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Marler Blog Providing Commentary on Food Poisoning Outbreaks & Litigation

Non – E. coli O157:H7 EHEC (O26, O45, O111, O121, O145, and O103) should be “Adulterants”

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-O157.jpgNon-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 too.

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.

  • John Munsell

    My perception is that the issue of declaring other EHEC serotypes of E.coli to be “Adulterants” is but a side issue. Please hear me out.
    To me, larger issues include FSIS’s blithe disregard for the adverse implications associated with these other EHEC’s. The mere decision to define all EHEC’s as adulterants will accomplish nothing, unless FSIS develops the courage to address another larger issue which is to Force the Source to implement meaningful corrective actions. Let’s be honest here: although FSIS piously proclaimed 0157:H7 to be an adulterant, the agency arduously circumvents tracebacks to the SOURCE, which is the originating slaugher plant.
    FSIS made friends with consumer groups and public health officials when it declared 0157:H7 to be an adulterant. So what? What actions and policies has FSIS implemented to aggressively require corrective actions in the gate-to-plate meat continuum? The agency is perfectly comfortable with assessing all liability against the downstream further processing plant, retail meat market, or institutions where “Adulterated” meat is detected. Therefore, if your local Safeway meat department unwittingly sells E.coli-laced meat, and their consumers are sickened, you guessed it, Safeway is solely accountable. The same scenario plays itself out if patrons at your local Olive Garden or Sizzlers get sick, or clients at your local nursing home. E.coli and Salmonella are enteric bacteria, which by definition emanate from within animals’ intestines, and proliferate on manure-covered hides. Well, Safeway, Olive Garden, Sizzlers, and nursing homes/hospitals/school cafeterias have no intestines or manure-covered hides on their premises. Nevertheless, when FSIS is left in charge of investigations, agency research starts and stops at the downstream destination facilities. FSIS monolithically resists tracebacks to the SOURCE of contamination. Why?
    Please know that 88% of America’s feedlot cattle are slaughtered at the Big 4 packers: (1) JBS-Swift (a Brazilian company), (2) Tyson, (3) Cargill, and (4) National Beef. These huge conglomerates, with multinational operations, enjoy enormous political clout. They also enjoy deep pockets, enabling them to legally challenge FSIS if the agency were ever stupid enough to attempt implementing meaningful corrective actions against any of these Big 4 packers. The Big 4 constitute a formidable litigation adversary, which the agency is loathe to challenge in court. In stark contrast, the smaller DESTINATION facilities lack political clout and the economic largesse to challenge the agency. Therefore, agency comfort is maximized by limiting its investigative work and enforcement actions against these feckless downstream destination facilities which innocently inherit meat which was previously contaminated with pathogens, which arrived at the downstream facilities in containers bearing the agency’s official Mark of Inspection which states “Inspected & Passed”. Strange as it may sound, FSIS inspects and passes E.coli.
    I suggest that public health’s primary enemy is NOT the label we place on pathogens (Adulterant versus Contaminant). Rather, the primary foe is the very government agency which claims it utilizes “An Abundance of Caution” to protect consumers from foodborne outbreaks, while it intentionally turns its back on the true SOURCE of unsafe food. Even if all the EHEC’s were labeled “Poison”, “Unfit for Human Consumption” or any deleterious label, the label has limited value as long as FSIS refuses to Force the Source to clean up its act.
    Decades ago, the Great Lakes were greatly polluted. How were they cleaned up? By identifying the sources of harmful discharge into the Lakes, and requiring these sources to eliminate their harmful discharges. Our government did NOT solve this problem merely by mandating that all destinations (municipalities as an example) clean all water removed from the lake. Although municipalities do indeed operate water purification facilities, such facilities did not clean up the Great Lakes. History has proven in countless occasions that ongoing problems are only solved when the source is detected, and to subsequently Force the Source to implement corrective actions. When the NASA Shuttle disintegrated several years ago when re-entering earth’s atmosphere, toxic debris was showered over several east Texas counties. If FSIS had been responsible for the ensuing investigation, FSIS would have concluded that the horrific accident was caused by inadequate air quality control standards in those east Texas counties because they allowed toxic debris to enter their air space. We would never claim that the accident would have been prevented if NASA had only previously declared that such toxic debris was considered to be “Adulterants”. Terminology changes are not the answer! Rather, changes in FSIS attitude to (a) determine the SOURCE of pathogens, and (b) to Force the Source to clean up its act is the answer.
    E.coli is NOT our ultimate enemy here! Our primary adversary is a government agency whose goal is to maximize its comfort level (don’t challenge the Big 4), and to assess all liability against downline destination entities, which includes allegedly ignorant consumers who fail to fully cook pathogen-laced meat. Yes, we stupid consumers are the primary culprit here, as proven by FSIS’s frequent reminders that we must use thermometers when cooking ground beef. Passing the buck didn’t clean up the Great Lakes, nor prevent additional Shuttle disasters.
    John W. Munsell, Manager
    Foundation for Accountability in Regulatory Enforcement (FARE)
    Miles City, MT

  • Brent

    Thank you for the informative article.
    How many clinical microbiology labs perform Shiga toxin testing in the US?
    FoodNet surveys show only 4% of labs surveyed in the FoodNet states test stools for ST.

  • Ken Linder

    Are there any commercially available tests for the six STEC strains currently available (Elizabeth Hagen recently stated that tests for 4 of the 6 are available — which are the 4, and who makes the tests)?

    thank you,

    Ken L.

  • FSIS in conjunction with Dow I believe has come up with 4 tests and are close to the other 2. IEH labs in Seattle did the testing for me and it worked well.