121.12—Biosafety.
(a)
An individual or entity required to register under this part must develop and implement a written biosafety plan that is commensurate with the risk of the select agent or toxin, given its intended use. 9 The biosafety plan must contain sufficient information and documentation to describe the biosafety and containment procedures.
Code of Federal Regulations
Footnote(s): 9 Technical assistance and guidance may be obtained by contacting APHIS.
(b)
The biosafety and containment procedures must be sufficient to contain the select agent or toxin (e.g., physical structure and features of the entity, and operational and procedural safeguards).
(1)
The CDC/NIH publication, “Biosafety in Microbiological and Biomedical Laboratories.” This document may be obtained from the U.S. Government Printing Office. It is also available on the Internet at http://www.aphis.usda.gov/programs/ag_selectagent/index.html.
(2)
The Occupational Safety and Health Administration (OSHA) regulations in 29 CFR 1910.1200 and 1910.1450.
(3)
The “NIH Guidelines for Research Involving Recombinant DNA Molecules.” This document is available on the Internet at http://www.aphis.usda.gov./programs/ag_selectagent/index.html.
(d)
The plan must be reviewed annually and revised as necessary. Drills or exercises must be conducted at least annually to test and evaluate the effectiveness of the plan. The plan must be reviewed and revised, as necessary, after any drill or exercise and after any incident.