2024 SA Grams

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.

If you have any questions about the report, please contact APHIS/DASAT at 301-851-2070 or DASAT@usda.gov, or CDC/DRSC at 404-718-2000 or LRSAT@CDC.gov.

The Federal Select Agent Program (FSAP) recently added a footnote to the current BSL-4/ABSL-4 Verification Policy Statement clarifying the definition of ‘annual’ as every 365 days.

If you have any questions regarding this email, please don’t hesitate to contact APHIS/DASAT at 301-851-2070 or DASAT@usda.gov, or CDC/DRSC at 404-718-2000 or LRSAT@cdc.gov.

The Federal Select Agent Program (FSAP) has recently revised the APHIS/CDC select agent and toxin reporting Forms found on the FSAP website and in the eFSAP information system. Major updates include:

• Updated new name for Division of Regulatory Science and Compliance (DRSC) and expiration date on all APHIS/CDC Forms
• APHIS/CDC Form 3 Section B:
  • Added ‘unknown’ box for strain designation of select agent or toxin question.
• APHIS/CDC Form 3 Section C:
  • Added sub-question on whether release poses a threat to animal or plant health, animal or plant products, or public health.
  • Added sub-question about number of individuals wearing PPE.
  • Added sub-question about medical surveillance and/or treatment provided to potentially exposed individuals.
  • Added ‘Signs and symptoms information provided’ as a response for provided medical surveillance and/or treatment question.
• APHIS/CDC Form 4A:
  • Simplified language for current responses and added ‘Vectors/arthropods’ response to sample type question.
• APHIS/CDC Form 4B:
  • Removed ‘Registration #’ for sponsor/entity question.

• APHIS/CDC Form 4C:
  • Removed ‘Fax #’.
  • Added ‘Entity address’.
  • Added dropdown responses for disposition of seized select agents and toxins question.

If you have any questions regarding this email, please don’t hesitate to contact APHIS/DASAT at 301-851-2070 or DASAT@usda.gov, or CDC/DRSC at 404-718-2000 or LRSAT@cdc.gov.

The Animal and Plant Health Inspection Service’s Division of Agricultural Select Agents and Toxins (DASAT) has updated the Guidelines for Avian Influenza Viruses (AIV) which provides guidance for the regulation of AIV, including categorization, biocontainment, transfer, and movement of highly pathogenic and low pathogenic avian influenza viruses. The updated document is now available here.

This version of the document includes revisions to DASAT contact information and updated information about the data requirements for excluding AIV reassortant viruses, clarifying the regulation, reporting the identification, and revised the laboratory biocontainment requirements.

If you have any questions regarding this email, please contact DASAT at 301-851-2070 or dasat@usda.gov.

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.

If you have any questions, please contact CDC/DRSC at 404-718-2000 or LRSAT@cdc.gov.

Respectfully,
Daniel Singer, MD
Acting Director
Division of Regulatory Science and Compliance

On behalf of the CDC Import Permit Program, the Federal Select Agent Program (FSAP) is sharing the below message regarding importations of H5 Avian Influenza Virus:

For the duration of the H5 Avian Influenza Virus exemption, APHIS, Veterinary Services (VS), Organisms and Vectors (OV) Permitting Unit will issue permits for importation and interstate transportation of all H5 avian influenza viruses pursuant to 9 C.F.R. Part 122.  The APHIS, VS, OV Permitting Unit can be contacted by email at: apie@usda.gov.

An import permit from the Centers for Disease Control and Prevention’s Import Permit Program will be required for all H5 Avian Influenza variants that are known or suspected to cause human disease. If any imported agent is determined to not cause disease in humans (e.g., attenuated strains that are no longer infectious), then an importer certification statement should be included to avoid potential shipping delays. The Import Permit Program can be contacted by email at: importpermit@cdc.gov.

If you have any questions regarding this email, please don’t hesitate to contact APHIS/DASAT at 301-851-2070 or DASAT@usda.gov.

The Federal Select Agent Program (FSAP) wishes to inform registered entities regarding the new H5 Avian Influenza Virus Exemption.

The Administrator of the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) has utilized his exemption authority under 9 C.F.R. § 121.5(f) in the select agent and toxin regulations to temporarily exempt H5 avian influenza viruses from the requirements of the regulations listed in 9 C.F.R. Part 121 for a period of three years.

Such an exemption is consistent with protecting animal health and animal products while allowing more laboratories to conduct research and develop solutions to address the disease.  This exemption replaces all previously issued and currently effective exemptions related to H5 avian influenza viruses.

For the duration of the exemption, APHIS, Veterinary Services (VS), Organisms and Vectors (OV) Permitting Unit will issue permits for importation and interstate transportation of all H5 avian influenza viruses pursuant to 9 C.F.R. Part 122.

The APHIS, VS, OV Permitting Unit can be contacted by email at apie@usda.gov.

Please feel free to share this information with interested persons and entities.  If you have any questions concerning the exemption, please contact the Division of Agricultural Select Agents and Toxins (DASAT) at 301-851-2070 or by email at DASAT@usda.gov. 

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.

The Federal Select Agent Program (FSAP) is pleased to announce the deployment of another update to the electronic Federal Select Agent Program information system (eFSAP).

Beginning May 30, 2024, eFSAP users will notice the following system updates:

• Simple Registration Withdrawal

• • eFSAP now has an additional amendment type: “Request Registration Withdrawal”
  • Upon approval of the amendment, eFSAP will automatically:
    • Withdraw all open technical amendments
    • “Terminate” all individuals from APHIS/CDC Form 1 Section 4
    • Update the status of all current work objectives to “removed”
    • Change the entity’s status to “withdrawn”
  • eFSAP will also upload an official registration withdrawal certification letter into the entity’s document library

• Automated Co-Principal Investigator (PI) removal
  • Upon removal of a PI from APHIS/CDC Form 1 Section 4, eFSAP automatically removes the PI from any work objective on which that PI is listed in conjunction with other PIs
    • This new feature prevents entity users from having to submit technical “Modify Approved Work Objective” amendments to remove a co-PI

For more information, please review the tutorial [PDF – 1 MB] with screenshots of the new features attached to this message.

Please note: After each eFSAP update, users should clear their internet browser cache/cookies for the system to function properly.  Instructions can be found on the eFSAP Resource Center page.  

FSAP would like to thank the regulated community for its continued feedback regarding eFSAP functionality.  We look forward to delivering continued improvements based upon your suggestions.

If you experience errors, have questions, or have challenges with access to the system, please continue to contact our eFSAP customer support desk using the online help form, through email at eFSAPSupport@cdc.gov, or reference our newly updated eFSAP user manual.

The Federal Select Agent Program (FSAP) has become aware of a potential issue for users accessing the eFSAP information system using the Microsoft Edge internet browser.  Microsoft Edge has implemented a new tool, called Copilot AI, which leverages the power of AI to help write or recommend changes to text being entered by pulling suggestions from throughout the internet.

If Copilot AI is causing issues while working within the eFSAP information system, or if you or your organization are concerned regarding the AI analysis of your text being analyzed prior to submission, please see these instructions [PDF – 261 KB] on how to disable it.

To be clear this is NOT part of the eFSAP information system application but is a tool deployed by Microsoft to individuals using the Edge browser.

If you have any questions regarding this email, please don’t hesitate to contact APHIS/DASAT at 301-851-2070 or DASAT@usda.gov, or CDC/DRSC at 404-718-2000 or LRSAT@cdc.gov.

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.

If you have any questions regarding this email, please contact APHIS/DASAT at 301-851-2070 or DASAT@usda.gov, or CDC/DRSC at 404-718-2000 or LRSAT@CDC.gov.

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.

If you have any questions regarding this email, please don’t hesitate to contact APHIS/DASAT at 301-851-2070 or DASAT@usda.gov, or CDC/DRSC at 404-718-2000 or LRSAT@cdc.gov.