42 CFR Part 73: Office of the Inspector General; 42 CFR Part 1003: Possession, Use, and Transfer of Select Agents and Toxins; Interim Final Rule, December 13, 2002 [open pdf - 173KB]
This document establishes requirements regarding possession, use, and transfer of select agents and toxins in the United States. This includes requirements concerning the following: (1) registration; (2) security risk assessments; (3) safety plans; (4) security plans; (5) emergency response plans; (6) training; (7) transfers; (8) record keeping; (9) inspections; and (10) notifications. It covers the delegations of authority to the Office of Inspector General regarding civil money penalties. The regulations only list the agencies with primary authority over transportation and exports: the Department of Commerce, for example, has primary responsibility for regulating the exportation of microorganisms and toxins at 15 CFR, the Department of Transportation has primary responsibility for regulating the transportation of such select agents and toxins as 49 CFR parts 171 through 180, and the FDA regulates unapproved products used in clinical trials. Helpful links include the Centers for Disease Control and Prevention (CDC), http://www.cdc.gov, and the United States Department of Health & Human Services (HHS), http://www.hhs.gov.
Federal Register (December 13, 2002), v.240 no.67, p.76886-76905