Guidance on the Transfer of Select Agents and Toxins

Due Diligence

A transfer authorization would not be needed for toxins under the control of a principal investigator, treating physician or veterinarian, or commercial manufacturer or distributor if the aggregate amount of toxin does not exceed the following amounts:

  • Abrin 1000 mg
  • Botulinum neurotoxin 1 mg
  • Conotoxins (Short, paralytic alpha conotoxins) 100 mg
  • Diacetoxyscirpenol 10,000 mg
  • Ricin 1000 mg
  • Saxitoxin 500 mg
  • Staphylcoccal enterotoxin (A, B, C, D, E subtypes) 100 mg
  • T-2 toxin 10,000 mg
  • Tetrodotoxin 500 mg

Anyone transferring an amount of toxin excluded under the provisions of section 73.3(d) of the select agent regulations, must use due diligence and document the identification of the recipient and the legitimate need (e.g., prophylactic, protective, bona fide research, or other peaceful purpose) claimed by the recipient to use such toxin in accordance with section 73.3(d)(7) or section 73.16 (l) of the select agent regulations.

Recipient identity information to be documented includes, but is not limited to:

  • Recipient’s name
  • Institution name
  • Address, telephone number and email address
  • Name of the toxin and the total amount transferred
  • The legitimate need claimed by the recipient
  • Aggregate amount of toxin in the possession of the recipient, if not registered with FSAP; will not exceed exempted quantity limit.

The entity must also report to FSAP if they detect a known or suspected violation of Federal law or become aware of suspicious activity related to a select toxin.