Changes to the Select Agent and Toxin List – Publication of HHS/USDA Final Rules

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On December 17, 2024, the U.S. Departments of Health and Human Services (HHS) and Agriculture (USDA) published parallel Final Rules in the Federal Register which set forth changes to the select agent and toxin list, including the removal of five agents from the list. These changes will take effect on January 16, 2025.

Highlights of the Changes

Key changes as set forth in the Final Rules are as follows:

  • Five select agents, including three of the Brucella species, are being removed from the list of regulated select agents and toxins
    • USDA and HHS are removing three biological agents from the list of Overlap Select Agents and Toxins – Brucella abortus, Brucella melitensis, and Brucella suis
    • USDA is removing one biological agent from the list of Veterinary Services Select Agents and Toxins – African horse sickness virus
    • USDA is removing one biological agent from the list of Plant Protection and Quarantine Select Agents and Toxins – Peronosclerospora philippinensis (also known as Peronosclerospora sacchari)
  • Implements several other changes to select agents and toxins already on the list
    • Nomenclature Updates:
      • Ebola virus to the genus Ebolavirus
      • SARS coronavirus (SARS-CoV) to Severe acute respiratory syndrome coronavirus (SARS-CoV)
    • Designates Nipah virus as a Tier 1 select agent
    • Increases the exclusion amount for Conotoxins (Short, paralytic alpha conotoxins containing the following amino acid sequence X1CCX2PACGX3X4X5X6CX7) from 100 mg to 200 mg

Reflection of an Extensive Process

Publication of these changes reflects the culmination of a multi-year process, including input received through previous Notices of Proposed Rulemaking published in the Federal Register (in 2020 and 2024), as well as expert input received through federal advisory boards.

Following the public comment period and further deliberation, the changes to the select agent and toxin list as reflected in the Final Rules differ from the 2024 proposal in two key areas:

  • HHS will not remove the Tier 1 designation for botulinum neurotoxin producing species of Clostridium
  • HHS will not update the nomenclature for Monkeypox virus to Mpox virus

We anticipate additional rulemaking to come focused on additional changes to the regulatory requirements related to biosafety and security.  These elements are still in progress and under deliberation.

Implementation and Next Steps

These changes will take effect on January 16, 2025.

For those entities impacted by these changes, the Federal Select Agent Program (FSAP) will be reaching out to discuss next steps.

Additional Resources

The Federal Register postings for the full text of the Final Rules can be found at the following links: