Biosecurity at CDCpre & post 9/11

Jonathan Y. Richmond, PhDDirector

Office of Health and Safety

CDC, Atlanta

A Bit of HistoryA 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

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

Appendix A To Part 72 - Select Agents

13 Viruses 9 Bacteria 3 Rickettsiae 1 Fungi12 Toxins

13 Viruses 9 Bacteria 3 Rickettsiae 1 Fungi12 Toxins

Genetically modified / genetic elements Genetically modified / genetic elements

Select Agent Rule, 1997 Select Agent Rule, 1997

Appendix F

Laboratory Security and Emergency Response for Microbiological & Biomedical Laboratories

Appendix FAppendix F

Laboratory Security and Laboratory Security and Emergency Response for Emergency Response for Microbiological & Biomedical Microbiological & Biomedical LaboratoriesLaboratories

BMBL, 4th edition, 1999

BioSecurity considerations for

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.

6

F r o n tF r o n t -- l in e R e s p o n s e l in e R e s p o n s e B e g in s a t th e L o c a l L e v e lB e g in s a t th e L o c a l L e v e l

Risk Assessments Risk Assessments

Why me?

People, facilities, data,product, animals, microbes …

Why me?

People, facilities, data,product, animals, microbes …

Lab security is related to but different than lab safety

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

Emergency planningEmergency 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

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)

AccessAccessAccess

Personnel

clearances?

ID badges (checked?)

Visitors

open to the public?

visiting fellows, post-docs, students

PersonnelPersonnel

clearances?clearances?

ID badges (checked?)ID badges (checked?)

VisitorsVisitors

open to the public?open to the public?

visiting fellows, postvisiting fellows, post--docs, studentsdocs, students

Adding Physical BarriersAdding Physical Barriers

“Hardening” access“Hardening” access

Physical barriersPhysical barriers

Vehicular ControlVehicular Control

Personnel MonitoringPersonnel Monitoring

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.

Control access to where agents are stored & usedControl 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

Controlling accessControlling access

Know your workersKnow 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.

Change the culture –challenge who is thereChange 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.

ConsiderlockboxesConsiderlockboxes

Know materials brought into labs & animal facilities

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.

Centralized ReceivingCentralized Receiving

Mail scanningMail scanning

Know materials removed for intra-facility transfer

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.

Typical transport carrierTypical transport carrier

Know materials removed for transfer to distant labs

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.

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

Have a protocol for reporting & investigating

incidents

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?

Credible RiskCredible RiskCredible Risk

Powders associated with mail

Dealing with suspicious packagesUSPS, FBI GuidelinesCDC:

MMWR 50/42 October 26, 2001

Powders associated with mailPowders associated with mail

Dealing with suspicious packagesDealing with suspicious packagesUSPS, FBI GuidelinesUSPS, FBI GuidelinesCDC:CDC:

MMWR 50/42 October 26, 2001MMWR 50/42 October 26, 2001

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

What’s to do?What’s to do?What’s to do?

Use common sense

Conduct risk assessments

Develop inventory control

Develop COOP & IEMP

Stay connected

Use common senseUse common sense

Conduct risk assessmentsConduct risk assessments

Develop inventory controlDevelop inventory control

Develop COOP & IEMPDevelop COOP & IEMP

Stay connectedStay connected