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Under the Occupational Safety & Health Act of 1970, only consensus standards that have been
adopted as or incorporated by reference into an Occupational Safety & Health Administration
(OSHA) standard pursuant to Section 6 of the OSH Act provide a means of compliance with Section
5(a)(2) of the OSH Act. In fact, most currently enforceable OSHA standards have their genesis in the
consensus standard environment. Specific national consensus standards [e.g., American National
Standards (ANSI) standards], which the Secretary of Labor adopted on May 29, 1971, were either
used as a source standard and published in Part 1910 as an OSHA standard or explicitly incorporated
by reference in an OSHA standard because, as a new agency, OSHA otherwise had no safety or
health regulations to enforce!
Even today, OSHA also often looks to consensus standards as a benchmark for "notice" to
employers for General Duty Clause enforcement under Section 5(a)(1) of the OSH Act or to
determine abatement requirements for violations. When OSHA determines that recognized experts
find, in a voluntary consensus standard, that a series of actions or conditions are required to prevent
harm to workers, this is likely to satisfy the requirement for GDC applicability under the applicable
legal tests. Voluntary guidelines, including standards promulgated by ANSI, have been used to
support GDC citations and to enunciate an industry standard of care even though the consensus
standards themselves are not specifically enforceable by the agency.
An increasingly troublesome issue has arisen with respect to whether a government agency's
action to IBR a VCS has implications for the validity of the copyright held by the standards
development organization for the incorporated standard. This is now being litigated by several SDOs,
as discussed below, and is under congressional scrutiny. As noted by the Administrative Conference
of the United States:
Ensuring that regulated and other interested parties have reasonable access to
incorporated materials is perhaps the greatest challenge agencies face when
incorporating by reference. When the relevant material is copyrighted as is
often the case with voluntary consensus standards access issues are
particularly problematic. There is some ambiguity in current law regarding the
continuing scope of copyright protection for materials incorporated into
regulations, as well as the question of what uses of such materials might
constitute fair use under section 107 of the Copyright Act. Efforts to increase
transparency of incorporated materials may conflict with copyright law and
with federal policies recognizing the significant value of the public-private
partnership in standards.
Administrative Conference Recommendation 2011-5, December 8, 2011.
In addition, the Office of the Federal Register (OFR) is statutorily charged with approving all
incorporations by reference, and has issued regulations and guidance establishing policies and
procedures for doing so. The OFR is now engaged in a rulemaking on the issue of IBR and what
constitutes "reasonably available" for purposes of the Federal Register Act.
This paper explores the legal and regulatory morass involving incorporation by reference or
enforcement of voluntary consensus standards at the federal government level, and the associated
litigation and recommendations on the subject.
standards). This ASTM standard also sets forth provisions for hygiene facilities, medical surveillance,
exposure monitoring, medical protection, worker training and education, and warning signs and
labels.
ASTM E2625 was developed to address occupational silica exposures during construction and
demolition activities. It is intended to protect workers against clinically significant disease from
exposure to respirable crystalline silica, to have silica exposure measured by techniques that are valid,
reproducible and readily available, and to be attainable with existing technology and protective
practices. It sets forth general requirements for exposure assessment and monitoring, methods of
compliance, work practices, and administrative controls. The standard also addresses respiratory
protection, advising that respirators should be mandated in work situations where engineering and
work practice controls are insufficient to reduce exposures below the applicable occupational
exposure limit. The standard emphasizes medical surveillance, medical protection for workers in
terms of x-ray screening criteria, worker training and education, competency of workers in terms of
task training, and recordkeeping.
ASTM E2625 also offers guidance for different operations and tasks associated with
construction and demolition in identifying what control measures and respiratory protection may be
approach in different situations, and information from these ASTM tables has been adopted by OSHA
in the proposed rule into "Table 1" which establishes protocols for certain construction tasks to limit
silica exposures. In short, these ASTM standards could easily form the basis for a comprehensive
crystalline silica health standard. If, however, OSHA simply incorporates these by reference, rather
than explaining in the Code of Federal Regulations the specific requirements, this will add fuel to the
fire on the issue of whether ASTM would have to make the standards available to the public free of
charge, in order to meet the "reasonably available" criteria in the Federal Register Act, as discussed in
more detail below.
has done to ensure the reasonable availability to interested parties of the to-be-incorporated material
or a summary of that material. At the final rule stage, the discussion of "reasonable availability"
would always be required in the preamble. The proposed rule also states that OFR plans to revise
its Document Drafting Handbook to encourage agencies to implement relevant provisions of
ACUS' Recommendation 2011-5 concerning IBR. Comments on the proposed rules were due
December 31, 2013. More than 35 comments were submitted, and OFR is now in the process of
evaluating the input before developing a final rule. Whether it will determine that any consensus
standards which are IBR by an agency must be available, free of charge, on the internet is at issue,
although OFR has already recognized the copyright interest of SDOs warrants serious consideration.
The petitioner's requested regulation text would require agencies to demonstrate that material
proposed to be IBR'd in the regulation text was available throughout the comment period: in the
Federal Docket Management System (FDMS) in the docket for the proposal or interim rule; on the
agency's Web site; or readable free of charge on the Web site of the voluntary standards organization
that created it during the comment period of a proposed rule or interim rule. The petition suggested
limiting IBR eligibility only to standards that are available online for free and to apply this to
documents that would otherwise be considered guidance documents, as well as formal rules. And, it
would limit the OFR's review of agency created materials to whether the material is available online.
The petition would then distinguish between required standards and those that could be used to show
compliance with a regulatory requirement. Finally, the petition (if granted in the final rule) would add
a requirement that, in the electronic version of a regulation, any VCS material IBR'd into that
regulation would be hyperlinked.
In summary, OFR is now considering whether to require that: (1) All material IBR'd into the
CFR be available for free online; and (2) the Director of the Federal Register (the Director) include a
review of all documents agencies list in their guidance, in addition to their regulations, as part of the
IBR approval process. OFR has already responded, in its proposal, that some of these requests go
beyond the agency's statutory authority. Nothing in the Administrative Procedure Act (APA) (5
U.S.C. chapter 5), E-FOIA, or other statutes specifically address this issue. Moreover, OFR seems
reluctant to require that all materials IBR'd into the CFR be available for free, recognizing that this
requirement would compromise the ability of regulators to rely on voluntary consensus standards,
possibly requiring them to create their own standards, which is contrary to the TTA and the OMB
Circular A-119.
Meanwhile, on October 28, 2013, the American National Standards Institute (ANSI) launched
the ANSI IBR Portal, http://ibr.ansi.org/, an online tool for free, read-only access to voluntary
consensus standards that have been IBRed into federal laws and regulations. IBR standards hosted on
the portal are available exclusively as read-only files. In order to protect the intellectual property
rights of the groups holding these standards copyrights, the portal has built in security features that
prevent users from printing, downloading, or transferring any of the posted standards; in addition,
screenshots will be disabled and the standards will contain an identifying watermark. ASSE is the
secretariat for many ANSI standards, including the popular A10 series of best practices for
construction and demolition projects.
According to ANSI, for this first phase of the portal, ANSI has secured the participation of
thirteen major domestic and international standards developers. Those that have agreed to have their
IBR standards directly available on the ANSI IBR Portal include:
In addition, seven SDOs have agreed to allow the portal to provide direct links to read-only versions
of IBR standards hosted on their own websites. Those organizations are:
With the launch of Phase I of the portal, ANSI expects that many more SDOs both in and
outside the community of ANSI-accredited standards developers will sign on to participate. Other
groups, such as ASTM International, have adopted "read only" access that permits mandatory users to
view the information without waiving copyright claims by the SDO. See
http://www.astm.org/READINGLIBRARY/index.html.
Of course, it bears mentioning that SDOs incur significant costs for initiating the standards
development process, convening and hosting meetings of technical committees (in person and via the
web), overseeing the editing, formatting and publication of standards, hosting websites, maintaining
inventory etc. ASSE participates in the development and maintenance of key privately developed
safety standards in two ways: by serving as secretariat for several standards committees and by
serving on many other safety standards committees. All ASSE standards development activities are
conducted within the framework established by ANSI for the development of consensus standards.
Without the ability to recoup these expenses, it is foreseeable that standards development could
wither away, or organizations would be reluctant to serve voluntarily as the secretariat. Moreover,
despite the opposition raised to "paying for the law," most consensus standards are affordable to
businesses, unions, consultants and professionals who use them. The average ASTM standard costs
$30, NFPA sells the 800-page National Electrical Code (NEC) for $75, and even highly technical
building codes can cost as little as $100. The SDOs have also pretty universally provided for
instantaneous electronic download of standards, both current and older editions. This is certainly a
service worth maintaining!
unfair competition and false designation of origin, and common law claims, was filed on August 6. 2013, in
the U.S. District Court for the District of Columbia. The plaintiffs are heavy-hitting SDOs: ASTM
International, the National Fire Protection Association (NFPA), and the American Society of Heating,
Refrigerating, and Air Conditioning Engineers, Inc. (ASHRAE). The plaintiffs seek a permanent injunction
against any unauthorized publication or distribution (printed or electronically) of plaintiffs' standards or use
of plaintiffs' trademarks, plus attorney fees and other relief appropriate.
What did the defendant, Public Resource, do? Without permission, it purchased 73 of plaintiffs'
standards, mailed them to various officials, the media and some members of the public, and also scanned
and posted on several internet websites the standards, most of which had been incorporated by reference
into federal, state or local laws. Significantly, the defendant also allegedly altered some of the standards,
including rekeying some text, altering graphics, and making mathematical changes. The plaintiff expressed
concern that such documents, bearing plaintiffs' logos, would be mistaken for the unaltered originals and
public safety could suffer due to lack of quality control and the unauthorized alterations (not approved by
the SDOs technical committee). In some cases, outdated standards were the ones posted, which increases
potential confusion that these represent the current "best practices."
The outcome of the litigation has not been determined, but this is also not the first such case to be
litigated. The landmark case in this area is Veeck v. Southern Building Code Congress International, In c.,
293 F.3d 791 (5th Cir. 2002). In Veeck, the court held that in some instances model building codes
developed by an organization adopted by government entities into regulations may become law, and to the
extent that the building code becomes law it enters the public domain. Federal law still provides exclusive
ownership rights for copyright holders, however, and provides that Federal agencies can be held liable for
copyright infringement. Additionally, both the TTA and OMB Circular A-119 require: "If a voluntary
standard is used and published in an agency document, your agency must observe and protect the rights of
the copyright holder and any other similar obligations."
Public Resource's theory in support of its action is set forth in the court documents:
The law belongs to the people, and cannot become the private property of some
governmental or non-governmental organization, no matter how seemingly welldeserved are the rents one could extract from winning a monopoly concession on a
parcel of the law. While standards bodies need money to carry out their valuable
work, and while it is clear that these standards bodies create high-quality
documents that are essential to our public safety, one cannot cordon off the public
domain simply because of an institutional desire for funds.
The plaintiff SDOs maintain that, if Public Resource succeeds in convincing the court that an SDO's
copyright is destroyed whenever the government incorporates the standard by reference into regulations,
SDOs will lose their exclusive rights to their work, and would be unable to charge fees to members of
industry or other interested persons who want copies of standards. The SDOs are all non-profit entities and
a majority of their revenue to fund operations and standards development activities comes from sale or
licensing of the standards. Plaintiffs argue that depriving them of this revenue source would substantially
diminish the quality of future standards (or drastically cut back on standards development activity),
especially impacting the health and safety areas which are most often IBR by government entities.
There are unintended costs as well, if SDOs cease standards development, as the federal, state and
local governments would then have to assume the costs of future standards development, and many
agencies lack the funds, experience and technical expertise to create standards comparable to those of the
SDOs, such as the regular updating of the National Electrical Code (NFPA 70) or the essential Life Safety
Code (NFPA 101). The government also lacks the flexibility to quickly respond to new technology by
updating a standard, which is why too often the IBR standards are those from the 1980s or beyond!
Any vitiation of copyright as a result of authorized or unauthorized IBR of a VCS could well have
potential to destroy the cooperative and transparent system of consensus standard development that has
grown and thrived for over 100 years. But, ultimately, inquiry as to whether a governmental action -forcing SDOs to make their standards work product available free of charge -- constitutes an
unconstitutional taking, in violation of the Fifth Amendment (federal) and Fourteenth Amendment (state
action), does not lend itself to any set formula. A determination of whether justice and fairness require that
economic injuries caused by public action be compensated by the government, rather than remain
disproportionately concentrated on a few persons, is essentially ad hoc and fact intensive. (10 A.L.R. Fed.
2d 231 (2006)).
ACUS has sought additional public input on the VCS/IBR issue in a variety of forums,
including workshops at the National Academy of Sciences and the George Washington University
Regulatory Studies Center, and through stakeholder meetings of the US Small Business
Administration.
Among the points made by participants at some of the ACUS meetings:
A systematic review of research evidence is necessary that is transparent and available. better
planning must be set forth before agencies begin the scientific research. This includes clearly
identifying what problem is to be solved, assessing all data available, identifying and providing
transparency on what data has been excluded from the study versus what data has been included.
The public and interested scientists are not provided the raw data to review and analyze.
However, challenges to this request have been made by parties who control the data. Often,
models are patented and the company who performed the research will not provide it to industry
for industry to perform an independent assessment of the data.
Peer review is viewed as a missing element to the agency process that some feel is a disservice to
the public, industry, and other scientists. Policy and research of papers developed for agencies
should be reviewed. Independent scientists who are experts in the field of study discussed should
perform reviews similar to academic reviews of papers submitted for professional publication.
In response to the ACUS project, OSHA Assistant Secretary David Michaels suggested
including a set of new recommendations that increase the ability of the public and the agencies to
scrutinize the science submitted by regulated parties. These recommendations build on existing
requirements in law and in the biomedical journal. Dr. Michaels cited both his own pre-OSHA work
and recommendations in the BiPartisan Policy Center Report as examples of potential
recommendations that would provide for this enhanced transparency of the data and provenance of
studies produced by regulated parties.
The next iteration of the ACUS report will include a new set of recommendations that provide
greater transparency for privately produced research that informs regulation. There was also a
recommendation regarding the Identification of Important Gaps in Scientific Research, calling on
agencies to identify significant knowledge gaps and discuss what might be done to fill them. Several
panelists suggested that in developing robust discussion of policies, agency staff should be allowed
and even encouraged to publish their dissents in the peer reviewed literature. By doing so, the dissent
would not only be public, but would undergo external checks on reliability and ensuring that there is
evidentiary support for the dissent.
While there is no one-size-fits-all approach to peer review, there are additional procedures that
could be added that will further improve the agencies use of external peer reviewers. Several
suggestions to be considered in the next iteration of the report include: the use of stopping rules for
peer review that limit the use of peer review when it is no longer necessary; soliciting letters or
comments from individual peer reviewers in advance of their collective deliberations in science
advisory boards; expecting agencies to provide a public response to significant peer review
comments; and soliciting from peer review panels whether and how they might view their charge as
incomplete when compared with the agencys regulatory decision. It was also notes that where
lawyers, economists, or others are involved in drafting staff technical reports, they should be
identified either by name or attributed as part of the agencys interdisciplinary team. The discussion
and recommendation concerning authorship and attribution in the report will be expanded to
underscore the need to disclose the identity of all staff who contributed to staff technical reports in
significant ways, even if they are not scientists.
For additional information on the ACUS project, see http://www.acus.gov/research/theconference-current-projects/science-in-the-administrative-process.
Conclusion
Standards developed by the consensus SDOs discussed herein are created through procedures that are
marked by their openness, balance of interests represented, fairness and transparency. Many
thousands of safety, health, engineering, and environmental professionals put countless hours into
developing a standard of practices that will protect persons, property and the environment.
Undoubtedly, the collective wisdom of the professionals who undertake standards development
allows for more rapid adoption of more protective technologies, work practices, analytical methods
and design principles than could ever be accomplished by a governmental agency. It is not just
prudent practice, but legally required, that the federal government consider whether there is a VCS
"on point" when embarking on a rulemaking initiative ... and either incorporate by reference the VCS
or explain why it is departing from the consensus practice. This saves government resources, taxpayer
dollars, and allows for more timely adoption of appropriate control methodologies.
This is an interesting time, however, for the future of voluntary consensus standards and the
SDOs that create them. The outcome of the copyright infringement litigation, and the determinations
made by the Office of Federal Register in defining at last what "reasonably available" means in
today's regulatory environment where the internet is the "go to" place for anyone wishing access to
information on proposed or final rules, will all influence whether governmental entities can continue
to IBR standards to comply with the TTA, or whether some sort of "pay for play" principle will be
approved.
Congress may intervene as well, given its current scrutiny of copyright issues, and the sleeper
provision that was included in the Pipeline and Hazardous Materials Safety Administration (PHMSA)
no longer IBR voluntary consensus standards into its regulations unless those standards have been
made available free of charge to the public on the Internet. See Section 24 of the Pipeline Safety,
Regulatory Certainty, and Job Creation Act of 2011 (Pub. L. 112-90).
Even in light of the legal considerations raised by incorporation by reference of voluntary
consensus standards into binding federal regulations, the utilization of such standards as an effective
and efficient option for meeting the demand of increased regulation and legislation in occupational
safety and health should be supported for the following reasons: (1) the consensus method provides
for a balance between competing interests; (2) the voluntary nature of consensus standards enables
users to adapt provisions to meet unusual circumstances; and (3) much lower standards development
costs are achieved. Governmental agencies such as OSHA, MSHA, and the Environmental Protection
Agency should be encouraged to utilize these consensus standards as they provide an efficient and
effective alternative to traditional public sector rule making and can ultimately improve occupational
and public health, safety and environmental protection in a more timely and cost-effective manner.