Biosafety/Biocontainment Plan Guidance

Changes and Highlights

Revisions: This is a living document subject to ongoing improvement. Feedback or suggestions for improvement from entities registered with the Federal Select Agent Program, as well as the general public, are welcomed. Submit comments directly to the Federal Select Agent Program at:

DSAT: LRSAT@cdc.gov
AgSAS: AgSAS@aphis.usda.gov

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Introduction

This document is intended to provide guidance and assist entities in developing and implementing a written biosafety/biocontainment plan, as required by section 12 of the select agent regulations (7 C.F.R. Part 331, 9 C.F.R. Part 121, and 42 C.F.R. Part 73). This guidance summarizes current regulatory and procedural criteria for registered entities and provides examples for verifying compliance. It does not add to, delete from, or change current regulatory requirements or standards. For entities registered for Tier 1 select agents and toxins that require an occupational health program, see the Occupational Health Program Guidance for more information. It should be noted that information regarding an occupational health program may be incorporated into the biosafety plan and that two plans are not required.

There are resources available to assist entities in development of biosafety/biocontainment plans such as:


These resources can be used as guidance to assist in the development of the biosafety/biocontainment plan. However, entities may use other biosafety/biocontainment guidelines and regulations when developing and implementing a written plan. It should be noted that the Federal Select Agent Program (FSAP) inspects registered entities in accordance with these currently nationally recognized standards.