2025 SA Grams

The Federal Select Agent Program (FSAP) is sending a reminder to the regulated community that the changes to the select agent and toxin list published by the U.S. Departments of Health and Human Services (HHS) and Agriculture (USDA) in the Federal Register on December 17, 2024 take effect today, January 16, 2025.

Here are the highlights of the Final Rules:

• Five select agents, including three of the Brucella species, have been removed from the list of select agents and toxins
  • Includes 3 overlap select agents – Brucella abortus, Brucella melitensis, and Brucella suis
  • Includes 2 USDA-only select agents – African horse sickness virus and Peronosclerospora philippinensis (also known as Peronosclerospora sacchari)

• Implements several other changes to select agents and toxins already on the list
  • Updates nomenclature for Ebola virus to the genus Ebolavirus, and 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

FSAP will continue to work with impacted entities to address these changes.

For more information, please visit:

• The FSAP website for a summary of the changes.
• The Federal Register postings for the full text of the Final Rules:
  • HHS/CDC Final Rule
  • USDA/APHIS Final Rule

If you have any questions, please contact APHIS/DASAT at 301-851-2070 or DASAT@usda.gov, or CDC/DRSC at 404-718-2000 or LRSAT@CDC.gov.