Draft Guidance for Industry: Guide to Minimize Food Safety Hazards of Fresh-cut Produce

This guidance is intended for those persons (“you”) who are subject to our regulation, in 21 CFR part 117 (part 117), entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk Based Preventive Controls for Human Food” and who manufacture, process, pack, or hold fresh-cut produce. In this guidance, “fresh-cut produce” means any fresh fruit or vegetable or combination thereof that has been physically altered from its whole state after being harvested from the field (e.g., by chopping, dicing, peeling, ricing, shredding, slicing, spiralizing, or tearing) without additional processing (such as blanching or cooking). Fresh-cut produce may or may not undergo a wash or other treatment before being packaged for use by the consumer or a retail food establishment. Fresh-cut produce can be a single commodity or two or more mixed in the same package, such as coleslaw or fruit salads, and sometimes called “ready to use,” “pre-cut,” or “value added” produce. Fresh-cut produce also does not include produce that has been processed by freezing, cooking, canning, or packing in a juice, syrup, or dressing.