UC Davis researchers using permissible amounts of select toxins are required to record it in their UC Chemicals inventory.
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 non-registered possession limits.
For that reason UC Davis researchers who use permissible amounts of select toxins are required to report any quantity of a select toxin in their possession using the UC Chemicals application. Research or other non-clinical uses of pharmaceutical packages of select toxins such as "Botox" and "Myobloc" are also subject to exempt limits. Please contact the Biosafety Office for assistance with exempt quantities of select toxins.
Permissible select toxin amount thresholds (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|
Principal Investigator responsibilities:
- The principal investigator (PI) is responsible for updating the information in UC Chemicals.
- The PI's inventory is subject to on-site audit by EH&S.
- Principal investigators should not transfer select toxins to another PI without due diligence to ensure the permissible toxin amount will not be exceeded.
These rules do not permit the culture of microorganisms that produce 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 Select Agent Program Responsible Official (RO), for information on registration in the select agent system.