BOX 1.2Presidential Executive Order

When the committee’s report was in the final stages of completion, the White House issued on July 2, 2010, a new Executive Order, “Optimizing the Security of Biological Select Agents and Toxins in the United States” (see Appendix M). Although the committee did not have time to consider fully the implications of this Executive Order, it notes that several issues are particularly relevant to this report:

1.

Sec. 4. Risk-based Tiering of the Select Agent List.

“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. HHS and USDA will also consider reducing the number of agents and toxins on the Select Agent List.”

This is in good agreement with near-term milestone d (see Chapter 4), which discusses stratification or reduction of the Select Agent list. Prioritizing the Select Agent list based on risk would make any sequence-based approach to oversight more feasible.

2.

Sec. 7. Implementation. (a) Establishment, Operation, and Functions of the Federal Experts Security Advisory Panel. “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.”

As discussed in the present report, (Chapter 3; Appendix L, near-term milestone f) a classification or yellow flag system would depend on the technical expertise of Scientific Workgroups and Advisory Panels. The Federal Experts Security Advisory Panel described in the EO could, if appropriately staffed with knowledgeable experts, be compatible with such scientific workgroups and advisory panels. For instance, the DHS sub-group is consistent with “Security Advisors” presented in Fig 4.1, 2b. It appears that the Federal Experts Security Advisory Panel could also include a sub group of “Scientific Advisors” as presented in Fig 4.1, 3b. (However, the FESAP may not be appropriate to perform the function of the yellow flag “Scientific Advisors,” shown in Fig 4.1, 9b.)

Image ch4f1

From: 1, The Select Agent Regulations

Cover of Sequence-Based Classification of Select Agents
Sequence-Based Classification of Select Agents: A Brighter Line.
National Research Council (US) Committee on Scientific Milestones for the Development of a Gene Sequence-Based Classification System for the Oversight of Select Agents.
Washington (DC): National Academies Press (US); 2010.
Copyright © 2010, National Academy of Sciences.

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