Guidance on the Inventory of Select Agents and Toxins
Changes and Highlights
Revisions: This is a living document subject to ongoing improvement. Feedback or suggestions for improvement from registered Select Agent entities or the public are welcomed. Submit comments directly to the Federal Select Agent Program at:
- October 12, 2012: Initial posting
- March 14, 2013 (Revision 1): The revisions are primarily changes to correct editorial errors from previous version and to clarify for toxin material that there is no differentiation between working stock and long-term storage.
- June 12, 2014 (Revision 2): The document was revised to update toxin language to reflect the technical amendment to the select agent regulations. Specifically, the following language on page 5 was revised: “An entity does not need to apply for an exclusion if the agent is non-viable or the toxin is nonfunctional as these are not regulated. However, it is recommended that an entity maintain information on file in support of the method used for rendering a select agent non-viable or a select toxin nonfunctional so that the entity is able to demonstrate that the agent or toxin is no longer subject to the select agent and toxin regulations.”
- April 16, 2015: The document was revised to update 1) recombinant and synthetic nucleic acid definitions, 2) language quoted from select agent regulation section 17 (a) (1), 3) include nucleic acids that can produce infectious forms of select agent viruses as regulated material, and 4) Tier 1 Personnel Suitability requirements. The revisions also included external hyperlinks to Security, Personnel Suitability, and Toxin Due Diligence guidance documents and internal hyperlinks to Appendices I and II.
- January 5, 2017: The document was revised to update 1) record maintenance and 2) Material Containing Select Agents of Regulated Nucleic Acids.
March 2017: The document was revised based on changes to the regulations.
The Federal Select Agent Program (FSAP) oversees the use, possession, and transfer of select agents and toxins at registered entities throughout the United States. The select agent regulations require an accurate and current inventory for: (1) “each select agent (including viral genetic elements, recombinant and/or synthetic nucleic acids, and recombinant and/or synthetic organisms) held in long-term storage (placement in a system designed to ensure viability for future use, such as in a freezer or other storage container or lyophilized materials)”; and (2) “any animals or plants intentionally or accidentally exposed to or infected with a select agent (including number and species, location, and appropriate disposition)” and (3) “for each toxin held.” The information in this guidance document is meant to provide additional information to regulated entities in meeting the requirements for (1), (2), and (3) above. See 42 CFR § 73.17, 7 CFR § 331.17, and 9 CFR § 121.17.