# Presentation: 442314

## The Review  Process for Laboratory Safety Programs

**February 5, 2008**
**Ron Barry, PhD, RBP**
**Office of Research Oversight**
**ronald.barry@va.gov**

**VISN 8 Safety & Health**

## Presentation Outline

- Overview of the VHA Facility Research
- 	 Safety Program

- Safety Review of the Research Laboratory

## 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:

- Federal statutes, regulations and guidelines

- Any other applicable state and local (municipal) regulations and requirements

- VA and VHA policies and guidelines

## Functions of the RSSP

_**Safety**_:  to ensure the safe 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.
_**Security**_:  to ensure policies and procedures are implemented to prevent theft, unauthorized removal, or inappropriate use of high-risk biological, physical, chemical, or radioactive materials.

## Role of the Research Compliance Officer

- Verify RSSP compliance with the various VA, VHA, federal, state and local policies, regulations and guidelines

- Effectively:  to 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 and Regulations

- 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 (Office of Biotechnology Activities),* *2002

**Federal Guidelines and Regulations**

## Federal GuidelinesSECURITY

_**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 & VHA Policies

_**VHA Handbook 1200.8**_, *Safety of Personnel Engaged in Research*, 2002
_**VHA Handbook 1200.06**_, *Control of Hazardous Materials in VA Research Laboratories, *2004
_**VA 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
- VHA Directive 1105.1, *Management of Radioactive Materials*, 2004

## Sate and Local Guidelines

- States are delegated EPA compliance oversight
- 	(hazardous chemical wastes, volatile emissions, etc.)
- Municipal landfill restrictions
- Sewage and water treatments
- Recycling programs
- Others . . .

## Developing andImplementing the RSSP

- The responsibility of the **Facility Director**, assisted by:
- The Associate Chief of Staff (ACOS), Research & Development
- 	  Administrative Officer (AO), Research & Development
- The Research and Development Committee
- 	   The Subcommittee for Research Safety

## RSSP Oversight & Support

**RSSP Oversight & Support**

## 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 its responsibilities

- Appoint a Research Safety Coordinator
- ACOS, or other research biosafety professional
- Supervises the operation of the RSSP

## R&DC Responsibilities (cont’d)

- Appoint a Biological Safety Officer
- recombinant DNA activities with BSL-3 or BSL-4 pathogens
- Large-scale production (> 10 liters) of recombinant DNA products

- Coordinate oversight of the RSSP with other programs
- The facility safety committee (Safety & Risk Management, EOC, etc.)
- The Radiation Safety Committee

- Appoint a Chemical Hygiene Officer
- Assist in development and implementation of the Chemical Hygiene Plan
- Member of the SRS
- Usually the facility Industrial Hygienist

## The SRS

- Review all research activities for compliance with applicable guidelines
- Review of biological, chemical, physical and radiations hazards
- Prior to submission for funding, and annually thereafter

- Coordinate all safety-related activities in the research laboratories
- Mandatory safety training, including research specific safety training
- Safety inspections
- Accident reporting

- 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

## 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

- Approval signatures must include:
- Safety (Biosafety) Officer
- Chair, SRS
- Chair, R&DC
- Radiation Safety Officer (if applicable)
- Facility Safety Officer

- SRS and R&DC approval is required prior to initiation of research activities

## SRS Membership

- At least 5 members, exclusive of ex-officio members
- Expertise in infectious agents and chemical, physical and radiation hazards
- If research is _non_-exempt from *NIH Guidelines for Research Involving rDNA Molecules*, two members must _not_ be affiliated with the institution
- 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

## The Principal Investigator

**Acknowledgement of Responsibility and Knowledge**
-      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 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
- 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
- Review and approval 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 VHA (Handbooks 1200.8 and 1200.06) guidelines
- Review and approval by SRS and R&DC

## Components of the CHP

- Procedures for work with hazardous chemicals
- 	Flammable, corrosive (acids, bases) and toxic chemicals and gases
- Chemical procurement, storage and disposal
- 	Primary and secondary container labeling, GEMS program
- Protective apparel and equipment
- 	PPE, biological safety cabinets, chemical fume hoods, autoclaves, . . .
- Environmental monitoring
- 	Chemical and infectious, and biological spills, noise, fumes,  . . .

## Components of the CHP (cont’d)

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

## The Radiation Safety Program

- Compliance NRC and NHPP guidelines
- 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
- Reviewed and approved by the Radiation Safety Committee,
- 		R&DC and SRS
- Procurement, storage, labeling, and disposal guidelines
- Proper use, surveillance, and response to emergency spills
- Security requirements

## Biosafety Training

- Required for all research personnel
- Initial appointment, and annually thereafter
- VA employees, WOCs (without compensation staff), etc.
- Includes general and research-specific safety training
- Fire, earthquake, bloodborne pathogens
- Laboratory safety (chemicals, biological materials, infectious agents, BSL-3 pathogens, radiation safety, etc.)
- 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
- 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)

## “Increased Controls”for the Radiation Safety Program

- Compliance with NRC and NHPP guidelines for security of radioactive material quantities of “concern”
- Effective November 2005
- Cumulative or source activity is > 1 Curie
- Increased security controls:
- Restricted access – requires full background security check
- Semiannual review of access records (SRS)
- Enhance “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

## 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

## 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

## Laboratory InspectionsTypes or Agencies?

## VA Handbook 7700.1Occupational Safety and Health

**5. Occupational Safety and Health Program - Department**
- a. **Annual OSH Inspections.**  _Annual OSH Inspections_ shall be performed at each VA workplace to qualitatively assess compliance of the facility's OSH program with VA requirements.  Qualified personnel **(e.g., safety managers, safety specialists, industrial hygienists, safety engineers, fire protection engineers, etc.)** shall conduct comprehensive OSH inspections of VA facilities for which they are responsible at least once every fiscal year (not to exceed 15 months between inspections).  These inspections shall be conducted and documented in accordance with requirements and guidance provided by the Designated Agency Safety and Health Official (DASHO).

**6. Occupational Safety Program - Facilities**
- a. **Hazard Surveillance Surveys.** _Hazard surveillance surveys_ shall be performed and documented at each VA facility by qualified personnel **(e.g., safety managers, safety specialists, industrial hygienists, safety engineers, fire protection engineers)**, who are trained in the recognition of physical hazards and unsafe work practices.  These surveys shall consist of a **walk-around inspection and a written report**.  **Quarterly surveys** must be performed of **high hazard areas** (e.g., **laboratories**, engineering shops) and _**semiannual**_** surveys must be performed for the entire facility**.  Deficiencies cited by these surveys that are not corrected within 30 days must be addressed in the facility OSH abatement plan (see par. 5c).

## Conducting Safety Reviewsof theResearch Laboratories

**Different from the typical review of  occupational safety hazards. . .**** **

## Lab Safety Reviews

**N**ational **H**ealth **P**hysics **P**rogram

**Verify research activities comply with VA, federal, state, and local policies and guidelines**** **

## An Abridged Checklist

**An Economy of**
**Time and Effort **

## Access to the laboratory is restricted to authorized personnel 

- State-of-the-art electronic security system

- Identification badges for lab personnel

- Visitors are escorted through research areas

- Labs locked when not occupied

- Accessible by emergency responders

- Door wedges not used (fire code violation)

## No food or drinks are evident in the laboratory 

- Cosmetics

- Lotions

- Contact lens solutions

**In addition to food and drinks, no:**

## Laboratory housekeeping is satisfactory, the lab is uncluttered 

- No storage on the floor

- Lab benches and work spaces clear

- Interior corridors not obstructed

- Waste materials properly contained

## All equipment is in good condition and functions properly 

- Electrical cords not cracked, frayed

- Locking lids on centrifuges

- Hazard labeling as needed

- No storage of old, outdated equipment

- Cabinetry operational, not corroded

## All refrigerators, freezers, and cold rooms are in good condition, and function and are used properly 

- Temperature adequately maintained

- No excessive ice buildup

- No mold or mildew present

- No outdated reagents or biological materials

- Reagents and materials are properly labeled

## Chemicals are properly stored

- Flammables

- Corrosives separated by compatibility
- 		 (separate strong acids & bases)

- Reactive chemicals
-          stored separately

- No old, outdated chemicals
-         present (RCRA, EPA)

## Secondary chemical containers are properly labeled

- Chemical name

**Hazard identification**

- Investigator

- Date
- Expiration
-       date

## All lab personnel have access to MSDS and the facility Chemical Hygiene Plan 

- MSDS for all hazardous chemicals

- Chemical inventories are posted

- CHP available in the lab

## Appropriate PPE are available and used as needed

- Hot plates

- Liquid nitrogen storage tanks

- UV light trans-illuminators

- Sonicators, homogenizers

## Fire protection equipment available, unobstructed

- Fire extinguishers

- Overhead sprinklers

- Door wedges not in use

## Appropriate blood borne pathogen preventive practices are in place

- Hand washing sinks available

- Disinfectants for lab benches & cabinets

- Laboratory coats available

- Protective gloves

- Pipetting aids present

- Sharps containers

- Biological waste containers used

- Liquid traps with disinfectant

## Biological or infectious wastes is properly labeled, stored and disposed

- Biological waste containers

- Liquid traps with disinfectant

- HEPA filters on vacuum lines

- Sharps containers secured

## Hazardous chemical waste is properly labeled, stored, and disposed

- Containers must be in good condition

- Labeled as “**Hazardous**”

- Labeled as to chemical contents

- Labels must always visible

- Labeled with collection start date

- Container never full

**Containers always sealed**

- No old, outdated chemicals present

## RCRA Compliance – Common EPA ViolationsImproperly labeled containers

**RCRA Compliance – Common EPA Violations****Improperly labeled containers**

- Contents unknown

- Label illegible

## RCRA Compliance – Common EPA ViolationsOpen containers

**RCRA Compliance – Common EPA Violations****Open containers**

## RCRA Compliance – Common EPA ViolationsImproper disposal

**RCRA Compliance – Common EPA Violations****Improper disposal**

- Discarded containers still contain chemicals

- Scintillation vials with toluene found in regular trash

## RCRA Compliance – Common EPA ViolationsUnsafe waste management

## RCRA Compliance – Common EPA ViolationsUnsafe waste management

## RCRA Compliance – Common EPA ViolationsStorage of outdated chemicals

## Chemical fume hoods & biological safety cabinets are inspected & certified

- Certified once each calendar year

- Certified semiannually for airborne pathogens

- Chemical fume hoods not cluttered

- Biological safety cabinets not cluttered

- Flammable gas is not used in BSCs

## Chemical fume hood operation

**Chemical fume hood operation**

**NOT used for storage!**

## Biosafety Cabinets

**Biosafety Cabinets**

## Safety showers and eyewash stations are accessible and regularly inspected/flushed

- Weekly (or biweekly) for eyewashes

- Maintenance records are posted

- Access is not blocked

- Quarterly for safety showers

## Compressed gas cylinders are properly stored and restrained

- Double-chained in earthquake-prone areas

- Caps must be in place

- Regulators removed
-          when tank in not in use

## DEA controlled substances are properly secured and recorded

- Drugs are secured

- No outdated drugs are present

- Monthly checks, Controlled Substances program
- (VHA Handbook 1108.1, October 2004)

## Select agents and toxins are properly secured and stored

- Access to exempt levels of toxins is restricted

- Inventories of exempt levels of toxins maintained

- SATs are secured

## Questions?