UPDATED CONTENT — General Mills provided additional information at the request of Food Safety News, including the volume of the flour recall expansion. Today’s addition of 15 million pounds brings the total to 45 million pounds, which is “a small percentage of the flour we produce,” according to company officials. Additional updated content throughout.

The Kansas City, MO, plant that produced 45 million pounds of recalled General Mills flour continues to operate as the recall expands and more people fall victim to a 21-state E. coli outbreak linked to flour made there. General Mills Inc. expanded the recall Monday after federal officials told company officials that four more people have been confirmed with E. coli infections matching strains of the pathogen proven by lab tests to be in the company’s flour. Thirteen of the 46 confirmed outbreak victims have been hospitalized and one has developed a type of kidney failure known as hemolytic uremic syndrome (HUS), which is often fatal. The first confirmed case began Dec, 21, 2015, with the most recent victim becoming ill June 25. The recall includes three main brands of flour, Gold Medal, Signature Kitchens and Wondra. Several sizes and varieties of these three brands are under recall. The complete list is available online.

The first recall on May 31 was for 10 million pounds of flour. A July 1 expansion added 20 million pounds. General Mills provided the Food and Drug Administration with some recalled flour recovered from its customers. The FDA reported Monday it had used whole genome sequencing and found the recovered flour was contaminated with a second E. coli outbreak strain that public health officials have confirmed in victims — E. coli O26. That finding is what spurred General Mills to add more lots of flour from the Kansas City plant to the recall on Monday, making the dates of production involved in the recall Nov. 4, 2015, through Feb. 10 this year. Status of the KC plant and advice to consumers General Mills continues to operate the production plant in Kansas City, MO, a company spokesperson said Monday evening. She said to date, the company hadn’t found any E. coli in the facility. “We don’t believe the facility to be the source, but out of an abundance of caution, elevated cleaning protocols have been followed,” the spokeswoman said. “Regarding current capacity, it varies day-to-day, as with any plant. …  Only a small sub-set of flour produced at the Kansas City plant has been traced back to individuals who have become ill.” General Mills’ Chief Operating Officer Jeff Harmening said in Monday’s news release that “the most important thing (consumers) can do to keep safe is to not eat uncooked flour.” The release also warned “flour is made from wheat that is grown outdoors where bacteria are often present and the normal flour milling process does not remove these bacteria. In order for severe E. coli illness to occur from flour, all three of the following things have to happen.” According to General Mills, those three things are:

1. The flour a consumer is using has to contain the sub-types of E.coli that can make you sick.
2. The consumer has to eat raw dough, batter or other uncooked food made with the flour, or handle the raw dough and not wash their hands.
3. The consumer’s individual health characteristics will impact if they get sick and how severely. Some consumers have mild symptoms and others get very sick. It is not always known who will get sick and who will not.

Consumers should also exercise caution and practice good food safety in their homes, according to the General Mills news release. “The illnesses reported to health officials continue to be connected with consumers reporting that they ate or handled uncooked dough or ate uncooked batter made with raw flour. No illnesses have been connected with flour that has been properly baked, cooked or handled,” General Mills said in the news release. Federal officials, however, advise that consumers not take a chance using the recalled flour. “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 such flour products away,” the FDA warned Monday. Seeking the root cause

While company officials and investigators from the FDA, CDC and state public health agencies continue to seek the root cause of the contamination of the flour, General Mills officials said Monday that the entire outbreak might not be that unusual. “At this time, it is unknown if we are experiencing a higher prevalence of E. coli in flour than normal, if this is an issue isolated to General Mills’ flour, or if this is an issue across the flour industry,” according the recall notice issued as a news release. “The newer detection and genome sequencing tools are also possibly making a connection to flour that may have always existed at these levels.” COO Harmening said in Monday’s news release that the company is “committed to convening experts to work with government officials to learn more and create new protocols, if needed.” The General Mills spokeswoman said Monday the company is working with government researchers to learn more about E. coli and flour in general. “Very little is known about what levels of naturally occurring environmental contamination E. coli-STEC subtypes have historically existed in flour because it has always been considered a raw ingredient intended to be cooked or baked, and it is known that the milling process does not remove these contaminates,” the company spokeswoman said. The FDA’s update Monday stated additional analysis is pending. The agency also reminded the public that it cannot reveal complete information about foods that may be compromised by the recalled General Mills flour because of rules about trade secrets. “General Mills also sells bulk flour to customers who use it to make other products. General Mills has contacted these customers directly to inform them of the recall,” FDA reported Monday.

“In general, supplier-customer relationships are confidential and, because of legal restrictions on disclosure of commercial confidential information, FDA is generally not authorized to release the names of these customers or the products they make with the flour.” The General Mills spokeswoman said she could not say what percentage of the recalled flour went to corporate trading partners vs. retailers and restaurants because “we don’t have the figures broken down that way to share.” Since the initial recall on May 31, FDA reports it “has facilitated at least four recalls of firms that received recalled flour. Those recalls are:

• July 9, Krusteaz brand pancake mix;
• July 11, Betty Crocker cake Mix;
• July 12, Golden Dipt breading mix; and
• July 13, Marie Callender’s cheese biscuit mix.

Who is at risk and what are the symptoms? The CDC’s update Monday afternoon stated additional outbreak victims are likely to be identified. “Illnesses that occurred after June 29, 2016, might not yet be reported due to the time it takes between when a person becomes ill and when the illness is reported to CDC. This takes an average of two to three weeks,” according to the CDC. Ill people range in age from 1 to 95 years old, with a median age of 18. “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,: according to the CDC. People usually get sick from STEC O121 and O26 two to eight days after swallowing the bacteria. Most people develop diarrhea that is often bloody, and abdominal cramps. Most people recover within a week. 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. (To sign up for a free subscription to Food Safety News, click here.)