Biosecurity at CDC pre

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Biosecurity at CDCpre post 9/11

• Jonathan Y. Richmond, PhD
• Director
• Office of Health and Safety
• CDC, Atlanta

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A Bit of History

• 1994 Tokyo, Sarin and biological attacks
• 1995 Larry Wayne Harris
• Select Agent program (1997)
• 1995 pre-Olympics security evaluation caused
  change
• open to somewhat closed campus
• 1997 Oklahoma City bombing
• COOP requirement

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Prior to the Select Agent Rule

• No uniform identification of facilities working
  with human pathogens
• No mandated safety requirements for handling
  these agents
• No tracking and verification of the transfer of
  these agents

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Appendix A To Part 72 - Select Agents
Select Agent Rule, 1997
13 Viruses 9 Bacteria 3 Rickettsiae
1 Fungi 12 Toxins
Genetically modified / genetic elements
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BMBL, 4th edition, 1999
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BioSecurity considerations for

• Laboratories using biological agents or toxins
  capable of causing serious or fatal illness to
  humans or animals, and to
• Minimize opportunities for accidental or
  intentional removal of these agents from the
  laboratory.

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Risk Assessments
Why me? People, facilities, data, product,
animals, microbes
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Lab security is related to but different than lab
safety

• Involve safety and security experts in facility
  evaluation and development of recommendations
• Review safety/security policies regularly and
  following an incident or threat

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Emergency planning

• Needs to be integrated throughout the
  organization cover all contingencies
• Evacuation accountability
• Physical events (fire, power, bombs, )
• Natural events (storms, earthquakes, )
• Breaches of containment
• Requires a 2-tiered approach
• Strategic
• Tactical

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Critical Biological Agents

• Category A
• Bacillus anthracis (Anthrax)
• Yersinia pestis (Plague)
• Franciscella tularensis (Tularemia)
• Hemorrhagic fever viruses (Ebola, Marburg)
• Clostridium botulinum toxin (Botulism)
• Variola major (Smallpox)

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Adding Physical Barriers

• Hardening access

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Physical barriers
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Vehicular Control
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Personnel Monitoring
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Accountability

• Know what you have (inventory).
• Know where it is.
• Know who has access to it.
• Know who gets it.
• Know when it is destroyed or transferred.
• Knowing means a written record.

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Control access to where agents are stored used

• Labs animal areas separated from public areas
  locked at all times
• Card-key or other controlled access
• Visitor entry recorded restricted to times when
  staff are available for escort
• Lock storage rooms, cabinets, freezers containing
  agents

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Controlling access
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Know your workers

• Depending on the agents involved, background
  checks /or security clearances should be done
  before workers are given access w/o escort.
• Provide appropriate training establish record
  base before issuing access authority.

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Change the culture challenge who is there

• All workers wear photo ID badges with name
  expiration date.
• Use color coding to indicate clearance to enter
  restricted areas.
• Guests are issued Visitor ID badges are
  escorted by workers.

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Consider lockboxes
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Know materials brought into labs animal
facilities

• Only accept packages you expect.
• Screen all packages (visually, x-ray) before
  transfer into lab.
• Open all packages containing toxins /or
  microbiologic agents in safety cabinets or fume
  hoods.

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Centralized Receiving
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Mail scanning
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Know materials removed for intra-facility transfer

• Transport in leak-proof carriers.
• Maintain appropriate records regarding transfer.
• Contaminated or possibly contaminated materials
  (waste, equipment) should be decontaminated
  before removal from lab.

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Typical transport carrier
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Know materials removed for transfer to distant
labs

• Microbes /or toxins shipped to other labs must
  be packaged transported in accordance with
  applicable regs.
• Obtain permits as needed (PHS, DOT, DOC, USDA)
  for shipment.
• Keep appropriate records.

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Have an emergency plan

• Controlling access to labs /or animal facilities
  complicates emergency response.
• Develop plan before the emergency
• Involve all appropriate parties in planning
• Inform community-based responders
• Conduct drills after-incident reviews

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Have a protocol for reporting investigating
incidents

• Report chain to Management, PR, Security,
  Biosafety
• Who investigates incidents?
• Unaccompanied visitors
• Missing agents
• Potential break-ins
• Who decides what happens next?

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Whats Pending?

• Registration if you possess a S/A
• Restrictions on clinical exemptions
• USA Patriot Act restricted persons
• Expanding penalties for violation
• Exempts CDC from FOIA requests

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