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 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

• 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