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Government Relations: Regulatory Interaction

PMA Comments on FDA Draft Fresh-cut Produce Guidance

May 4, 2006

To: U.S. Food and Drug Administration, www.fda.gov/dockets/ecomments

Re: Docket No. 2006D-0079

The Produce Marketing Association (PMA) is pleased to submit these comments on the Food and Drug Administration's "Draft Guidance for Industry: Guide to Minimize Food Safety Hazards of Fresh-cut Fruits and Vegetables."

PMA is the largest global not-for-profit trade association representing companies that market fresh fruits and vegetables. Our more than 2,100 members range from grower-shippers and supermarket retailers to hotel and restaurant chains and overseas importers. Within the United States, PMA members handle more than 90% of fresh produce sold at the consumer level. PMA's purpose is to sustain and enhance an environment that advances the marketing of produce and related products and services and the association is funded primarily by member dues and event registration/exhibition fees.

In addition to submitting these comments, we encourage the agency’s attention to comments submitted by the International Fresh-cut Produce Association and the United Fresh Fruit and Vegetable Association. We concur with their comments.

In the Introduction, fourth paragraph, the draft guidance says: “This draft guidance is intended for all fresh-cut produce firms, both domestic and firms importing or offering fresh cut product for import into the U.S., to enhance the safety of fresh-cut produce by minimizing the microbial food safety hazards.” We encourage the agency to modify the beginning of the sentence to read “This draft guidance is intended for all fresh-cut processing firms….” The guidance appears to apply to processing firms only, not to purchasers of fresh-cut produce, such as wholesalers, distributors, retailers, or foodservice operators. We encourage the agency to make that clear.

In addition, in the Scope and Use section, the agency outlines what the guidance covers, the use of Current Good Manufacturing Practices, and HACCP systems. We encourage the agency to add a paragraph that clearly distinguishes what types of companies are covered within the “scope” of this guidance, informing the reader that it applies to processors, not to their customers such as wholesalers, distributors, retailers, or foodservice operators. It is particularly important that this be clear so that guidance about storage, transportation, product rotation, record-keeping, etc. are not mistakenly applied to businesses for which it is not intended.

We note that in the draft guidance, the agency calls for storage and other temperatures of ≤ 40 degrees F (≤ 4 degrees C). We encourage the agency to change that to ≤ 41 degrees F (≤ 5 degrees C) to be consistent with the agency’s 2005 Model Food Code.

Further, we note that storage temperatures, with few exceptions, relate to quality issues, not food safety issues. For those items identified as needing temperature control for safety (i.e. cut melons), the temperature recommendations are for safety. However, for other fresh-cut items, the industry uses such temperatures to maintain quality. Certainly, fresh-cut produce marketers throughout the supply chain strive to retain optimum quality by maintaining the cold chain. However, FDA’s advice for items other than fresh-cut melons may be interpreted, particularly by health inspectors, as a safety issue unless the agency clarifies that in the guidance.

PMA encourages all of its members, including those producing, processing, distributing, and retailing fresh-cut fruits and vegetables, to have robust, active, verifiable food safety programs. It is our members’ top priority, and guidance such as this from FDA will help them refine and enhance their existing systems. We concur with the agency’s emphasis on issues such as proper procedures, employee hygiene, water safety, and traceback.

We appreciate the opportunity to present these comments and commend the agency for its thorough review of this and other food safety issues. Please do not hesitate to call upon us if we can be of further assistance. We look forward to working with you.

Kathy Means, CAE

Vice President