1. Biosecurity at CDC pre & post 9/11 Jonathan Y. Richmond, PhD Director Office of Health and Safety CDC, Atlanta

2. 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 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

3. 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 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

4. Appendix A To Part 72 - Select Agents 13Viruses 9Bacteria 3Rickettsiae 1Fungi 12Toxins 13Viruses 9Bacteria 3Rickettsiae 1Fungi 12Toxins Genetically modified / genetic elements Select Agent Rule, 1997

5. BMBL, 4 th edition, 1999

6. 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. 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.

10. Risk Assessments Why me? People, facilities, data, product, animals, microbes … Why me? People, facilities, data, product, animals, microbes …

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

12. 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 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

13. 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)

15. Adding Physical Barriers “Hardening” access

16. Physical barriers

17. Vehicular Control

18. Personnel Monitoring

19. 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. 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.

20. 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 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

21. Controlling access

22. 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. 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.

23. 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. 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.

24. Consider lockboxes Consider lockboxes

25. 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. 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.

26. Centralized Receiving

27. Mail scanning

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

29. Typical transport carrier

30. 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. 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.

31. 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 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

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

34. What’s 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 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