Chapter 26

BIOSAFETY

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Appendix A. Biological Safety Worker Health & Safety Program (10 CFR 851)

A.1 Scope

This appendix describes specific requirements and program elements for biological etiologic agents and select agents that are included in the Lawrence Berkeley National Laboratory (Berkeley Lab or LBNL) Worker Health and Safety Program and Biosafety Program, as required by the DOE Worker Safety and Health Program (10 CFR 851, Appendix A, Section 7).

A.2 General Policy

Work with biological etiologic agents and any select agents at Berkeley Lab is conducted in a safe, environmentally sound, and compliant manner using the principles and functions of Integrated Safety Management (ISM) and work authorization. Line managers and researchers define their work with biological materials, evaluate the biological hazards, determine the risk, and implement required biosafety containment controls (e.g., establish a biosafety level). This is accomplished with the assistance and oversight of the Institutional Biosafety Committee (IBC), the Environment/Health/Safety (EHS) Division (e.g., Health & Safety, Waste Management, and Health Services), and other Berkeley Lab ES&H functions as part of the Biosafety Program.

A.3 Definitions

Biological etiologic agents and select agents have the following specific definitions.

 

1.   Biological Etiologic Agents are agents of biological origin (e.g., bacterium, fungus, parasite, virus, etc.) that cause disease in humans (i.e., are pathogenic to humans). See Appendix B of the Biosafety Program or the NIH Guidelines for a list and risk group categorization of human etiologic agents. Agents requiring implementation of Biosafety Level 3 or 4 containment are not used or stored at Berkeley Lab.

 

2.   Select Agents. The term “select agents” is used to describe a list of specific pathogenic agents that are strictly regulated by the Centers for Disease Control and Prevention (CDC) and U.S. Department of Agriculture (USDA) because they may be used as biological weapons or pose a severe threat to human, animal, and plant health. See Appendix B of the Biosafety Program or the National Select Agent Registry for a list of select agents.

 

A.4 Program Elements

LBNL’s Biosafety Program for managing biological etiologic agents and select agents under the LBNL Worker Health and Safety Program Plan includes the program elements listed below:

 

1.   LBNL’s Institutional Biosafety Committee (IBC) reviews the following work, plans, and procedures:

a.   Work Review and Assessment. The IBC (i) reviews work with biological etiologic agents for compliance with applicable CDC, NIH, WHO, and other international, federal, state, and local guidelines applicable to biological etiologic agents, and (ii) assesses the containment level, facilities, procedures, practices, training, and expertise of personnel using these agents. Applicable guidelines include the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, the CDC-NIH Biosafety in Microbiological and Biomedical Laboratories (BMBL), and the WHO Laboratory Biosafety Manual.

b.   Security, Safeguards, and Emergency Management Plan and Procedure Review. The IBC reviews LBNL’s security, safeguards, and emergency management plans and procedures to ensure they adequately consider work involving biological etiologic agents.

2.   Agent Inventory and Status Report. The EHS Division Health & Safety Research Support Team maintains an inventory and status of biological etiologic agents, and provides the DOE Berkeley Site Office (through the LBNL IBC) with an annual status report describing the status and inventory of biological etiologic agents and their Biosafety Program. The inventory includes a list of agents, the principal investigator’s or owner’s name, and location(s) of the researcher’s laboratory operation. 

3.   Select Agent Application for Registration. Berkeley Lab did not possess or have plans to possess select agents when this Appendix was last revised. If Berkeley Lab researchers request use of a select agent, the requirements related to select agents in this Appendix will be implemented. The LBNL EHS Division Responsible Official (RO) or Alternate Responsible Official (ARO) for select agents submits any and each CDC Laboratory Registration or Select Agent Program registration application package to the U.S. Department of Energy (DOE) Berkeley Site Office (BSO) when the application is registering a new laboratory facility for the purpose of transferring, receiving, or handling select agents. DOE’s review of the application and concurrence is required before transmittal to the CDC.

4.   Select Agent Transfer, Disposition, and/or Destruction. The LBNL EHS RO or ARO for select agents submits to the DOE BSO:

a.   A copy of each CDC Transfer of Select Agents form (i) upon initial submission of the form to a vendor or other supplier requesting or ordering a select agent for transfer, receipt, and handling in a registered facility, and (ii) within 10 days upon completion of the form documenting final disposition of the select agent.

b.   Documentation of the destruction of a complete stock of a select agent within 10 days of the destruction.

5.   Safeguards, Security, and Emergency Management Plans and/or Program Confirmation. The Protective Services Department’s Security and Emergency Services and the EHS Health & Safety Research Support Team confirm that the site safeguards and security plans and emergency management programs address biological etiologic agents and any biological select agents.

6.   Immunization Policy. The IBC (which includes the LBNL Medical Director and Biosafety Officer) assesses potential vaccines and the need for immunizations when it reviews work to be conducted with biological etiologic agents. Any immunization recommendations are then incorporated into the research operation’s biosafety documentation.

 

 

 

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