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Proposed Changes to the Select Agent Regulations

Select agents and toxins are regulated by the Federal Select Agent Program. This program is jointly enforced by the Department of Health and Human Services (HHS)/Centers for Disease Control and Prevention (CDC)/Division of Select Agents and Toxins (DSAT) and the US Department of Agriculture (USDA)/Animal and Plant Health Inspection Service (APHIS)/Division of Agricultural Select Agents and Toxins (DASAT).

On January 30, 2024, HHS and the 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 present changes to the list of select agents and toxins, and to regulatory requirements related to biosafety and security.

 

Background

The Select Agents and Toxins List is made up of those biological agents and toxins that have the potential to pose a severe threat to both human and animal health, to plant health, or to animal and plant products.  The select agent regulations were implemented to protect against acts of bioterrorism, and to reduce the risk that others with illicit intentions would gain access to and misuse these materials.

An individual or entity that intends to possess, use, or transfer a select agent or toxin must register with the Federal Select Agent Program. A certificate of registration must be obtained before select agents or toxins may be shipped or received.

As part of the registration, a written site-specific Security Plan must be developed and implemented to ensure that only authorized individuals with proper clearance have access to select agents and toxins, prevent unauthorized transfers of this material, and track its final destruction.

An attenuated strain of a select agent, or an inactive form of a select toxin, may be excluded from the requirements of the select agent regulations if it’s included on the exclusions list.  In addition, there are also permissible toxin amounts established for some toxins which exempt these toxins from regulation if the amount under the control of the PI (or other approved individual) does not exceed the permissible toxin limit.

 

Proposed Changes

Key components outlined in the NPRMs include proposed changes to the list of select agents and toxins, an increase in the exclusion amount of one toxin, the codification and/or clarification of several definitions and policies, and the addition of several new regulatory requirements. A summary of the proposals can be found on the FSAP website, and some of the more significant proposed updates are noted below:

  • Changes to the list of select agents: These include removing three biological agents from the list of Overlap Select Agents and Toxins (Brucella abortus, Brucella melitensis and Brucella suis); renaming biological agents (Ebola Virus, Monkeypox Virus, and SARS Conronavirus); and removing the Tier 1 designation for botulinum neurotoxin producing species of  (Note that the Tier 1 designation has been given to those select agents and toxins that present the greatest risk of deliberate misuse).
  • Increase in the exclusion amount of conotoxins: This applies to short, paralytic alpha conotoxins containing a specific amino acid sequence from 100 mg to 200 mg.
  • Codification of existing policies: Policies include those regarding the items that each entity’s annual internal inspections must address and policies on validated inactivation procedures and defining related terms.
  • Clarifying definitions and policies: Examples are clarifying definitions of theft, loss, and release of a select agent or toxin and clarifying security enhancements regarding screening visitors for those entities possessing Tier 1 select agents and toxins.
  • Addition of new regulatory requirements: These include proposing that an entity’s effluent decontamination system (EDS) must be addressed in its biosafety, security, and incident response plans and requiring facility verification every 12 months for registered entities that maintain BSL-3/ABSL-3 labs.

 

Comment Period

Public comments are being accepted 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 these Federal Register links: HHS/CDC and USDA/APHIS.

For additional information on the proposed changes to the list of select agents and toxins, as well as changes to regulatory requirements related to biosafety and security, please contact us. If your facility is required to register with the Federal Select Agent Program, we can help. If you aren’t required to register, but possess toxins below permissible amounts, we can work with you to establish a program to safely handle and track these agents.

This blog was written by Beth Graham, Director of Quality, Research, and Training

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