1. Scientific Workgroups and Advisory Panel: A work group of scientific experts would be assembled for each Select Agent (or Select Agent group). These expert groups would evaluate the agents and identify a “minimal parts list” for each. This is a highly technical and necessary step in developing a sequence-based classification system. The “Content Workgroups” would also identify genes necessary (though not sufficient) for virulence, and other “sequences of concern” that should be monitored as part of the yellow flag system.1 An additional benefit of such “Content Workgroups” is that participation in this undertaking could raise awareness of dual-use issues among researchers. Moreover, to include the top experts, these content workgroups would necessarily include international scientists, which may strengthen international engagement. These are major objectives of the National Strategy of for Countering Biological Threats,2 as well as the NSABB.

    In addition to the “Content Workgroups,” a panel of scientific advisors would be established for assessment of the Select Agent list and the yellow flag sequences. As previously mentioned, advisors for the yellow flag system would be charged to review biological data and make determinations as to whether a sequence raises sufficient concern to merit a yellow flag, needs further study, or should be removed from the yellow flag list. This panel would offer advice regarding whether a sequence construct merits consideration for Select Agent designation. The panel would be expected to consider information provided by the “Content Workgroups,” and would likely have joint members.

    The same (or a second) panel of scientific advisors would be charged with determining if biological criteria have been met to warrant designation of a pathogen or toxin as a Select Agent. In this capacity, the advisory panel would also work with stakeholders from the security community and government agencies, and therefore, the scientific advisors should be represented on (or function as a subcom-

1

The committee stresses that this should not be confused with prediction. It would be a mistake to assume that these genes would function in a genome backbone independent manner, or to apply this information to designate a “sequence of concern” as a Select Agent. The purpose is to classify genomes as “complete” and subject to the SAR, and to identify “sequences of concern” that are worth monitoring.

2

“The objectives of our Strategy are: … Reinforce norms of safe and responsible conduct: Activities that should be taken to reinforce a culture of responsibility, awareness, and vigilance among all who utilize and benefit from the life sciences to ensure that they are not diverted to harmful purposes. Transform the international dialogue on biological threats: Activities targeted to promote a robust and sustained discussion among all nations as to the evolving biological threat and identify mutually agreed steps to counter it.”



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