ARTICLE
26 January 2016

APHIS Proposes Amendments To Select Agent And Toxin Regulations

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These changes would increase the usability of the select agent regulations as well as provide for enhanced program oversight.
United States Food, Drugs, Healthcare, Life Sciences

In the January 19, 2016, Federal Register, USDA's Animal and Plant Health Inspection Service ("APHIS") proposed to amend and republish the list of select agents and toxins that have the potential to pose a severe threat to animal or plant health, or to animal or plant products. The Agricultural Bioterrorism Protection Act of 2002 requires the biennial review and republication of the list of select agents and toxins and the revision of the list as necessary. This action would implement the findings of the fourth biennial review of the list. In addition, APHIS is proposing several amendments to the regulations, including the addition of provisions to address the inactivation of select agents, provisions addressing biocontainment and biosafety, and clarification of regulatory language concerning security, training, incident response, and records. These changes would increase the usability of the select agent regulations as well as provide for enhanced program oversight. Comments are due March 21, 2016.

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