2015 Annual Report of the Federal Select Agent Program: Infographic of Findings

FEDERAL SELECT AGENT PROGRAM

2015 Annual Report | Key Statistics

The Federal Select Agent Program (FSAP) published its first annual report of key program data for 2015 as part of its ongoing commitment to increasing transparency and understanding of the program. These data provide insight into work conducted with select agents and toxins at laboratories across the nation, as well as the regulatory functions 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

291 ENTITIES WERE REGISTERED WITH FSAP

• 32% ACADEMIC
• 18% COMMERCIAL
• 15% FEDERAL GOVERNMENT
• 29% NON-FEDERAL GOVERNMENT
• 6% PRIVATE

51% of entities are registered for Tier 1* BSAT

TOP REGISTERED AGENTS BY AGENCY

CDC’s Division of Select Agents and Toxins

1. Brucella melitensis
2. Brucella suis
3. Brucella abortus
4. Bacillus anthracis
   (Pasteur strain)
5. Francisella tularensis*
6. Yersinia pestis*
7. Bacillus anthracis*
8. Burkholderia pseudomallei*
9. Burkholderia mallei*
10. Botulinum neurotoxin producing species of Clostridium*

APHIS’s Agriculture Select Agent Services

1. Avian influenza virus
2. Newcastle disease virus
3. Brucella abortus
4. Bacillus anthracis*
5. Ralstonia solanacearum
6. Xanthomonas oryzae
7. Brucella melitensis
8. Brucella suis
9. Burkholderia pseudomallei*
10. Burkholderia mallei*

COMPLIANCE & ENFORCEMENT

• 6 entities agreed to participate in a corrective action plan
• 3 entities were put under suspension
• 16 entities were referred to FBI (no criminal intents found)
• 4 entities were referred to the HHS Office of Inspector General or APHIS Investigative and Enforcement Services

THEFT, LOSS, & RELEASE

• 0 thefts reported
• 199 potential occupational exposure incidents reported (resulting in monitoring for 908
• 12 reports of losses determined to be records management errors or samples mistakenly autoclaved as waste
• 0 potential exposures resulting in illness, death, or transmission

TRANSFER APPROVALS: 337 DSAT | 126 AgSAS

• 32% of these were initiated by unregistered entities, mostly due to identification of BSAT in a diagnostic specimen

216 TOTAL INSPECTIONS CONDUCTED BY FSAP

• 145 by DSAT
• 33 by AgSAS
• 38 joint DSAT & AgSAS

3 AVERAGE DURATION (IN DAYS) FOR INSPECTION

• Range of 1 to 8 days

4,426 SECURITY RISK ASSESSMENTS APPROVED IN 2015

• Restricted access for 16 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
• AgSAS: Agriculture Select Agent Services
• BSAT: Biological select agents and toxins

*Tier 1 agent, those that pose the greatest risk through misuse

Source: 2015 Annual Report of the Federal Select Agent Program, June 2016 | www.selectagents.gov/annualreport2015.htmlexternal icon