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The Food and Drug Administration announces the availability of the draft final fresh-cut guidance, entitled "Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables" (the Guide). The purpose of the Guide is to minimize the potential for microbial contamination during the processing of fresh-cut produce by providing recommendations to fresh-cut processors.
Fresh-cut produce is produce that is minimally processed (no lethal kill step) and altered in form by peeling, slicing, chopping, shredding, coring or trimming with or without washing or other treatment prior to being packaged for use by the consumer or a retail establishment. Examples of fresh-cut products are shredded lettuce, sliced tomatoes, salad mixes (raw vegetable salads), peeled baby carrots, broccoli florets, cut melons and sectioned grapefruit.
The fresh-cut produce sector is the fastest growing sector of the produce industry. As the fresh-cut sector grows, a larger volume and greater variety of fresh-cut products have become available. From 1996 to 2006, twenty-six percent of all outbreaks associated with fresh produce implicated fresh-cut produce.
If pathogens are present, the processing of fresh-cut produce by peeling, slicing, shredding, coring, or trimming may increase the risk of bacterial contamination and growth by breaking the natural exterior barrier of the produce thereby supplying nutrients for pathogens to grow. In addition, the high degree of handling common in fresh-cut operations may increase the risk of cross-contamination if adequate controls (e.g., adequate levels of free chlorine in a dump tank) are not in place.
The Guide is a continuation of existing programs such as the good agricultural practices (GAPs) program and covers the processing of fresh produce into fresh-cut produce, the next link in the supply chain. In FDA's 2004 Produce Safety Action (PSAP), the issuance of the Guide was identified as an action that could help achieve the PSAP's first objective, to prevent contamination from occurring.
The Guide complements FDA's Current Good Manufacturing Practice regulations for food (21 CFR 110) and provides a framework for identifying and implementing appropriate measures to minimize the risk of microbial contamination during the processing of fresh-cut produce. Specifically, it discusses the production and harvesting of fresh produce and provides recommendations for fresh-cut processing in the following areas: (1) personnel health and hygiene, (2) training, (3) building and equipment, (4) sanitation operations, and (5) fresh-cut produce production and processing controls from product specification to packaging, storage and transport. The Guide also provides recommendations on recordkeeping and on recalls and tracebacks.
In the Guide, FDA recommends that processors encourage the adoption of safe practices by their partners throughout the supply chain, including produce growers, packers, distributors, transporters, importers, exporters, retailers, food service operators, and consumers.
The Guide also recommends that fresh-cut processors consider a preventive control program such as the Hazard Analysis and Critical Control Points (HACCP) system to build safety into their processing operations. HACCP is a system designed to prevent, eliminate, or reduce to acceptable levels the microbial, chemical, and physical hazards associated with food production.
FDA will hold two public hearings concerning the safety of fresh produce including fresh-cut produce on March 20, 2007, in Oakland, CA and April 13, 2007, in College Park, MD (Wiley Building).
FDA Issues Final Guidance For Safe Production of Fresh-Cut Fruits And
Vegetables
(Press Release, March 12, 2007)
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