Link to an amendment published at 82 FR 6293, January 19, 2017.
This amendment was delayed until March 21, 2017, at 82 FR 10863, Feb. 16, 2017.
(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. The biosafety plan must contain sufficient information and documentation to describe the biosafety and containment procedures for the select agent or toxin, including any animals (including arthropods) or plants intentionally or accidentally exposed to or infected with a select agent.
(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).
(c) In developing a biosafety plan, an individual or entity should consider:
(1) The CDC/NIH publication, “Biosafety in Microbiological and Biomedical Laboratories.” This document is available on the National Select Agent Registry Web site at http://www.selectagents.gov.
(2) The Occupational Safety and Health Administration (OSHA) regulations in 29 CFR parts 1910.1200 and 1910.1450. This document is available on the National Select Agent Registry Web site at http://www.selectagents.gov.
(3) The “NIH Guidelines for Research Involving Recombinant DNA Molecules,” (NIH Guidelines). This document is available on the National Select Agent Registry Web site at http://www.selectagents.gov.
(d) The biosafety plan must include an occupational health program for individuals with access to Tier 1 select agents and toxins, and those individuals must be enrolled in the occupational health program.
(e) 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.