331.12—Biocontainment.

(a) An individual or entity required to register under this part must develop and implement a written biocontainment plan that is commensurate with the risk of the select agent or toxin, given its intended use. 4 The biocontainment plan must contain sufficient information and documentation to describe the containment procedures.

Code of Federal Regulations


Footnote(s): 4 Technical assistance and guidance may be obtained by contacting APHIS.
(b) The biocontainment 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).
(c) In developing a biocontainment plan, an individual or entity should consider the following:
(1) “Containment Facilities and Safeguards for Exotic Plant Pathogens and Pests” (Robert P. Kahn and S.B. Mathur eds., 1999); and
(2) “A Practical Guide to Containment: Greenhouse Research with Transgenic Plants and Microbes” (Patricia L. Traynor ed., 2001).
(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.