Fact Sheet: Executive Order on Optimizing the Security of Biological Select Agents and Toxins in the United States

Today, President Barack Obama issued an Executive Order that directs fundamental changes to the way highly hazardous pathogens and toxins in the United States are secured against misuse. Research on such so-called Biological Select Agents and Toxins (BSAT) is critical for the development and availability of public health and medical tools that are needed to detect, diagnose, recognize, and respond to outbreaks of infectious disease of both natural and deliberate origin. At the same time, the expansion since 2001 of infrastructure and resources dedicated to work with BSAT – coupled with the revelation that the perpetrator of the 2001 Bacillus anthracis (anthrax) attacks likely was a United States Government researcher – have raised concerns regarding the need to ensure BSAT are properly secured against those who would deliberately misuse them to harm people, animals, plants, or the environment.

To address these concerns, the Administration led a review of Federal policies and procedures associated with the security of BSAT. This review – informed by a number of studies performed by experts in the United States Government, academia, and the private sector – highlighted the need for significant improvements in the structure, coordination, and oversight of these activities across the Federal government. Importantly, the review concluded that as part of these improvements, Federal activities for securing BSAT should be more fully consolidated under a revised Select Agent Program/Select Agent Regulations (SAP/SAR) that will continue to be jointly led by the Departments of Health and Human Services (HHS) and Agriculture (USDA) with key support from the Department of Justice (DOJ) and Federal Bureau of Investigation (FBI).

Executive Order XXXXX directs HHS, USDA, DOJ, and FBI to institute a number of substantive changes to their implementation of the SAP/SAR within their existing statutory authorities. In addition, it directs a number of other Departments and Agencies to undertake specific actions to support the revised SAP/SAR and improve the overall coordination, consolidation, and oversight of Federal programs to secure BSAT. Specifically, the Executive Order will provide for:

•     Tiering and potential reduction of the Select Agent List: HHS and USDA will, through their current biennial process of reviewing the Select Agent List, tier the existing list based upon the risk posed by the pathogen or toxin in enabling a mass casualty incident through deliberate misuse. For those pathogens and toxins in the highest risk tier, HHS and USDA will evaluate options for the targeted application of physical security and personnel reliability measures in a manner commensurate to risk.

•     Revision of Select Agent Regulations, Rules, and guidance: HHS and USDA will, through their existing rulemaking process, revise the SAP/SAR, Rules, and guidance to communicate the specific physical security and personnel reliability practices that registrants will apply in accordance with the tiered Select Agent List.

•     Creation of a Federal Experts Security Advisory Panel (Panel) for the SAP: A panel of Federal security and scientific experts will serve as the principal security advisory body to the SAP. The Panel will advise the SAP on a range of topics, including considerations in the tiering and/or reduction of the Select Agent List, best practices regarding physical security and personnel reliability that should be considered in the revision of the SAR and related Rules and guidance, and other topics as determined by HHS and USDA. The Department of Homeland Security will chair a sub-Group of the Panel that will advise the SAP on recommended physical security practices for high-risk pathogens and toxins. In addition, the EO directs the National Science Advisory Board for Biosecurity to serve as a source for external advice and input on SAP/SAR policies and practices.

•     Coordination of Federal Oversight for BSAT Security: Department and Agency heads will establish and implement a plan to coordinate oversight of BSAT security. The plan will articulate processes by which inspections are conducted in a coordinated and reciprocal manner, security and compliance issues will be identified and resolved, and information legally will be shared among participating Departments and Agencies.

•     Rescission or revision of Department and Agency policies and practices for BSAT security: Heads of Departments and Agencies will conduct a thorough review of their own policies and practices regarding security of BSAT and revise or rescind them to ensure they are fully aligned with the revised SAP/SAR.