regulated community. The creation of the National Select Agent Registry as a single point of contact for agents regulated by both CDC and APHIS has been almost universally applauded for simplifying the regulatory environment and providing coordinated guidance. But because BSAT research is carried out and supported by several federal agencies, not just the Department of Health and Human Services (HHS) and the U.S. Department of Agriculture (USDA), the committee believes a more formal structure is needed to engage the community of stakeholders in the operation of the program.

To provide a locus for both feedback from the research community and discussion of issues of common interest, the committee recommends the establishment of a Biological Select Agents and Toxins Advisory Committee (BSATAC), whose membership would be drawn from the BSAT research community. This committee would provide an ongoing conduit for discussion of the implementation of the select agent regulations and would be made up of microbiologists and other infectious disease researchers (including select agent researchers) at various career stages, responsible officials, and those with experience in biosecurity, animal care and use, compliance, biosafety, operation of BSAT facilities as well as viewpoints from the public health, risk assessment, and legal communities. Representatives from the federal agencies with a responsibility for funding, conducting, or overseeing select agent research would serve in an ex officio capacity.1 The committee would operate under the provisions of the Federal Advisory Committee Act, which mandates public meetings, adequate advance notice, and public accessibility of records—all of which would serve to broaden the reach of the BSATAC.

Such an advisory committee should have several specific responsibilities. Based on results of the consultations and site visits, it is clear that an important responsibility for the BSATAC would be the promulgation of guidance on the implementation of the Select Agent Program. A survey of the principal investigators (PIs) and co-PIs of the National Institutes of Health (NIH) Regional Centers of Excellence (RCEs) for Biodefense and Emerging Infectious Diseases found that more than 90 percent believed that select agents should be regulated, but also that a majority were concerned about whether or not they were in compliance with the rules and that they lacked a source to go to with their questions (Sutton 2009). In addition to providing formal guidance, the Advisory Committee would facilitate exchange of information about the program—such as aggregate data on laboratory-acquired infections—and promote the sharing of

1

Among the agencies it would be appropriate to have represented are the Office of Science and Technology Policy; the National Security Council/Homeland Security Council; the Office of Management and Budget; the Department of Health and Human Services; the Department of Agriculture; the Department of Justice; the Department of Homeland Security; the Department of Defense; the Department of Energy; the Department of Transportation; the Department of Commerce; the Department of State; the Environmental Protection Agency; the National Science Foundation; and the Office of the Director of National Intelligence.



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