FDA Issues Final Guidance For Safe Production

The Food and Drug Administration (FDA) today published a draft final guidance advising processors of fresh-cut produce how to minimize microbial food safety hazards common to the processing of most fresh-cut fruits and vegetables, which are often sold to consumers in a ready-to-eat form.

The document -- “Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables” (http://www.cfsan.fda.gov/~dms/prodgui3.html)-- suggests that fresh-cut processors consider a state-of-the-art food safety program such as the Hazard Analysis and Critical Control Points (HACCP) system, which is designed to prevent, eliminate, or reduce to acceptable levels the microbial, chemical, and physical hazards associated with food production.

The guidance complements FDA’s regulations of manufacturing practices and incorporates comments received in response to its draft issued in March 2006. The current version will not be final until the White House Office of Management and Budget completes an authorization step required by the Paperwork Reduction Act, and the agency announces that the guidance is final.

“Ensuring the safety of the American food supply is one of this Agency’s top priorities,” said Andrew C. von Eschenbach, MD, Commissioner of Food and Drugs. “ Americans are eating more fresh-cut produce, which we encourage as part of a healthy diet. But fresh cut-produce is one area in which we see foodborne illness occur. Offering clearer guidance to industry should aid in the reduction of health hazards that may be introduced or increased during the fresh-cut produce production process.”

Dr. von Eschenbach will testify before a hearing by the Agriculture, Rural Development, and Related Agencies Subcommittee of the Senate Committee on Appropriations, which will address the processes in place and improvements being made regarding food safety, specifically the safety of fresh produce and vegetables. The hearing will take place in Madison, Wisconsin, on March 12, 2007.

Processing produce into fresh-cut product increases the risk of bacterial contamination and growth by breaking the natural exterior barrier of the produce by peeling, slicing, coring, or trimming the produce with or without washing or other treatment before the produce is packaged for consumers. Examples of fresh-cut products are shredded lettuce, sliced tomatoes, salad mixes (raw vegetable salads), peeled baby carrots, broccoli florets, cauliflower florets, cut celery stalks, shredded cabbage, cut melons, sliced pineapple, and sectioned grapefruit.

Consumers can reduce their risk of illness from fresh-cut produce by following safe handling practices such as refrigerating the product after purchase; using only clean hands, utensils or dishes in preparing the product; and discarding the product when the “use by” date has expired.

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.

The Guide also 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. These practices include:

-Establishing a company policy that employees report any active case of illness to supervisors before beginning work and training;

-Training supervisors to recognize typical signs/symptoms of infectious disease; maintain the proper first aid to protect and cover any wound; and not allow an employee to work with any aspect of fresh or fresh-cut produce, processing equipment or tools until the wound has healed and/or the infectious disease has been treated.

FDA believes awareness of the common risk factors discussed in this guidance and implementation of preventive controls determined by a firm to be appropriate to its individual operations will enhance the safety of fresh-cut fruits and vegetables. More information on safe handling practices of produce can be found at http://www.fightbac.org/.

Written comments on the Guide are acceptable at any time and should be sent to FDA’s Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Comments on the Guide-specific to issues involving the Paperwork Reduction Act should be faxed within 30 days of the publishing date of the Federal Register notice to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-6974.

The Guide is accessible on the FDA Website at: http://www.cfsan.fda.gov/guidance.html

Additional Information about the Guidance:
Fact Sheet: “Fresh-Cut Fruits and Vegetables Draft Final Guidance” (http://www.fda.gov/oc/factsheets/foodsafety2007.html)

Federal Register Notice (Pre-Publication Display) [PDF, 600 KB](http://www.fda.gov/OHRMS/DOCKETS/98fr/06d-0079-nad0002.pdf)

Dr. von Eschenbach’s Statement before the Agriculture, Rural Development, and Related Agencies Subcommittee of the Senate Committee on Appropriations (http://www.fda.gov/ola/2007/foodsafety31207.html)

Relevant Food Safety Information:

“How the FDA Works to Keep Produce Safe” (http://www.fda.gov/fdac/features/2007/207_foodsafety.html)

www.foodsafety.gov

Alert: Food Defense Awareness Program (http://www.cfsan.fda.gov/~dms/alerttoc.html)