# Presentation: 397179

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

**DOE O 151.1**

## 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

## 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

## 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

## 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

## 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)

## 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

## 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***

## 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

## 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***

## 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**

## 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)

## Proposed Guidance

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

## Proposed Guidance

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

## 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

## 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)

## 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

## Biological Scenarios

## 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

## Status of DOE/NNSA BSL Facilities

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

## Biosafety Officers 

- THANKS