[Code of Federal Regulations]
[Title 42, Volume 1]
[Revised as of October 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR73.10]

[Page 456-457]
 
                         TITLE 42--PUBLIC HEALTH
 
    CHAPTER I--PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 73_SELECT AGENTS AND TOXINS--Table of Contents
 
Sec. 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

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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.
    (d) [Reserved]