Select Agents are biological agents and toxins regulated by the U.S. Department of Health and Human Services (HHS) and the U.S. Department of Agriculture (USDA) due to their potential to pose a severe threat to public health, agriculture, and safety. The current list includes groups of agents, toxins, and plant pathogens.
Anyone wishing to obtain an agent or toxin on the select agent list must register with the Centers for Disease Control and Prevention (CDC) Select Agent Office and/or the USDA Animal and Plant Health Inspection Service (APHIS). The following registration requirements must be met before an entity or individual can acquire, possess, use, or transfer a select agent or toxin:
- A Responsible Official and Alternate Responsible Official must be designated as the institutional representatives to the regulating agencies.
- These designated officials, as well as anyone at the institution granted access to select agents must undergo a security risk assessment, to include fingerprint analysis, conducted by the U.S. Department of Justice.
- The institution must meet all laboratory safety conditions for the agents to be handled.
- The institution must ensure that select agents are secure at all times, and must develop and implement a security plan for review by the federal agencies.
- The institution must undergo a safety and security inspection by either the CDC, USDA, or both, depending on the agents listed in the registration.
- The institution must meet all requirements found in 42 CFR Part 73 and any other applicable federal regulations.
The investigator must provide the following documentation to BEI Resources after submitting a request for a select agent:
- Verification of registration with CDC and/or USDA for possession, use, and transfer of select agents.
- Name and contact information for your institution's Responsible Official.
- Description of the facilities in which work will be conducted with the select agents.
- Certification via signature by the institution's Biosafety Officer that the laboratory, facility, and practices are compatible with the risks associated with the agents requested.
- Curriculum vitae of the principle investigator and any additional end-users responsible for work with the requested agents.
Each request will be evaluated individually, and BEI Resources will contact the requestor after all materials are reviewed to provide permit details.
Links to more information
USDA Select Agent Program
CDC and USDA Select Biological Agents