Official word of the spinach outbreak broke with the FDA’s announcement, on September 14, 2006, that a number of E. coli O157:H7 illnesses across the country “may be associated with the consumption of produce.” “Preliminary epidemiological evidence suggests,” the statement continued, “that bagged fresh spinach may be a possible cause of this outbreak.” By the date of the announcement, fifty cases had been reported to the CDC, including eight cases of hemolytic uremic syndrome (HUS) and one death. States reporting illness included Connecticut, Idaho, Indiana, Michigan, New Mexico, Oregon, Utah, and Wisconsin.
The much-publicized outbreak grew substantially over the next several days. By September 15, the FDA had confirmed 94 cases of illness, including fourteen cases of HUS and, sadly, one death. Recognizing the lethality of the developing outbreak, the FDA’s September 15 release warned people should “not eat fresh spinach or fresh spinach containing products.”
Press Releases over the ensuing days announced steady growth in the number of people sickened, hospitalized, and with HUS as a result of the outbreak—109 cases from nineteen states by September 17, and 131 cases from twenty-one states just two days later. The latter statistic included 66 hospitalizations and twenty cases of HUS.
Meanwhile, the FDA and CDC, in conjunction with local and state health agencies from across the country, worked feverishly to figure out the brand names associated with illness. Early statistical analysis suggested that many brands were implicated, but the spinach sold under the several brand names had all come from the Natural Selection Foods processing center in San Juan Batista, California. Accordingly, Natural Selection recalled all of its spinach products with “use by” dates from August 17 to October 1, 2006. The recall, of course, included Dole brand spinach. But further data and study ultimately narrowed the possible sources of the outbreak down to one brand of packaged greens: Dole.
Though epidemiological evidence had already strongly linked Dole to the outbreak, the FDA found the proverbial “smoking gun” on September 20. The bag of Dole baby spinach had been purchased and consumed by an Albuquerque, New Mexico woman, and testing by the New Mexico State Health Department had confirmed that the product was contaminated with E. coli O157:H7 bearing the same genetic marker as the outbreak strain. The FDA announced the critical finding on September 21, 2006—also disclosing the “best by” date on the positive Dole bag of August 30—thereby giving a worried public a bit more information on what spinach products to eat, if any, and what to avoid.
By the date of the FDA’s September 21 announcement, the number of confirmed cases had swelled to 157 people from twenty-three states. Ultimately, the FDA confirmed 204 outbreak-related cases, with 102 hospitalizations, thirty-one cases of HUS, and three deaths, though the actual number of people affected by the outbreak was certainly much larger. In addition to the elderly Wisconsin resident, the FDA stated that the outbreak had claimed the lives of two-year-old Kyle Algood, from Chubbuck, Idaho, and also 81-year-old Ruby Trautz, from Bellevue, Nebraska.[1] The tragedy of this outbreak can hardly be overstated.
Epidemiological and laboratory evidence, which had already proved the link to Natural Selection and Dole, soon revealed that the contaminated spinach had been grown at Paicines Ranch in San Benito County, California. More specifically, investigators had traced the source of the contaminated spinach to one field on the ranch that had been leased by Mission Organics.
Once identified as the likely source for the outbreak, Mission Organics became host to health officials looking for the outbreak strain of E. coli O157:H7. State and federal investigators took hundreds of environmental samples and swabs from the vicinity of the implicated spinach field, which was fifty acres in size, including from a nearby cattle pasture and water source. Investigators also sampled the intestinal lining of feral pigs that had been killed as part of the investigation.[2] Samples from a variety of sources, including the pigs, the water, and cattle feces, tested positive for the same strain of E. coli O157:H7 that had now been isolated in over 205 people nationally. Finally, the outbreak strain of E. coli O157:H7 has been isolated in at least thirteen separate bags of Dole baby spinach. There were five deaths.
Once the investigation was completed, a final report on the outbreak was prepared by the California Food Emergency Response Team (CalFERT), a team comprised of members from the FDA and the California Department of Health Services.[3] The Final Report is replete with facts damning of all those involved in the growing, harvesting, processing, distribution, and sale of the implicated spinach products. For example, speaking of the NSF processing facility, it states:
During the production week from August 14-19, 2006, the NSF South facility had the highest weekly production volume of the month. Between August 13-20, 2006 production email exchanges revealed a string of personnel shortages, including nine absent employees on Sunday, August 13, the date of the weekly extended sanitation shift. Personnel records reveal that a number of absences were due to illness or illness in the family…NSF did not conduct ATP testing on a daily basis as required by the firm’s SOP. No ATP testing was conducted from August 15-25, 2006. One ATP test collected from a scale vibrator failed on August 10, 2006, and no retest was documented.[4]
The Final Report also faulted with NSF’s procedures for monitoring the quality of processing-water, its record-keeping, and its inability to demonstrate that harvesting bins were being washed to prevent cross-contamination.[5]
As for the Mission Organics growing operation, the findings were even more disturbing. The Final Report found that the land on the ranch where the spinach was grown “was primarily utilized for cattle grazing.” Moreover:
Investigators observed evidence of wild pigs in and around the cattle pastures as well as in the row crop growing regions of the ranch[6]….Potential environmental risk factors for E. coli O157:H7 contamination identified during this investigation included the presence of the wild pigs in and around spinach fields and the proximity of irrigation wells used for ready-to-eat produce to surface waterways exposed to feces from cattle and wildlife.[7]
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[1] Two more deaths are also related: Betty Howard and Ruth Dunning.
[2] Investigators had found tracks from feral pigs in the spinach field, as well as broken, run-down fences surrounding the field.
[3] See Investigation of an Escherichia coli O157:H7 Outbreak Associated with Dole Pre-Packaged Spinach, Final, March 21, 2007 (hereinafter “Final Report”).
[4] Final Report, supra note 56, at 44-45.
[5] Id. at 45.
[6] In a May 7, 2007 addendum to the CalFERT report, the presence of pigs and their possible role as a source of the E. coli O157:H7 was clarified as follows: “This sentence was not intended to indicate that wild pig tracks were observed in the implicated 50.9 lot (lot 1) on Paicines Ranch. Investigators observed wild pig tracks in fields and on dirt roads approximately 1 mile south of lot 1. Additionally, as described in the report, numerous wild pigs were observed on the Paicines Ranch.”
[7] Id. at 3-4; see also Final Report at 31-33, and 45-47.