What You Need to Know About the FDA Regulation

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. As a key element of the preventive approach to better protect public health, FDA published in the Federal Register the final rule entitled “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption" (the produce safety rule, or the rule) (80 FR 74354, November 27, 2015). The produce safety rule establishes, for the first time, science-based minimum standards for the safe growing, harvesting, packing and holding of fruits and vegetables grown for human consumption. The regulations are found at Title 21 of the Code of Federal Regulations part 112 (21 CFR part 112). The rule became effective on January 26, 2016, but compliance dates are staggered – see section II. F “When Do I Have to Comply with the Rule?”

We have prepared this Small Entity Compliance Guide in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Pub. Law 104-121). This guidance document is intended to assist small entities in complying with the rule set forth in 21 CFR Part 112 concerning Produce Safety. 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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Related Information

• FSMA Rules & Guidance for Industry