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In addition to these inspections by agencies with statutory responsibility for the Select Agent Program, many funding agencies—including the Department of Defense and Department of Homeland Security—conduct their own inspections of research and facilities they support. Other federal agencies also may have responsibility for overseeing aspects of the facility and may conduct inspections. Finally, some state and local authorities inspect facilities within their jurisdiction. Close coordination between CDC and APHIS in the Select Agent Program has served the research community well and should be expanded to include other government agencies with an involvement in BSAT research.

12 Unlike these models, the oversight and screening structures for the Select Agent Program are considerably more substantial than those applicable to other biological research, especially in the involvement of outside oversight bodies and groups not necessarily composed of scientific peers. Moreover, BSAT research is the only area of biological research that requires verification of personnel beyond assessment of technical competence to carry out the proposed research protocols. For non-BSAT research, there has been no issue as to whether the individual may be trusted not to do harm.

In most cases, this has been local to the institution, with committees designated by the federal government to carry out the review. These review committees usually comprise scientific peers and those from other fields of study who have appropriate expertise, as well as representatives of the public (see Box 1-1 for examples of oversight committees operated at the institutional level). Where safety concerns extend beyond the institution, national-level bodies provide oversight that is consistent across the country.

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