Food

Guidance for Industry: Clarification on Food Establishment Waiver from Requirements of the Sanitary Transportation of Human and Animal Food Rule

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How to Comment

Submit electronic comments on http://www.regulations.gov to docket number FDA-2013-N-0013.

Submit written comments to:
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, rm. 1061
Rockville, MD 20852
All comments should be identified with the docket number FDA-2013-N-0013.

Contains Nonbinding Recommendations

August 2017

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.

This guidance represents the current thinking of the Food and Drug Administration (FDA or we) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact FDA’s Technical Assistance Network by submitting the form available at http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm459719.htm.

 

Page Last Updated: 08/14/2017
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