Division of Select Agents and Toxins: Program Reviews and Progress Updates

Background

The Federal Select Agent Program, which is managed jointly by CDC (through the Division of Select Agents and Toxins, or DSAT) and the USDA (through the Animal and Plant Health Inspection Services’ Agriculture Select Agent Services, known as AgSAS) helps to ensure that research with select agents and toxins is conducted as safely and securely as possible.

Following high-profile laboratory incidents involving select agents and toxins that occurred at federally regulated laboratories, multiple groups within the federal government took a closer look at the biosafety and security practices involved in the conduct and oversight of this critical work.

In October 2015, three federal reviews were released, each of which contained recommendations designed to strengthen the federal government’s biosafety and security practices and oversight, both through the Federal Select Agent Program and at a broader national level. There are many recommendations across the three reports that complement one another and that seek to support the same focus area.

The Division of Select Agents and Toxins, in conjunction with its AgSAS colleagues, continues to work diligently to implement these improvements and will provide periodic updates on this website.

CDC 90-Day Internal Review

In summer 2015, CDC Director Dr. Tom Frieden ordered an internal 90-day review of the Division of Select Agents and Toxins to examine the Federal Select Agent Program (FSAP) and make recommendations to improve the CDC select agent and toxin regulatory program.

The resulting online report: CDC 90 Day Internal Review of the Division of Select Agents and Toxins Report, produced recommendations in three main areas – addressing inspections, incident reporting, and transparency and public understanding.

White House Reports and Recommendations

Two other federal-level reports analyzing the oversight of laboratory work involving select agents and toxins were ordered by the White House to identify ways to strengthen policies and practices both at a national level and as a part of the FSAP, and included the following:

• Report of the Federal Experts Security Advisory Panel, or FESAP. A report and recommendations developed by a federal advisory panel.
• Fast Track Action Committee Report on Select Agent Regulations, or FTAC-SAR. A report and recommendations informed by external stakeholder input.
• Implementation plan. A federal implementation plan for the recommendations was also issued by the White House.

Progress Towards Change

Following the 90-Day and the White House reports, CDC published an online resource called Progress Towards Change. This website provides ongoing updates relevant to CDC’s role within the Federal Select Agent Program on the progress towards implementation of program improvement initiatives related to these recommendations.

Learn more about CDC’s history and role with the Federal Select Agent Program.