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Select toxin guidance
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May 2017
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Description:The Federal Select Agent Program (FSAP) oversees the possession, use, and transfer of select agents and toxins at registered entities throughout the United States. Select agents or toxins can be regulated as HHS only, APHIS only (Veterinary Services (VS)), Plant Protection and Quarantine (PPQ)), or Overlap Agents (regulated by both agencies). Currently select toxins are only regulated by HHS (42 CFR Part 73). This guidance document is intended to assist those entities that work with select toxins in meeting the requirements of the regulations. The majority of the guidance is intended for those entities that are registered to possess, use, or transfer a select toxin, regardless of whether they actually possess any amount of a select toxin. The guidance on exclusions, exemptions, and due diligence is pertinent for unregistered entities that work with select toxins below the regulatory threshold.
Select_Toxin_Guidance.pdf
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