Wednesday, June 1, 2016

Flour Recalled As Investigators Try to Link to E. coli Outbreak

General Mills is recalling 10 million pounds of raw flour as federal and state agencies are investing 38 occurrences of E.coli infections across 20 states between December 21, 2015, and May 3, 2016.  The specific type of E. coli is E. coli O121, a non-O157 STEC, that can cause bloody diarrhea, dehydration, and in more susceptible people, it can cause kidney damage.   In 2013, this organism was responsible for an outbreak linked to frozen chicken quesadilla, a product that required cooking.

The outbreak investigation showed that roughly half of the 38 people infected used flour, some of them stated using Gold Medal brand.  So far, the flour has not tested positive for the organism.

So how does E. coli get into flour?  Probably from the raw material.  One study looking at a large number of samples, found that 12.8% of flour samples found E. coli (not strain specific) in raw flour. 

Of course, if the products made from the flour are properly cooked, that cooking will destroy the organism. However, people do eat raw dough products, including cookie dough. Nestle raw cookie dough was involved in an E. coli outbreak in 2009 where people were probably eating raw cookie dough.   In a report of that incident, investigators were not able to find the actual source of the E. coli. And like that case, it is not likely that they will be able to find this strain of E. coli.From that report:
Despite extensive traceback and environmental investigations and testing by regulatory agencies and company A, the source and route of product contamination remains undetermined. Possible means of contamination include introduction of a contaminated ingredient during processing, a lapse in plant biosecurity measures, intentional contamination, or cross contamination with another food processed in the plant. Although the manufacturing plant is located in a rural area in the mid-Atlantic United States, investigators did not observe any obvious breach in biosecurity that would facilitate introduction of E. coli O157 into the facility from the outside. No significant food handling or safety violations were identified at the plant that could result in cross-contamination within the plant.
In the end, don't eat raw dough, including cookie dough.  Clean up as you go, washing up any spilt flour.

Product image front label, Gold Medal All Purpose Flour 10 lb

 FDA News Release
Gold Medal, Gold Medal Wondra, and Signature Kitchens Flour Recalled Due to Possible E. coli O121 Contamination

For Immediate Release
May 31, 2016

Consumers  General Mills   1-800-230-8103

View Product Photos

MINNEAPOLIS – General Mills is collaborating with health officials to investigate an ongoing, multistate outbreak of E. coli O121 that may be potentially linked to Gold Medal flour, Wondra flour, and Signature Kitchens flour (sold in Safeway, Albertsons, Jewel, Shaws, Vons, United, Randalls, and Acme). Out of an abundance of caution, a voluntary recall is being made. To date, E. coli O121 has not been found in any General Mills flour products or in the flour manufacturing facility and the company has not been contacted directly by any consumer reporting confirmed illnesses related to these products.

State and federal authorities have been researching 38 occurrences of illnesses across 20 states related to a specific type of E. coli (E. coli O121), between December 21, 2015, and May 3, 2016. While attempting to track the cause of the illness, CDC found that approximately half of the individuals reported making something homemade with flour at some point prior to becoming ill. Some reported using a General Mills brand of flour.

Based on the information that has been shared with General Mills, some of the ill consumers may have also consumed raw dough or batter. Consumers are reminded to not consume any raw products made with flour. Flour is an ingredient that comes from milling wheat, something grown outdoors that carries with it risks of bacteria which are rendered harmless by baking, frying or boiling. Consumers are reminded to wash their hands, work surfaces, and utensils thoroughly after contact with raw dough products or flour, and to never eat raw dough or batter.

“As a leading provider of flour for 150 years, we felt it was important to not only recall the product and replace it for consumers if there was any doubt, but also to take this opportunity to remind our consumers how to safely handle flour,” said Liz Nordlie, President of General Mills Baking division.

Although most strains of E. coli are harmless, others can make you sick.E. coli O121 is a potentially deadly bacterium that can cause bloody diarrhea and dehydration. Seniors, the very young, and persons with compromised immune systems are the most susceptible to foodborne illness.

Any consumers concerned about an illness should contact a physician. Anyone diagnosed by a physician as having an illness related to E. coli O121 is also urged to contact state and local public health authorities.

The recall affects the following retail flour products that could be currently in stores or in consumers’ pantries. It includes 6 SKUs (stock keeping units or UPC codes) of Gold Medal Flour, 2 SKU’s of Signature Kitchens Flour and 1 SKU of Gold Medal Wondra flour.

If you have any of the products listed below, they should be thrown away. Consumers with additional questions or requesting a replacement should contact the company at 800-230-8103. Additional recall information can also be found at

The specific products in the recall include:

Click here for recalled product list

FDA News Release
FDA Investigates Multistate Outbreak of E. coli O121 Infections Linked to Flour
June 1, 2016

What is the Problem and What is Being Done About It?

The FDA, CDC and state and local officials are investigating a multi-state outbreak of Shiga toxin-producing Escherichia coli O121 (STEC O121) infections.

The CDC reports that 38 people infected with the outbreak strain of E. coli O121 have been reported from 20 states. Illnesses started on dates ranging from December 21, 2015 to May 3, 2016. Ten ill people have been hospitalized. In its investigation, CDC learned that some people who got sick had eaten or handled raw dough.

FDA’s traceback investigation determined that the raw dough eaten or handled by ill people or used in restaurant locations was made using General Mills flour that was produced in the same week in November 2015 at the General Mills facility in Kansas City, Missouri. Epidemiology and traceback evidence available at this time indicate that General Mills flour manufactured at this facility is the likely source of the outbreak.

On May 31, 2016, following a conference call among FDA, CDC and the firm, General Mills conducted a voluntary recall of flour products produced between November 14, 2015 and December 4, 2015. Recalled products are sold in stores nationwide or may be in consumers’ pantries and are sold under three brand names: Gold Medal flour, Signature Kitchens flour and Gold Medal Wondra flour. The varieties include unbleached, all-purpose, and self-rising flours.

Flour has a long shelf life, and bags of flour may be kept in peoples’ homes for a long time. Consumers unaware of the recall could continue to eat these recalled flours and potentially get sick. If consumers have any of these recalled flours in their homes, they should throw them away.

The investigation is ongoing and FDA will provide updated information as it becomes available.

What are the Symptoms of E.coli O121?

People usually get sick from STEC O121 2-8 days (average of 3-4 days) after swallowing the bacteria. Most people develop diarrhea (often bloody) and abdominal cramps. Most people recover within a week.

Some illnesses last longer and can be more severe, resulting in a type of kidney failure called hemolytic uremic syndrome (HUS). HUS can occur in people of any age, but is most common in young children under 5 years, older adults, and people with weakened immune systems.

Symptoms of HUS can include fever, abdominal pain, pale skin tone, fatigue and irritability, small, unexplained bruises or bleeding from the nose and mouth, and decreased urination.

People who experience these symptoms should seek emergency medical care immediately.

Who is at Risk?

People of any age can become infected. Very young children and the elderly are more likely than others to develop severe illness and HUS, but even healthy older children and young adults can become seriously ill.

What Specific Products are Being Recalled?

Recalled products are currently sold in stores or may be in consumers’ pantries and are sold under three brand names: Gold Medal Flour, Signature Kitchens Flour, and Gold Medal Wondra flour. The recalled products were sold nationwide and include unbleached, all-purpose, and self-rising flours varieties.

The specific products in the recall include:

See List

Cereal foods world
Microbiological quality of flours [1993]
Richter, K.S. (Central Flour Milling Laboratory, Omaha, NE) Dorneanu, E. Eskridge, K.M. Rao, C.S.

Over 4,000 wheat flour samples were tested according to FDA/BAM methods for Salmonella and Escherichia coli in addition to yeast and mold, aerobic plate count (APC), and coliform most probable number (MPN) counts. The data were analyzed statistically based on flour type-hard red winter (HRW), soft red winter (SRW), spring (SPG), or durum (DUR)-and season of milling production. SRW had the highest mold count (log10 3.06 cfu/g) and DUR the lowest (log10 2.85 cfu/g). SPG had the highest yeast count (log10 2.27 cfu/g) and SRW the lowest (log10 2.07 cfu/g). Highest APCs were found in DUR (log10 4.24 cfu/g), whereas the lowest were in SRW (log10 3.83 cfu/g). Of the samples tested, 12.8% were E. coli positive and 1.3% were Salmonella positive with the highest frequency of each pathogen occurring in the fall and winter months, respectively. The lowest E. coli frequency occurred during spring, whereas Salmonella had the lowest incidence in summer. The highest percentage of E. coli positives was observed in DUR (17%), and the lowest was observed in HRW samples (6.7%). The highest percentage of Salmonella positives existed in SRW (2.3%) and the lowest in DUR flour samples (0.3%). From the data, 95% confidence limits of 5,700 cfu/g for mold, 110,000 cfu/g for APC, and 150 MPN/g for coliforms were determined for all wheat flours
[infection, bacteria, produit alimentaire, farine de ble, harina de trigo, biodegradation, qualite, infeccion, calidad, alimentos, biodegradacion]
[Cereal foods world (USA)]

Clin Infect Dis. (2012) 54 (4): 511-518. doi: 10.1093/cid/cir831
A Novel Vehicle for Transmission of Escherichia coli O157:H7 to Humans: Multistate Outbreak of E. coli O157:H7 Infections Associated With Consumption of Ready-to-Bake Commercial Prepackaged Cookie Dough—United States, 2009

Karen P. Neil,1,2 Gwen Biggerstaff,2 J. Kathryn MacDonald,3 Eija Trees,2 Carlota Medus,4 Kimberlee A. Musser,5 Steven G. Stroika,2 Don Zink,6 and Mark J. Sotir2
1Epidemic Intelligence Service, Office of Workforce and Career Development, and 2Division of Foodborne, Waterborne, and Environmental Diseases, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia; 3Communicable Disease Epidemiology, Washington State Department of Health, Shoreline; 4Foodborne, Vectorborne, and Zoonotic Diseases, Acute Disease Investigation and Control, Minnesota Department of Health, St Paul; 5Bacteriology Laboratory, Wadsworth Center, New York State Department of Health, Albany; and 6Office of the Center Director, Center for Food Safety and Applied Nutrition, US Food and Drug Administration, Silver Spring, Maryland

Background. Escherichia coli O157:H7 is a Shiga toxin–producing E. coli (STEC) associated with numerous foodborne outbreaks in the United States and is an important cause of bacterial gastrointestinal illness. In May 2009, we investigated a multistate outbreak of E. coli O157:H7 infections.
Methods. Outbreak-associated cases were identified using serotyping and molecular subtyping procedures.
Traceback investigation and product testing were performed. A matched case-control study was conducted to identify exposures associated with illness using age-, sex-, and state-matched controls.
Results. Seventy-seven patients with illnesses during the period 16 March–8 July 2009 were identified from 30 states; 35 were hospitalized, 10 developed hemolytic-uremic syndrome, and none died. Sixty-six percent of patients were ,19 years; 71% were female. In the case-control study, 33 of 35 case patients (94%) consumed ready-to-bake commercial prepackaged cookie dough, compared with 4 of 36 controls (11%) (matched odds ratio5 41.3; P, .001); no other reported exposures were significantly associated with illness. Among case patients consuming cookie dough, 94% reported brand A. Three non-outbreak STEC strains were isolated from brand A cookie dough. The investigation led to a recall of 3.6 million packages of brand A cookie dough and a product reformulation.
Conclusions. This is the first reported STEC outbreak associated with consuming ready-to-bake commercial prepackaged cookie dough. Despite instructions to bake brand A cookie dough before eating, case patients consumed the product uncooked. Manufacturers should consider formulating ready-to-bake commercial prepackaged cookie dough to be as safe as a ready-to-eat product. More effective consumer education about the risks of eating unbaked cookie dough is needed.

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