Select Agents & Toxins Rule

Excerpt From the Federal Register / Vol. 70, No. 52/Friday, March 18, 2005 / Rules and Regulations

“Facility Inspections Under the CDC Select Biological Agents and Toxins Rule Inspections may be required under 42 CFR §73.16 Inspections.

The HHS Secretary, without prior notification and with or without cause, shall be allowed to inspect any site at which activities regulated by this part are conducted and shall be allowed to inspect and copy any records relating to the activities covered by this part.

The purpose of the inspections is to:

  1. Verification of information provided in registration package sent to CDC
  2. Ensure the facility meets the safety and security requirements of the rule
  3. Review records required by regulation

Ensure the facility meets minimum safety requirements:

  • Laboratories working with infectious agents must meet:
    1. Biosafety in Microbiological and Biomedical Laboratories (BMBL), 4th Edition
    2. “NIH Guidelines for Research Involving Recombinant DNA molecules”
  • Laboratories working with select agent toxins:
    1. 29 CFR 1910.1450, “Occupational Exposure to Hazardous Chemicals in Laboratories”
    2. Toxin guidelines in Appendix I of the BMBL
  • Intact select toxin-producing organisms or recombinant DNA encoding for select agent toxins must meet the cccBMBL or NIH guidelines
    1. Distributors of toxins in which the toxins are only handled in sealed containers should meet the requirements 29 CFR 1910.1200, “Hazard Communication”

This is required by 42 CFR §73.10 Safety.

(a) An entity subject to the provisions of this part, must develop and implement a safety plan. In developing a safety plan, an entity should consider:

(1) The biosafety standards and requirements for BSL 2, 3, or 4 operations, as they pertain to the respective select agents, that are contained in the CDC/NIH publication, “Biosafety in Microbiological and Biomedical Laboratories,” including all appendices except Appendix F. Copies may be obtained from the Superintendent of Documents, U.S. Government Printing Office, Post Office Box 371954, Pittsburgh, Pennsylvania, 75250–7954 or call in the Washington, DC metropolitan area 202–512–1800 or outside that area call toll free 1–866–512–1800. Copies may be inspected at the Centers for Disease Control and Prevention, 1600 Clifton Road, Mail Stop E–79, Atlanta, Georgia. This publication is also available on the CDC Web site at http://www.cdc.gov.

(2) The specific requirements for handling toxins found in 29 CFR 1910.1450, “Occupational Exposure to Hazardous Chemicals in Laboratories” and/or 29 CFR 1910.1200, “Hazard Communication,” whichever applies and specific provisions for handling toxins found in Appendix I in the CDC/NIH publication, “Biosafety in Microbiological and Biomedical Laboratories,”

(3) For provisions of the safety plan relating to genetic elements, recombinant nucleic acids and recombinant organisms, the “NIH Guidelines for Research Involving Recombinant DNA Molecules,” (NIH Guidelines). This includes, among other things, provisions regarding risk assessment, physical containment, biological containment, and local review and applies to all recombinant DNA research, regardless of funding. Copies may be obtained from the Centers for Disease Control and Prevention, 1600 Clifton Road, Mail Stop E–79, Atlanta, Georgia, 30333. Copies may be inspected at the Centers for Disease Control and Prevention, 1600 Clifton Road, Mail Stop E–79, Atlanta, Georgia. The “NIH Guidelines for Research Involving Recombinant DNA Molecules,” is also available on the CDC Web site at http://www.cdc.gov.

(b) The Responsible Official or his or her designee must conduct regular inspections (at least annually) of the laboratory where select agents and toxins are stored or used to ensure compliance with all of the procedures and protocols of the safety plan. The results of these inspections must be documented, and any deficiencies identified during inspections must be corrected.

(c) An entity may not conduct the following experiments unless approved by the HHS Secretary after consultation with experts:

(1) Experiments utilizing recombinant DNA that involve the deliberate transfer of a drug resistance trait to select agents that are not known to acquire the trait naturally, if such acquisition could compromise the use of the drug to control disease agents in humans, veterinary medicine, or agriculture.

(2) Experiments involving the deliberate formation of recombinant DNA containing genes for the biosynthesis of select toxins lethal for vertebrates at an LD50 < 100 ng/kg body weight.”