD policy; safeguards contingency plans that either means a schedule that averages more
(2) Had authorization denied or are required under Part 73 of this than 11 hours, but not more than 12
terminated unfavorably under chapter if the licensee is a construction hours, per workday over the entire shift
§§ 26.35(c)(2), 26.53(i), 26.63(d), permit applicant or holder or an early cycle.
26.65(g), 26.67(c), 26.69(f), or 26.75(b) site permit holder, as described in Unit outage means, for the purposes
through (e); § 26.3(c)(3) through (c)(5), respectively, of this part, that the reactor unit is
(3) Used, sold, or possessed illegal or are included in the licensee’s disconnected from the electrical grid.
drugs; application if the licensee is a combined Validity screening test means a test to
(4) Abused legal drugs or alcohol; license applicant or holder, as described determine the need for initial validity
(5) Subverted or attempted to subvert in § 26.3(c)(1) and (c)(2), respectively. testing of a urine specimen, using a non-
a drug or alcohol testing program; Shift cycle means a series of instrumented test in which the endpoint
(6) Refused to take a drug or alcohol result is obtained by visual evaluation
consecutive work shifts and days off
test; (read by the human eye), or a test that
that is planned by the licensee or other
(7) Been subjected to a plan for is instrumented to the extent that results
entity to repeat regularly, thereby
substance abuse treatment (except for are machine-read.
constituting a continuous shift
self-referral); or Validity screening test lot means a
(8) Had legal action or employment schedule.
Standard means a reference material group of validity screening tests that
action, as defined in this section, taken were made from the same starting
for alcohol or drug use. of known purity or a solution containing
a reference material at a known material.
Protected area has the same meaning
as in § 73.2(g) of this chapter: An area concentration. § 26.7 Interpretations.
encompassed by physical barriers and to Strategic special nuclear material Except as specifically authorized by
which access is controlled. (SSNM) means uranium-235 (contained the Commission in writing, no
Quality control sample means a in uranium enriched to 20 percent or interpretation of the meaning of the
sample used to evaluate whether an more in the uranium-235 isotope), regulations in this part by any officer or
analytical procedure is operating within uranium-233, or plutonium. employee of the Commission other than
predefined tolerance limits. Calibrators, Substance abuse means the use, sale, a written interpretation by the General
controls, negative samples, and blind or possession of illegal drugs, or the Counsel will be recognized to be
samples are collectively referred to as abuse of prescription and over-the- binding on the Commission.
‘‘quality control samples’’ and each is counter drugs, or the abuse of alcohol.
individually referred to as a ‘‘sample.’’ Substituted specimen means a § 26.8 Information collection
Questionable validity means the specimen with creatinine and specific requirements: OMB approval.
results of validity screening or initial gravity values that are so diminished or (a) The NRC has submitted the
validity tests at a licensee testing facility so divergent that they are not consistent information collection requirements
indicating that a urine specimen may be with normal human physiology. contained in this part for approval by
adulterated, substituted, dilute, or Subversion and subvert the testing the Office of Management and Budget
invalid. process mean a willful act to avoid (OMB), as required by the Paperwork
Reviewing official means an employee being tested or to bring about an Reduction Act (44 U.S.C. 3501 et seq.).
of a licensee or other entity specified in inaccurate drug or alcohol test result for The NRC may not conduct or sponsor,
§ 26.3(a) through (c), who is designated oneself or others at any stage of the and a person is not required to respond
by the licensee or other entity to be testing process (including selection and to, a collection of information unless it
responsible for reviewing and notification of individuals for testing, displays a currently valid OMB control
evaluating any potentially disqualifying specimen collection, specimen analysis, number. OMB has approved the
FFD information about an individual, and test result reporting), and information collection requirements
including, but not limited to, the results adulterating, substituting, or otherwise contained in this part under control
of a determination of fitness, as defined causing a specimen to provide an number 3150–0146.
in § 26.189, in order to determine inaccurate test result. (b) The approved information
whether the individual may be granted Supervises or manages means the collection requirements contained in
or maintain authorization. exercise of control over a work activity this part appear in §§ 26.9, 26.27, 26.29,
Safety-related structures, systems, and by an individual who is not directly 26.31, 26.33, 26.35, 26.37, 26.39, 26.41,
components (SSCs) mean, for the involved in the execution of the work 26.53, 26.55, 26.57, 26.59, 26.61, 26.63,
purposes of this part, those structures, activity, but who either makes technical 26.65, 26.67, 26.69, 26.75, 26.77, 26.85,
systems, and components that are relied decisions for that activity without 26.87, 26.89, 26.91, 26.93, 26.95, 26.97,
on to remain functional during and subsequent technical review, or is 26.99, 26.101, 26.103, 26.107, 26.109,
26.111, 26.113, 26.115, 26.117, 26.119, § 26.4(a) through (e) and (g), and, at the (ii) The abuse of legal drugs and
26.125, 26.127, 26.129, 26.135, 26.137, licensee’s or other entity’s discretion, alcohol; and
26.139, 26.153, 26.155, 26.157, 26.159, § 26.4(f), and, if necessary, § 26.4(j) shall (iii) The misuse of prescription and
26.163, 26.165, 26.167, 26.168, 26.169, be subject to these FFD programs. over-the-counter drugs;
26.183, 26.185, 26.187, 26.189, 26.203, Licensees and other entities may rely on (2) Describe the requirement that
26.205, 26.207, 26.211, 26.401, 26.403, the FFD program or program elements of individuals who are notified that they
26.405, 26.406, 26.407, 26.411, 26.413, a C/V, as defined in § 26.5, if the C/V’s have been selected for random testing
26.415, 26.417, 26.711, 26.713, 26.715, FFD program or program elements meet must report to the collection site within
26.717, 26.719, and 26.821. the applicable requirements of this part. the time period specified by the licensee
or other entity;
§ 26.9 Specific exemptions. § 26.23 Performance objectives. (3) Describe the actions that constitute
Upon application of any interested Fitness-for-duty programs must— a refusal to provide a specimen for
person or on its own initiative, the (a) Provide reasonable assurance that testing, the consequences of a refusal to
Commission may grant such exemptions individuals are trustworthy and reliable test, as well as the consequences of
from the requirements of the regulations as demonstrated by the avoidance of subverting or attempting to subvert the
in this part as it determines are substance abuse; testing process;
authorized by law and will not endanger (b) Provide reasonable assurance that (4) Prohibit the consumption of
life or property or the common defense individuals are not under the influence alcohol, at a minimum—
and security, and are otherwise in the of any substance, legal or illegal, or (i) Within an abstinence period of 5
public interest. mentally or physically impaired from hours preceding the individual’s arrival
any cause, which in any way adversely at the licensee’s or other entity’s facility,
§ 26.11 Communications. affects their ability to safely and except as permitted in § 26.27(c)(3); and
Except where otherwise specified in competently perform their duties; (ii) During the period of any tour of
this part, all communications, (c) Provide reasonable measures for duty;
applications, and reports concerning the the early detection of individuals who (5) Convey that abstinence from
regulations in this part must be sent are not fit to perform the duties that alcohol for the 5 hours preceding any
either by mail addressed to ATTN: NRC require them to be subject to the FFD scheduled tour of duty is considered to
Document Control Desk, U.S. Nuclear program; be a minimum that is necessary, but
Regulatory Commission, Washington, (d) Provide reasonable assurance that may not be sufficient, to ensure that the
DC 20555–0001; by hand delivery to the the workplaces subject to this part are individual is fit for duty;
NRC’s offices at 11555 Rockville Pike, free from the presence and effects of (6) Address other factors that could
Rockville, Maryland, between the hours illegal drugs and alcohol; and affect FFD, such as mental stress,
of 8:15 a.m. and 4 p.m. eastern time; or, (e) Provide reasonable assurance that fatigue, or illness, and the use of
where practicable, by electronic the effects of fatigue and degraded prescription and over-the-counter
submission, for example, via Electronic alertness on individuals’ abilities to medications that could cause
Information Exchange, e-mail, or CD- safely and competently perform their impairment;
ROM. Electronic submissions must be duties are managed commensurate with (7) Provide a description of any
made in a manner that enables the NRC maintaining public health and safety. program that is available to individuals
to receive, read, authenticate, distribute, who are seeking assistance in dealing
and archive the submission, and process § 26.25 [Reserved] with drug, alcohol, fatigue, or other
and retrieve it a single page at a time. problems that could adversely affect an
§ 26.27 Written policy and procedures.
Detailed guidance on making electronic individual’s ability to safely and
submissions can be obtained by visiting (a) General. Each licensee and other competently perform the duties that
the NRC’s Web site at http:// entity shall establish, implement, and require an individual to be subject to
www.nrc.gov/site-help/eie.html, by maintain written policies and this subpart;
calling (301) 415–6030, by e-mail to procedures to meet the general (8) Describe the consequences of
EIE@nrc.gov, or by writing to the Office performance objectives and applicable violating the policy;
of Information Services, U.S. Nuclear requirements of this part. (9) Describe the individual’s
Regulatory Commission, Washington, (b) Policy. The FFD policy statement responsibility to report legal actions, as
DC 20555–0001. The guidance must be clear, concise, and readily defined in § 26.5;
discusses, among other topics, the available, in its most current form, to all (10) Describe the responsibilities of
formats the NRC can accept, the use of individuals who are subject to the managers, supervisors, and escorts to
electronic signatures, and the treatment policy. Methods of making the report FFD concerns; and
of nonpublic information. Copies of all statement readily available include, but (11) Describe the individual’s
communications must be sent to the are not limited to, posting the policy in responsibility to report FFD concerns.
appropriate regional office and resident multiple work areas, providing (c) Procedures. Each licensee and
inspector (addresses for the NRC individuals with brochures, or allowing other entity shall prepare, implement,
Regional Offices are listed in Appendix individuals to print the policy from a and maintain written procedures that
D to Part 20 of this chapter). computer. The policy statement must be describe the methods to be used in
written in sufficient detail to provide implementing the FFD policy and the
Subpart B—Program Elements affected individuals with information requirements of this part. The
on what is expected of them and what procedures must—
§ 26.21 Fitness-for-duty program. consequences may result from a lack of (1) Describe the methods and
The licensees and other entities adherence to the policy. At a minimum, techniques to be used in testing for
specified in § 26.3(a) through (c) shall the written policy statement must— drugs and alcohol, including procedures
establish, implement, and maintain FFD (1) Describe the consequences of the for protecting the privacy and other
programs that, at a minimum, comprise following actions: rights (including due process) of an
the program elements contained in this (i) The use, sale, or possession of individual who provides a specimen,
subpart. The individuals specified in illegal drugs on or off site; procedures for protecting the integrity of
the specimen, and procedures used to an individual who has been called in for (6) Knowledge of the potential
ensure that the test results are valid and an unscheduled working tour to adverse effects on job performance of
attributable to the correct individual; respond to an emergency may be prescription and over-the-counter drugs,
(2) Describe immediate and followup impaired, the procedure must require alcohol, dietary factors, illness, mental
actions that will be taken, and the the establishment of controls and stress, and fatigue;
procedures to be used, in those cases in conditions under which the individual (7) Knowledge of the prescription and
which individuals are determined to who has been called in can perform over-the-counter drugs and dietary
have— work, if necessary; and factors that have the potential to affect
(i) Been involved in the use, sale, or (E) State that no sanctions may be drug and alcohol test results;
possession of illegal drugs; imposed on an individual who is called (8) Ability to recognize illegal drugs
(ii) Consumed alcohol to excess before in to perform any unscheduled working and indications of the illegal use, sale,
the mandatory pre-work abstinence tour for having consumed alcohol or possession of drugs;
period, or consumed any alcohol during within the pre-duty abstinence period (9) Ability to observe and detect
the mandatory pre-work abstinence stated in the policy. performance degradation, indications of
period or while on duty, as determined (iii) If the individual reports that he impairment, or behavioral changes; and
by a test that measures BAC; or she considers himself or herself to be (10) Knowledge of the individual’s
(iii) Attempted to subvert the testing unfit for duty for other reasons, responsibility to report an FFD concern
process by adulterating or diluting including illness, fatigue, or other and the ability to initiate appropriate
specimens (in vivo or in vitro), potentially impairing conditions, and actions, including referrals to the EAP
substituting specimens, or by any other the individual is called in, the and person(s) designated by the licensee
means; procedure must require the or other entity to receive FFD concerns.
(iv) Refused to provide a specimen for establishment of controls and (b) Comprehensive examination.
analysis; or conditions under which the individual Individuals who are subject to this
(v) Had legal action taken relating to
can perform work, if necessary; subpart shall demonstrate the successful
drug or alcohol use, as defined in § 26.5;
(3) Describe the process that the (4) Describe the process to be completion of training by passing a
licensee or other entity will use to followed if an individual’s behavior comprehensive examination that
ensure that individuals who are called raises a concern regarding the possible addresses the KAs in paragraph (a) of
in to perform an unscheduled working use, sale, or possession of illegal drugs this section. The examination must
tour are fit for duty. At a minimum— on or off site; the possible possession or include a comprehensive random
(i) The procedure must require the consumption of alcohol on site; or sampling of all KAs with questions that
individual who is called in to state impairment from any cause which in test each KA, including at least one
whether the individual considers any way could adversely affect the question for each KA. The minimum
himself or herself fit for duty and individual’s ability to safely and passing score required must be 80
whether he or she has consumed competently perform his or her duties. percent. Remedial training and testing
alcohol within the pre-duty abstinence The procedure must require that are required for individuals who fail to
period stated in the policy; individuals who have an FFD concern answer correctly at least 80 percent of
(ii) If the individual has consumed about another individual’s behavior the test questions. The examination may
alcohol within this period and the shall contact the personnel designated be administered using a variety of
individual is called in for an in the procedures to report the concern. media, including, but not limited to,
unscheduled working tour, including an (d) Review. The NRC may, at any time, hard-copy test booklets with separate
unscheduled working tour to respond to review the written policy and answer sheets or computer-based
an emergency, the procedure must— procedures to assure that they meet the questions.
(A) Require a determination of fitness performance objectives and (c) Training administration. Licensees
by breath alcohol analysis or other requirements of this part. and other entities shall ensure that
means; individuals who are subject to this
§ 26.29 Training. subpart are trained, as follows:
(B) Permit the licensee or other entity
to assign the individual to duties that (a) Training content. Licensees and (1) Training must be completed before
require him or her to be subject to this other entities shall ensure that the the licensee or other entity grants initial
subpart, if the results of the individuals who are subject to this authorization, as defined in § 26.55, and
determination of fitness indicate that subpart have the following KAs: must be current before the licensee or
the individual is fit to safely and (1) Knowledge of the policy and other entity grants an authorization
competently perform his or her duties; procedures that apply to the individual, update, as defined in § 26.57, or
(C) Prohibit the licensee or other the methods that will be used to authorization reinstatement, as defined
entity from assigning the individual to implement them, and the consequences in § 26.59;
duties that require him or her to be of violating the policy and procedures; (2) Individuals shall complete
subject to this subpart, if the individual (2) Knowledge of the individual’s role refresher training on a nominal 12-
is not required to respond to an and responsibilities under the FFD month frequency, or more frequently
emergency and the results of the program; where the need is indicated. Indications
determination of fitness indicate that (3) Knowledge of the roles and of the need for more frequent training
the individual may be impaired; responsibilities of others, such as the include, but are not limited to, an
(D) State that consumption of alcohol MRO and the human resources, FFD, individual’s failure to properly
during the 5-hour abstinence period and EAP staffs; implement FFD program procedures
required in paragraph (b)(4)(i) of this (4) Knowledge of the EAP services and the frequency, nature, or severity of
section may not by itself preclude a available to the individual; problems discovered through audits or
licensee or other entity from using (5) Knowledge of the personal and the administration of the program.
individuals who are needed to respond public health and safety hazards Individuals who pass a comprehensive
to an emergency. However, if the associated with abuse of illegal and annual examination that meets the
determination of fitness indicates that legal drugs and alcohol; requirements in paragraph (b) of this
section may forgo the refresher training; criminal history checks and (2) For cause. In response to an
and psychological assessments must be individual’s observed behavior or
(3) Initial and refresher training may updated nominally every 5 years; physical condition indicating possible
be delivered using a variety of media (ii) Individuals who have personal substance abuse or after receiving
(including, but not limited to, classroom relationships with a donor may not credible information that an individual
lectures, required reading, video, or perform any assessment or evaluation is engaging in substance abuse, as
computer-based training systems). The procedures, including, but not limited defined in § 26.5;
licensee or other entity shall monitor to, determinations of fitness. These (3) Post-event. As soon as practical
the completion of training and provide personal relationships may include, but after an event involving a human error
a qualified instructor or designated are not limited to, supervisors, that was committed by an individual
subject matter expert to answer coworkers within the same work group, who is subject to this subpart, where the
questions during the course of training. and relatives of the donor; human error may have caused or
(d) Acceptance of training. Licensees (iii) Except if a directly observed contributed to the event. The licensee or
and other entities may accept training of collection is required, a collector who other entity shall test the individual(s)
individuals who have been subject to has a personal relationship with the who committed the error(s), and need
another training program that meets the donor may collect specimens from the not test individuals who were affected
requirements of this section and who donor only if the integrity of specimen by the event whose actions likely did
have, within the past 12 months, either collections in these instances is assured not cause or contribute to the event. The
had initial or refresher training, or have through the following means: individual(s) who committed the human
successfully passed a comprehensive (A) The collection must be monitored error(s) shall be tested if the event
examination that meets the by an individual who does not have a resulted in—
requirements in paragraph (b) of this personal relationship with the donor (i) A significant illness or personal
section. and who is designated by the licensee injury to the individual to be tested or
or other entity for this purpose, another individual, which within 4
§ 26.31 Drug and alcohol testing.
including, but not limited to, security hours after the event is recordable under
(a) General. To provide a means to the Department of Labor standards
deter and detect substance abuse, force or quality assurance personnel;
and contained in 29 CFR 1904.7, ‘‘General
licensees and other entities who are Recording Criteria,’’ and subsequent
subject to this part shall implement drug (B) Individuals who are designated to
monitor collections in these instances amendments thereto, and results in
and alcohol testing programs for death, days away from work, restricted
individuals who are subject to this shall be trained to monitor specimen
collections and the preparation of work, transfer to another job, medical
subpart. treatment beyond first aid, loss of
(b) Assuring the honesty and integrity specimens for transfer or shipping
under the requirements of this part; consciousness, or other significant
of FFD program personnel. (1) Licensees illness or injury as diagnosed by a
and other entities who are subject to this (iv) If a specimen must be collected
under direct observation, the collector physician or other licensed health care
subpart shall carefully select and professional, even if it does not result in
monitor FFD program personnel, as or an individual who serves as the
observer, as permitted under § 26.115(e), death, days away from work, restricted
defined in § 26.4(g), based on the work or job transfer, medical treatment
highest standards of honesty and may not have a personal relationship
with the donor; and beyond first aid, or loss of
integrity, and shall implement measures consciousness;
to ensure that these standards are (v) FFD program personnel shall be
(ii) A radiation exposure or release of
maintained. The measures must ensure subject to a behavioral observation
radioactivity in excess of regulatory
that the honesty and integrity of these program designed to assure that they
limits; or
individuals are not compromised and continue to meet the highest standards (iii) Actual or potential substantial
that FFD program personnel are not of honesty and integrity. When an MRO degradations of the level of safety of the
subject to influence attempts and MRO staff are on site at a licensee’s plant;
attributable to personal relationships or other entity’s facility, the MRO and (4) Followup. As part of a followup
with any individuals who are subject to MRO staff shall be subject to behavioral plan to verify an individual’s continued
testing, an undetected or untreated observation. abstinence from substance abuse; and
substance abuse problem, or other (2) Licensees and other entities may (5) Random. On a statistically random
factors. At a minimum, these measures rely on a local hospital or other and unannounced basis, so that all
must include the following organization that meets the individuals in the population subject to
considerations: requirements of 49 CFR Part 40, testing have an equal probability of
(i) Licensees and other entities shall ‘‘Procedures for Department of being selected and tested.
complete appropriate background Transportation Workplace Drug and (d) General requirements for drug and
investigations, credit and criminal Alcohol Testing Programs’’ (65 FR alcohol testing. (1) Substances tested. At
history checks, and psychological 41944; August 9, 2001) to collect a minimum, licensees and other entities
assessments of FFD program personnel specimens for drug and alcohol testing shall test for marijuana metabolite,
before assignment to tasks directly from the FFD program personnel listed cocaine metabolite, opiates (codeine,
associated with administration of the in § 26.4(g). morphine, 6-acetylmorphine),
FFD program. The background (c) Conditions for testing. Licensees amphetamines (amphetamine,
investigations, credit and criminal and other entities shall administer drug methamphetamine), phencyclidine,
history checks, and psychological and alcohol tests to the individuals who adulterants, and alcohol.
assessments that are conducted to grant are subject to this subpart under the (i) In addition, licensees and other
unescorted access authorization to following conditions: entities may consult with local law
individuals under a nuclear power plant (1) Pre-access. In order to grant initial, enforcement authorities, hospitals, and
licensee’s access authorization program updated, or reinstated authorization to drug counseling services to determine
are acceptable to meet the requirements an individual, as specified in subpart C whether other drugs with abuse
of this paragraph. The credit and of this part; potential are being used in the
geographical locale of the facility and by action under subpart D of this part. If individual that he or she has been
the local workforce that may not be the drug or metabolites for which testing selected for testing;
detected in the panel of drugs and drug will be performed under this paragraph (vi) Provide that an individual
metabolites specified in paragraph (d)(1) are not included in the FFD program’s completing a test is immediately eligible
of this section. drug panel, the assay and cutoff levels for another unannounced test; and
(A) When appropriate, the licensee or to be used in testing for the additional (vii) Ensure that the sampling process
other entity may add other drugs drugs must be certified by a forensic used to select individuals for random
identified under paragraph (d)(1)(i) of toxicologist under paragraph (d)(1)(i)(D) testing provides that the number of
this section to the panel of substances of this section. Test results that fall random tests performed annually is
for testing, but only if the additional below the established cutoff levels may equal to at least 50 percent of the
drugs are listed in Schedules I through not be considered when determining population that is subject to the FFD
V of section 202 of the Controlled appropriate action under subpart D of program.
Substances Act [21 U.S.C. 812]. this part, except if the specimen is (3) Drug testing. (i) Testing of urine
(B) The licensee or other entity shall dilute and the licensee or other entity specimens for drugs and validity, except
establish appropriate cutoff limits for has requested the HHS-certified validity screening and initial drug and
these substances. laboratory to evaluate the specimen validity tests performed by licensee
(C) The licensee or other entity shall under §§ 26.163(a)(2) or 26.185(g)(3). testing facilities under paragraph
establish rigorous testing procedures for (iii) The licensee or other entity shall (d)(3)(ii) of this section, must be
these substances that are consistent with document the additional drug(s) for performed in a laboratory that is
the intent of this part, so that the MRO which testing will be performed in certified by HHS for that purpose,
can evaluate the use of these substances. written policies and procedures in consistent with its standards and
(D) The licensee or other entity may procedures for certification. Specimens
which the substances for which testing
not conduct an analysis for any drug or sent to HHS-certified laboratories must
will be performed are described.
drug metabolites except those identified be subject to initial validity and initial
in paragraph (d)(1) of this section unless (2) Random testing. Random testing
drug testing by the laboratory.
the assay and cutoff levels to be used are must—
Specimens that yield positive initial
certified in writing as scientifically (i) Be administered in a manner that drug test results or are determined by
sound and legally defensible by an provides reasonable assurance that initial validity testing to be of
independent, qualified forensic individuals are unable to predict the questionable validity must be subject to
toxicologist who has no relationships time periods during which specimens confirmatory testing by the laboratory,
with manufacturers of the assays or will be collected. At a minimum, the except for invalid specimens that cannot
instruments to be used or the HHS- FFD program shall— be tested. Licensees and other entities
certified laboratory that will conduct the (A) Take reasonable steps to either shall ensure that laboratories report
testing for the licensee or other entity, conceal from the workforce that results for all specimens sent for testing,
which could be construed as a potential collections will be performed during a including blind performance test
conflict of interest. The forensic scheduled collection period or create samples.
toxicologist may not be an employee of the appearance that specimens are being (ii) Licensees and other entities may
the licensee or entity, and shall either be collected during a portion of each day conduct validity screening, initial
a Diplomate of the American Board of on at least 4 days in each calendar week validity, and initial drug tests of urine
Forensic Toxicology or currently holds, at each site. In the latter instance, the aliquots to determine which specimens
has held, or is eligible to hold, the portions of each day and the days of the are valid and negative and need no
position of Responsible Person at an week must vary in a manner that cannot further testing, provided that the
HHS-certified laboratory, as specified in be predicted by donors; and licensee’s or other entity’s staff
§ 26.155(a). All new assays and cutoff (B) Collect specimens on an possesses the necessary training and
levels must be properly validated unpredictable schedule, including skills for the tasks assigned, the staff’s
consistent with established forensic weekends, backshifts, and holidays, and qualifications are documented, and
toxicological standards before at various times during a shift; adequate quality controls for the testing
implementation. Certification of the (ii) At a minimum, be administered by are implemented.
assay and cutoff levels is not required if the FFD program on a nominal weekly (iii) At a minimum, licensees and
the HHS Guidelines are revised to frequency; other entities shall apply the cutoff
authorize use of the assay in testing for (iii) Require individuals who are levels specified in § 26.163(a)(1) for
the additional drug or drug metabolites selected for random testing to report to initial drug testing at either the licensee
and the licensee or other entity uses the the collection site as soon as reasonably testing facility or HHS-certified
cutoff levels established in the HHS practicable after notification, within the laboratory, and in § 26.163(b)(1) for
Guidelines for the drug or drug time period specified in the FFD confirmatory drug testing at the HHS-
metabolites, or if the licensee or other program policy; certified laboratory. At their discretion,
entity received written approval of the (iv) Ensure that all individuals in the licensees and other entities may
NRC to test for the additional drug or population subject to testing have an implement programs with lower cutoff
drug metabolites before April 30, 2008. equal probability of being selected and levels in testing for drugs and drug
(ii) When conducting post-event, tested; metabolites.
followup, and for-cause testing, as (v) Require that individuals who are (A) If a licensee or other entity
defined in § 26.31(c), licensees and off site when selected for testing, or who implements lower cutoff levels, and the
other entities may test for any drugs are on site and are not reasonably MRO determines that an individual has
listed on Schedules I through V of available for testing when selected, shall violated the FFD policy using the
section 202 of the Controlled Substances be tested at the earliest reasonable and licensee’s or other entity’s more
Act [21 U.S.C. 812] that an individual is practical opportunity when both the stringent cutoff levels, the individual
suspected of having abused, and may donor and collectors are available to shall be subject to all management
consider any drugs or metabolites so collect specimens for testing and actions and sanctions required by the
detected when determining appropriate without prior notification to the licensee’s or other entity’s FFD policy
and this part, as if the individual had a (6) Limitations of testing. Specimens (2) If EAP personnel determine that an
confirmed positive drug test result using collected under NRC regulations may individual poses or has posed an
the cutoff levels specified in this only be designated or approved for immediate hazard to himself or herself
subpart. The licensee or other entity testing as described in this part and may or others, EAP personnel shall so inform
shall document the more stringent not be used to conduct any other FFD program management, and need
cutoff levels in any written policies and analysis or test without the written not obtain a written waiver of the right
procedures in which cutoff levels for permission of the donor. Analyses and to privacy from the individual. The
drug testing are described. tests that may not be conducted include, individual conditions or actions that
(B) The licensee or other entity shall but are not limited to, DNA testing, EAP personnel shall report to FFD
uniformly apply the cutoff levels listed serological typing, or any other medical program management include, but are
in § 26.163(a)(1) for initial drug testing or genetic test used for diagnostic or not limited to, substantive reasons to
and in § 26.163(b)(1) for confirmatory specimen identification purposes. believe that the individual—
drug testing, or any more stringent (i) Is likely to commit self-harm or
§ 26.33 Behavioral observation. harm to others;
cutoff levels implemented by the FFD
program, to all tests performed under Licensees and other entities shall (ii) Has been impaired from using
this part and equally to all individuals ensure that the individuals who are drugs or alcohol while in a work status
who are tested under this part, except as subject to this subpart are subject to and has a continuing substance abuse
permitted in §§ 26.31(d)(1)(ii), behavioral observation. Behavioral disorder that makes it likely he or she
26.163(a)(2), and 26.165(c)(2). observation must be performed by will be impaired while in a work status
(C) In addition, the scientific and individuals who are trained under in the future; or
§ 26.29 to detect behaviors that may (iii) Has ever engaged in any acts that
technical suitability of any more
indicate possible use, sale, or possession would be reportable under
stringent cutoff levels must be evaluated
of illegal drugs; use or possession of § 26.719(b)(1) through (b)(3).
and certified, in writing, by a forensic (3) If a licensee or other entity
toxicologist who meets the requirements alcohol on site or while on duty; or
impairment from fatigue or any cause receives a report from EAP personnel
set forth in § 26.31(d)(1)(i)(D). under paragraph (c)(2) of this section,
Certification of the more stringent cutoff that, if left unattended, may constitute
a risk to public health and safety or the the licensee or other entity shall ensure
levels is not required if the HHS that the requirements of §§ 26.69(d) and
Guidelines are revised to lower the common defense and security.
Individuals who are subject to this 26.77(b) are implemented, as applicable.
cutoff levels for the drug or drug
metabolites in Federal workplace drug subpart shall report any FFD concerns § 26.37 Protection of information.
testing programs and the licensee or about other individuals to the personnel (a) Each licensee or other entity who
other entity implements the cutoff levels designated in the FFD policy. is subject to this subpart who collects
published in the HHS Guidelines, or if § 26.35 Employee assistance programs. personal information about an
the licensee or other entity received (a) Each licensee and other entity who individual for the purpose of complying
written approval of the NRC to test for is subject to this part shall maintain an with this part, shall establish, use, and
lower cutoff levels before April 30, EAP to strengthen the FFD program by maintain a system of files and
2008. offering confidential assessment, short- procedures that protects the individual’s
(4) Alcohol testing. Initial tests for term counseling, referral services, and privacy.
alcohol must be administered by breath treatment monitoring to individuals (b) Licensees and other entities shall
or oral fluids analysis using alcohol obtain a signed consent that authorizes
who have problems that could adversely
analysis devices that meet the the disclosure of the personal
affect the individuals’ abilities to safely
requirements of § 26.91(a). If the initial information collected and maintained
and competently perform their duties.
test shows a BAC of 0.02 percent or under this part before disclosing the
Employee assistance programs must be
greater, a confirmatory test for alcohol personal information, except for
designed to achieve early intervention
must be performed. The confirmatory disclosures to the following individuals:
and provide for confidential assistance. (1) The subject individual or his or
test must be performed with an EBT that (b) Licensees and other entities need
meets the requirements of § 26.91(b). her representative, when the individual
not provide EAP services to a C/V’s
(5) Medical conditions. (i) If an has designated the representative in
employees, including those whose work
individual has a medical condition that writing for specified FFD matters;
location is a licensee’s or other entity’s (2) Assigned MROs and MRO staff;
makes collection of breath, oral fluids, facility, or to individuals who have (3) NRC representatives;
or urine specimens difficult or applied for, but have not yet been (4) Appropriate law enforcement
hazardous, the MRO may authorize an granted, authorization under subpart C officials under court order;
alternative evaluation process, tailored of this part. (5) A licensee’s or other entity’s
to the individual case, to meet the (c) The EAP staff shall protect the representatives who have a need to have
requirements of this part for drug and identity and privacy of any individual access to the information to perform
alcohol testing. The alternative process (including those who have self-referred) their assigned duties under the FFD
must include measures to prevent seeking assistance from the EAP, except program, including determinations of
subversion and achieve results that are if the individual waives the right to fitness, FFD program audits, or some
comparable to those produced by privacy in writing or a determination is human resources functions;
urinalysis for drugs and breath analysis made that the individual’s condition or (6) The presiding officer in a judicial
for alcohol. actions pose or have posed an or administrative proceeding that is
(ii) If an individual requires medical immediate hazard to himself or herself initiated by the subject individual;
attention, including, but not limited to, or others. (7) Persons deciding matters under
an injured worker in an emergency (1) Licensees and other entities may review in § 26.39; and
medical facility who is required to have not require the EAP to routinely report (8) Other persons pursuant to court
a post-event test, treatment may not be the names of individuals who self-refer order.
delayed to conduct drug and alcohol to the EAP or the nature of the (c) Personal information that is
testing. assistance the individuals sought. collected under this subpart must be
disclosed to other licensees and entities, personnel in § 26.4(g)]. Individuals who (2) Audits of HHS-certified
including C/Vs, or their authorized conduct the review may be management laboratories that are conducted for
representatives, who are legitimately personnel. licensees and other entities who are
seeking the information for (d) If the review finds in favor of the subject to this subpart need not
authorization decisions as required by individual, the licensee or other entity duplicate areas inspected in the most
this part and who have obtained a shall update the relevant records to recent HHS certification inspection.
signed release from the subject reflect the outcome of the review and However, the licensee and other entity
individual. delete or correct all information the shall review the HHS certification
(d) Upon receipt of a written request review found to be inaccurate. inspection records and reports to
by the subject individual or his or her (e) When a C/V is administering an identify any areas in which the licensee
designated representative, the FFD FFD program on which licensees and or other entity uses services that the
program, including but not limited to, other entities rely, and the C/V HHS certification inspection did not
the collection site, HHS-certified determines that its employee, address. The licensee or other entity
laboratory, substance abuse expert subcontractor, or applicant has violated shall ensure that any such areas are
(SAE), or MRO, possessing such records its FFD policy, the C/V shall ensure that audited on a nominal 12-month
shall promptly provide copies of all FFD the review procedure required in this frequency. Licensees and other entities
records pertaining to the individual, section is provided to the individual. need not audit organizations and
including, but not limited to, records Licensees and other entities who rely on professionals who may provide an FFD
pertaining to a determination that the a C/V’s FFD program need not provide program service to the licensee or other
individual has violated the FFD policy, the review procedure required in this entity, but who are not routinely
drug and alcohol test results, MRO section to a C/V’s employee, involved in providing services to a
reviews, determinations of fitness, and subcontractor, or applicant when the C/ licensee’s or other entity’s FFD program,
management actions pertaining to the V is administering its own FFD program as specified in § 26.4(i)(1).
subject individual. The licensee or other and the FFD policy violation was (d) Contracts. (1) The contracts of
entity shall obtain records related to the determined under the C/V’s program. licensees and other entities contracts
results of any relevant laboratory with C/Vs and HHS-certified
§ 26.41 Audits and corrective action.
certification, review, or revocation-of- laboratories must reserve the right to
(a) General. Each licensee and other audit the C/V, the C/V’s subcontractors
certification proceedings from the HHS- entity who is subject to this subpart is
certified laboratory and provide them to providing FFD program services, and
responsible for the continuing the HHS-certified laboratories at any
the subject individual on request. effectiveness of the FFD program,
(e) A licensee’s or other entity’s time, including at unannounced times,
including FFD program elements that as well as to review all information and
contracts with HHS-certified
are provided by C/Vs, the FFD programs documentation that is reasonably
laboratories and C/Vs providing
of any C/Vs that are accepted by the relevant to the audits.
specimen collection services, and
licensee or other entity, any FFD (2) Licensees’ and other entities’
licensee testing facility procedures,
program services that are provided to contracts with C/Vs and HHS-certified
must require test records to be
the C/V by a subcontractor, and the laboratories must also permit the
maintained in confidence, except as
programs of the HHS-certified licensee or other entity to obtain copies
provided in paragraphs (b), (c), and (d)
laboratories on whom the licensee or of and take away any documents,
of this section.
(f) This section does not authorize the other entity and its C/Vs rely. Each including reviews and inspections
licensee or other entity to withhold licensee and other entity shall ensure pertaining to a laboratory’s certification
evidence of criminal conduct from law that these programs are audited and that by HHS, and any other data that may be
enforcement officials. corrective actions are taken to resolve needed to assure that the C/V, its
any problems identified. subcontractors, or the HHS-certified
§ 26.39 Review process for fitness-for-duty (b) FFD program. Each licensee and laboratory are performing their
policy violations. other entity who is subject to this functions properly and that staff and
(a) Each licensee and other entity who subpart shall ensure that the entire FFD procedures meet applicable
is subject to this subpart shall establish program is audited as needed, but no requirements. In a contract with a
procedures for the review of a less frequently than nominally every 24 licensee or other entity who is subject
determination that an individual who months. Licensees and other entities are to this subpart, an HHS-certified
they employ or who has applied for responsible for determining the laboratory may reasonably limit the use
authorization has violated the FFD appropriate frequency, scope, and depth and dissemination of any documents
policy. The procedure must provide for of additional auditing activities within copied or taken away by the licensee’s
an objective and impartial review of the the nominal 24-month period based on or other entity’s auditors in order to
facts related to the determination that the review of FFD program performance, ensure the protection of proprietary
the individual has violated the FFD including, but not limited to, the information and donors’ privacy.
policy. frequency, nature, and severity of (3) In addition, before awarding a
(b) The procedure must provide discovered problems, testing errors, contract, the licensee or other entity
notice to the individual of the grounds personnel or procedural changes, and shall ensure completion of pre-award
for the determination that the individual previous audit findings. inspections and/or audits of the
has violated the FFD policy, and must (c) C/Vs and HHS-certified procedural aspects of the HHS-certified
provide an opportunity for the laboratories. (1) FFD services that are laboratory’s drug-testing operations,
individual to respond and submit provided to a licensee or other entity by except as provided in paragraph (g)(5) of
additional relevant information. C/V personnel who are off site or are not this section.
(c) The procedure must ensure that under the direct daily supervision or (e) Conduct of audits. Audits must
the individual who conducts the review observation of the licensee’s or other focus on the effectiveness of the FFD
is not associated with the entity’s personnel and HHS-certified program or program element(s), as
administration of the FFD program [see laboratories must be audited on a appropriate, and must be conducted by
the description of FFD program nominal 12-month frequency. individuals who are qualified in the
subject(s) being audited. The Subpart C—Granting and Maintaining authorization under another FFD
individuals performing the audit of the Authorization program that is implemented by a
FFD program or program element(s) licensee or entity who is subject to this
shall be independent from both the § 26.51 Applicability. subpart may rely on the transferring
subject FFD program’s management and The requirements in this subpart FFD program to satisfy the requirements
from personnel who are directly apply to the licensees and other entities of this subpart. The individual may
responsible for implementing the FFD identified in § 26.3(a), (b), and, as maintain his or her authorization if he
program. applicable, (c) for the categories of or she continues to be subject to either
(f) Audit results. The result of the individuals in § 26.4(a) through (d), and, the receiving FFD program or the
audits, along with any at the licensee’s or other entity’s transferring FFD program, or a
recommendations, must be documented discretion, in § 26.4(g) and, if necessary, combination of elements from both
and reported to senior corporate and site § 26.4(j). The requirements in this programs that collectively satisfy the
management. Each audit report must subpart also apply to the licensees and applicable requirements of this part.
identify conditions that are adverse to other entities specified in § 26.3(c), as The receiving FFD program shall ensure
the proper performance of the FFD applicable, for the categories of that the program elements to which the
program, the cause of the condition(s), individuals in § 26.4(e). At the individual is subject under the
and recommended corrective actions. discretion of a licensee or other entity transferring FFD program remain
The licensee or other entity shall review in § 26.3(c), the requirements of this current.
the audit findings and take corrective subpart also may be applied to the (e) Licensees and other entities in
actions, including re-auditing of the categories of individuals identified in § 26.3(a) through (c) may also rely on a
deficient areas where indicated, to § 26.4(f). In addition, the requirements C/V’s FFD program or program elements
preclude, within reason, repetition of in this subpart apply to the entities in when granting or maintaining the
the condition. The resolution of the § 26.3(d) to the extent that a licensee or authorization of an individual who is or
audit findings and corrective actions other entity relies on the C/V to meet has been subject to the C/V’s FFD
must be documented. the requirements of this subpart. Certain program, if the C/V’s program or
(g) Sharing of audits. Licensees and requirements in this subpart also apply program elements meet the applicable
other entities may jointly conduct to the individuals specified in § 26.4(h). requirements of this part.
audits, or may accept audits of C/Vs and (1) A C/V’s FFD program may grant
HHS-certified laboratories that were § 26.53 General provisions. and maintain an individual’s
conducted by other licensees and (a) In order to grant authorization to authorization, as defined in § 26.5,
entities who are subject to this subpart, an individual, a licensee or other entity under the C/V’s FFD program. However,
if the audit addresses the services shall ensure that the requirements in only a licensee or other entity in
obtained from the C/V or HHS-certified this subpart have been met for either § 26.3(a) through (c) may grant or
laboratory by each of the sharing initial authorization, authorization maintain an individual’s authorization
licensees and other entities. update, authorization reinstatement, or to have the types of access or perform
(1) Licensees and other entities shall authorization with potentially the duties specified in § 26.4(a) through
review audit records and reports to disqualifying FFD information, as (e) and (g), and, at the licensee’s or other
identify any areas that were not covered applicable. entity’s discretion, § 26.4(f).
by the shared or accepted audit. (b) For individuals who have (2) If a C/V’s FFD program denies or
(2) Licensees and other entities shall previously held authorization under this unfavorably terminates an individual’s
ensure that FFD program elements and part but whose authorization has since authorization, and the individual is
services on which the licensee or entity been favorably terminated, the licensee performing any duties for a licensee or
relies are audited, if the program or other entity shall implement the other entity that are specified in
elements and services were not requirements for either initial § 26.4(a) through (e) and (g), or, at the
addressed in the shared audit. authorization, authorization update, or licensee’s or other entity’s discretion,
(3) Sharing licensees and other authorization reinstatement, based on § 26.4(f), then the C/V shall inform the
entities need not re-audit the same C/V the total number of days that the affected licensee or other entity of the
or HHS-certified laboratory for the same individual’s authorization is denial or unfavorable termination. The
period of time. interrupted, to include the day after the licensee or other entity shall deny or
(4) Each sharing licensee and other individual’s last period of authorization unfavorably terminate the individual’s
entity shall maintain a copy of the was terminated and the intervening authorization to perform those duties on
shared audit and HHS certification days until the day on which the licensee the day that the licensee or other entity
inspection records and reports, or other entity grants authorization to receives the information from the C/V,
including findings, recommendations, the individual. If potentially or implement the applicable process in
and corrective actions. disqualifying FFD information is § 26.69 to maintain the individual’s
(5) If an HHS-certified laboratory loses disclosed or discovered about an authorization.
its certification, in whole or in part, a individual, licensees and other entities (3) If an individual is maintaining
licensee or other entity is permitted to shall implement the applicable authorization under a C/V’s FFD
immediately use another HHS-certified requirements in § 26.69 in order to grant program, a licensee or other entity in
laboratory that has been audited within or maintain an individual’s § 26.3(a) through (c) may grant
the previous 12 months by another NRC authorization. authorization to the individual to have
licensee or entity who is subject to this (c) The licensee or other entity shall the types of access and perform the
subpart. Within 3 months after the ensure that an individual has met the duties specified in § 26.4(a) through (e)
change, the licensee or other entity shall applicable FFD training requirements in and (g), and, at the licensee’s or other
ensure that an audit is completed of any §§ 26.29 and 26.203(c) before granting entity’s discretion, § 26.4(f), and
areas that have not been audited by authorization to the individual. maintain his or her authorization, if the
another licensee or entity who is subject (d) Licensees and other entities who individual continues to be subject to
to this subpart within the past 12 are seeking to grant authorization to an either the receiving FFD program or a
months. individual who is maintaining combination of elements from the
receiving FFD program and the C/V’s authorization that the following actions (b) If potentially disqualifying FFD
program that collectively satisfy the related to providing and sharing the information is disclosed or discovered,
applicable requirements of this part. personal information required under the licensee or other entity may not
The receiving licensee’s or other entity’s this subpart are sufficient cause for grant authorization to the individual,
FFD program shall ensure that the denial or unfavorable termination of except under § 26.69.
program elements to which the authorization:
individual is subject under the C/V’s (1) Refusal to provide written consent § 26.59 Authorization reinstatement.
FFD program remain current. for the suitable inquiry; (a) In order to grant authorization to
(f) Licensees and other entities who (2) Refusal to provide or the an individual whose authorization has
are seeking to grant authorization to an falsification of any personal information been interrupted for a period of more
individual who has been subject to an required under this part, including, but than 30 days but no more than 365 days
FFD program under subpart K may not not limited to, the failure to report any and whose last period of authorization
rely on that program or its program previous denial or unfavorable was terminated favorably, the licensee
elements to meet the requirements of termination of authorization; or other entity shall ensure that—
this subpart, except if the program or (3) Refusal to provide written consent (1) A self-disclosure has been
program element(s) of the FFD program for the sharing of personal information obtained and reviewed under the
for construction satisfy the applicable with other licensees or other entities applicable requirements of § 26.61;
requirements of this part. required under this part; and (2) A suitable inquiry has been
(g) The licensees and other entities (4) Failure to report any legal actions, completed under the requirements of
specified in § 26.3(a) and, as applicable, as defined in § 26.5. § 26.63 within 5 business days of
(c) and (d), shall identify any violation reinstating authorization. If the suitable
§ 26.55 Initial authorization.
of any requirement of this part to any inquiry is not completed within 5
licensee who has relied on or intends to (a) Before granting authorization to an business days due to circumstances that
rely on the FFD program element that is individual who has never held are outside of the licensee’s or other
determined to be in violation of this authorization under this part or whose entity’s control and the licensee or other
part. authorization has been interrupted for a entity is not aware of any potentially
(h) The licensees and other entities period of 3 years or more and whose last disqualifying information regarding the
specified in § 26.3(a) and, as applicable, period of authorization was terminated individual within the past 5 years, the
(c) and (d), may not initiate any actions favorably, the licensee or other entity licensee or other entity may maintain
under this subpart without the shall ensure that— the individual’s authorization for an
knowledge and written consent of the (1) A self-disclosure has been additional 5 business days. If the
subject individual. The individual may obtained and reviewed under the suitable inquiry is not completed within
withdraw his or her consent at any time. applicable requirements of § 26.61; 10 business days of reinstating
If an individual withdraws his or her (2) A suitable inquiry has been
authorization, the licensee or other
consent, the licensee or other entity may completed under the applicable
entity shall administratively withdraw
not initiate any elements of the requirements of § 26.63;
the individual’s authorization until the
(3) The individual has been subject to
authorization process specified in this suitable inquiry is completed;
pre-access drug and alcohol testing
subpart that were not in progress at the (3) The individual has been subject to
under the applicable requirements of
time the individual withdrew his or her pre-access drug and alcohol testing
§ 26.65; and
consent, but shall complete and under the applicable requirements of
(4) The individual is subject to
document any elements that are in § 26.65; and
random drug and alcohol testing under
progress at the time consent is (4) The individual is subject to
the applicable requirements of § 26.67.
withdrawn. The licensee or other entity random drug and alcohol testing under
(b) If potentially disqualifying FFD
shall record the individual’s application the applicable requirements of § 26.67.
information is disclosed or discovered,
for authorization; his or her withdrawal (b) If a licensee or other entity
the licensee or other entity may not
of consent; the reason given by the administratively withdraws an
grant authorization to the individual,
individual for the withdrawal, if any; individual’s authorization under
except under § 26.69.
and any pertinent information gathered paragraph (a)(2) of this section, and
from the elements that were completed § 26.57 Authorization update. until the suitable inquiry is completed,
(e.g., the results of pre-access drug tests, (a) Before granting authorization to an the licensee or other entity may not
information obtained from the suitable individual whose authorization has record the administrative action to
inquiry). The licensee or other entity to been interrupted for more than 365 days withdraw authorization as an
whom the individual has applied for but less than 3 years and whose last unfavorable termination and may not
authorization shall inform the period of authorization was terminated disclose it in response to a suitable
individual that— favorably, the licensee or other entity inquiry conducted under the provisions
(1) Withdrawal of his or her consent shall ensure that— of § 26.63, a background investigation
will withdraw the individual’s current (1) A self-disclosure has been conducted under the provisions of this
application for authorization under the obtained and reviewed under the chapter, or any other inquiry or
licensee’s or other entity’s FFD program; applicable requirements of § 26.61; investigation. The individual may not
and (2) A suitable inquiry has been be required to disclose the
(2) Other licensees and entities will completed under the applicable administrative action in response to
have access to information documenting requirements of § 26.63; requests for self-disclosure of
the withdrawal as a result of the (3) The individual has been subject to potentially disqualifying FFD
information sharing that is required pre-access drug and alcohol testing information, except if the individual’s
under this part. under the applicable requirements of authorization was subsequently denied
(i) The licensees and other entities § 26.65; and or terminated unfavorably by the
specified in § 26.3(a) and, as applicable, (4) The individual is subject to licensee or other entity.
(c) and(d), shall inform, in writing, any random drug and alcohol testing under (c) Before granting authorization to an
individual who is applying for the applicable requirements of § 26.67. individual whose authorization has
been interrupted for a period of no more (viii) Had legal action or employment conducted, on a best effort basis, by
than 30 days and whose last period of action, as defined in § 26.5, taken for questioning former employers, and the
authorization was terminated favorably, alcohol or drug use; employer by whom the individual
the licensee or other entity shall ensure (2) Address the specific type, claims to have been employed on the
that— duration, and resolution of any matter day before he or she completes the
(1) A self-disclosure has been disclosed, including, but not limited to, employment history, if an employment
obtained and reviewed under the the reason(s) for any unfavorable history is required under § 26.61.
applicable requirements of § 26.61; termination or denial of authorization; (1) For the claimed employment
(2) The individual has been subject to and period, the suitable inquiry must
pre-access drug and alcohol testing (3) Address the shortest of the ascertain the reason for termination,
under the applicable requirements of following periods: eligibility for rehire, and other
§ 26.65, if the individual’s authorization (i) The past 5 years; information that could reflect on the
was interrupted for more than 5 days; (ii) Since the individual’s eighteenth individual’s fitness to be granted
and birthday; or authorization.
(3) The individual is subject to (iii) Since the individual’s last period (2) If the claimed employment was
random drug and alcohol testing under of authorization was terminated, if military service, the licensee or other
the applicable requirements of § 26.67. authorization was terminated favorably entity who is conducting the suitable
(d) If potentially disqualifying FFD within the past 3 years. inquiry shall request a characterization
information is disclosed or discovered, (c) The individual shall provide a list of service, reason for separation, and
the licensee or other entity may not of all employers, including the any disciplinary actions related to
grant authorization to the individual, employer by whom the individual potentially disqualifying FFD
except under § 26.69. claims to have been employed on the information. If the individual’s last duty
day before he or she completes the station cannot provide this information,
§ 26.61 Self-disclosure and employment employment history, if any, with dates
history. the licensee or other entity may accept
of employment, for the shortest of the a hand-carried copy of the DD 214
(a) Before granting authorization, the following periods: presented by the individual which on
licensee or other entity shall ensure that (1) The past 3 years; face value appears to be legitimate. The
a written self-disclosure and (2) Since the individual’s eighteenth licensee or other entity may also accept
employment history has been obtained birthday; or a copy of a DD 214 provided by the
from the individual who is applying for (3) Since authorization was last
custodian of military records.
authorization, except as follows: terminated, if authorization was (3) If a company, previous employer,
(1) If an individual previously held terminated favorably within the past 3 or educational institution to whom the
authorization under this part, and the years. licensee or other entity has directed a
licensee or other entity has verified that
§ 26.63 Suitable inquiry. request for information refuses to
the individual’s last period of provide information or indicates an
authorization was terminated favorably, (a) In order to grant authorization,
licensees and other entities shall ensure inability or unwillingness to provide
and the individual has been subject to information within 3 business days of
a behavioral observation program that that a suitable inquiry has been
conducted, on a best effort basis, to the request, the licensee or other entity
includes arrest reporting, which meets shall document this refusal, inability, or
the requirements of this part, verify the individual’s self-disclosed
information and determine whether any unwillingness in the licensee’s or other
throughout the period since the entity’s record of the investigation, and
individual’s last authorization was potentially disqualifying FFD
information is available, except if all of obtain a confirmation of employment or
terminated, the granting licensee or educational enrollment and attendance
other entity need not obtain the self- the following conditions are met:
(1) The individual previously held from at least one alternate source, with
disclosure or employment history in suitable inquiry questions answered to
order to grant authorization; and authorization under this part;
(2) The licensee or other entity has the best of the alternate source’s ability.
(2) If the individual’s last period of This alternate source may not have been
authorization was terminated favorably verified that the individual’s last period
of authorization was terminated previously used by the licensee or other
within the past 30 days, the licensee or entity to obtain information about the
other entity need not obtain the favorably; and
(3) The individual has been subject to individual’s character. If the licensee or
employment history. other entity uses an alternate source
a behavioral observation program that
(b) The written self-disclosure must— because employer information is not
(1) State whether the individual has— includes arrest reporting, which meets
(i) Violated a licensee’s or other the requirements of this part, forthcoming within 3 business days of
entity’s FFD policy; throughout the period of interruption. the request, the licensee or other entity
(ii) Had authorization denied or (b) To meet the suitable inquiry need not delay granting authorization to
terminated unfavorably under requirement, licensees and other entities wait for any employer response, but
§§ 26.35(c)(2), 26.53(i), 26.63(d), may rely on the information that other shall evaluate and document the
26.65(g), 26.67(c), 26.69(f), or 26.75(b) licensees and entities who are subject to response if it is received.
through (e); this subpart have gathered for previous (d) When any licensee or other entity
(iii) Used, sold, or possessed illegal periods of authorization. Licensees and in § 26.3(a) through (d) is legitimately
drugs; other entities may also rely on those seeking the information required for an
(iv) Abused legal drugs or alcohol; licensees’ and entities’ determinations authorization decision under this
(v) Subverted or attempted to subvert of fitness that were conducted under subpart and has obtained a signed
a drug or alcohol testing program; § 26.189, as well as their reviews and release from the subject individual
(vi) Refused to take a drug or alcohol resolutions of potentially disqualifying authorizing the disclosure of
test; FFD information, for previous periods of information, any licensee or other entity
(vii) Been subject to a plan for authorization. who is subject to this part shall disclose
substance abuse treatment (except for (c) The licensee or other entity shall whether the subject individual’s
self-referral); or ensure that the suitable inquiry has been authorization was denied or terminated
unfavorably as a result of a violation of individual claims to have been this part, from the date the individual’s
an FFD policy and shall make available employed the longest within each last authorization was terminated
the information on which the denial or calendar month, if the individual claims through the date the individual is
unfavorable termination of employment during the given calendar granted authorization; or
authorization was based, including, but month. (2) The licensee or other entity relies
not limited to, drug or alcohol test (3) Authorization reinstatement after on negative results from drug and
results, treatment and followup testing an interruption of more than 30 days. alcohol tests that were conducted under
requirements or other results from a The period of the suitable inquiry must the requirements of this part at any time
determination of fitness, and any other be the period since authorization was before the individual applied for
information that is relevant to an terminated. The licensee or other entity authorization, and the individual has
authorization decision. shall ensure that the suitable inquiry remained subject to a drug and alcohol
(e) In conducting a suitable inquiry, a has been conducted with the employer testing program that includes random
licensee or other entity may obtain by whom the individual claims to have testing and a behavioral observation
information and documents by been employed the longest within the program that includes arrest reporting,
electronic means, including, but not calendar month, if the individual claims which both meet the requirements of
limited to, telephone, facsimile, or e- employment during the given calendar this part, beginning on the date the drug
mail. The licensee or other entity shall month. and alcohol testing was conducted
make a record of the contents of the through the date the individual is
telephone call and shall retain that § 26.65 Pre-access drug and alcohol
testing. granted authorization and thereafter.
record, and any documents or electronic (d) Authorization reinstatement after
files obtained electronically, under (a) Purpose. This section contains pre-
access testing requirements for granting an interruption of more than 30 days.
§§ 26.711 and 26.713(a), (b), and (c), as (1) To reinstate authorization for an
applicable. authorization to an individual who
either has never held authorization or individual whose authorization has
(f) For individuals about whom no been interrupted for a period of more
potentially disqualifying FFD whose last period of authorization was
terminated favorably and about whom than 30 days but no more than 365 days,
information is known (or about whom except as permitted in paragraph (d)(2)
potentially disqualifying FFD no potentially disqualifying FFD
information has been discovered or of this section, the licensee or other
information is known, but it has been
disclosed that was not previously entity shall—
resolved by a licensee or other entity
reviewed and resolved by a licensee or (i) Verify that the individual has
who is subject to this subpart) at the
other entity under the requirements of negative results from alcohol testing and
time at which the suitable inquiry is
this subpart. collect a specimen for drug testing
initiated, the licensee or other entity
(b) Accepting tests conducted within within the 30-day period preceding the
shall ensure that a suitable inquiry has
been conducted as follows: the past 30 days. If an individual has day the licensee reinstates the
(1) Initial authorization. The period of negative results from drug and alcohol individual’s authorization; and
the suitable inquiry must be the past 3 tests that were conducted under the (ii) Verify that the drug test results are
years or since the individual’s requirements of this part before the negative within 5 business days of
eighteenth birthday, whichever is individual applied for authorization specimen collection or administratively
shorter. For the 1-year period from the licensee or other entity, and withdraw authorization until the drug
immediately preceding the date on the specimens for such testing were test results are received.
which the individual applies for collected within the 30-day period (2) The licensee or other entity need
authorization, the licensee or other preceding the day on which the licensee not conduct pre-access testing of these
entity shall ensure that the suitable or other entity grants authorization to individuals if—
inquiry has been conducted with every the individual, the licensee or other (i) The individual previously held
employer, regardless of the length of entity may rely on the results of those authorization under this part and has
employment. For the remaining 2-year drug and alcohol tests to meet the been subject to a drug and alcohol
period, the licensee or other entity shall requirements for pre-access testing in testing program that includes random
ensure that the suitable inquiry has been this section. testing and a behavioral observation
conducted with the employer by whom (c) Initial authorization and program that includes arrest reporting,
the individual claims to have been authorization update. Before granting which both meet the requirements of
employed the longest within each authorization to an individual who has this part, beginning on the date the
calendar month, if the individual claims never held authorization or whose individual’s last authorization was
employment during the given calendar authorization has been interrupted for a terminated through the date the
month. period of more than 365 days, the individual is granted authorization; or
(2) Authorization update. The period licensee or other entity shall verify that (ii) The licensee or other entity relies
of the suitable inquiry must be the the results of pre-access drug and on negative results from drug and
period since authorization was alcohol tests, which must be performed alcohol tests that were conducted under
terminated. For the 1-year period within the 30-day period preceding the the requirements of this part at any time
immediately preceding the date on day the licensee or other entity grants before the individual applied for
which the individual applies for authorization to the individual, are authorization, and the individual
authorization, the licensee or other negative. The licensee or other entity remains subject to a drug and alcohol
entity shall ensure that the suitable need not conduct pre-access testing if— testing program that includes random
inquiry has been conducted with every (1) The individual previously held testing and a behavioral observation
employer, regardless of the length of authorization under this part and has program that includes arrest reporting,
employment. For the remaining period been subject to a drug and alcohol which both meet the requirements of
since authorization was terminated, the testing program that includes random this part, beginning on the date the drug
licensee or other entity shall ensure that testing and a behavioral observation and alcohol testing was conducted
the suitable inquiry has been conducted program that includes arrest reporting, through the date the individual is
with the employer by whom the which both meet the requirements of granted authorization.
(e) Authorization reinstatement after or entity. Immediately on receipt of (3) Grant authorization to the
an interruption of 30 or fewer days. (1) negative test results, the licensee or individual under § 26.69.
The licensee or other entity need not other entity shall ensure that any matter
conduct pre-access testing before that could link the individual to the § 26.69 Authorization with potentially
disqualifying fitness-for-duty information.
granting authorization to an individual temporary administrative action is
whose authorization has been eliminated from the donor’s personnel (a) Purpose. This section defines the
interrupted for 5 or fewer days. In record and other records. management actions that licensees and
addition, the licensee or other entity (g) Sanctions. If an individual has other entities who are subject to this
need not conduct pre-access testing if confirmed positive, adulterated, or subpart shall take to grant or maintain,
the individual has been subject to a drug substituted test results from any drug, at the licensee’s or other entity’s
and alcohol testing program that validity, or alcohol tests that may be discretion, the authorization of an
includes random testing and a required in this section, the licensee or individual who is in the following
behavioral observation program that other entity shall, at a minimum and as circumstances:
includes arrest reporting, which both appropriate— (1) Potentially disqualifying FFD
meet the requirements of this part, from (1) Deny authorization to the information within the past 5 years has
the date the individual’s last individual, as required by § 26.75(b), been disclosed or discovered about the
authorization was terminated through (d), (e)(2), or (g); individual by any means, including, but
the date the individual is granted (2) Terminate the individual’s not limited to, the individual’s self-
authorization. authorization, if it has been reinstated, disclosure, the suitable inquiry, drug
(2) In order to reinstate authorization under § 26.75(e)(1) or (f); or and alcohol testing, the administration
for an individual whose authorization (3) Grant authorization to the of any FFD program under this part, a
has been interrupted for a period of individual under § 26.69. self-report of a legal action, behavioral
more than 5 days but not more than 30 observation, or other sources of
§ 26.67 Random drug and alcohol testing
days, except as permitted in paragraph information, including, but not limited
of individuals who have applied for
(e)(1) of this section, the licensee or authorization. to, any background investigation or
other entity shall take the following credit and criminal history check
(a) When the licensee or other entity
actions: conducted under the requirements of
collects specimens from an individual
(i) The licensee or other entity shall this chapter; and
for any pre-access testing that may be
subject the individual to random (2) The potentially disqualifying FFD
required under §§ 26.65 or 26.69, and
selection for pre-access drug and information has not been reviewed and
thereafter, the licensee or other entity
alcohol testing at a one-time probability favorably resolved by a previous
shall subject the individual to random
that is equal to or greater than the licensee or other entity under this
testing under § 26.31(d)(2), except if—
normal testing rate specified in (1) The licensee or other entity does section.
§ 26.31(d)(2)(vii) calculated for a 30-day (b) Authorization after a first
not grant authorization to the
period; confirmed positive drug or alcohol test
individual; or
(ii) If the individual is not selected for (2) The licensee or other entity relies result or a 5-year denial of
pre-access testing under paragraph on drug and alcohol tests that were authorization. The requirements in this
(e)(2)(i) of this section, the licensee or conducted before the individual applied paragraph apply to individuals whose
other entity need not perform pre-access for authorization to meet the applicable authorization was denied or terminated
drug and alcohol tests; or requirements for pre-access testing. If unfavorably for a first violation of an
(iii) If the individual is selected for the licensee or other entity relies on FFD policy involving a confirmed
pre-access testing under this paragraph, drug and alcohol tests that were positive drug or alcohol test result and
the licensee or other entity shall— conducted before the individual applied individuals whose authorization was
(A) Verify that the individual has for authorization, the licensee or other denied for 5 years under § 26.75(c), (d),
negative results from alcohol testing and entity shall subject the individual to (e)(2), or (f). To grant, and subsequently
collect a specimen for drug testing random testing when the individual maintain, the individual’s authorization,
before reinstating authorization; and arrives at a licensee’s or other entity’s the licensee or other entity shall—
(B) Verify that the drug test results are facility for in-processing and thereafter. (1) Obtain and review a self-
negative within 5 business days of (b) If an individual is selected for one disclosure and employment history
specimen collection or administratively or more random tests after any from the individual that addresses the
withdraw authorization until negative applicable requirement for pre-access shorter period of either the past 5 years
drug test results are received. testing in §§ 26.65 or 26.69 has been or since the individual’s last period of
(f) Administrative withdrawal of met, the licensee or other entity may authorization was terminated, and
authorization. If a licensee or other grant authorization before random verify that the self-disclosure does not
entity administratively withdraws an testing is completed, if the individual contain any previously undisclosed
individual’s authorization under has met all other applicable potentially disqualifying FFD
paragraphs (d)(1)(ii) or (e)(2)(iii)(B) of requirements for authorization. information before granting
this section, and until the drug test (c) If an individual has confirmed authorization;
results are known, the licensee or other positive, adulterated, or substituted test (2) Complete a suitable inquiry with
entity may not record the administrative results from any drug, validity, or every employer by whom the individual
action to withdraw authorization as an alcohol test required in this section, the claims to have been employed during
unfavorable termination. The individual licensee or other entity shall, at a the period addressed in the employment
may not be required to disclose the minimum and as appropriate— history obtained under paragraph (b)(1)
administrative action in response to (1) Deny authorization to the of this section, and obtain and review
requests for self-disclosure of individual, as required by § 26.75(b), any records that other licensees or
potentially disqualifying FFD (d), (e)(2), or (g); entities who are subject to this part may
information, except if the individual’s (2) Terminate the individual’s have developed related to the
authorization was subsequently denied authorization, if it has been granted, as unfavorable termination or denial of
or terminated unfavorably by a licensee required by § 26.75(e)(1) or (f); or authorization;
(3) If the individual was subject to a the 15 tests required in this paragraph, § 26.187(a), has indicated that the
5-year denial of authorization under this the licensee or other entity shall ensure individual is fit to safely and
part, verify that he or she has abstained that an SAE conducts a determination of competently perform his or her duties;
from substance abuse for at least the fitness to assess whether further (4) Ensure that the individual is in
past 5 years; followup testing is required and compliance with, or has completed, any
(4) Ensure that an SAE has conducted implement the SAE’s recommendations; plans for treatment and drug and
a determination of fitness and and alcohol testing from the determination
concluded that the individual is fit to (7) Verify that any drug and alcohol of fitness, which may include the
safely and competently perform his or tests required in this paragraph, and any collection of a urine specimen under
her duties. other drug and alcohol tests that are direct observation; and
(i) If the individual’s authorization conducted under this part since (5) Verify that the results of pre-access
was denied or terminated unfavorably authorization was terminated or denied, drug and alcohol tests are negative
for a first confirmed positive drug or yield results indicating no further drug before granting authorization, and that
alcohol test result, ensure that clinically abuse, as determined by the MRO after the individual is subject to random
appropriate treatment and followup review, or alcohol abuse, as determined testing after the specimens have been
testing plans have been developed by an by the result of confirmatory alcohol collected for pre-access testing and
SAE before granting authorization; testing. thereafter.
(ii) If the individual was subject to a (c) Granting authorization with other (d) Maintaining authorization with
5-year denial of authorization, ensure potentially disqualifying FFD other potentially disqualifying FFD
that any recommendations for treatment information. The requirements in this information. If an individual is
and followup testing from an SAE’s paragraph apply to an individual who authorized when other potentially
determination of fitness are initiated has applied for authorization, and about disqualifying FFD information is
before granting authorization; and whom potentially disqualifying FFD disclosed or discovered, in order to
(iii) Verify that the individual is in information has been discovered or maintain the individual’s authorization,
compliance with, and successfully disclosed that is not a first confirmed the licensee or other entity shall—
completes, any followup testing and positive drug or alcohol test result or a (1) Ensure that the licensee’s or other
treatment plans. 5-year denial of authorization. If entity’s designated reviewing official
(5) Within 10 business days before potentially disqualifying FFD completes a review of the circumstances
granting authorization, perform a pre- information is obtained about an associated with the information;
access alcohol test, collect a specimen individual by any means, including, but (2) If the designated reviewing official
for drug testing under direct not limited to, the individual’s self- concludes that a determination of
observation, and ensure that the disclosure, the suitable inquiry, the fitness is required, verify that a
individual is subject to random testing administration of any FFD program professional with the appropriate
thereafter. Verify that the pre-access under this part, a self-report of a legal qualifications, as specified in
drug and alcohol test results are action, behavioral observation, or other § 26.187(a), has indicated that the
negative before granting authorization. sources of information, including, but individual is fit to safely and
(6) If the individual’s authorization not limited to, any background competently perform his or her duties;
was denied or terminated unfavorably investigation or credit and criminal and
for a first confirmed positive drug or history check conducted under the (3) If the reviewing official determines
alcohol test result and a licensee or requirements of this chapter, before that maintaining the individual’s
other entity grants authorization to the granting authorization to the individual, authorization is warranted, implement
individual, ensure that the individual is the licensee or other entity shall— any recommendations for treatment and
subject to unannounced testing at least (1) Obtain and review a self- followup drug and alcohol testing from
quarterly for 3 calendar years after the disclosure and employment history that the determination of fitness, which may
date the individual is granted addresses the shortest of the following include the collection of urine
authorization. Both random and periods: specimens under direct observation, and
followup tests, as defined in § 26.31(c), (i) The past 5 years; ensure that the individual complies
satisfy this requirement. Verify that the (ii) Since the individual’s eighteenth with and successfully completes the
individual has negative test results from birthday; or treatment plans.
a minimum of 15 tests distributed over (iii) Since the individual’s last period (e) Accepting followup testing and
the 3-year period, except as follows: of authorization was terminated; treatment plans from another FFD
(i) If the individual does not (2) Complete a suitable inquiry with program. Licensees and other entities
continuously hold authorization during every employer by whom the individual may rely on followup testing, treatment
the 3-year period, the licensee or other claims to have been employed during plans, and determinations of fitness that
entity shall ensure that at least one the period addressed in the employment meet the requirements of § 26.189 and
unannounced test is conducted in any history required under paragraph (c)(1) were conducted under the FFD program
quarter during which the individual of this section. If the individual held of another licensee or entity who is
holds authorization; authorization within the past 5 years, subject to this subpart.
(ii) If the 15 tests are not completed obtain and review any records that other (1) If an individual leaves the FFD
within the 3-year period specified in licensees or entities who are subject to program in which a treatment and/or
this paragraph due to periods during this part may have developed with followup testing plan was required
which the individual does not hold regard to potentially disqualifying FFD under paragraphs (b), (c), or (d) of this
authorization, the followup testing information about the individual from section, the licensee or other entity who
program may be extended up to 5 the past 5 years; imposed the treatment and/or followup
calendar years to complete the 15 tests; (3) If the designated reviewing official testing plan shall ensure that
(iii) If the individual does not hold determines that a determination of information documenting the treatment
authorization during the 5-year period a fitness is required, verify that a and/or followup testing plan is
sufficient number of times or for professional with the appropriate identified to any subsequent licensee or
sufficient periods of time to complete qualifications, as specified in other entity who seeks to grant
authorization to the individual. If the than 30 continuous days, then the unfavorable termination of
individual is granted authorization by licensee or other entity shall terminate authorization.
the same or another licensee or entity, the individual’s authorization and the (d) Any individual who resigns or
the licensee or other entity who grants individual shall meet the requirements withdraws his or her application for
authorization to the individual shall in this subpart, as applicable, to regain authorization before authorization is
ensure that any followup testing authorization. terminated or denied for a first violation
requirements are met and that the of the FFD policy involving a confirmed
individual complies with any treatment Subpart D—Management Actions and positive drug or alcohol test result shall
plan, with accountability assumed by Sanctions To Be Imposed immediately have his or her
the granting licensee or other entity. If authorization denied for a minimum of
§ 26.73 Applicability.
it is impractical for the individual to 5 years from the date of termination or
comply with a treatment plan that was The requirements in this subpart denial. If an individual resigns or
developed under another FFD program apply to the licensees and other entities withdraws his or her application for
because of circumstances that are identified in § 26.3(a), (b), and, as authorization before his or her
outside of the individual’s or licensee’s applicable, (c) for the categories of authorization is terminated or denied
or other entity’s control (e.g., individuals specified in § 26.4(a) for any violation of the FFD policy, the
geographical distance, closure of a through (d) and (g). The requirements in licensee or other entity shall record the
treatment facility), then the granting this subpart also apply to the licensees resignation or withdrawal, the nature of
FFD program shall ensure that an SAE and other entities specified in § 26.3(c), the violation, and the minimum
develops a comparable treatment plan, as applicable, for the categories of sanction that would have been required
with accountability for monitoring the individuals in § 26.4(e). At the under this section had the individual
individual’s compliance with the plan discretion of a licensee or other entity not resigned or withdrawn his or her
assumed by the granting licensee or in § 26.3(c), the requirements of this application for authorization.
other entity. subpart also may be applied to the (e) Lacking any other evidence to
(2) If the previous licensee or other categories of individuals identified in indicate the use, sale, or possession of
entity determined that the individual § 26.4(f). In addition, the requirements illegal drugs or consumption of alcohol
successfully completed any required in this subpart apply to the entities in on site, a confirmed positive drug or
treatment and followup testing, and the § 26.3(d) to the extent that a licensee or alcohol test result must be presumed to
individual’s last period of authorization other entity relies on the C/V to meet be an indication of offsite drug or
was terminated favorably, the receiving the requirements of this subpart. The alcohol use in violation of the FFD
licensee or entity may rely on the regulations in this subpart also apply to policy.
previous determination of fitness and no the individuals specified in § 26.4(h) (1) The first violation of the FFD
further review or followup is required. and (j), as appropriate. policy involving a confirmed positive
(f) Sanctions. If an individual has drug or alcohol test result must, at a
§ 26.75 Sanctions. minimum, result in the immediate
confirmed positive, adulterated, or (a) This section defines the minimum
substituted test results from any drug, unfavorable termination of the
sanctions that licensees and other individual’s authorization for at least 14
validity, or alcohol test required in this entities shall impose when an
section, the licensee or other entity days from the date of the unfavorable
individual has violated the drug and termination.
shall, at a minimum and as alcohol provisions of an FFD policy. A
appropriate— (2) Any subsequent confirmed
licensee or other entity may impose positive drug or alcohol test result,
(1) Deny authorization to the
more stringent sanctions, except as including during an assessment or
individual, as required by § 26.75(b),
specified in paragraph (h) of this treatment period, must result in the
(d), (e)(2), or (g); or
section. denial of authorization for a minimum
(2) Terminate the individual’s
(b) Any act or attempted act to subvert of 5 years from the date of denial.
authorization, if it has been granted, as
the testing process, including, but not (f) Paragraph (e) of this section does
required by § 26.75(e)(1) or (f).
limited to, refusing to provide a not apply to the misuse of prescription
§ 26.71 Maintaining authorization. specimen and providing or attempting and over-the-counter drugs, except if the
(a) Individuals may maintain to provide a substituted or adulterated MRO determines that misuse of the
authorization under the following specimen, for any test required under prescription or over-the-counter drug
conditions: § 26.31(c) must result in the immediate represents substance abuse. Sanctions
(1) The individual complies with the unfavorable termination of the for misuse of prescription and over-the-
licensee’s or other entity’s FFD policies individual’s authorization and counter drugs must be sufficient to deter
and procedures, as described in § 26.27, permanent denial of authorization misuse of those substances.
including the responsibility to report thereafter. (g) For individuals whose
any legal actions, as defined in § 26.5; (c) Any individual who is determined authorization was denied for 5 years
(2) The individual remains subject to to have been involved in the sale, use, under paragraphs (c), (d), (e)(2), or (f) of
a drug and alcohol testing program that or possession of illegal drugs or the this section, any subsequent violation of
meets the requirements of § 26.31, consumption of alcohol within a the drug and alcohol provisions of an
including random testing; protected area of any nuclear power FFD policy must immediately result in
(3) The individual remains subject to plant, within a facility that is licensed permanent denial of authorization.
a behavioral observation program that to possess or use formula quantities of (h) A licensee or other entity may not
meets the requirements of § 26.33; and SSNM, within a transporter’s facility or terminate an individual’s authorization
(4) The individual successfully vehicle, or while performing the duties and may not subject the individual to
completes required FFD training on the that require the individual to be subject other administrative action based solely
schedule specified in § 26.29(c). to this subpart shall immediately have on a positive test result from any initial
(b) If an authorized individual is not his or her authorization unfavorably drug test, other than positive initial test
subject to an FFD program that meets terminated and denied for a minimum results for marijuana or cocaine
the requirements of this section for more of 5 years from the date of the metabolites from a specimen that is
reported to be valid on the basis of under the provisions of § 26.41, and to permit the individual to return to
either validity screening or initial NRC inspectors. performing his or her duties only after
validity testing performed at a licensee (ii) The licensee or other entity shall the impairing or questionable
testing facility, unless other evidence, provide the donor with a written conditions are resolved and a
including information obtained under statement that the records specified in determination of fitness indicates that
the process set forth in § 26.189, §§ 26.713 and 26.715 have not been the individual is fit to safely and
indicates that the individual is impaired retained with respect to the temporary competently perform his or her duties.
or might otherwise pose a safety hazard. administrative action and shall inform (c) If a licensee or other entity has a
The licensee or other entity may not the donor in writing that the temporary reasonable belief that an NRC employee
terminate an individual’s authorization administrative action that was taken or NRC contractor may be under the
or subject an individual to any other will not be disclosed and need not be influence of any substance, or is
administrative action under this section disclosed by the individual in response otherwise unfit for duty, the licensee or
based on the results of validity to requests for self-disclosure of other entity may not deny access but
screening or initial validity testing potentially disqualifying FFD shall escort the individual. In any such
performed at a licensee testing facility information. instance, the licensee or other entity
indicating that a specimen is of shall immediately notify the appropriate
questionable validity. § 26.77 Management actions regarding Regional Administrator by telephone,
(i) With respect to positive initial drug possible impairment. followed by written notification (e.g., e-
test results from a licensee testing (a) This section defines management mail or fax) to document the oral
facility for marijuana and cocaine actions that licensees and other entities notification. If the Regional
metabolites from a valid specimen, who are subject to this subpart must Administrator cannot be reached, the
licensee testing facility personnel may take when an individual who is subject licensee or other entity shall notify the
inform licensee or other entity to this subpart shows indications that he NRC Operations Center.
management of the positive initial drug or she may not be fit to safely and
test result and the specific drugs or competently perform his or her duties. Subpart E—Collecting Specimens for
metabolites identified, and licensees or (b) If an individual appears to be Testing
other entities may administratively impaired or the individual’s fitness is
questionable, except as permitted under § 26.81 Purpose and applicability.
withdraw the donor’s authorization or
§§ 26.27(c)(3), 26.207, and 26.209, the This subpart contains requirements
take lesser administrative actions
licensee or other entity shall take for collecting specimens for drug testing
against the donor, provided that the
immediate action to prevent the and conducting alcohol tests by or on
licensee or other entity complies with
individual from performing the duties behalf of the licensees and other entities
the following conditions:
(1) For the drug for which action will that require him or her to be subject to in § 26.3(a) through (d) for the categories
be taken, at least 85 percent of the this subpart. of individuals specified in § 26.4(a)
specimens that were determined to be (1) If an observed behavior or physical through (d) and (g). At the discretion of
positive as a result of initial drug tests condition creates a reasonable suspicion a licensee or other entity in § 26.3(c),
at the licensee testing facility during the of possible substance abuse, the licensee specimen collections and alcohol tests
past 12-month data reporting period or other entity shall perform drug and must be conducted either under this
submitted to the NRC under § 26.717 alcohol testing. The results must be subpart for the individuals specified in
were subsequently reported as positive negative before the individual returns to § 26.4(e) and (f) or the licensee or other
performing the duties that require the entity may rely on specimen collections
by the HHS-certified laboratory as the
individual to be subject to this subpart. and alcohol tests conducted under the
result of confirmatory testing;
(2) There is no loss of compensation However, if the physical condition is requirements of 49 CFR Part 40 for the
or benefits to the donor during the the smell of alcohol with no other individuals specified in § 26.4(e) and (f).
period of temporary administrative behavioral or physical indications of The requirements of this subpart do not
action; impairment, then only an alcohol test is apply to specimen collections and
(3) Immediately on receipt of a required and the results must be alcohol tests that are conducted under
negative report from the HHS-certified negative before the individual returns to the requirements of 49 CFR Part 40, as
laboratory or MRO, any matter that performing his or her duties. permitted in this paragraph and under
could link the donor to the temporary (2) If a licensee or C/V who is subject §§ 26.4(j) and 26.31(b)(2) and Subpart K.
administrative action is eliminated from to subpart I of this part is certain that § 26.83 Specimens to be collected.
the donor’s personnel record and other the observed behavior or physical
Except as permitted under
records; and condition is the result solely of fatigue,
§ 26.31(d)(5), licensees and other
(4) Licensees and other entities may the licensee or C/V shall ensure that a
entities who are subject to this subpart
not disclose the temporary fatigue assessment is conducted under
shall—
administrative action against an § 26.211. If the results of the fatigue (a) Collect either breath or oral fluids
individual whose initial drug test result assessment confirm that the observed for initial tests for alcohol. Breath must
is not subsequently confirmed by the behavior or physical condition is the be collected for confirmatory tests for
MRO as a violation of the FFD policy in result solely of fatigue, the licensee or alcohol; and
response to a suitable inquiry conducted C/V need not perform drug and alcohol (b) Collect only urine specimens for
under the provisions of § 26.63, a tests or implement the determination of both initial and confirmatory tests for
background investigation conducted fitness process otherwise required by drugs.
under the provisions of this chapter, or § 26.189.
to any other inquiry or investigation. (3) For other indications of possible § 26.85 Collector qualifications and
(i) To ensure that no records are impairment that do not create a responsibilities.
retained, access to the system of files reasonable suspicion of substance abuse (a) Urine collector qualifications.
and records must be provided to (or fatigue, in the case of licensees and Urine collectors shall be knowledgeable
personnel who are conducting reviews, C/Vs who are subject to subpart I of this of the requirements of this part and the
inquiries into allegations, or audits part), the licensee or other entity may FFD policy and procedures of the
licensee or other entity for whom may serve as a collector without the collection of oral fluids or breath
collections are performed, and shall meeting the collector qualification specimens; and the security of alcohol
keep current on any changes to urine requirements in paragraphs (a) or (b) of testing devices and test results. A
collection procedures. Collectors shall this section, as applicable, only if all of properly equipped mobile facility that
receive qualification training that meets the following conditions are met: meets the requirements of this section is
the requirements of this paragraph and (1) A collector who meets the an acceptable collection site.
demonstrate proficiency in applying the requirements of paragraphs (a) or (b) of (b) The collection site must provide
requirements of this paragraph before this section cannot reasonably be made for the donor’s visual privacy while the
serving as a collector. At a minimum, available at the time the collection must donor and collector are viewing the
qualification training must provide occur; results of an alcohol test, and for
instruction on the following subjects: (2) The individual is not employed by individual privacy while the donor is
(1) All steps necessary to complete a the licensee’s or other entity’s FFD submitting a urine specimen, except if
collection correctly and the proper program and his or her normal a directly observed urine specimen
completion and transmission of the workplace is not at the licensee’s or collection is required. Unauthorized
custody-and-control form; other entity’s facility; personnel may not be present for the
(2) Methods to address ‘‘problem’’ (3) The individual does not routinely specimen collection.
collections, including, but not limited provide FFD program services to the (c) Contracts for collection site
to, collections involving ‘‘shy bladder’’ licensee or other entity; services must permit representatives of
and attempts to tamper with a (4) The individual is licensed or the NRC, licensee, or other entity to
specimen; otherwise approved to practice in the conduct unannounced inspections and
(3) How to correct problems in jurisdiction in which the collection audits and to obtain all information and
collections; and occurs; and documentation that is reasonably
(4) The collector’s responsibility for (5) The individual is provided with
relevant to the inspections and audits.
maintaining the integrity of the detailed, clearly-illustrated, written
(d) Licensees and other entities shall
specimen collection and transfer instructions for collecting specimens
take the following measures to prevent
process, carefully ensuring the modesty under this subpart and follows those
unauthorized access to the collection
and privacy of the donor, and avoiding instructions.
site that could compromise the integrity
any conduct or remarks that might be (d) Personnel available to testify at
of the collection process or the
construed as accusatorial or otherwise proceedings. The licensee or other
specimens.
offensive or inappropriate. entity shall ensure that qualified
collection site personnel, when (1) Unauthorized personnel may not
(b) Alcohol collector qualifications.
required, are available to testify in an be permitted in any part of the
Alcohol collectors shall be
administrative or disciplinary designated collection site where
knowledgeable of the requirements of
proceeding against an individual when specimens are collected or stored;
this part and the FFD policy and
that proceeding is based on positive (2) A designated collection site must
procedures of the licensee or other
drug or alcohol test results or be secure. If a collection site is
entity for whom collections are
adulterated or substituted test results dedicated solely to specimen collection,
performed, and shall keep current on
from specimens collected by or under it must be secure at all times. Methods
any changes to alcohol collection
contract to the licensee or other entity. of assuring security may include, but are
procedures. Collectors shall receive
(e) Files. Collection site personnel not limited to, physical measures to
qualification training meeting the
files must include each individual’s control access, such as locked doors,
requirements of this paragraph and
resume of training and experience; alarms, or visual monitoring of the
demonstrate proficiency in applying the
certification or license, if any; collection site when it is not occupied;
requirements of this paragraph before
references; job descriptions; records of and
serving as a collector. At a minimum,
performance evaluations and (3) If a collection site cannot be
qualification training must provide
advancement; incident reports, if any; dedicated solely to collecting
instruction on the following subjects:
(1) The alcohol testing requirements results of tests to establish employee specimens, the portion of the facility
of this part; competency for the position he or she that is used for specimen collection
(2) Operation of the particular alcohol holds, including, but not limited to, must be secured and, during the time
testing device(s) [i.e., the alcohol certification that collectors are period during which a specimen is
screening devices (ASDs) or EBTs] to be proficient in administering alcohol tests being collected, a sign must be posted
used, consistent with the most recent consistent with the most recent to indicate that access is permitted only
version of the manufacturers’ manufacturer’s instructions for the for authorized personnel.
instructions; instruments and devices used; and (e) The following steps must be taken
(3) Methods to address ‘‘problem’’ appropriate data to support to deter the dilution and adulteration of
collections, including, but not limited determinations of honesty and integrity urine specimens at the collection site:
to, collections involving ‘‘shy lung’’ and conducted under § 26.31(b). (1) Agents that color any source of
attempts to tamper with a specimen; standing water in the stall or room in
(4) How to correct problems in § 26.87 Collection sites. which the donor will provide a
collections; and (a) Each FFD program must have one specimen, including, but not limited to,
(5) The collector’s responsibility for or more designated collection sites that the toilet bowl or tank, must be placed
maintaining the integrity of the have all necessary personnel, materials, in the source of standing water, so that
specimen collection process, carefully equipment, facilities, and supervision to the reservoirs of water are neither
ensuring the privacy of the donor, and collect specimens for drug testing and to yellow nor colorless;
avoiding any conduct or remarks that perform alcohol testing. Each collection (2) There must be no other source of
might be construed as accusatorial or site must provide for the collection, water (e.g., no shower or sink) in the
otherwise offensive or inappropriate. security, temporary storage, and enclosure where urination occurs, or the
(c) Alternative collectors. A medical shipping or transportation of urine source of water must be rendered
professional, technologist, or technician specimens to a drug testing laboratory; unusable; and
(3) Chemicals or products that could specimen is presented until the sealed an attempt to subvert the testing
be used to contaminate or otherwise container is transferred for shipment, process. The donor may not leave the
alter the specimen must be removed the specimen must remain under the collection site except under supervision
from the collection site or secured. The direct control of an individual who is until his or her identity has been
collector shall inspect the enclosure in authorized by the licensee or other established.
which urination will occur before each entity until the specimen is prepared for (3) If the donor is scheduled for pre-
collection to ensure that no materials transfer, storage, or shipping, as access testing and cannot produce
are available that could be used to required by § 26.117. The authorized acceptable identification, the collector
subvert the testing process. individual shall be instructed on his or may not proceed with the collection,
(f) In the exceptional event that a her responsibilities for maintaining and shall inform FFD program
designated collection site is inaccessible custody and control of the specimen management that the individual did not
and there is an immediate requirement and his or her custody of the specimen present acceptable identification. When
to collect a urine specimen, including, must be documented on the custody- so informed, FFD program management
but not limited to, an event and-control form. will take the necessary steps to
investigation, then the licensee or other determine whether the lack of
entity may use a public rest room, onsite § 26.89 Preparing to collect specimens for
testing.
identification was an attempt to subvert
rest room, or hospital examining room the testing process.
according to the following procedures: (a) When an individual has been (4) The collector shall explain the
(1) The facility must be secured by notified of a requirement for testing and testing procedure to the donor, show the
visual inspection to ensure that no does not appear at the collection site donor the form(s) to be used, and ask
unauthorized persons are present, and within the time period specified by FFD the donor to sign a consent-to-testing
that undetected access (e.g., through a program procedures, the collector shall form. The donor may not be required to
rear door not in the view of the inform FFD program management that list prescription medications or over-
collector) is impossible. Security during the individual has not reported for the-counter preparations that he or she
the collection may be maintained by testing. FFD program management shall has recently used.
restricting access to collection materials ensure that the necessary steps are taken (c) The collector shall inform the
and specimens. In the case of a public to determine whether the individual’s donor that, if the donor refuses to
rest room, a sign must be posted or an undue tardiness or failure to appear for cooperate in the specimen collection
individual assigned to ensure that no testing constitutes a violation of the process (including, but not limited to,
unauthorized personnel are present licensee’s or other entity’s FFD policy. behaving in a confrontational manner
during the entire collection procedure to If FFD program management determines that disrupts the testing process;
avoid embarrassment of the donor and that the undue tardiness or failure to admitting to the collector that he or she
distraction of the collector. report for testing represents an attempt adulterated, diluted, or adulterated the
(2) If practical, a water coloring agent to subvert the testing process, the specimen; is found to have a device,
that meets the requirements of licensee or other entity shall impose on such as a prosthetic appliance, the
§ 26.87(e)(1) must be placed in the toilet the individual the sanctions in purpose of which is to interfere with
bowl to be used by the donor and in any § 26.75(b). If FFD program management providing an actual urine specimen; or
other accessible source of standing determines that the undue tardiness or leaving the collection site before all of
water, including, but not limited to, the failure to report does not represent a the collection procedures are
toilet tank. The collector shall instruct subversion attempt, the licensee or other completed), it will be considered a
the donor not to flush the toilet. entity may not impose sanctions but refusal to test, and sanctions for
(3) A collector of the same gender as shall ensure that the individual is tested subverting the testing process will be
the donor shall accompany the donor at the earliest reasonable and practical imposed under § 26.75(b). If the donor
into the area that will be used for opportunity after locating the refuses to cooperate in the collection
specimen collection, but remain outside individual. procedures, the collector shall inform
of the stall, if it is a multi-stalled rest (b) Donors shall provide acceptable FFD program management to obtain
room, or outside of the door to the room, identification before testing. guidance on the actions to be taken.
if it is a single rest room, in which the (1) Acceptable identification includes (d) In order to promote the security of
donor will provide the specimen. If a photo-identification issued by a licensee specimens, avoid distraction of the
collector of the same gender is not or other entity who is subject to this collector, and ensure against any
available, the collector shall select a part, or by the Federal, State, or local confusion in the identification of
same-gender person to accompany the government. Licensees and other specimens, a collector shall conduct
donor. This person shall be instructed entities may not accept faxes or only one collection procedure at any
on the collection procedures specified photocopies of identification. given time. For this purpose, a urine
in this subpart and his or her identity (2) If the donor cannot produce
collection procedure is complete when
must be documented on the custody- acceptable identification before any
the urine specimen container has been
and-control form. testing that is required under this part
sealed and initialed, the chain-of-
(4) After the collector has possession other than pre-access testing, the
custody form has been executed, and
of the specimen, the collector shall collector shall proceed with the test and
the donor has departed the collection
inspect the toilet bowl and area to immediately inform FFD program
site.
ensure that there is no evidence of a management that the donor did not
subversion attempt and shall then flush present acceptable identification. When § 26.91 Acceptable devices for conducting
the toilet. The collector shall instruct so informed, FFD program management initial and confirmatory tests for alcohol
the donor to participate with the shall contact the individual’s supervisor and methods of use.
collector in completing the chain-of- to verify in-person the individual’s (a) Acceptable alcohol screening
custody procedures. identity, or, if the supervisor is not devices. Alcohol screening devices
(5) If it is impractical to maintain available, take other steps to establish (ASDs), including devices that test
continuous physical security of a the individual’s identity and determine specimens of oral fluids or breath, must
collection site from the time a urine whether the lack of identification was be approved by the National Highway
Traffic Safety Administration (NHTSA) than at the intervals specified in the paragraph (a)(1) of this section during
and listed in the most current version of manufacturer’s instructions. the collection process;
NHTSA’s Conforming Products List (2) When conducting external (5) Explain that the initial and
(CPL) for such devices. An ASD that is calibration checks, licensees and other confirmatory tests, if a confirmatory test
listed in the NHTSA CPL may be used entities shall use only calibration is necessary, will be conducted at the
only for initial tests for alcohol, and devices appearing on NHTSA’s CPL for end of the waiting period, even if the
may not be used for confirmatory tests. ‘‘Calibrating Units for Breath Alcohol donor has not followed the instructions;
(b) Acceptable evidential breath Tests.’’ and
testing devices. Evidential breath testing (3) If an EBT fails an external check (6) Document that the instructions
devices listed in the NHTSA CPL for of calibration, the licensee or other were communicated to the donor.
evidential devices that meet the entity shall take the EBT out of service. (b) With the exception of the 15-
requirements of paragraph (c) of this The EBT may not be used again for minute waiting period, if necessary, the
section must be used to conduct alcohol testing under this subpart until collector shall begin for-cause alcohol
confirmatory alcohol tests, and may be it is repaired and passes an external and/or drug testing as soon as
used to conduct initial alcohol tests. calibration check. reasonably practical after the decision is
Note that, among the devices listed in (4) In order to ensure that confirmed made that for-cause testing is required.
the CPL for EBTs, only those devices positive alcohol test results are derived When for-cause alcohol testing is
listed without an asterisk (*) may be from an EBT that is calibrated, the required, alcohol testing may not be
used for confirmatory alcohol testing licensee or other entity shall implement delayed by collecting a specimen for
under this subpart. one of the following procedures: drug testing.
(c) EBT capabilities. An EBT that is (i) If an EBT fails any external check
listed in the NHTSA CPL for evidential of calibration, cancel every confirmed § 26.95 Conducting an initial test for
positive test result that was obtained alcohol using a breath specimen.
devices that has the following
capabilities may be used for conducting using the EBT from any tests that were (a) The collector shall perform the
initial alcohol tests and must be used for conducted after the EBT passed the last initial breath test as soon as practical
confirmatory alcohol tests under this external calibration check; or after the donor indicates that he or she
subpart: (ii) After every confirmed positive test has not engaged in the activities listed
(1) Provides a printed result of each result obtained from using an EBT, in § 26.93(a)(1) or after the 15-minute
breath test; conduct an external check of calibration waiting period has elapsed, if required.
(2) Assigns a unique number to each of the EBT in the presence of the donor. (b) To perform the initial test, the
completed test, which the collector and If the EBT fails the external calibration collector shall—
donor can read before each test and check, cancel the donor’s test result and (1) Select, or allow the donor to select,
which is printed on each copy of the conduct another initial and an individually wrapped or sealed
test result; confirmatory test on a different EBT as mouthpiece from the testing materials;
(3) Prints, on each copy of the test soon as practicable. (2) Open the individually wrapped or
result, the manufacturer’s name for the (5) Inspection, maintenance, and sealed mouthpiece in view of the donor
device, its serial number, and the time calibration of the EBT must be and insert it into the device as required
of the test; performed by its manufacturer or a by the manufacturer’s instructions;
(4) Distinguishes alcohol from acetone maintenance representative or other (3) Instruct the donor to blow steadily
at the 0.02 alcohol concentration level; individual who is certified either by the and forcefully into the mouthpiece for at
(5) Tests an air blank; and manufacturer or by a State health least 6 seconds or until the device
(6) Permits performance of an external agency or other appropriate State indicates that an adequate amount of
calibration check. agency. breath has been obtained;
(d) Quality assurance and quality (4) Show the donor the displayed or
control of ASDs. (1) Licensees and other § 26.93 Preparing for alcohol testing. printed test result; and
entities shall implement the most recent (a) Immediately before collecting a (5) Ensure that the test result record
version of the quality assurance plan specimen for alcohol testing, the can be associated with the donor and is
submitted to NHTSA for any ASD that collector shall— maintained secure.
is used for initial alcohol testing. (1) Ask the donor whether he or she, (c) Unless problems in administering
(2) Licensees and other entities may in the past 15 minutes, has had anything the breath test require an additional
not use an ASD that fails the specified to eat or drink, belched, or put anything collection, only one breath specimen
quality control checks or that has passed into his or her mouth (including, but not may be collected for the initial test. If an
its expiration date. limited to, a cigarette, breath mint, or additional collection(s) is required, the
(3) For ASDs that test breath chewing gum), and instruct the donor collector shall rely on the test result
specimens and meet EBT requirements that he or she should avoid these from the first successful collection to
for confirmatory testing, licensees and activities during the collection process; determine the need for confirmatory
other entities shall also follow the (2) If the donor states that he or she testing.
device use and care requirements has not engaged in the activities listed
specified in paragraph (e) of this in paragraph (a)(1) of this section, § 26.97 Conducting an initial test for
section. alcohol testing may proceed; alcohol using a specimen of oral fluids.
(e) Quality assurance and quality (3) If the donor states that he or she (a) To perform the initial test, the
control of EBTs. (1) Licensees and other has engaged in any of the activities collector shall—
entities shall implement the most recent listed in paragraph (a)(1) of this section, (1) Check the expiration date on the
version of the manufacturer’s inform the donor that a 15-minute device and show it to the donor (the
instructions for the use and care of the waiting period is necessary to prevent device may not be used after its
EBT consistently with the quality an accumulation of mouth alcohol from expiration date);
assurance plan submitted to NHTSA for leading to an artificially high reading; (2) Open an individually wrapped or
the EBT, including performing external (4) Explain that it is to the donor’s sealed package containing the device in
calibration checks no less frequently benefit to avoid the activities listed in the presence of the donor;
(3) Offer the donor the choice of using shall ensure that the time at which the EBT may be used for confirmatory
the device or having the collector use it. test was concluded (i.e., the time at testing.
If the donor chooses to use it, instruct which the test result was known) is
the donor to insert the device into his recorded and inform the donor that a § 26.103 Determining a confirmed positive
test result for alcohol.
or her mouth and use it in the manner confirmatory test for alcohol is required.
described by the device’s manufacturer; (a) A confirmed positive test result for
(4) If the donor chooses not to use the § 26.101 Conducting a confirmatory test alcohol must be declared under any of
device, or in all cases when a new test for alcohol. the following conditions:
is necessary because the device failed to (a) The confirmatory test must begin (1) When the result of the
activate, insert the device into the as soon as possible, but no more than 30 confirmatory test for alcohol is 0.04
donor’s mouth, and gather oral fluids in minutes after the conclusion of the percent BAC or higher;
the manner described by the device’s initial test. (2) When the result of the
manufacturer (wear single-use (b) To complete the confirmatory test, confirmatory test for alcohol is 0.03
examination or similar gloves while the collector shall— percent BAC or higher and the donor
doing so and change them following (1) In the presence of the donor, had been in a work status for at least 1
each test); and conduct an air blank on the EBT before hour at the time the initial test was
(5) When the device is removed from beginning the confirmatory test and concluded (including any breaks for
the donor’s mouth, follow the show the result to the donor; rest, lunch, dental/doctor appointments,
manufacturer’s instructions regarding (2) Verify that the reading is 0.00. If etc.); or
necessary next steps to ensure that the the reading is 0.00, the test may (3) When the result of the
device has activated. proceed. If not, then conduct another air confirmatory test for alcohol is 0.02
(b) If the steps in paragraph (a) of this blank; percent BAC or higher and the donor
section could not be completed (3) If the reading on the second air had been in a work status for at least 2
successfully (e.g., the device breaks, the blank is 0.00, the test may proceed. If hours at the time the initial test was
device is dropped on the floor, the the reading is greater than 0.00, take the concluded (including any breaks for
device fails to activate), the collector EBT out of service and proceed with the rest, lunch, dental/doctor appointments,
shall— test using another EBT. If an EBT is etc.).
(1) Discard the device and conduct a (b) When the result of the
taken out of service for this reason, the
new test using a new device. The new confirmatory test for alcohol is equal to
EBT may not be used for further testing
device must be one that has been under or greater than 0.01 percent BAC but
until it is found to be within tolerance
the collector’s control before the test; less than 0.02 percent BAC and the
(2) Record the reason for the new test; limits on an external check of
donor has been in a work status for 3
(3) Offer the donor the choice of using calibration;
hours or more at the time the initial test
the device or having the collector use it (4) Open an individually wrapped or
was concluded (including any breaks for
unless the donor, in the opinion of the sealed mouthpiece in view of the donor
rest, lunch, dental/doctor appointments,
collector, was responsible for the new and insert it into the device as required
etc.), the collector shall declare the test
test needing to be conducted. If the by the manufacturer’s instructions;
result as negative and inform FFD
collector concludes that the donor was (5) Read the unique test number program management. The licensee or
responsible, then the collector shall use displayed on the EBT, and ensure that other entity shall prohibit the donor
the device to conduct the test; and the donor reads the same number; from performing any duties that require
(4) Repeat the procedures in (6) Instruct the donor to blow steadily the individual to be subject to this
paragraph (a) of this section. and forcefully into the mouthpiece for at subpart and may not return the
(c) If the second collection attempt in least 6 seconds or until the device individual to performing such duties
paragraph (b) of this section could not indicates that an adequate amount of until a determination of fitness indicates
be completed, the collector shall— breath has been obtained; and
(1) End the collection of oral fluids that the donor is fit to safely and
(7) Show the donor the result competently perform his or her duties.
and document the reason(s) that the displayed on or printed by the EBT,
collection could not be completed; and record the result, and document the § 26.105 Preparing for urine collection.
(2) Immediately conduct another time at which the confirmatory test (a) The collector shall ask the donor
initial test using an EBT. result was known. to remove any unnecessary outer
(d) The collector shall read the result (c) Unless there are problems in garments, such as a coat or jacket, which
displayed on the device no sooner than administering the breath test that might conceal items or substances that
the device’s manufacturer instructs. In require an additional collection, the the donor could use to tamper with or
all cases, the collector shall read the collector shall collect only one breath adulterate his or her urine specimen.
result within 15 minutes of the test. The specimen for the confirmatory test. If an The collector shall ensure that all
collector shall then show the device and additional collection(s) is required personal belongings such as a purse or
its reading to the donor, record the because of problems in administering briefcase remain with the outer
result, and record that an ASD was the breath test, the collector shall rely garments outside of the room or stall in
used. on the breath specimen from the first
(e) Devices, swabs, gloves, and other which the urine specimen is collected.
successful collection to determine the The donor may retain his or her wallet.
materials used in collecting oral fluids
confirmatory test result. Collection (b) The collector shall also ask the
may not be re-used.
procedures may not require collectors to donor to empty his or her pockets and
§ 26.99 Determining the need for a calculate an average or otherwise display the items in them to enable the
confirmatory test for alcohol. combine results from two or more collector to identify items that the donor
(a) If the initial test result is less than breath specimens to determine the could use to adulterate or substitute his
0.02 percent BAC, the collector shall confirmatory test result. or her urine specimen. The donor shall
declare the test result as negative. (d) If an EBT that meets the permit the collector to make this
(b) If the initial test result is 0.02 requirements of § 26.91(b) and (c) was observation. If the donor refuses to show
percent BAC or higher, the collector used for the initial alcohol test, the same the collector the items in his or her
pockets, this is considered a refusal to into the private area used for urination). laboratory for testing. If the donor
test. If an item is found that appears to If any such conduct is detected, the provides a specimen of at least the
have been brought to the collection site collector shall document the conduct on predetermined quantity, the specimen
with the intent to adulterate or the custody-and-control form and may be processed under the FFD
substitute the specimen, the collector contact FFD program management to program’s usual testing procedures;
shall contact the MRO or FFD program determine whether a directly observed (3) If the donor has not provided a
manager to determine whether a directly collection is required, as described in specimen of at least 30 mL within 3
observed collection is required. If the § 26.115. hours of the first unsuccessful attempt
item appears to have been inadvertently (c) After the donor has provided the to provide a specimen of the
brought to the collection site, the urine specimen and submitted it to the predetermined quantity, the collector
collector shall secure the item and collector, the donor shall be permitted shall discontinue the collection and
continue with the normal collection to wash his or her hands. The collector notify the FFD program manager or
procedure. If the collector identifies shall inspect the toilet bowl and room MRO to initiate the ‘‘shy bladder’’
nothing that the donor could use to or stall in which the donor voided to procedures in § 26.119; and
adulterate or substitute the specimen, identify any evidence of a subversion (4) Neither the donor nor the collector
the donor may place the items back into attempt, and then flush the toilet. may combine specimens. The collector
his or her pockets. shall discard specimens of less than 30
§ 26.109 Urine specimen quantity. mL, except if there is reason to believe
(c) The collector shall instruct the
donor to wash and dry his or her hands (a) Licensees and other entities who that the donor has diluted, adulterated,
before urinating. are subject to this subpart shall establish substituted, or otherwise tampered with
(d) After washing his or her hands, a predetermined quantity of urine that the specimen, based on the collector’s
the donor shall remain in the presence donors are requested to provide when observations of the donor’s behavior
of the collector and may not have access submitting a specimen. At a minimum, during the collection process or the
to any water fountain, faucet, soap the predetermined quantity must specimen’s characteristics, as specified
dispenser, cleaning agent, or other include 30 milliliters (mL) to ensure in § 26.111. If the collector has a reason
materials that he or she could use to that a sufficient quantity of urine is to believe that a specimen that is 15 mL
adulterate the urine specimen. available for initial and confirmatory or more, but less than 30 mL, has been
(e) The collector may select, or allow validity and drug tests at an HHS- diluted, adulterated, substituted, or
the donor to select, an individually certified laboratory, and for retesting of altered, the collector shall prepare the
wrapped or sealed collection container an aliquot of the specimen if requested suspect specimen for shipping to the
from the collection kit materials. Either by the donor under § 26.165(b). The HHS-certified laboratory and contact
the collector or the donor, with both licensee’s or other entity’s FFD program management to determine
present, shall unwrap or break the seal predetermined quantity may include whether a directly observed collection is
of the collection container. With the more than 30 mL, if the testing program required, as described in § 26.115.
exception of the collection container, follows split specimen procedures, tests
for additional drugs, or performs initial § 26.111 Checking the acceptability of the
the donor may not take anything from
testing at a licensee testing facility. urine specimen.
the collection kit into the room or stall
used for urination. Where collected specimens are to be (a) Immediately after the donor
split under the provisions of this provides the urine specimen to the
§ 26.107 Collecting a urine specimen. subpart, the predetermined quantity collector, including specimens of less
(a) The collector shall direct the donor must include an additional 15 mL. than 30 mL but greater than 15 mL, the
to go into the room or stall used for (b) If the quantity of urine in the first collector shall measure the temperature
urination, provide a specimen of the specimen provided by the donor is less of the specimen. The temperature-
quantity that has been predetermined by than 30 mL, the collector shall take the measuring device used must accurately
the licensee or other entity, as defined following steps: reflect the temperature of the specimen
in § 26.109(a), not flush the toilet, and (1) The collector shall encourage the and not contaminate the specimen. The
return with the specimen as soon as the donor to drink a reasonable amount of time from urination to temperature
donor has completed the void. liquid (normally, 8 ounces of water measurement may not exceed 4
(1) The donor shall provide his or her every 30 minutes, but not to exceed a minutes. If the temperature of a urine
urine specimen in the privacy of a room, maximum of 40 ounces over 3 hours) specimen is outside the range of 90 °F
stall, or otherwise partitioned area until the donor provides a specimen to 100 °F (32 °C to 38 °C), that is a
(private area) that allows for individual containing at least 30 mL. The collector reason to believe the donor may have
privacy, except if a directly observed shall provide the donor with a separate altered or substituted the specimen.
collection is required, as described in collection container for each successive (b) Immediately after the donor
§ 26.115; specimen; provides a urine specimen, including
(2) Except in the case of a directly (2) Once the donor provides a specimens of less than 30 mL but equal
observed collection, no one may go with specimen of at least 30 mL, the to or greater than 15 mL, the collector
the donor into the room or stall in collection must end. If the specimen shall also inspect the specimen to
which the donor will provide his or her quantity is at least 30 mL but is less than determine its color and clarity and look
specimen; and the licensee’s or other entity’s for any signs of contaminants or
(3) The collector may set a reasonable predetermined quantity, the licensee or adulteration. The collector shall note
time limit for voiding. other entity may not require the donor any unusual findings on the custody-
(b) The collector shall pay careful to provide additional specimens and and-control form.
attention to the donor during the entire may not impose any sanctions on the (c) If there is reason to believe that the
collection process to note any conduct donor. If the donor provides a specimen donor may have attempted to dilute,
that clearly indicates an attempt to of 30 mL or more, but the specimen substitute, or adulterate the specimen
tamper with a specimen (e.g., substitute quantity is less than the predetermined based on specimen temperature or other
urine is in plain view or an attempt to quantity, the collector shall forward the observations made during the
bring an adulterant or urine substitute specimen to the HHS-certified collection, the collector shall contact the
designated FFD program manager, who (c) Licensees and other entities may (f) If someone other than the collector
may consult with the MRO, to use aliquots of the specimen collected is to observe the collection, the collector
determine whether the donor has for validity screening and initial validity shall instruct the observer to follow the
attempted to subvert the testing process and drug testing at the licensee testing procedures in this paragraph. The
or whether other circumstances may facility, as permitted under individual who observes the collection
explain the observations. The FFD § 26.31(d)(3)(ii), or to test for additional shall follow these procedures:
program manager or MRO may require drugs, as permitted under (1) The observer shall instruct the
the donor to provide a second specimen § 26.31(d)(1)(i)(A), but only if sufficient donor to adjust his or her clothing to
as soon as possible under direct urine is available for this testing after ensure that the area of the donor’s body
observation. In addition, the collector the specimen has been split into Bottle between the waist and knees is exposed;
shall inform the donor that he or she A and Bottle B. (2) The observer shall watch the
may volunteer to submit a second donor urinate into the collection
specimen under direct observation to § 26.115 Collecting a urine specimen container. Specifically, the observer
under direct observation. shall watch the urine go from the
counter the reason to believe the donor
may have altered or substituted the (a) Procedures for collecting urine donor’s body into the collection
specimen. specimens must provide for the donor’s container;
(d) Any specimen of 15 mL or more privacy unless directed by this subpart (3) If the observer is not the collector,
that the collector suspects has been or the MRO or FFD program manager the observer may not take the collection
diluted, substituted, or adulterated, and determines that a directly observed container from the donor, but shall
any specimen of 15 mL or more that has collection is warranted. The following observe the specimen as the donor takes
been collected under direct observation circumstances constitute the exclusive it to the collector; and
under paragraph (c) of this section, must grounds for performing a directly (4) If the observer is not the collector,
be sent directly to the HHS-certified observed collection: the collector shall record the observer’s
laboratory for initial and, if required, (1) The donor has presented, at this or name on the custody-and-control form.
confirmatory testing, and may not be a previous collection, a urine specimen (g) If a donor declines to allow a
subject to initial testing at a licensee that the HHS-certified laboratory directly observed collection that is
testing facility. reported as being substituted, required or permitted under this
(e) As much of the suspect specimen adulterated, or invalid to the MRO and section, the donor’s refusal constitutes
as possible must be preserved. the MRO reported to the licensee or an act to subvert the testing process.
(f) An acceptable specimen is free of other entity that there is no adequate (h) If a collector learns that a directly
any apparent contaminants, meets the medical explanation for the result; observed collection should have been
required basic quantity of at least 30 (2) The donor has presented, at this performed but was not, the collector
mL, and is within the acceptable collection, a urine specimen that falls shall inform the FFD program manager,
temperature range. outside the required temperature range; or his or her designee. The FFD program
(3) The collector observes conduct manager or designee shall ensure that a
§ 26.113 Splitting the urine specimen. directly observed collection is
clearly and unequivocally indicating an
(a) Licensees and other entities may, immediately performed.
attempt to dilute, substitute, or
but are not required to, use split-
adulterate the specimen; and § 26.117 Preparing urine specimens for
specimen methods of collection.
(b) If the urine specimen is to be split (4) A directly observed collection is storage and shipping.
into two specimen bottles, hereinafter required under § 26.69. (a) Both the donor and the collector
referred to as Bottle A and Bottle B, the (b) Before collecting a urine specimen shall keep the donor’s urine specimen(s)
collector shall take the following steps: under direct observation, the collector in view at all times before the
(1) The collector shall instruct the shall obtain the agreement of the FFD specimen(s) are sealed and labeled. If
donor to urinate into a specimen program manager or MRO to obtain a any specimen or aliquot is transferred to
container; urine specimen under direct another container, the collector shall ask
(2) The collector, in the presence of observation. After obtaining agreement, the donor to observe the transfer and
the donor and after determining the collector shall ensure that a sealing of the container with a tamper-
specimen temperature as described in specimen is collected under direct evident seal.
§ 26.111(a), shall split the urine observation as soon as reasonably (b) Both the collector and the donor
specimen. The collector shall pour 30 practicable. shall be present (at the same time)
mL of urine into Bottle A and a (c) The collector shall explain to the during the procedures outlined in this
minimum of 15 mL of urine into Bottle donor the reason for direct observation section.
B. If the quantity of urine available for of the collection under paragraph (a) of (c) The collector shall place an
Bottle B is less than 15 mL, the collector this section. identification label securely on each
shall pour the remaining urine into (d) The collector shall complete a new container. The label must contain the
Bottle B and forward the specimens in custody-and-control form for the date, the donor’s specimen number, and
Bottles A and B to the HHS-certified specimen that is obtained from the any other identifying information
laboratory for drug and validity testing; directly observed collection. The provided or required by the FFD
and collector shall record that the collection program. The collector shall also apply
(3) The collector shall ask the donor was observed and the reason(s) for the a tamper-evident seal on each container
to observe the splitting of the urine directly observed collection on the form. if it is separate from the label. The
specimen and to maintain visual contact (e) The collector shall ensure that the specimen bottle must be securely sealed
with both specimen bottles until the observer is the same gender as the to prevent undetected tampering.
custody-and-control form(s) for both individual. A person of the opposite (d) The donor shall initial the
specimens are completed, the gender may not act as the observer identification label(s) on the specimen
specimens are sealed, and the under any conditions. The observer may bottle(s) for the purpose of certifying
specimens and form(s) are prepared for be a different person from the collector that the specimen was collected from
secure storage or shipping. and need not be a qualified collector. him or her. The collector shall also ask
the donor to read and sign a statement specimen during shipment (e.g., (2) The potential consequences of
on the custody-and-control form specimen boxes, shipping bags, padded refusing to take the required drug test;
certifying that the specimen(s) mailers, or bulk insulated shipping and
identified as having been collected from containers with that capability), so that (3) The physician must agree to follow
the donor is, in fact, the specimen(s) the contents of the shipping containers the requirements of paragraphs (c)
that he or she provided. are no longer accessible without through (f) of this section.
(e) The collector shall complete the breaking a tamper-evident seal. (c) The physician who conducts this
custody-and-control form(s) and shall (j) Collection site personnel shall evaluation shall make one of the
certify proper completion of the arrange to transfer the collected following determinations:
collection. specimens to the HHS-certified (1) A medical condition has, or with
(f) The specimens and chain-of- laboratory or the licensee testing a high degree of probability could have,
custody forms must be packaged for facility. Licensees and other entities precluded the donor from providing a
transfer to the HHS-certified laboratory shall take appropriate and prudent sufficient amount of urine; or
or the licensee’s testing facility. If the actions to minimize false negative (2) There is an inadequate basis for
specimens are not immediately results from specimen degradation. determining that a medical condition
prepared for transfer, they must be Specimens that have not been shipped has, or with a high degree of probability
appropriately safeguarded during to the HHS-certified laboratory or the could have, precluded the donor from
temporary storage. licensee testing facility within 24 hours providing a sufficient quantity of urine.
(g) While any part of the chain-of- of collection and any specimen that is (d) For purposes of this section, a
custody procedures is being performed, suspected of having been substituted, medical condition includes an
the specimens and custody documents adulterated, or tampered with in any ascertainable physiological condition
must be under the control of the way must be maintained cooled to not (e.g., a urinary system dysfunction) or a
involved collector. The collector may more than 6°C (42.8 °F) until they are medically documented pre-existing
not leave the collection site during the shipped to the HHS-certified laboratory. psychological disorder, but does not
interval between presentation of the Specimens must be shipped from the include unsupported assertions of
specimen by the donor and securing of collection site to the HHS-certified ‘‘situational anxiety’’ or dehydration.
the specimens with identifying labels laboratory or the licensee testing facility (e) The physician who conducts this
bearing the donor’s specimen as soon as reasonably practical but, evaluation shall provide a written
identification numbers and seals except under unusual circumstances, statement of his or her determination
initialed by the donor. If the involved the time between specimen shipment and the basis for it to the MRO. This
collector momentarily leaves his or her and receipt of the specimen at the statement may not include detailed
workstation, the sealed specimens and licensee testing facility or HHS-certified information on the donor’s medical
custody-and-control forms must be laboratory should not exceed 2 business condition beyond what is necessary to
secured or taken with him or her. If the days. explain the determination.
collector is leaving for an extended (k) Couriers, express carriers, and (f) If the physician who conducts this
period of time, the specimens must be postal service personnel do not have evaluation determines that the donor’s
packaged for transfer to the HHS- direct access to the custody-and-control medical condition is a serious and
certified laboratory or the licensee forms or the specimen bottles. permanent or long-term disability that is
testing facility and secured before the Therefore, there is no requirement that highly likely to prevent the donor from
collector leaves the collection site. such personnel document chain of providing a sufficient amount of urine
(h) The specimen(s) sealed in a custody on the custody-and-control for a very long or indefinite period of
shipping container must be immediately forms during transit. Custody time, the physician shall set forth this
transferred, appropriately safeguarded accountability of the shipping determination and the reasons for it in
during temporary storage, or kept under containers during shipment must be the written statement to the MRO.
the personal control of an authorized maintained by a tracking system (g) The MRO shall seriously consider
individual until transferred. These provided by the courier, express carrier, and assess the information provided by
minimum procedures apply to the or postal service. the physician in deciding whether the
transfer of specimens to licensee testing donor has a medical condition that has,
facilities from collection sites (except § 26.119 Determining ‘‘shy’’ bladder. or with a high degree of probability
where co-located) as well as to the (a) When a donor has not provided a could have, precluded the donor from
shipping of specimens to HHS-certified specimen of at least 30 mL within the providing a sufficient amount of urine,
laboratories. As an option, licensees and 3 hours permitted for urine collection, as follows:
other entities may ship several FFD program personnel shall direct the (1) If the MRO concurs with the
specimens via courier in a locked or donor to obtain, within 5 business days, physician’s determination, then the
sealed shipping container. an evaluation from a licensed physician MRO shall declare that the donor has
(i) Collection site personnel shall who is acceptable to the MRO and has not violated the FFD policy and the
ensure that a custody-and-control form expertise in the medical issues raised by licensee or other entity shall take no
is packaged with its associated urine the donor’s failure to provide a further action with respect to the donor;
specimen bottle. Unless a collection site sufficient specimen. The MRO may (2) If the MRO determines that the
and a licensee testing facility are co- perform this evaluation if the MRO has medical condition has not, or with a
located, the sealed and labeled the appropriate expertise. high degree of probability could not
specimen bottles, with their associated (b) If another physician will perform have, precluded the donor from
custody-and-control forms that are being the evaluation, the MRO shall provide providing a sufficient amount of urine,
transferred from the collection site to the other physician with the following then the MRO shall declare that there
the drug testing laboratory must be information and instructions: has been a refusal to test; or
placed in a second, tamper-evident (1) The donor was required to take a (3) If the MRO determines that the
shipping container. The second drug test, but was unable to provide a medical condition is highly likely to
container must be designed to minimize sufficient quantity of urine to complete prevent the donor from providing a
the possibility of damage to the the test; sufficient amount of urine for a very
long or indefinite period of time, then § 26.127 Procedures. § 26.129 Assuring specimen security,
the MRO shall authorize an alternative (a) Licensee testing facilities shall chain of custody, and preservation.
evaluation process, tailored to the develop, implement, and maintain clear (a) Each licensee testing facility must
individual case, for drug testing. and well-documented procedures for be secure at all times. Each licensee or
accession, shipment, and testing of other entity shall have sufficient
Subpart F—Licensee Testing Facilities urine specimens. security measures in place to control
(b) Written chain-of-custody access to the licensee testing facility and
§ 26.121 Purpose.
procedures must describe the methods to ensure that no unauthorized
This subpart contains requirements personnel handle specimens or gain
for facilities that are operated by to be used to maintain control and
accountability of specimens from access to the licensee testing facility’s
licensees and other entities who are processes or areas where records are
subject to this part to perform initial receipt through completion of testing
and reporting of results, during storage stored. Access to these secured areas
tests of urine specimens for validity, must be limited to specifically
drugs, and drug metabolites. and shipping to the HHS-certified
laboratory, and continuing until final authorized individuals whose
§ 26.123 Testing facility capabilities. disposition of the specimens. authorization is documented. All
Each licensee testing facility shall (c) Licensee testing facilities shall authorized visitors and maintenance
have the capability, at the same develop, implement, and maintain and service personnel shall be escorted
premises, to perform either validity written standard operating procedures at all times while in the licensee testing
screening tests or initial validity tests or for each assay performed for drug and facility.
both, and initial drug tests for each drug (b) When specimens are received,
specimen validity testing. If a licensee
and drug metabolite for which testing is licensee testing facility personnel shall
testing facility performs validity
conducted. inspect each package for evidence of
screening tests, the licensee testing
possible tampering and shall compare
facility shall develop, implement, and
§ 26.125 Licensee testing facility information on the specimen containers
personnel. maintain written standard operating
within each package to the information
procedures for each test. The procedures
(a) Each licensee testing facility shall on the accompanying custody-and-
must include, but are not limited to,
have one or more individuals who are control forms. Licensee testing facility
detailed descriptions of—
responsible for day-to-day operations personnel shall attempt to resolve any
(1) The principles of each test; discrepancies identified in the
and supervision of the testing
technicians. The designated (2) Preparation of reagents, standards, information on specimen bottles or on
individual(s) shall have at least a and controls; the accompanying custody-and-control
bachelor’s degree in the chemical or (3) Calibration procedures; forms. When resolving any
biological sciences, medical technology, (4) Derivation of results; discrepancies, licensee testing facility
or equivalent. He or she shall also have (5) Linearity of the methods; personnel shall obtain a memorandum
training and experience in the theory (6) Sensitivity of the methods; for the record from the specimen
and practice of the procedures used in (7) Cutoff values; collector involved in the discrepancy to
the licensee testing facility, and a (8) Mechanisms for reporting results; document correction of the discrepancy.
thorough understanding of quality (9) Controls; This memorandum must accompany the
control practices and procedures, the (10) Criteria for unacceptable specimen(s) and custody-and-control
review, interpretation, and reporting of specimens and results; forms to the HHS-certified laboratory if
test results, and proper remedial actions (11) Reagents and expiration dates; the specimen(s) must be transferred.
to be taken in response to detection of and (1) Indications of tampering with
abnormal test or quality control results. (12) References. specimens in transit from the collection
(b) Other technicians or non-technical (d) Licensee testing facilities shall site, or at a licensee testing facility, must
staff shall have the necessary training develop, implement, and maintain be reported to senior licensee or other
and skills for their assigned tasks. written procedures for instrument and entity management as soon as practical
Technicians who perform urine test setup and normal operation, and no later than 8 hours after the
specimen testing shall have documented including the following: indications are identified. In response to
proficiency in operating the testing (1) A schedule for checking critical a report, licensee or other entity
instruments and devices used at the operating characteristics for all management personnel shall initiate an
licensee testing facility. instruments and validity screening tests; investigation to determine whether
(c) Licensee testing facility personnel (2) Tolerance limits for acceptable tampering has occurred.
files must include each individual’s function checks; and (i) If the investigation determines that
resume of training and experience; (3) Instructions for major tampering has occurred, licensee or
certification or license, if any; troubleshooting and repair. other entity management shall ensure
references; job descriptions; records of (e) Licensee testing facilities shall that corrective actions are taken.
performance evaluations and develop, implement, and maintain (ii) If there is reason to believe that
advancement; incident reports, if any; written procedures for remedial actions the integrity or identity of a specimen is
results of tests that establish employee to be taken when systems, and in question (as a result of tampering or
competency for the position he or she instrumented and non-instrumented discrepancies between the information
holds, including, but not limited to, tests are out of acceptable limits or on the specimen bottle and on the
certification that personnel are errors are detected. Each facility shall accompanying custody-and-control
proficient in conducting testing in maintain documentation that these forms that cannot be resolved), the
accordance with manufacturer’s most procedures are followed and that all specimen may not be tested and the
recent instructions for the instruments necessary corrective actions are taken. licensee or other entity shall ensure that
and devices used and tests for color In addition, each facility shall have another collection occurs as soon as
blindness; and appropriate data to systems in place to verify all stages of reasonably practical, except if a split
support determinations of honesty and testing and reporting and to document specimen collection was performed,
integrity required by this part. the verification. either the Bottle A or Bottle B seal
remains intact, and the intact specimen (f) Licensee testing facility personnel or initial validity test result to the HHS-
contains at least 15 mL of urine. In this shall take appropriate and prudent certified laboratory for further testing.
instance, the licensee testing facility actions to minimize false negative Licensee testing facilities need not
shall forward the intact specimen for results from specimen degradation. If perform validity screening tests before
testing to the HHS-certified laboratory validity screening or initial validity conducting initial validity tests of a
and may not conduct any testing at the testing indicate that the specimen is of specimen.
licensee testing facility. questionable validity, or initial drug test (b) At a minimum, the licensee testing
(2) The following are exclusive results are positive, or if a specimen has facility shall test each urine specimen
grounds requiring the MRO to cancel not been tested within 24 hours of for creatinine, pH, and one or more
the testing of a donor’s urine specimen: receipt at the licensee testing facility, oxidizing adulterants. Licensees and
(i) The custody-and-control form does then the facility shall maintain the other entities may not specify more
not contain information to identify the specimen cooled to not more than 6 °C stringent cutoff levels for validity
specimen collector and the collection (42.8 °F) until it is forwarded to the screening and initial validity tests than
site cannot provide conclusive evidence HHS-certified laboratory for further those specified in this section. If tests or
of the collector’s identity; testing, if required. Split specimens in observations indicate one or more of the
(ii) The identification numbers on the Bottle B that are associated with following from either a validity
specimen bottle seal(s) do not match the positive specimens or specimens of screening test or an initial validity test,
identification numbers on the custody- questionable validity in Bottle A must the licensee testing facility shall forward
and-control form; also be maintained cooled (as the specimen to the HHS-certified
(iii) A specimen bottle seal is broken previously specified) until test results laboratory for additional testing:
or shows evidence of tampering and an from the HHS-certified laboratory are (1) Creatinine is less than 20
intact specimen, as specified in known to be negative for Bottle A; until milligrams (mg) per deciliter (dL);
paragraph (b)(1)(ii) of this section, does the MRO informs the licensee testing (2) The pH of the specimen is either
not exist; facility that Bottle B must be forwarded less than 4.5 or equal to or greater than
(iv) The specimen appears to have to an HHS-certified laboratory for 9, using either a colorimetric pH test
leaked out of its sealed bottle and there testing; or until the specimen is moved with a dynamic range of 2 to 12 or pH
is less than 15 mL remaining, and an to long-term, frozen storage, under meter that is capable of measuring pH
intact specimen, as specified in § 26.135(c). to one decimal place (for initial validity
paragraph (b)(1)(ii) of this section, does (g) Licensee testing facility personnel tests), or colorimetric pH tests,
not exist; or shall ensure that the original custody- dipsticks, and pH paper (for pH validity
(v) As required under § 26.165(f)(2). and-control form is packaged with its screening tests) that have a narrow
(c) The licensee testing facility shall associated urine specimen bottle. Sealed dynamic range;
retain specimen containers within the and labeled specimen bottles, with their (3) Nitrite or other oxidant
testing facility’s accession area until all associated custody-and-control forms, concentration is equal to or greater than
analyses have been completed. Testing being transferred from the licensee 200 micrograms (mcg) per mL or equal
facility personnel shall use aliquots of testing facility to the HHS-certified to or greater than 200 mcg/mL nitrite-
the specimen and licensee testing laboratory must be placed in a second, equivalents using either a nitrite
facility chain-of-custody forms, or other tamper-evident shipping container colorimetric test or a general oxidant
appropriate methods of tracking aliquot designed to minimize the possibility of colorimetric test;
custody and control, when conducting damage to the specimen during (4) The possible presence of an
validity screening and initial validity shipment (e.g., specimen boxes, padded oxidizing adulterant (e.g., chromium
and drug tests. The original specimen mailers, or bulk insulated shipping (VI), pyridine (pyridinium
bottles and the original custody-and- containers with that capability) so that chlorochromate)) is determined using
control forms must remain in secure the contents of the shipping containers either a general oxidant colorimetric test
storage. Licensee testing facility are no longer accessible without (with a cutoff equal to or greater than 50
personnel may discard specimens and breaking a tamper-evident seal. mcg/mL chromium (VI)-equivalents) or
aliquots as soon as practical after (h) Couriers, express carriers, and a chromium (VI) colorimetric test
validity screening or initial validity tests postal service personnel do not have (chromium (VI) concentration equal to
have demonstrated that the specimen direct access to the custody-and-control or greater than 50 mcg/mL);
appears valid and initial test results for forms or the specimen bottles. (5) The possible presence of halogen
drugs and drug metabolites are negative. Therefore, such personnel are not (e.g., bleach, iodine, fluoride) is
(d) The licensee testing facility’s required to document chain of custody determined using a general oxidant
procedure for tracking custody and on the custody-and-control forms during colorimetric test (with a cutoff equal to
control of specimens and aliquots must transit. Custody accountability of the or greater than 200 mcg/mL nitrite-
protect the identity of the donor, and shipping containers during shipment equivalents or equal to or greater than
provide documentation of the testing must be maintained by a tracking 50 mcg/mL chromium (VI)-equivalents),
process and transfers of custody of the system provided by the courier, express a halogen colorimetric test (halogen
specimen and aliquots. Each time a carrier, or postal service. concentration equal to or greater than
specimen or aliquot is handled or the limit of detection (LOD)), or the odor
transferred within the licensee testing § 26.131 Cutoff levels for validity of the specimen;
facility, testing facility personnel shall screening and initial validity tests. (6) The possible presence of
document the date and purpose and (a) Each validity test result from the glutaraldehyde is determined using
every individual in the chain of custody licensee testing facility must be based either an aldehyde test (aldehyde
must be identified. on performing either a validity present) or the characteristic
(e) Urine specimens identified as screening test or an initial validity test, immunoassay response is observed on
positive or of questionable validity at a or both, on one or more aliquots of a one or more drug immunoassay tests;
licensee testing facility must be shipped urine specimen. The licensee testing (7) The possible presence of a
to an HHS-certified laboratory for facility shall forward any specimen that surfactant is determined by using a
testing as soon as reasonably practical. yields a questionable validity screening surfactant colorimetric test with a cutoff
equal to or greater than 100 mcg/mL and shall retain Bottle B in secure laboratory is capable of conducting
dodecylbenzene sulfonate-equivalent or storage, under the requirements of confirmatory testing for any adulterant
a foam/shake test; or § 26.159(i), or may forward it to the for which the licensee testing facility
(8) The specimen shows evidence of HHS-certified laboratory for storage. conducts validity screening tests.
adulterants, including, but not limited (b) If the MRO confirms any positive, Licensee testing facilities shall use only
to, the following: adulterated, or substituted result for a validity screening tests that meet the
(i) Abnormal physical characteristics; specimen in Bottle A, based on the following criteria:
(ii) Reactions or responses results of confirmatory testing at an (i) Either the test, by lot number, has
characteristic of an adulterant obtained HHS-certified laboratory, and the been placed on the Substance Abuse
during the validity screening or initial licensee testing facility has elected to and Mental Health Services
test; or retain Bottle B of the specimen, and the Administration (SAMHSA) list of point-
(iii) A possible unidentified donor requests testing of the specimen of-collection tests that are approved for
interfering substance or adulterant, in Bottle B, as permitted under use in the Federal Workplace Drug
demonstrated by interference occurring § 26.165(b), the MRO shall ensure that Testing Program; or
on the immunoassay drug tests on two Bottle B is forwarded to an HHS- (ii) Before using the test, the licensee
separate aliquots (i.e., valid certified laboratory other than the or other entity has ensured that the
immunoassay drug test results cannot be laboratory that tested the specimen in validity screening test, by lot number,
obtained). Bottle A, under the procedures specified effectively identifies specimens of
in § 26.165(b). questionable validity by meeting the
§ 26.133 Cutoff levels for drugs and drug
metabolites. (c) If the MRO confirms that the following performance testing and
specimen in Bottle A is positive, quality control requirements:
Subject to the provisions of (A) The creatinine validity screening
adulterated, substituted, or invalid and
§ 26.31(d)(3)(iii), licensees and other test must use a 20 mg/dL cutoff
entities may specify more stringent the donor does not request that Bottle B
be tested, the licensee or other entity concentration;
cutoff levels for drugs and drug (B) A pH specimen validity screening
metabolites than those in the table shall ensure that Bottle B is maintained
in long-term, frozen storage (¥20 °C/ test must be able to determine if pH is
below and, in such cases, may report less than 4.5 and if pH is equal to or
initial test results for only the more ¥68 °F or less) for a minimum of 1 year.
If a licensee testing facility elects to greater than 9; and
stringent cutoff levels. Otherwise, the (C) An oxidant validity screening test
following cutoff levels must be used for retain the specimen in Bottle B, rather
than forwarding it to the HHS-certified must be able to determine if an oxidant
initial testing of urine specimens to concentration is equal to or greater than
determine whether they are negative for laboratory with Bottle A, the licensee
testing facility shall ensure proper a 200 mcg/mL nitrite-equivalent cutoff,
the indicated drugs and drug and/or a chromium screening test must
metabolites: storage conditions in the event of a
prolonged power failure. After the end be able to determine concentrations
of 1 year, the licensee or other entity equal to or greater than a 50 mcg/mL
INITIAL TEST CUTOFF LEVELS FOR chromium(VI)-equivalent cutoff, and/or
may discard Bottle B, with the
DRUGS AND DRUG METABOLITES exception that the licensee testing a halogen screening test must be able to
facility shall retain any specimens determine the halogen concentration is
Cutoff level equal to or greater than the LOD.
Drug or metabolites [nanograms under legal challenge, or as requested by
(ng)/mL] the NRC, until the specimen is no longer Licensees and other entities who use
needed. validity screening tests for additional
Marijuana metabolites .......... 50 adulterants shall establish performance
Cocaine metabolites ............. 300 § 26.137 Quality assurance and quality testing requirements to challenge the
Opiate metabolites ................ 2000 control. licensee testing facility and the HHS-
Phencyclidine (PCP) ............. 25 (a) Quality assurance program. Each certified laboratory for the additional
Amphetamines ...................... 1000 licensee testing facility shall have a validity screening test(s);
quality assurance program that (D) The manufacturer has conducted
§ 26.135 Split specimens. encompasses all aspects of the testing validation studies to document the
(a) If the FFD program follows split- process including, but not limited to, validity screening test’s performance
specimen procedures, as described in specimen acquisition, chain of custody, characteristics around each applicable
§ 26.113, the licensee testing facility security and reporting of results, cutoff specified in this section, using
shall analyze aliquots of the specimen validity screening (if validity screening performance testing samples that have
for the licensee’s or other entity’s tests are performed), initial validity and been formulated to challenge the
purposes as described in this part. drug testing, and validation of analytical validity screening test around the
Except as provided in paragraph (b) in procedures. Quality assurance applicable cutoffs. These validation
this section, the licensee testing facility procedures must be designed, studies must demonstrate the validity
shall store Bottles A and B of the implemented, and reviewed to monitor screening test’s ability to differentiate
specimen in a secure manner until the the conduct of each step of the process valid samples from those of
facility has finished testing. If the initial of validity testing and testing for drugs questionable validity and the
validity and drug test results are and drug metabolites. performance of the validity screening
negative and the specimen in Bottle A (b) Performance testing and quality test(s) around the applicable cutoffs
will not be forwarded to the HHS- control requirements for validity specified in this section; and
certified laboratory, the licensee testing screening tests. (1) Licensee testing (E) The licensee testing facility shall
facility may discard both Bottle A and facilities may rely on validity screening submit three consecutive sets of
Bottle B. If any test results are positive tests to determine the need for initial performance testing samples to the
or indicate that the specimen is of tests of specimen validity either at the manufacturer, using performance testing
questionable validity, the licensee licensee testing facility or HHS-certified samples that have been formulated to
testing facility shall forward Bottle A to laboratory. Licensees and other entities challenge the validity screening test
the HHS-certified laboratory for testing shall ensure that the HHS-certified around the applicable cutoffs specified
in this paragraph and whose specimen validity screening test, that (c) Validity screening test results. If
formulation levels have been confirmed the test, by lot number, correctly the results of a validity screening test
by an HHS-certified laboratory. For identified at least 90 percent of the indicate that the specimen is of
example, one set of performance testing validity test challenges. This questionable validity, the licensee
samples used to challenge a creatinine performance testing must be performed testing facility may either perform
validity screening test must include at at a nominal annual frequency after the initial validity testing or shall forward
least six samples formulated at different date on which the manufacturer the specimen to the HHS-certified
concentrations ranging from 0 to 20 mg/ completed the initial validation studies laboratory for further testing.
dL. A set of performance testing samples required under paragraph (b)(1)(ii)(D) of (d) Quality control requirements for
used to challenge a pH validity this section. The performance testing performing initial validity tests.
screening test must include at least six samples used must be formulated to Licensees and other entities shall ensure
samples formulated with different pH challenge the validity screening test that the HHS-certified laboratory is
levels that are equal to or less than 4.5, around the applicable cutoffs of this capable of conducting confirmatory
and six samples formulated with subpart. testing for any adulterant for which the
different pH levels that are equal to or (2) In addition, licensee testing licensee testing facility conducts initial
greater than 9. And, a set of performance facility personnel who perform the validity tests.
testing samples used to challenge an validity screening tests shall conduct (1) Creatinine. Creatinine
oxidizing adulterant validity screening quality control testing of validity concentration must be measured to 1
test must include at least six samples to screening tests as follows: decimal place. The initial creatinine test
challenge each validity screening test (i) At the beginning of any 8-hour must have a control in the range of 3 to
used. The performance testing samples period during which the licensee testing 20 mg/dL and a control in the range of
for oxidizing adulterants must contain facility will perform validity screening 21 to 25 mg/dL.
nitrite and other oxidizing adulterant tests, licensee testing facility personnel (2) Requirements for performing
concentrations in a range of less than or shall test a minimum of one quality initial pH tests are as follows:
equal to a 200 mcg/mL nitrite- control sample that is negative for each (i) Colorimetric pH tests that have a
equivalent cutoff to a 500 mcg/mL specific validity test to be performed dynamic range of 2 to 12 and pH meters
nitrite-equivalent cutoff; chromium (e.g., creatinine, pH, nitrites, chromium) and must be capable of measuring pH to
samples formulated in a range less than during the 8-hour period, and one one decimal place.
or equal to a 50 mcg/mL chromium(VI)- quality control sample that is (ii) An initial colorimetric pH test
equivalent cutoff to 100 mcg/mL formulated to challenge the validity must have the following calibrators and
chromium(VI)-equivalent cutoff; or screening test(s) around the cutoffs controls:
specified in this subpart for each (A) One calibrator at 3;
halogen samples formulated in a
specific validity test to be performed (B) One calibrator at 11;
concentration at or near the LOD and 25
during the 8-hour period. The results of (C) One control in the range of 2 to
percent above the LOD. The results of
these quality control tests must be 2.8;
analyzing the three consecutive sets of
correct before any donor specimens may (D) One control in the range of 3.2 to
performance test samples for each
be tested. 4;
validity screening test (i.e., creatinine, (ii) After screening every ten donor
pH, nitrite and general oxidants, (E) One control in the range of 4.5 to
specimens during the 8-hour period, 9;
chromium, or halogen) must licensee testing facility personnel shall
demonstrate that the validity screening (F) One control in the range of 10 to
also challenge each validity screening 10.8; and
test, by lot number, correctly identified test with at least one quality control
at least 90 percent of the total validity (G) One control in the range of 11.2
sample that is formulated to challenge to 12.
performance test challenges on each of the validity screening test(s) around the
three sets of performance testing (iii) If a pH screening test is not used,
cutoffs specified in this subpart. If fewer an initial pH meter test must have the
samples, and, for each individual than ten donor specimens were
specimen validity screening test, the following calibrators and controls:
screened during the 8-hour period or the (A) One calibrator at 4;
test, by lot number, correctly identified number of donor specimens tested (B) One calibrator at 7;
at least 90 percent of the validity exceeds a multiple of ten but is less than (C) One calibrator at 10;
performance test challenges on each of the next multiple of ten (e.g., 24 donor (D) One control in the range of 2 to
three sets of performance testing specimens, 48 donor specimens), 2.8;
samples; and licensee testing facility personnel shall (E) One control in the range of 3.2 to
(iii) After the licensee testing facility challenge each validity screening test at 4;
has placed a validity screening test in the end of the 8-hour period during (F) One control in the range of 10 to
service, the licensee or other entity shall which the validity screening tests were 10.8; and
verify that the test, by lot number, performed. (G) One control in the range of 11.2
remains on the SAMHSA-approved list. (3) The licensee testing facility shall to 12.
Or, if the SAMHSA-approved list is also submit at least one specimen out of (iv) If a pH screening test is used, an
unavailable, the licensee or other entity every ten donor specimens that test initial pH meter test must have the
shall ensure that the test continues to negative using each validity screening following calibrators and controls when
identify specimens of questionable test that the licensee testing facility uses the screening result indicates that the
validity, as demonstrated by to an HHS-certified laboratory as part of pH is below the lower decision point in
documentation from the manufacturer the licensee testing facility’s quality use:
that a set of validity screening tests from assurance program. (A) One calibrator at 4;
each lot in use by the licensee testing (4) Licensee testing facilities shall (B) One calibrator at 7;
facility correctly identified at least 90 store specimen validity tests as (C) One control in the range of 2 to
percent of the total validity test specified by the manufacturer’s 2.8; and
challenges on a set of performance instructions and may not use such tests (D) One control in the range of 3.2 to
testing samples, and, for each individual after the manufacturer’s expiration date. 4.
(v) If a pH screening test is used, an certified laboratory that the specimens (iii) At least one positive control with
initial pH meter test must have the are negative and valid. Licensee testing drug(s) or drug metabolite(s) targeted at
following calibrators and controls when facilities may not retain any information 25 percent below the cutoff;
the screening test result indicates that linking donors to specimens that are (iv) A sufficient number of calibrators
the pH is above the upper decision pooled for use in the internal quality to ensure and document the linearity of
point in use: control program. the assay method over time in the
(A) One calibrator at 7; (3) Licensee testing facilities may concentration area of the cutoff (after
(B) One calibrator at 10; perform multiple initial drug tests for acceptable values are obtained for the
(C) One control in the range of 10 to the same drug or drug class, provided known calibrators, those values will be
10.8; and that all tests meet the cutoffs and quality used to calculate sample data); and
(D) One control in the range of 11.2 (v) At least one positive control,
control requirements of this part. For
to 12. certified to be positive by an HHS-
(3) Oxidizing adulterants. Initial tests example, a licensee testing facility may
certified laboratory, that appears to be a
for oxidizing adulterants must include a use immunoassay technique ‘‘A’’ for all
donor specimen to the laboratory
calibrator at the appropriate cutoff drugs using the licensee’s or other
analysts.
concentration for the compound of entity’s cutoff levels, but specimens (7) Licensee testing facilities shall
interest, a control without the testing positive for amphetamines may document the implementation of
compound of interest (i.e., a certified also be tested using immunoassay procedures to ensure that carryover does
negative control), and a control with at technique ‘‘B’’ to eliminate any possible not contaminate the testing of a donor’s
least one of the compounds of interest positives due to structural analogues; or, specimen.
at a measurable concentration. For a valid analytical result cannot be (f) Errors in testing. Each licensee
nitrite, the licensee testing facility shall obtained using immunoassay technique testing facility shall investigate any
have one control in the range of 200 to ‘‘A’’ and immunoassay technique ‘‘B’’ is testing errors or unsatisfactory
400 mcg/mL, one control in the range of used in an attempt to obtain a valid performance discovered in the testing of
500 to 625 mcg/mL, and a control analytical result. quality control samples, in the testing of
without nitrite (i.e., a certified negative (4) Licensee testing facilities need not actual specimens, or through the
control). assess their false positive testing rates processing of management reviews and/
(4) Other adulterants. Initial tests for for drugs, because all specimens that or MRO reviews, as well as any other
other adulterants must include an test as positive on the initial tests for errors or matters that could adversely
appropriate calibrator, a control without drugs and drug metabolites must be reflect on the licensee testing facility’s
the compound of interest (i.e., a forwarded to an HHS-certified testing process.
certified negative control), and a control laboratory for initial and confirmatory (1) Whenever possible, the
with the compound of interest at a testing. investigation must determine relevant
measurable concentration. (5) To ensure that the rate of false facts and identify the root cause(s) of the
(5) Each analytical run performed to negative drug tests is kept to the testing or process error.
conduct initial validity testing shall minimum that the immunoassay (2) The licensee testing facility shall
include at least one quality control technology supports, licensee testing take action to correct the cause(s) of any
sample that appears to be a donor facilities shall submit to the HHS- errors or unsatisfactory performance
specimen to the laboratory analysts. certified laboratory a minimum of 5 that are within the licensee testing
(6) The licensee testing facility shall percent (or at least one) of the donor facility’s control.
also submit at least one specimen out of specimens screened as negative from (3) If false negative results are
every 10 donor specimens that test every analytical run. obtained in any analytical run from
negative on the initial validity tests testing the quality control samples
(6) A minimum of 10 percent of all
performed by the licensee testing specified in paragraphs (b), (d), and (e)
specimens in each analytical run of
facility to an HHS-certified laboratory as of this section at the licensee testing
specimens to be initially tested for drugs
part of the licensee testing facility’s facility, the licensee testing facility shall
by the licensee testing facility must be
quality assurance program. forward all donor specimens from that
quality control samples, which the
(e) Quality control requirements for analytical run to the HHS-certified
licensee testing facility shall use for
initial drug tests. (1) Any initial drug laboratory for additional testing and
internal quality control purposes.
test performed by a licensee testing implement corrective actions before
(These samples are not forwarded to the
facility must use an immunoassay that resuming testing of donor specimens for
HHS-certified laboratory for further
meets the requirements of the Food and the drug(s), drug metabolite(s),
testing, other than for performance
Drug Administration for commercial adulterant(s), or other specimen
testing of the samples.) Licensee testing
distribution. Licensee testing facilities characteristics (i.e., creatinine, pH)
facilities shall ensure that quality
may not use non-instrumented associated with the quality control
control samples that are positive for
immunoassay testing devices that are sample that yielded the false negative
each drug and metabolite for which the
pending HHS/SAMHSA review and result(s).
FFD program conducts testing are (4) If a donor specimen that yielded
approval for initial drug testing under
included in at least one analytical run negative validity or drug test results at
this part. In addition, licensees and
each calendar quarter. The quality the licensee testing facility yields
other entities may not take management
control samples for each analytical run positive, substituted, adulterated, or
actions on the basis of any drug test
must include— invalid results after confirmatory testing
results obtained from non-instrumented
devices that may be used for validity (i) Sample(s) certified by an HHS- by the HHS-certified laboratory under
screening tests. certified laboratory to contain no drugs paragraphs (b)(3), (d)(6), or (e)(5) of this
or drug metabolites (i.e., negative urine
(2) Licensee testing facilities shall section, the licensee or other entity shall
discard negative specimens or may pool samples); implement corrective actions before
them for use in the licensee testing (ii) At least one positive control with resuming testing of donor specimens for
facility’s internal quality control drug(s) or drug metabolite(s) targeted at the drug(s), drug metabolite(s),
program after certification by an HHS- 25 percent above the cutoff; adulterant(s), or other specimen
characteristics (i.e., creatinine, pH) and, when appropriate, EAP staff and Register on April 11, 1988 (53 FR
associated with the donor specimen that the SAE. 11970), and as amended, June 9, 1994
yielded the false negative result(s). In (c) The licensee testing facility shall (59 FR 29908), November 13,1998 (63
addition to resolving any technical, provide qualified personnel, when FR 63483), and April 13, 2004 (69 FR
methodological, or administrative errors required, to testify in an administrative 19643)] for specimen validity and drug
in the licensee testing facility’s testing or disciplinary proceeding against an testing, except as permitted under
process, the licensee or other entity may individual when that proceeding is § 26.31(d)(3)(ii). Information concerning
re-collect and test specimens from any based on urinalysis results reported by the current certification status of
donor whose test results from the the licensee testing facility. laboratories is available from the
licensee testing facility may have been (d) The licensee testing facility shall Division of Workplace Programs, Center
inaccurate. prepare the information required for the for Substance Abuse Prevention,
(5) A record of the investigative annual report to the NRC, as required in Substance Abuse and Mental Health
findings and the corrective actions § 26.717. Services Administration, Room 815,
taken, where applicable, must be dated (e) The data in the annual report to 5600 Fishers Lane, Rockwall 2 Bldg.,
and signed by the individuals who are the NRC must be presented for either Rockville, Maryland 20857.
responsible for the day-to-day the cutoff levels specified in this part, (b) HHS-certified laboratories shall
management of the licensee testing or for more stringent cutoff levels, if the have the capability, at the same
facility and reported to appropriate FFD program uses more stringent cutoff premises, to perform both initial and
levels of management. levels for drugs and drug metabolites. If confirmatory tests for specimen validity
(g) Accuracy. Volumetric pipettes and the FFD program tests for drugs and and for each drug and drug metabolite
measuring devices must be certified for drug metabolites that are not specified for which the HHS-certified laboratory
accuracy or be checked by gravimetric, in § 26.31(d)(1), the summary must also provides services to the licensee or
colorimetric, or other verification include the number of positive test other entity.
procedure. Automatic pipettes and results and the cutoff levels used for (c) An HHS-certified laboratory may
dilutors must be checked for accuracy those drugs and drug metabolites. not subcontract and shall perform all
and reproducibility before being placed (f) The designated FFD program work with its own personnel and
in service, and periodically thereafter. official shall use the available equipment unless otherwise authorized
(h) Calibrators and controls. information from the licensee testing by the licensee or other entity.
Calibrators and controls must be facility’s validity and drug test results, (d) Licensees and other entities shall
prepared using pure drug reference the results of quality control testing use only HHS-certified laboratories that
materials, stock standard solutions performed at the licensee testing agree to follow the same rigorous
obtained from other laboratories, or facility, and the results from testing the specimen testing, quality control, and
standard solutions that are obtained quality control samples that the licensee chain-of-custody procedures when
from commercial manufacturers and are testing facility submits to the HHS- testing for more stringent cutoff levels as
properly labeled as to content and certified laboratory to evaluate may be specified by licensees and other
concentration. Calibrators and controls continued testing program effectiveness entities for the classes of drugs
may not be prepared from the same and detect any local trends in drugs of identified in this part, and for any other
stock solution. The standards and abuse that may require management substances included in the licensees’ or
controls must be labeled with the action or FFD program adjustments. other entities’ panels.
following dates: when received; when (e) Before awarding a contract to an
FFD program adjustments may include,
prepared or opened; when placed in HHS-certified laboratory, the licensee or
but are not limited to, training
service; and when scheduled for other entity shall ensure that qualified
enhancements, procedure changes, the
expiration. personnel conduct a pre-award
expansion of the FFD program’s drug
inspection and evaluation of the
§ 26.139 Reporting initial validity and drug panel to include additional drugs to be
procedural aspects of the laboratory’s
test results. tested, or changes in the types of assays,
drug testing operations. However, if an
(a) The licensee testing facility shall validity screening tests, or instruments
HHS-certified laboratory loses its
report as negative all specimens that are used.
certification, in whole or in part, a
valid on the basis of validity screening Subpart G—Laboratories Certified by licensee or other entity may
or initial validity tests, or both, and are the Department of Health and Human immediately begin using another HHS-
negative on the initial tests for drugs Services certified laboratory that is being used by
and drug metabolites. Except as another licensee or entity who is subject
permitted under § 26.75(h), positive test § 26.151 Purpose. to this part, as permitted by
results from initial drug tests at the This subpart contains requirements § 26.41(g)(5).
licensee testing facility may not be for the HHS-certified laboratories that (f) All contracts between licensees or
reported to licensee or other entity licensees and other entities who are other entities who are subject to this
management. In addition, the licensee subject to this part use for testing urine part and HHS-certified laboratories must
testing facility may not report results specimens for validity and the presence require the laboratory to implement all
from validity screening or initial of drugs and drug metabolites. applicable requirements of this part. At
validity testing indicating that a a minimum, licensees’ and other
specimen is of questionable validity or § 26.153 Using certified laboratories for entities’ contracts with HHS-certified
positive initial drug test results from testing urine specimens. laboratories must include the following
specimens that are of questionable (a) Licensees and other entities who requirements:
validity. are subject to this part shall use only (1) Laboratory facilities shall comply
(b) Except as provided in §§ 26.37 and laboratories certified under the with the applicable provisions of any
26.75(h), access to the results of initial Department of Health and Human State licensor requirements;
tests must be limited to the licensee Services (HHS) Mandatory Guidelines (2) The laboratory shall make
testing facility’s staff, the MRO and for Federal Workplace Drug Testing available qualified personnel to testify
MRO staff, the FFD program manager, Programs [published in the Federal in an administrative or disciplinary
proceeding against an individual when natural sciences, such as a medical or (6) This individual shall be
that proceeding is based on urinalysis scientific degree with additional responsible for taking all remedial
results reported by the HHS-certified training and laboratory/research actions that may be necessary to
laboratory; experience in biology, chemistry, and maintain satisfactory operation and
(3) The laboratory shall maintain test pharmacology or toxicology; and performance of the laboratory in
records in confidence, consistent with (iv) In addition to the requirements in response to quality control systems not
the requirements of § 26.39, and use paragraphs (a)(1)(i) through (a)(1)(iii) of being within performance
them with the highest regard for this section, the responsible person specifications, including errors in result
individual privacy; shall also have the following minimum reporting or in the analysis of
(4) Consistent with the principles qualifications: performance testing results. This
established in section 503 of Public Law (A) Appropriate experience in individual shall ensure that test results
100–71, any employee of a licensee or analytical forensic toxicology including are not reported until all corrective
other entity who is the subject of a drug experience with the analysis of actions have been taken and he or she
test (or his or her representative biological material for drugs of abuse; can assure that the test results provided
designated under § 26.37(d)) shall, on and are accurate and reliable.
written request, have access to the (B) Appropriate training and/or (b) Certifying scientist. (1) HHS-
laboratory’s records related to his or her experience in forensic applications of certified laboratories shall have one or
validity and drug test and any records analytical toxicology (e.g., publications, more certifying scientists who review all
related to the results of any relevant court testimony, research concerning pertinent data and quality control
certification, review, or revocation-of- analytical toxicology of drugs of abuse, results to certify the laboratory’s test
certification proceedings; or other factors that qualify the results.
(5) The laboratory may not enter into individual as an expert witness in (2) A certifying scientist shall be an
any relationship with the licensee’s or forensic toxicology). individual with at least a bachelor’s
other entity’s MRO(s) that may be (2) This individual shall be engaged degree in the chemical or biological
construed as a potential conflict of in and responsible for the day-to-day sciences, medical technology, or an
interest, including, but not limited to, management of the testing laboratory, equivalent field who reviews all
the relationships described in even if another individual has overall pertinent data and quality control
§ 26.183(b), and may not derive any responsibility for an entire multi- results. The individual shall have
financial benefit by having a licensee or specialty laboratory. training and experience in the theory
(3) This individual shall be and practice of all methods and
other entity use a specific MRO; and
(6) The laboratory shall permit responsible for ensuring that there are procedures used in the laboratory,
representatives of the NRC and any enough personnel with adequate including a thorough understanding of
licensee or other entity using the training and experience to supervise chain-of-custody procedures, quality
laboratory’s services to inspect the and conduct the work of the drug testing control practices, and analytical
laboratory at any time, including laboratory. He or she shall ensure the procedures relevant to the results that
unannounced inspections. continued competency of laboratory the individual certifies. Relevant
(g) If licensees or other entities use a personnel by documenting their in- training and experience must also
form other than the current Federal service training, reviewing their work include the review, interpretation, and
custody-and-control form, licensees and performance, and verifying their skills. reporting of test results; maintenance of
other entities shall provide a (4) This individual shall be chain of custody; and proper remedial
memorandum to the laboratory responsible for ensuring that the action to be taken in response to
explaining why a non-Federal form was laboratory has a manual of standard aberrant test or quality control results,
used, but must ensure, at a minimum, operating procedures that are complete, or a determination that test systems are
that the form used contains all the up-to-date, available for personnel out of control limits.
required information on the Federal performing tests, and followed by those (3) A laboratory may designate
custody-and-control form. personnel. The procedures must be certifying scientists who only certify
reviewed, signed, and dated by this results that are reported negative and
§ 26.155 Laboratory personnel. responsible person whenever the certifying scientists who certify results
(a) Day-to-day management of the procedures are first placed into use or that are reported both negative and
HHS-certified laboratory. HHS-certified changed or when a new individual adulterated, substituted, dilute, or
laboratories shall have a responsible assumes responsibility for management invalid.
person to assume professional, of the laboratory. This individual shall (c) Day-to-day operations and
organizational, educational, and ensure that copies of all procedures and supervision of analysts. HHS-certified
administrative responsibility for the records of the dates on which they are laboratories shall assign one or more
laboratory’s drug testing facilities. in effect are maintained. (Specific individuals who are responsible for day-
(1) This individual shall have contents of the procedures are described to-day operations and supervision of the
documented scientific qualifications in in § 26.157.) technical analysts. The designated
analytical forensic toxicology. Minimum (5) This individual shall be individual(s) shall have at least a
qualifications are as follows: responsible for maintaining a quality bachelor’s degree in the chemical or
(i) Certification by the appropriate assurance program to assure the proper biological sciences, medical technology,
State as a laboratory director in forensic performance and reporting of all test or an equivalent field. The individual(s)
or clinical laboratory toxicology; or results; maintaining acceptable shall also have training and experience
(ii) A PhD in one of the natural analytical performance for all controls in the theory and practice of the
sciences with an adequate and standards; maintaining quality procedures used in the laboratory,
undergraduate and graduate education control testing; and assuring and resulting in his or her thorough
in biology, chemistry, and documenting the validity, reliability, understanding of quality control
pharmacology or toxicology; or accuracy, precision, and performance practices and procedures; review,
(iii) Training and experience characteristics of each test and test interpretation, and reporting of test
comparable to a Ph.D. in one of the system. results; maintenance of the chain of
custody; and proper remedial actions to (3) Instructions for major specimens may not be tested and the
be taken in response to aberrant test or troubleshooting and repair. licensee or other entity shall ensure that
quality control results, or the finding (e) HHS-certified laboratories shall another collection occurs as soon as
that test systems are out of control develop, implement, and maintain reasonably practical, except if a split
limits. written procedures for remedial actions specimen collection was performed,
(d) Other personnel. Other to be taken when errors are detected or either the Bottle A or Bottle B seal
technicians or nontechnical staff shall systems are out of acceptable limits. remains intact, and the intact specimen
have the necessary training and skills The laboratory shall maintain contains at least 15 mL of urine. In this
for their assigned tasks. documentation that its personnel follow instance, if the licensee testing facility
(e) Training. HHS-certified these procedures and take all necessary has retained the specimen in Bottle B,
laboratories shall make available corrective actions. In addition, the the licensee testing facility shall forward
continuing education programs to meet laboratory shall have systems in place to the intact specimen for testing to the
the needs of laboratory personnel. verify all stages of testing and reporting HHS-certified laboratory and may not
(f) Files. At a minimum, each and to document the verification. conduct any testing at the licensee
laboratory personnel file must include a testing facility.
résumé, any professional certification(s) § 26.159 Assuring specimen security,
chain of custody, and preservation. (2) The following are exclusive
or license(s), a job description, and grounds requiring the MRO to cancel
documentation to show that the (a) The HHS-certified laboratories
the testing of a donor’s urine specimen:
individual has been properly trained to performing services for licensees and
(i) The custody-and-control form does
perform his or her job. other entities under this part shall be
not contain information to identify the
secure at all times. Each laboratory shall
specimen collector and the collection
§ 26.157 Procedures. have in place sufficient security
site cannot provide conclusive evidence
(a) HHS-certified laboratories shall measures to control access to the
of the collector’s identity;
develop, implement, and maintain clear premises and to ensure that no
unauthorized personnel handle (ii) The identification numbers on the
and well-documented procedures for specimen bottle seal(s) do not match the
accession, receipt, shipment, and testing specimens or gain access to the
laboratory processes or areas where identification numbers on the custody-
of urine specimens. and-control form;
(b) Written chain-of-custody records are stored. Access to these
secured areas must be limited to (iii) A specimen bottle seal is broken
procedures must describe the methods or shows evidence of tampering and an
to be used to maintain control and specially authorized individuals whose
authorization is documented. All intact specimen, as specified in
accountability of specimens from paragraph (b)(1)(ii) of this section, does
receipt through completion of testing authorized visitors, and maintenance
and service personnel, shall be escorted not exist;
and reporting of results, during storage
at all times in the laboratory, except (iv) The specimen appears to have
and shipping to another HHS-certified
personnel who are authorized to leaked out of its sealed bottle and there
laboratory, if required, and continuing
conduct inspections and audits on is less than 15 mL remaining, and an
until final disposition of specimens.
behalf of licensees, other entities, the intact specimen, as specified in
(c) HHS-certified laboratories shall
NRC, or the HHS Secretary, and paragraph (b)(1)(ii) of this section, does
develop, implement, and maintain a
emergency personnel (including but not not exist; or
written manual of standard operating
limited to firefighters and medical (v) As required under § 26.165(f)(2).
procedures for each assay performed for
rescue teams). (c) The HHS-certified laboratory shall
licensees and other entities for drug and
(b) When a shipment of specimens is retain specimen bottles within the
specimen validity testing. The
received, laboratory personnel shall laboratory’s accession area until all
procedures must include, but are not
inspect each package for evidence of analyses have been completed.
limited to, detailed descriptions of—
(1) The principles of each test; possible tampering and shall compare Laboratory personnel shall use aliquots
(2) Preparation of reagents, standards, information on specimen bottles within and laboratory internal custody-and-
and controls; each package to the information on the control forms when conducting initial
(3) Calibration procedures; accompanying custody-and-control and confirmatory tests. The original
(4) Derivation of results; forms. specimen and the original custody-and-
(5) Linearity of methods; (1) Any direct evidence of tampering control form must remain in secure
(6) Sensitivity of the methods; or discrepancies in the information on storage.
(7) Cutoff values; the specimen bottles and the custody- (d) The laboratory’s internal custody-
(8) Mechanisms for reporting results; and-control forms attached to the and-control form must allow for
(9) Controls; shipment must be reported to the identification of the donor, and
(10) Criteria for unacceptable licensee or other entity within 24 hours documentation of the testing process
specimens and results; of the discovery and must be noted on and transfers of custody of the
(11) Reagents and expiration dates; the custody-and-control forms for each specimen.
and specimen contained in the package. (e) Each time a specimen is handled
(12) References. When notified, the licensee or other or transferred within the laboratory,
(d) HHS-certified laboratories shall entity shall ensure that an investigation laboratory personnel shall document the
develop, implement, and maintain is initiated to determine whether date and purpose on the custody-and-
written procedures for instrument setup tampering has occurred. control form and every individual in the
and normal operation, including the (i) If the investigation determines that chain shall be identified. Authorized
following: tampering has occurred, the licensee or technicians are responsible for each
(1) A schedule for checking critical other entity shall ensure that corrective urine specimen or aliquot in their
operating characteristics for all actions are taken. possession and shall sign and complete
instruments; (ii) If the licensee or other entity has custody-and-control forms for those
(2) Tolerance limits for acceptable reason to question the integrity and specimens or aliquots as they are
function checks; and identity of the specimens, the received.
(f) If a specimen is to be transferred specimens are negative and valid. The initial test on the first aliquot and a
to a second HHS-certified laboratory, laboratory may not retain any different confirmatory test (e.g., multi-
laboratory personnel shall ensure that a information linking donors to wavelength spectrophotometry, ion
copy of the custody-and-control form is specimens that are pooled for use in the chromatography, capillary
packaged with the aliquot of a single internal quality control program. electrophoresis) on the second aliquot;
specimen or Bottle B of a split (3) The presence of chromium (VI) is
specimen, as appropriate. Sealed and § 26.161 Cutoff levels for validity testing.
verified using either a general oxidant
labeled specimen bottles and aliquots, (a) Validity test results. Each validity colorimetric test (with a cutoff equal to
with their associated custody-and- test result for a specimen that the HHS- or greater than 50 mcg/mL chromium
control forms, being transferred from certified laboratory reports to the MRO (VI)-equivalents) or a chromium (VI)
one laboratory to another must be as adulterated, substituted, dilute, or colorimetric test (chromium (VI)
placed in a second, tamper-evident invalid must be based on performing an concentration equal to or greater than 50
shipping container designed to initial validity test on one aliquot and mcg/mL) for the initial test on the first
minimize the possibility of damage to a confirmatory validity test on a second aliquot and a different confirmatory test
the specimen during shipment (e.g., aliquot. Licensees and other entities (e.g., multi-wavelength
specimen boxes, padded mailers, or shall ensure that the HHS-certified spectrophotometry, ion
bulk insulated shipping containers with laboratory is capable of conducting, and chromatography, atomic absorption
that capability) so that the contents of conducts, confirmatory testing for at spectrophotometry, capillary
the shipping containers are inaccessible least one oxidizing adulterant and any electrophoresis, inductively coupled
without breaking a tamper-evident seal. other adulterants specified by the plasma-mass spectrometry) with the
(g) Couriers, express carriers, and licensee’s or other entity’s testing chromium (VI) concentration equal to or
postal service personnel do not have program. If initial validity test results greater than the LOD of the confirmatory
direct access to the custody-and-control indicate that the specimen is valid test on the second aliquot;
forms or the specimen bottles. under the criteria in paragraphs (c) (4) The presence of halogen (e.g.,
Therefore, such personnel are not through (f) of this section, the HHS- bleach, iodine, fluoride) is verified
required to document chain of custody certified laboratory need not perform using either a general oxidant
on the custody-and-control forms during confirmatory validity testing of the colorimetric test (with a cutoff equal to
transit. Custody accountability of the specimen. or greater than 200 mcg/mL nitrite-
shipping containers during shipment (b) Initial validity testing. The HHS- equivalents or a cutoff equal to or
must be maintained by a tracking certified laboratory shall perform initial greater than 50 mcg/mL chromium (VI)-
system provided by the courier, express validity testing of each specimen as equivalents) or a halogen colorimetric
carrier, or postal service. follows:
(h) Specimens that do not receive an test (halogen concentration equal to or
(1) Determine the creatinine greater than the LOD) for the initial test
initial test within 7 days of arrival at the concentration;
laboratory must be placed in secure on the first aliquot and a different
(2) Determine the specific gravity of
refrigeration units for short-term storage. confirmatory test (e.g., multi-wavelength
every specimen for which the creatinine
Temperatures may not exceed 6 °C spectrophotometry, ion
concentration is less than 20 mg/dL;
(42.8 °F). The laboratory shall ensure chromatography, inductively coupled
(3) Determine the pH;
proper storage conditions in the event of (4) Perform one or more initial plasma-mass spectrometry) with a
a prolonged power failure. validity tests for oxidizing adulterants; specific halogen concentration equal to
(i) Long-term frozen storage at a and or greater than the LOD of the
temperature of ¥20 °C (¥68 °F) or less (5) Perform additional validity tests, confirmatory test on the second aliquot;
ensures that positive, adulterated, the choice of which depends on the (5) The presence of glutaraldehyde is
substituted, and invalid urine observed indicators or characteristics verified using either an aldehyde test
specimens and Bottle B of a split below, when the following conditions (aldehyde present) or the specimen
specimen will be available for any are observed: yields the characteristic immunoassay
necessary retests. Unless otherwise (i) Abnormal physical characteristics; response on one or more drug
authorized in writing by the licensee or (ii) Reactions or responses immunoassay tests for the initial test on
other entity, laboratories shall retain characteristic of an adulterant obtained the first aliquot and gas
and place in properly secured long-term during initial or confirmatory drug tests chromatography/mass spectrometry
frozen storage all specimens reported as (e.g., non-recovery of internal standards, (GC/MS) for the confirmatory test with
positive, adulterated, substituted, or unusual response); or the glutaraldehyde concentration equal
invalid. At a minimum, such specimens (iii) Possible unidentified interfering to or greater than the LOD of the
must be stored for 1 year. Within this 1- substance or adulterant. analysis on the second aliquot;
year period, a licensee, other entity, or (c) Results indicating an adulterated (6) The presence of pyridine
the NRC may ask the laboratory to retain specimen. The laboratory shall report a (pyridinium chlorochromate) is verified
the specimen for an additional period of specimen as adulterated when the using either a general oxidant
time. If no retention request is received, specimen yields any one or more of the colorimetric test (with a cutoff equal to
the laboratory may discard the specimen following validity testing results: or greater than 200 mcg/mL nitrite-
after the end of 1 year. However, the (1) The pH is less than 3, or equal to equivalents or a cutoff equal to or
laboratory shall retain any specimens or greater than 11, using either a pH greater than 50 mcg/mL chromium (VI)-
under review or legal challenge until meter or a colorimetric pH test for the equivalents) or a chromium (VI)
they are no longer needed. initial test on the first aliquot and a pH colorimetric test (chromium (VI)
(j) The laboratory shall discard a valid meter for the confirmatory test on the concentration equal to or greater than 50
specimen that tests negative on initial or second aliquot; mcg/mL) for the initial test on the first
confirmatory drug tests or may pool (2) The nitrite concentration is equal aliquot and GC/MS for the confirmatory
such specimens for use in the to or greater than 500 mcg/mL using test with the pyridine concentration
laboratory’s internal quality control either a nitrite colorimetric test or a equal to or greater than the LOD of the
program after certifying that the general oxidant colorimetric test for the analysis on the second aliquot;
(7) The presence of a surfactant is nitrite colorimetric test, or equal to or collection is used) are clearly different,
verified by using a surfactant greater than the equivalent of 200 mcg/ and either the test result for Bottle A
colorimetric test with a cutoff equal to mL nitrite using a general oxidant indicated it is an invalid specimen or
or greater than 100 mcg/mL colorimetric test for both the initial test the specimen in Bottle A was screened
dodecylbenzene sulfonate-equivalent for and the confirmatory test, or, using negative for drugs, or both.
the initial test on the first aliquot and a either initial test, the nitrite (g) Additional testing by a second
different confirmatory test (e.g., multi- concentration is equal to or greater than laboratory. If the presence of an
wavelength spectrophotometry) with a 200 mcg/mL but less than 500 mcg/mL interfering substance/adulterant is
cutoff equal to or greater than 100 mcg/ using a different confirmatory test (e.g., suspected that could make a test result
mL dodecylbenzene sulfonate multi-wavelength spectrophotometry, invalid, but it cannot be identified (e.g.,
equivalent on the second aliquot; or ion chromatography, capillary a new adulterant), laboratory personnel
(8) The presence of any other electrophoresis) on two separate shall consult with the licensee’s or other
adulterant not specified in paragraphs aliquots; entity’s MRO and, with the MRO’s
(c)(3) through (c)(7) of this section is (4) The possible presence of agreement, shall send the specimen to
verified using an initial test on the first chromium (VI) is determined using the another HHS-certified laboratory that
aliquot and a different confirmatory test same chromium (VI) colorimetric test has the capability to identify the
on the second aliquot. with a cutoff equal to or greater than 50 suspected substance.
(d) Results indicating a substituted mcg/mL chromium (VI) for both the (h) More stringent validity test cutoff
specimen. The laboratory shall report a initial test and the confirmatory test on levels are prohibited. Licensees and
specimen as substituted when the two separate aliquots; other entities may not specify more
specimen’s creatinine concentration is (5) The possible presence of a halogen stringent cutoff levels for validity tests
less than 2 mg/dL and its specific (e.g., bleach, iodine, fluoride) is than those specified in this section.
gravity is less than or equal to 1.0010, determined using the same halogen
or equal to or greater than 1.0200, on colorimetric test with a cutoff equal to § 26.163 Cutoff levels for drugs and drug
both the initial and confirmatory or greater than the LOD for both the metabolites.
creatinine tests (i.e., the same initial test and the confirmatory test on (a) Initial drug testing. (1) HHS-
colorimetric test may be used to test two separate aliquots or relying on the certified laboratories shall apply the
both aliquots) and on both the initial odor of the specimen as the initial test; following cutoff levels for initial testing
and confirmatory specific gravity tests (6) The possible presence of of specimens to determine whether they
(i.e., a refractometer is used to test both glutaraldehyde is determined using the are negative for the indicated drugs and
aliquots) on two separate aliquots. same aldehyde test (aldehyde present) drug metabolites, except if validity
(e) Results indicating a dilute or the characteristic immunoassay testing indicates that the specimen is
specimen. The laboratory shall report a response is observed on one or more dilute or the licensee or other entity has
specimen as dilute when the specimen’s drug immunoassay tests for both the established more stringent cutoff levels:
creatinine concentration is equal to or initial test and the confirmatory test on
greater than 2 mg/dL but less than 20 two separate aliquots; INITIAL TEST CUTOFF LEVELS FOR
mg/dL and its specific gravity is greater (7) The possible presence of an DRUGS AND DRUG METABOLITES
than 1.0010 but less than 1.0030 on a oxidizing adulterant is determined by
single aliquot. using the same general oxidant Cutoff level
(f) Results indicating an invalid colorimetric test (with cutoffs equal to Drug or metabolites [nanograms
specimen. The laboratory shall report a (ng)/mL]
or greater than 200 mcg/mL nitrite-
specimen as invalid when the laboratory equivalents, equal to or greater than 50 Marijuana metabolites .......... 50
obtains any one or more of the following mcg/mL chromium (VI)-equivalents, or Cocaine metabolites ............. 300
validity testing results: a halogen concentration equal to or Opiate metabolites ................ 2000
(1) Inconsistent creatinine greater than the LOD) for both the initial Phencyclidine (PCP) ............. 25
concentration and specific gravity test and the confirmatory test on two Amphetamines ...................... 1000
results are obtained (i.e., the creatinine separate aliquots;
concentration is less than 2 mg/dL on (8) The possible presence of a (2) At the licensee’s or other entity’s
both the initial and confirmatory surfactant is determined using the same discretion, as documented in the FFD
creatinine tests and the specific gravity surfactant colorimetric test with a cutoff program policies and procedures, the
is greater than 1.0010 but less than equal to or greater than 100 mcg/mL licensee or other entity may require the
1.0200 on the initial and/or dodecylbenzene sulfonate-equivalent for HHS-certified laboratory to conduct
confirmatory specific gravity test, the both the initial test and the confirmatory special analyses of dilute specimens as
specific gravity is less than or equal to test on two separate aliquots or a foam/ follows:
1.0010 on both the initial and shake test for the initial test; (i) If initial validity testing indicates
confirmatory specific gravity tests and (9) Interference occurs on the that a specimen is dilute, the HHS-
the creatinine concentration is equal to immunoassay drug tests on two separate certified laboratory shall compare the
or greater than 2 mg/dL on either or aliquots (i.e., valid immunoassay drug responses of the dilute specimen to the
both the initial or confirmatory test results cannot be obtained); cutoff calibrator in each of the drug
creatinine tests); (10) Interference with the drug classes;
(2) The pH is equal to or greater than confirmation assay occurs on at least (ii) If any response is equal to or
3 and less than 4.5, or equal to or greater two separate aliquots of the specimen, greater than 50 percent of the cutoff, the
than 9 and less than 11, using either a and the laboratory is unable to identify HHS-certified laboratory shall conduct
colorimetric pH test or pH meter for the the interfering substance; confirmatory testing of the specimen
initial test and a pH meter for the (11) The physical appearance of the down to the LOD for those drugs and/
confirmatory test on two separate specimen indicates that testing may or drug metabolites; and
aliquots; damage the laboratory’s equipment; or (iii) The laboratory shall report the
(3) The nitrite concentration is equal (12) The physical appearances of numerical values obtained from this
to or greater than 200 mcg/mL using a Bottles A and B (when a split specimen special analysis to the MRO.
(b) Confirmatory drug testing. (1) A confirmatory testing, if required, of the office and the answering machine was
specimen that is identified as positive specimen in Bottle A. not working), or other circumstances
on an initial drug test must be subject (3) At the licensee’s or other entity’s unavoidably prevented the donor from
to confirmatory testing for the class(es) discretion, Bottle B must either be making a timely request. If the MRO
of drugs for which the specimen forwarded to the HHS-certified concludes from the donor’s information
initially tested positive. The HHS- laboratory or maintained in secure that there was a legitimate reason for the
certified laboratory shall apply the storage at the licensee testing facility, as donor’s failure to contact the MRO
confirmatory cutoff levels specified in required by § 26.135(a) and (c), as within the 3 business days permitted,
this paragraph, except if the licensee or applicable. If the specimen in Bottle A the MRO shall direct the retesting of an
other entity requires the special analysis is free of any evidence of drugs or drug aliquot of the single specimen or the test
of dilute specimens permitted in metabolites, and is a valid specimen, of the split specimen (Bottle B) take
paragraph (a)(2) of this section or the then the licensee testing facility or HHS- place, as if the donor had made a timely
licensee or other entity has established certified laboratory may discard the request.
more stringent cutoff levels. specimens in Bottles A and B. (5) As soon as reasonably practical
(b) Donor request to MRO for a retest and not more than 1 business day
CONFIRMATORY TEST CUTOFF LEVELS of a single specimen or testing Bottle B following the day of the donor’s request,
FOR DRUGS AND DRUG METABOLITES of a split specimen. (1) For a confirmed as permitted in paragraph (b)(3) or (b)(4)
positive, adulterated, or substituted of this section, the MRO shall ensure
Cutoff result reported on a single specimen of that the HHS-certified laboratory
Drug or metabolites level 30 mL or more, or a specimen in Bottle forwards an aliquot of a single
(ng/mL) A of a split specimen which the donor specimen, or that the HHS-certified
submitted to the licensee or other entity, laboratory (or licensee testing facility, as
Marijuana metabolite1 ................... 15 a donor may request (through the MRO) appropriate) forwards Bottle B of a split
Cocaine metabolite 2 ..................... 150
that an aliquot from the single specimen specimen, to a second HHS-certified
Opiates:
Morphine ................................ 2000
or the split (Bottle B) specimen be tested laboratory that did not test the specimen
Codeine ................................. 2000 by a second HHS-certified laboratory to in Bottle A.
6-acetylmorphine 3 ................. 10 verify the result reported by the first (6) The HHS-certified laboratory that
Phencyclidine (PCP) ..................... 25 laboratory. For an invalid test result, a retests an aliquot of a single specimen
Amphetamines: donor may not request that an aliquot or tests the specimen in Bottle B shall
Amphetamine ........................ 500 from the single specimen or the split provide quantitative test results to the
Methamphetamine 4 ............... 500 specimen in Bottle B be tested by a MRO and the MRO shall provide them
1 As delta-9-tetrahydrocannabinol-9-car- second HHS-certified laboratory. to the donor.
boxylic acid. (2) The MRO shall inform the donor (c) Retesting a specimen for drugs. (1)
2 As benzoylecgonine. that he or she may, within 3 business The second laboratory shall use its
3 Test for 6–AM when the confirmatory test
days of notification by the MRO of the confirmatory drug test when retesting an
shows a morphine concentration exceeding confirmed positive, adulterated, or
2,000 ng/mL. aliquot of a single specimen or testing
4 Specimen must also contain amphetamine substituted test result, request the Bottle B of a split specimen for the
at a concentration equal to or greater than 200 retesting of an aliquot of the single drug(s) or drug metabolite(s) for which
ng/mL. specimen or the testing of the Bottle B the first laboratory reported a positive
(2) Each confirmatory drug test must split specimen. The MRO shall provide result(s), including retesting specimens
provide a quantitative result. When the the donor with specific instructions for that have been subject to the special
concentration of a drug or metabolite making this request (i.e., providing analysis permitted in § 26.163(a)(2).
exceeds the linear range of the standard telephone numbers or other contact (2) Because some drugs or drug
curve, the laboratory may record the information). The MRO shall have the metabolites may deteriorate during
result as ‘‘exceeds the linear range of the ability to receive the donor’s calls at all storage, the retest by the second
test’’ or as ‘‘equal to or greater than times during the 3-day period (e.g., by laboratory is not subject to a specific
<insert the value for the upper limit of use of an answering machine with a drug cutoff level, but must provide data
the linear range>,’’ or may dilute an ‘‘time stamp’’ feature when there is no sufficient to reconfirm the presence of
aliquot of the specimen to obtain an one in the MRO’s office to answer the the drug(s) or drug metabolite(s) down
accurate quantitative result when the phone). The donor’s request may be oral to the assay’s LOD.
concentration is above the upper limit or in writing. (3) If the second laboratory fails to
of the linear range. (3) The donor shall provide his or her reconfirm the presence of the drug(s) or
permission for retesting an aliquot of the drug metabolite(s) for which the first
§ 26.165 Testing split specimens and single specimen or the testing of Bottle laboratory reported a positive result(s),
retesting single specimens. B. Neither the licensee, MRO, NRC, nor the second laboratory shall attempt to
(a) Testing split specimens. (1) If a any other entity may order retesting of determine the reason for not
specimen has been split into Bottle A the single specimen or testing of the reconfirming the first laboratory’s
and Bottle B at the collection site, and specimen in Bottle B without the findings by conducting specimen
the specimen was not initially tested at donor’s written permission, except as validity tests. The second laboratory
a licensee testing facility, then the HHS- permitted in § 26.185(l). shall conduct the same specimen
certified laboratory shall perform initial (4) If the donor has not requested a validity tests it would conduct on a
and confirmatory validity and drug retest of an aliquot of a single specimen single specimen or the specimen in
testing, if required, of the specimen in or a test of the split specimen (Bottle B) Bottle A of a split specimen.
Bottle A. within 3 business days, the donor may (4) The second laboratory shall report
(2) If a specimen was initially tested present to the MRO information all results to the licensee’s or other
at a licensee testing facility and positive documenting that serious injury, illness, entity’s MRO.
or questionable validity test results were lack of actual notice of the confirmed (d) Retesting a specimen for
obtained, then the HHS-certified test result, inability to contact the MRO adulterants. A second laboratory shall
laboratory shall perform initial and (e.g., there was no one in the MRO’s use the required confirmatory validity
test and criteria in § 26.161(c) to (iv) Shall provide the tested Periodic re-verification of analytical
reconfirm an adulterant result when individual with a written statement that procedures is required. Quality
retesting an aliquot from a single the records specified in §§ 26.713 and assurance procedures must be designed,
specimen or when testing Bottle B of a 26.715 have not been retained and shall implemented, and reviewed to monitor
split specimen. The second laboratory inform the individual in writing that the the conduct of each step of the testing
may only conduct the confirmatory temporary administrative action that process.
validity test needed to reconfirm the was taken will not be disclosed and (b) Calibrators and controls required.
adulterant result reported by the first need not be disclosed by the individual Each analytical run of specimens for
laboratory. in response to requests for self- which an initial or confirmatory validity
(e) Retesting a specimen for disclosure of potentially disqualifying test, or an initial or confirmatory drug
substitution. A second laboratory shall FFD information. test, is being performed must include
use its confirmatory creatinine and (2) If a donor requests that Bottle B be the appropriate calibrators and controls.
confirmatory specific gravity tests, when tested or that an aliquot of a single (c) Quality control requirements for
retesting an aliquot of a single specimen specimen be retested, and either Bottle performing initial and confirmatory
or testing Bottle B of a split specimen, B or the single specimen are not validity tests. (1) Requirements for
to reconfirm that the creatinine available due to circumstances outside performing creatinine tests:
concentration was less than 2 mg/dL of the donor’s control (including, but (i) The creatinine concentration must
and the specific gravity was less than or not limited to, circumstances in which be measured to one decimal place on
equal to 1.0010 or equal to or greater there is an insufficient quantity of the both the initial and the confirmatory
than 1.0200. The second laboratory may single specimen or the specimen in creatinine tests;
only conduct the confirmatory Bottle B to permit retesting, either Bottle (ii) The initial creatinine test must
creatinine and specific gravity tests to B or the original single specimen is lost have a calibrator at 2 mg/dL;
reconfirm the substitution result in transit to the second HHS-certified (iii) The initial creatinine test must
reported by the first laboratory. laboratory, or Bottle B has been lost at have a control in the range of 1 to 1.5
(f) Management actions and the HHS-certified laboratory or licensee mg/dL, a control in the range of 3 to 20
sanctions. (1) If the MRO confirms a testing facility), the MRO shall cancel mg/dL, and a control in the range of 21
positive, adulterated, or substituted test the test and inform the licensee or other to 25 mg/dL; and
result(s) from the first HHS-certified entity that another collection is required (iv) The confirmatory creatinine test
laboratory and the donor requests under direct observation as soon as (performed on those specimens with a
testing of Bottle B of a split specimen or reasonably practical. The licensee or creatinine concentration less than 2 mg/
other entity shall eliminate from the dL on the initial test) must have a
retesting of an aliquot from a single
donor’s personnel and other records any calibrator at 2 mg/dL, a control in the
specimen, the licensee or other entity
matter that could link the donor to the range of 1.0 to 1.5 mg/dL, and a control
shall administratively withdraw the
original positive, adulterated, or in the range of 3 to 4 mg/dL.
individual’s authorization on the basis
substituted test result(s) and any (2) Requirements for performing
of the first confirmed positive,
temporary administrative action, and specific gravity tests:
adulterated, or substituted test result
may not impose any sanctions on the (i) The refractometer must report and
until the results of testing Bottle B or
donor for a cancelled test. If test results display the specific gravity to four
retesting an aliquot of the single
from the second specimen collected are decimal places, and must be interfaced
specimen are available and have been
positive, adulterated, or substituted and with a laboratory information
reviewed by the MRO. If the MRO
the MRO determines that the donor has management system, or computer, and/
reports that the results of testing Bottle
violated the FFD policy, the licensee or or generate a hard copy or digital
B or retesting the aliquot of a single
other entity shall impose the electronic display to document the
specimen reconfirm any of the original
appropriate sanctions specified in numerical result;
positive, adulterated, or substituted test
subpart D of this part, but may not (ii) The initial and confirmatory
result(s), the licensee or other entity
consider the original confirmed specific gravity tests must have a
shall impose the appropriate sanctions
positive, adulterated, or substituted test calibrator or control at 1.0000; and
specified in subpart D. If the results of (iii) The initial and confirmatory
result in determining the appropriate
testing Bottle B or retesting the aliquot specific gravity tests must have the
sanctions.
of a single specimen are negative, the following controls:
licensee or other entity— § 26.167 Quality assurance and quality (A) One control targeted at 1.0020;
(i) May not impose any sanctions on control. (B) One control in the range of 1.0040
the individual; (a) Quality assurance program. Each to 1.0180; and
(ii) Shall eliminate from the donor’s HHS-certified laboratory shall have a (C) One control equal to or greater
personnel file and other records any quality assurance program that than 1.0200 but not greater than 1.0250.
matter that could link the individual to encompasses all aspects of the testing (3) Requirements for performing pH
the temporary administrative action; process, including, but not limited to, tests:
(iii) May not disclose the temporary specimen accessioning, chain of (i) Colorimetric pH tests that have the
administrative action in response to a custody, security and reporting of dynamic range of 2 to 12 to support the
suitable inquiry conducted under the results, initial and confirmatory testing, 3 and 11 pH cutoffs and pH meters must
provisions of § 26.63 or to any other certification of calibrators and controls, be capable of measuring pH to one
inquiry or investigation required in this and validation of analytical procedures. decimal place. Dipsticks, colorimetric
chapter. To ensure that no records have The performance characteristics (e.g., pH tests, and pH paper that have a
been retained, access to the system of accuracy, precision, LOD, limit of narrow dynamic range and do not
files and records must be provided to quantitation (LOQ), specificity) of each support the 2 to 12 pH cutoffs may be
personnel conducting reviews, inquiries test must be validated and documented used only to determine whether initial
into allegations, or audits under the for each test. Validation of procedures validity tests must be performed;
provisions of § 26.41, or to NRC must document that carryover does not (ii) At a minimum, pH screening tests
inspectors; and affect the donor’s specimen results. must have the following controls:
(A) One control below the lower interest at a measurable concentration; used in an attempt to obtain a valid
decision point in use; and analytical result.
(B) One control between the decision (ii) A confirmatory test for a specific (3) Quality control samples for each
points in use; and oxidizing adulterant must use a analytical run of specimens for initial
(C) One control above the upper different analytical method than that testing must include—
decision point in use; used for the initial test. Each (i) Sample(s) certified to contain no
(iii) If a pH screening test is not used, confirmatory analytical run must drugs or drug metabolites (i.e., negative
an initial pH meter test must have the include a calibrator at the appropriate urine samples);
following calibrators and controls: cutoff concentration for the compound (ii) At least one positive control with
(A) One calibrator at 4; of interest as specified in § 26.161(c) a drug(s) or drug metabolite(s) targeted
(B) One calibrator at 7; and (f), a control without the compound at 25 percent above the cutoff;
(C) One calibrator at 10; of interest (i.e., a certified negative (iii) At least one positive control with
(D) One control in the range of 2 to control), and a control with the a drug(s) or drug metabolite(s) targeted
2.8; compound of interest at a measurable at 25 percent below the cutoff;
(E) One control in the range of 3.2 to concentration. (iv) A sufficient number of calibrators
4; (5) Requirements for performing to ensure and document the linearity of
(F) One control in the range of 10 to nitrite tests: The initial and the assay method over time in the
10.8; and confirmatory nitrite tests must have a concentration area of the cutoff (after
(G) One control in the range of 11.2 calibrator at the cutoff concentration, a acceptable values are obtained for the
to 12; control without nitrite (i.e., certified known calibrators, those values will be
(iv) If a pH screening test is used, an negative urine specimen), one control in used to calculate sample data); and
initial or confirmatory pH meter test the range of 200 to 400 mcg/mL, and (v) At least one control that appears
must have the following calibrators and one control in the range of 500 to 625 to be a donor specimen to the laboratory
controls when the screening result mcg/mL. analysts.
indicates that the pH is below the lower (6) Requirements for performing (4) A minimum of 10 percent of the
decision point in use: ‘‘other’’ adulterant tests: total specimens in each analytical run
(A) One calibrator at 4; (i) The initial and confirmatory tests must be quality control samples, as
(B) One calibrator at 7; for any ‘‘other’’ adulterant that may be defined by paragraphs (d)(3)(i) through
(C) One control in the range of 2 to identified in the future must satisfy the (iv) of this section.
2.8; and requirements in § 26.161(a); (e) Quality control requirements for
(D) One control in the range of 3.2 to (ii) The confirmatory test for ‘‘other’’ performing confirmatory drug tests. (1)
4; adulterants must use a different Confirmatory tests for drugs and drug
(v) If a pH screening test is used, an analytical principle or chemical reaction metabolites must be performed using
initial or confirmatory pH meter test than that used for the initial test; and gas chromatography/mass spectrometry
must have the following calibrators and (iii) The initial and confirmatory tests (GC/MS) or other confirmatory test
controls when the screening result for ‘‘other’’ adulterants must include an methodologies that HHS-certified
indicates that the pH is above the upper appropriate calibrator, a control without laboratories are permitted to use in
decision point in use: the compound of interest (i.e., a Federal workplace drug testing
(A) One calibrator at 7; certified negative control), and a control programs for this purpose.
(B) One calibrator at 10; with the compound of interest at a (2) At least 10 percent of the samples
(C) One control in the range of 10 to measurable concentration. in each analytical run of specimens
10.8; and (d) Quality control requirements for must be calibrators and controls.
(D) One control in the range of 11.2 performing initial drug tests. (1) Any (3) Each analytical run of specimens
to 12; and initial drug test performed by an HHS- that are subjected to confirmatory
(vi) An initial colorimetric pH test certified laboratory must use an testing must include—
must have the following calibrators and immunoassay that meets the (i) Sample(s) certified to contain no
controls: requirements of the Food and Drug drug (i.e., negative urine samples);
(A) One calibrator at 3; Administration for commercial (ii) Positive calibrator(s) and
(B) One calibrator at 11; distribution. Non-instrumented control(s) with a drug(s) or drug
(C) One control in the range of 2 to immunoassay testing devices that are metabolite(s);
2.8; pending HHS/SAMHSA review and (iii) At least one positive control with
(D) One control in the range of 3.2 to approval may not be used for initial a drug(s) or drug metabolite(s) targeted
4; drug testing under this part. at 25 percent above the cutoff; and
(E) One control in the range of 4.5 to (2) HHS-certified laboratories may (iv) At least one calibrator or control
9; perform multiple initial drug tests for that is targeted at or below 40 percent
(F) One control in the range of 10 to the same drug or drug class, provided of the cutoff.
10.8; that all tests meet the cutoffs and quality (f) Errors in testing. The licensee or
(G) One control in the range of 11.2 control requirements of this part. For other entity shall ensure that the HHS-
to 12. example, an HHS-certified laboratory certified laboratory investigates any
(4) Requirements for performing may use immunoassay technique ‘‘A’’ testing errors or unsatisfactory
oxidizing adulterant tests: for all drugs using the licensee’s or other performance discovered in blind
(i) Initial tests for oxidizing entity’s cutoff levels, but specimens performance testing, as required under
adulterants must include a calibrator at testing positive for amphetamines may § 26.168, in the testing of actual
the appropriate cutoff concentration for also be tested using immunoassay specimens, or through the processing of
the compound of interest as specified in technique ‘‘B’’ to eliminate any possible reviews, as well as any other errors or
§ 26.161(c) and (f), a control without the positives due to structural analogues; or, matters that could adversely reflect on
compound of interest (i.e., a certified a valid analytical result cannot be the testing process.
negative control), and at least one obtained using immunoassay technique (1) Whenever possible, the
control with one of the compounds of ‘‘A’’ and immunoassay technique ‘‘B’’ is investigation must determine relevant
facts and identify the root cause(s) of the properly labeled as to content and (d) To challenge the HHS-certified
testing or process error. The licensee or concentration. Calibrators and controls laboratory’s ability to limit false
other entity, and the HHS-certified may not be prepared from the same negatives, approximately 10 percent of
laboratory, shall take action to correct stock solution. The standards and the blind performance test samples
the causes of any errors or controls must be labeled with the submitted to the laboratory each quarter
unsatisfactory performance that are following dates: when received; when must be formulated at the
within each entity’s control. Sufficient prepared or opened; when placed in concentrations established in paragraph
records shall be maintained to furnish service; and when scheduled for (g)(3) of this section.
evidence of activities affecting quality. expiration. (e) To challenge the HHS-certified
The licensee or other entity shall assure laboratory’s ability to determine
that the cause of the condition is § 26.168 Blind performance testing. specimen validity, the licensee or other
determined and that corrective action is (a) Each licensee and other entity entity shall submit blind samples each
taken to preclude repetition. The shall submit blind performance test quarter that are appropriately
identification of the significant samples to the HHS-certified laboratory. adulterated, diluted, or substituted, in
condition, the cause of the condition, (1) During the initial 90-day period of the amount of 20 percent of the
and the corrective action taken shall be any contract with an HHS-certified specimens submitted that quarter or at
documented and reported to appropriate laboratory (not including rewritten or least three samples per quarter (one
levels of management. renewed contracts), each licensee or each that is adulterated, diluted, or
(2) If a false positive error occurs on other entity shall submit blind substituted), whichever is greater. These
a blind performance test sample or on performance test samples to each HHS- samples must be formulated at the
a regular specimen, the licensee or other certified laboratory with whom it concentrations established in
entity shall require the laboratory to contracts in the amount of at least 20 paragraphs (g)(4) through (g)(6) of this
take corrective action to minimize the percent of the total number of section.
occurrence of the particular error in the specimens submitted (up to a maximum (f) Approximately 10 percent of the
future. If there is reason to believe that of 100 blind performance specimens) or blind performance test samples
the error could have been systematic, 30 blind performance test samples, submitted to the laboratory each quarter
the licensee or other entity may also whichever is greater. must be negative, as specified in
require review and re-analysis of (2) Following the initial 90-day paragraph (g)(1) of this section.
previously run specimens. period, the number of blind (g) Licensees and other entities shall
(3) If a false positive error occurs on performance test samples submitted per use only blind performance test samples
a blind performance test sample and the quarter must be a minimum of one that have been certified by the supplier
error is determined to be technical or percent of all specimens (up to a to be—
methodological, the licensee or other maximum of 100) or ten blind (1) Negative. A negative blind
entity shall instruct the laboratory to performance test samples, whichever is performance test sample may not
provide all quality control data from the greater. contain a measurable amount of a target
batch or analytical run of specimens drug analyte and must be certified by
(3) Both during the initial 90-day
that included a false positive sample. In immunoassay and confirmatory testing;
period and quarterly thereafter, (2) Drug positive. These samples must
addition, the licensee or other entity
licensees and other entities should contain a measurable amount of the
shall require the laboratory to retest all
attempt to submit blind performance target drug or analyte in concentrations
specimens that analyzed as positive for
test samples at a frequency that ranging between 150 and 200 percent of
that drug or metabolite, or as
corresponds to the submission the initial cutoff values and be certified
adulterated, substituted, dilute, or
invalid in validity testing, from the time frequency for other specimens. by immunoassay and confirmatory
of final resolution of the error back to (b) Approximately 60 percent of the testing to contain one or more drug(s) or
the time of the last satisfactory blind performance test samples drug metabolite(s);
performance test cycle. This retesting submitted to the laboratory must be (3) A false negative challenge. This
must be documented by a statement positive for one or more drugs or drug blind performance test sample must
signed by the laboratory’s responsible metabolites per sample and submitted contain a measurable amount of the
person. The licensee or other entity and so that all of the drugs for which the target drug or analyte in concentrations
the NRC also may require an onsite FFD program is testing are included at ranging between 130 and 155 percent of
review of the laboratory, which may be least once each calendar quarter, except the initial cutoff values;
conducted unannounced during any as follows: (4) Adulterated. The adulterated blind
hours of operation of the laboratory. (1) Licensees and other entities shall performance test sample must have a pH
(g) Accuracy. Volumetric pipettes and submit blind performance test samples of less than or equal to 2, or greater than
measuring devices must be certified for that are positive for marijuana or equal to 12, or a nitrite or other
accuracy or be checked by gravimetric, metabolite at least two times each oxidant concentration equal to or greater
colorimetric, or other verification quarter; and than 500 mcg/mL, equal to or greater
procedures. Automatic pipetttes and (2) In at least two quarters each year, than 50 mcg/mL chromium (VI)-
dilutors must be checked for accuracy licensees and other entities shall submit equivalents, or a halogen concentration
and reproducibility both before being an additional blind performance test equal to or greater than the LOD. Blind
placed in service and periodically sample that is positive for cocaine performance test samples for other
thereafter. instead of the required sample that is adulterants must have adulterant
(h) Calibrators and controls. positive for PCP. concentrations equal to or greater than
Laboratory calibrators and controls must (c) The positive blind performance (or equal to or less than, as appropriate)
be prepared using pure drug reference test samples must be positive for only the initial cutoff levels used by the
materials, stock standard solutions those drugs for which the FFD program licensee’s or other entity’s HHS-certified
obtained from other laboratories, or is testing and formulated at laboratory;
standard solutions that are obtained concentrations established in paragraph (5) Dilute. The dilute blind
from commercial manufacturers and are (g)(2) of this section. performance test sample must contain a
creatinine concentration that is equal to (3) The licensee or other entity shall reported result. The MRO may not
or greater than 5 mg/dL but less than 20 ensure that all blind performance test disclose the numerical values to the
mg/dL, and the specific gravity must be samples include split samples, when the licensee or other entity, except as
greater than 1.0010 but less than 1.0030; FFD program includes split specimen permitted in § 26.37(b). If the numerical
or procedures. values for creatinine are below the LOD,
(6) Substituted. The substituted blind the laboratory shall report to the MRO
performance test sample must contain § 26.169 Reporting Results.
‘‘creatinine: none detected’’ (i.e.,
less than 2 mg/dL of creatinine, and the (a) The HHS-certified laboratory shall substituted) along with the numerical
specific gravity must be less than or report test results to the licensee’s or values of the specific gravity test.
equal to 1.0010, or equal to or greater other entity’s MRO within 5 business (4) For a specimen that has an invalid
than 1.0200. days after receiving the specimen from result, the laboratory shall contact the
(h) In order to ensure that blind the licensee or other entity. Before MRO and both will decide whether
performance test samples continue to reporting any test result to the MRO, the testing by another certified laboratory
meet the criteria set forth in paragraph laboratory’s certifying scientist shall would be useful in being able to report
(g) of this section, licensees and other certify the result as correct. The report a positive or adulterated result. This
entities shall— must identify the substances for which contact may occur through any secure
(1) Ensure that all blind performance testing was performed; the results of the electronic means (e.g., telephone, fax, e-
test sample lots are placed in service by validity and drug tests; the cutoff levels mail). If no further testing is necessary,
the supplier only after confirmation by for each; any indications of tampering, the laboratory shall report the invalid
an HHS-certified laboratory, and for no adulteration, or substitution that may be result to the MRO.
more than 6 months; present; the specimen identification
(2) Ensure that the supplier provides (5) When the concentration of a drug,
number assigned by the licensee or
the expiration date for each blind metabolite, or adulterant exceeds the
other entity; and the specimen
performance test sample to ensure that linear range of the standard curve, the
identification number assigned by the
each sample will have the expected laboratory may report to the MRO that
laboratory.
value when it is submitted to and tested (b) If licensees or other entities the quantitative value ‘‘exceeds the
by a laboratory; and specify cutoff levels for drugs or drug linear range of the test,’’ that the
(3) At a minimum, require the metabolites that are more stringent than quantitative value is ‘‘equal to or greater
supplier to check each open lot bi- those specified in this part, the than <insert the value for the upper
monthly (i.e., every two months) to laboratory need only conduct the more limit of the linear range>,’’ or may
ensure that samples remaining in the lot stringent tests and shall report the report an accurate quantitative value
do not fall below 130 percent of the results of the initial and confirmatory above the upper limit of the linear range
initial cutoff test concentration tests only for the more stringent cutoff that was obtained by diluting an aliquot
established by the assay manufacturer. levels. of the specimen.
Thus, for example, a lot that was (c) The HHS-certified laboratory shall (d) The MRO and MRO staff may not
certified by an HHS-certified laboratory report as negative all specimens that are disclose quantitative test results to a
at 155 percent of the manufacturer’s negative on the initial or confirmatory licensee or other entity, but shall report
assay cutoff level, and was reported by drug and validity tests. Specimens that only whether the specimen was positive
the licensee’s or other entity’s HHS- test as positive, adulterated, substituted, (and for which analyte), adulterated,
certified laboratory to be at or above 130 dilute, or invalid on the confirmatory substituted, dilute, invalid, or negative,
percent of that standard is acceptable. A analysis must be reported to the MRO as except as permitted under § 26.37(b).
test that indicated a result below 130 positive for a specific drug(s) or drug This paragraph does not preclude either
percent of that standard would be metabolite(s), or as meeting the criteria the HHS-certified laboratory or the MRO
unacceptable. Licensees and other for an adulterated, substituted, dilute, or from providing program performance
entities shall discard blind performance invalid specimen. data, as required under § 26.717.
test samples from any lot that is outside (1) The laboratory shall report all (e) The laboratory may transmit
of these parameters and may not use any positive, adulterated, substituted, dilute, results to the MRO by various electronic
further samples from that lot. and invalid test results for each means (e.g., teleprinters, facsimile, or
(i) Licensees and other entities shall specimen to the MRO. For example, a computer) in a manner designed to
ensure that each blind performance test specimen may be both adulterated and ensure the confidentiality of the
sample is indistinguishable to positive for one or more specific drugs. information. The laboratory may not
laboratory personnel from a donor’s (2) For a specimen that has a positive provide results orally by telephone. The
specimen, as follows: test result, the laboratory shall provide licensee or other entity, directly or
(1) The licensee or other entity shall numerical values if the MRO requests through the HHS-certified laboratory,
submit blind performance test samples such information. The MRO’s request shall ensure the security of the data
to the laboratory using the same for positive confirmatory test results transmission and ensure only
channels (i.e., from the licensee’s or may be either a general request covering authorized access to any data
other entity’s collection site or licensee all such results or a specific case-by- transmission, storage, and retrieval
testing facility, as appropriate) through case request. The laboratory shall system.
which donors’ specimens are sent to the routinely provide quantitative values for (f) For negative test results, the HHS-
laboratory; confirmatory opiate test results for certified laboratory may fax, courier,
(2) The collector and licensee testing morphine or codeine that are greater mail, or electronically transmit a
facility personnel, as appropriate, shall than or equal to 15,000 ng/mL, even if computer-generated electronic report
use a custody-and-control form, place the MRO has not requested quantitative and/or a legible image or copy of the
fictional initials on the specimen values for the test result. completed custody-and-control form to
bottles’ labels/seals, and indicate for the (3) For a specimen that has an the MRO. However, for positive,
MRO on the MRO’s copy that the adulterated or substituted test result, the adulterated, substituted, dilute, and
specimen is a blind performance test laboratory shall provide the MRO with invalid results, the laboratory shall fax,
sample; and the numerical values that support the courier, mail, or electronically transmit
a legible image or copy of the completed (6) Total number of specimens use, gives the licensee or other entity a
custody-and-control form to the MRO. reported as positive and dilute slate of MROs from which to choose, or
(g) For a specimen that has a positive, [including an indication as to whether recommends certain MROs;
adulterated, substituted, dilute, or the specimen was subject to the special (4) The laboratory gives the licensee
invalid result, the laboratory shall retain analysis permitted in § 26.163(a)(2)]; or other entity a discount or other
the original custody-and-control form (7) Total number of specimens incentive to use a particular MRO;
and transmit to the MRO a copy of the reported as invalid; and (5) The laboratory has its place of
original custody-and-control form (8) Number of specimens reported as business co-located with that of an MRO
signed by a certifying scientist. rejected for testing and the reason for or MRO staff who review test results
(h) The HHS-certified laboratory shall the rejection. produced by the laboratory; or
provide to the licensee’s or other (6) The laboratory permits an MRO, or
entity’s official responsible for Subpart H—Determining Fitness-for- an MRO’s organization, to have a
coordination of the FFD program an Duty Policy Violations and Determining financial interest in the laboratory.
annual statistical summary of urinalysis Fitness (c) Responsibilities. The primary role
testing, which may not include any of the MRO is to review and interpret
personal identifying information. To § 26.181 Purpose.
This subpart contains requirements positive, adulterated, substituted,
avoid sending data from which it is invalid, and at the licensee’s or other
likely that information about a donor’s for determining whether a donor has
violated the FFD policy and for making entity’s discretion, dilute test results
test result can be readily inferred, the obtained through the licensee’s or other
laboratory may not send a summary a determination of fitness.
entity’s testing program and to identify
report if the licensee or other entity has
§ 26.183 Medical review officer. any evidence of subversion of the
fewer than 10 specimen test results in
(a) Qualifications. The MRO shall be testing process. The MRO is also
a 1-year period. The summary report
knowledgeable of this part and of the responsible for identifying any issues
must include test results that were
FFD policies of the licensees and other associated with collecting and testing
reported within the year period. The
entities for whom the MRO provides specimens, and for advising and
laboratory shall send the summary
services. The MRO shall be a physician assisting FFD program management in
report to the licensee or other entity
holding either a Doctor of Medicine or planning and overseeing the overall FFD
within 14 calendar days after the end of
Doctor of Osteopathy degree who is program.
the 1-year period covered by the report.
The statistics must be presented either licensed to practice medicine by any (1) In carrying out these
for the cutoff levels specified in this part State or Territory of the United States, responsibilities, the MRO shall examine
or for any more stringent cutoff levels the District of Columbia, or the alternate medical explanations for any
that the licensee or other entity may Commonwealth of Puerto Rico. By positive, adulterated, substituted,
specify. The HHS-certified laboratory March 31, 2010, the MRO shall have invalid, or, at the licensee’s or other
shall make available quantitative results passed an examination administered by entity’s discretion, dilute test result.
for all specimens tested when requested a nationally-recognized MRO This action may include, but is not
by the NRC, licensee, or other entity for certification board or subspecialty board limited to, conducting a medical
whom the laboratory is performing for medical practitioners in the field of interview with the donor, reviewing the
drug-testing services. If the FFD medical review of Federally mandated donor’s medical history, or reviewing
program tests for additional drugs drug tests. any other relevant biomedical factors.
beyond those listed in § 26.31(d), the (b) Relationships. The MRO may be The MRO shall review all medical
summary must include drug test results an employee of the licensee or other records that the donor may make
for the additional drugs. The summary entity or a contractor. However, the available when a positive, adulterated,
report must contain the following MRO may not be an employee or agent substituted, invalid, or dilute test result
information: of, or have any financial interest in, an could have resulted from responsible
(1) Total number of specimens HHS-certified laboratory or a contracted use of legally prescribed medication, a
received; operator of a licensee testing facility for documented condition or disease state,
(2) Number of specimens reported whom the MRO reviews drug test or the demonstrated physiology of the
as— results. Additionally, the MRO may not donor.
(i) Negative, and derive any financial benefit by having (2) The MRO may only consider the
(ii) Negative and dilute; the licensee or other entity use a results of tests of specimens that are
(3) Number of specimens reported as specific drug testing laboratory or collected and processed under this part,
positive on confirmatory tests by drug or licensee testing facility operating including the results of testing split
drug metabolite for which testing is contractor and may not have any specimens, in making his or her
conducted, including, but not limited agreement with such parties that may be determination, as long as those split
to— construed as a potential conflict of specimens have been stored and tested
(i) Marijuana metabolite; interest. Examples of relationships under the procedures described in this
(ii) Cocaine metabolite; between laboratories and MROs that part.
(iii) Opiates (total); create conflicts of interest, or the (d) MRO staff. Individuals who
(A) Codeine; appearance of such conflicts, include, provide administrative support to the
(B) Morphine; and MRO may be employees of a licensee or
(C) 6-AM; but are not limited to—
(iv) Phencyclidine; (1) The laboratory employs an MRO other entity, employees of the MRO, or
(v) Amphetamines (total); who reviews test results produced by employees of an organization with
(A) Amphetamine; and the laboratory; whom a licensee or other entity
(B) Methamphetamine; (2) The laboratory has a contract or contracts for MRO services. Employees
(4) Total number of specimens retainer with the MRO for the review of of a licensee or other entity who serve
reported as adulterated; test results produced by the laboratory; MRO staff functions may also perform
(5) Total number of specimens (3) The laboratory designates which other duties for the licensee or other
reported as substituted; MRO the licensee or other entity is to entity and need not be under the
direction of the MRO while performing medical information related to a (d) Donor unavailability. The MRO
those other duties. positive, adulterated, substituted, or may determine that a positive,
(1) Direction of MRO staff activities. invalid test result or other matter from adulterated, substituted, dilute, or
MROs shall be directly responsible for a donor. invalid test result or other occurrence is
all administrative, technical, and (iv) Staff may not report nor discuss an FFD policy violation without having
professional activities of individuals with any individuals other than the discussed the test result or other
who are serving MRO staff functions MRO and other MRO staff any positive, occurrence directly with the donor in
while they are performing those adulterated, substituted, invalid, or the following three circumstances:
functions, and those functions must be dilute test results received from the (1) The MRO has made and
under the MRO’s direction. HHS-certified laboratory before those documented contact with the donor and
(i) The duties of MRO staff must be results have been reviewed and the donor expressly declined the
maintained independent from any other confirmed by the MRO. Any MRO staff opportunity to discuss the test result or
activity or interest of a licensee or other discussions of confirmed positive, other occurrence that may constitute an
entity, in order to protect the integrity adulterated, substituted, invalid, or FFD policy violation;
of the MRO function and donors’ dilute test results must be limited to (2) A representative of the licensee or
privacy. discussions only with the licensee’s or other entity, or an MRO staff member,
(ii) An MRO’s responsibilities for other entity’s FFD program personnel has successfully made and documented
directing MRO staff must include, but and may not reveal quantitative test contact with the donor and has
are not limited to, ensuring that— results or any personal medical instructed him or her to contact the
(A) The procedures being performed MRO, and more than 1 business day has
information about the donor that the
by MRO staff meet NRC regulations and elapsed since the date on which the
MRO may have obtained in the course
HHS’ and professional standards of licensee’s representative or MRO’s staff
of reviewing confirmatory test results
practice; member successfully contacted the
from the HHS-certified laboratory.
(B) Records and other donor personal donor; or
information are maintained confidential § 26.185 Determining a fitness-for-duty (3) The MRO, after making all
by MRO staff and are not released to policy violation. reasonable efforts and documenting the
other individuals or entities, except as (a) MRO review required. A positive, dates and time of those efforts, has been
permitted under this part; adulterated, substituted, dilute, or unable to contact the donor. Reasonable
(C) Data transmission is secure; and efforts include, at a minimum, three
invalid drug test result does not
(D) Drug test results are reported to attempts, spaced reasonably over a 24-
automatically identify an individual as
the licensee’s or other entity’s hour period, to reach the donor at the
having used drugs in violation of the
designated reviewing official only as day and evening telephone numbers
NRC’s regulations, or the licensee’s or
required by this part. listed on the custody-and-control form.
other entity’s FFD policy, or as having (e) Additional opportunity for
(iii) The MRO may not delegate any
attempted to subvert the testing process. discussion. If the MRO determines that
of his or her responsibilities for
An individual who has a detailed the donor has violated the FFD policy
directing MRO staff to any other
knowledge of possible alternate medical without having discussed the positive,
individual or entity, except another
explanations is essential to the review of adulterated, substituted, dilute, or
MRO.
(2) MRO staff responsibilities. MRO the results. The MRO shall review all invalid test result or other occurrence
staff may perform routine administrative positive, adulterated, substituted, and directly with the donor, the donor may,
support functions, including receiving invalid test results from the HHS- on subsequent notification of the MRO
test results, reviewing negative test certified laboratory to determine determination and within 30 days of
results, and scheduling interviews for whether the donor has violated the FFD that notification, present to the MRO
the MRO. policy before reporting the results to the information documenting the
(i) The staff under the direction of the licensee’s or other entity’s designated circumstances, including, but not
MRO may receive, review, and report representative. limited to, serious illness or injury,
negative test results to the licensee’s or (b) Reporting of initial test results which unavoidably prevented the donor
other entity’s designated representative. prohibited. Neither the MRO nor MRO from being contacted by the MRO or a
(ii) The staff reviews of positive, staff may report positive, adulterated, representative of the licensee or other
adulterated, substituted, invalid, and, at substituted, dilute, or invalid initial test entity, or from contacting the MRO in a
the licensee’s or other entity’s results that are received from the HHS- timely manner. On the basis of this
discretion, dilute test results must be certified laboratory to the licensee or information, the MRO may reopen the
limited to reviewing the custody-and- other entity. procedure for determining whether the
control form to determine whether it (c) Discussion with the donor. Before donor’s test result or other occurrence is
contains any errors that may require determining that a positive, adulterated, an FFD policy violation and permit the
corrective action and to ensure that it is substituted, dilute, or invalid test result individual to present information
consistent with the information on the or other occurrence is an FFD policy related to the issue. The MRO may
MRO’s copy. The staff may resolve violation and reporting it to the licensee modify the initial determination based
errors in custody-and-control forms that or other entity, the MRO shall give the on an evaluation of the information
require corrective action(s), but shall donor an opportunity to discuss the test provided.
forward the custody-and-control forms result or other occurrence with the (f) Review of invalid specimens. (1) If
to the MRO for review and approval of MRO, except as described in paragraph the HHS-certified laboratory reports an
the resolution. (d) of this section. After this discussion, invalid result, the MRO shall consult
(iii) The staff may not conduct if the MRO determines that a positive, with the laboratory to determine
interviews with donors to discuss adulterated, substituted, dilute, or whether additional testing by another
positive, adulterated, substituted, invalid test result or other occurrence is HHS-certified laboratory may be useful
invalid, or dilute test results nor request an FFD policy violation, the MRO shall in determining and reporting a positive
medical information from a donor. Only immediately notify the licensee’s or or adulterated test result. If the MRO
the MRO may request and review other entity’s designated representative. and the laboratory agree that further
testing would be useful, the HHS- the presence of the drug(s) or drug (h) Review of substituted specimens.
certified laboratory shall forward the metabolite(s) in the specimen, and a (1) If the HHS-certified laboratory
specimen to a second laboratory for clinical examination, if required under reports a specimen as substituted (i.e.,
additional testing. paragraph (g)(4) of this section, has been the creatinine concentration is less than
(2) If the MRO and the laboratory conducted under paragraph (j) of this 2 mg/dL and the specific gravity is less
agree that further testing would not be section, the MRO shall determine than or equal to 1.0010 or equal to or
useful and there is no technical whether the positive and dilute greater than 1.0200), the MRO shall
explanation for the result, the MRO specimen is a refusal to test. If the MRO contact the donor and offer the donor an
shall contact the donor and determine does not have sufficient reason to opportunity to provide a legitimate
whether there is an acceptable medical believe that the positive and dilute medical explanation for the substituted
explanation for the invalid result. If specimen is a subversion attempt, he or result. The burden of proof resides
there is an acceptable medical she shall determine that the drug test solely with the donor, who must
explanation, the MRO shall report to the results are positive and that the donor provide legitimate medical evidence
licensee or other entity that the test has violated the FFD policy. When within 5 business days that he or she
result is not an FFD policy violation, but determining whether the donor has produced the specimen for which the
that a negative test result was not diluted the specimen in a subversion HHS-certified laboratory reported a
obtained. If the medical reason for the attempt, the MRO shall also consider substituted result. Any medical
invalid result is, in the opinion of the the following circumstances, if evidence must be submitted through a
MRO, a temporary condition, the applicable: physician who is experienced and
licensee or other entity shall collect a (i) The donor has presented, at this or qualified in the medical issues involved,
second urine specimen from the donor a previous collection, a urine specimen as verified by the MRO. Claims of
as soon as reasonably practical and rely that the HHS-certified laboratory excessive hydration, or claims based on
on the MRO’s review of the test results reported as being substituted, unsubstantiated personal
from the second collection. The second adulterated, or invalid to the MRO and characteristics, including, but not
specimen collected for the purposes of the MRO determined that there is no limited to, race, gender, diet, and body
this paragraph may not be collected adequate technical or medical weight, are not acceptable evidence
under direct observation. If the medical explanation for the result; without medical studies which
reason for the invalid result would (ii) The donor has presented a urine demonstrate that the donor did produce
similarly affect the testing of another specimen of 30 mL or more that falls the laboratory result.
urine specimen, the MRO may authorize outside the required temperature range,
(2) If the MRO determines that there
an alternative method for drug testing. even if a subsequent directly observed
is no legitimate medical explanation for
Licensees and other entities may not collection was performed; or
(iii) The collector observed conduct the substituted test result, the MRO
impose sanctions for an invalid test shall report to the licensee or other
result due to a medical condition. clearly and unequivocally indicating an
attempt to dilute the specimen. entity that the specimen was
(3) If the MRO and the laboratory
(3) If a dilute specimen was collected substituted.
agree that further testing would not be
useful and there is no legitimate under direct observation, the MRO may (3) If the MRO determines that there
technical or medical explanation for the require the laboratory to conduct is a legitimate medical explanation for
invalid test result, the MRO shall confirmatory testing at the LOD for any the substituted test result and no drugs
require that a second collection take drugs or drug metabolites, as long as or drug metabolites were detected in the
place as soon as practical under direct each drug class is evaluated as required specimen, the MRO shall report to the
observation. The licensee or other entity by § 26.31(d)(1)(ii). licensee or other entity that no FFD
shall rely on the MRO’s review of the (4) If the drugs detected in a dilute policy violation has occurred.
test results from the directly observed specimen are any opium, opiate, or (i) Review of adulterated specimens.
collection. opium derivative (e.g., morphine/ (1) If the HHS-certified laboratory
(g) Review of dilute specimens. (1) If codeine), or if the drugs or metabolites reports a specimen as adulterated with
the HHS-certified laboratory reports that detected indicate the use of prescription a specific substance, the MRO shall
a specimen is dilute and that drugs or or over-the-counter medications, before contact the donor and offer the donor an
drug metabolites were detected in the determining that the donor has violated opportunity to provide a legitimate
specimen at or above the cutoff levels the FFD policy under paragraph (a) of medical explanation for the adulterated
specified in this part or the licensee’s or this section, the MRO or his/her result. The burden of proof resides
other entity’s more stringent cutoff designee, who shall also be a licensed solely with the donor, who must
levels, and the MRO determines that physician with knowledge of the provide legitimate medical evidence
there is no legitimate medical clinical signs of drug abuse, shall within 5 business days that he or she
explanation for the presence of the conduct the clinical examination for produced the adulterated result. Any
drugs or drug metabolites in the abuse of these substances that is medical evidence must be submitted
specimen, and a clinical examination, if required in paragraph (j) of this section. through a physician experienced and
required under paragraph (g)(4) of this An evaluation for clinical evidence of qualified in the medical issues involved,
section, has been conducted, the MRO abuse is not required if the laboratory as verified by the MRO.
shall determine that the drug test results confirms the presence of 6–AM (i.e., the (2) If the MRO determines there is no
are positive and that the donor has presence of this metabolite is proof of legitimate medical explanation for the
violated the FFD policy. heroin use) in the dilute specimen. adulterated test result, the MRO shall
(2) If the licensee or other entity (5) An MRO review is not required for report to the licensee or other entity that
requires the HHS-certified laboratory to specimens that the HHS-certified the specimen is adulterated.
conduct the special analysis of dilute laboratory reports as negative and (3) If the MRO determines that there
specimens permitted in § 26.163(a)(2), dilute. The licensee or other entity may is a legitimate medical explanation for
the results of the special analysis are not take any administrative actions or the adulterated test result and no drugs
positive, the MRO determines that there impose any sanctions on a donor who or drug metabolites were detected in the
is no legitimate medical explanation for submits a negative and dilute specimen. specimen, the MRO shall report to the
licensee or other entity that no FFD professional judgment consistently with the MRO is authorized to order retesting
policy violation has occurred. the following principles: of an aliquot of the original specimen or
(j) Review for opiates, prescription (i) There can be a legitimate medical the analysis of any split specimen
and over-the-counter medications. (1) If explanation only with respect to a drug (Bottle B) in order to determine whether
the MRO determines that there is no that is obtained legally in a foreign the FFD policy has been violated.
legitimate medical explanation for a country; Retesting must be performed by a
positive confirmatory test result for (ii) There can be a legitimate medical second HHS-certified laboratory. The
opiates and before the MRO determines explanation only with respect to a drug MRO is also the only individual who
that the test result is a violation of the that has a legitimate medical use. Use of may authorize a reanalysis of an aliquot
FFD policy, the MRO or his/her a drug of abuse (e.g., heroin, PCP) or any of the original specimen or an analysis
designee, who shall also be a licensed other substance that cannot be viewed of any split specimen (Bottle B) in
physician with knowledge of the as having a legitimate medical use can response to a request from the donor
clinical signs of drug abuse, shall never be the basis for a legitimate tested.
determine that there is clinical medical explanation, even if the drug is (m) Result scientifically insufficient.
evidence, in addition to the positive obtained legally in a foreign country; Based on the review of inspection and
confirmatory test result, that the donor and audit reports, quality control data,
has illegally used opium, an opiate, or (iii) Use of the drug can form the basis multiple specimens, and other pertinent
an opium derivative (e.g., morphine/ of a legitimate medical explanation only results, the MRO may determine that a
codeine). This requirement does not if it is used consistently with its proper positive, adulterated, substituted or
apply if the laboratory confirms the and intended medical purpose. invalid test result is scientifically
presence of 6-AM (i.e., the presence of (5) The MRO may not consider insufficient for further action and may
this metabolite is proof of heroin use), consumption of food products, declare that a drug or validity test result
or the morphine or codeine supplements, or other preparations is not an FFD policy violation, but that
concentration is equal to or greater than containing substances that may result in a negative test result was not obtained.
15,000 ng/mL and the donor does not a positive confirmatory drug test result, In this situation, the MRO may request
present a legitimate medical explanation including, but not limited to retesting of the original specimen before
for the presence of morphine or codeine supplements containing hemp products making this decision. The MRO is
at or above this concentration. The MRO or coca leaf tea, as a legitimate medical neither expected nor required to request
may not determine that the explanation for the presence of drugs or such retesting, unless in the sole
consumption of food products is a drug metabolites in the urine specimen opinion of the MRO, such retesting is
legitimate medical explanation for the above the cutoff levels specified in warranted. The MRO may request that
presence of morphine or codeine at or § 26.163 or a licensee’s or other entity’s the reanalysis be performed by the same
above this concentration. more stringent cutoff levels. laboratory, or that an aliquot of the
(2) If the MRO determines that there (6) The MRO may not consider the original specimen be sent for reanalysis
is no legitimate medical explanation for use of any drug contained in Schedule to another HHS-certified laboratory. The
a positive confirmatory test result for I of section 202 of the Controlled licensee testing facility and the HHS-
drugs other than opiates that are Substances Act [21 U.S.C. 812] as a certified laboratory shall assist in this
commonly prescribed or included in legitimate medical explanation for a review process, as requested by the
over-the-counter preparations (e.g., positive confirmatory drug test result, MRO, by making available the
benzodiazepines in the first case, even if the drug may be legally individual(s) responsible for day-to-day
barbiturates in the second) and are prescribed and used under State law. management of the licensee testing
listed in the licensee’s or other entity’s (k) Results consistent with legitimate facility or the HHS-certified laboratory,
panel of substances to be tested, the drug use. If the MRO determines that or other individuals who are forensic
MRO shall determine whether there is there is a legitimate medical explanation toxicologists or who have equivalent
clinical evidence, in addition to the for a positive confirmatory drug test forensic experience in urine drug
positive confirmatory test result, of result, and that the use of a drug testing, to provide specific consultation
abuse of any of these substances or their identified through testing was in the as required by the MRO.
derivatives. manner and at the dosage prescribed, (n) Evaluating results from a second
(3) If the MRO determines that the and the results do not reflect a lack of laboratory. After a second laboratory
donor has used another individual’s reliability or trustworthiness, then the tests an aliquot of a single specimen or
prescription medication, including a donor has not violated the licensee’s or the split (Bottle B) specimen, the MRO
medication containing opiates, and no other entity’s FFD policy. The MRO shall take the following actions if the
clinical evidence of drug abuse is found, shall report to the licensee or other second laboratory reports the following
the MRO shall report to the licensee or entity that no FFD policy violation has results:
other entity that the donor has misused occurred. The MRO shall further (1) If the second laboratory reconfirms
a prescription medication. If the MRO evaluate the positive confirmatory test any positive test results, the MRO may
determines that the donor has used result and medical explanation to report an FFD policy violation to the
another individual’s prescription determine whether use of the drug and/ licensee or other entity;
medication and clinical evidence of or the medical condition poses a (2) If the second laboratory reconfirms
drug abuse is found, the MRO shall potential risk to public health and safety any adulterated, substituted, or invalid
report to the licensee that the donor has as a result of the individual being validity test results, the MRO may
violated the FFD policy. impaired while on duty. If the MRO report an FFD policy violation to the
(4) In determining whether a determines that such a risk exists, he or licensee or other entity;
legitimate medical explanation exists for she shall ensure that a determination of (3) If the second laboratory does not
a positive confirmatory test result for fitness is performed. reconfirm the positive test results, the
opiates or prescription or over-the- (l) Retesting authorized. Should the MRO shall report that no FFD policy
counter medications, the MRO may MRO question the accuracy or scientific violation has occurred; or
consider the use of a medication from a validity of a positive, adulterated, (4) If the second laboratory does not
foreign country. The MRO shall exercise substituted, or invalid test result, only reconfirm the adulterated, substituted,
or invalid validity test results, the MRO (2) A licensed or certified social (2) Continuing education activities
shall report that no FFD policy violation worker; must include documented assessment
has occurred. (3) A licensed or certified tools to assist in determining that the
(o) Re-authorization after a first psychologist; SAE has learned the material.
violation for a positive test result. The (4) A licensed or certified employee (f) Documentation. The SAE shall
MRO is responsible for reviewing drug assistance professional; or maintain documentation showing that
test results from an individual whose (5) An alcohol and drug abuse he or she currently meets all
authorization was terminated or denied counselor certified by the National requirements of this section. The SAE
for a first violation of the FFD policy Association of Alcoholism and Drug shall provide this documentation on
involving a confirmed positive drug test Abuse Counselors Certification request to NRC representatives,
result and who is being considered for Commission or by the International licensees, or other entities who are
re-authorization. In order to determine Certification Reciprocity Consortium/ relying on or contemplating relying on
whether subsequent positive Alcohol and Other Drug Abuse. the SAE’s services, and to other
confirmatory drug test results represent (c) Basic knowledge. An SAE shall be individuals and entities, as required by
new drug use or remaining metabolites knowledgeable in the following areas: § 26.37.
from the drug use that initially resulted (1) Demonstrated knowledge of and (g) Responsibilities and prohibitions.
in the FFD policy violation, the MRO clinical experience in the diagnosis and The SAE shall evaluate individuals who
shall request from the HHS-certified treatment of alcohol and controlled- have violated the substance abuse
laboratory, and the laboratory shall substance abuse disorders; provisions of an FFD policy and make
provide, quantitation of the test results (2) Knowledge of the SAE function as recommendations concerning
and other information necessary to it relates to the public’s interests in the education, treatment, return to duty,
make the determination. If the drug for duties performed by the individuals followup drug and alcohol testing, and
which the individual first tested who are subject to this subpart; and aftercare. The SAE is not an advocate for
(3) Knowledge of this part and any
positive was marijuana and the the licensee or other entity, or the
changes thereto.
confirmatory assay for delta-9- (d) Qualification training. SAEs shall individual. The SAE’s function is to
tetrahydrocannabinol-9-carboxylic acid receive qualification training on the protect public health and safety and the
yields a positive result, the MRO shall following subjects: common defense and security by
determine whether the confirmatory test (1) Background, rationale, and scope professionally evaluating the individual
result indicates further marijuana use of this part; and recommending appropriate
since the first positive test result, or (2) Key drug testing requirements of education/treatment, follow-up tests,
whether the test result is consistent with this part, including specimen collection, and aftercare.
the level of delta-9- laboratory testing, MRO review, and (1) The SAE is authorized to make
tetrahydrocannabinol-9-carboxylic acid problems in drug testing; determinations of fitness in at least the
that would be expected if no further (3) Key alcohol testing requirements following three circumstances:
marijuana use had occurred. If the test of this part, including specimen (i) When potentially disqualifying
result indicates that no further collection, the testing process, and FFD information has been identified
marijuana use has occurred since the problems in alcohol tests; regarding an individual who has
first positive test result, then the MRO (4) SAE qualifications and applied for authorization under this
shall declare the drug test result as prohibitions; part;
negative. (5) The role of the SAE in making (ii) When an individual has violated
(p) Time to complete MRO review. determinations of fitness and the return- the substance abuse provisions of a
The MRO shall complete his or her to-duty process, including the initial licensee’s or other entity’s FFD policy;
review of positive, adulterated, evaluation, referrals for education and/ and
substituted, and invalid test results and, or treatment, the followup evaluation, (iii) When an individual may be
in instances when the MRO determines continuing treatment recommendations, impaired by alcohol, prescription or
that there is no legitimate medical and the followup testing plan; over-the-counter medications, or illegal
explanation for the test result(s), notify (6) Procedures for SAE consultation drugs.
the licensee’s or other entity’s and communication with licensees or (2) After determining the best
designated representative within 10 other entities, MROs, and treatment recommendation for assisting the
business days of an initial positive, providers; individual, the SAE shall serve as a
adulterated, substituted, or invalid test (7) Reporting and recordkeeping referral source to assist the individual’s
result. The MRO shall notify the requirements of this part; and entry into an education and/or
licensee or other entity of the results of (8) Issues that SAEs confront in treatment program.
his or her review in writing and in a carrying out their duties under this part. (i) To prevent the appearance of a
manner designed to ensure the (e) Continuing education. During each conflict of interest, the SAE may not
confidentiality of the information. 3-year period following completion of refer an individual requiring assistance
initial qualification training, the SAE to his or her private practice or to a
§ 26.187 Substance abuse expert. shall complete continuing education person or organization from whom the
(a) Implementation. By March 31, consisting of at least 12 continuing SAE receives payment or in which the
2010, any SAEs on whom licensees and professional education hours relevant to SAE has a financial interest. The SAE is
other entities rely to make performing SAE functions. precluded from making referrals to
determinations of fitness under this part (1) This continuing education must entities with whom the SAE is
shall meet the requirements of this include material concerning new financially associated.
section. An MRO who meets the technologies, interpretations, recent (ii) There are four exceptions to the
requirements of this section may serve guidance, rule changes, and other prohibitions contained in the preceding
as both an MRO and as an SAE. information about developments in SAE paragraph. The SAE may refer an
(b) Credentials. An SAE shall have at practice pertaining to this part, since the individual to any of the following
least one of the following credentials: time the SAE met the qualification providers of assistance, regardless of his
(1) A licensed physician; training requirements of this section. or her relationship with them:
(A) A public agency (e.g., treatment who may have experienced mental face-to-face interaction between the
facility) operated by a state, county, or illness, significant emotional stress, or subject individual and the professional
municipality; cognitive or psychological impairment making the determination. Electronic
(B) A person or organization under from causes unrelated to substance means of communication may not be
contract to the licensee or other entity abuse, but may not be qualified to assess used.
to provide alcohol or drug treatment the fitness of an individual who may
and/or education services (e.g., the (1) If there is neither conclusive
have a substance abuse disorder, unless
licensee’s or other entity’s contracted the psychologist is also an SAE; evidence of an FFD policy violation nor
treatment provider); (3) A psychiatrist may determine the a significant basis for concern that the
(C) The sole source of therapeutically fitness of an individual who is taking individual may be impaired while on
appropriate treatment under the psychoactive medications consistently duty, then the individual must be
individual’s health insurance program with one or more valid prescription(s), determined to be fit for duty.
(e.g., the single substance abuse in- but may not be qualified to assess (2) If there is no conclusive evidence
patient treatment program made potential impairment attributable to of an FFD policy violation but there is
available by the individual’s insurance substance abuse, unless the psychiatrist a significant basis for concern that the
coverage plan); or has had specific training to diagnose individual may be impaired while on
(D) The sole source of therapeutically and treat substance abuse disorders; duty, then the subject individual must
appropriate treatment reasonably (4) A physician may determine the be determined to be unfit for duty. This
available to the individual (e.g., the only fitness of an individual who may be ill,
treatment facility or education program result does not constitute a violation of
injured, fatigued, taking medications in
reasonably located within the general this part nor of the licensee’s or other
accordance with one or more valid
commuting area). prescriptions, or using over-the-counter entity’s FFD policy, and no sanctions
medications, but may not be qualified to may be imposed. However, the
§ 26.189 Determination of fitness. professional who made the
assess the fitness of an individual who
(a) A determination of fitness is the may have a substance abuse disorder, determination of fitness shall consult
process entered when there are unless the physician is also an SAE; and with the licensee’s or other entity’s
indications that an individual specified (5) As a physician with specialized management personnel to identify the
in § 26.4(a) through (e), and at the training, the MRO may determine the actions required to ensure that any
licensee’s or other entity’s discretion as fitness of an individual who may have possible limiting condition does not
specified in § 26.4(f) and (g), may be in engaged in substance abuse or may be represent a threat to workplace or public
violation of the licensee’s or other ill, injured, fatigued, taking medications health and safety. Licensee or other
entity’s FFD policy or is otherwise under one or more valid prescriptions, entity management personnel shall
unable to safely and competently and/or using over-the-counter implement the required actions. When
perform his or her duties. A medications, but may not be qualified to appropriate, the subject individual may
determination of fitness must be made assess an individual’s fitness to be also be referred to the EAP.
by a licensed or certified professional granted authorization following an
who is appropriately qualified and has (d) Neither the individual nor
unfavorable termination or denial of
the necessary clinical expertise, as licensees and other entities may seek a
authorization under this part, unless the
verified by the licensee or other entity, MRO is also an SAE. second determination of fitness if a
to evaluate the specific fitness issues (b) A determination of fitness must be determination of fitness under this part
presented by the individual. A made in at least the following has already been performed by a
professional called on by the licensee or circumstances: qualified professional employed by or
other entity may not perform a (1) When there is an acceptable under contract to the licensee or other
determination of fitness regarding medical explanation for a positive, entity. After the initial determination of
fitness issues that are outside of his or adulterated, substituted, or invalid test fitness has been made, the professional
her specific areas of expertise. The types result, but there is a basis for believing may modify his or her evaluation and
of professionals and the fitness issues that the individual could be impaired recommendations based on new or
for which they are qualified to make while on duty; additional information from other
determinations of fitness include, but (2) Before making return-to-duty sources including, but not limited to,
are not limited to, the following: recommendations after an individual’s the subject individual, another licensee
(1) An SAE who meets the authorization has been terminated or entity, or staff of an education or
requirements of § 26.187 may determine unfavorably or denied under a licensee’s treatment program. Unless the
the fitness of an individual who may or other entity’s FFD policy; professional who made the initial
have engaged in substance abuse and (3) Before an individual is granted
shall determine an individual’s fitness determination of fitness is no longer
authorization when potentially
to be granted authorization following an employed by or under contract to the
disqualifying FFD information is
unfavorable termination or denial of identified that has not previously been licensee or other entity, only that
authorization under this part, but may evaluated by another licensee or entity professional is authorized to modify the
not be qualified to assess the fitness of who is subject to this subpart; and evaluation and recommendations. When
an individual who may have (4) When potentially disqualifying reasonably practicable, licensees and
experienced mental illness, significant FFD information is otherwise identified other entities shall assist in arranging
emotional stress, or other mental or and the licensee’s or other entity’s for consultation between the new
physical conditions that may cause reviewing official concludes that a professional and the professional who is
impairment but are unrelated to determination of fitness is warranted no longer employed by or under
substance abuse, unless the SAE has under § 26.69. contract to the licensee or other entity,
additional qualifications for addressing (c) A determination of fitness that is to ensure continuity and consistency in
those fitness issues; conducted for cause (i.e., because of the recommendations and their
(2) A clinical psychologist may observed behavior or a physical implementation.
determine the fitness of an individual condition) must be conducted through
Subpart I—Managing Fatigue and risk factors for common sleep individuals who received only one
disorders, shiftwork strategies for waiver during the reporting period, the
§ 26.201 Applicability. obtaining adequate rest, and the number of individuals who received a
The requirements in this subpart effective use of fatigue countermeasures; total of two waivers during the reporting
apply to the licensees and other entities and period).
identified in § 26.3(a), and, if applicable, (2) Ability to identify symptoms of (2) A summary of corrective actions,
(c) and (d). The requirements in worker fatigue and contributors to if any, resulting from the analyses of
§§ 26.203 and 26.211 apply to the decreased alertness in the workplace. these data, including fatigue
individuals identified in § 26.4 (a) (d) Recordkeeping. Licensees shall assessments.
through (c). In addition, the retain the following records for at least (f) Audits. Licensees shall audit the
requirements in § 26.205 through 3 years or until the completion of all management of worker fatigue as
§ 26.209 apply to the individuals related legal proceedings, whichever is required by § 26.41.
identified in § 26.4(a). later:
(1) Records of work hours for § 26.205 Work hours.
§ 26.203 General provisions. individuals who are subject to the work (a) Individuals subject to work hour
(a) Policy. Licensees shall establish a hour controls in § 26.205; controls. Any individual who performs
policy for the management of fatigue for (2) Records of shift schedules and duties identified in § 26.4(a)(1) through
all individuals who are subject to the shift cycles of individuals who are (a)(5) shall be subject to the
licensee’s FFD program and incorporate subject to the work hour controls in requirements of this section.
it into the written policy required in § 26.205; (b) Calculating work hours. For the
§ 26.27(b). (3) The documentation of waivers that purposes of this section, a licensee shall
(b) Procedures. In addition to the is required in § 26.207(a)(4), including calculate the work hours of individuals
procedures required in § 26.27(c), the bases for granting the waivers; who are subject to this section as the
licensees shall develop, implement, and (4) The documentation of work hour
amount of time the individuals perform
maintain procedures that— reviews that is required in § 26.205(e)(3)
(1) Describe the process to be duties for the licensee. Except as
and (e)(4); and
followed when any individual (5) The documentation of fatigue permitted by paragraphs (b)(1) through
identified in § 26.4(a) through (c) makes assessments that is required in (b)(5) of this section, the calculated
a self-declaration that he or she is not § 26.211(g). work hours must include all time
fit to safely and competently perform (e) Reporting. Licensees shall include performing duties for the licensee,
his or her duties for any part of a the following information in a standard including all within-shift break times
working tour as a result of fatigue. The format in the annual FFD program and rest periods during which there are
procedure must— performance report required under no reasonable opportunities or
(i) Describe the individual’s and § 26.717: accommodations appropriate for
licensee’s rights and responsibilities (1) A summary for each nuclear power restorative sleep.
related to self-declaration; plant site of all instances during the (1) Shift turnover. Licensees may
(ii) Describe requirements for previous calendar year when the exclude shift turnover from the
establishing controls and conditions licensee waived the work hour controls calculation of an individual’s work
under which an individual may be specified in § 26.205(d)(1) through hours. Shift turnover includes only
permitted or required to perform work (d)(5)(i) for individuals described in those activities that are necessary to
after that individual declares that he or § 26.4(a). The summary must include safely transfer information and
she is not fit due to fatigue; and only those waivers under which work responsibilities between two or more
(iii) Describe the process to be was performed. If it was necessary to individuals between shifts. Shift
followed if the individual disagrees waive more than one work hour control turnover activities may include, but are
with the results of a fatigue assessment during any single extended work period, not limited to, discussions of the status
that is required under § 26.211(a)(2); the summary of instances must include of plant equipment, and the status of
(2) Describe the process for each of the work hour controls that were ongoing activities, such as extended
implementing the controls required waived during the period. For each tests of safety systems and components.
under § 26.205 for the individuals who category of individuals specified in Licensees may not exclude work hours
are performing the duties listed in § 26.4(a), the licensee shall report— worked during turnovers between
§ 26.4(a); (i) The number of instances when individuals within a shift period due to
(3) Describe the process to be each applicable work hour control rotations or relief within a shift.
followed in conducting fatigue specified in § 26.205(d)(1)(i) through Activities that licensees may not
assessments under § 26.211; and (d)(1)(iii), (d)(2)(i) and (d)(2)(ii), and exclude from work hours calculations
(4) Describe the disciplinary actions (d)(3)(i) through (d)(3)(v) was waived for also include, but are not limited to, shift
that the licensee may impose on an individuals not working on outage holdovers to cover for late arrivals of
individual following a fatigue activities; incoming shift members; early arrivals
assessment, and the conditions and (ii) The number of instances when of individuals for meetings, training, or
considerations for taking those each applicable work hour control pre-shift briefings for special evolutions;
disciplinary actions. specified in § 26.205(d)(1)(i) through and holdovers for interviews needed for
(c) Training and examinations. (d)(1)(iii), (d)(2)(i) and (d)(2)(ii), (d)(3)(i) event investigations.
Licensees shall add the following KAs through (d)(3)(v), and (d)(4) and (d)(5)(i) (2) Within-shift break and rest
to the content of the training that is was waived for individuals working on periods. Licensees may exclude from
required in § 26.29(a) and the outage activities; and the calculation of an individual’s work
comprehensive examination required in (iii) A summary that shows the hours only that portion of a break or rest
§ 26.29(b): distribution of waiver use among the period during which there is a
(1) Knowledge of the contributors to individuals within each category of reasonable opportunity and
worker fatigue, circadian variations in individuals identified in § 26.4(a) (e.g., accommodations for restorative sleep
alertness and performance, indications a table that shows the number of (e.g., a nap).
(3) Beginning or resuming duties either the beginning or end of a shift but (i) During the first 60 days of a unit
subject to work hour controls. If an not both. Except as permitted in outage or a planned security system
individual begins or resumes § 26.207, licensees shall ensure that outage, licensees need not meet the
performing for the licensee any of the individuals have, at a minimum— requirements of paragraph (d)(3) of this
duties listed in § 26.4(a) during the (i) A 10-hour break between section. However, licensees shall ensure
calculation period, the licensee shall successive work periods or an 8-hour that these individuals have at least 4
include in the calculation of the break between successive work periods days off in each successive (i.e., non-
individual’s work hours all work hours when a break of less than 10 hours is rolling) 15-day period; and
worked for the licensee, including hours necessary to accommodate a crew’s (ii) During the first 60 days of an
worked performing duties that are not scheduled transition between work unplanned security system outage or
listed in § 26.4(a), and control the schedules or shifts; and increased threat condition, licensees
individual’s work hours under the (ii) A 34-hour break in any 9-day need not meet the requirements of either
requirements of paragraph (d) of this period. paragraph (d)(3) or (d)(5)(i) of this
section. (3) Licensees shall ensure that section.
(4) Unannounced emergency individuals have, at a minimum, the (6) The 60-day periods in paragraphs
preparedness exercises and drills. number of days off specified in this (d)(4) and (d)(5) of this section may be
Licensees may exclude from the paragraph. For the purposes of this extended for each individual in 7-day
calculation of an individual’s work subpart, a day off is defined as a increments for each non-overlapping 7-
hours the time the individual works calendar day during which an day period the individual has worked
unscheduled work hours for the individual does not start a work shift. not more than 48 hours during the unit
purpose of participating in the actual For the purposes of calculating the or security system outage or increased
conduct of an unannounced emergency average number of days off required in threat condition, as applicable.
preparedness exercise or drill. this paragraph, the duration of the shift (e) Reviews. Licensees shall evaluate
(5) Incidental duties performed off cycle may not exceed 6 weeks. the effectiveness of their control of work
site. Licensees may exclude from the (i) Individuals who are working 8- hours of individuals who are subject to
calculation of an individual’s work hour shift schedules shall have at least this section. Licensees shall conduct the
hours unscheduled work performed off 1 day off per week, averaged over the reviews once per calendar year. If any
site (e.g., technical assistance provided shift cycle; plant or security system outages or
by telephone from an individual’s (ii) Individuals who are working 10- increased threat conditions occurred
home) provided the total duration of the hour shift schedules shall have at least since the licensee completed the most
work does not exceed a nominal 30 2 days off per week, averaged over the recent review, the licensee shall include
minutes during any single break period. shift cycle; in the review an evaluation of the
For the purposes of compliance with the (iii) Individuals who are working 12- control of work hours during the
minimum break requirements of hour shift schedules while performing outages or increased threat conditions.
paragraph (d)(2) of this section and the the duties described in § 26.4(a)(1) Licensees shall complete the review
minimum day off requirements of through (a)(3) shall have at least 2.5 within 30 days of the end of the review
paragraph (d)(3) through (d)(5) of this days off per week, averaged over the period. Licensees shall—
section, such duties do not constitute shift cycle; (1) Review the actual work hours and
work periods or work shifts. (iv) Individuals who are working 12- performance of individuals who are
(c) Work hours scheduling. Licensees subject to this section for consistency
hour shift schedules while performing
shall schedule the work hours of with the requirements of § 26.205(c). At
the duties described in § 26.4(a)(4) shall
individuals who are subject to this a minimum, this review must address—
have at least 2 days off per week,
section consistent with the objective of (i) Individuals whose actual hours
averaged over the shift cycle; and
preventing impairment from fatigue due worked during the review period
(v) Individuals who are working 12-
to the duration, frequency, or exceeded an average of 54 hours per
hour shift schedules while performing
sequencing of successive shifts. week in any shift cycle while the
(d) Work hour controls. Licensees the duties described in § 26.4(a)(5) shall
have at least 3 days off per week, individuals’ work hours are subject to
shall control the work hours of
averaged over the shift cycle. the requirements of § 26.205(d)(3);
individuals who are subject to this
(4) During the first 60 days of a unit (ii) Individuals who were granted
section.
(1) Except as permitted in § 26.207, outage, licensees need not meet the more than one waiver during the review
licensees shall ensure that any requirements of paragraph (d)(3) of this period; and
individual’s work hours do not exceed section for individuals specified in (iii) Individuals who were assessed
the following limits: § 26.4(a)(1) through (a)(4), while those for fatigue under § 26.211 during the
(i) 16 work hours in any 24-hour individuals are working on outage review period.
period; activities. However, the licensee shall (2) Review individuals’ hours worked
(ii) 26 work hours in any 48-hour ensure that the individuals specified in and the waivers under which work was
period; and § 26.4(a)(1) through (a)(3) have at least 3 performed to evaluate staffing adequacy
(iii) 72 work hours in any 7-day days off in each successive (i.e., non- for all jobs subject to the work hour
period. rolling) 15-day period and that the controls of this section;
(2) Licensees shall ensure that individuals specified in § 26.4(a)(4) (3) Document the methods used to
individuals have, at a minimum, the rest have at least 1 day off in any 7-day conduct the review and the results of
breaks specified in this paragraph. For period; the review; and
the purposes of this subpart, a break is (5) During the first 60 days of a unit (4) Record, trend, and correct, under
defined as an interval of time that falls outage, security system outage, or the licensee’s corrective action program,
between successive work periods, increased threat condition, licensees any problems identified in maintaining
during which the individual does not shall control the hours worked by control of work hours consistent with
perform any duties for the licensee other individuals specified in § 26.4(a)(5) as the specific requirements and
than one period of shift turnover at follows: performance objectives of this part.
§ 26.207 Waivers and exceptions. circumstances that necessitate the (1) For cause. In addition to any other
(a) Waivers. Licensees may grant a waiver, a statement of the scope of work test or determination of fitness that may
waiver of the work hour controls in and time period for which the waiver is be required under §§ 26.31(c) and 26.77,
§ 26.205(d)(1) through (d)(5)(i), as approved, and the bases for the a fatigue assessment must be conducted
follows: determinations required in paragraphs in response to an observed condition of
(1) To grant a waiver, the licensee (a)(1)(i) and (ii) of this section. impaired individual alertness creating a
shall meet both of the following (b) Force-on-force tactical exercises. reasonable suspicion that an individual
requirements: For the purposes of compliance with the is not fit to safely and competently
(i) An operations shift manager minimum days off requirements of perform his or her duties, except if the
determines that the waiver is necessary § 26.205(d)(3), licensees may exclude condition is observed during an
to mitigate or prevent a condition shifts worked by security personnel individual’s break period. If the
adverse to safety, or a security shift during the actual conduct of NRC- observed condition is impaired alertness
manager determines that the waiver is evaluated force-on-force tactical with no other behaviors or physical
necessary to maintain site security, or a exercises when calculating the conditions creating a reasonable
site senior-level manager with requisite individual’s number of days off. suspicion of possible substance abuse,
signature authority makes either (c) Common defense and security. then the licensee need only conduct a
determination; and When informed in writing by the NRC fatigue assessment. If the licensee has
(ii) A supervisor assesses the reason to believe that the observed
that the requirements of § 26.205, or any
individual face to face and determines condition is not due to fatigue, the
subset thereof, are waived for security
that there is reasonable assurance that licensee need not conduct a fatigue
personnel to ensure the common
the individual will be able to safely and assessment;
defense and security, licensees need not
competently perform his or her duties
during the additional work period for meet the specified requirements of (2) Self-declaration. A fatigue
which the waiver will be granted. The § 26.205 for the duration of the period assessment must be conducted in
supervisor performing the assessment defined by the NRC. response to an individual’s self-
shall be trained as required by §§ 26.29 (d) Plant emergencies. Licensees need declaration to his or her supervisor that
and 26.203(c) and shall be qualified to not meet the requirements of § 26.205(c) he or she is not fit to safely and
direct the work to be performed by the and (d) during declared emergencies, as competently perform his or her duties
individual. If there is no supervisor on defined in the licensee’s emergency for any part of a working tour because
site who is qualified to direct the work, plan. of fatigue, except if, following the self-
the assessment may be performed by a declaration, the licensee permits or
§ 26.209 Self-declarations. requires the individual to take a rest
supervisor who is qualified to provide
oversight of the work to be performed by (a) If an individual is performing, or break of at least 10 hours before the
the individual. At a minimum, the being assessed for, work under a waiver individual returns to duty;
assessment must address the potential of the requirements contained in (3) Post-event. A fatigue assessment
for acute and cumulative fatigue § 26.205(d)(1) through (d)(5)(i) and must be conducted in response to events
considering the individual’s work declares that, due to fatigue, he or she requiring post-event drug and alcohol
history for at least the past 14 days, the is unable to safely and competently testing as specified in § 26.31(c).
potential for circadian degradations in perform his or her duties, the licensee Licensees may not delay necessary
alertness and performance considering shall immediately stop the individual medical treatment in order to conduct a
the time of day for which the waiver from performing any duties listed in fatigue assessment; and
will be granted, the potential for fatigue- § 26.4(a), except if the individual is
(4) Followup. If a fatigue assessment
related degradations in alertness and required to continue performing those
was conducted for cause or in response
performance to affect risk-significant duties under other requirements of this
to a self-declaration, and the licensee
functions, and whether any controls and chapter. If the subject individual must
returns the individual to duty following
conditions must be established under continue performing the duties listed in
a break of less than 10 hours in
which the individual will be permitted § 26.4(a) until relieved, the licensee
duration, the licensee shall reassess the
to perform work. shall immediately take action to relieve
individual for fatigue as well as the
(2) To the extent practicable, licensees the individual.
need to implement controls and
shall rely on the granting of waivers (b) Following a self-declaration, as conditions before permitting the
only to address circumstances that described in paragraph (a) of this individual to resume performing any
could not have been reasonably section, the licensee— duties.
controlled; (1) May reassign the individual to
(b) Only supervisors and FFD program
(3) Licensees shall ensure that the duties other than those listed in
personnel who are trained under
timing of the face-to-face supervisory § 26.4(a), but only if the results of a
§§ 26.29 and 26.203(c) may conduct a
assessment that is required by paragraph fatigue assessment, conducted under the
fatigue assessment. The fatigue
(a)(1)(ii) of this section supports a valid requirements of § 26.211, indicate that
assessment must be conducted face to
assessment of the potential for worker the individual is fit to safely and
face with the individual whose alertness
fatigue during the time the individual competently perform those other duties;
may be impaired.
will be performing work under the and
waiver. Licensees may not perform the (2) Shall permit or require the (1) In the case of a fatigue assessment
face-to-face assessment more than 4 individual to take a break of at least 10 conducted for cause, the individual who
hours before the individual begins hours before the individual returns to observed the condition of impaired
performing any work under the waiver; performing any duties listed in § 26.4(a). alertness may not conduct the fatigue
assessment.
and
(4) Licensees shall document the § 26.211 Fatigue assessments. (2) In the case of a post-event fatigue
bases for individual waivers. The (a) Licensees shall ensure that fatigue assessment, the individual who
documented basis for a waiver must assessments are conducted under the conducts the fatigue assessment may not
include a description of the following conditions: have—
(i) Performed or directed (on site) the through (c). Each summary must written procedures that address the
work activities during which the event include— following topics:
occurred; (1) The conditions under which each (1) The methods and techniques to be
(ii) Performed, within 24 hours before fatigue assessment was conducted (i.e., used in testing for drugs and alcohol,
the event occurred, a fatigue assessment self-declaration, for cause, post-event, including procedures for protecting the
of the individuals who were performing followup); privacy of an individual who provides
or directing (on site) the work activities (2) A statement of whether or not the a specimen, procedures for protecting
during which the event occurred; and individual was working on outage the integrity of the specimen, and
(iii) Evaluated or approved a waiver of activities at the time of the self- procedures used to ensure that the test
the limits specified in § 26.205(d)(1) declaration or condition resulting in the results are valid and attributable to the
through (d)(5)(i) for any of the fatigue assessment; correct individual;
individuals who were performing or (3) The category of duties the (2) The immediate and followup
directing (on site) the work activities individual was performing, if the actions that will be taken, and the
during which the event occurred, if the individual was performing the duties procedures to be used, in those cases in
event occurred while such individuals described in § 26.4(a)(1) through (a)(5) at which individuals who are subject to
were performing work under that the time of the self-declaration or the FFD program are determined to
waiver. condition resulting in the fatigue have—
(c) A fatigue assessment must provide assessment; and (i) Been involved in the use, sale, or
the information necessary for (4) The management actions, if any, possession of illegal drugs;
management decisions and actions in resulting from each fatigue assessment. (ii) Consumed alcohol to excess before
response to the circumstance that or while constructing safety-or security-
Subpart J—[Reserved]
initiated the assessment. related SSCs, as determined by a test
(1) At a minimum, the fatigue that accurately measures BAC;
assessment must address the following Subpart K—FFD Program for
(iii) Attempted to subvert the testing
factors: Construction
process by adulterating or diluting
(i) Acute fatigue; § 26.401 General. specimens (in vivo or in vitro),
(ii) Cumulative fatigue; and (a) At the licensee’s or other entity’s substituting specimens, or by any other
(iii) Circadian variations in alertness means;
discretion, a licensee or other entity in
and performance. (iv) Refused to provide a specimen for
§ 26.3(c) may establish, implement, and
(2) Individuals shall provide complete analysis; or
maintain an FFD program that meets the
and accurate information that may be (v) Had legal action taken relating to
requirements of this subpart to apply to
required by the licensee to address the drug or alcohol use.
the individuals specified in § 26.4(f). If
factors listed in paragraph (c)(1) of this (3) The process to be followed if an
a licensee or other entity in § 26.3(c)
section. Licensees shall limit any individual’s behavior or condition raises
does not elect to implement an FFD
inquiries to obtaining from the subject a concern regarding the possible use,
program that meets the requirements of
individual only the personal sale, or possession of illegal drugs on or
this subpart, the individuals specified in
information that may be necessary to § 26.4(f) shall be subject to an FFD off site; the possible use or possession
assess the factors listed in paragraph program that meets the requirements of of alcohol while constructing safety-or
(c)(1) of this section. subparts A through H, N, and O of this security-related SSCs; or impairment
(d) The licensee may not conclude from any cause which in any way could
part.
that fatigue has not or will not degrade (b) Entities who intend to implement adversely affect the individual’s ability
the individual’s ability to safely and an FFD program under this subpart shall to safely and competently perform his or
competently perform his or her duties submit a description of the FFD program her duties.
solely on the basis that the individual’s and its implementation as part of the
work hours have not exceeded any of § 26.405 Drug and alcohol testing.
license, permit, or limited work
the limits specified in § 26.205(d)(1) or authorization application. (a) To provide means to deter and
that the individual has had the (c) Nothing in this subpart prohibits detect substance abuse, licensees and
minimum breaks required in the licensees and other entities in other entities who implement an FFD
§ 26.205(d)(2) or minimum days off § 26.3(c) from subjecting the individuals program under this subpart shall
required in § 26.205(d)(3) through (d)(5), in § 26.4(f) to an FFD program that perform drug and alcohol testing that
as applicable. meets all of the requirements of this part complies with the requirements of this
(e) Following a fatigue assessment, the or FFD program elements that meet all section.
licensee shall determine and implement of the applicable requirements of this (b) If the licensee or other entity elects
the controls and conditions, if any, that part. to impose random testing for drugs and
are necessary to permit the individual to alcohol on the individuals identified in
resume performing duties for the § 26.403 Written policy and procedures. § 26.4(f), random testing must—
licensee, including the need for a break. (a) Licensees and other entities who (1) Be administered in a manner that
(f) Licensees shall document the implement an FFD program under this provides reasonable assurance that
results of any fatigue assessments subpart shall ensure that a clear, individuals are unable to predict the
conducted, the circumstances that concise, written FFD policy statement is time periods during which specimens
necessitated the fatigue assessment, and provided to individuals who are subject will be collected;
any controls and conditions that were to the program. The policy statement (2) Require individuals who are
implemented. must be written in sufficient detail to selected for random testing to report to
(g) Licensees shall also prepare an provide affected individuals with the collection site as soon as reasonably
annual summary for each nuclear power information on what is expected of them practicable after notification, within the
plant site of instances of fatigue and what consequences may result from time period specified in the FFD
assessments that were conducted during a lack of adherence to the policy. program policy;
the previous calendar year for any (b) Licensees and other entities shall (3) Ensure that all individuals in the
individual identified in § 26.4(a) develop, implement, and maintain population that is subject to random
testing on a given day have an equal drug testing must be subject to validity impairment from any cause that if left
probability of being selected and tested; testing. unattended may result in a risk to
and (e) The specimen collection and drug public health and safety or the common
(4) Provide that an individual and alcohol testing procedures of FFD defense and security.
completing a test is immediately eligible programs under this subpart must (c) Licensees and other entities shall
for another random test. protect the donor’s privacy and the establish procedures that monitors shall
(c) Individuals identified in § 26.4(f) integrity of the specimen, and follow in response to the indications
shall be subject to drug and alcohol implement stringent quality controls to and actions specified in paragraph (b) of
testing under the following conditions: ensure that test results are valid and this section and train the monitors to
(1) Pre-assignment. Before assignment attributable to the correct individual. At implement the program.
to construct safety-or security-related the licensee’s or other entity’s (d) Licensees and other entities shall
SSCs; discretion, specimen collections and ensure that the fitness of individuals
(2) For-cause. In response to an alcohol testing may be conducted at a specified in § 26.4(f) is monitored
individual’s observed behavior or local hospital or other facility under the effectively while the individuals are
physical condition indicating possible specimen collection and alcohol testing constructing safety- and security-related
substance abuse or after receiving requirements of 49 CFR Part 40 and SSCs, commensurate with the potential
credible information that an individual subsequent amendments thereto. risk to public health and safety and the
is engaging in substance abuse, as (f) Testing of urine specimens for common defense and security imposed
defined in § 26.5; drugs and validity, except validity by the construction activity. To achieve
screening and initial drug and validity this objective, licensees and other
(3) Post-accident. As soon as practical
tests that may be performed by licensee entities shall consider the number and
after an event involving a human error
testing facilities, must be performed in placement of monitors required, the
that was committed by an individual
a laboratory that is certified by HHS for necessary ratio of monitors to
specified in § 26.4(f), where the human
that purpose, consistent with its individuals specified in § 26.4(f), and
error may have caused or contributed to
standards and procedures for the frequency with which the
the accident. The licensee or other
certification. Any initial drug test individuals specified in § 26.4(f) shall
entity shall test the individual(s) who
performed by a licensee or other entity be monitored while constructing each
committed the error(s), and need not
subject to this subpart must use an safety- or security-related SSC.
test individuals who were affected by
immunoassay that meets the
the event but whose actions likely did § 26.407 Behavioral observation.
requirements of the Food and Drug
not cause or contribute to the event. The
Administration for commercial While the individuals specified in
individual(s) who committed the human
distribution. Urine specimens that yield § 26.4(f) are constructing safety- or
error(s) shall be tested if the event
positive, adulterated, substituted, or security-related SSCs, licensees and
resulted in—
invalid initial validity or drug test other entities shall ensure that these
(i) A significant illness or personal
results must be subject to confirmatory individuals are subject to behavioral
injury to the individual to be tested or
testing by the HHS-certified laboratory, observation, except if the licensee or
another individual, which within 4
except for invalid specimens that cannot other entity has implemented a fitness
hours after the event is recordable under
be tested. Other specimens that yield monitoring program under § 26.406.
the Department of Labor standards
positive initial drug test results must be
contained in 29 CFR 1904.7, and § 26.409 Sanctions.
subject to confirmatory testing by a
subsequent amendments thereto, and Licensees and other entities who
laboratory that meets stringent quality
results in death, days away from work, implement an FFD program under this
control requirements that are
restricted work, transfer to another job, subpart shall establish sanctions for FFD
comparable to those required for
medical treatment beyond first aid, loss policy violations that, at a minimum,
certification by the HHS.
of consciousness, or other significant (g) Licensees and other entities shall prohibit the individuals specified in
illness or injury as diagnosed by a provide for an MRO review of positive, § 26.4(f) from being assigned to
physician or other licensed health care adulterated, substituted, and invalid construct safety- or security-related
professional, even if it does not result in confirmatory drug and validity test SSCs unless or until the licensee or
death, days away from work, restricted results to determine whether the donor other entity determines that the
work or job transfer, medical treatment has violated the FFD policy, before individual’s condition or behavior does
beyond first aid, or loss of reporting the results to the individual not pose a potential risk to public health
consciousness; or designated by the licensee or other and safety or the common defense and
(ii) Significant damage, during entity to perform the suitability and security.
construction, to any safety-or security- fitness evaluations required under
related SSC; and § 26.411 Protection of information.
§ 26.419.
(4) Followup. As part of a followup (a) Licensees and other entities who
plan to verify an individual’s continued § 26.406 Fitness monitoring. collect personal information about an
abstinence from substance abuse. (a) The requirements in this section individual for the purpose of complying
(d) At a minimum, licensees and other apply only if a licensee or other entity with this subpart shall establish and
entities shall test specimens for does not elect to subject the individuals maintain a system of files and
marijuana metabolite, cocaine specified in § 26.4(f) to random testing procedures to protect the personal
metabolite, opiates (codeine, morphine, for drugs and alcohol under § 26.405(b). information. FFD programs must
6-acetylmorphine), amphetamines (b) Licensees and other entities shall maintain and use such records with the
(amphetamine, methamphetamine), implement a fitness monitoring program highest regard for individual privacy.
phencyclidine, adulterants, and alcohol to deter substance abuse and detect (b) Licensees and other entities shall
at the cutoff levels specified in this part, indications of possible use, sale, or obtain a signed consent that authorizes
or comparable cutoff levels if specimens possession of illegal drugs; use or the disclosure of the personal
other than urine are collected for drug possession of alcohol while constructing information collected and maintained
testing. Urine specimens collected for safety-or security-related SSCs; or under this subpart before disclosing the
personal information, except for discovers any intentional act that casts of his or her right to review information
disclosures to the individuals and doubt on the integrity of the FFD about the individual that is collected
entities specified in § 26.37(b)(1) program and any programmatic failure, and maintained under this part to assure
through (b)(6), (b)(8), and persons degradation, or discovered vulnerability its accuracy. Licensees and other
deciding matters under review in of the FFD program that may permit entities shall provide the individual
§ 26.413. undetected drug or alcohol use or abuse with an opportunity to correct any
by individuals who are subject to this inaccurate or incomplete information
§ 26.413 Review process. subpart. These events must be reported that is documented by licensees and
Licensees and other entities who under this subpart, rather than under other entities about the individual.
implement an FFD program under this the provisions of 10 CFR 73.71; and (d) Licensees and other entities shall
subpart shall establish and implement (2) Annual program performance ensure that only correct and complete
procedures for the review of a reports for the FFD program. information about individuals is
determination that an individual in retained and shared with other licensees
§ 26.4(f) has violated the FFD policy. § 26.419 Suitability and fitness
evaluations. and entities. If, for any reason, the
The procedure must provide for an shared information used for determining
objective and impartial review of the Licensees and other entities who
implement FFD programs under this an individual’s eligibility for
facts related to the determination that authorization under this part changes or
the individual has violated the FFD subpart shall develop, implement, and
maintain procedures for evaluating new information is developed about the
policy. individual, licensees and other entities
whether to assign individuals to
§ 26.415 Audits. construct safety- and security-related shall correct or augment the shared
SSCs. These procedures must provide information contained in the records. If
(a) Licensees and other entities who
reasonable assurance that the the changed or developed information
implement an FFD program under this
individuals are fit to safely and has implications for adversely affecting
subpart shall ensure that audits are
competently perform their duties, and an individual’s eligibility for
performed to assure the continuing
are trustworthy and reliable, as authorization, a licensee and other
effectiveness of the FFD program,
demonstrated by the avoidance of entity specified in § 26.3(a) and, as
including FFD program elements that
substance abuse. applicable, (c) and (d), who has
are provided by C/Vs, and the FFD
discovered the incorrect information, or
programs of C/Vs that are accepted by
Subpart L—[Reserved] develops new information, shall inform
the licensee or other entity.
(b) Each licensee and other entity the reviewing official of any FFD
shall ensure that these programs are Subpart M—[Reserved] program under which the individual is
audited at a frequency that assures their maintaining authorization of the
continuing effectiveness and that Subpart N—Recordkeeping and updated information on the day of
corrective actions are taken to resolve Reporting Requirements discovery. The reviewing official shall
any problems identified. Licensees and evaluate the information and take
§ 26.709 Applicability. appropriate actions, which may include
entities may conduct joint audits, or The requirements of this subpart
accept audits of C/Vs conducted by denial or unfavorable termination of the
apply to the FFD programs of licensees individual’s authorization.
others, so long as the audit addresses and other entities specified in § 26.3,
the relevant C/Vs’ services. except for FFD programs that are § 26.713 Recordkeeping requirements for
(c) Licensees and other entities need implemented under subpart K of this licensees and other entities.
not audit HHS-certified laboratories or part. (a) Each licensee and other entity who
the specimen collection and alcohol is subject to this subpart shall retain the
testing services that meet the § 26.711 General provisions. following records for at least 5 years
requirements of 49 CFR Part 40, (a) Each licensee and other entity after the licensee or other entity
‘‘Procedures for Department of shall maintain records and submit terminates or denies an individual’s
Transportation Workplace Drug and certain reports to the NRC. Records that authorization or until the completion of
Alcohol Testing Programs’’ (65 FR are required by the regulations in this all related legal proceedings, whichever
41944; August 9, 2001), on which part must be retained for the period is later:
licensees and other entities may rely to specified by the appropriate regulation. (1) Records of self-disclosures,
meet the drug and alcohol testing If a retention period is not otherwise employment histories, and suitable
requirements of this subpart. specified, these records must be inquiries that are required under
retained until the Commission §§ 26.55, 26.57, 26.59, and 26.69 that
§ 26.417 Recordkeeping and reporting.
terminates the facility’s license, result in the granting of authorization;
(a) Licensees and other entities who certificate, or other regulatory approval.
implement FFD programs under this (2) Records pertaining to the
(b) All records may be stored and
subpart shall ensure that records determination of a violation of the FFD
archived electronically, provided that
pertaining to the administration of the policy and related management actions;
the method used to create the electronic
program, which may be stored and (3) Documentation of the granting and
records meets the following criteria:
archived electronically, are maintained (1) Provides an accurate termination of authorization; and
so that they are available for NRC representation of the original records; (4) Records of any determinations of
inspection purposes and for any legal (2) Prevents the alteration of any fitness conducted under § 26.189,
proceedings resulting from the archived information and/or data once it including any recommendations for
administration of the program. has been committed to storage; and treatment and followup testing plans.
(b) Licensees and other entities shall (3) Permits easy retrieval and re- (b) Each licensee and other entity who
make the following reports: creation of the original records. is subject to this subpart shall retain the
(1) Reports to the NRC Operations (c) The licensees and other entities following records for at least 3 years or
Center by telephone within 24 hours specified in § 26.3(a) and, as applicable, until the completion of all related legal
after the licensee or other entity (c) and (d), shall inform each individual proceedings, whichever is later:
(1) Records of FFD training and documentation of all aspects of the § 26.717 Fitness-for-duty program
examinations conducted under § 26.29; testing process for at least 2 years or performance data.
and until the completion of all legal (a) Licensees and other entities shall
(2) Records of audits, audit findings, proceedings related to a determination collect and compile FFD program
and corrective actions taken under of an FFD violation, whichever is later. performance data for each FFD program
§ 26.41. This 2-year period may be extended on that is subject to this subpart.
(c) Licensees and other entities shall written notification by the NRC or by (b) The FFD program performance
ensure the retention and availability of any licensee or other entity for whom data must include the following
records pertaining to any 5-year denial services are being provided. information:
of authorization under § 26.75(c), (d), or (b) Documentation that must be (1) The random testing rate;
(e)(2) and any permanent denial of retained includes, but is not limited to, (2) Drugs for which testing is
authorization under § 26.75(b) and (g) the following: conducted and cutoff levels, including
for at least 40 years or until, on (1) Personnel files, including training results of tests using lower cutoff levels,
application, the NRC determines that records, for all individuals who have tests for drugs not included in the HHS
the records are no longer needed. been authorized to have access to panel, and any special analyses of dilute
(d) Licensees and other entities shall specimens, but are no longer under specimens permitted under
retain any superseded versions of the contract to or employed by the § 26.163(a)(2);
written FFD policy and procedures (3) Populations tested (i.e.,
collection site, licensee testing facility,
required under §§ 26.27, 26.39, and individuals in applicant status,
or HHS-certified laboratory;
26.203(b) for at least 5 years or until permanent licensee employees, C/Vs);
(2) Chain-of-custody documents (4) Number of tests administered and
completion of all legal proceedings (other than forms recording specimens
related to an FFD violation that may results of those tests sorted by
with negative test results and no FFD population tested (i.e., individuals in
have occurred under the policy and violations or anomalies, which may be
procedures, whichever is later. applicant status, permanent licensee
destroyed after appropriate summary employees, C/Vs);
(e) Licensees and other entities shall information has been recorded for
retain written agreements for the (5) Conditions under which the tests
program administration purposes); were performed, as defined in
provision of services under this part for
(3) Quality assurance and quality § 26.31(c);
the life of the agreement or until
control records; (6) Substances identified;
completion of all legal proceedings
related to an FFD policy violation that (4) Superseded procedures; (7) Number of subversion attempts by
involved those services, whichever is (5) All test data (including calibration type;
later. curves and any calculations used in (8) Summary of management actions;
(f) Licensees and other entities shall determining test results); and
retain records of the background (6) Test reports; (9) The information required under
investigations, credit and criminal (7) Records pertaining to performance § 26.203(e)(1) and (e)(2).
history checks, and psychological testing; (c) Licensees and other entities who
assessments of FFD program personnel, (8) Records pertaining to the have a licensee-approved FFD program
conducted under § 26.31(b)(1)(i), for the investigation of testing errors or shall analyze the data at least annually
length of the individual’s employment unsatisfactory performance discovered and take appropriate actions to correct
by or contractual relationship with the in quality control or blind performance any identified program weaknesses.
licensee or other entity, or until the testing, in the testing of actual Records of the data, analyses, and
completion of all related legal specimens, or through the processing of corrective actions taken must be
proceedings, whichever is later. appeals and MRO reviews, as well as retained for at least 3 years or until the
(g) If a licensee’s or other entity’s FFD any other errors or matters that could completion of any related legal
program includes tests for drugs in adversely reflect on the integrity of the proceedings, whichever is later.
addition to those specified in this part, testing process, investigation findings, (d) Any licensee or other entity who
as permitted under § 26.31(d)(1), or uses and corrective actions taken, where terminates an individual’s authorization
more stringent cutoff levels than those applicable; or takes administrative action on the
specified in this part, as permitted basis of the results of a positive initial
(9) Performance records on
under § 26.31(d)(3), the licensee or other drug test for marijuana or cocaine shall
certification inspections;
entity shall retain documentation also report these test results in the
(10) Records of preventative annual summary by processing stage
certifying the scientific and technical maintenance on licensee testing facility
suitability of the assays and cutoff levels (i.e., initial testing at the licensee testing
instruments; facility, testing at the HHS-certified
used, as required under § 26.31(d)(1)(i) (11) Records that summarize any test
and (d)(3)(iii)(C), respectively, for the laboratory, and MRO determinations).
results that the MRO determined to be The report must also include the
time the FFD program follows these scientifically insufficient for further
practices or until the completion of all number of terminations and
action; administrative actions taken against
related legal proceedings, whichever is (12) Either printed or electronic
later. individuals for the reporting period.
copies of computer-generated data; (e) Licensees and other entities shall
§ 26.715 Recordkeeping requirements for (13) Records that document the dates, submit the FFD program performance
collection sites, licensee testing facilities, times of entry and exit, escorts, and data (for January through December) to
and laboratories certified by the Department purposes of entry of authorized visitors, the NRC annually, before March 1 of the
of Health and Human Services. maintenance personnel, and service following year.
(a) Collection sites providing services personnel who have accessed secured (f) Licensees and other entities may
to licensees and other entities who are areas of licensee testing facilities and submit the FFD program performance
subject to this subpart, licensee testing HHS-certified laboratories; and data in a consolidated report, as long as
facilities, and HHS-certified laboratories (14) Records of the inspection, the report presents the data separately
shall maintain and make available maintenance, and calibration of EBTs. for each site.
(g) Each C/V who maintains a unsatisfactory performance discovered § 26.823 Violations.
licensee-approved drug and alcohol in performance testing at either a (a) An injunction or other court order
testing program is subject to the licensee testing facility or an HHS- may be obtained to prohibit a violation
reporting requirements of this section certified laboratory, in the testing of of any provision of—
and shall submit the required quality control or actual specimens, or (1) The Atomic Energy Act of 1954, as
information either directly to the NRC through the processing of reviews under amended;
or through the licensee’s) or other § 26.39 and MRO reviews under (2) Title II of the Energy
entities to whom the C/V provided § 26.185, as well as any other errors or Reorganization Act of 1974; or
services during the year. Licensees, matters that could adversely reflect on (3) Any regulation or order issued
other entities, and C/Vs shall share the integrity of the random selection or under these Acts.
information to ensure that the testing process, the licensee or other (b) A court order may be obtained for
information is reported completely and entity shall submit to the NRC a report the payment of a civil penalty imposed
is not duplicated in reports submitted to of the incident and corrective actions under section 234 of the Atomic Energy
the NRC. taken or planned. If the error involves Act of 1954, for violations of—
an HHS-certified laboratory, the NRC (1) Section 53, 57, 62, 63, 81, 82, 101,
§ 26.719 Reporting requirements. shall ensure that HHS is notified of the 103, 104, 107, or 109 of the Act;
(a) Required reports. Each licensee finding. (2) Section 206 of the Energy
and entity who is subject to this subpart Reorganization Act of 1974;
(2) If a false positive error occurs on
shall inform the NRC of significant (3) Any rule, regulation, or order
a blind performance test sample
violations of the FFD policy, significant issued under these sections;
submitted to an HHS-certified
FFD program failures, and errors in drug (4) Any term, condition, or limitation
laboratory, the licensee or other entity
and alcohol testing. These events must of any license issued under these
shall notify the NRC within 24 hours
be reported under this section, rather sections; or
after discovery of the error.
than under the provisions of 10 CFR (5) Any provisions for which a license
73.71. (3) If a false negative error occurs on
a quality assurance check of validity may be revoked under section 186 of the
(b) Significant FFD policy violations Atomic Energy Act of 1954.
or programmatic failures. The following screening tests, as required in
significant FFD policy violations and § 26.137(b), the licensee or other entity 26.825 Criminal penalties.
programmatic failures must be reported shall notify the NRC within 24 hours (a) Section 223 of the Atomic Energy
to the NRC Operations Center by after discovery of the error. Act of 1954, as amended, provides for
telephone within 24 hours after the (d) Indicators of programmatic criminal sanctions for willful violation
licensee or other entity discovers the weaknesses. Licensees and other entities of, attempted violation of, or conspiracy
violation: shall document, trend, and correct non- to violate, any regulation issued under
(1) The use, sale, distribution, reportable indicators of FFD sections 161b, 161i, or 161o of the Act.
possession, or presence of illegal drugs, programmatic weaknesses under the For the purposes of section 223, all of
or the consumption or presence of licensee’s or other entity’s corrective the regulations in Part 26 are issued
alcohol within a protected area; action program, but may not track or under one or more of sections 161b,
(2) Any acts by any person licensed trend drug and alcohol test results in a 161i, or 161o, except for the sections
under 10 CFR parts 52 and/or 55 to manner that would permit the listed in paragraph (b) of this section.
operate a power reactor, as well as any identification of any individuals. (b) The regulations in Part 26 that are
acts by SSNM transporters, FFD not issued under sections 161b, 161i, or
program personnel, or any supervisory Subpart O—Inspections, Violations, 161o for the purposes of section 223 are
personnel who are authorized under and Penalties as follows: §§ 26.1, 26.3, 26.5, 26.7, 26.8,
this part, if such acts— 26.9, 26.11, 26.51, 26.81, 26.121, 26.151,
§ 26.821 Inspections.
(i) Involve the use, sale, or possession 26.181, 26.201, 26.823, and 26.825.
of a controlled substance; (a) Each licensee and other entity who
(ii) Result in a determination that the * * * * *
is subject to this part shall permit duly
individual has violated the licensee’s or authorized NRC representatives to Dated at Rockville, Maryland, this 7th day
other entity’s FFD policy (including inspect, copy, or take away copies of its of March, 2008.
subversion as defined in § 26.5); or records and to inspect its premises, For the Nuclear Regulatory Commission.
(iii) Involve the consumption of activities, and personnel as may be Annette Vietti-Cook,
alcohol within a protected area or while necessary to accomplish the purposes of Secretary of the Commission.
performing the duties that require the this part.
individual to be subject to the FFD Note: This Appendix will not appear in
(b) Written agreements between The Code of Federal Regulations.
program; licensees or other entities and their C/
(3) Any intentional act that casts Vs must clearly show that— Appendix A to This Document—
doubt on the integrity of the FFD
(1) The licensee or other entity is Derivation and Distribution Tables for
program; and
(4) Any programmatic failure, responsible to the NRC for maintaining Part 26.
degradation, or discovered vulnerability an effective FFD program under this
of the FFD program that may permit part; and TABLE 1.—DERIVATION TABLE FOR
undetected drug or alcohol use or abuse (2) Duly authorized NRC PART 26
by individuals within a protected area, representatives may inspect, copy, or
take away copies of any licensee’s, other New section Based on
or by individuals who are assigned to
perform duties that require them to be entity’s, or C/V’s documents, records, 26.1 ........................... 26.1 first sentence.
subject to the FFD program. and reports related to implementation of 26.3(a) ....................... 26.2(a).
(c) Drug and alcohol testing errors. (1) the licensee’s or other entity’s FFD 26.3(b) ....................... 26.1 (2nd sentence)
Within 30 days of completing an program under the scope of the and 26.2(a) (1st
investigation of any testing errors or contracted activities. sentence).
TABLE 1.—DERIVATION TABLE FOR TABLE 1.—DERIVATION TABLE FOR TABLE 1.—DERIVATION TABLE FOR
PART 26—Continued PART 26—Continued PART 26—Continued
New section Based on New section Based on New section Based on
26.3(c) ....................... 26.2(c). 26.31(d) ..................... NEW. 26.67(c) ..................... NEW.

26.3(d) ....................... 26.23(a)(1). 26.31(d)(1) ................ Section 2.1(a) in Ap- 26.69 ......................... 26.27(b)(4).
26.3(e) ....................... 26.2(b). pendix A to Part 26.69(a) ..................... NEW. 26.27(b)(2).
26.4(a) ....................... 26.2(a) and 26.2(d). 26. 26.69(b)(1) ................ NEW.
26.4(b) ....................... 26.2(a) and 26.2(d). 26.31(d)(1)(i)(A) ........ 26.24(c). 26.69(b)(2) ................ NEW. 26.27(b)(2).
26.4(c) ....................... 26.2(a) and 26.2(d). 26.31(d)(1)(i)(B) ........ 26.24(c). 26.69(b)(3) ................ 26.27(b)(4).
26.4(d) ....................... 26.2(a) and 26.2(d). 26.31(d)(1)(i)(C) ........ Section 2.1(c). 26.69(b)(4) ................ 26.27(b)(2).
26.4(e) ....................... NEW. 26.31(d)(1)(i)(D) ........ 26.31(d)(1)(i)(C). 26.69(b)(5) ................ NEW.
26.4(f) ........................ NEW. 26.31(d)(1)(ii) ............ Section 2.1(b) and 26.69(b)(6) ................ 26.27(b)(4).
26.4(g) ....................... NEW. 26.31(d)(1)(i)(D). 26.69(b)(7) ................ NEW.
26.4(h) ....................... NEW. 26.31(d)(1)(iii) ............ NEW. 26.69(c)(1) ................. NEW.
26.4(i)(1) .................... 26.20(a). 26.31(d)(2) ................ 26.24(a). 26.69(c)(2) ................. NEW.
26.4(i)(2) .................... 26.2(b) first sentence. 26.31(d)(3) ................ NEW. 26.69(c)(3) ................. NEW.
26.4(i)(3) .................... 26.2(b) first sentence. 26.31(d)(3)(i) ............. Appendix A Subpart 26.69(c)(4) ................. NEW.
26.4(i)(4) .................... NEW. A 1.1(3); 26.24(f); 26.69(c)(5) ................. NEW.
26.4(j) ........................ NEW. Appendix A Sub- 26.69(d) ..................... NEW.
26.5 ........................... 26.3 and Appendix A part B 2.8(e); 2.8(a) 26.69(e) ..................... NEW.
Subpart 1.2. and (b). 26.69(f) ...................... 26.27(a)(2).
26.7 ........................... 26.4. 26.31(d)(3)(ii) ............ 26.24(d)(1). 26.71 ......................... NEW.
26.8 ........................... 26.8. 26.31(d)(3)(iii) ............ Sections 2.7(e)(1) 26.73 ......................... NEW.
26.9 ........................... 26.6. and (f)(2). 26.75(a) (1st sen- NEW.
26.11 ......................... NEW. 26.31(d)(3)(iii)(A) ....... 26.24(b). tence).
26.21 ......................... 26.23(b). 26.31(d)(3)(iii)(B) ....... NEW. 26.75(a) (2nd sen- 26.27(b) (1st sen-
26.23(a) ..................... 26.10(a). 26.31(d)(3)(iii)(C) ....... NEW. tence). tence).
26.23(b) ..................... 26.10(a). 26.31(d)(4) ................ 26.24(g). 26.75(b) ..................... NEW.
26.23(c) ..................... 26.10(b). 26.31(d)(5) ................ NEW. 26.75(c) ..................... 26.27(b)(3).
26.23(d) ..................... 26.10(c). 26.31(d)(6) ................ Section 2.1(d). 26.75(d) ..................... 26.27(c).
26.23(e) ..................... NEW. 26.33 ......................... 26.22. 26.75(e) ..................... 26.27(b)(2).
26.27(a) ..................... 26.20 1st paragraph. 26.35 ......................... 26.25. 26.75(f) ...................... 26.27(b)(5).
26.27(b)(1) ................ 26.20(a). 26.37 ......................... 26.29. 26.75(g) ..................... 26.27(b)(4).
26.27(b)(2) ................ NEW. 26.39 ......................... 26.27. 26.75(h) ..................... 26.24(d)(2).
26.27(b)(3) ................ NEW. 26.41(a) ..................... 26.80(a). 26.75(i) ...................... 26.24(d)(2).
26.27(b)(4)(i) ............. 26.20(a)(1). 26.41(b) ..................... 26.80(a). 26.77 ......................... 26.26(b)(1).
26.27(b)(4)(ii) ............ 26.20(a)(2). 26.41(c) ..................... 26.80(a); Appendix A 26.77(a) ..................... NEW.
26.27(b)(5) ................ NEW. Subpart B 2.7(m). 26.77(b)(1) ................ 26.27(b)(1).
26.27(b)(6) ................ 26.20(a). 26.41(d) ..................... Section 2.7(m). 26.77(b)(2) ................ NEW.
26.27(b)(7) ................ 26.20(b). 26.41(e) ..................... 26.80(b). 26.77(b)(3) ................ NEW.
26.27(b)(8) ................ 26.20(d). 26.41(f) ...................... 26.80(c). 26.77(c) ..................... 26.27(d).
26.27(b)(9) ................ NEW. 26.41(g) ..................... 26.80(a). 26.83(b) ..................... 26.24(b).
26.27(b)(10) .............. NEW. 26.51 ......................... 26.1. 26.85(a) ..................... Appendix A Subpart
26.27(b)(11) .............. NEW. 26.53 ......................... NEW. B 2.2(d).
26.27(c)(1) ................. 26.20(c). 26.55(a) ..................... NEW. 26.85(b) ..................... NEW.
26.27(c)(2) ................. 26.20(d). 26.55(b) ..................... NEW. 26.85(c) ..................... Appendix A Subpart
26.27(c)(3) ................. 26.20(e). 26.57(a) ..................... NEW. B 2.2(d)(2) (last
26.27(c)(4) ................. NEW. 26.57(b) ..................... NEW. sentence).
26.27(d) ..................... 26.20(f). 26.59 ......................... NEW. 26.85(d) ..................... Appendix A Subpart
26.29(a) ..................... 26.21(a)(1)–(5); 26.61 ......................... 26.27(a)(1). B 2.7(o)(5).
26.22(a)(1)–(5); 26.61(a) ..................... NEW. 26.85(e) ..................... NEW.
26.22(b). 26.61(b) ..................... NEW. 26.87(a) ..................... Appendix A Subpart
26.29(b) ..................... NEW. 26.61(c) ..................... NEW. B 2.4(a).
26.29(c) ..................... 26.21(b) and 26.61(d) ..................... 26.27(a)(4). 26.87(b) ..................... Appendix A Subpart
26.21(c). 26.63 ......................... 26.27(a)(2). B 2.4(f) (1st sen-
26.31 ......................... 26.24. 26.63(a) ..................... NEW. tence).
26.31(a) ..................... 26.24(a). 26.63(b) ..................... NEW. 26.87(c) ..................... Appendix A Subpart
26.31(b) ..................... Section 2.3 in Appen- 26.63(c) ..................... NEW. B 2.7(m).
dix A to Part 26. 26.63(d) ..................... NEW. 26.87(d) ..................... Appendix A Subpart
26.31(b)(1) ................ First paragraph, Sec- 26.63(e) ..................... NEW. B 2.4(c).
tion 2.3 in Appen- 26.63(f)(1) ................. 26.71(c) and 26.87(d)(1) ................ Appendix A Subpart
dix A to Part 26. 26.27(b)(2)(vii). B 2.4(e).
26.31(b)(1)(i) ............. Section 2.3(2). 26.63(f)(2) ................. NEW. 26.87(d)(2) ................ Appendix A Subpart
26.31(b)(1)(ii) ............ Section 2.3(1). 26.63(f)(3) ................. NEW. B 2.4(c) (2nd sen-
26.31(b)(1)(iii) ............ Section 2.3(1). 26.65 ......................... 26.24(a)(1). tence).
26.31(b)(1)(iv) ........... NEW. 26.65(a) ..................... NEW. 26.87(d)(3) ................ Appendix A Subpart
26.31(b)(1)(v) ............ Section 2.3(3). 26.65(b) ..................... NEW. B 2.4(c).
26.31(b)(2) ................ NEW. 26.65(c) ..................... NEW. 26.87(e) ..................... NEW.
26.31(c) ..................... 26.24(a)(1)–(4). 26.65(d) ..................... NEW. 26.87(e)(2) ................ Appendix A Subpart
26.31(c)(1) ................. 26.24(a)(1). 26.65(e) ..................... NEW. B 2.4(g)(1) (2nd

26.31(c)(2) ................. 26.24(a)(3). 26.65(f) ...................... NEW. sentence).
26.31(c)(3) ................. 26.24(a)(3). 26.65(g) ..................... NEW. 26.87(e)(3) ................ NEW.
26.31(c)(4) ................. 26.24(a)(4). 26.67(a) ..................... NEW. 26.87(f)(1) ................. Appendix A Subpart
26.31(c)(5) ................. 26.24(a)(2). 26.67(b) ..................... NEW. B 2.4(c)(1).
26.87(f)(2) ................. Appendix A Subpart 26.111(e) ................... NEW. 26.129(b) ................... Appendix A Subpart
B 2.4(g)(10) (3rd 26.111(f) .................... NEW. B 2.2(b)(1).
sentence). 26.113(a) ................... NEW. 26.129(c) ................... Appendix A Subpart
26.87(f)(3) ................. Appendix A Subpart 26.113(b) ................... Appendix A Subpart B 2.7(b)(2).
B 2.4(g)(10) (2nd B 2.4(g)(20) and 26.129(d) ................... Appendix A Subpart
sentence). 2.7(j). B 2.7(a)(2).
26.87(f)(4) ................. Appendix A Subpart 26.113(c) ................... NEW. 26.129(e) ................... Appendix A Subpart
B 2.4(g)(10) and 26.115(a)(1) .............. Appendix A Subpart B 2.7(d) 1st sen-
new material. B 2.4(f)(2). tence.
26.87(f)(5) ................. Appendix A Subpart 26.115(a)(2) .............. Appendix A Subpart 26.129(f) .................... Appendix A Subpart
B 2.4(c)(2). B 2.4(f)(1) and B 2.7(c).
26.89(a) ..................... Appendix A Subpart (g)(14). 26.129(g) ................... Appendix A Subpart
B 2.4(g)(3). 26.115(a)(3) .............. Appendix A Subpart B 2.4(i).
26.89(b) ..................... Appendix A Subpart B 2.4(f)(3). 26.129(h) ................... Appendix A Subpart
B 2.4(g)(2). 26.115(a)(4) .............. Appendix A Subpart B 2.4(i).
26.89(b)(1) ................ Appendix A Subpart B 2.4(f)(4). 26.131 ....................... NEW.
B 2.4(g)(2). 26.115(b) ................... Appendix A Subpart 26.133 ....................... Appendix A Subpart
26.89(b)(2) ................ Appendix A Subpart B 2.4(g)(25). B 2.7(e)(1).
B 2.4(g)(2). 26.115(c) ................... NEW. 26.135(a) ................... Appendix A Subpart
26.89(b)(3) ................ NEW. 26.115(d) ................... NEW. B 2.7(j).
26.89(b)(4) ................ Appendix A Subpart 26.115(e) ................... Appendix A Subpart 26.135(b) ................... Appendix A Subpart
B 2.4(g)(4) and A 1.2 and Subpart B 2.7(j).
(g)(23)(ii). B 2.4. 25.135(c) ................... Appendix A Subpart
26.89(c) ..................... NEW. 26.115(f) .................... NEW. B 2.7(h).
26.89(d) ..................... Appendix A Subpart 26.117(a) ................... Appendix A Subpart 26.137 ....................... Appendix A Subpart
B 2.4(e). B 2.4(g)(20). B 2.8(a).
26.91(a) ..................... Appendix A Subpart
26.117(b) ................... Appendix A Subpart 26.137(e)(4–5) .......... Appendix A Subpart
B 2.7(o)(3)(ii).
B 2.4(g)(21). B 2.8(b).
26.91(b) ..................... Appendix A Subpart
26.117(c) ................... Appendix A Subpart 26.137(e)(6–7) .......... Appendix A Subpart
B 2.7(o)(3)(ii).
B 2.4(g)(22). B 2.8(c).
26.91(c) ..................... NEW.
26.117(d) ................... Appendix A Subpart 26.137(f) .................... NEW.
26.91(d) ..................... NEW.
26.91(e) ..................... NEW. B 2.4(g)(23). 26.137(g) ................... Appendix A Subpart
26.93 ......................... Appendix A Subpart 26.117(e) ................... Appendix A Subpart B 2.7(o)(3)(i).
B 2.4(g)(18) and B 2.4(g)(26). 26.137(h) ................... Appendix A Subpart
new material. 26.117(f) .................... Appendix A Subpart B 2.7(o)(2).
26.95 ......................... Appendix A Subpart B 2.4(g)(27). 26.139(a) ................... Appendix A Subpart
B 2.4(g)(18) and 26.117(g) ................... Appendix A Subpart B 2.7(g)(2).
new material. B 2.4(g)(28). 26.139(b) ................... 26.24(d)(1).
26.97 ......................... NEW. 26.117(h) ................... Appendix A Subpart 26.139(c) ................... Appendix A Subpart
26.99 ......................... 26.24(g) and Appen- B 2.4(c)(2). B 2.7(o)(5).
dix A Subpart B 26.117(i) .................... Appendix A Subpart 26.139(d) ................... Appendix A Subpart
2.7(e)(1). B 2.7(i). B 2.7(g)(6).
26.101 ....................... Appendix A Subpart 26.117(j) .................... Appendix A Subpart 26.139(e) ................... Appendix A Subpart
B 2.4(g)(18) and B 2.4(1) and 2.7(c). B 2.7(g)(7).
new material. 26.117(k) ................... Appendix A Subpart 26.139(f) .................... NEW.
26.103 ....................... 26.24(g), Appendix A B 2.4(h). 26.151 ....................... NEW.
Subpart B 2.7(f)(2), 26.119 ....................... NEW. 26.153(a) ................... 26.24(f), Appendix A
and new material. 26.121 ....................... NEW. Subpart A 1.1(3)
26.105(a) ................... Appendix A Subpart 26.123 ....................... Appendix A Subpart and Subpart D
B 2.4(g)(5). B 2.7(l)(2). 4.1(a).
26.105(b) ................... NEW. 26.125(a) ................... Appendix A Subpart 26.153(b) ................... Appendix A Subpart
26.105(c) ................... Appendix A Subpart B 2.6(a). B 2.7(l)(2).
B 2.4(g)(6). 26.125(b) ................... Appendix A Subpart 26.153(c) ................... Appendix A Subpart
26.105(d) ................... Appendix A Subpart B 2.6(b). B 2.7(k).
B 2.4(g)(7). 26.125(c) ................... Appendix A Subpart 26.153(d) ................... Appendix A Subpart
26.105(e) ................... NEW. B 2.6(c). D 4.1(b).
26.107 ....................... Appendix A Subpart 26.127(a) ................... Appendix A Subpart 26.153(e) ................... Appendix A Subpart
B 2.4(g) and new B 2.2 1st para- B 2.7(m).
material. graph. 26.153(f)(1) ............... Appendix A Subpart
26.109 ....................... Appendix A Subpart 26.127(b) ................... Appendix A Subpart B 2.7(l)(1).
B 2.4 and new ma- B 2.7(a)(2) and 26.153(f)(2) ............... Appendix A Subpart
terial. 2.4(d). B 2.7(o)(5).
26.111(a) ................... Appendix A Subpart 26.127(c) ................... Appendix A Subpart 26.153(f)(3) ............... Appendix A Subpart
B 2.4(g)(13) and B 2.7(o)(1). C 3.1.
(g)(14). 26.127(d) ................... Appendix A Subpart 26.153(f)(4) ............... Appendix A Subpart
26.111(b) ................... Appendix A Subpart B 2.7(o)(3)(iii). C 3.2.

B 2.4(g)(15). 26.127(e) ................... Appendix A Subpart 26.153(f)(5) ............... NEW.
l26.111(c) .................. NEW. B 2.7(o)(4). 26.153(f)(6) ............... Appendix A Subpart
26.111(d) ................... Appendix A Subpart 26.129(a) ................... Appendix A Subpart B 2.7(m).
B 2.4(g)(16). B 2.7(a)(1). 26.153(g) ................... NEW.
26.155 ....................... Appendix A Subpart 26.167(f) .................... Appendix A Subpart 26.709 ....................... NEW.
B 2.5. B 2.8(e)(4)–(e)(6). 26.711 ....................... NEW.
26.157(a) ................... Appendix A Subpart 26.167(g) ................... Appendix A Subpart 26.713(a)(1) .............. 26.71(a).
B 2.2 1st para- B 2.7(o)(3)(i). 26.713(a)(2) .............. 26.71(b).
graph. 26.167(h) ................... Appendix A Subpart 26.713(a)(3) .............. NEW.
26.157(b) ................... Appendix A Subpart B 2.7(o)(2). 26.713(a)(4) .............. NEW.
B 2.4(d) and 26.168 ....................... Appendix A Subpart 26.713(b) ................... 26.21(b); 26.22(c);
2.7(a)(2). B 2.8(e) and new 26.80(c).
26.157(c) ................... Appendix A Subpart material. 26.713(c) ................... 26.71(c).
B 2.7(o)(1). 26.169 ....................... Appendix A Subpart 26.713(d) ................... 26.20.
26.157(d) ................... Appendix A Subpart B 2.7(g) (substan- 26.713(e) ................... 26.23(a).
B 2.2(o)(3)(iii). tially revised).
26.713(f) .................... NEW.
26.157(e) ................... Appendix A Subpart 26.181 ....................... NEW.
26.713(g) ................... NEW.
B 2.7(o)(4). 26.183(a) ................... 26.3 and Appendix A
26.715(a) ................... Appendix A, Section
26.159(a) ................... Appendix A Subpart Subpart A 1.2 and
2.7(n).
B 2.7(a)(1). Appendix A Sub-
part B 2.9(b). 26.715(b)(1)–(14) ...... NEW.
26.159(b) ................... Appendix A Subpart 26.717 ....................... 26.71(d).
B 2.7(b)(1). 26.183(b) ................... Appendix A Subpart
B 2.9(b). 26.719(a)–(b) ............ 26.73.
26.159(c) ................... Appendix A Subpart 26.719(c)(1) ............... Appendix A Subpart
B 2.7(b)(2). 26.183(c) ................... 26.3 and Appendix A
Subparts A 1.2, B B 2.8(e)(4).
26.159(d) ................... Appendix A Subpart 26.719(c)(2) ............... Appendix A Subpart
B 2.7(a)(2). 2.4(j), B 2.9(a), and
B 2.9(b). B 2.8(e)(5).
26.159(e) ................... Appendix A Subpart 26.719(c)(3) ............... NEW.
B 2.7(a)(2). 26.183(d) ................... NEW.
26.185(a) ................... Appendix A Subpart 26.719(d) ................... NEW.
26.159(f) .................... Appendix A Subpart 26.821 ....................... 26.70.
B 2.4(i). B 2.9(a).
26.185(b) ................... Appendix A Subpart 26.823 ....................... 26.90.
26.159(g) ................... Appendix A Subpart
B 2.9(b). 26.825 ....................... 26.91.
B 2.4(i).
26.185(c) ................... Appendix A Subpart
26.159(h) ................... NEW.
B 2.9(c).
26.159(i) .................... Appendix A Subpart TABLE 2.—DISTRIBUTION TABLE FOR
26.185(d) ................... NEW.
B 2.7(h).
26.159(j) .................... NEW.
26.185(e) ................... NEW. PART 26
26.185(f) .................... NEW.
26.161 ....................... NEW. 26.185(g) ................... NEW.
26.163(a) ................... Appendix A Subpart Former section Replaced by
26.185(h) ................... NEW.
B 2.7(e). 26.185(i) .................... NEW.
26.163(a)(2) .............. NEW. 26.1 (from beginning 26.1.
26.185(j)(1) ................ Appendix A Subpart to ‘‘programs’’).
26.163(b) ................... Appendix A Subpart B 2.9(d).
B 2.7(f). 26.1 (following ‘‘pro- Deleted.
26.185(j)(2) ................ Appendix A Subpart grams’’).
26.165(a) ................... 26.24(f) and Appen- B 2.9(d).
dix A Subpart B 26.2(a) (first clause) .. 26.3(a).
26.185(j)(3) ................ NEW. 26.2(a) (balance of 26.3(b) first clause.
2.7(j). 26.185(j)(4) ................ NEW.
26.165(b) ................... Appendix A Subpart 1st sentence).
26.185(j)(5) ................ NEW. 26.2(a) (2nd sen- 26.21 (1st sentence).
B 2.7(j) and new 26.185(j)(6) ................ NEW.
material. tence).
26.185(k) ................... Appendix A Subpart 26.2(a) (3rd sentence 26.4(a), (b), (c), and
26.165(c) ................... Appendix A Subpart B 2.9(f).
B 2.7(i). to end). (d).
26.185(l) .................... Appendix A Subpart 26.2(b) (1st sentence) 26.4(i) (2) and (3).
26.165(c)(1) ............... NEW. B 2.9(e).
26.165(c)(2) ............... Appendix A Subpart 26.2(b) (2nd sentence 26.3(e).
26.185(m) .................. Appendix A Subpart to end).
B 2.7(i). B 2.9(g).
26.165(c)(3) ............... NEW. 26.2(c) (1st sentence) 26.3(c); Subpart K.
26.185(n) ................... NEW.
26.165(c)(4) ............... Appendix A Subpart 26.2(c) (from ‘‘shall Subpart K.
26.185(o) ................... NEW.
B 2.7(j) (last sen- implement’’ to end).
26.185(p) ................... 26.24(e).
tence). 26.2(d) ....................... 26.3(c).
26.187 ....................... NEW.
26.165(d) ................... NEW. 26.189 ....................... NEW. 26.3 ........................... 26.5.
26.165(e) ................... NEW. 26.201 ....................... NEW. 26.4 ........................... 26.7.
26.165(f) .................... NEW. 26.203 ....................... NEW. 26.6 ........................... 26.9.
26.167(a) ................... Appendix A Subpart 26.205 ....................... NEW. 26.8 ........................... 26.13.
B 2.8(a) and (d). 26.207 ....................... NEW. 26.10(a) (from begin- 26.23(a).
26.167(b) ................... Appendix A Subpart 26.209 ....................... NEW. ning through ‘‘man-
B 2.8(c) and (d) 26.211 ....................... NEW. ner’’).
and new material. 26.401 ....................... 26.2(c). 26.10(a) (balance of 26.23(b).
26.167(c) ................... NEW. 26.403 ....................... 26.2(c). 1st sentence).
26.167(d)(1) .............. Appendix A Subpart 26.405 ....................... 26.2(c). 26.10(b) ..................... 26.23(c).
B 2.7(e)(1). 26.407 ....................... 26.2(c). 26.10(c) ..................... 26.23(d).
26.167(d)(2) .............. NEW. 26.409 ....................... 26.2(c). 26.20 (introductory 26.27(a).
26.167(d)(3) .............. Appendix A Subpart 26.411 ....................... 26.2(c). paragraph, 1st sen-
B 2.8(c). 26.413 ....................... 26.2(c). tence).
26.167(e) ................... Appendix A Subpart 26.415 ....................... 26.2(c). 26.20 (introductory 26.713(d).
B 2.7(f)(2) and 26.417 ....................... 26.2(c). paragraph, 2nd
2.8(d). 26.419 ....................... 26.2(c). sentence).
TABLE 2.—DISTRIBUTION TABLE FOR TABLE 2.—DISTRIBUTION TABLE FOR TABLE 2.—DISTRIBUTION TABLE FOR
Former section Replaced by Former section Replaced by Former section Replaced by
26.20 (introductory 26.27(b) (sentence Appendix A Subpart Deleted. Appendix A Subpart Validity screening and
paragraph, final before ‘‘(1)’’). B.2.2(d)(4). B 2.7(e). initial validity test
sentence). Appendix A Subpart 26.31(b), and require- requirements in
26.20(a) ..................... 26.27(b). B.2.3. ments in Subparts 26.131 and 26.161
26.20(b) ..................... 26.27(b)(7). E, F, and G. and initial cutoff
26.20(c) ..................... 26.27(c)(1). Appendix A Subpart 26.87(a). levels in 26.133
26.20(d) ..................... 26.27(c)(2). B.2.4(a). and 26.163(a).
26.20(e) ..................... 26.27(c)(3). Appendix A Subpart 26.85 and 26.115(e). Appendix A Subpart 26.103, 26.115(a),
26.20(f) ...................... 26.27(d). B.2.4(b). B 2.7(f). 26.163(b), 26.167
26.21(a) ..................... 26.29(a). and 26.169.
Appendix A Subpart 26.87 (d) and (f),
26.21(b) ..................... 26.29(c). Appendix A Subpart 26.169.
B.2.4(c). 26.117(h).
26.21(b) (last sen- 26.713(b)(1). B 2.7(g)(1) through
Appendix A Subpart 26.117 and
tence). (5).
B 2.4(d). 26.127(b).
26.22 ......................... Deleted. Appendix A Subpart Requirement for an-
Appendix A Subpart 26.87(d)(1). B 2.7(g)(6) and (7). nual summary in
26.23(a) ..................... 26.3(d) and 26.21.
B 2.4(e). 26.169(h).
26.23(b) ..................... 26.21.
Appendix A Subpart 26.87(b). Appendix A Subpart 26.215.
26.24(a) (first sen- 26.31(a).
B 2.4(f) 1st sen- B 2.7(g)(8).
tence to ‘‘(1)’’).
tence. Appendix A Subpart 26.159(i) and by
26.24(a)(1)–(4) .......... 26.31(c) (substantially
revised). Appendix A Subpart 26.95 through 26.115 B 2.7(h). 26.135(c).
26.24(b) ..................... Subparts E, F, and G. B 2.4(f)(1) through and Subparts Fand Appendix A Subpart 26.117(i) and Sub-
26.24(c) ..................... 26.31(d). (f)(4). G. B 2.7(i). parts F and G.
26.24(d) ..................... Subparts E, F, and G. Appendix A Subpart Subparts E, F, and G. Appendix A Subpart 26.113, 26.135,
26.24(e) ..................... Subpart H. B 2.4(g)(1) through B 2.7(j). 26.165.
26.24(f) ...................... 26.31(d)(2) and re- (g)(25). Appendix A Subpart 26.153(c).
quirements in Sub- Appendix A Subpart 26.87(f)(5). B 2.7(k).
part G. B 2.4(h) (1st sen- Appendix A Subpart 26.123 and 26.153.
26.24(g) ..................... 26.31(d)(4) and Sub- tence). B 2.7(l).
parts E, F, and G. Appendix A Subpart 26.129(d) and Appendix A Subpart 26.87(c), 26.153 and
26.25 ......................... 26.35. B 2.4(h) (balance of 26.157. B 2.7(m). 26.221.
26.27(a) ..................... Subpart C. section). Appendix A Subpart 26.215(a).
26.27(b) ..................... Subpart D. Appendix A Subpart 26.117(j), 26.129(h) B 2.7(n).
26.27(c) ..................... Subpart D. B 2.4(i). and 26.159. Appendix A Subpart 26.127(c) and
26.27(d) ..................... 26.77(c). Appendix A Subpart 26.115 and 26.185. B 2.7(o)(1). 26.157(c).
26.28 ......................... 26.39. B 2.4(j) (first two Appendix A Subpart 26.91, 26.127,
26.29 ......................... 26.37. sentences). B 2.7(o)(2), (o)(3), 26.137, 26.157 and
26.70 ......................... 26.721. Appendix A Subpart Deleted. and (o)(4). 26.167.
26.71 ......................... 26.711, 26.713, and B 2.4(j) (final sen- Appendix A Subpart 26.85(d), 26.139(c)
26.715. tence). B 2.7(o)(5). and 26.153(f)(2).
26.73 ......................... 26.719 (substantially Appendix A Subpart 26.155(a). Appendix A Subpart 26.137(a) and
revised). B 2.5(a). B 2.8(a). 26.167(a).
26.80 ......................... 26.41 (substantially Appendix A Subpart 26.137.
Appendix A Subpart 26.153(c) and
revised). B 2.8(b).
B 2.5(b). 26.155(c).
26.90 ......................... 26.723. Appendix A Subpart 26.167.
Appendix A Subpart 26.155(c). B 2.8(c).
26.91 ......................... 26.725. B 2.5(c).
Appendix A Subpart 26.3. Appendix A Subpart 26.137 and 26.167.
Appendix A Subpart 26.155(d). B 2.8(d).
A, 1.1(1). B 2.5(d).
Appendix A Subpart Subparts F and G. Appendix A Subpart 26.137 and 26.167.
Appendix A Subpart 26.155(e). B 2.8(e)(1) to (e)(3).
A, 1.1(3).
B 2.5(e). Appendix A Subpart 26.137, 26.167, and
Appendix A Subpart 26.5, and 26.115(e).
A, 1.2. Appendix A Subpart 26.155(f). B 2.8(e)(4), (e)(5), 26.219.
Appendix A Subpart 26.31(d)(1). B 2.5(f). and (e)(6).
B, 2.1(a). Appendix A Subpart 26.125(a). Appendix A Subpart 26.183.
Appendix A Subpart 26.31(d)(1)(ii). B 2.6(a). B 2.9 (a) and (b)
B, 2.1(b). Appendix A Subpart 26.125(b). (through ‘‘contract
Appendix A Subpart Subparts E, F, and G. B 2.6(b). employee’’).
B.2.1(c). Appendix A Subpart 26.125(c). Appendix A Subpart 26.185.
Appendix A Subpart 26.31(d)(6). B 2.6(c). B 2.9(b) (balance of
B.2.1(d). Appendix A Subpart 26.127, 26.129, section), (c), (d),
Appendix A Subpart 26.31. B 2.7(a). 26.157, and (e), (f), and (g).
B.2.1(e). 26.159. Appendix A Subpart 26.37(e) and
Appendix A Subpart Subparts F and G. Appendix A Subpart 26.129(b) and C 3.1. 26.153(f)(3).
B.2.2 (Initial para- B 2.7(b). 26.159. Appendix A Subpart 26.75(I)(4),
graph). Appendix A Subpart 26.117(j), 26.129(f) C 3.2. 26.153(f)(4), and
Appendix A Subpart 26.115, 26.117, B 2.7(c). and 26.159(h). 26.165(f).
B.2.2 (a), (b), and 26.129, 26.159, Appendix A Subpart 26.153(d).

Appendix A Subpart 26.157 and 26.159.
(c). 26.169. D 4.1.
B 2.7(d).
Appendix A Subpart 26.85 and 26.157(b).
B.2.2 (d)(1), (2), [FR Doc. E8–4998 Filed 3–28–08; 8:45 am]
and (3). BILLING CODE 7590–01–P

Rule: Fitness For Duty Programs

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Monday,

March 31, 2008

NUCLEAR REGULATORY Subpart I must be implemented by I. Background

requirements included general implications for maintaining a work

#49, and supported by several other information as a premise for the

conducting background checks and or security-related SSCs and the

the applicable requirements of § 26.67 those required for initial authorization

concise statement of its FFD policy and is the individual’s successful

enclosure to ensure that no potential donor in the exceptional event of a guidelines.

any specimens are collected, donors explicitly state, the donor’s

require the implementation of ‘‘shy initial and confirmatory (if necessary)

the donor’s specimens, the final rule maintained. the collection.

as required by the manufacturer’s concentration. results and therefore meets Goal 3 of

permitted to have access to records to reference § 26.157, consistent with

implement any necessary limitations on adversely affecting the job performance

Section 26.207(a)(1)(i) requires an considerable stakeholder comment and guidelines. Accordingly,

Document PDR Web EPDR NRC staff

Part 26 Derivation and Distribution Tables ................ X .................................................. ML080570421 .......................... X

regulatory analysis is sufficient for

26.3(c) ....................... 26.2(c). 26.31(d) ..................... NEW. 26.67(c) ..................... NEW.

26.31(c)(1) ................. 26.24(a)(1). 26.65(e) ..................... NEW. B 2.4(g)(1) (2nd

26.111(b) ................... Appendix A Subpart B 2.7(o)(3)(iii). C 3.2.

B.2.2 (a), (b), and 26.129, 26.159, Appendix A Subpart 26.153(d).

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