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GUIDANCE DOCUMENT

Guidance for Industry: Guide to Minimize Biological Hazards in Ready-to-Eat Fresh-Cut Produce August 2026

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2018-D-3583
Issued by:
Guidance Issuing Office
Human Foods Program

This guidance is intended to help manufacturers/processors of ready-to-eat (RTE) fresh-cut produce that is not a low-moisture food (“you”) comply with applicable requirements in 21 CFR part 117 (part 117), titled “Current Good Manufacturing Practice (CGMP), Hazard Analysis, and Risk-Based Preventive Controls for Human Food (PCHF).” In this guidance, “fresh-cut produce” means any fresh fruit or vegetable (or combination thereof) that has been physically altered to no longer be in its whole state (e.g., by chopping, dicing, peeling, ricing, shredding, slicing, spiralizing, or tearing) without additional processing (such as blanching, freezing, cooking, canning, or packing in a juice, syrup, or dressing), with or without a wash or other treatment before being distributed in fresh form (e.g., to a consumer, a retail food establishment, or a manufacturing/processing facility). Fresh-cut produce is a processed food that can be a single produce commodity (such as cut lettuce, sliced cantaloupe, diced celery, diced onions, and shredded carrots) or two or more produce commodities mixed in the same package (such as coleslaw mix and a fruit salad that contains a variety of cut melons).

The recommendations in this guidance are tailored to apply to the control of known or reasonably foreseeable (“potential”) biological hazards in fresh-cut produce that:

  • Is ready-to-eat. Part 117 defines “ready-to-eat food” as “any food that is normally eaten in its raw state or any other food, including a processed food, for which it is reasonably foreseeable that the food will be eaten without further processing that would significantly minimize biological hazards” (21 CFR 117.3).
  • Exhibits a water activity above 0.85. Almonds, walnuts, pistachios, pecans, macadamias, and peanuts are examples of produce commodities with a water activity below 0.85 and therefore would not be covered by this guidance.

This guidance is intended for fresh-cut produce processing activities that take place on farm mixed-type facilities (i.e., an establishment that is both a farm as defined in 21 CFR 1.227 and a food facility required to register with FDA). This guidance is not intended for farms. Manufacturers/processors of RTE foods (such as frozen, cut fruit) that are not fresh-cut produce as that term is defined in this guidance, but include steps such as cutting produce raw agricultural commodities (RACs) or washing cut produce in the production of RTE foods, might find this guidance useful for their operations, particularly with respect to control measures for washing cut produce.

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidance documents 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 guidance means that something is suggested or recommended but not specifically required.

Related Information

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2018-D-3583.

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