November 4, 2005

FDA Issues Letter To California Lettuce Industry

The FDA Center for Food Safety and Applied Nutrition has issued a letter to California firms that grow, pack, process or ship fresh and fresh-cut lettuce.

The letter is intended to make the industry aware of the FDA’s serious concern with the continuing outbreaks associated with the consumption of fresh and fresh-cut lettuce and other leafy greens. According to the letter, FDA is aware of 18 outbreaks of foodborne illness since 1995 caused by E. coli O157:H7, for which fresh or fresh-cut lettuce was implicated as the outbreak vehicle. In one additional case, fresh-cut spinach was implicated. These 19 outbreaks account for approximately 409 reported cases of illness and two deaths. Although tracebacks to growers were not completed in all 19 outbreak investigations, completed traceback investigations of eight of the outbreaks were associated with lettuce and spinach. In September 2005, a foodborne illness outbreak associated with lettuce began in Minnesota. FDA’s traceback investigation revealed that the source of the lettuce was Salinas, Calif.

In the letter, FDA stated “because these products are commonly consumed in their raw state without processing to reduce or eliminate pathogens, the manner in which they are grown, harvested, packed, processed and distributed is crucial to ensuring that microbial contamination is minimized, thereby reducing the risk of illness to consumers.”

This is not the first time FDA has issued such a letter. On Feb. 5, 2004, FDA issued a letter to the lettuce and tomato industries to make them aware of its concerns regarding continuing outbreaks associated with these two commodities and to encourage the industries to review their practices in light of FDA’s GAPs/GMPs guidance and other available guidance.

Consistent with the Action Plan, we strongly encourage your industry to immediately begin or intensify efforts such as, but not limited to, the following:

•Communication – actively participate in dialog with FDA, California Department of Health Services and the California Department of Food and Agriculture (CDFA), academia and other industry partners to ensure widespread, active participation and support of activities to address the issue of E. coli O157:H7 contamination of lettuce and leafy greens; develop an industry action plan with tangible measures of progress;

•Guidance – expedite completion of the industry-led lettuce and leafy green-specific supply chain guidance. (We recommend that this guidance include what to do if crops are flooded.);

•Outreach – promote implementation of the lettuce and leafy green supply chain guidance and other best practice recommendations;

•Research – establish a coalition to identify critical, risk-based research, including research to address environmental reservoirs for E. coli O157:H7; provide adequate support for such research to ensure it is conducted; and facilitate technology transfer of research findings.

Visit www.cfsan.fda.gov/~dms/prodltr2.html to read the whole text of the FDA’s letter.







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