9 CFR 121.12 - Biosafety.

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§ 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 for the select agent or toxin, including any animals (including arthropods) or plants intentionally or accidentally exposed to or infected with a select agent.

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).

(c) In developing a biosafety plan, an individual or entity should consider the following:

(1) The CDC/NIH publication, “Biosafety in Microbiological and Biomedical Laboratories.” This document is available on the National Select Agent Registry at http://www.selectagents.gov/.

(2) The Occupational Safety and Health Administration (OSHA) regulations in 29 CFR 1910.1200 and 1910.1450. This document is available on the National Select Agent Registry at http://www.selectagents.gov/.

(3) The “NIH Guidelines for Research Involving Recombinant DNA Molecules.” This document is available on the Internet 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.

[70 FR 13284, Mar. 18, 2005, as amended at 73 FR 61331, Oct. 16, 2008; 77 FR 61080, Oct. 5, 2012]

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.

United States Code

Title 9 published on 2015-01-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 9 CFR Part 121 after this date.

  • 2015-02-27; vol. 80 # 39 - Friday, February 27, 2015
    1. 80 FR 10627 - Agricultural Bioterrorism Protection Act of 2002; Biennial Review and Republication of the Select Agent and Toxin List
      GPO FDSys XML | Text
      DEPARTMENT OF AGRICULTURE, Animal and Plant Health Inspection Service
      Advance notice of proposed rulemaking and request for comments.
      We will consider all comments that we receive on or before April 28, 2015.
      7 CFR Part 331