42 CFR 73.12 - Biosafety.

§ 73.12 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. 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. The current biosafety plan must be submitted for initial registration, renewal of registration, or when requested. The biosafety plan must include the following provisions:

(1) The hazardous characteristics of each agent or toxin listed on the entity's registration and the biosafety risk associated with laboratory procedures related to the select agent or toxin;

(2) Safeguards in place with associated work practices to protect entity personnel, the public, and the environment from exposure to the select agent or toxin including, but not limited to: Personal protective equipment and other safety equipment; containment equipment including, but not limited to, biological safety cabinets, animal caging systems, and centrifuge safety containers; and engineering controls and other facility safeguards;

(3) Written procedures for each validated method used for disinfection, decontamination or destruction, as appropriate, of all contaminated or presumptively contaminated materials including, but not limited to: Cultures and other materials related to the propagation of select agents or toxins, items related to the analysis of select agents and toxins, personal protective equipment, animal caging systems and bedding (if applicable), animal carcasses or extracted tissues and fluids (if applicable), laboratory surfaces and equipment, and effluent material; and

(4) Procedures for the handling of select agents and toxins in the same spaces with non-select agents and toxins to prevent unintentional contamination.

(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 “NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid 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. Drills or exercises must be documented to include how the drill or exercise tested and evaluated the plan, any problems that were identified and corrective action(s) taken, and the names of registered entity personnel participants.

[ 70 FR 13316, Mar. 18, 2005, as amended at 77 FR 61114, Oct. 5, 2012; 82 FR 6293, Jan. 19, 2017]

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.

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United States Code
U.S. Code: Title 42 - THE PUBLIC HEALTH AND WELFARE

Title 42 published on 14-Sep-2017 03:57

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 42 CFR Part 73 after this date.

  • 2017-04-12; vol. 82 # 69 - Wednesday, April 12, 2017
    1. 82 FR 17569 - Possession, Use, and Transfer of Select Agents and Toxins—Addition of Bacillus cereus Biovar anthracis to the HHS List of Select Agents and Toxins
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Centers for Disease Control and Prevention (CDC)
      Interim rule; adoption as final and response to public comments.
      Effective April 12, 2017.
      42 CFR Part 73
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