February 5, 2004
Note To: Firms that Grow, Pack or Ship Fresh Lettuce and Fresh Tomatoes
This letter is intended to make you aware of the Food and Drug Administration's (FDA's) concern regarding continuing outbreaks of foodborne illness associated with the consumption of fresh lettuce and fresh tomatoes, and actions we recommend that your industries take to enhance the safety of these products.
Since 1996, the Food and Drug Administration has responded to 14 outbreaks of foodborne illness for which fresh lettuce or fresh tomatoes were the confirmed or suspected vehicle. These outbreaks account for approximately 859 reported cases of illness. The lettuce and fresh tomatoes associated with these outbreaks were of U.S. and non-U.S. origin; the causative agents included Salmonella (fresh tomatoes), and E. coli O157:H7, Cyclospora, and Hepatitis A virus (lettuce).
Because fresh vegetables such as lettuce and tomatoes are commonly consumed in their raw state without processing to reduce or eliminate pathogens, the manner in which they are grown, harvested, sorted, packed, and distributed is crucial to ensuring that the potential for microbial contamination is minimized, thereby reducing the risk of illness to consumers.
In 1998, the FDA issued a "Guide to Minimize Microbial Food Safety Hazards for Fruits and Vegetables," which discusses recommended good agricultural practices (GAPs) and good manufacturing practices (GMPs) that growers, packers and shippers can undertake to address common risk factors in their operations and thereby, minimize food safety hazards potentially associated with fresh produce. We have worked in partnership with your industries in the U.S. and abroad since that time to promote our recommendations and to advance the scientific knowledge applicable to enhancing the safety of fresh fruits and vegetables.
In addition, in 2001, FDA made available a report prepared for the agency under contract by the Institute for Food Technologists, "Analysis and Evaluation of Preventive Control Measures for the Control and Reduction/Elimination of Microbial Hazards on Fresh and Fresh-Cut Produce". This report summarizes the current scientific research relating to the various methods of eliminating or reducing pathogens, while maintaining fresh attributes, on whole and fresh-cut produce.
In view of continuing outbreaks associated with fresh lettuce and fresh tomatoes, we strongly encourage firms in your industries to review their current operations in light of the agency's guidance for minimizing microbial food safety hazards in fresh lettuce and fresh tomatoes, as well as other available information regarding pathogen reduction or elimination on fresh produce. We further encourage these firms to consider modifying their operations accordingly, to ensure that they are taking the appropriate measures to provide a safe product to the consumer. Since the available information concerning some of the recent outbreaks does not definitively identify the point of origin of the contamination, we recommend that firms from the farm level through the distribution level undertake these steps.
The agency intends to monitor the safety of fresh produce, including fresh lettuce and fresh tomatoes, whether produced domestically or abroad, and to continue to encourage the use of good agricultural and good manufacturing practices. As you are aware, food produced under unsanitary conditions whereby it may be rendered injurious to health is adulterated under § 402(a)(4) of the Federal Food, Drug, and Cosmetic Act ((21 U.S.C. 342(a)(4)). FDA will consider enforcement actions against firms and farms that grow or pack fresh produce under such unsanitary conditions.
We recognize and appreciate the efforts that your industries have taken to date to provide fresh produce that is safe to U.S. consumers, and we are confident that you will continue to work proactively to pursue this goal.
Terry C. Troxell, Ph.D.
Director, Office of Plant and Dairy Foods
Center for Food Safety and Applied Nutrition