FDA has come out with its guidance document for fresh-cut processors, entitled Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables. You can read the document here. This is the way FDA describes what it is doing in a “fact sheet” about the release:
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.
PMA has welcomed the guidance and United was able to report that “…Sixty-eight of our 73 submitted suggested edits were accepted and incorporated by the Agency into the final guidance document.”
As for us, we welcome any guidance from FDA since half the time we can’t figure out exactly what they would like the industry to do.
At the same time much of the document is so elementary it scares us to think someone may find this useful. The document is filled with brilliant statements such as this:
“We recommend replacing a tool if it cannot be fixed so that it can be adequately cleaned.”
Well, yes, of course, that would be a good idea. After all, what is the alternative — to continue using a dirty tool and contaminate the produce?
In reading the document one yearns for a stronger hand. With all the talk in the industry of different types of mandatory regulation, the document provides many reminders of laws that already exist:
When used for washing, cooling, rinsing, or conveying food, we recommend that water comply with applicable Federal, State, and local requirements.
The FDA is going to “recommend” that companies follow the law? Aren’t they supposed to say we will lock you away if you don’t obey mandatory laws and regulations?
And much of the document, while making perfect sense, doesn’t come with evidence that the FDA has actually tested these methods. For example, look at this on handwashing:
We recommend that employees be trained to follow good personal hygiene practices, including the use of proper hand washing techniques, wearing clean clothes and any additional outer coverings (e.g., hairnets and beard covers, disposable gloves, aprons), and appropriate conduct on the job. FDA also recommends that employees be trained on how, when, and to whom to report illness. Hand washing training is particularly important. We recommend that employees be trained about how, when, and why they must properly wash their hands and exposed portions of their arms. We also recommend that employees be taught to wash and sanitize their hands before entering areas where fresh or fresh-cut produce is present.
Figure 1 is an example of an aid that could be used to train employees on the proper technique to use in washing hands:
Figure 1. Example of a training aid on how to wash your hands
How to wash your hands
Use soap and warm running water
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Wet hands
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Apply soap
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Vigorously rub hands up to elbows for 20 seconds
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Rinse Hands
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Turn off running water with a paper towel, not bare hands
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Dry hands with a paper towel or air dry. Do not share towels
Soap combined with scrubbing helps dislodge and remove dirt and germs.
The point is well taken, but one wonders if there is actually much evidence that, say, training employees to wash their hands in this manner actually has any effect on the cleanliness of their hands six months later?
Guidance like this can only help and it never hurts to review what you already know. Still, when you read it, you sort of come away with the feeling that if we have any fresh-cut processors out there for whom this document is presenting new and exciting principles of food safety, then we are really in trouble.
