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:
March 2017: Initial posting
July 2018: Revised format, removed appendices 1 and 2 and added “Disinfectants” section to appendix.
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 template 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, reference 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 separate plans are not required.
There are resources available to assist entities in the development of biosafety/biocontainment plans such as:
- “Biosafety in Microbiological and Biomedical Laboratories (BMBL),”
- “NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines),”
- Occupational Safety and Health Administration, “Laboratory Safety Guidance,”
- “Containment Facilities and Safeguards for Exotic Plant Pathogens and Pests” (Robert P. Kahn and S.B. Mathur eds., 1999),
- “A Practical Guide to Containment: Plant Biosafety in Research Greenhouses” (Dann Adair and Ruth Irwin, 2008), and
- Detailed instructions on training requirements, including Biosafety/Biocontainment Training, can be found in Guidance for Select Agent Regulation Training Requirements.
These resources can be used as guidance to assist in the development of the biosafety/biocontainment plan. However, entities may use other comparable biosafety/biocontainment guidelines when developing and implementing a written plan. It should be noted that the Federal Select Agent Program inspects registered entities in accordance with the current versions of these nationally recognized standards.