As of March 21, 2017, an amendment to the Select Agent Regulations (42 CFR Part 73) updated the select toxin permissible amounts*. The toxins and their updated permissible amounts are listed in the table below.
|
Select Toxin |
Permissible 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 |
*Permissible amount: the maximum amount of select toxin that a principal investigator (PI), treating physician or veterinarian, commercial manufacturer or distributor may maintain/possess without obtaining approval from and registering with the Federal Select Agent Program (FSAP).
It is important to ensure that the total amount of toxin per PI is maintained below these limits at all times in order to remain exempt from registration with FSAP and the associated restrictive requirements. Due to the severe penalties associated with non-compliance with the Select Agent Regulations, it is imperative that each laboratory using and storing select toxins maintains current inventory information for these substances. Failure to register a select toxin is a criminal offense, punishable by up to five years in prison and/or $500,000 in fines (Public Health Security & Preparedness Response Act of 2002).