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Small Entity Compliance Guide: Sanitary Transportation of Human and Animal Food: What You Need to Know About the FDA Regulation November 2017

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Center for Food Safety and Applied Nutrition

For questions regarding this document contact FDA’s Technical Assistance Network by submitting the inquiry form.

The FDA Food Safety Modernization Act of 2011 (FSMA) directs the Food and Drug Administration (FDA) as the food regulatory agency of the U.S. Department of Health and Human Services to better protect public health by, among other things, adopting a modern, preventive, and risk-based approach to food safety regulation. On April 6, 2016, FDA published in the Federal Register a final rule, Sanitary Transportation of Human and Animal Food (Sanitary Transportation rule) (81 FR 20091), that establishes requirements for shippers, loaders, carriers by motor vehicle and rail vehicle, and receivers engaged in the transportation of food, including food for animals, to use sanitary transportation practices to ensure the safety of the food they transport. The final rule became effective on June 6, 2016.

We have prepared this Small Entity Compliance Guide in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121, as amended by Public Law 110-28). This guidance document is intended to assist small entities in complying with the rule set forth in 21 CFR Part 1, subpart O concerning Sanitary Transportation of Human and Animal Food. The rule is binding and has the full force and effect of law.

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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All written comments should be identified with this document's docket number: FDA-2013-N-0013.

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