Select Agents and Toxins
The Federal Select Agent Program (FSAP) under the DHHS and USDA oversee the possession, use and transfer of specific biological select agents and toxins, which they have determined can pose a threat to public health and safety. These biological agents and toxins, more often referred to as "Select Agents", are heavily regulated and any possession or research use of such materials must be registered with the DHHS or USDA. The FSAP will however permit researchers to possess and use small amount of Select Toxins without under going the FSAP registration process. These are known as the "permissible toxin amounts". The Biosafety Program at NYU helps Principal Investigators (PIs) avoid obtaining quantities of select toxins that will cause them to inadvertently exceed the exclusion limits and become subject to and violate the federal regulations.
Permissible Toxin Amounts
|HHS Toxins [§73.3(d)(3)]||Amount|
|Botulinum neurotoxins||0.5 mg|
|Short, paralytic alpha conotoxins||100 mg|
|Diacetoxyscirpenol (DAS)||1000 mg|
|Staphylococcal Enterotoxins (Subtypes A, B, C, D, and E)||5 mg|
|T-2 toxin||1000 mg|
Things to know:
- Select Toxins in any amount must be registered with the IBC.
- Working with Permissible amounts of select toxins requires notification to Biosafety. You must select "Select Agent Biological Toxin" under the project details on your biosafey registration.
- Applicable safety standards relevant to the use of biological toxins are described in the CDC BMBL (PDF: 5 MB).
- NYU does not permit the use of regulated Select Agents and Toxins.