HHS/USDA Notices of Proposed Rulemaking – Select Agent Regulations

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On January 30, 2024, the U.S. Departments of Health and Human Services (HHS) and Agriculture (USDA) published parallel Notices of Proposed Rulemaking (NPRM) in the Federal Register regarding the biennial review and republication of the select agent and toxin list.  The proposals set forth a number of changes to the list of select agents and toxins, as well as regulatory requirements related to biosafety and security.

Public comments are being accepted for the next 60 days, until April 1, 2024.  Following this period, input received will be considered prior to finalization of the regulations.

The documents and instructions for providing public comment can be found at:

All comments should be submitted via the instructions provided in the Federal Register Notices at the links above.

Highlights

Key components outlined in the NPRMs include multiple changes to the list of select agents and toxins, a change in the exclusion amount of one toxin, the codification and/or clarification of several definitions and policies, and the addition of four new regulatory requirements.  Major proposals include the following:

Proposed changes to the list of select agents

  • Removing three biological agents from the list of Overlap Select Agents and Toxins
    • Brucella abortus
    • Brucella melitensis
    • Brucella suis
  • Removing one biological agent from the list of USDA Veterinary Services Select Agents and Toxins
    • African horse sickness fever
  • Removing one biological agent from the list of USDA Plant Protection and Quarantine Select Agents and Toxins
    • Peronosclerospora philippinensis (also known as Peronosclerospora sacchari)
  • Renaming:
    • Ebola virus to the genus Ebolavirus
    • Monkeypox virus to Mpox virus (clade I)
    • SARS coronavirus (SARS-CoV) to Severe acute respiratory syndrome coronavirus (SARS-CoV)
  • Designating Nipah virus as a Tier 1 select agent
  • Removing the Tier 1 designation for botulinum neurotoxin producing species of Clostridium

Proposed change to the exclusion amount of one toxin

  • Increasing the exclusion amount for Conotoxins (Short, paralytic alpha conotoxins containing the following amino acid sequence X1CCX2PACGX3X4X5X6CX7) from 100 mg to 200 mg

Codification of policies

  • Codifying existing policy regarding the definition of “conclusion of patient care”
  • Codifying existing policy regarding when animals naturally infected with select agents are excluded from the requirements of the regulations
  • Codifying existing policy regarding the role of the Responsible Official (RO) and Alternate Responsible Official (ARO) as it relates to multiple entities
  • Codifying existing policy regarding the items that each entity’s annual internal inspections must address
  • Codifying existing policy regarding validated inactivation procedures and defining related terms

Clarifying definitions and policies

  • Clarifying definitions of theft, loss, and release of a select agent or toxin
  • Clarifying that APHIS/CDC Forms 2, 3, and 4 and amendments can be submitted via the program’s electronic information system, eFSAP, and there is no requirement for entities to retain a separate copy
  • Clarifying that registered entities are required to meet all of the regulatory requirements for those select agents and toxins listed on the individual or entity’s certificate of registration regardless of whether the select agent or toxin is in the actual possession of the individual or entity and without regard to the amount of toxin possessed
  • Clarifying security enhancements regarding screening visitors for those entities possessing Tier 1 select agents and toxins
  • Clarifying that a receiving entity must amend their certificate of registration and receive approval to possess the products of a restricted experiment
  • Clarifying the records provisions to ensure accurate, current inventory is maintained for each select agent held in long-term storage and all toxins to more clearly specify the requirements and aid in compliance

Addition of new regulatory requirements

  • Proposing a new APHIS/CDC Form 6 for the discovery of select agents/toxins
  • Proposing that an entity’s effluent decontamination system (EDS) must be addressed in its biosafety, security, and incident response plans
  • Proposing to require facility verification every 12 months for registered entities that maintain BSL-3/ABSL-3 labs
  • Proposing to add to the training section a requirement for unapproved individuals whose responsibilities routinely place them in close proximity to laboratory facilities and those individuals who perform administrative or oversight functions

More information on these proposed changes can be found in the HHS and USDA Notices of Proposed Rulemaking at the links above.