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March 2016

dole_manufacturing_code1The CDC reported Eighteen people infected with the outbreak strain of Listeria have been reported from nine states since July 5, 2015. The number of ill people reported from each state is as follows: Connecticut (1), Indiana (1), Massachusetts (1), Michigan (4), Missouri (2), New Jersey (1), New York (5), Ohio (2), and Pennsylvania (1). Whole genome sequencing has been performed on clinical isolates from all ill people and has shown that the isolates are highly related genetically.Listeria specimens were collected from ill people between July 5, 2015 and January 31, 2016. Ill people range in age from 3 years to 83, and the median age is 66. Seventy-two percent of ill people are female. All 18 (100%) ill people were hospitalized, including one person from Michigan who died as a result of listeriosis. One of the illnesses reported was in a pregnant woman.

In Canada, there were 14 cases of Listeria monocytogenes in five provinces related to this outbreak: Ontario (9), Quebec (2), New Brunswick (1), Prince Edward Island (1), and Newfoundland and Labrador (1). Individuals became sick between May 2015 and February 2016. The majority of Canadians cases (64%) are female, with an average age of 78 years. All cases have been hospitalized, and three people have died, however it has not been determined if Listeria contributed to the cause of these deaths.

Epidemiologic and laboratory evidence indicate that packaged salads produced at the Dole processing facility in Springfield, Ohio and sold under various brand names are the likely source of this outbreak. Although the investigation began in September 2015, the source of these illnesses wasn’t known until January 2016 when a laboratory result from a packaged salad collected in Ohio linked the illnesses to the Dole processing facility in Springfield, Ohio. On January 27, 2016, Dole recalled all salad mixes produced in the Springfield, Ohio processing facility.

oak-leaf-dairy-farmThe Connecticut State Department of Public Health (DPH) today issued the following update on the E. coli outbreak linked to the Oak Leaf Farm in Lebanon, CT:

As of 1:00 p.m. today, DPH is investigating 15 confirmed cases of E. coli O157 infection.  The number of cases could increase in the near future as DPH is actively identifying individuals who were not initially reported.

So far, investigators have been able to link 14 of these cases to Oak Leaf Farm.  The patients range in age from 1-44 years old, with a median age of six.  In total, five patients have been hospitalized with three still in the hospital.  Two of the hospitalized patients have been diagnosed with Hemolytic Uremic Syndrome (HUS), as first reported last week.

Yesterday, the Centers for Disease Control and Prevention (CDC) dispatched a team to Connecticut to assist in the investigation of this outbreak.  Today, officials from DPH, the Connecticut Department of Agriculture, the Uncas Health District, and the CDC team are at the Oak Leaf Farm conducting an onsite investigation.  The Farm remains voluntarily closed to the public, and the owners are cooperating with the investigation.

The outbreak was first identified on Thursday, March 24th when six of seven individuals sickened with E. coli were confirmed by DPH to have recently visited Oak Leaf Farm and come into contact with goats on the farm.  Two of the seven initial patients had subsequently developed Hemolytic Uremic Syndrome (HUS), a rare but serious illness that affects the kidneys and blood clotting system. As of today, both of those patients continue to be hospitalized.

Unclear at this point if people should have been reading www.fair-safety.com or www.realrawmilkfacts.com – or both.

OakLeafDairyLogo1-300x77The Connecticut Department of Public Health (DPH) announced that it is investigating an outbreak of seven confirmed cases of E. coli and two cases of Hemolytic Uremic Syndrome (HUS).  Patients sickened in this outbreak range in age from 2 to 25.  DPH has confirmed at this point that six of the seven patients recently visited the Oak Leaf Dairy Farm, a goat farm in Lebanon, CT. As a precaution, Oak Leaf Farm is currently not permitting the public to visit the animals.

“Earlier today, DPH was informed of several patients from Southeastern Connecticut who have become ill with E. coli,” said DPH Commissioner Raul Pino.  “We are closely monitoring the situation and working with our partners at the CDC and other relevant stakeholders. We will continue to work diligently to provide the public with the information it needs as we investigate.”

E. coli is a bacterium that is found in animal and human feces and in foods.  The particular strain a bacteria found in this outbreak is E. coli O157. Typical symptoms can include abdominal cramping, watery diarrhea, frequently bloody, vomiting, and a low-grade fever. Symptoms usually resolve over several days.  The best way to prevent the spread of infection is to wash your hands thoroughly after contact with animals and after going to the bathroom and by thoroughly cooking meats and washing fruits and vegetables.  E. coli can easily spread, especially among household members, if proper hand-washing is not consistently used.

“We strongly encourage anyone who visited the farm in March and developed symptoms of this illness to contact their physician,” added Dr. Pino.

Hemolytic Uremic Syndrome (HUS) is a rare but serious illness that affects the kidneys and blood clotting system.  It can develop in some patients who have been sickened with E. coli.  It is more common in children than in adults and may be mild or severe. In severe cases, kidney function is greatly reduced, and dialysis may be necessary.

big-map-3-21-16As of March 21 2016, 27 people infected with the outbreak strain of Salmonella Virchow have been reported from 20 states. A list of states and the number of cases in each can be found on the Case Count Map page.

Among people for whom information is available, illnesses started on dates ranging from December 5, 2015 to March 13, 2016. Ill people range in age from less than 1 year to 84, with a median age of 35. Fifty-six percent of ill people are female. Among 19 ill people with available information, 5 (26%) reported being hospitalized, and no deaths have been reported.

Illnesses that occurred after February 28, 2016 might not be reported yet. This takes an average of 2 to 4 weeks. Please see the Timeline for Reporting Cases of Salmonella Infection for more details. The recalled products have a long shelf life and may still be in people’s homes, and illnesses may continue to be reported.

Epidemiologic and laboratory evidence indicates that RAW Meal Organic Shake & Meal products made by Garden of Life, LLC are the likely source of this outbreak.

As a result of this investigation, Garden of Life, LLC voluntarily recalled several lots of RAW Meal Organic Shake & Meal products, available in chocolate, original, vanilla, and vanilla chai, on January 29, 2016 (initial recall) and February 12, 2016 (expanded recall).

cucumberA total of 907 people infected with the outbreak strains of Salmonella Poona were reported from 40 states. A list of states and the number of cases in each can be found on the Case Count Map page.

Among people for whom information was available, illnesses started on dates ranging from July 3, 2015 to February 29, 2016. Ill people ranged in age from less than 1 year to 99, with a median age of 18. Forty-nine percent of ill people were children younger than 18 years. Fifty-six percent of ill people were female. Among 720 people with available information, 204 (28%) were hospitalized. Six deaths were reported from Arizona (1), California (3), Oklahoma (1), and Texas (1).

Epidemiologic, laboratory, and traceback investigations identified imported cucumbers from Mexico and distributed by Andrew & Williamson Fresh Produce as the likely source of the infections in this outbreak.

Several state health and agriculture departments collected and tested cucumbers from retail locations and isolated the outbreak strains of Salmonella Poona. Information indicated that these cucumbers were distributed by Andrew & Williamson Fresh Produce. Additionally, testing of cucumbers collected from the Andrew & Williamson Fresh Produce facility isolated the outbreak strains of Salmonella Poona.

Traceback information collected from the 11 illness clusters indicated that cucumbers eaten by ill people were imported from Mexico and distributed by Andrew & Williamson Fresh Produce.

Two recalls of garden variety cucumbers distributed by Andrew & Williamson Fresh Produce were announced because the cucumbers were likely contaminated with Salmonella. Recalled cucumbers were grown in Baja California, Mexico and distributed to many U.S. states. On September 4, 2015, Andrew & Williamson Fresh Produce voluntarily recalled all cucumbers sold under the Limited Edition brand label from August 1, 2015 through September 3, 2015. On September 11, 2015, Custom Produce Sales voluntarily recalled all cucumbers sold under the Fat Boy brand label starting August 1, 2015. These cucumbers were sent to Custom Produce Sales from Andrew & Williamson Fresh Produce.

dairy-milk-cream-butterCollaborative investigative efforts of state, local, and federal public health and regulatory officials indicate that raw milk produced by Miller’s Organic Farm in Bird-In-Hand, Pennsylvania is the likely source of this outbreak. Raw milk is milk from cows or other animals that has not been pasteurized to kill harmful bacteria. This raw, unpasteurized milk can carry dangerous bacteria such as Listeria, Salmonella, E. coli, and Campylobacter, which are responsible for causing numerous foodborne illnesses and outbreaks.

In November 2015, samples of raw chocolate milk were collected from a raw milk conference held in Anaheim, California. The raw chocolate milk was produced by Miller’s Organic Farm. The U.S. Food and Drug Administration (FDA) isolated Listeria from the raw chocolate milk and conducted WGS testing on the isolate to get more genetic information about the bacteria. On January 29, 2016, FDA informed CDC that WGS determined that the Listeria bacteria from the raw chocolate milk was closely related genetically to Listeria bacteria from two people in two states who got sick in 2014, one from California and one from Florida.

The age of ill people from California and Florida ranged from 73 to 81 years. Both ill people were hospitalized, and the ill person from Florida died as a result of listeriosis.

Once the two illnesses were identified in late January, public health officials worked over several weeks to interview them or their family members about the foods they may have eaten and other exposures in the month before their illness started. Interviews were conducted with the ill person from California and family members for both ill people. It was reported that both ill people drank raw milk before they got sick. The family of the deceased person in Florida reported purchasing raw milk from Miller’s Organic Farm.

Raw milk and raw dairy products can pose severe health risks, including death, especially for people at higher risk for foodborne illness, including children younger than 5, pregnant women, adults 65 and older, and people with weakened immune systems. We recommend that people drink and eat only pasteurized dairy products. Learn more about the dangers of drinking raw milk at the CDC Food Safety and Raw Milk website.

10298684_10152794480259144_870828925358065408_n.0.0The outbreak started in December, mainly among people who had eaten at the Iowa-based chain’s restaurants.The CDC reports that 13 people were sickened in Illinois, Iowa, Kansas, Minnesota, North Carolina, Nebraska, New Jersey, South Dakota and Wisconsin. Nine of the people recently had eaten at Pizza Ranches.  Two children, in Kansas and Nebraska, suffered kidney failure (hemolytic uremic syndrome – HUS).

The investigation has focused on a dry dough mix used to make desserts.

small-map-03-07-16CDC is collaborating with public health officials in multiple states and the U.S. Food and Drug Administration (FDA) to investigate a multistate outbreak of Salmonella Montevideo infections.

A total of 11 people infected with the outbreak strain of Salmonella Montevideo have been reported from 9 states. A list of states and the number of cases in each can be found on the Case Count Map page. States reporting illnesses are: Alabama 1, Arizona 2, Connecticut 1, Georgia 1, Michigan 1, Minnesota 1, North Dakota 1, Virginia 1, Washington 2.

Illnesses started on dates ranging from December 12, 2015 to February 9, 2016. Ill people range in age from 9 years to 69, with a median age of 31. Seventy-three percent of ill people are male. Among 9 ill people with available information, 2 reported being hospitalized, and no deaths have been reported.

Collaborative investigative efforts of state, local, and federal public health and regulatory officials indicate that pistachios produced by Wonderful Pistachios of Lost Hills, California are a likely source of this outbreak.

Recent laboratory testing isolated the outbreak strain of Salmonella Montevideo from samples of raw pistachios collected from Paramount Farms, where Wonderful pistachios are grown.

On March 9, 2016, Wonderful Pistachios voluntarily recalled a limited number of flavors and sizes of in-shell and shelled pistachios because they may be contaminated with Salmonella. The pistachios were sold under the brand names Wonderful, Paramount Farms, and Trader Joe’s and were sold nationwide and in Canada.

According to a CDC report in 2004, Paramount Farms was linked to a previous Salmonella outbreak tied to raw almonds that sickened at least 29.  On May 12, 2004, the Oregon State Public Health Laboratory identified a cluster of five patients infected with Salmonella enterica serotype Enteritidis.  The five patients were from four Oregon counties; their onsets of illness occurred during February-April 2004. A subsequent investigation identified a total of 29 patients in 12 states and Canada since at least September 2003. Seven patients were hospitalized.

On May 18, 2004 Paramount announced a recall of all raw almonds sold under the Kirkland Signature, Trader Joe’s, and Sunkist labels. Costco mailed 1,107,552 letters to members known to have purchased the recalled product in the United States. The recall was expanded on May 22, 2004 to include nuts sold in bulk to approximately 50 other commercial customers, some of whom repackaged almonds for sale under other brand names. In addition to sales in the United States, almonds were exported to France, Italy, Japan, Korea, Malaysia, Mexico, Taiwan, the United Kingdom.  13,000,000 pounds of almonds were recalled.

Michael_R._Taylor_01Here is the FDA Press Release:  The U.S. Food and Drug Administration’s Deputy Commissioner for Foods and Veterinary Medicine Michael Taylor announced today that he is leaving the agency on June 1, 2016. As part of a succession plan that ensures both continuity in the program and strong new leadership for the future, Dr. Stephen Ostroff will become the second Deputy Commissioner for Foods and Veterinary Medicine upon Mr. Taylor’s departure. Dr. Ostroff led the FDA as acting commissioner until the recent confirmation of Dr. Robert Califf as FDA commissioner.

Mr. Taylor joined FDA in July 2009 and was named to this position in 2010. Since that time, he has led the implementation of the FDA Food Safety Modernization Act, the most sweeping food safety reform in more than 70 years, and guided nutrition-related initiatives to reduce the risk factors for chronic disease and other adverse diet-related outcomes. He has overseen the move to eliminate the use of certain antibiotics that can contribute to the development of antimicrobial-resistant bacteria. Understanding the importance of dialogue, partnership, and active stakeholder engagement in effecting change, Mr. Taylor has sought to ensure everyone had a place at the table in designing rules and taking actions to protect Americans and contribute to a safer, more wholesome food supply.

A nationally recognized food safety expert, Mr. Taylor has served in numerous high-level positions at FDA, as a research professor in the academic community, and on several National Academy of Sciences expert committees studying food-related issues. He also served as administrator of USDA’s Food Safety and Inspection Service (FSIS) and acting under secretary for food safety at USDA, where he spearheaded public health-oriented reform of FSIS, guided the development of new safety requirements for meat and poultry products, and addressed the hazard associated with E. coli O157:H7 in beef products.

Mr. Taylor plans to continue working on in the food safety arena, focusing on those settings where people lack regular access to sufficient, nutritious and safe food.

Prior to serving as acting FDA commissioner, Dr. Ostroff was named the agency’s chief scientist in 2014, and was responsible for leading and coordinating FDA’s cross-cutting scientific and public health efforts. Dr. Ostroff joined FDA in 2013 as chief medical officer in the Center for Food Safety and Applied Nutrition and senior public health advisor to Mr. Taylor. Prior to that, he served as deputy director of the National Center for Infectious Diseases at the Centers for Disease Control and Prevention (CDC), and as Director of the Bureau of Epidemiology and Acting Physician General at the Pennsylvania Department of Health. He is a graduate of the University of Pennsylvania of Medicine and completed residencies in internal medicine at the University of Colorado Health Sciences Center and in preventive medicine at CDC.

Dr. Ostroff’s expertise in public health and knowledge of food safety, nutrition and veterinary medicine programs will ensure a smooth and seamless transition. Between now and June 1, Mr. Taylor and Dr. Ostroff will work closely together, with FDA Commissioner Califf’s strong support, to manage a transition that sustains the program’s momentum on the many challenges and opportunities that lie ahead for FDA.

dole_manufacturing_codeOhio resident Constance Georgostathis has filed suit against Dole Fresh Vegetables, Inc., after a salad mix tainted with Listeria placed her mother, Kiki Christofield, in a coma. Ms. Georgostathis is seeking damages caused by her mother’s subsequent illness and current condition.  The case number is 1:16-cv-00360-TSB.

In late January, 2016, Ms. Georgostathis bought a Dole salad mix from a Kroger in Ohio. Days later, her mother, Kiki Christofield, ate some of the salad from the package. The product was later found to be contaminated with the same strain of Listeria found in the recent Listeria outbreak linked to Dole salad products from the Springfield, Ohio processing plant.

On January 23, Kiki Christofield began to feel unwell, and by the 26th of January, she was experiencing extreme head and neck pain, confusion and an altered mental state. The next morning, Mrs. Christofield was taken by ambulance to Bethesda North Hospital in the Cincinnati area. She was treated with morphine for the pain, but discharged soon after.

Her condition worsened over the next several days. On January 31st she was again taken to Bethesda North Hospital. Before the day ended, Kiki Christofield was in a coma, from which she has yet to awaken. She remains hospitalized at Bethesda North Hospital.

The Listeria outbreak from Dole’s Springfield, Ohio plant has been identified as starting July 5, 2015. On January 27, 2016, Dole issued a voluntary recall of all salad mixes produced at the Springfield plant. These salad mixes are packaged in bags and clamshell plastic containers and can be identified by the letter “A” at the beginning of the manufacturer’s code on the package.

Thus far, 18 people in the United States and 11 in Canada have been identified as contracting Listeria from this outbreak, including one pregnant woman in Michigan. Every patient identified has been hospitalized, and 4 have died. 72% of US cases and 55% of Canadian cases are female. Every age group has been affected: in the United States, victims range in age from 3 to 83 years old.

Prior Dole Outbreaks Linked to Lettuce and Other Leafy Greens

October 13, 2015 – Dole Fresh Vegetables voluntarily recalled a limited number of cases of bagged salad. The product recalled was Dole Spinach coded A27409B & A27409A, with an Enjoy By date of October 15 and UPC 7143000976 due to a possible health risk from Salmonella. No illnesses had been reported in association with the recall. The product code and Enjoy By date are in the upper right-hand corner of the package; the UPC code is on the back of the package, below the barcode. The salads were distributed in 13 U.S. states (Connecticut, Indiana, Kentucky, Maryland, Massachusetts, Michigan, Missouri, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Wisconsin). This precautionary recall notification is being issued due to an isolated instance in which 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; Laboratory Division.

March 13, 2014 – Dole Fresh Vegetables voluntarily recalled a limited number of cases of bagged salad. The products being recalled are 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 due to a possible health risk from Listeria monocytogenes. No illnesses had been reported in association with the recall. The product code and Use-by date are in the upper right-hand corner of the package; the UPC code is on the back of the package, below the barcode. 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 3 Canadian provinces (New Brunswick, Ontario & Quebec). No illnesses have been reported in association with the recall. This precautionary recall notification is being issued due one sample of Dole Italian salad which yielded a positive result for Listeria monocytogenes in a random sample test conducted by the Canadian Food Inspection Agency.

August 22, 2012 – Dole Fresh Vegetables voluntarily recalled 1,039 cases of bagged salad. The product being recalled was 10 oz. Dole Italian Blend coded 0049N2202008, with a Use-By date of August 20 and UPC 7143000819 due to a possible health risk from Listeria monocytogenes. No illnesses had been reported in association with the recall. The product code and Use-By date are in the upper right-hand corner of the package; the UPC code is on the back of the package, below the barcode. The salads were distributed in eight U.S. states (Florida, Alabama, North Carolina, South Carolina, Pennsylvania, Maryland, Mississippi and Virginia). No illnesses have been reported in association with the recall. This recall notification is being issued due to an isolated instance in which 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 – Dole Fresh Vegetables voluntarily recalled 1,077 cases of bagged salads. The products being 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 June19 and UPC code 81131 02781 due to a possible health risk from Listeria monocytogenes. No illnesses have been reported in association with the recall. The Product Code and Use-by date are in the upper right-hand corner of the package; the UPC code is on the back of the package, below the barcode. The salads were distributed in six U.S. states (Georgia, Kentucky, North Carolina, South Carolina, Tennessee and Virginia). This precautionary recall notification is being issued due to an isolated instance in which 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 – Dole Fresh Vegetables voluntarily 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. No illnesses had been reported in association with the recall. The Product Code and Use-by Date are in the upper right-hand corner of the package; the UPC code is on the back of the package, below the barcode. 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, and Wisconsin). This precautionary recall notification is being issued due to an isolated instance in which 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 – Dole Fresh Vegetables, a division of Dole Food Company, Inc., today announced that it voluntarily 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 September 19, 2007, and a production code of “A24924A” or “A24924B” stamped on the package.  The “best if use by (BIUB)” code date can be located in the upper right hand corner of the front of the bag.  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. To date, Dole has received no reports that anyone has become sick from eating these products.  The recall is occurring because a sample in a grocery store in Canada was found through random screening to contain E. coli O157:H7.

2006 Spinach E. coli Outbreak – 205 Sick with 5 Death: 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. 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. 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. 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. 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. 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….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 Outbreak – 32 Sick: On September 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 September 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 September 19, the Bln I pattern had not been posted on PulseNet. Isolates obtained from culture of stool submitted by two new ill patients were received at the MDH PHL on September 23, 2005 and subtyped. PFGE results showed that the two new isolates and the isolate received on September 22 were indistinguishable by two enzymes. By September 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 laboratory testing was performed, MDH epidemiologists conducted preliminary interviews with patients who were laboratory confirmed with E. coli O157:H7. On the morning of September 28 investigators had identified pre-packaged lettuce produced by Dole Food Company, Inc. as the likely vehicle of transmission for infection with 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 cases. On September 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 September 30 the MDH issued a press 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.  Persons with symptoms of E. coli were told to contact the MDH and their physician. 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, October 3 the agency reported that sample number M-05-2310, Lot Number B250215B received on September 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 Food and Drug Administration (FDA) to issue a nationwide health alert regarding Dole pre-packaged salads on October 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 recognized. 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 September 21, 2005. The patient had experienced onset of symptoms on September 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 Ms. Scheetz 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 the 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 6 and 12 bags, approximately 244,866 bags of lettuce had made it to market. On October 11, 2005 the MDH counted 23 laboratory confirmed cases of E. coli O157:H7 and seven epidemiologically linked cases. Illness onset dates ranged from September 16 to September 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 persons from three states would be linked to the E. coli O157:H7 outbreak.