Safety in the VA Research Setting

1
Safety in theVA Research Setting

• Ron Barry, PhD, RBP
• Office of Research Oversight
• Ronald.Barry_at_va.gov
• October 14, 2007

2
The Research Safety andSecurity Program (RSSP)

• Every VA facility sponsoring research
  activities must develop a Research Safety and
  Security Program which is consistent with
• VA and VHA policies and guidelines
• Federal statutes, regulations and guidelines
• Any other applicable state and local (municipal)
  regulations and requirements

3
Function of the RSSP

• To ensure the safe and secure conduct of
  research activities involving any biological,
  physical and chemical materials and agents that
  could pose a potential hazard to VA staff,
  patients, volunteers, and the community.

4
Role of the Research Compliance Officer

• Verify RSSP compliance with the various VA, VHA,
  federal, state and local policies, regulations
  and guidelines, and thereby facilitate the safe
  and secure conduct of VA research activities.

5
What are the policies, statutes, regulations, and
guidelines that govern a VA Research RSSP?
6
Federal Guidelines

• 29 CFR Part 1910, Occupational Safety and Health
  (OSHA) Standards. OSHA
• Section 1910.1030, Bloodborne Pathogens
• Section 1910.1200, Hazard Communication
• Section 1910.1450, Occupational Exposure to
  Hazardous Chemicals in Laboratories
• 29 CFR Part 1960, Basic Program Elements for
  Federal Employee Occupational Safety and Health
  Programs and Related Matters. OSHA
• Biosafety in Microbiological and Biomedical
  Laboratories (5th Edition). CDC, NIH, 2007
• NIH Guidelines for Research Involving Recombinant
  DNA Molecules, NIH, 2002

7
Federal Guidelines (contd)

• 42 CFR Part 73, Possession, Use, and Transfer of
  Select Agents and Toxins (Final Rule), HHS
• 7 CFR Part 331 and 9 CFR Part 121, Agricultural
  Bioterrorism Protection Action of 2002
  Possession, Use, and Transfer of Biological
  Agents and Toxins. Department of Agriculture
• Guidance Document for Application for Laboratory
  Registration for Possession, Use, and Transfer of
  Select Agents and Toxins. HHS and DOA, OMB Nos.
  0579-0213 0920-0576.

8
VA Policies(Handbooks and Directives)

• VHA Handbook 1200.8, Safety of Personnel Engaged
  in Research, 2002
• VHA Handbook 1200.06, Control of Hazardous
  Materials in VA Research Laboratories, 2004
• VHA Handbook 7700.1, Occupational Safety and
  Health, 1998
• VHA Handbook 7701.1, Occupational Safety and
  Health Program Procedures, 2003
• VHA Directive 2003-030, Management of Hazardous
  Chemicals, 2003

9
VA Policies (contd)

• VHA Directive 1105.1, Management of Radioactive
  Materials, 2004
• VHA Directive 2005-003, Requirements for
  Submittal and Approval of Biosafety Level-3
  (BSL-3) Research Laboratory Construction and
  Renovation, 2005
• VHA Handbook 0730, Security and Law Enforcement,
  2000
• VA Directive 6500, Information Security Program,
  2006
• VA Directive 6600, Responsibility of employees
  and others supporting VA in protecting personally
  identifiable information (PII), 2007
• VHA Directive 6601, Removable storage media, 2007
• VA Handbook 6500, Information Security Program,
  2007

10
Sate and Local Guidelines

• States are delegated EPA compliance oversight
• (hazardous chemical wastes, volatile emissions,
  etc.)
• Municipal landfill restrictions
• Sewage and water treatment facilities
• Recycling programs
• Others . . .
• (e.g., earthquake abatement mercury
  reduction
• hurricane preparedness,
  etc.)

11
Developing andImplementing the RSSP

• The responsibility of the Facility Director,
  assisted by
• The Associate Chief of Staff (ACOS), Research
• Administrative Officer (AO), Research
• The Research and Development Committee
• The Subcommittee for Research Safety
• One of many responsibilities of the Facility
  Director
• Facility Directors Research Oversight
  Checklist and Certification
• (http//www1.va.gov/oro/docs/Facility-Director-
  Cert-Checklist-032307.doc)

12
RSSP Oversight Support
13
The Role of the Research Development Committee
(RDC)

• Review and approve all research activities
• Establish a Subcommittee for Research Safety
  (SRS) and/or other multiple subcommittees
• Assist with oversight and implementation of RSSP
• Does not absolve RDC of its responsibilities
• Appoint a Research Safety Coordinator
• ACOS, or other research and biosafety
  professional
• Supervises the operation of the RSSP

14
RDC Responsibilities (contd)

• Appoint a Biological Safety Officer
• Recombinant DNA (rDNA) activities with Risk
  Group-3 or RG-4 pathogens
• Large-scale production (gt 10 liters) of
  recombinant DNA products
• Research regulated by the NIH Guidelines for
  Research Involving rDNA Molecules
• Appoint a Chemical Hygiene Officer
• Assist in development and implementation of the
  Chemical Hygiene Plan
• Member of the SRS
• Usually the facility Industrial Hygienist
• Coordinate oversight of the RSSP with other
  programs
• The facility safety committee (Safety Risk
  Management Committee)
• The Radiation Safety Committee

15
The SRS

• Review all research activities for compliance
  with applicable guidelines
• Review the use of biological, chemical, physical
  and radiations hazards
• Reviews conducted prior to submission for
  funding, and annually thereafter
• Ensure hazardous chemical inventories are
  submitted to the Facility Safety Officer
• Required for SRS review and approval of proposed
  research activities
• Active research programs must submit (semi)annual
  updates
• Coordinate all safety-related activities in the
  research laboratories
• Mandatory safety training, including
  research-specific safety training
• Safety inspections
• Accident reporting

16
SRS Review of Research Activities

• The Principal Investigator (PI) must submit the
  Research Protocol Safety Survey, VA Form 10-0398
• Appendix G of VHA Handbook 1200.8
• Supplemental information may be required
• Regardless of funding or funding source
• SRS and RDC approval is required prior to
  initiation of research activities
• Approval signatures must include
• Biosafety Officer (if applicable)
• Chair, SRS
• Chair, RDC
• Radiation Safety Officer (if applicable)
• Facility Safety Officer

17
SRS Membership

• At least 5 members, exclusive of ex-officio
  members
• Expertise in infectious agents and chemical,
  physical and radiation hazards
• Members should include representatives from the
  Facility Safety Office, the Institutional Animal
  Care and Use Committee, and the Radiation Safety
  Office
• Ex-officio members
• Liaison member from the RDC (voting)
• The Chemical Hygiene Officer (CHO) (voting)
• The AO or other Research Office representative
  (non-voting)
• An employee union representative or other union
  designee (voting or non-voting)
• Director must formally appoint members
• 3-year terms, annually for the SRS Chair

18
Other Supporting Committees

• Institutional Biosafety Committee (IBC)
• If research is non-exempt according to the NIH
  Guidelines for Research Involving rDNA Molecules
• a) large-scale production (gt 10 liters) of
  recombinant DNA products
• b) rDNA activities with Risk Group-3 or RG-4
  pathogens
• Two members must not be affiliated with the
  institution
• Must be registered with NIH
• Research Space Subcommittee
• Ensure adequate resources for funded research and
  personnel
• Equipment Committee/Subcommittee
• Inventory and housing of research equipment

19
The Principal Investigator

• Acknowledgement of Responsibility and Knowledge
• (VA Form 10-0398)
• I certify that my research studies will be
  conducted in compliance with and full knowledge
  of Federal, State, and local policies,
  regulations, and CDC-NIH Guidelines governing the
  use of, biohazardous materials, chemicals,
  radioisotopes, and physical hazards. I further
  certify that all technical and incidental workers
  involved with my research studies will be aware
  of potential hazards, the degree of personal risk
  (if any), and will receive instructions and
  training on the proper handling and use of
  biohazardous materials, chemicals, radioisotopes,
  and physical hazards. A chemical inventory of
  all Occupational Safety and Health Administration
  (OSHA) and Environmental Protection Agency
  (EPA)-regulated hazardous chemicals is attached
  to this survey.

20
PI Responsibilities

• Ensure all research activities have been reviewed
  and approved by the SRS
• Identify specific safety hazards associated with
  laboratory research activities
• Train and supervise laboratory staff with respect
  to standard and laboratory-specific safety
  practices
• Ensure appropriate PPE and laboratory safety
  equipment (biological safety cabinets, chemical
  fume hoods, autoclaves) are available and
  operational
• Ensure laboratory personnel comply with annual
  safety training requirements

21
PI Responsibilities (contd)

• Ensure up-to-date chemical inventories are
  available in the laboratory
• Ensure the Chemical Hygiene Plan (CHP) and
  Material Data Safety Sheets (MSDS) are available
  in the laboratory
• Ensure all biological, infectious and chemical
  wastes are managed according to Federal, State
  and local guidelines
• Ensure laboratory personnel maintain a clean,
  orderly research environment
• Notify Research Office of personnel changes

22
The Research Safety Program
23
The Research Biosafety Plan

• Provides guidance for Research staff,
  investigators, and laboratory personnel
• Ensures compliance with VHA Handbooks 1200.8
  1200.06, and Federal, State and local guidelines
• May be incorporated into the Research CHP
• Reviewed and approved by SRS and RDC

24
The Chemical Hygiene Plan (CHP)

• Educate research personnel in safe practices and
  procedures associated with use of chemicals and
  other hazardous materials
• Developed and implemented by the IH, CHO and
  other safety professionals
• Mandated by federal (29 CFR1 1910.1450) and VA
  (VHA Handbooks 1200.8 and 1200.06) guidelines
• Reviewed and approved by SRS and RDC

25
Components of the CHP

• Chemical procurement, storage and disposal
  guidelines
• Primary and secondary container labeling
• Appropriate storage cabinetry
• GEMS program instituted
• Special procedures for work with hazardous
  chemicals
• Flammable, corrosive (acids, bases) and toxic
  chemicals and gases
• Protective apparel and equipment
• Personal Protective Equipment (PPE)
• Biological safety cabinets, chemical fume hoods,
  autoclaves, . .
• Environmental monitoring
• Chemical, infectious and biological spills
• Noise, air quality, ergonometrics, . . .

26
Components of the CHP (contd)

• Laboratory housekeeping, maintenance and
  inspections
• Medical surveillance program
• Recordkeeping
• Chemical inventories, MSDS, autoclave records, .
  . .
• Employee safety information and training
  requirements
• Emergency response procedures
• Physical safety guidelines
• Electrical, fire, earthquake, hurricanes,
  cryogenic liquids, autoclaves, . . .

27
The Radiation Safety Program

• Compliance Nuclear Regulatory Commission and the
  National Health Physics Program guidelines
• VHA Handbooks 1105.1 and 1105.2
• Implemented and overseen by the facility
  Radiation Safety Committee and the Radiation
  Safety Officer
• RSO serves as a SRS member
• RSO conducts annual reviews of the radiation
  safety program
• Radiation Safety Manual
• Procurement, storage, labeling, and disposal
  guidelines
• Proper use, surveillance, and response to
  emergency spills
• Security requirements
• Reviewed and approved by the Radiation Safety
  Committee,
• RDC and SRS

28
Biosafety Training

• Required for all research personnel
• Initial appointment, and annually thereafter
• VA employees, WOCs, volunteers, etc.
• Includes general and research-specific safety
  training
• Fire, earthquake, bloodborne pathogens
• Laboratory safety (chemicals, biological
  materials, infectious agents, BSL-3 pathogens,
  etc.)
• Radiation safety
• Monitored by SRS
• Annual training documented and reviewed

29
The Research Security Program
30
Select Agents and Toxins (SAT)

• Final Rule on possession, use and transfer of
  SAT (42 CFR Parts 72, 73, 1003)
• Now addresses physical security of SAT
• Includes authority for civil penalties
  (250-500k)
• VHA Handbook 1200.06, Control of Hazardous Agents
  in VA Research Laboratories
• Physical security of all the research areas
• Designation of the Responsible Official (RO) and
  Alternate RO
• Security of SAT, hazardous chemical agents and
  radioactive materials (see Appendix A)
• Handling and security of exempt levels of select
  agent toxins
• Security of BSL-3 Laboratories
• Full Security Risk Assessment by Dept. of Justice
  (FBI Form FD-961)

31
Security of BSL-3 Facilities

• BSL-3 Laboratory Standard Operating Procedure
  (SOP) Manual includes a Physical Security Plan
• Annually reviewed and approved by SRS (RDC)
• Security background checks required for access to
  BSL-3 facility
• State-of-the Art security system required
• Monitors entry to and egress from the facility
• Entry and egress records recorded and reviewed
• Video surveillance of entry areas required
• Intrusion alarm systems installed, monitored and
  tested
• Annual Security Assessment performed and reviewed
  by SRS (RDC)
• Vulnerability assessment by Police Security
  Service
• Emergency response drill performed and documented

32
Increased Controlsfor the Radiation Safety
Program

• Compliance with NRC and NHPP guidelines for
  security of radioactive material quantities of
  concern
• Effective November 2005
• Stored cumulative or irradiator source activity
  is gt 1 Curie
• Increased security controls
• Restricted access requires full background
  security check
• Semiannual review of access records (SRS)
• Enhanced delay methods for access to materials
  or source
• State-of-the-art security system
• Compliance with 10 CFR 20.1802 constant
  surveillance
• Annual vulnerability assessment by Police
  Security Service

33
Suggestions forEffective RSSP Oversightby the
Research Compliance Officer

• Review the VA, VHA and federal policies and
  guidelines
• Participate or attend SRS and/or RDC meetings
• Participate in the safety and security
  inspections of the Research areas
• Review the ORO Safety and Security Checklists for
  BSL-1, BSL-2 and BSL-3 Laboratories

34
Research Laboratory Inspections

• External agencies
• Occupational Safety and Health Administration
• Environmental Protection Agency
• State environmental quality agencies
• Municipal or county agencies (fire marshal, water
  quality, etc.)
• Internal inspections
• Annual Workplace Evaluation
• Environment of Care Committee, or similar entity
• (semiannual or quarterly hazard surveillance
  surveys)
• SRS members or representatives
• Deficiencies noted must be resolved within 30
  days
• Facility Director is responsible (VHA Handbook
  1200.8)
• SRS must provide follow up evaluations of
  resolution process (VHA Handbook 1200.8)

35
Online Resources

• Biosafety in Microbiological and Biomedical
  Laboratories (BMBL)
• http//www.cdc.gov/OD/ohs/biosfty/bmbl5/bmbl5toc
  .htm
• Dept. of Labor Occupational Safety and Health
  Administration (OSHA)
• http//www.osha.gov/
• Recombinant DNA and Gene Transfer - Office of
  Biotechnology Activities (OBA), NIH Guidelines
  for Research Involving Recombinant DNA Molecules
• http//www4.od.nih.gov/oba/Rdna.htm
• Select Agents and Toxins
• http//www.cdc.gov/od/sap/
• http//www.cdc.gov/od/sap/42_cfr_73_final_rule.p
  df
• ORO Research Safety Checklist and the Security
  Checklists for BSL-1, BSL-2 and BSL-3
  Laboratories
• http//www1.va.gov/oro/page.cfm?pg139
• Facility Directors Research Oversight Checklist
  and Certification
• http//vaww1.va.gov/oro/docs/Facility-Director-C
  ert-Checklist-032307.doc

36
Online Resources (contd)

• VHA Handbook 1200.8, Safety of Personnel Engaged
  in Research
• http//www1.va.gov/vhapublications/ViewPublicati
  on.asp?pub_ID401
• VHA Handbook 1200.06, Control of Hazardous
  Materials in VA Research Laboratories
• http//www1.va.gov/vhapublications/ViewPublicati
  on.asp?pub_ID1336
• VHA Handbook 7700.1, Occupational Safety and
  Health
• http//www1.va.gov/vasafety/page.cfm?pg232
• VHA Directive 6600, Responsibility of employees
  and others supporting VA in protecting personally
  identifiable information
• http//www1.va.gov/vapubs/viewPublication.asp?Pu
  b_ID341
• VHA Directive 6601, Removable storage media
• http//www1.va.gov/vapubs/viewPublication.asp?Pu
  b_ID342