The Federal Select Agent Program is jointly comprised of the Centers for Disease Control and Prevention/Division of Select Agents and Toxins and the Animal and Plant Health Inspection Services/ Agriculture Select Agent Services. The Federal Select Agent Program oversees the possession, use and transfer of biological select agents and toxins, which have the potential to pose a severe threat to public, animal or plant health or to animal or plant products. The Federal Select Agent Program regulates 65 select agents and toxins. The select agent list is reviewed at least every two years to determine if agents need to be added to or deleted from the list.

As part of the federal government’s decision to implement robust oversight of select agents and toxins, the Federal Select Agent Program issued the Select Agent Regulations. One of the fundamental elements of the Select Agent Regulations is to keep select agents and toxins out of the possession of individuals who might intend to misuse them, such as a bioterrorist. The Federal Select Agent Program works closely with the Department of Justice’s Criminal Justice Information Services Division (CJIS) to identify those individuals who are prohibited from access to the select agents and toxins regulated by the Federal Select Agent Program based on the restrictions identified in the USA PATRIOT Act (Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism Act of 2001; Public Law 107-56): Restricted access to select agents USA PATRIOT Act(PDF format).

The Federal Select Agent Program has greatly enhanced the nation’s oversight of the safety and security of dangerous biological agents and toxins. The program promotes laboratory safety and security to minimize the inherent risks that accompany work with select agents by:

Strengthening oversight by inspecting entities working with select agents

• 347 entities are registered with and inspected by the Federal Select Agent Program. All aspects of the registration are managed by the program, including amendments to the registration; approval of transfers of select agents; and investigation of reports of theft, loss, or release of select agents. Entities are inspected to ensure compliance with Select Agent Regulations. These assessments allow inspectors to confirm that the appropriate safety and security measures are in place as well as ensure that laboratorians are adequately trained.
• Approximately 11,000 individuals have active approvals to access select agents.

Assisting the regulated community by providing guidance and support

• The Federal Select Agent Program provides technical assistance and guidance to registered entities to promote laboratory safety and security. This website includes applicable regulations, guidance documents, frequently asked questions, links to guidelines, and other helpful information.
• The Federal Select Agent Program proactively works to provide assistance to registered entities in advance of natural disasters or national events to ensure that all select agents are properly secured to protect them from theft, loss, or release. A Geographic Information System was developed to track and monitor the potential impact of natural hazards and man-made disasters for entities registered with the Federal Select Agent Program.
• Workshops for registered entities and partners help inform individuals of their legal responsibilities for implementing the Select Agent Regulations.
• An independent whistleblower hotline provides a mechanism for anonymous reporting of safety, security, or other concerns associated with select agents and toxins.

History of the Division of Select Agents and Toxins