Division of Regulatory Science and Compliance: Regulation of Select Agents and Toxins

CDC’s Division of Regulatory Science and Compliance regulates laboratories that use select agents and toxins through the Federal Select Agent Program (FSAP). FSAP was authorized by Congress to help ensure that research with select agents and toxins, which does come with inherent risks, is conducted as safely and securely as possible.

FSAP regulates the possession, use, and transfer of these agents that have the potential to pose a severe threat to public health and safety, to animal and plant health, or to animal or plant products through:

• Development of Regulations for programs that work with select agents and toxins.
• Inspections and Registrations of programs that work with select agents and toxins.
• Authorization of the Import and Transfer of select agents and toxins into the country or between programs.
• Enforcement of regulation compliance for programs that work with select agents and toxins.

FSAP is managed jointly by CDC and the U.S. Department of Agriculture (USDA); CDC provides oversight for the select agents and toxins that cause diseases in people, and USDA provides oversight for select agents and toxins that cause diseases in animals and plants. CDC and USDA share the responsibility for agents that threaten both humans and animals, such as anthrax. FSAP also works closely with the Federal Bureau of Investigation/Criminal Justice Information Service to conduct security background checks of employees who work with select agents or toxins.

SelectAgents.gov
The Federal Select Agent website provides applicable regulations, guidance documents, frequently asked questions, links to guidelines, and other helpful information. All Select Agent forms can be downloaded at this website.