2023 Annual Report of the Federal Select Agent Program:
Infographic of Findings
Federal Select Agent Program 2023 Annual Report: Key Statistics
The 2023 Annual Report of the Federal Select Agent Program (FSAP) provides insight into the program’s regulatory activities and includes a look at 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 content 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. The publication, now in its ninth year, reflects the program’s ongoing commitment to transparency.
Background
FSAP is managed jointly by the Centers for Disease Control and Prevention and the Animal and Plant Health Inspection Service. The program regulates the possession, use, and transfer of biological select agents and toxins – which are materials that have the potential to pose a severe threat to public, animal or plant health, or to animal or plant products – so that important work with dangerous and deadly pathogens can be conducted as safely and securely as possible.
226 Entities Were Registered With FSAP
- 36% Academic
- 16% Commercial
- 13% Federal Government
- 29% Non-Federal Government
- 5% Private
Percentages do not add up to 100% due to rounding.
50% of entities were registered for Tier 1* select agents and toxins
Lab Biosafety Levels (BSL)
Entities May Have Multiple Types
- 29% had BSL-2 and/or ABSL-2 labs
- 79% had BSL-3 and/or ABSL-3 labs
- 3% had BSL-4 and/or ABSL-4 labs
Top Registered Agents by Agency
Some positions have multiple agents tied.
Centers for Disease Control and Prevention
- Brucella melitensis
- Brucella suis
- Brucella abortus
Bacillus anthracis (Pasteur strain) - Francisella tularensis*
- Yersinia pestis*
Animal and Plant Health Inspection Service
- Newcastle disease virus
- Avian influenza virus
- Ralstonia solanacearum
- Xanthomonas oryzae
- African swine fever virus
Bacillus anthracis*
Brucella abortus
Some positions have multiple agents tied.
Compliance & Enforcement
- 1 entity participated in a corrective action plan (with 0 entities newly participating in 2023)
- 1 entity had its registration revoked
- 0 entities had suspended registrations
- 16 security-related matters were shared with the Federal Bureau of Investigation for potential investigation (7 were considered for criminal investigation)
- 1 entity was referred to the Department of Health and Human Services Office of Inspector General (with 0 entities referred to APHIS Investigative and Enforcement Services)
Theft, Loss, or Release
- 0 thefts reported
- 8 reports of losses determined to be related to record keeping issues and not the actual loss of material
- 0 releases resulted in illness among the general public, death or transmission among workers, or transmission to the outside of a laboratory into the surrounding environment or community (out of 215 reports)
- 1 report of occupational exposure resulted in illness of a worker, but no disease transmission to others
197 Total Inspections Conducted by FSAP
- 124 by CDC
- 23 by APHIS
- 50 joint CDC & APHIS
8,599 Active Individual Security Risk Assessments
- Denied access for 17 individuals
Outreach
- 6 webinars for the regulated community on in-depth select agent topics – 1,483 total attendees
- 17 entities contacted as a result of emergency management activities during which FSAP offered assistance due to events such as severe weather, natural disasters, or other situations with potential impacts to safety or security (7 events, 0 entities required assistance)
Key Abbreviations:
- FSAP: Federal Select Agent Program
- ABSL: Animal biosafety level
- CDC: Centers for Disease Control and Prevention
- APHIS: Animal and Plant Health Inspection Service
*Tier 1 agent: those that pose the greatest risk through misuse
Source: 2023 Annual Report of the Federal Select Agent Program, October 2024