successful practices across institutions and sectors. Both of these actions would substantially assist in the implementation of the program. At present, they do not occur on a regular basis, to the detriment of efficiency and uniform compliance. To carry out these responsibilities, the Advisory Committee would convene regular public meetings of key constituency groups. All of these actions would contribute to another important potential Advisory Committee responsibility: promoting harmonization of regulatory policies and practices.

In addition to these responsibilities, the Advisory Committee should fulfill two other important functions. Below, we recommend that the Select Agent Program carry out regular evaluation of the relative security benefits it provides and of their consequences, both intended and unintended, that their implementation is having on BSAT research. We believe these evaluations are necessary, whether or not the recommended Advisory Committee is created, but it would be a natural body to provide oversight for the conduct of such evaluations and for determining how the results are used by the Select Agent Program.

We also believe the Advisory Committee should provide advice on the composition and/or stratification of the list of select agents and toxins, as discussed below. The BSATAC would not be a substitute for the rulemaking required by statute, but it could be a source of important input to decision-making and provide a mechanism for ongoing community engagement.

RECOMMENDATION 2: To provide continued engagement of stakeholders in oversight of the Select Agent Program, a Biological Select Agents and Toxins Advisory Committee (BSATAC) should be established. The members, who should be drawn from academic/research institutions and the private sector, should include microbiologists and other infectious disease researchers (including select agent researchers), directors of BSAT laboratories, and those with experience in biosecurity, animal care and use, compliance, biosafety, and operations. Representatives from the federal agencies with a responsibility for funding, conducting, or overseeing select agent research would serve in an ex officio capacity. Among the responsibilities of this advisory committee should be the following:

  • Promulgate guidance on the implementation of the Select Agent Program;

  • Facilitate exchange of information across institutions and sectors;

  • Promote sharing of successful practices across institutions and sectors;

  • Provide oversight for evaluation of the Select Agent Program;

  • Provide advice on composition/stratification of the list of select agents and toxins;

  • Convene regular meetings of key constituency groups; and

  • Promote harmonization of regulatory policies and practices.

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