[Code of Federal Regulations]
[Title 9, Volume 1]
[Revised as of January 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR121.12]

[Page 776]
 
                  TITLE 9--ANIMALS AND ANIMAL PRODUCTS
 
  CHAPTER I--ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF 
                               AGRICULTURE
 
PART 121_POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS--Table 
of Contents
 
Sec. 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.\8\ 
The biosafety plan must contain sufficient information and documentation 
to describe the biosafety and containment procedures.
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    \8\ Technical assistance and guidance may be obtained by contacting 
APHIS.
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    (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 may be obtained from the U.S. 
Government Printing Office. It is also available on the Internet at 
http://www.aphis.usda.gov/programs/ag--selectagent/index.html.
    (2) The Occupational Safety and Health Administration (OSHA) 
regulations in 29 CFR 1910.1200 and 1910.1450.
    (3) The ``NIH Guidelines for Research Involving Recombinant DNA 
Molecules.'' This document is available on the Internet at http://
www.aphis.usda.gov./programs/ag--selectagent/index.html.
    (d) 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.