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GAO-03-315R 1 (2002-11-22)

handle is hein.gao/gaocrptapfu0001 and id is 1 raw text is: Accountability * Integrity* Reliability United States General Accounting Office Washington, DC 20548 November 22, 2002 The Honorable Tommy G. Thompson Secretary of Health and Human Services Subject: Homeland Security: CDC's Oversight of the Select Agent Program Dear Mr. Secretary: The intentional dissemination of anthrax in the U.S. mail last fall demonstrates the devastating effect a biological agent can have if it falls into the wrong hands. Exposures to anthrax-tainted mail resulted in five deaths and 17 other infections, as well as significant disruption to postal service and other government operations. The sources from which terrorists can potentially obtain biological agents include public and private research laboratories located in the United States, and there is concern that the anthrax used in these incidents may have been obtained from federal or other domestic laboratories. In the Antiterrorism and Effective Death Penalty Act of 1996,' the Congress included provisions to regulate the transfer between laboratories of certain biological agents and toxins-called select agents-and required the Secretary of Health and Human Services (HHS) to issue regulations to implement these provisions. In response, HHS established in 1997 the Laboratory Registration/Select Agent Transfer Program at the Centers for Disease Control and Prevention (CDC), which developed the current list of 42 select agents covered by the program. The Select Agent Program is responsible for regulating the transfer of select agents to limit their distribution to only those laboratories that have the appropriate safety and security controls for handling biologic agents. Facilities interested in transferring-sending or receiving-select agents must be registered with CDC.3 To register, facilities must demonstrate in their applications that they meet the conditions for safety and security and have legitimate research needs for the agents, and CDC may inspect facilities before and after registration to ensure compliance. Laboratories possessing but not transferring select agents are not subject to the act. In the wake of the anthrax incidents and mounting concerns about the potential for another bioterrorism attack, we have assessed CDC's oversight of the Select Agent 'Pub. L. No. 104-132, § 511, 110 Stat. 1214, 1284-1285 (1996). 2CDC oversees the domestic transfer and possession of select agents. The Commerce Department's Bureau of Export Administration oversees a separate select agent export program for transfers outside the United States. 3CDC's own laboratories that transfer select agents must also register with the program and are subject to its requirements. GAO-03-315R CDC's Select Agent Program

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