The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353) (FSMA) enables the Food and Drug Administration (FDA or the Agency) to better protect public health by helping to ensure the safety and security of the food supply. It requires FDA to promulgate food safety rules that focus on preventing food safety issues rather than relying on detecting issues and reacting to them after they occur. FSMA recognizes that FDA has previously established preventive control type regulations for juice (Title 21, Code of Federal Regulations (21 CFR) part 120, the Juice HACCP regulation) based on the Hazard Analysis and Critical Control Point (HACCP) concept. See FSMA §§ 103(a), 103(f), 105(d), and 301 (§§ 418(j) and 805(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 350g(j), 350g note, 350h note, and 384a(e))). The juice HACCP regulation requires juice processors to identify food safety hazards that are reasonably likely to occur with the products they process [2] and to develop plans for the control of those hazards. In addition, the juice HACCP regulation requires importers of certain juice products to comply with requirements designed to help ensure that these imported products are processed in accordance with the juice HACCP regulation.

Importantly, several of the regulations that FDA has issued under FSMA provide exemptions that are related to the juice HACCP regulation. This guidance addresses those exemptions, and also provides information about the juice HACCP regulation in connection with the FSMA regulations.

Though not the subject of this guidance, we also note that some juice products are also subject to 21 CFR part 113 (Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers). Certain FSMA regulations provide additional exemptions related to part 113.

This guidance summarizes how the following FSMA regulations affect processors and importers covered under 21 CFR part 120, the Juice HACCP regulation:

• 21 CFR part 117, Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (the CGMP & PC Regulation)
• 21 CFR 1, subpart L, Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (the FSVP Regulation)
• 21 CFR 112, Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (the Produce Safety Regulation)
• 21 CFR part 121, Mitigation Strategies To Protect Food Against Intentional Adulteration (the IA Regulation)
• 21 CFR 1, subpart O, Sanitary Transportation of Human and Animal Food (the ST Regulation)

The contents of this document do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract. This document is intended only to provide clarity to the public regarding existing requirements under the law. FDA’s guidance documents, including this guidance, should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

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Related Information

• Juice HACCP Regulation - Questions and Answers
• FSMA Rules & Guidance for Industry