2015 Annual Report of the Federal Select Agent Program

The 2015 Annual Report of the Federal Select Agent Program pdf icon[PDF – 641 KB], released in June 2016, summarizes 2015 data for the Federal Select Agent Program (FSAP), which regulates the possession, use and transfer of biological select agents and toxins so that important work with potentially dangerous and deadly pathogens is conducted as safely and securely as possible. This program is a partnership between CDC and USDA.

Our activities include registering and inspecting labs where select agents are handled, conducting security checks on workers who are trusted with these organisms, and making sure that materials are transferred safely from one lab to another.

This first annual report is part of the program’s ongoing commitment to increasing transparency and understanding of the program. The data in the report provide insight into work conducted with biological select agents and toxins at laboratories across the nation, as well as the how the program provides regulation and oversight of these labs.

Key Scientific Findings

  • As of December 31, 2015, 291 entities were registered with FSAP to possess a select agent or toxin. Most were from academic (32 percent) or non-federal government (29 percent) institutes, with the remaining from commercial (18 percent), federal government (15 percent), or private entities (6 percent).
  • 216 inspections of registered entities were conducted by FSAP. The average length of an inspection was 3 days, with a range of 1 to 8 days.
  • After undergoing security risk assessments, 4,426 individuals were approved in 2015 to have access to select agents or toxins; access was restricted for 16 individuals.
  • FSAP was notified of 199 separate incidents resulting in potential occupational exposure to workers. These incidents resulted in the monitoring of 908 laboratory workers. None of these workers developed illness or transmitted a virus to others, either inside or outside of the laboratory.
  • 12 reports of losses were received in 2015. All were determined to be the result of records management errors or samples that were mistakenly destroyed as waste. No thefts of select agents or toxins were reported.
  • The vast majority of labs are doing well in following the select agent regulations. When a violation is identified, enforcement actions are determined according to the level of severity of the situation. In 2015:
    • 6 entities agreed to participate in a corrective action plan
    • 3 entities were put under suspension
    • 16 entities were referred to FBI (no criminal intent found)
    • 4 entities were referred to the HHS Office of Inspector General or APHIS Investigative and Enforcement Services
  • In 2015, FSAP approved 463 transfers of select agents or toxins. Approximately one-third of those (32 percent) were initiated by unregistered entities, mostly as a result of the identification of an agent in a diagnostic specimen.

Questions & Answers

Six Things You Need to Know About the Annual Report

Page last reviewed: September 10, 2020, 10:25 AM