Select Agents & Toxins Overview
Select Agents and Toxins are a subset of biological agents and toxins that the Departments of Health and Human Services (HHS) and Agriculture (USDA) have determined to have the potential to pose a severe threat to public health and safety, to animal or plant health, or to animal or plant products.
A complete list of federally protected Select Agents and toxins can be found at Comprehensive Select Agent and Toxins List.
The Select Agent regulations, found at 42 CFR Part 73, 9 CFR Part 121, and 7 CFR Part 331, implement the Subtitle A and Subtitle B (also known as the Agricultural Bioterrorism Protection Act of 2002) of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, setting forth the requirements for the possession, use, and transfer of select agents and toxins.
The Federal Select Agent Program is jointly comprised of the Centers for Disease Control and Prevention and the Animal and Plant Health Inspection Services. Working with Select Agents and toxins requires higher scrutiny and increased responsibility for biosecurity. Researchers who work with Select Agents must comply with all components of the Federal Select Agent Program, including federal security clearance, ongoing training, inventory management and authorization. The Federal Select Agent and Toxins Program website has more information about personnel restrictions, agent registration, laboratory security requirements, and strict criteria required to receive or transfer Select Agents and Toxins. At LSUHSC, there is currently not an established Select Agent Program, therefore work with Select Agents is at present prohibited.
Any laboratory interested in research using regulated biological Select Agents and Toxins listed in the Federal Select Agent Program must contact the Institutional Biosafety Committee (IBC), the Director of the Office of Research Services, and the EH&S, Biological Safety Officer in writing if planning to initiate the approval process to obtain a Select Agent. See the LSUHSC EH&S Select Agents Policy and Toxins for approval process details.
Failure to comply with the Select Agent and Toxins regulations is considered a violation of federal law and may be associated with criminal and civil liability.
Additional Resources
- CDC Regulatory Science and Compliance
- Federal Select Agent Program
- USDA Animal and Plant Health Inspection Service (APHIS)
- Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act)
- Comprehensive Select Agent List
- Federal Due Diligence Information
Forms