Select agents and toxins are regulated by the Federal Select Agent Program. This program is jointly enforced by the Department of Health and Human Services (HHS)/Centers for Disease Control and Prevention (CDC)/Division of Select Agents and Toxins (DSAT) and US Department of Agriculture (USDA)/Animal and Plant Health Inspection Service (APHIS)/Agriculture Select Agent Services (AgSAS). An individual or entity that intends to possess, use, or transfer a select agent or toxin must register appropriately with the Federal Select Agent Program. The select agent and toxin regulations include 7 CFR Part 331, 9 CFR Part 121, and 42 CFR Part 73.
The Select Agents and Toxins List publishes the biological agents and toxins that have the potential to pose a severe threat to both human and animal health, to plant health, or to animal and plant products. This list is mandated to be reviewed on a biennial basis, at a minimum. There are specific exclusions that can be applied to an attenuated strain of a select agent and or an inactive form of a select toxin, which have been deemed not to pose a severe threat to public health, animal health, or animal products. There are also permissible toxin amounts established for several toxins, which exempts these toxins controlled under the established possession limits from regulation.
Be sure to review the select agents and toxins list on an annual basis when you are conducting updates to your programs. If you possess toxins below the permissible toxin amounts, be certain to establish a program to safely handle and track the toxins.