Possession use and transfer of select agents and toxins biennial review a proposed rule by the health and human services department on 03 17 2020 document details information about this document as published in the federal register printed version pdf publication date 03 17 2020 agency department of health and human services dates comments should be received on or before may 18 . Benefits the objectives of the hhs final rule are to create a means of ensuring enhanced oversight in the transfer storage and use of select agents and toxins clarify that an entity must use a validated method to render a select agent non viable or a regulated infectious nucleic acid sample non infectious for future use and require that entities in possession of such agents and toxins . On january 19 2017 hhs cdc published a final rule titled possession use and transfer of select agents and toxins biennial review and enhanced biosafety requirements 82 fr 6278 with an effective date of february 21 2017 with this document hhs cdc announces a new effective date of march 21 2017 for this final rule. Accordingly hhs and usda have promulgated regulations requiring individuals or entities that possess use or transfer select agents and toxins to register with hhs cdc or usda animal and plant health inspection service aphis see 42 cfr part 73 7 cfr part 331 and 9 cfr part 121 the select agent regulations. This document establishes a final rule regarding possession use and transfer of select agents and toxins the final rule implements provisions of the public health security and bioterrorism preparedness and response act of 2002 and is designed to protect public health and safety
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