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The CDC has regulated the laboratories which may possess, use, or transfer select agents within the United States under the SAP since 2001. The SAP was established to satisfy requirements of the USA PATRIOT Act of 2001 and the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, which were enacted in the wake of the September 11, 2001 attacks and the subsequent 2001 ...
The Division of Select Agents and Toxins (DSAT) of the Centers for Disease Control and Prevention is responsible for the Select Agent Program and the Etiologic Agent Import Permit Program. They inspect the laboratories of more than 300 organizations approved to use and transfer select agents , and put regulations in place to minimize risk in ...
Not all select agents require BSL-4 handling, namely select bacteria and toxins, but most select agent viruses do (with the notable exception of SARS-CoV-1 which can be handled in BSL3). Many non-select agent viruses are often handled in BSL-4 according to facility SOPs or when dealing with new viruses closely related to viruses that require BSL-4.
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FSAP is jointly managed by the Division of Select Agents and Toxins (DSAT) at the CDC, which is part of the HHS, and the Agriculture Select Agent Services (AgSAS) at APHIS, which is part of the US Department of Agriculture (USDA). DSAT is concerned with human health, while AgSAS is concerned with animals and plants. [9]
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DHHS is to establish and maintain a list of agents that may pose a threat to public health and safety, provide regulation of transfers, provide for enforcement of standards for their possession and use, require registration of their possession, use, and transfer, and creates security requirements for people possessing select agents commensurate ...
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