2022 Annual Report of the Federal Select Agent Program

The 2022 Annual Report of the Federal Select Agent Program, released in November 2023, summarizes Federal Select Agent Program (FSAP) data for calendar year 2022. FSAP regulates the possession, use and transfer of biological select agents and toxins so that important work with dangerous and deadly pathogens can be conducted as safely and securely as possible. FSAP is a partnership between HHS’s Centers for Disease Control and Prevention and USDA’s Animal and Plant Health Inspection Service.

The report, now in its eighth year, continues to provide the American public with insight into the regulatory activities of the program. The content includes a look at the regulatory functions of the program, 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.

The annual publication of this report reflects FSAP’s ongoing commitment to transparency.

Report Content

The report summarizes aggregate program data in areas such as:

• Numbers and types of registered entities, as well as amendments to registrations
• Top registered select agents or toxins
• Security risk assessments performed
• Number of inspections conducted
• Key observations related to inspection findings and compliance with the select agent regulations
• Reported thefts, losses, and releases of select agents or toxins
• Identifications and transfers of select agents or toxins
• Publications and outreach activities

Summary

As in previous years, the content of the report underscores 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 20^th 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 work with dangerous biological agents and toxins in a safe and secure manner. This essential work continues to lead to important scientific discoveries that can improve detection and prevention of human, animal, and plant diseases, as well as diagnostic and treatment options to address them.

For more information about the Federal Select Agent Program, please visit About Us.