[Code of Federal Regulations]
[Title 42, Volume 1]
[Revised as of October 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR73.12]

[Page 449]
 
                         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. 73.12  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 agent or toxin, given its intended use. The 
biosafety plan must contain sufficient information and documentation to 
describe the biosafety and containment procedures.
    (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'', including all appendices. Copies may be 
obtained from the Superintendent of Documents, U.S. Government Printing 
Office, Post Office Box 371954, Pittsburgh, Pennsylvania, 75250-7954 or 
from the CDC Web site at http://www.cdc.gov/. Copies may be inspected at 
the Centers for Disease Control and Prevention, 1600 Clifton Road, Mail 
Stop E-79, Atlanta, Georgia.
    (2) The Occupational Safety and Health Administration (OSHA) 
regulations in 29 CFR parts 1910.1200 and 1910.1450.
    (3) The ``NIH Guidelines for Research Involving Recombinant DNA 
Molecules,'' (NIH Guidelines). Copies may be obtained from the Centers 
for Disease Control and Prevention, 1600 Clifton Road, Mail Stop E-79, 
Atlanta, Georgia, 30333 or from the CDC Web site at http://www.cdc.gov/. 
Copies may be inspected at the Centers for Disease Control and 
Prevention, 1600 Clifton Road, Mail Stop E-79, Atlanta, Georgia.
    (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.