Select Agent Regulations

Final Rule

The Centers for Disease Control and Prevention (CDC) has issued the Final Rule of 42 CFR Part 73, Possession, Use and Transfer of Select Agents and Toxins, which implements the provisions of Public Law 107-188, the "Public Health Security and Bioterrorism Preparedness Response Act of 2002" (The Act). The Final Rule governs the possession, use and transfer of select biological agents and toxins ("select agents") that pose a potential threat to public health and safety.

The final rule, published in the March 18th, 2005 issue of the Federal Register, updates the interim final rule (IFR) originally issued by the CDC in December 2002 and amended in November 2003. The Final Rule takes into consideration hundreds of comments on the initial interim final rule from experts and the general public.

Download CDC Final Rule (42 CFR 73) (PDF format)

Other changes reflected in the Final Rule include clarifications to ensure consistency with regulations developed by the United States Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS), which regulates the safe use and security of high consequence pathogens and toxins that pose a potential threat to animal and plant health.

Download APHIS Final Rules (7 CFR 331 and 9 CFR 121) (one document) (PDF format)

Dates

The Final Rule was published in the Federal Register on March 18th, 2005

The effective date for the Final Rule was April 18, 2005.