What’s New: 2024
Today, 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. Highlights are as follows:
- Five select agents, including three of the Brucella species, are being removed from the list of regulated 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
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.
The publication of these Final Rules reflects the culmination of the multi-year rulemaking process. 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:
Today, the Federal Select Agent Program (FSAP) is pleased to announce the publication of its ninth annual report of aggregate program data, the 2023 Annual Report of the Federal Select Agent Program. The report summarizes data for calendar year 2023 and is part of FSAP’s continued efforts to provide the American public with insight into the regulatory activities of the program.
For more than two decades, FSAP has provided critical leadership and oversight in the areas of biosafety and security. With the oversight provided by FSAP during this time, laboratories have been able to continue to work with dangerous biological agents and toxins in a safe and secure manner.
Once again, the content includes a look at the regulatory functions of FSAP, as well as compliance with the select agent and toxin regulations at laboratories across the nation. The report also highlights FSAP’s efforts to engage with the regulated community throughout the year to enhance regulatory compliance.
As in previous years, data from this year’s report underscore that overall, laboratories registered with the program are compliant with the regulations, and none of the small number of reported incidents during the year resulted in a significant risk to public health or agriculture.
The report also reflects the program’s ongoing commitment to transparency.
The full report, along with an infographic summarizing the key findings, is now available here.
The Federal Select Agent Program wishes to announce a change in leadership at the Centers for Disease Control and Prevention (CDC)’s Division of Regulatory Science and Compliance (DRSC). Dr. Samuel Edwin, previous DRSC director, now holds the position of Senior Scientist within DRSC’s Office of the Director. In this position, Dr. Edwin will continue to support CDC’s Federal Select Agent Program and support the transition to a new director. Effective July 1, 2024, Dr. Daniel Singer has taken over the position of acting DRSC division director.
Dr. Daniel Singer most recently served as the Director for Countering Biological Threats on the National Security Council at the White House. He is an internal medicine physician with expertise in infectious disease outbreak response and health policy who has worked in multiple countries on five continents.
Dr. Singer began his public health career at CDC as an Epidemic Intelligence Service Officer in 1999. He left the agency for a series of distinguished federal positions focusing on global health and the integration of science and policy (including at HHS, the Department of State, and the National Institutes of Health). He returned to CDC in 2012, first to the CDC programs in Malawi and Mozambique and then as the Regional Director for Central Asia where he managed four CDC offices in Kazakhstan, Kyrgyzstan, Tajikistan, and Uzbekistan.
Dr. Singer received his B.A. from the University of Pennsylvania and his M.D. from the University of Pittsburgh. He did his internal medicine residency at the University of Maryland and completed his Masters in Public Health in International Health at Johns Hopkins University.
Please be assured that while this leadership change is underway, our steadfast commitment to the program’s mission remains unchanged.
More information will be shared regarding the appointment of a permanent DRSC division director as it is available.
The Federal Select Agent Program (FSAP) is pleased to announce the publication of its sixth annual joint-program analysis of inspection report timeliness data, the 2023 FSAP Inspection Report Processing Annual Summary.
Inspections play a critical role in ensuring the safety and security of work with select agents and toxins. Timely issuance of reports following an inspection is essential so that FSAP can quickly provide important feedback to entities, therefore allowing the entities to promptly address any identified concerns.
The new analysis for 2023 finds continued success by FSAP in providing timely feedback to entities following an inspection. For the second consecutive year, FSAP issued 100% of final inspection reports to the entities within the program’s goal of 30 business days.
Key findings include the following:
- In 2023, FSAP issued all 208 final inspection reports (100%) on time.
- The average time to issue a final report was 19 days.
- FSAP issued 1 immediate action observation, also within the target timeframe of 10 business days.
These data reflect the seventh consecutive year for CDC’s Division of Regulatory Science and Compliance, and the fifth consecutive year for APHIS’ Division of Agricultural Select Agents and Toxins, in which at least 95% of final inspection reports were issued on time. While the program is pleased by these results, FSAP will continue to track and analyze this data to ensure that entities receive timely feedback and to identify any necessary opportunities for improvement.
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.