Regulatory Interpretation: Transfer of Excluded or Permissible Amounts of HHS Toxins

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Date: January 20, 2022

Subject: Transfer of excluded or permissible amounts of HHS toxins

This is in response to your request, dated October 18, 2021, for a regulatory interpretation to clarify the requirements for the transfer of less than or equal to permissible toxin amounts by or to entities registered to possess toxin covered on the permissible toxin amounts outlined under §73.3(d)(7).  Specifically,

  1. When a registered entity transfers an amount, less than on the list, to a site not registered with the Federal Select Agent Program (FSAP), is an APHIS-CDC Form 2 required?
    • No. An approved APHIS/CDC Form 2 is not required to transfer less than or equal to a permissible amount of toxin under §73.3(d) to an entity that is not registered with FSAP.
  1. When a registered entity transfers an amount, less than on the list, to another FSAP registered entity, is an APHIS-CDC Form 2 required?
    • No. An approved APHIS/CDC Form 2 is not required to transfer less than or equal to a permissible amount of toxin under §73.3(d) to another registered entity.
  1. When a registered entity receives an amount, less than on the list, is an APHIS-CDC Form 2 required?
    • No. An approved APHIS/CDC Form 2 is not required for a registered entity to receive less than or equal to a permissible amount of toxin under §73.3(d).
  1. When a registered entity receives an amount, less than on the list, via import from outside the US, is an APHIS-CDC Form 2 required?
    • No. An approved APHIS/CDC Form 2 is not required for a registered entity to receive less than or equal to a permissible amount of toxin under §73.3(d) via import from outside of the US.

It is the policy of the Division of Select Agents and Toxins that the regulatory provision which states “an entity registered for possession, use or transfer of a toxin must be in compliance with the requirements of 42 CFR Part 73 regardless of the amount of toxin currently in its possession” (§ 73.7(b)) does not require registered entities to submit an APHIS/CDC Form 2 for the transfer or receipt of permissible amounts of toxins that are excluded in accordance with §73.3(d)(7).