# Presentation: 197214

## Safety in theVA Research Setting 

**Ron Barry, PhD, RBP**
**Office of Research Oversight**
- Ronald.Barry@va.gov
**October 14, 2007**

## The Research Safety andSecurity 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

## 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.

## 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.

## What are the policies, statutes, regulations, and guidelines that govern a VA Research RSSP?

## 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

## Federal Guidelines (cont’d)

- 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.

## 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

## VA Policies (cont’d)

- 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

## 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.)

## Developing andImplementing 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 Director’s Research Oversight Checklist and Certification**
- 	  (http://www1.va.gov/oro/docs/Facility-Director-Cert-Checklist-032307.doc)

## RSSP Oversight & Support

**RSSP Oversight & Support**

## The Role of the Research & Development Committee (R&DC)

- 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 R&DC of its responsibilities
- Appoint a Research Safety Coordinator
- ACOS, or other research and biosafety professional
- Supervises the operation of the RSSP

## R&DC Responsibilities (cont’d)

- Appoint a Biological Safety Officer
- Recombinant DNA (rDNA) activities with Risk Group-3 or RG-4 pathogens
- Large-scale production (> 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

## 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

## 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 R&DC approval is required prior to initiation of research activities
- Approval signatures must include:
- Biosafety Officer (if applicable)
- Chair, SRS
- Chair, R&DC
- Radiation Safety Officer (if applicable)
- Facility Safety Officer

## 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 R&DC (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

## 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 (> 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

## 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.**”**

## 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

## PI Responsibilities (cont’d)

- 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**

## The Research Safety Program

## 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 R&DC

## 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 R&DC

## 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, . . .

## Components of the CHP (cont’d)

- 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, . . .

## 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,
- 		R&DC and SRS

## 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

## The Research Security Program

## 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)

## Security of BSL-3 Facilities

- BSL-3 Laboratory Standard Operating Procedure (SOP) Manual includes a Physical Security Plan
- Annually reviewed and approved by SRS (R&DC)
- 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 (RD&C)
- Vulnerability assessment by Police & Security Service
- Emergency response drill performed and documented

## “Increased Controls”for 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 > 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

## Suggestions forEffective RSSP Oversightby the Research Compliance Officer

- Review the VA, VHA and federal policies and guidelines
- Participate or attend SRS and/or R&DC 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

## 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)

## 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.pdf
- ORO Research Safety Checklist and the Security Checklists for BSL-1, BSL-2 and BSL-3 Laboratories
- 		http://www1.va.gov/oro/page.cfm?pg=139
- Facility Director’s Research Oversight Checklist and Certification
- 		http://vaww1.va.gov/oro/docs/Facility-Director-Cert-Checklist-032307.doc

## Online Resources (cont’d)

- VHA Handbook 1200.8, *Safety of Personnel Engaged in Research*
- 		http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=401
- VHA Handbook 1200.06, *Control of Hazardous Materials in VA Research Laboratories*
- 		http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1336
- VHA Handbook 7700.1, *Occupational Safety and Health*
- 		http://www1.va.gov/vasafety/page.cfm?pg=232
- VHA Directive 6600,* Responsibility of employees and others supporting VA in protecting personally identifiable information*
- 		http://www1.va.gov/vapubs/viewPublication.asp?Pub_ID=341
- VHA Directive 6601, *Removable storage media*
- 		http://www1.va.gov/vapubs/viewPublication.asp?Pub_ID=342