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Biosecurity at CDC pre & post 9/11

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Biosecurity at CDC pre & post 9/11. Jonathan Y. Richmond, PhD Director Office of Health and Safety CDC, Atlanta. 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 - PowerPoint PPT Presentation
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Biosecurity at CDC pre & post 9/11 Jonathan Y. Richmond, PhD Director Office of Health and Safety CDC, Atlanta
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Page 1: Biosecurity at CDC pre & post 9/11

Biosecurity at CDCpre & post 9/11

Jonathan Y. Richmond, PhDDirector

Office of Health and Safety

CDC, Atlanta

Page 2: Biosecurity at CDC pre & post 9/11

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

Page 3: Biosecurity at CDC pre & post 9/11

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

Page 4: Biosecurity at CDC pre & post 9/11

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

Page 5: Biosecurity at CDC pre & post 9/11

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

Page 6: Biosecurity at CDC pre & post 9/11

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.

Page 7: Biosecurity at CDC pre & post 9/11
Page 8: Biosecurity at CDC pre & post 9/11
Page 9: Biosecurity at CDC pre & post 9/11

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

Page 10: Biosecurity at CDC pre & post 9/11

Risk Assessments Risk Assessments

Why me?

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

Why me?

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

Page 11: Biosecurity at CDC pre & post 9/11

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

Page 12: Biosecurity at CDC pre & post 9/11

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

Page 13: Biosecurity at CDC pre & post 9/11

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)

Page 14: Biosecurity at CDC pre & post 9/11

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

Page 15: Biosecurity at CDC pre & post 9/11

Adding Physical BarriersAdding Physical Barriers

“Hardening” access“Hardening” access

Page 16: Biosecurity at CDC pre & post 9/11

Physical barriersPhysical barriers

Page 17: Biosecurity at CDC pre & post 9/11

Vehicular ControlVehicular Control

Page 18: Biosecurity at CDC pre & post 9/11

Personnel MonitoringPersonnel Monitoring

Page 19: Biosecurity at CDC pre & post 9/11

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.

Page 20: Biosecurity at CDC pre & post 9/11

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

Page 21: Biosecurity at CDC pre & post 9/11

Controlling accessControlling access

Page 22: Biosecurity at CDC pre & post 9/11

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.

Page 23: Biosecurity at CDC pre & post 9/11

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.

Page 24: Biosecurity at CDC pre & post 9/11

ConsiderlockboxesConsiderlockboxes

Page 25: Biosecurity at CDC pre & post 9/11

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.

Page 26: Biosecurity at CDC pre & post 9/11

Centralized ReceivingCentralized Receiving

Page 27: Biosecurity at CDC pre & post 9/11

Mail scanningMail scanning

Page 28: Biosecurity at CDC pre & post 9/11

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.

Page 29: Biosecurity at CDC pre & post 9/11

Typical transport carrierTypical transport carrier

Page 30: Biosecurity at CDC pre & post 9/11

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.

Page 31: Biosecurity at CDC pre & post 9/11

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

Page 32: Biosecurity at CDC pre & post 9/11

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?

Page 33: Biosecurity at CDC pre & post 9/11

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

Page 34: Biosecurity at CDC pre & post 9/11

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

Page 35: Biosecurity at CDC pre & post 9/11

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

Page 36: Biosecurity at CDC pre & post 9/11

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