The Federal Select Agent Program (FSAP) is comprised of the Centers for Disease Control and Prevention, the U.S. Division of Select Agents and Toxins (DSAT) and the U.S. Department of Agriculture. The FSAP oversees the possession, use, and transfer of biological select agents and toxins. Every individual or entity that possesses, uses, or transfers these agents or toxins must be registered with the FSAP. For information regarding select agents or toxins, contact the Responsible Official
The following toxins are not regulated if the amount under the control of a Principal Investigator or treating physician does not exceed, at any time, the amounts indicated in the table below.
|
HHS Toxins [§73.3(d)(3)] |
Amount |
|
Abrin |
1000 mg |
|
Botulinum neurotoxins |
1 mg |
|
Short, paralytic alpha conotoxins |
100 mg |
|
Diacetoxyscirpenol (DAS) |
10,000 mg |
|
Ricin |
1000 mg |
|
Saxitoxin |
500 mg |
|
Staphylococcal Enterotoxins (Subtypes A, B, C, D, and E) |
100 mg |
|
T-2 toxin |
10,000 mg |
|
Tetrodotoxin |
500 mg |
The Select Agent Regulations require the Principal Investigator use “due diligence” when transferring an amount of a HHS select toxin otherwise excluded under the Regulations. This provision requires the Principal Investigator to take reasonable actions to ensure that the recipient:
- Is eligible to receive the select toxin (Principal Investigator, treating physician or veterinarian, or commercial manufacturer or distributor).
- Has a legitimate need (i.e., reasonably justified by a prophylactic, protective, bona fide research, or other peaceful purpose) to handle or use such select toxins.