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Biosafety/Biosecurity: An Update

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... 8 Safety of Personnel Engaged in Research VA Directive 7701 & Handbook 7701.1 Occupational Safety & Health OSHA s regulations Plans Minor updates ... – PowerPoint PPT presentation

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Title: Biosafety/Biosecurity: An Update


1
Biosafety/Biosecurity An Update
  • February 27, 2004

2
Where is the emphasis?
  • Biosafety
  • ? ?
  • Biosecurity

3
Biosafety
  • Policy
  • Handbook 1200.8 Safety of Personnel Engaged in
    Research
  • VA Directive 7701 Handbook 7701.1 Occupational
    Safety Health
  • OSHAs regulations
  • Plans
  • Minor updates to 1200.8
  • Revise biosafety form (10-0398)
  • Define training needs

4
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

5
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

6
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

7
The Concurrence Process
  • Draft ? Concurring Offices ? Final Document

8
Control of Hazardous Agents(Why The Re-draft)
  • Approach
  • Facilitys comprehensive program
  • Address concerns of IG
  • Meet new standards
  • HHS (CDC)
  • USDA (APHIS)
  • Clarify current requirements

9
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

10
DefinitionSelect 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

11
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

12
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

13
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 RD committee/SRS
  • Ensure compliance

14
Roles and Responsibilities RD/SRS committee
  • Advises the MCD on the RD program
  • RD responsibilities
  • M-3, Part 1, Chapter 2 3
  • Safety of Personnel in Research (1200.8)
  • Hazardous Agents directive
  • RD committee may form a Subcommittee on Research
    Safety (SRS)
  • SRS Institutional Biosafety Committee (IBC)

15
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

16
Roles and Responsibilities RD/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

17
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

18
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

19
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

20
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.

21
Control of Hazardous AgentsSpecific
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

22
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

23
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

24
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

25
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

26
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

27
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

28
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

29
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

30
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

31
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

32
Required Policies and Procedures
  • Safety plan
  • Security plan
  • Physical
  • Personnel Access
  • Cyber
  • Inventory control
  • Emergency planning response
  • Training

33
Policies Procedures
  • Written updated as required
  • Implementation must occur
  • Documentation

34
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

35
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

36
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

37
Submitting Biosafety FormsVA 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!

38
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

39
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_at_hq.med.va.gov

40
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