2024 SA Grams
The Federal Select Agent Program (FSAP), via the CDC Division of Regulatory Science and Compliance (DRSC), recently received a request for a regulatory interpretation. This interpretation, which has been posted to the FSAP website, clarifies whether messenger RNA (mRNA) from Botulinum neurotoxin producing species of Clostridium would be subject to the select agent and toxin regulations as outlined in 42 CFR § 73.3(c)(2).
To read the full regulatory interpretation, please visit https://www.selectagents.gov/regulations/interpretations/mrna.htm.
If you have any questions regarding this email, please contact CDC/DRSC at 404-718-2000 or LRSAT@CDC.gov.
Today, 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:
- HHS/CDC: Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review of the List of Select Agents and Toxins
- USDA/APHIS: Agricultural Bioterrorism Protection Act of 2002; Biennial Review and Republication of the Select Agent and Toxin List
All comments should be submitted via the instructions provided in the Federal Register Notices at the links above.
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. A summary of the major proposals can be found on the here.
In 2023, the Federal Select Agent Program (FSAP) held a series of six webinars for Responsible Officials (RO) and Alternate Responsible Officials (ARO). Each webinar was designed to provide participants with information related to compliance with the select agent and toxin regulations, as well as updates from FSAP on a variety of topics.
The webinar presentations have been posted to the FSAP website and are now available for download here.