Guidance on the Inventory of Select Agents and Toxins: Regulated Select Agents and Toxins

The select agents and toxins lists can be found in 42 CFR § 73.3 (Health and Human Services (HHS) only agents), 42 CFR § 73.4 and 9 CFR § 121.4 (Overlap agents), 7 CFR § 331.3 (Plant Protection and Quarantine (PPQ) only agents), and 9 CFR § 121.3 (Veterinary Service only agents).

Accordingly, select agent infected materials, including confirmed clinical specimens, laboratory cultures, animals, animal tissues, plants, and plant tissues, are subject to regulation. As directed by 42 CFR 73.5(a)(3) clinical or diagnostic specimens collected from a patient infected with a select agent must be transferred or destroyed within seven calendar days after delivery of patient care by health care professionals has concluded. Animals inoculated with toxins, however, are not regulated; only toxins or recombinant/synthetic nucleic acids encoding functional forms of the select toxins are regulated.

Inventory records are not required for select agent and toxin strains or constructs that FSAP has excluded from the provisions of the select agent regulations pursuant to 42 CFR § 73.3€ (HHS only agents), 42 CFR § 73.4(e) and 9 CFR § 121.4(e) (Overlap agents), 7 CFR § 331.3(e) (PPQ only agents), and 9 CFR § 121.3(e) (VS only agents). Please see the Exclusion Guidance Document for more information. To apply for a novel exclusion, an entity must provide sufficient documentation that an attenuated select agent or modified toxin no longer poses a severe threat to public health and safety, and/or animal health or animal products, or plant health or plant products, as appropriate. An entity does not need to apply for an exclusion if the agent is non-viable or the toxin is non-toxic as these are not regulated.

However, it is required that an entity maintain information on file in support of the method used for rendering a select agent non-viable or a select toxin non-toxic so that the entity is able to demonstrate that the agent or toxin is no longer subject to the select agent and toxin regulations. See 42 CFR § 73.17(a)(8), 7 CFR § 331.17(a)(8), and 9 CFR § 121.17(a)(8).