What’s New: 2023
Today, the Federal Select Agent Program (FSAP) published its eighth annual report of aggregate program data, the 2022 Annual Report of the Federal Select Agent Program. The report summarizes data for calendar year 2022 and is part of FSAP’s continued efforts to provide the American public with insight into the regulatory activities of the program.
Once again, the content includes a look at the regulatory functions of FSAP, as well as compliance with the select agent 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.
In addition, FSAP is pleased to note that this year marks the 20th anniversary of the Federal Select Agent Program – two decades of the program providing critical leadership 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.
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.
Effective October 1, the CDC’s Division of Select Agents and Toxins (DSAT) will be known as the Division of Regulatory Science and Compliance (DRSC).
While the Division’s name is changing, its regulatory authority has not. DRSC will continue to implement the same regulatory programs – including the Federal Select Agent Program and the Import Permit Program.
The Division will continue to develop and implement U.S. Federal regulations for compliance to help enhance biosafety and security in laboratory science that can lead to improved detection, prevention, diagnostic, and treatment options for some of the most deadly diseases impacting public health.
We would like to make the regulated community aware of this change and assure you that this organizational change will not affect the division’s regulatory oversight.
Please note that our materials and website are currently in the process of being updated to reflect these changes.
Today, the Federal Select Agent Program (FSAP) is pleased to announce the publication of its fifth annual joint-program analysis of inspection report timeliness data, the 2022 FSAP Inspection Report Processing Annual Summary.
Inspection reports play a critical role in ensuring the safety and security of work with select agents and toxins. Timely feedback following an inspection is essential so that FSAP can quickly get important information back to entities, therefore allowing the entities to promptly address any identified concerns.
The new FSAP analysis finds continued program success in providing timely feedback to entities following an inspection, with 100% of final inspection reports sent to entities in 2022 within the program’s goal of 30 business days.
Key findings include the following:
- FSAP issued 198 final inspection reports in 2022, with 100% of those reports on time.
- The average time to issue a final report was 17 days.
- FSAP issued 1 immediate action observation, also within the target timeframe of 10 business days.
These data reflect the sixth consecutive year for CDC’s Division of Select Agents and Toxins, and the fourth 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.
For more information, please see the full report, available here.
Today, the Federal Select Agent Program (FSAP) is announcing the Centers for Disease Control and Prevention (CDC)’s publication of a Final Rule in the Federal Register regarding the addition of SARS-CoV/SARS-CoV-2 Chimeric Viruses to the HHS list of Select Agents and Toxins.
The Final Rule states that HHS/CDC has amended the select agents and toxins regulations to add SARS-CoV/SARS-CoV-2 chimeric viruses resulting from any deliberate manipulation of SARS-CoV-2 to incorporate nucleic acids coding for SARS-CoV virulence factors to the list of HHS select agents and toxins. HHS/CDC also requires regulated entities to obtain prior approval from CDC to conduct deliberate manipulation of SARS-CoV-2 to incorporate nucleic acids coding for SARS-CoV virulence factors because these chimeric viruses have the potential to pose a severe threat to public health and safety.
No changes were made to the regulatory requirements in the Interim Final Rule as a result of public comments received; however, CDC has developed the Guidance on the Regulation of SARS-CoV/SARS-CoV-2 Chimeric Viruses and Frequently Asked Questions to help entities comply with the regulations.
Today, the Federal Select Agent Program (FSAP) is announcing the Centers for Disease Control and Prevention’s publication of the Notice of Availability in the Federal Register for the Policy Statement for Biosafety Level 4 (BSL-4)/Animal Biosafety Level 4 (ABSL-4) Laboratory Facility Verification. The policy statement assists individuals and entities in verifying that facility design parameters and operational procedures are functioning as intended to meet the biosafety requirements in the select agent and toxin regulations (42 CFR 73.12(b)).
A draft version of this policy was published in the Federal Register on January 19, 2022 for public comment. All comments were taken into account during the finalization of the policy; as a result of comments received, clarification was added to address HVAC operational verification, examples of major changes to the HVAC system, and what BSL-4/ABSL-4 facility verification entails and how often and when it should be performed. A full summary of the comments and responses can be reviewed in the Federal Register Notice.