2025 Annual Report of the Federal Select Agent Program:
Infographic of Findings

Federal Select Agent Program 2025 Annual Report: Key Statistics

The 2025 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 and toxin regulations at laboratories across the nation.

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 eleventh 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.

219 Entities Were Registered With FSAP

• 36% Academic
• 27% Non-Federal Government
• 17% Commercial
• 14% Federal Government
• 5% Private

Percentages do not add up to 100% due to rounding.

53% of entities were registered for Tier 1* select agents and toxins

Top Registered Agents by Agency

Some positions have multiple agents tied.

Centers for Disease Control and Prevention

1. Bacillus anthracis (Pasteur strain)
2. Francisella tularensis*
3. Yersinia pestis*
4. Botulinum neurotoxin producing
   species of Clostridium*
   Eastern equine encephalitis virus
5.  Bacillus anthracis*

Animal and Plant Health Inspection Service

1. Avian influenza virus
2. Newcastle disease virus
3. Ralstonia solanacearum
4. Xanthomonas oryzae
5. African swine fever virus

Some positions have multiple agents tied.

Lab Biosafety Levels (BSL)

Entities May Have Multiple Types

• 30% had BSL-2 and/or ABSL-2 labs
• 78% had BSL-3 and/or ABSL-3 labs
• 4% had BSL-4 and/or ABSL-4 labs

Outreach

• 1 multi-day workshop held for the regulated community on in-depth select agent and toxin topics
  • 356 registrants

169 Total Inspections Conducted by FSAP

• 103 by CDC
• 20 by APHIS
• 46 joint CDC & APHIS

8,287 Active Individual Security Risk Assessments

• Denied access for 17 individuals

Compliance & Enforcement

• 2 entities participated in a corrective action plan (with 1 entity newly participating in 2025)
• 0 entities had their registrations revoked
• 2 entities had partially suspended registrations
• 23 security-related matters were shared with the Federal Bureau of Investigation for potential investigation
• 0 entities were referred to APHIS Investigative and Enforcement Services or the Department of Health and Human Services Office of Inspector General

Theft, Loss, or Release

• 0 thefts reported
• 17 reports of losses; 1 loss was recovered by the entity and the other 16 were determined to be related to record keeping issues and not the actual loss of material
• 0 reported releases resulted in illness, death, or transmission among workers or to the outside of a laboratory into the surrounding environment or community (out of 165 reports)

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: 2025 Annual Report of the Federal Select Agent Program, October 2026 [PDF – 2 MB]