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In June 2011, the Federal Experts Security Advisory Panel (FESAP) released Recommendations Concerning the Select Agent Program.  The FESAP was created in July 2010 by Executive Order (EO) 13546, “Optimizing the Security of Biological Select Agents and Toxins in the United States,” and was tasked to make recommendations regarding the biosecurity measures of the national Select Agent Program (SAP).  The FESAP made recommendations to address the following five issues:
  1. Designation of Tier 1 biological select agents and toxins (BSAT) 
  2. Reduction in the number of BSAT on the Select Agent List
  3. Establishment of appropriate practices to ensure reliability of
    personnel with access to Tier 1 BSAT at registered facilities
  4. Establishment of appropriate practices for physical and cyber
    security for facilities that possess Tier 1 BSAT
  5. Other emerging policy issues relevant to the security of BSAT

On July 2, 2010, the White House issued an Executive Order, Optimizing the Security of Biological Select Agents and Toxins in the United States, that directs federal agencies to institute changes in the current implementation of the Select Agent Program (SAP) and Regulations (SAR) within their existing statutory authorities.  The American Society of Microbiology noted in a July 7, 2010 email to its members that the Executive Order directs federal agencies to take actions to improve the overall coordination, consolidation and oversight of select agents and toxins and provides for:  

  • Tiering and potential reduction of the Select Agent list. The U.S. Department of Health and Human Services (HHS) and U.S. Department of Agriculture (USDA) will, through the biennial review process, tier the existing list of select agents and toxins based on the risk posed by the pathogen or toxin in enabling a mass casualty incident through deliberate misuse. For pathogens and toxins in the highest risk tier, HHS and USDA will designate these as Tier 1 agents and evaluate options for the targeted application of physical security and personnel reliability measures in a manner commensurate with risk. HHS and USDA will also consider reducing the number of agents and toxins on the Select Agent List.

  • Revision of Select Agent Regulations, Rules and Guidance. HHS and USDA, will through their existing rulemaking process, revise the Select Agent regulations 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 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 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 determined by HHS and USDA. The Department of Homeland Security will chair a subgroup of the Panel that will advise the SAP on recommended physical security practices for high risk pathogens and toxins. 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 SAT Security: Federal departments and agencies will establish and implement a plan to coordinate oversight of select agents and toxins 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.

  • Coordination of Federal Oversight for SAT Security: Federal departments and agencies will establish and implement a plan to coordinate oversight of select agents and toxins 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 SAT security. Departments and agencies will conduct a thorough review of their own policies and practices regarding security of select agents and toxins and revise or rescind them to ensure they are fully aligned with the revised SAP/SAR.