July 7, 1010 - President's Executive Order on Optimizing the Security of Biological Agents and Toxins in the United States

The ASM would like to bring to your attention President Obama's July 2 Executive Order which 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 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. HHS and 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.
  • 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.

Many of the provisions of the Executive Order have been supported by the ASM in congressional testimony, letters and statements on select agents and toxins.  The Society looks forward to working with the Administration and federal agencies as they begin the process to revise and change the program and regulations for select agents and toxins. 

Sincerely, 

Roberto Kolter, Ph.D., Chair, Public and Scientific Affairs Board
Ronald M. Atlas, Ph.D., Co-chair, Committee on Biodefense
Kenneth I. Berns, M.D., Ph.D., Co-chair, Committee on Biodefense

Stephen M. Ostroff, M.D., Chair, Committee on Public Health

 

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