Summary

In the wake of anthrax incidents and mounting concerns about the potential for another bioterrorism attack, we assessed the Centers for Disease Control and Prevention's (CDC) oversight of the Department of Health and Human Services' (HHS) Laboratory Registration/ Select Agent Transfer Program. We brought program weaknesses we identified to the immediate attention of CDL and HHS officials, who agreed that improvements were warranted. The purpose of this report is to summarize our findings.

As the agency responsible for identifying and controlling biological agents that have the potential to pose a severe threat to public health and safety, CDC can improve its management of the Select Agent Program to reduce the likelihood of unauthorized access to biological agents. During the course of our review, we identified and brought to the immediate attention of CDC and HHS officials areas in which program oversight could be strengthened, including inspection and approval of facilities and monitoring of the transfer and shipment of select agents. To better position CDC to reasonably ensure that appropriate security and safety protections are in place for select agents, we made recommendations aimed at establishing proper internal control in accordance with OMB Circular A-123 over the Select Agent Program.