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 by no means a new phenomenon.
In October 2003, 13 residents of a California retirement center were sickened and 2 died after eating E. coli-contaminated “pre-washed” spinach.
In September 2003, nearly 40 patrons of a California restaurant chain became ill after eating salads prepared with bagged, “pre-washed” lettuce.
In July 2002, over 50 young women were stricken with E. coli at a dance camp after eating “pre-washed” lettuce, leaving several hospitalized, and 1 with life-long kidney damage.
The Center for Science in the Public Interest found that of 225 food-poisoning outbreaks from 1990 to 1998, nearly 20 percent (55 outbreaks) were linked to fresh fruits, vegetables or salads.

An example of additional outbreaks follows:

Aug. 1993 Salad bar E. coli O157:H7531 Washington
July 1995 Lettuce (leafy green, red, romaine )E. coli O157:H7701 Montana
Sept. 1995 Lettuce (romaine) E. coli O157:H7201 Idaho
Sept. 1995 Lettuce (iceberg) E. coli O157:H7301 Maine
Oct. 1995 Lettuce (iceberg; unconfirmed) E. coli O157:H7111 Ohio
May-June 1996 Lettuce (mesclun; red leaf) E. coli O157:H7613 Connecticut, Illinois, New York
May 1998 Salad E. coli O157:H721 California
Feb.-Mar. 1999 Lettuce (iceberg) E. coli O157:H7721 Nebraska
July-Aug. 2002 Lettuce (romaine) E. coli O157:H7292 Washington, Idaho
Oct 2003-May 2004 Lettuce (mixed salad) E. coli O157:H7571 California
Apr. 2004 Spinach E. coli O157:H7161 California

It is clear that the risks associated with E. coli O157:H7 and lettuce were well known to Dole and the industry prior to the 2005 outbreak. For some time prior to the outbreak, the FDA had been aggressively trying to get the industry to address serious ongoing deficiencies it saw as creating a serious risk to consumers. Apparently, Dole, and the others in the industry did not respond adequately prior to the 2005 outbreak.
In November, 2005, the FDA elucidated its past efforts and present concerns in its “Letter to California Firms that Grow, Pack, Process, or Ship Fresh and Fresh-Cut Lettuce.” The letter begins:

This letter is intended to make you aware of the Food and Drug Administration’s (FDA’s) serious concern with the continuing outbreaks of foodborne illness associated with the consumption of fresh and fresh-cut lettuce and other leafy greens.

The FDA goes 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 traceback investigations in 8 of the outbreaks including the 2005 Dole outbreak 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 FDA efforts to lead the lettuce industry to safer practices were nothing new. In 1998, the FDA issued guidance to industry entitled “Guide to Minimize Microbial Food Safety Hazards for Fruits and Vegetables.” The guide manufacturing practices for growers, packers, and shippers. The FDA subsequently issued a letter to the lettuce and tomato industries on February 5, 2004 to “make them aware of [FDA’s] concerns regarding continuing outbreaks associated with these two commodities and to encourage the industries to review their practices.”
The 2005 Dole outbreak prompted more admonition for the industry from FDA: “In light of continuing outbreaks associated with fresh and fresh-cut lettuce and other leafy greens, particularly form California, we are issuing this second letter to reiterate our concerns and to strongly encourage firms in your industry to review their current operations.”
The 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 exposure to sewage, animal waste, and other contaminated water sources. The research further indicated that industry practices, including irrigation and field drainage methods, may have led directly to the contamination of the lettuce with E. coli O157:H7. As a result the FDA stated that it considers any ready to eat crops that have come in contact with flood waters to be adulterated. The FDA closed by warning industry members that food produced under insanitary conditions is adulterated under 402(a)(4) of the Food, Drug, and Cosmetic Act, and that enforcement actions would be considered.