The Federal Select Agent Program (FSAP) oversees possession, transfer, and use of certain "select" biological agents and toxins that have the potential to pose a severe threat to public, animal or plant health, or to animal or plant products. The FSAP currently requires registration of facilities including government agencies, universities, research institutions, and commercial entities that possess, use or transfer biological agents and toxins. FSAP permits researchers to possess "permissible toxin amounts" of the 9 select toxins (Table 1) without registering in the select agent program, and FSAP expects institutions such as UC Davis to ensure that individual researchers never exceed possession limits. For that reason UC Davis researchers who use permissible amounts of select toxins are required to register with the Environmental Health and Safety Biological Safety Office (the campus select agent administrative office). In addition, researchers must report any quantity of a select toxin in possession in the annual report to the laboratory Chemical Inventory System (CIS). Research or other non-clinical uses of pharmaceutical packages of select toxins such as "Botox" and "Myobloc" are also subject to exempt limits and registration. Please contact the Biosafety Office for assistance with registration of exempt quantities of select toxins.
|Table 1. Exempt quantities of select toxins (42 CFR § 73, 7 CFR § 331, 9 CFR § 121)|
|Botulinum neurotoxins||1 mg|
|Diacetoxyscirpenol (DAS)||10, 000 mg|
|Staphylococcal enterotoxins||100 mg|
|T-2 toxin||10, 000 mg|
NOTE: separate registration is required for each Select Toxin.
- The principal investigator is responsible for updating the information on-file with the Biosafety Office.
- The principal investigator's inventory is subject to on-site audit by the Biosafety Office.
- Principal investigators are not currently required to keep special inventory records.
- Registration expires when the principal investigator permanently ceases working with select toxins and inactivates remaining stocks by an approved process (toxins may not be transferred to another user without notifying the Biosafety Office).
These rules do not permit the culture of select toxin-secreting agents for the purposes of obtaining select toxins, nor do they permit extraction of select toxins from natural sources. Those activities require Institutional Biosafety Committee approval and registration with the Select Agent program. Please contact the Biosafety Officer, for information on registration in the select agent system.