Or, I will send you this t-shirt.

For Babies sake, make

Cronobacter sakazakii reportable

The Abbott infant formula recall could have been prevented. The FDA had reports of safety failures months before the contaminated formula sickened babies and caused two deaths. 

Here is what the head of the FDA said in testimony to congress months ago:

The CDC receives reports on foodborne disease outbreaks from state, local, and territorial health departments. On average, CDC receives two to four Cronobacter case reports annually; however, because Cronobacter infection is not reportable in most states, the total number of cases that occur in the United States each year is not known.

Here is a bit of history about why having bacterial infections reportable make a difference.

California – 34 ill: From mid-November to mid-January, 9 cases of E. coli O157:H7-associated bloody diarrhea and the hemolytic-uremic syndrome had been reported in San Diego County, California and 1 child died. A total of 34 persons had bloody diarrhea, the hemolytic-uremic syndrome, or E. coli O157:H7 organisms isolated from stool during the period November 15, 1992, through January 31, 1993. E. coli O157:H7 was ultimately identified from 6 persons were indistinguishable from those of the Washington outbreak strain linked to Jack in the Box restaurants in Washington, Idaho, Nevada and California.  All the pre-formed frozen hamburgers were produced by Von’s in California and shipped to those restaurants in those states.

According to public health officials:

Improved surveillance by mandating laboratory – and physician – based reporting of cases of E coli O157:H7 infection and the hemolytic uremic syndrome might have alerted health officials to this outbreak sooner, which could have resulted in earlier investigation and the institution of measures to prevent more cases.

Clearly, had E. coli O157:H7 been reportable, public health officials in California would have caught the illnesses and most likely prevented the hamburgers from being shipped to other states.  Hundreds of people – specifically children – would not have been sickened and three would likely not have died.

The final outbreak report by the CDC found that nearly all illnesses in states other than California occurred AFTER the cluster of 34 cases that went unreported in California.

Washington – 602: On January 13, 1993, a physician reported to the Washington Department of Health a cluster of children with hemolytic uremic syndrome (HUS) and an increase in emergency room visits for bloody diarrhea. During January-February 1993, 602 patients with bloody diarrhea or HUS were reported to the state health department. 144 were hospitalized, 30 developed HUS and three died.

Idaho – 14: Following the outbreak report from Washington, the Division of Health, Idaho Department of Health and Welfare, identified 14 persons with culture-confirmed E. coli O157:H7 infection. 1 developed hemolytic uremic syndrome (HUS).

Nevada – 58: On January 22, after receiving a report of a child with HUS who had eaten at a local chain A restaurant, the Clark County (Las Vegas) Health District issued a press release requesting that persons with recent bloody diarrhea contact the health department. Of 58 persons whose illnesses met the case definition 9 were hospitalized and 3 developed hemolytic uremic syndrome (HUS).

So, do something to prevent the next Cronobacter Sakazakii outbreak from being larger than necessary.

03162023_mrler1_142529.jpg

By Sandi Doughton , Seattle Times staff reporter

Our stories on the E. coli outbreak 30 years ago drew memories and advice

SINCE OUR FEB. 26 cover story on food safety, Bill Marler, and regulatory gaps 30 years after the Jack in the Box E. coli outbreak in the Pacific Northwest, federal agencies have issued 15 recalls for mislabeled, uninspected and contaminated food. That includes powdered infant formula laced with bacteria, granola bars tainted with listeria, and frozen organic strawberries sold at Costco and PCC Community Markets in Washington that, as of press time, had infected at least five people with hepatitis A.

Interestingly, none is on the list of foods Marler avoids, which attracted even more reader feedback. Some of you scoffed at what you saw as living in fear. Others pointed out that Marler works with people harmed by food poisoning every day, so it makes sense he would be careful. One discussion pointed out that whole cuts of meat, like steak, are most likely to be contaminated only on the surface. That makes them safer to eat less-well-done than hamburger, where pathogens can be mixed throughout. Thanks for all the comments — and keep them coming. Here are a couple more:

Weighing the risks

Everyone has a different risk tolerance and has to balance their desires with the risks. I know that eating some of these foods puts me at risk for foodborne illness, but I choose to eat them, anyway … it’s important that everyone knows the potential risk for various foods so that each person can make their own decisions. 

As a public health major, I took environmental health and food safety classes at UW, and even shadowed a health inspector as he inspected Seattle restaurants. When I was pregnant, my risk tolerance changed for 9 months. I actually consider myself fairly food-safety-conscious, but I do partake in over-easy eggs and rare steaks.

I don’t think, however, that everyone realizes that everyday convenience foods, like bagged salads, are potentially risky. When you’re pregnant, you are warned not to eat specific foods, like lunch meat and soft cheese. Maddeningly, however, recent multistate listeria outbreaks have included foods like ice cream, frozen vegetables and … prewashed bagged salad. 
— Elizabeth Espinosa-Snow

Go ahead and eat! 

Not surprising that [Bill Marler] would avoid these foods, especially as he is a food safety attorney. I’m sure he has seen or heard a lot of very, very gross things and is very aware of illnesses that can happen. For most folks, his fears are not an everyday issue with the foods identified in the article. Eat foods how you want! Make sure it is fresh, prepared in a clean environment and safety measures are taken. Bon appétit!
— De-De Herbert

Well, rumor has it that the documentary version of the story of the 1993 Jack in the Box E. coli outbreak will be out in June 2023. When all thought it would go to the “silver screen” in January there was a rush to reprint the book.

Here are a few pages that made it into the first paperback version, but not the current one:

Here is the latest update that also did not make it:

October 11, 2022

Just over 20 years after Bill penned an Op-ed for the Denver Post in which he challenged the USDA/FSIS and the Beef Industry to “Put me out of Business,” E. coli cases linked to ground beef have nearly, but not completely, disappeared. As Bill tells it, “I could count on a significant E. coli outbreak and recall occurring like clockwork nearly every Spring or Summer. When 2003 came, there were no outbreaks, and other than the tragic uptick in 2007 that impacted Stephanie Smith, E. coli cases linked to ground beef are no longer a part of the work we do anymore.  The industry to its credit did its job and met my challenge.”

Since the 2018 E. coli outbreak linked to Romaine lettuce from Yuma, E. coli, Salmonella, Listeria, and hepatitis A outbreaks linked fresh fruits and vegetables now take up the bulk of Bill’s attention.  Romaine lettuce E. coli outbreaks have now replaced ground beef as the staple of the Marler Clark practice.

In 2019 Bill launched a petition to ban Salmonella from chicken like E. colis were banned from ground beef.  Thus far the USDA/FSIS has resisted, but it has banned Salmonella from certain chicken products.  As Bill says, “a win is a win, even if a small one.”

The COVID-19 Pandemic may have slowed Bill’s world-wide travel schedule, but it barely impacted reported foodborne outbreaks and the litigation that surrounds them.  Salmonella-tainted onions in 2020 and 2021 sickened thousands in the United States and Canada.  Salmonella-laced ground turkey sickened dozens, organic yogurt nearly caused the death of three children with E. coli-mediated HUS in 2021.  Hepatitis A outbreaks linked to ill workers in multiple restaurants (Bill has for decades urged the restaurant industry to offer hepatitis A vaccines to employees) in New Jersey and Virginia sickened nearly 100, causing five deaths and three liver transplants.  In 2022, a Salmonella outbreak hit peanut butter, again, and Listeria in ice cream raising its deadly head.

2022 has also put social media and “influencers” from Instagram and TikTok on the same footing as CDC epidemiologists.  Public health officials seemed completely oblivious to hundreds of people suffering with acute liver failure after consuming an organic, vegan home-delivered food produced by a company backed by the power of Serena Williams and Gwyneth Paltrow.  Bill now represents 361 of the customers in a Federal Court lawsuit that stretches from New York City to the mountains of Peru.

The pandemic years has turned Bill into nearly a “virtual” lawyer.  Instead of crisscrossing the world to appear in Court or to give a speech on “why it is a bad idea to poison your customers,” Bill will login to his custom-built studio from his Bainbridge Island satellite office.  The pandemic has also ushered in other changes at Marler Clark, with three of the four founding partners retiring.  Bruce Clark, Denis Stearns and Andy Weisbecker have opted for a bit slower pace out of Bill’s wake.

Bill when asked when he might retire as well, quickly responds, “I still have much too do. I still love helping people and trying to do my part to make sure there are fewer Bri’s in the future than in the past or the present.” 

Well, perhaps the next version.

I know we expect to have an update on a Listeria outbreak linked again to leafy greens early this coming week. And, I appreciate the transparency of the FDA now listing investigation – even it the cause is not determined. The bigger question is how to prevent them from happening in the first place?

CDC’s MMWR published an article this week about the 2021 Hepatitis A Outbreak linked to a ill worker at a Virginia restaurant – over 50 were sickened – 4 died and one person had a liver and kidney transplant.

Perhaps we need a new t-shirt campaign?

This was such a preventable tragedy.  Here is something my clients asked me to do for them.  

Someone asked me in an email this morning. I said, I was not done trying to Get the F out of the FDA. Far too many lives depend on the FDA paying more attention to food safety and human nutrition. We all should not stop pushing the House, the Senate, the HHS Secretary and the U.S. President to rethink how the safety of our food is organized – both food safety and nutrition – so we are far more proactive in helping the millions sickened by food both because of pathogens, but also salt, sugar, fat and processed foods.

But, it did get me thinking about the next possible t-shirt. Perhaps this one:

Remember this as you prepare the holiday meal for your family and as you read this post – it is Food Safety and Inspection Service (FSIS) Mission Statement: Protecting the public’s health by ensuring the safety of meat, poultry, and processed egg products.

USDA/FSIS has the authority to deem Salmonella and other pathogens adulterants – they just need to use it.

Everyday Americans will bring a food product (poultry) into their homes that is likely teeming with Salmonella that the manufacturer – by law and with the USDA stamp of approval – knowingly can sell knowing that it may well be tainted with a pathogen that sickens over 1,000,000 yearly.  This is because USDA/FSIS does not consider Salmonella an adulterant.

Personally, as I said to the Los Angeles Times some time ago, “I think that anything that can poison or kill a person should be listed as an adulterant [in food].”

Ignoring Salmonella in meat makes little, if any, sense.

Even after the Court’s twisted opinion in Supreme Beef v. USDA, where it found Salmonella “not an adulterant per se, meaning its presence does not require the USDA to refuse to stamp such meat ‘inspected and passed’, ” our government’s failure to confront the reality of Salmonella, especially antibiotic-resistant Salmonella, is inexcusable.

The Wisconsin Supreme Court in Kriefall v Excel called it as it saw it – at least with respect to E. coli – but the analysis is spot on for Salmonella as well:

The E. coli strain that killed Brianna and made the others sick is a “deleterious substance which may render [meat] injurious to health.” There is no dispute about this. Thus, under the first part of 21 U.S.C. § 601(m)(1), meat that either “bears or contains” E. coli O157:H7 (the “deleterious substance”) is “adulterated.” That E. coli O157:H7 contamination can be rendered non-“injurious to health” by cooking thoroughly, as discussed below, does not negate this; Congress used the phrase “may render,” not “in every circumstance renders.” Moreover, if the E. coli bacteria is not considered to be “an added substance,” because it comes from some of the animals themselves and is not either applied or supplied during the slaughtering process (although we do not decide this), it cannot be said that the E. coli strain “does not ordinarily render [the meat on or in which it appears] injurious to health.” Accordingly, meat contaminated by E. coli O157:H7 is also “adulterated” under the second part of § 601(m)(1).

Now, why would Salmonella be different? According to the CDC, it is estimated that 1.4 million cases of salmonellosis occur each year in the United States. Of those cases, 95 percent are related to foodborne causes. Approximately 220 of each 1,000 cases result in hospitalization, and 8 of every 1,000 cases result in death. About 500 to 1,000 deaths – 31 percent of all food-related deaths – are caused by Salmonella infections each year.

So, where do we stand with the existing USDA/FSIS law on adulteration?

Here is the law:

21 U.S.C. § 601(m)(4) – SUBCHAPTER I – INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING – CHAPTER 12 – MEAT INSPECTION – TITLE 21—FOOD AND DRUGS

(m) The term “adulterated” shall apply to any carcass, part thereof, meat or meat food product under one or more of the following circumstances:

(1) if it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance, such article shall not be considered adulterated under this clause if the quantity of such substance in or on such article does not ordinarily render it injurious to health; …

(3) if it consists in whole or in part of any filthy, putrid, or decomposed substance or is for any other reason unsound, unhealthful, unwholesome, or otherwise unfit for human food;

(4) if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health; …

Here is the law specifically related to poultry:

Title 21 – FOOD AND DRUGS CHAPTER 10 – POULTRY AND POULTRY PRODUCTS INSPECTION

(g) The term “adulterated” shall apply to any poultry product under one or more of the following circumstances:

(1) if it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance, such article shall not be considered adulterated under this clause if the quantity of such substance in or on such article does not ordinarily render it injurious to health; …

(3) if it consists in whole or in part of any filthy, putrid, or decomposed substance or is for any other reason unsound, unhealthful, unwholesome, or otherwise unfit for human food;

(4) if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health;

Hmmm. It is hard to read the above and not think that the words equate to all E. coli as well as Salmonella — frankly, all pathogens in food.

I know, I am just a lawyer, but don’t ya think that when food with animal feces (and a dash of E. coli O157:H7) in it is considered an adulterant, that other animal feces (with dashes of other pathogens, like Salmonella) in them, should be considered adulterated too?  But, hey, that is just me.

Another odd governmental fact is that the FDA does not seem to make a distinction between pathogens it considers adulterants or not.

FDA’s enabling legislation – Sec. 402. [21 USC §342] of the Food, Drug & Cosmetic Act also defines “Adulterated Food” as food that is:

(a) Poisonous, insanitary, or deleterious ingredients.

(1) If it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance such food shall not be considered adulterated under this clause if the quantity of such substance in such food does not ordinarily render it injurious to health;

(2) If it bears or contains any added poisonous or added deleterious substance … that is unsafe within the meaning of section 406;

(3) if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food;

(4) if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health …

It would be interesting, and perhaps entertaining, to have House and Senate hearings focusing on what should and should not be considered adulterants in our food. I can see panels of scientists from various fields, FDA, USDA and FSIS officials, beef, poultry, fish and produce industry representatives, and consumers discussing this.

I would pay to watch it.

And so now onto some history to ruin your appetite.

In 1971 the American Public Health Association (APHA) sued the USDA on the grounds that its mark of inspection (“USDA inspected for wholesomeness”) was misleading because, even though the USDA had put its stamp of approval on meat—literally—it did not, for example, test the meat for bacteria. Moreover, APHA argued that raw meat was commonly contaminated with Salmonella, which posed a risk to the public health. According to APHA, the USDA should instead require that meat carry both a warning label and cooking instructions. The USDA opposed the APHA, helped ably (and predictably) by the meat industry. As quoted by Marion Nestle in her great book, Safe Food, the USDA’s position was that, given how many foods are contaminated with Salmonella, “it would be unjustified to single out the meat industry and ask that the [USDA] require it to identify its raw products as being hazardous to health.” Nestle at 66. (Note to Reader: No, I am really not making this up.)

In 1974, the DC Circuit Court of Appeals upheld the position of the USDA and the meat industry, doing so in a way that was as nonsensical as it was sexist. The court stated that: “The presence of salmonellae on meat does not constitute adulteration within this definition [of ‘adulterated,’ provided in 21 U.S.C. § 601 (m)]….As it said in its letter of August 18, 1971 ‘the American consumer knows that raw meat and poultry are not sterile and, if handled improperly, perhaps could cause illness.” In other words, American housewives and cooks normally are not ignorant or stupid and their methods of preparing and cooking of food do not ordinarily result in salmonellosis.’” APHA v. Butz, 511 F.2d 331, 334 (1974).

This remained the position of the USDA and the meat industry until 1994 when, in an act of both common-sense and bravado, Michael Taylor, then FSIS Administrator, announced that E. coli O157:H7 would be deemed an adulterant in raw ground beef. The Agency did not, however, change its tune with regard to any other pathogens, especially Salmonella. Indeed, in 1999, when FSIS announced it inane distinction between E. coli O157:H7 in “intact” meat versus “non-intact” meat, the Agency continued to focus on how a given meat was “customarily cooked” as a chief determinant of whether it must be treated as an adulterant. Thus, for example, because it decided that “intact steaks and roasts are customarily cooked in a manner that ensures that these products are not contaminated with E. coli O157:H7,” there was no need to treat this deadly pathogen as an adulterant on intact cuts of meat. Of course, this FSIS policy is also one that appears to have been silently jettisoned by the Agency of late.

The Agency’s position on Salmonella and meat came back to haunt it in a big way when FSIS tried to shut down Supreme Beef Processors, Inc. for repeatedly failing Salmonella performance standards that, according to the Agency, was proof that the ground beef being made there was being processed under “insanitary conditions.” Supreme Beef sued the USDA and not only won an injunction, but it succeeded in having the Salmonella regulations struck down as being “beyond the authority granted the Secretary [of the USDA] by the Federal Meat Inspection Act.” Supreme Beef v. USDA, 275 F.3d 432, 434 (5th Cir. 2001). Explaining its holding, the Court wrote:

The difficulty in this case arises, in part, because Salmonella, present in a substantial proportion of meat and poultry products, is not an adulterant per se, 21 meaning its presence does not require the USDA to refuse to stamp such meat “inspected and passed.” 22 This is because normal cooking practices for meat and poultry destroy the Salmonella organism, 23 and therefore the presence of Salmonella in meat products does not render them “injurious to health” 24 for purposes of § 601(m)(1). Salmonella-infected beef is thus routinely labeled “inspected and passed” by USDA inspectors and is legal to sell to the consumer.

Supreme Beef, 275 F.2d at 438-39. And, of course, not surprisingly, the court in this case was quick to cite the decision in APHA v. Butz, and to note that even now the “USDA agrees that Salmonella is not an adulterant per se.” Id. at 439 n. 21.

In my view the Supreme Beef decision is poorly reasoned and ill-informed. (For example, could not someone at the Court figure out that it is impossible for meat to be “infected” with Salmonella, and the proper term here is “contaminated”?) But the real lesson of Supreme Beef is that the USDA was, and continues to be, an Agency that is unable to decide whose side it is on. Sometimes it puts on its public safety hat, and sometimes—actually, most often—it puts on its pro-meat industry hat. And, unfortunately, these roles are too often contradictory. That is why USDA policy when it comes to meat safety is also too often contradictory.

Perhaps it is just time for the FSIS to take the the position that all pathogens that can kill you in meat are adulterants.  You have the authority – you just need to use it.

Let the meat industry sue you.  I know a good lawyer to defend you.

Screenshot 2023-04-04 at 7.30.40 AM

According to press reports of a recent FDA inspection, Global Pharma, the maker of eye drops linked to a deadly outbreak of drug-resistant infections in the US had a slew of manufacturing violations—from brown slime on filling equipment to a lack of basic measures and systems to ensure sterility—according to an inspection report released by the Food and Drug Administration – PDF.

As of March 14, 68 people in 16 states have been infected with the strain, the Centers for Disease Control and Prevention reports. Three people have died from the infection, eight have lost vision, and four have had their eyeballs surgically removed.

FDA inspectors noted that Global Pharma didn’t verify that components of the solutions, bought from suppliers, were sterile to begin with. And the areas of the facility where the solution was supposed to be made aseptically—contamination-free—weren’t fit for producing sterile products.

The FDA found that the walls, ceilings, and floors were not smooth, hard surfaces that could be readily sterilized. Instead, there were cracks, protruding nails, and holes in the wall. But, even if the area was cleanable, the company’s protocols for cleaning were also deficient.

FDA inspectors noted problems with cleaning and maintenance of machinery, which could have led to cross-contamination from other products manufactured in the facility. 

On the second inspection day, an inspector also noted “black, brown colored greasy deposit” on parts of the filling machine, and the facilities equipment logbook noted that it hadn’t been cleaned in nearly a month. A few days later, a manager told the inspector that there was “no procedure for cleaning” the filling machine.

Environmental monitoring for contamination in the facility was also lacking, the report found. And the sterility of primary packaging—including bottle caps—were not verified before they were used. Once the eye drops were bottled, the formula did not contain a preservative to prevent microbial contamination, and batches were released to the US without going through the quality control unit.

uncooked-flour

With another flour-related foodborne illness outbreak brewing – this time Salmonella – a bit(e) of history might be on the menu. Here is the latest one:

As of March 30, 2023, 12 people infected with the outbreak strain of Salmonella have been reported from 11 states – California, Oregon, Nebraska, Minnesota, Iowa, Missouri, Illinois, Tennessee, Ohio, Virginia and New York. Illnesses started on dates ranging from December 6, 2022, to February 13, 2023. Sick people range in age from 12 to 81 years, with a median age of 64, and 92% are female. Of 10 people with race or ethnicity information available, 8 are White, 2 are Asian, and no one reported Hispanic ethnicity. Of 12 people with information available, 3 have been hospitalized. No deaths have been reported. Investigators are working to identify specific brands of flour that are linked to illness. In the meantime, CDC always advises you not to eat raw cookie dough or cake batter.

2021 Multistage Outbreak of E. Coli O121 linked to Flour

As of July 27, 2021, 16 people infected with the outbreak strain of E. coli O121 have been reported from 12 states. Illnesses started on dates ranging from February 26, 2021 to June 21, 2021. Sick people range in age from 2 to 73 years, with a median age of 13, and 100% are female. Of 16 people with information available, 7 have been hospitalized. One person has developed a type of kidney failure called hemolytic uremic syndrome (HUS), and no deaths have been reported. FDA is conducting a traceback investigation using purchase records from locations where sick people bought cake mix to try to determine a common cake mix brand or production facility. CDC advises people not to eat raw cake batter, whether made from a mix or homemade. Eating raw cake batter can make you sick. Raw cake batter can contain harmful bacteria. Bacteria are killed only when raw batter is baked or cooked.

2018-2019 Multistate Outbreak of E coli O26 Linked to Flour

In May 2019 the CDC announced an investigation of E. coli O26 infections linked to flour produced by ADM Milling Company and sold at ALDI grocery stores. As of July 11, 2019 there were 21 outbreak associated cases reported by 9 states. Illnesses started on dates ranging from December 11, 2018 to May 21, 2019. Three people were hospitalized. No one died. In interviews, 4 ill people reported eating, licking, or tasting raw, homemade dough or batter. Investigators with the Rhode Island Department of Health collected records and flour samples at a bakery where an ill person reported eating raw dough. The bakery used Baker’s Corner All Purpose Flour from ALDI. The outbreak strain was isolated from an unopened bag of Baker’s Corner All Purpose Flour collected at the bakery. On May 23, 2019 ADM Milling Co. and ALDI recalled 5-lb. bags of Baker’s Corner All Purpose Flour. Recalled flour was sold at retail locations in Connecticut, Delaware, Massachusetts, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Vermont and West Virginia. On June 13, 2019 King Arthur Flour, Inc. a customer of ADM announced a recall of 14,218 cases of 5-lb. bags of King Arthur Unbleached All-Purpose Flour. On June 14, 2019 another customer of ADM Milling Company, Hometown Food Company, announced a recall of 5-lb. bags of Pillsbury Best Bread Flour. On June 14, 2019 Hometown food Company, a customer of ADM Milling Co., announced a recall of Pillsbury Best Bread Flour. On June 21, 2019 Brand Castle, LLC of Bedford Heights, Ohio recalled several brands of cookie and brownie mix because the flour used in them was potentially contaminated.

2015-2016 Outbreak of E. coli O121 linked to General Mills’ Flour

In June 2016 the CDC announced that public health officials were investigating a multistate outbreak of E. coli O121 linked to flour produced at the General Mills’ Kansas City, Missouri facility. In interviews with ill persons, sixteen (76%) reported that they or someone in their household used flour in the week before they became ill. Twelve (55%)of 22 people reported using Gold Medal brand flour. On September 29, 2016 the outbreak was declared to be over. There were 63 ill people reported by 24 states. Seventeen people were hospitalized. One person developed hemolytic uremic syndrome. No one had died. Illness onset dates ranged from December 21, 2015 to September 5, 2016. The FDA identified STEC O121 in an open sample of General Mills flour collected from the homes of ill persons in Colorado, Arizona and Oklahoma. On May 31, 2016 General Mills recalled several sizes and varieties of Gold Medal Flour, Gold Medal Wondra Flour, and Signature Kitchens Flour. On July 1 General Mills expanded the recall. the recall was expanded again on July 25, 2016.

2015-2016 Multistate Outbreak of E. coli O157 Linked to Dough Mix at Pizza Ranch

In 2016 public health officials investigated an outbreak of E. coli O157 linked to consumption of products made with contaminated dough mix. A total of 13 cases were reported by 9 states. Eight were hospitalized. There were no deaths. Illness onset dates ranged from December 6, 2015 to February 9, 2016. Nine of 12 persons interviewed reported eating at one of 9 locations of Restaurant A during the week preceding illness onset. Eight ate a specific dessert pizza made through a proprietary dough mix provided by manufacturer A. The ninth patient consumed bread sticks made from the same dough mix. Eighty-eight samples of dry dough mix from five restaurant A locations where patients reported eating were collected by public health officials in 5 states. The Minnesota Department of Agriculture identified non-0157 STEC in 17 collected samples, including one Shiga toxin-1-producing non-O157 STEC isolate and six Shiga toxin 2 (stx2)-producing non-O157 STEC isolates. FDA collected 6 samples of dry dough mix from manufacturer A. All six samples tested negative for STEC O157, but one yielded an stx2 producing STEC O8:H28. All identified strains lacked known adherence factors and were therefore considered to present low health risk.

2009 Multistate Outbreak of E. coli O157:H7 Linked to Nestle Raw Refrigerated Prepackaged Cookie Dough

Eighty ill persons infected with a single strain of E. coli O157:H7 were identified in at least 31 states. At least 70 of these illnesses were confirmed by an advanced DNA test as being the same strain of E.coli O157: H7. An epidemiological study indicated a strong association between eating raw, prepackaged, cookie dough and infection; Nestle Toll House brand cookie dough was mentioned by most ill persons who had reported eating cookie dough. On June 29, 2009, the Food and Drug Administration announced that they had found E.coli O157:H7 in a package of cookie dough that had been collected from a Nestle plant on June 25. The strain identified from the package was different from the outbreak strain. E.coli O157:H7 infection had not been previously associated with eating raw cookie dough. The strain of E.coli O157:H7 associated with this outbreak had been associated with earlier outbreaks going back to February, 2005. Although the investigation found no conclusive evidence that contaminated flour was the outbreak source, contaminated flour remained the prime suspect in this outbreak. A single, large purchase of contaminated flour could have been used to manufacture multiple lots and varieties of dough over time as was consistent with the variety of UBD codes on product packages from ill consumers.

I have the Honor to speak today at this conference.

It is our pleasure to invite you to a symposium sponsored by the University of Minnesota. There is no fee for this in-person symposium designed to bring together academia, veterinary science and research, public health, agriculture, and affiliated industry in Minnesota to discuss foodborne outbreaks of Salmonella. 

The goal of the symposium is to inform you with “behind the scenes” science and legal issues that occur during these outbreaks, to stimulate open discussion between groups from different backgrounds, and to promote future collaborative efforts between the different groups in attendance.

Our program features world-renowned experts on Salmonella biology, epidemiology, outbreak investigations, and food safety litigation. The program starts with a complimentary lunch, then takes a deep dive into the complex issues surrounding foodborne Salmonella from various perspectives. There will be opportunities for engagement and interaction with the audience and speakers, both during roundtable discussions and at the reception following our symposium.