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Publisher’s Platform: Will the Justice Department look at Dole’s history of recalls and outbreaks?

Opinion

dole-lettuce-recall

In a press release last week Dole announced that it had “recently been contacted by the Department of Justice in connection with its own investigation, and we will be similarly cooperating with the DOJ to answer questions and address any concerns.”  Dole’s announcement and the Justice Department’s investigation stems from a Listeria outbreak that sickened 19 in the U.S. and 14 in Canada and may have contributed to four deaths.

How much, if any, will the Justice Department pay attention to Dole’s recall and outbreak history?

Recalls:

October 13, 2015 (Salmonella) – Dole Fresh Vegetables recalled a limited number of cases of bagged salad. The products recalled were Dole Spinach coded A27409B & A27409A, with an Enjoy-By date of October 15 and UPC 7143000976 due to a possible health risk from Salmonella. The salads were distributed in 13 U.S. states: Connecticut, Indiana, Kentucky, Maryland, Massachusetts, Michigan, Missouri, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Wisconsin. The recall notification was issued because a sample of Dole Spinach salad yielded a positive result for Salmonella in a random sample test conducted by the Michigan Department of Agriculture & Rural Development’s Laboratory Division.

March 13, 2014 (Listeria) – Dole Fresh Vegetables recalled a limited number of cases of bagged salad. The products recalled were Dole Italian Blend (UPC 7143000819), Fresh Selections Italian Style Blend (UPC 1111091045), Little Salad Bar Italian Salad (UPC 4149811014) and Marketside Italian Style Salad (UPC 8113102780) coded A058201A or B, with Use-by date of March 12, 2014, because of a possible health risk from Listeria monocytogenes. The salads were distributed in 15 U.S. states: Connecticut, Florida, Illinois, Indiana, Kentucky, Maryland, Massachusetts, Michigan, New Jersey, New York, North Carolina, Ohio, Pennsylvania, South Carolina, Virginia; and three Canadian provinces: New Brunswick, Ontario, Quebec. The recall notification was issued because one sample of Dole Italian salad yielded a positive result for Listeria monocytogenes in a random sample test conducted by the Canadian Food Inspection Agency.

August 22, 2012 (Listeria) – Dole Fresh Vegetables recalled 1,039 cases of bagged salad. The products recalled were 10 oz. Dole Italian Blend coded 0049N2202008, with a Use-By date of August 20 and UPC 7143000819 because of a possible health risk from Listeria monocytogenes.  The salads were distributed in eight U.S. states: Florida, Alabama, North Carolina, South Carolina, Pennsylvania, Maryland, Mississippi, Virginia.  The recall notification was issued because a sample of Dole Italian Blend salad yielded a positive result for Listeria monocytogenes in a random sample test conducted by the North Carolina Department of Agriculture.

June 22, 2012 (Listeria) – Dole Fresh Vegetables recalled 1,077 cases of bagged salads. The products recalled were Kroger Fresh Selections Greener Supreme coded N158 211B 1613 KR04 with Use-by date of June 19 and UPC 11110 91039, Kroger Fresh Selections Leafy Romaine coded N158 111B KR11 with Use-by date of June 19 and UPC 11110 91046 and WalMart Marketside Leafy Romaine coded N158111B with Use-by date of June 19 and UPC code 81131 02781 due to a possible health risk from Listeria monocytogenes. The salads were distributed in six U.S. states: Georgia, Kentucky, North Carolina, South Carolina, Tennessee, Virginia. The recall notification was issued because a sample of Marketside Leafy Romaine salad yielded a positive result for Listeria monocytogenes in a random sample test conducted by the State of North Carolina.

April 14, 2012 (Salmonella) – Dole Fresh Vegetables recalled 756 cases of Dole Seven Lettuces salad with Use-by Date of April 11, 2012, UPC code 71430 01057 and Product Codes 0577N089112A and 0577N089112B, due to a possible health risk from Salmonella. The salads were distributed in fifteen U.S. states: Alabama, Florida, Illinois, Indiana, Maryland, Massachusetts, Michigan, Mississippi, New York, North Carolina, Ohio, Pennsylvania, Tennessee, Virginia, Wisconsin. The recall notification was issued because a sample of Seven Lettuces salad yielded a positive result for Salmonella in a random sample test collected and conducted by the State of New York.

Sept. 17, 2007 (E. coli) – Dole Fresh Vegetables recalled all salad bearing the label “Dole Hearts Delight” sold in the U.S. and Canada with a “best if used by (BIUB)” date of Sept. 19, 2007, and a production code of “A24924A” or “A24924B” stamped on the package. The salad was sold in plastic bags of 227 grams in Canada and one-half pound in the U.S., with UPC code 071430-01038.The recall occurred because a sample in a grocery store in Canada was found through random screening to contain E. coli O157:H7.

Outbreaks and recalls:

2006 spinach E. coli outbreak – 205 sick with five deaths: Official word of the spinach outbreak broke with an announcement, on Sept. 14, 2006, by the Food and Drug Administration 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, 50 cases of E. coli infection had been reported to the Centers for Disease Control and Prevention, 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 Sept. 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 Sept. 15 release warned people should “not eat fresh spinach or fresh spinach containing products.”

News releases during 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 19 states by Sept. 17, and 131 cases from 21 states just two days later. The latter statistic included 66 hospitalizations and 20 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, CA. Accordingly, Natural Selection recalled all of its spinach products with “use by” dates from Aug. 17 to Oct. 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 Sept. 20. The bag of Dole baby spinach had been purchased and consumed by an Albuquerque, NM, woman. Testing by the New Mexico State Health Department confirmed 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 Sept. 21, 2006 — also disclosing the “best by” date on the positive Dole bag of Aug. 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 Sept. 21 announcement, the number of confirmed cases had swelled to 157 people across 23 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 an elderly Wisconsin resident, the FDA reported the outbreak claimed the lives of 2-year-old Kyle Algood from Chubbuck, ID, and 81-year-old Ruby Trautz from Bellevue, NE. 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, CA. More specifically, investigators  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 50 acres in size, including samples 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. 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 more than 205 people nationally. The outbreak strain of E. coli O157:H7 was also isolated in at least 13 separate bags of Dole baby spinach. There were five deaths, according to the final numbers from CDC.

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. The CalFERT 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.”

The CalFERT Report also faulted 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.

As for the Mission Organics growing operation, the findings were even more disturbing. The CalFERT 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. …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.”

2005 lettuce E. coli 0utbreak – 32 sick: On Sept. 22, 2005, the Minnesota Department of Health (MDH) Public Health Laboratory (PHL) received an E. coli O157:H7 isolate for confirmatory testing and Pulse Field Gel Electrophoresis (PFGE) subtyping. PFGE results were reported on Sept. 26 and uploaded to PulseNet, a national database of PFGE patterns or “fingerprints” maintained at the federal Centers for Disease Control and Prevention (CDC).

The pattern derived from digestion with the restriction endonuclease Xba I was assigned Pattern number EXHX01.0238. The isolate was soon tested with a second enzyme, Bln I, and the resulting pattern was assigned pattern number EXHA26.1040. Prior to Sept. 19, the Bln I pattern had not been posted on PulseNet.

Isolates obtained from cultures of stool submitted by two new ill patients were received at the MDH PHL on Sept. 23, 2005 and subtyped. PFGE results showed that the two new isolates and the isolate received on Sept. 22 were indistinguishable by two enzymes. By Sept. 29, 2005, isolates obtained from seven more patients arrived at the MDH PHL for further analysis. Public health investigators recognized that an E. coli O157:H7 outbreak was underway in Minnesota.

While additional laboratory testing was performed, MDH epidemiologists conducted preliminary interviews with patients who were already laboratory confirmed with E. coli O157:H7.

By the morning of Sept. 28, investigators had identified pre-packaged lettuce produced by Dole Food Co. Inc. as the likely vehicle of transmission for the E. coli O157:H7. A supplemental questionnaire focusing on the type and brand of lettuce consumed and where it was purchased was developed and administered to case-patients previously interviewed and newly identified ones.

On Sept. 29 Minnesota Department of Agriculture (MDA) staff collected a bag of Dole lettuce at the home of a case patient and began microbiologic testing for the presence of E. coli O157:H7.

On Sept. 30 the MDH issued a news release advising the public that 11 cases of E. coli O157:H7 had been identified in Minnesota residents who had eaten Dole lettuce purchased from at least four different stores in the Twin Cities area. People with symptoms of E. coli were told to contact the MDH and their physicians. Dr. Chris Braden at the Foodborne and Diarrheal Disease Branch at the CDC announced that no other states were reporting outbreak associated cases.

Meanwhile, MDA microbiologists continued to process lettuce specimens obtained from households with cases of confirmed E. coli O157:H7. On Monday, Oct. 3, the agency reported that sample number M-05-2310, Lot Number B250215B received on Sept. 30 had tested positive for E. coli O157:H7. The isolate obtained from the sample was sent to the MDH for PFGE analysis. The resulting pattern was indistinguishable to the pattern identified in case-patients. A second specimen, M-05-2318, lot number unavailable, would also yield positive results.

News of the positive lettuce specimen prompted the FDA to issue a nationwide health alert regarding Dole pre-packaged salads on Oct. 2. The FDA announcement reiterated warnings expressed in the MDH press release and further described the Dole products associated with illness, Classic Romaine, American Blend and Greener Selection. Although cases had only been identified in Minnesota, the product was noted to have been distributed nationwide.

It would not be long before cases of E. coli O157:H7 in Wisconsin and Oregon would be identified. The Wisconsin case was a 12-year-old female with E. coli O157:H7 who had a history of eating Dole pre-packaged lettuce. PFGE subtyping showed that her isolate was indistinguishable to the EXHX01.0238 pattern and one band different on the second enzyme pattern. Despite the one band difference, MDH molecular epidemiologists considered the girl to be part of the outbreak concluding that the difference was not enough to preclude the case from being considered outbreak related.

The Oregon case was indisputably associated with consumption of Dole pre-packaged salad mix. A 60-year-old Portland resident was hospitalized and laboratory confirmed with E. coli O157:H7 on Sept. 21, 2005. The patient had experienced onset of symptoms on Sept. 18, four days after purchasing and consuming Dole brand “Classic Romaine” salad mix. Michael Roberson, representative for Albertsons’, the grocery store of purchase, confirmed that the chain’s Portland area distributing center had received Dole Greener Selection and Dole Classic Romaine. A portion of the salad mix was still in the patient’s refrigerator. A photograph taken of the packaging documents that the patient purchased Dole salad mix with a “Best if Used By” date of 9/23/05, lot number was B250215B. PFGE subtyping showed that the Oregon isolate was indistinguishable by two enzymes to other ill Dole lettuce consumers in Minnesota.

Aware of the potential severity of an E. coli O157:H7 outbreak, the FDA and the Food and Drug Branch at the California Department of Health Services initiated an investigation at a Dole processing plant. Preliminary information indicated that 22,321 cases of Dole pre-packaged lettuce with a “Best If Used By” date of 9/23/05 and a production code starting with “B250” were shipped from a single Dole processing facility in central California to 34 states in early September. Investigators estimated that since each case contained between six and 12 bags, approximately 244,866 bags of lettuce had made it to market.

On Oct. 11, 2005, the MDH counted 23 laboratory confirmed cases of E. coli O157:H7 and seven epidemiologically linked cases. Illness onset dates ranged from Sept. 16 to Sept. 30. Two cases had developed Hemolytic Uremic Syndrome (HUS).

Oregon and Wisconsin reported one case each. Case control study data show a statistically significant association between illness and consuming Dole pre-packaged lettuce with a matched odds ratio of 6.8, 95% confidence interval, 1.4-31.9, and a p-value of 0.01. The California Department of Health Services continues to conduct a trace back investigation to farms implicated in earlier lettuce outbreaks. A final outbreak report and traceback summary has not been provided.  Eventually, a total of 32 people from three states would be linked to the E. coli O157:H7 outbreak.

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