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Marler Blog Providing Commentary on Food Poisoning Outbreaks & Litigation

A bit(e) of history – It is now time for the USDA and FSIS to deem another six EHEC E. coli strains – O26, O45, O111, O121, O145, and O103 – “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.

  • Joan

    Can you help me understand the relationship between generic E. coli testing and EHEC’s? Is it possible that EHEC’s may be detected in a sample that tests positive for generic E. coli? I don’t know enough about the science behind this micro testing…thanks!

  • doc raymond

    BIll, after the 2007 meeting, changes were initiated. At that meeting, it became obvious that we did not have a good estimate of the number of food borne illnesses caused by the non-O157 STECs because few labs were even testing for them. Secondly, we did not have testing that could be relied upon for accuracy when sampling ground beef and thirdly, we did not have any estimate of the frequency with which ground beef was contaminated. FSIS began testing ground beef shortly after the meeting, the Ag Research Service of USDA began developing testing protocols for ground beef and public health labs were encouraged to begin testing of human specimens for non-O157s. Those deficiencies have now been corrected and I agree that it is time to declare these deadly pathogens as adulterants, but it was not prudent to do so in 2007.
    Also, the new CDC estimates of foodborne illnesses, published in the January 2011 journal “Emerging Infectious Diseases” present an even stronger case than the older numbers you cite in this blog. Since testing for non-O157s has increased we have become more informed of the frequency, and the CDC now estimates 113,000 foodborne illnesses annually from them. The O157 estimate has dropped to 63,000 but only 20 deaths.

  • John Munsell

    FSIS bureaucrats will steadfastly resist declaring any other pathogens to be adulterants, because the agency would then force itself to implement enforcement actions against noncompliant meat & poultry plants.
    To the agency’s benefit, USDA-style HACCP has essentially deregulated the industry’s biggest players from any meaningful gov oversight. At the same time, HACCP has resulted in hyper-regulation of small plants, but that is a story for another time. FSIS is paralyzed with fear of litigation emanating from the industry’s biggest players, and for good reason. When the agency rolled out HACCP, FSIS promised the industry that the agency would embrace a “Hands Off” non-involvement role. Secondly, FSIS promised it would disband its previous command and control authority. Also, FSIS stated that it would no longer police the industry, but that the industry would police itself. FSIS has forgotten lessons from Upton Sinclair.
    Therefore, if a future outbreak occurs caused by one of the non-O157:H7 STECs, what can the agency ethically do about it? How can FSIS initiate enforcement actions against the source of contamination, realizing the agency has unilaterally devolved into a “Hands Off”, non-policing entity committed to not policing the industry? FSIS can’t have it both ways: it can’t go into retirement, then subsequently re-energize itself and reassume authority when an outbreak occurs. This would constitute Bait & Switch. FSIS unwittingly painted itself into a feckless corner when it mandated its version of HACCP, hoping against hope that a deregulated industry would unilaterally devise fool-safe food handling protocol which would mostly eliminate food borne pathogens. Unfortunately, these pathogens mutate more quickly than we can develop efficacious interventions.
    Many inspection personnel believe that FSIS introduced HACCP primarily to minimize the agency’s legal accountability in the event of outbreaks. After all, how can FSIS be held even partially responsible for contaminated meat which the agency didn’t inspect in the first place? It has been suggested that USDA-style HACCP be renamed “HASSLE”, as in Hazard Analysis, Sorta Scientific, Liability Evasion”, an apt description for USDA-style HACCP.
    Allowing the industry to police itself would also insulate the agency from the discomfort associated with enforcement actions against the biggest plants, which enjoy political clout and deep pockets to engage the agency in lenghty litigation. Thus, HACCP has become a source of COMFORT to an agency which lacks the courage to challenge the industry’s giants.
    FSIS is fully cognizant of the adverse media criticism the agency will face if these non-O157:H7 STEC’s are declared adulterants, while the agency lacks due diligence to require noncompliant plants to remove these bugs from their products. FSIS does NOT desire police authority at the large plants, preferring its current semi-retirement status, gratis USDA-style HACCP, which by the way, is NOT HACCP. Pillsbury’s original HACCP protocol was intended for consistently safe, ready to eat food products. Plants which produce consistently safe food do indeed deserve deregulation. However, raw meat and poultry products by their very nature harbor pathogens in the absence of a kill step, disqualifying them from HACCP’s deregulatory benefit. FSIS intentionally ignores this fact, and blithely states that all USDA-inspected plants must have HACCP Plans, which pale in comparison to true Pillsbury-style HACCP protocol. By a mere sweep on its rule-making process, FSIS requires all plants to have HACCP Plans, which then justifies the agency to go into semi-retirement. This relaxed, comfortable agency apathy will be upset by declaring all these other lethal bugs to be adulterants, forcing FSIS into action, which is prohibited by the agency’s public pronouncements of its new “Hands Off’ non-inspection role. Any attempt by the agency to reassert itself into meaningful oversight is against the very heart of HACCP.
    Premier examples of agency unwillingness to (a) detect the SOURCE of contamination, and (b) force the SOURCE to implement corrective actions are recent agency admissions. Less than one year ago, on Oct 8, 2010, FSIS issued Notice 58-10 which requires inspectors to document supplier information when collecting meat samples for lab analysis. It is hard to comprehend that the agency had historically prohibited inspectors from timely documention of all source evidence in the past! This prohibition was certainly a non-scientific, biased protocol.
    Secondly, USDA Sec Tom Vilsack made the following statements on August 3, 2011:
    “Another tool we are using to reduce illnesses from ground beef is tracing adulterants to the source – the very point of contamination”. Odd…….why hasn’t the agency been doing this from day one? Answer: FSIS doesn’t want to, and HACCP is their excuse.
    “In 90 days, I expect the agency to announce the first step in transforming our traceback policy”. I ask again, why hasn’t FSIS been aggressively pursuing meaningful traceback policies since time immemorial? Answer: FSIS doesn’t want to identify the true SOURCE, because the agency would then be forced to implement delicately uncomfortable enforcement actions at the SOURCE, an uncomfortable task which the agency ardently avoids.
    Even if these non-O157:H7 STEC’s are declared adulterants, any meaningful benefits will be short-circuited by FSIS’s commitment to semi-retirement, which subjugates public health to secondary status. The ultimate enemy we face here is FSIS lethargy, an unwillingness to force the source to clean up its act, regardless of the size of the source plant. Secondly, USDA-style HACCP is the apron behind which the agency hides, while its wrings its hands with the excuse that it can’t police the industry. Admittedly, such changes will require monumental mid-course revisions in failed FSIS HACCP thinking. FSIS is faced with one primary decision at this point in time: is its primary focus agency comfort, or public health? If public health concerns win out, USDA-style HACCP must change, which will then empower the agency to do something about these non-O157:H7 STEC’s.
    Improving Public Health considerations requires much more than mere “Adulteration” classifications (which are good in themselves). It requires FSIS to proactively determine the true SOURCE of contamination, and to aggressively force the SOURCE to clean up its act. As long as FSIS is allowed to primarily focus at the downstream destination entities which unwittingly purchase meat which is laced with invisible bacteria, outbreaks and recalls will remain a part of our normal daily lives. We deserve better. And we deserve a FSIS whose primary focus is Public Health.
    John Munsell

  • Minkpuppy

    Joan,

    It is absolutely possible that EHEC’s could be found in samples that test positive for generic e. coli. Generic E. coli testing is a tool used to show the possible presence of pathogenic fecal bacteria in a sample. That fecal bacteria could be EHECs, Salmonella, or Campylobacter to name a few. High levels of generic E. coli should prompt the lab/establishment to do more specialized testing for the presence of specific pathogens.

  • Margaret

    Bill, in your opinion, should we also be testing for E coli 0104, the one responsible for such a large and devastating outbreak this past summer in Germany ?

  • Short answer is that IMHO all pathogens should be adulterants (this is the way the FDA does it). Testing for pathogens is always an evolving science. I am happy to do the “big six” for now and move to others as the science develops.