Select Toxin Guidance: Inventory Requirements

Individuals and entities1 that possess aggregate amounts of select toxins that exceed the amounts listed in 42 CFR § 73.3(d)(7)external icon of the SAR must maintain records containing all of the information required in section 17(a)(3)external icon for all regulated select toxin materials2. See Appendix II for further information.

All regulated select toxin material must be entered into inventory records. All regulated select toxin material, including working stock and material in long-term storage, must be entered into the inventory records. The current quantity of each vial must be documented for select toxins following each use. The current quantity of each vial that is recorded following the last usage may be examined during inspection. All personnel with access to select toxin materials must have FSAP approval to access select agents and toxins and be in compliance with the SAR. Clinical or diagnostic laboratories and other entities that possess, use, or transfer an HHS select toxin that is contained in a specimen presented for diagnosis or verification will be exempt from the SAR requirements including inventory requirements for seven calendar days after identification of the select toxin (except for Botulinum neurotoxin and/or Staphylococcal enterotoxin (Subtypes A-E)), or within 30 calendar days after identification of Botulinum neurotoxin and/or Staphylococcal enterotoxin (Subtypes A-E). The select toxin must be transferred in accordance with § 73.16external icon or destroyed on-site by a recognized sterilization or inactivation process. The toxin must be secured against theft, loss, or release during the period between identification of the select toxin and either the transfer or destruction of the toxin. Any theft, loss, or release of such toxin must be reported, and the identification of the select toxin must be reported to CDC or APHIS either immediately for BoNT or within seven days after identification for the other select toxins.

See Guidance on the Inventory of Select Agents and Toxins on the FSAP website for more information.

1It is of course possible that an entity could be in possession of an aggregate amount of select toxin that exceeds the amounts listed in 42 CFR § 73.3(d)(7) of the SAR and not be required to be registered with the FSAP if the aggregate amount of the select toxin is distributed across multiple individual PIs at the entity, each of whom possess below the regulatory threshold for the toxin.

2Select toxin material is material that contains select toxin (serum, stool, culture, etc.).

Page last reviewed: September 9, 2020