2019 Annual Report of the Federal Select Agent Program

The 2019 Annual Report of the Federal Select Agent Program, released in September 2020, summarizes 2019 program data for the Federal Select Agent Program (FSAP), which regulates the possession, use and transfer of biological select agents and toxins so that important work with potentially 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 fifth year, continues to provide the American public with insight into the regulatory activities of the program.  The contents include a look at both the regulatory functions of the program, as well as compliance with the select agent regulations at laboratories across the nation.  In addition, the report highlights FSAP’s efforts to engage with the regulated community throughout the year to help ensure regulatory compliance.

As in previous years, 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

The findings underscore that overall, most laboratories registered with the program are compliant with the regulations, and none of the relatively small number of reported incidents during the year resulted in a risk to public or agricultural health.  By providing oversight through FSAP, laboratories are able to work with potentially dangerous biological agents and toxins in a safe and secure manner. This work is essential because it leads 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.

The annual publication of this report reflects FSAP’s continued commitment to increasing transparency and understanding of the program.

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