D. Exclusions

Select agents or toxins that are excluded from regulation include:

  • Those agents or toxins that are in their naturally occurring environment, provided that it has not been intentionally introduced, cultivated, collected, or otherwise extracted from its natural source.
  • Non-viable select agent organisms or non-functional toxins.
  • Certain attenuated and vaccine strains of select agents and toxins. Please check the following link for the Notification of Excluded Attenuated Strains.
  • Certain toxins, under the control of an investigator, if the aggregate amount does not at any time exceed the following: (Note: the toxin quantities listed below are referred to as “Exempt” quantities throughout the remainder of this document. Those toxins whose aggregate amount exceeds that listed below are referred to as “Non-exempt” toxins.)

HHS Toxins

Amount

Abrin

100 mg

Botulinum neurotoxins

0.5 mg

Short, paralytic alpha conotoxin

100 mg

Diacetoxyscirpenol (DAS)

 1000 mg

Ricin

100 mg

Saxitoxin

100 mg

Staphylococcal enterotoxins (Subtypes A - E)

5 mg

T-2 toxin

1000 mg

Tetrodotoxin

100 mg