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Oversight of the Select Agent Program

The Federal Select Agent Program oversees the possession, use, and transfer of biological select agents and toxins, which, if handled improperly, have the potential to pose a severe threat to public health. Entities registered with the program must conduct annual internal inspections to ensure compliance with regulatory requirements (42 CFR ß 73.9(a)(6)), and the Centers for Disease Control and Prevention (CDC) conducts periodic inspections of entities to oversee the program. We are conducting a three-evaluation series on CDCís oversight of the Federal Select Agent Program. The first report (OEI-04-15-00430) found that CDC generally met its inspection goals for the Federal Select Agent Program, but opportunities exist to strengthen oversight. The second report will examine reporting of theft, loss, or releases (TLRs) to CDC within a sample of entities, as well as describe sampled entitiesí experiences and perspectives on reporting TLR events. Our third report will examine the extent to which CDC ensures that sampled entities comply with annual internal inspection requirements and correct observations identified during these inspections. This third report will also identify any differences and/or similarities between observations identified in CDCís and sampled entitiesí inspections.

Announced or Revised Agency Title Component Report Number(s) Expected Issue Date (FY)
Nov-16 Centers for Disease Control and Prevention Oversight of the Select Agent Program Office of Evaluation and Inspections OEI-04-15-00431; OEI-04-15-00432 2018

Office of Inspector General, U.S. Department of Health and Human Services | 330 Independence Avenue, SW, Washington, DC 20201