E. coli O157:H7 outbreaks associated with lettuce or spinach, specifically the "pre-washed" and "ready-to-eat" varieties sold under various brand and trade names, are clearly by no means a new phenomenon. The FDA efforts to lead the lettuce industry to safer practices were nothing new. In 1998, the FDA issued guidance to the industry entitled "Guide to Minimize Microbial Food Safety Hazards for Fruits and Vegetables." The guide is specifically designed to assist growers and packers in the implementation of safer manufacturing practices. On February 5, 2004, the FDA wrote a letter to the lettuce and tomato industries to voice its concern about the frequent outbreaks linked to those products. In the letter, the FDA counted 14 such outbreaks since 1996 that it had investigated. Among other things, the letter stated:
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.
After an outbreak involving Dole lettuce, in November 2005, the FDA elucidated its past efforts and present concerns in its "Letter to California (should have added Arizona) Firms that Grow, Pack, Process, or Ship Fresh and Fresh-Cut Lettuce." The letter began:
This letter is intended to make you aware of the Food and Drug Administration’s (FDA’s) serious concern with the continuing outbreaks of food borne illness associated with the consumption of fresh and fresh-cut lettuce and other leafy greens.
The FDA went on to identify 18 outbreaks of E. coli O157:H7 associated with fresh or fresh-cut lettuce, resulting in 409 illnesses and two deaths since 1995. According to the FDA, completed trace back investigations in eight of the outbreaks “the 2005 Dole outbreak included” were traced to Salinas, California. The FDA further states that the industry’s role in preventing these illnesses is crucial because "these products are commonly consumed in their raw state without processing to reduce or eliminate pathogens."
The 2005 Dole outbreak prompted even more industry-admonition by the FDA: "In light of continuing outbreaks associated with fresh and fresh-cut lettuce and other leafy greens, particularly from California, we are issuing this second letter to reiterate our concerns and to strongly encourage firms in your industry to review their current operations." This November 2005 FDA letter explicitly rejected industry excuses for not having taken prior action. Further, the FDA cited to research linking some or all of the outbreaks to sewage exposure, animal waste, and other contaminated water sources. The research further indicated that industry practices, including irrigation and field drainage methods, might have led directly to the contamination of the lettuce with E. coli O157:H7. As a result the FDA stated that it considers "adulterated" any ready to eat crops that have come in contact with flood waters. The FDA closed by warning industry members that food produced under unsanitary conditions is adulterated under ß402 (a)(4) of the Food, Drug, and Cosmetic Act, and that enforcement actions would be considered.
And, then we had the massive Dole spinach E. coli case that sickened 205 and killed five in 2006. So, how far have we actually come? Since Dole 2006 there has been Taco Bell, Taco Johns, Aunt Mids and many others that never saw the light of an investigation (primarily due to a lack of funding by FDA and California).
