2017 Annual Report of the Federal Select Agent Program: Infographic of Findings
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FEDERAL SELECT AGENT PROGRAM
2017 Annual Report | Key Statistics
The 2017 Annual Report of the Federal Select Agent Program continues to provide insight into the regulatory activities of the Federal Select Agent Program (FSAP). The report includes a look at both the regulatory functions of the program, as well as compliance with the select agent regulations at laboratories across the nation. This annual report is FSAP’s third report of aggregate program data, and reflects the program’s ongoing commitment to transparency and increasing understanding of the program.
- FSAP is managed jointly by the Centers for Disease Control and Prevention’s Division of Select Agents and Toxins & the Animal and Plant Health Inspection Service’s Agriculture Select Agent Services
- FSAP regulates the possession, use, and transfer of biological select agents and toxins (BSAT) so that important work with potentially dangerous and deadly pathogens is conducted as safely and securely as possible
- BSAT are materials that have the potential to pose a severe threat to public, animal or plant health, or to animal or plant products
263 ENTITIES WERE REGISTERED WITH FSAP
- 33% ACADEMIC
- 18% COMMERCIAL
- 15% FEDERAL GOVERNMENT
- 29% NON-FEDERAL GOVERNMENT
- 6% PRIVATE
50% of entities are registered for Tier 1* BSAT
LAB BIOSAFETY LEVELS (BSL)
ENTITIES MAY HAVE MULTIPLE TYPES
- 31% have BSL-2 and/or ABSL-2 labs
- 79% 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
- Bacillus anthracis*
Brucella abortus
Ralstonia solanacearum
COMPLIANCE & ENFORCEMENT
- 8 total entities participated in a corrective action plan (including 1 entity that newly agreed to participate in 2017)
- 4 total entities had suspended registrations (including 2 entities newly put under suspension in 2017)
- 18 matters were shared with the Federal Bureau of Investigation for potential investigation (no action was needed in 17 of those cases, with one pending)
- 7 entities were referred to the HHS Office of Inspector General or APHIS Investigative and Enforcement Services
THEFT, LOSS, & RELEASE
- 0 thefts reported
- 199 incidents reported involving potential occupational exposure of 1,152 laboratory workers
- 9 reports of losses determined to be records management errors
- 0 potential exposures resulting in illness, death, or transmission
TRANSFER APPROVALS: 188 DSAT | 72 AgSAS
- 29% of the transfers were from unregistered entities to registered entities, mostly as a result of identification of BSAT in a diagnostic specimen
169 TOTAL INSPECTIONS CONDUCTED BY FSAP
- 106 by DSAT
- 31 by AgSAS
- 32 joint DSAT & AgSAS
2.6 AVERAGE DURATION (IN DAYS) FOR INSPECTION
- Range of 1 to 9 days
3,982 ACTIVE INDIVIDUAL SECURITY RISK ASSESSMENTS
- Denied access for 17 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: 2017 Annual Report of the Federal Select Agent Program, December 2018 | www.selectagents.gov/annualreport2017.htmlexternal icon