2022 Annual Report of the Federal Select Agent Program:
Infographic of Findings
Federal Select Agent Program 2022 Annual Report: Key Statistics
The 2022 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 eighth 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.
234 Entities Were Registered With FSAP
- 35% ACADEMIC
- 17% COMMERCIAL
- 13% FEDERAL GOVERNMENT
- 29% NON-FEDERAL GOVERNMENT
- 6% PRIVATE
51% of entities are registered for Tier 1* select agents and toxins
Lab Biosafety Levels (BSL)
ENTITIES MAY HAVE MULTIPLE TYPES
- 28% have BSL-2 and/or ABSL-2 labs
- 80% have BSL-3 and/or ABSL-3 labs
- 3% have BSL-4 and/or ABSL-4 labs
Top Registered Agents by Agency
Centers for Disease Control and Prevention
- Brucella melitensis
- Brucella suis
- Brucella abortus
- Bacillus anthracis (Pasteur strain)
- Francisella tularensis*
Animal and Plant Health Inspection Service
- Newcastle disease virus
- Avian influenza virus
- Ralstonia solanacearum
- Xanthomonas oryzae
- Brucella anthracis*
Compliance & Enforcement
- 3 total entities participated in corrective action plans (with 0 entities newly participating in 2022)
- 0 entities had suspended registrations
- 24 security-related matters were shared with the Federal Bureau of Investigation for potential investigation (none were considered by the FBI for criminal investigation)
- 0 entities were referred to the HHS Office of Inspector General or APHIS Investigative and Enforcement Services
Theft, Loss, or Release
- 0 thefts reported
- 6 reports of losses determined to be related to record keeping issues and not the actual loss of material
- 0 releases resulted in illness, death, or transmission among workers or to the outside of a laboratory into the surrounding environment or community (out of 170 reports)
197 Total Inspections Conducted by FSAP
- 133 by CDC
- 18 by APHIS
- 46 joint CDC & APHIS
8,516 Active Individual Security Risk Assessments
- Denied access for 16 individuals
Outreach
- 5 webinars for the regulated community on in-depth select agent topics – 984 total attendees
- 43 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: 2022 Annual Report of the Federal Select Agent Program, November 2023