Docket Number:
FDA-2013-N-0013
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine
Center for Food Safety and Applied Nutrition

This guidance is intended for those persons who are subject to the Sanitary Transportation of Human and Animal Food Rule (81 FR 20091), published on April 6, 2016. Specifically, this guidance provides clarification on the scope of the waiver for food establishments that provide food directly to consumers from the requirements of the Sanitary Transportation of Human and Animal Food Rule (the food establishment waiver) in response to questions the Agency has received since publication of the final rule.

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidances means that something is suggested or recommended, but not required.

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