DOENNSA Biosafety Level BSL Facilities and

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• DOE/NNSA Biosafety Level (BSL) Facilities and
• DOE O 151.1

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AGENDA

• Introductions
• Emergency Management and Biological Hazards
• Proposed DOE Order 151.1X
• Proposed Guidance
• Status of Emergency Management in DOE/NNSA
  Biosafety Level (BSL) Facilities

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Emergency Management and Biological Hazards

• Focus on biological materials used/stored for
  research at DOE/NNSA facilities
• NOT
• Materials that may be brought onto DOE/NNSA sites
  and employed in malevolent events by terrorists

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Emergency Management and Biological Hazards

• IF Select Agents and Toxins
• HHS (Health and Human Services)
• Overlap (I.e., human and animal pathogens)
• PPQ (Plant Protection and Quarantine Programs)
• VS (Veterinary Services Programs)
• Are used/stored in DOE/NNSA facilities, they are
  regulated by Select Agent rules
• 42 CFR Part 73
• 7 CFR Part 331 and 9 CFR Part 121
• Subject to the applicable exclusions exemptions

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Emergency Management and Biological Hazards

• DOE/NNSA Facilities are currently subject to DOE
  Order 151.1B
• All DOE/NNSA facilities/sites and activities with
  sufficient quantities of hazardous materials
• Planning, preparedness, and response to hazardous
  material releases
• Defines requirements for Emergency Planning
  Hazards Assessment (EPHA) and Operational
  Emergency Hazardous Materials Program
• Defines Operational Emergencies related to
  release of hazardous materials

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Emergency Management and Biological Hazards

• DOE/NNSA Biosafety Level (BSL) facilities are
  currently being planned, constructed, or exist
• Emergency response is a developing area
• Hard and fast guidelines for emergency response
  are not yet established therefore . . . Proposed
  DOE Order and Guidance are based on
• Foundations of DOE emergency management
• Approach to Incident Response in Final Select
  Agent rules (e.g., notifications, Incident
  Response Plans)

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Emergency Management and Biological Hazards

• Key Concepts from
• DOE Emergency Management
• Emergency Response is Last Line of Defense
• Planning and Preparedness are Commensurate with
  Hazards
• Prompt Recognition is vital to effective and
  commensurate response

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Emergency Management and Biological Hazards

• Key Concepts from
• Select Agent Rules
• Commensurate with hazards is a basic concept
  related to Biosafety Levels (BSLs)
• Minimum quantity of hazardous biological
  materials subject to regulation??
• None specified for agents
• Minimum quantities specified for toxins

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Emergency Management and Biological Hazards

• Key Concepts from
• Select Agent Rules
• ANY release of select agents/toxins from primary
  containment requires immediate notification to
  CDC/APHIS
• No measure of severity associated with release
• Incident Response planning includes protective
  actions

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Proposed DOE Order 151.1X

• ANY DOE/NNSA facility subject to the Select
  Agent rules requires an EPHA and an Operational
  Emergency Hazardous Materials Program
• ANY release of Select Agents/Toxins from primary
  containment is an Operational Emergency

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Proposed DOE Order 151.1X

• OPERATIONAL EMERGENCY
• Definitions
• ANY actual or potential release of a hazardous
  biological agent/toxin
• Outside of primary containment barriers
• Outside of primary containment barriers causing
  occupational exposure
• Outside of secondary containment barriers

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Proposed DOE Order 151.1X

• OPERATIONAL EMERGENCIES
• Categorized, but NOT classified
• Notifications to CDC/APHIS, DOE/NNSA HQ and Field
  Elements, and Local and State Response/Public
  Health Agencies (by prior agreement)

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Proposed Guidance

• Responsible Official at DOE/NNSA BSL facility
  has responsibility for emergency management
  program
• Focus/emphasis on integration with site emergency
  management program

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Proposed Guidance

• Analyze emergency events (qualitative
  semi-quantitative quantitative)
• Response is scenario- and agent/toxin-specific
• Commensurate with hazards
• Early Recognition

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Proposed Guidance

• Consequence Assessment
• Traditional concepts if dispersion calculations
  appropriate (cf. SCAPA presentations)
• Release source term estimates required for
  notifications
• Confirmation of release is added responsibility,
  especially for potential or undetected release
  scenarios

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Proposed Guidance

• Protective Actions
• Agent/toxin characteristics
• Transport mechanism
• Stability in the environment
• Contagiousness, communicability, . . .
• No severity level for consequences
• No Protective Action Criteria (PAC) identified
• Infective Dose Lethal Dose values (cf.
  USAMRIID)

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Proposed Guidance

• Emergency Response Organization (ERO)
• Response role for biological expertise
• ERO positions in Command Center or Emergency
  Operations Center (EOC)
• Offsite Response Interfaces
• Local State Public Health Agencies, CDC APHIS
• Local medical expertise
• First responders

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Biological Scenarios

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SUMMARY

• First DRAFT of Guidance for DOE/NNSA Biosafety
  Level (BSL) Facilities sent to Biosafety Officers
• Strawman
• Incomplete, but indicates current direction of
  development by NA-41
• Constructive comments and suggestions appreciated

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Status of DOE/NNSA BSL Facilities

• Status of Facility
• Developed/Implemented
• Biosafety Program
• Emergency Management Program
• Incident Response Plan
• Integration with Site Plans

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Biosafety Officers

• THANKS