According to Washington State Health, two Whatcom County residents are known to have been sickened by cheese tainted with E. coli O103, and test results showed a genetic link between their illness and Twin Sisters Creamery products. An additional case in Oregon has also been genetically linked. One is a child under five years old, and two are adults. One person was hospitalized. All illnesses occurred between September 5 and September 16, 2025.
It reminded me of the history of deeming additional Shiga-tozin producing E. coli as adulterants – including E. coli O103.
The history of deeming non-O157:H7 adulterants
E. coli strains as adulterants is a direct result of aggressive and persistent advocacy and litigation by the food safety law firm Marler Clark, following years of foodborne illness outbreaks. The effort was a critical expansion of food safety policy, building on the initial success of having E. coli O157:H7 declared an adulterant after the deadly 1993 Jack in the Box outbreak.
The precedent: E. coli O157:H7 is deemed an adulterant
The pivotal moment in U.S. food safety occurred in 1994, after the Jack in the Box outbreak sickened hundreds and killed four children.
- Trigger event: The outbreak was linked to undercooked hamburgers, with litigation handled by attorney Bill Marler.
- Legal precedent: As a direct result of this crisis and the ensuing litigation, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) declared E. coliO157:H7 an “adulterant” in raw ground beef.
- Major policy shift: This declaration was a dramatic shift from the prior stance that pathogens in raw meat were not adulterants. It established a zero-tolerance policy, making it illegal to sell ground beef contaminated with O157:H7.
The push for non-O157:H7 STEC adulterants
After 1994, public health experts, including Marler Clark, recognized that other Shiga toxin-producing E. coli (STEC) strains posed similar public health risks.
- Persistent outbreaks: Several high-profile outbreaks tied to non-O157 STECs occurred in the 2000s, including an O111 outbreak in Oklahoma in 2008 and O26 illnesses linked to Cargill ground beef in 2010.
- Marler Clark’s campaign: Bill Marler and his law firm, Marler Clark, took a leading role in advocating for regulatory change. Citing the ongoing illnesses and deaths, they repeatedly petitioned the USDA and FSIS to expand the adulterant classification to other dangerous STECs.
- Strategic actions: As part of their campaign, Marler Clark funded independent lab tests on ground beef to demonstrate the prevalence of non-O157 STECs. They published articles and gave presentations to press for action and public awareness.
The official regulatory change
The collective pressure from Marler Clark, other food safety advocates, and federal agencies culminated in a major regulatory announcement in 2011 and implementation in 2012.
- Final determination (2011): The FSIS officially determined that six additional STEC strains—O26, O45, O103, O111, O121, and O145—would be classified as adulterants in raw ground beef. This decision was announced in September 2011 and followed years of deliberation and public comment.
- Implementation (2012): FSIS began implementing a zero-tolerance policy for these six non-O157 STECs in raw beef trim in 2012.
- Expanded testing (2013): Over time, testing for these adulterants was expanded to include ground beef, bench trim, and other raw ground beef components.
The impact of the change
Deeming these non-O157 STECs as adulterants had a profound effect on the meat industry and public health.
- Legal accountability: It provided a new basis for legal action against companies whose products caused illness, aligning liability with the broader range of dangerous STEC pathogens, not just O157:H7.
- Industry innovation: The adulterant classification spurred the meat industry to develop new and improved testing methods, sanitation protocols, and risk-management strategies to prevent contamination.
- Public health improvement: The expanded testing and industry changes resulted in a significant reduction of illnesses from both O157:H7 and non-O157 STECs.
From a Blog Post in 2010:
In light of this weekends recall by Cargill Meat Solutions of approximately 8,500 pounds of ground beef products that may be contaminated with E. coli O26, and the sickening of three people, it is time for the United States Department of Agriculture (USDA) and Food Safety and Inspection Service (FSIS) to deem another six “enterohemorrhagic (EHEC) Shiga toxin-producing serotypes of Escherichia coli (E. coli) strains – O26, O45, O111, O121, O145, and O103 – “adulterants.”
Non-E. coli O157:H7 EHEC as “Adulterants.”
According to the CDC, E. coli O157:H7 causes 73,000 illnesses and 50 deaths every year in the United States. Another six E. coli strains – O26, O45, O111, O121, O145, and O103 – are considered less pervasive, sickening “only” an estimated 37,000 people a year and killing nearly 30. E. coli O157:H7 is considered an adulterant in beef by the USDA (particularly ground beef), the other six strains are not.
Under 21 U.S.C. § 601 … (m), the Federal Meat Inspection Act (FMIA), 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; …
It is hard to read the above and not think that the word “adulterated” does not apply to all E. coli. Presently, industry does not test for it because the USDA and FSIS does not require it – because they are not considered “adulterants.” In addition, only five percent of labs in the U.S. routinely test for these other E. coli leaving a gap in our food safety network and the true level of illness unknown.
Non-E. coli O157:H7 EHEC have been found in ground beef.
In 2008 Marler Clark hired a private lab to conduct a large-scale, nationwide study of ground beef, a key vector in E. coli O157:H7 cases. During the past year and a half, that lab has tested 5,000 samples from a variety of manufacturers. IEH Laboratories found that about 1 percent of the samples were tainted by E. coli O26, O45, O111, O121, O145, and O103. The results and the testing methodology have been shared with USDA and FSIS and the beef industry.
A history of E. coli O157:H7 as an “Adulterant” and why other EHEC’s should be.
It seems that any serious discussion of E. coli O157:H7 always has to start with one event: the 1993 outbreak associated with the Jack in the Box restaurant chain. This, of course, is with good reason. That outbreak left over 650 persons ill (many with life-long complications) and 4 children dead. The “9/11 for the food industry,” precipitated a whirlwind of events including media coverage, consumer outrage, lawsuits, and stricter federal regulations regarding meat safety. Though the swell of emotion that spiraled out of the Jack in the Box disaster dulls somewhat with each passing year, the federal regulations that sprung up in its wake continue to generate more questions.
To understand the significance of these regulations, a little background information is useful. The FSIS stated mission renders it “responsible for ensuring that the nation’s commercial supply of meat, poultry, and egg products is safe, wholesome, and correctly labeled and packaged.” FSIS operates as part of the USDA. To promote its mission, FSIS has the power under the FMIA to, among other things, seek the recall of products that have been deemed “adulterated.” FSIS drastically shifted how it interpreted and enforced the FMIA in 1994 when, following the Jack in the Box outbreak, the agency declared E. coli O157:H7 to be an “adulterant.” This marked a dramatic change from its previous stance that pathogens in raw meat were not “adulterants.”
The declaration of E. coli O157:H7 as an “adulterant” was met with strong opposition from the meat industry. In a lawsuit filed soon after the 1994 declaration, the industry accused the FSIS of not following proper rulemaking procedures and of acting in an arbitrary and capricious manner beyond its legal authority. The United States District Court held, however, that the FSIS was allowed to interpret the FMIA and that the FSIS has the power to declare substances to be “adulterants” with the intended purpose of spurring the meat industry to create and implement preventative measures.
During the early part of this decade, however, it became readily apparent that E. coli O157:H7 was not the only deadly pathogen in E. coli family – in fact, far from it. The Centers for Disease Control (CDC) recognized this fact when, in 2000, the agency made all EHEC’s nationally notifiable. The CDC subsequently referred to non-O157 EHEC’s as emerging pathogens that pose a significant health threat, with more strains reported every year.
Still, FSIS remained steadfast in its stance that O157:H7 is the only EHEC that should be deemed to be an adulterant. So what’s wrong with FSIS’s position regarding E. coli O157:H7? The simple answer is this: the people of this nation do not deserve another Jack in the Box-sized catastrophe as a pre-requisite for currently needed agency action.
The scientific and medical communities have recognized the dangers of all EHEC’s, not just O157:H7. Nearly three years ago, on October 17, 2007, the CDC, FDA and FSIS even went so far as to hold a public meeting to consider the public health significance of non-O157 EHEC’s. In the Notice of the meeting, FSIS referred to the “growing awareness that EHEC’s other than E. coli O157:H7 cause sporadic and outbreak-associated illnesses.” Nevertheless, following the meeting, FSIS failed to re-interpret its policies.
It is time for the USDA and FSIS to deem another six EHEC strains – O26, O45, O111, O121, O145, and O103 – “adulterants.”
This brings us to today. We’re nearing the end of 2010, closing in on eighteen years since the Jack in the Box outbreak. Millions of Americans have suffered foodborne illnesses, injuries, and deaths in that time, thousands of them likely due to EHEC’s other than E. coli O157:H7.
It was on behalf of those persons that the law firm of Marler Clark has authored a petition to FSIS requesting the agency to issue an interpretive rule declaring all EHEC’s to be adulterants within the meaning of the FMIA. The petition details the scientific and legal bases for the requested action, but perhaps more importantly it details the suffering that food contaminated with non-O157:H7 E. coli inflicted upon three individuals: June Dunning, Megan Richards, and Shiloh Johnson. Ms. Dunning, whose infection was caused by E. coli O146:H21, unfortunately succumbed to her illness, passing in 2006. Ms. Richards and Ms. Johnson endured lengthy hospitalizations, kidney failure, and will both endure a lifetime of medical complications as a result of their E. coli O121:H19 and E. coli O111 infections (respectively).
It would be naïve to assume that a change to FSIS policy will immediately rid the world of all foodborne E. coli infections. It has been unequivocally proven, however, that all EHEC’s are potentially lethal pathogens that we must fight tooth and nail to keep out of this nation’s food supply. If we trust science, and do our part to push government agencies to enact regulations to require better monitoring, we can no doubt begin to prevent further harm. In the end, after all, the requisite wading through the mess of bureaucracy required to change federal regulation is all worth it, so long as the outcome prevents at least one more case like that of June Dunning, Megan Richards, or Shiloh Johnson.