Biosafety/Biosecurity:

An Update

February 27, 2004

Where is the emphasis?

Biosafety

 
Biosecurity
 Biosafety
• Policy
– Handbook 1200.8 “Safety of Personnel Engaged in
Research”
– VA Directive 7701 & Handbook 7701.1 “Occupational
Safety & Health”
– OSHA’s regulations
• Plans
– Minor updates to 1200.8
– Revise biosafety form (10-0398)
– Define training needs
 Role for Research Biosafety
• Ensure safety of personnel
• Identify hazards: chemical, physical, and
biological
• Incorporate into VAMC wide occupational safety
program, fire safety, PPE and precautions
• Safety & health inspections: local, VA CO, or
others
• Policies, plans and procedures
 Hazard Categories
• Chemical: corrosive, toxins, carcinogens,
mutagens, flammables, explosive

• Physical: ionizing and non-ionizing radiation,

noise, temperature extremes, electrical mechanical

• Biological: pathogens, organism, recombinant

DNA, toxins produced by organisms and human
or animal tissue, body secretions, & blood
 Biosecurity
• An increasing concern
• Effects all research laboratories
• Special emphasis on BSL-3s & labs with
select agents or toxins
• Required revising Directive 2002.075
(Control of Hazardous Agents)
• Draft is unofficial & in concurrence
 The Concurrence Process

Draft  Concurring Offices  Final Document

 Control of Hazardous Agents
(Why The Re-draft)

• Approach:
– Facility’s comprehensive program
• Address concerns of IG
• Meet new standards
– HHS (CDC)
– USDA (APHIS)
• Clarify current requirements
 Control of Hazardous Agents
Program
• A unified approach
• Integrates:
– VAMC safety & security program and
– Research safety & security program
• Medical Center Director (MCD) is
responsible institutional official
• Requires coordination and cooperation of
many offices
 Definition:Select Agents (SA)
& Toxins
• SA: Group of agents designated by HHS/CDC as
requiring registration with CDC lab registration
program
– Viruses, bacteria, rickettsiae, fungal, toxins,
recombinant DNA
• Biological agents and toxins (USD/APHIS):
agents with potential to be severe threat to animal
& plant health -- Labs must also register
• Overlap agents: found in CDC & APHIS lists
• Directive refers to CDC & APHIS agents
collectively as SA & toxins
 Definition: Hazardous Agents
• Hazardous agents include:
– Select agents & toxins
– Exempt quantities of toxins
– Other hazardous chemicals
– Radioactive material
– Sensitive material
• List in Directive 2002-075 and draft
directive
 Control of Hazardous Agents
Program (cont)
• Based on regulatory, scientific & ethical principals
• Relevant policies and regulations
– VHA Research & non-research
– HHS/CDC
– USDA/APHIS
– Dept. of Commerce
– Dept. of Transportation
– EPA
– OSHA
 Roles and Responsibilities
• MCD is the Responsible Official
• ACOS/AO
– Research point of contact
– Liaison with VAMC committees, personnel, police etc
– Personnel, lab access, resources
– Annual assessments and drills
– Role with R&D committee/SRS
– Ensure compliance
 Roles and Responsibilities:
R&D/SRS committee
• Advises the MCD on the R&D program
• R&D responsibilities:
– M-3, Part 1, Chapter 2 & 3
– Safety of Personnel in Research (1200.8)
– Hazardous Agents directive
• R&D committee may form a Subcommittee on
Research Safety (SRS)
• SRS = Institutional Biosafety Committee (IBC)
 SRS/IBC: A Special Issue
• Research on recombinant DNA & gene transfer
– Regulated under NIH Guidelines
– Incorporated into VHA policy
• IBC
– Specific membership
– Specific responsibilities
– Specific requirements
• www4.od.nih.gov/oba
 Roles and Responsibilities:
R&D/SRS committee
• In addition to other responsibilities
• Ensure biosafety review completed & determines
need for changes to protocol
• Oversee requests for lab registration
• Reviews requests for:
– Lab access & access to BSL-3/SA labs
– Purchase transfer or destruction of SA & toxins
– Policies & procedures
– Results of vulnerability assessments, drills, incidents
• Document all reviews and findings
 Roles and Responsibilities:
Biosafety Officer
Varies from institution to institution
• Expertise: science, safety, security, & applicable
policies
• Responsible for or delegates:
– Training (delivery & record keeping)
– Inventory control
– Vulnerability assessments/drills
– Ensure compliance
• POC and resident expert
 Roles and Responsibilities: Lab
Directors & Investigators
• Ethical conduct of research
• Compliance with regulations
– Handook1200.8, Directive 2002-075
– Select agents (SA) & toxins
– BSL-3
• Safety & security within the lab
• All lab staff
– Trained
– Work within their scope of work
• Inventory control
 Responsible Official & Alternate
Responsible Official
• Term specific to select agents & toxins
regulations (CDC: 42 CFR 73; APHIS: 7
CFR 331, 9 CFR 121)
• RO = MCD
• Alternate RO can be the Biosafety Officer,
ACOS, AO, other qualified person
 Responsible Official (RO)
Alternate Responsible Official
• Approved security risk assessment
• Ensure facility compliance
• Alternate RO
– Delegated authority from RO
– Day to day operations
– Knowledgeable (regulations, policy, science)
– Coordinate with non-research offices: Human
Resources, Police, Safety, etc.
 Control of Hazardous Agents:
Specific Requirements
1. Controlling lab access
2. Physical security
3. Registering labs for select agent or toxin use
4. Inventory control
5. Emergency preparedness
6. Training
7. Policies and procedures/plans
 Controlling Laboratory Access
• Approve/authorize all staff (paid & WOC)
– Approve for all labs
• HRM “credentialing”
• OPM background check (SF 85)
– Authorize for SA & toxin labs
• HRM procedures plus
• Security Risk Assessment (FBI Form FD 961, approval by
CDC or USDA)
• Visitors/visiting scientists, students, etc. escorted
at all times unless approved or authorized
 Physical Security:
A Two Tiered System
• Laboratories in general
– Security is for research area
– Individual labs: ordinary locks
• BSL-3s and labs with SA or toxins
– More sophisticated security
– Ensures 2 security perimeters
– 3rd perimeter: locked refrigerators/cabinets
 Physical Security
All Laboratories
• Control access 24/7
• Keycard or more sophisticated system that
records access
• Doors self-closing
• Intrusion alarm integrated into VAMC
• Video surveillance at entrances suggested
• Unobstructed view of exterior entrances
 Physical Security
BSL-3s & Labs with SA or Toxins

• Security requirements apply to:

– BSL-3 without Select Agents or Toxins
– BSL-3 with SA or Toxins
– Laboratories using SA or T
– Storage areas for SA or T
 BSL-3s and SA or Toxins
Security Requirements
• Security as required by Select Agents regulations
(CDC or APHIS)
• Cardkey or more sophisticated system
– Code/keys specific to the laboratory
– Must record entrance & egress
• Access only to those who work in lab
– For SA & toxin labs: Authorized (approved Security
Risk Assessment & MCD concurrence)
– Special approval: BSL-3 without SA or toxins
 BSL-3s and SA or Toxins
Security Requirements (cont.)
• Audible alarms monitored by police
• Telephone in lab
• Video surveillance
• Lock all containers when out of site, not in use
• Meet requirements in Handbook 0730 “Security
and Law Enforcement for:
– Windows
– Doors
– Overhead spaces
 Registering Labs for
SA or Toxin Use
• Can NOT begin using SA or toxins unless:
– Lab registered
– All staff are authorized & have approved SRA
• Registration by HHS (CDC) or USDA
(APHIS)
• CDC/APHIS inspection of lab
 Inventory Control
• For Hazardous Agents
• Know:
– How much on hand
– Where it is
– Who has control of it
• Inventory adjusted when purchased, used,
transferred or destroyed.
• Purchase or store only for active or soon to be
active protocols
 Emergency Preparedness &
Response
• Plan coordinated with facility & outside
officials (Fire, police etc.)
• Specific to facility & agents in labs
• Incorporate OSHA, VHA & research
requirements
• Vulnerability assessments & drills annually
• Document all activities
 Training Requirements
• Integrate Biosafety & Security
• Applicable regulation (VA, OSHA, CDC)
• Must occur prior to assignments
• Annual refresher
• Generic training
• Specific to laboratory & agents
• Maintain good records
Required Policies and Procedures
• Safety plan
• Security plan
– Physical
– Personnel & Access
– Cyber
– Inventory control
• Emergency planning & response
• Training
 Policies & Procedures

• Written & updated as required

• Implementation must occur

• Documentation
 REVIEW: Control of Hazardous
Agents: Specific Requirements
1. Controlling lab access
2. Physical security
3. Registering labs for select agent or toxin use
4. Inventory control
5. Emergency preparedness
6. Training
7. Policies and procedures/plans
 Other New Issues
• BSL-3 Laboratories
– Annual Safety & Security visits by ORO
– IG remains interested in BSL-3 security
– Pans for new or decommissioning BSL-3: call ORD
• Select Agents or Toxins
– Final rule may be out in November
– No major changes expected
– New SA or Toxin use: report to CO
• Exempt Quantities of Toxins
 Exempt Quantities of Toxins
• Remain under tight security
• Prevent misuse or theft
• If not in sight or use must be locked up
• Accurate inventory
• Acquisition, transfer, destruction similar to
SA & toxins
• Possess only for specific protocol
 Submitting Biosafety Forms:
VA Form 10-0398
• Required for SRS review
• Just-in-time document for protocols
submitted to CO
• Problems found:
– Not filled out completely
– Missing required signatures
– Information in form does not match protocol
• Avoid HOLDS!
 Requesting Waivers
• Waivers only if referenced in VHA policy
• Rarely given for BSL-3 or SA and toxin lab
requirements
• Request sent to ORD
• Required information: Directive 2002-075,
Appendix B.
• Call or e-mail if any questions
 Remember!

• Directive 2002-075 as published in November

2002 is still the official policy

• Information on slides may change once the new

draft of this Directive is signed by the Under
Secretary for Health

• Please contact ORD for questions & help

– Brenda Cuccherini, Ph.D. (202)254-0277
– brenda.cuccherini@hq.med.va.gov