Division of Select Agents and Toxins: CDC 90-Day Internal Review

The nation relies on research to improve the rapid detection of biological threats and to develop the medical countermeasures to prevent and treat them. The Federal Select Agent Program oversees the possession, use, and transfer of biological select agents and toxins which have the potential to pose a severe threat to human, animal, or plant health or to animal or plant products. The Federal Select Agent Program consists of the Centers for Disease Control and Prevention (CDC) Division of Select Agents and Toxins (DSAT) and the Animal and Plant Health Inspection Serviceexternal icon (APHIS) Agriculture Select Agent Servicesexternal icon (AgSAS). CDC provides oversight for the select agents and toxins that cause diseases in people, and USDA provides oversight for select agents and toxins that cause diseases in animals and plants (CDC and USDA share the responsibility for agents that threaten both humans and animals, such as anthrax).

In summer 2015, CDC Director Dr. Tom Frieden ordered an internal 90-day review of CDC’s select agent and toxin regulatory program overseen by DSAT. A CDC Internal Review Workgroup was established to examine the Federal Select Agent Program and make recommendations to improve CDC’s responsibilities within FSAP. The Workgroup has not yet involved AgSAS to reconcile recommendations that have impact on both programs.

The Workgroup noted ongoing reviews of biosafety and biosecurity conducted by the U.S. Government since the time Executive Order 13546 was published in 2010external icon. They made observations leading to actionable recommendations in three broad categories (inspections, incident reporting, and transparency) to improve the CDC select agent and toxin regulatory program. The recommendations, referred to as the CDC 90-Day Internal Review of the Division of Select Agents and Toxins, are detailed below:

90 day review cover image

A PDF version of the report is available here pdf icon[PDF – 360 KB].

Page last reviewed: June 30, 2021, 09:30 AM