2019 Annual Report of the Federal Select Agent Program:
Infographic of Findings
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FEDERAL SELECT AGENT PROGRAM
2019 Annual Report | Key Statistics
The 2019 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 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. The report reflects the program’s continued commitment to increasing transparency.
BACKGROUND
FSAP is managed jointly by the Centers for Disease Control and Prevention’s Division of Select Agents and Toxins and the Animal and Plant Health Inspection Service’s Agriculture Select Agent Services. 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 potentially dangerous and deadly pathogens can be conducted as safely and securely as possible.
247 ENTITIES WERE REGISTERED WITH FSAP
- 34% ACADEMIC
- 17% COMMERCIAL
- 16% FEDERAL GOVERNMENT
- 28% NON-FEDERAL GOVERNMENT
- 6% PRIVATE
Note: Percentages are rounded and do not equal 100%.
51% of entities are registered for Tier 1* BSAT
LAB BIOSAFETY LEVELS (BSL)
ENTITIES MAY HAVE MULTIPLE TYPES
- 30% have BSL-2 and/or ABSL-2 labs
- 81% have BSL-3 and/or ABSL-3 labs
- 3% have BSL-4 and/or ABSL-4 labs
TOP REGISTERED AGENTS BY AGENCY
CDC’s Division of Select Agents and Toxins
- Brucella melitensis
- Brucella suis
- Brucella abortus
- Bacillus anthracis
(Pasteur strain) - Francisella tularensis*
APHIS’s Agriculture Select Agent Services
- Newcastle disease virus
- Avian influenza virus
- Ralstonia solanacearum
- Xanthomonas oryzae
- Brucella abortus
COMPLIANCE & ENFORCEMENT
- 1 total entity participated in a corrective action plan (with 1 entity newly participating in 2019)
- 3 total entities had suspended registrations, either partially or fully (with 1 entity newly put under a full suspension in 2019)
- 18 matters were shared with the Federal Bureau of Investigation for potential investigation (FBI determined no action was needed in 9 of those cases, with 9 pending)
- 1 entity was referred to both the HHS Office of Inspector General and the APHIS Investigative and Enforcement Services
THEFT, LOSS, OR RELEASE
- 0 thefts reported
- 13 reports of losses determined to be inventory volume discrepancies or record keeping discrepancies
- 0 occupational exposures resulting in illness, death, or transmission, out of the 195 incidents reported involving occupational exposures
TRANSFER APPROVALS: 136 DSAT | 35 AgSAS
- 158 transfers occurred
189 TOTAL INSPECTIONS CONDUCTED BY FSAP
- 122 by DSAT
- 21 by AgSAS
- 46 joint DSAT & AgSAS
2.4 AVERAGE DURATION (IN DAYS) FOR INSPECTION
- Range of 1 to 8 days
8,360 ACTIVE INDIVIDUAL SECURITY RISK ASSESSMENTS
- Denied access for 27 individuals
KEY ABBREVIATIONS:
- FSAP: Federal Select Agent Program
- CDC: Centers for Disease Control and Prevention
- DSAT: Division of Select Agents and Toxins
- APHIS: Animal and Plant Health Inspection Service
- BSAT: Biological select agents and toxins
- AgSAS: Agriculture Select Agent Services
- ABSL: Animal biosafety level
*Tier 1 agent, those that pose the greatest risk through misuse
Source: 2019 Annual Report of the Federal Select Agent Program, September 2020 | www.selectagents.gov/annualreport2019.htmlexternal icon