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BackgrounderThe Select Agent RuleDecember 9, 2002 Introduction History The Act authorized the Secretary of Health and Human Services (HHS) to regulate the transfer of select agents harmful to humans. HHS requested that CDC develop a regulation that would regulate select agents to protect the public without hindering scientific research. In addition, CDC was designated the agency within HHS responsible for enforcing this regulation. The CDC formed an interagency group and developed a list of select agents that included 38 microorganisms and toxins. After receiving public comment, the Select Agent Rule was finalized and required that affected facilities register with CDC. The Act also required facilities to report all transfers of select agents and to assure the transferee was registered. Following the events of September 11, 2001, The USA Patriot Act and the Public Health Safety Bioterrorism Preparedness and Response Act of 2002 were passed. The USA Patriot Act sets requirements for the appropriate use of select biological agents. It also specifies those persons who should be restricted from working with select agents, and imposes criminal and civil penalties for the inappropriate use of select agents. The Public Health Security Bioterrorism Preparedness and Response Act of 2002 updated the existing Select Agent Rule by requiring facilities to register if they possess select agents. Previously, only facilities that wished to transfer select agents needed to register with CDC. The Act of 2002 also added a one-time notification of possession requirement, incorporated the "restricted persons" provision of the Patriot Act, developed a similar select agent program for the United States Department of Agriculture (USDA) for plant and animal pathogens, and provided for the protection of certain information associated with the registration of these facilities. Current Situation Timeline
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