# Presentation: 286994

## Biosafety/Biosecurity: An Update

- <date/time>

- Biosafety/Biosecurity: An Update

- February 27, 2004

## Where is the emphasis?

- <date/time>

- Biosafety
- 		         
- 		Biosecurity

## Biosafety

- <date/time>

- 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

- <date/time>

- 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

- <date/time>

- 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

- <date/time>

- 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)

- <date/time>

- 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

- <date/time>

- 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

- <date/time>

- 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 

- <date/time>

- 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)

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- 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

- <date/time>

- 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

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- 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

- <date/time>

- 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 

- <date/time>

- 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

- <date/time>

- 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

- <date/time>

- 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

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- 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

- <date/time>

- 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 

- <date/time>

- 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

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- 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

- <date/time>

- 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

- <date/time>

- 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

- <date/time>

- Physical SecurityBSL-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

- <date/time>

- 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.)

- <date/time>

- 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

- <date/time>

- 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

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- 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

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- 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

- <date/time>

- 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

- <date/time>

- Safety plan
- Security plan
- Physical
- Personnel & Access
- Cyber
- Inventory control
- Emergency planning & response
- Training

## Policies & Procedures

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- Written & updated as required
- Implementation must occur
- Documentation

## REVIEW: Control of Hazardous Agents: Specific Requirements 

- <date/time>

- 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

- <date/time>

- 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

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- 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

- <date/time>

- 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

- <date/time>

- 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!

- <date/time>

- 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

## Why we are here!