[Code of Federal Regulations]

[Title 42, Volume 1]

[Revised as of October 1, 2005]

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.