Biosafety/Biosecurity: An Update

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Biosafety/Biosecurity An Update

• February 27, 2004

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Where is the emphasis?

• Biosafety
• ? ?
• Biosecurity

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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

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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

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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

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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

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The Concurrence Process

• Draft ? Concurring Offices ? Final Document

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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

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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

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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

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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

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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

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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

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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)

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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

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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

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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

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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

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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

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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.

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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Required Policies and Procedures

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

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Policies Procedures

• Written updated as required
• Implementation must occur
• Documentation

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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

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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

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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

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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!

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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

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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. [phone]
• brenda.cuccherini_at_hq.med.va.gov

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Why we are here!