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USDA Should Declare non-O157 E. coli an Adulterant

Why Should the Food Safety and Inspection Service Declare Enterohemorrhagic non-O157 E. coli to be an Adulterant?



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 700 persons ill and 4 children dead.  The “9/11 for the food industry,” as a certain trial lawyer has occasionally referred to the outbreak, 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 Food Safety and Inspection Service’s (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 United States Department of Agriculture (USDA).  To promote its mission, FSIS has the power–under the Federal Meat Inspection Act (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 USDA 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 USDA was allowed to interpret the FMIA and that the USDA 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 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 Shiga toxin-producing E. coli (STEC) nationally notifiable.  The CDC subsequently referred to non-O157 STEC 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 enterohemorrhagic E. coli strain 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 enterohemorrhagic E. coli, not just O157:H7, again and again.  Representatives of the CDC estimate that non-O157 STEC causes 36,700 illnesses, 1,100 hospitalizations, and 30 deaths annually.  Nearly two years ago today, on October 17, 2007, the CDC and FSIS even went so far as to hold a public meeting to consider the public health significance of non-O157 STEC.  In the Notice of the meeting, FSIS referred to the “growing awareness that STECs other than E. coli O157:H7 (non-O157:H7 STECs) cause sporadic and outbreak-associated illnesses.”  Nevertheless, following the meeting, FSIS failed to re-interpret its policies.

This brings us to today.  We’re nearing the end of 2009, closing in on seventeen 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 enterohemorrhagic E. coli other than O157:H7.  It is 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 enterohemorrhagic STEC, including non-O157:H7 serotypes, to be adulterants within the meaning of the Federal Meat Inspection Act.  

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 enterohemorrhagic 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 enterohemorrhagic E. coli 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.

© Food Safety News
  • http://www.thewatchers.us Jim Bynum

    Other non-0157 serotypes of E coli –eg O29, O39, O145 produce shiga-like toxins, causing bloody inflammatory diarrhea, evoking Hemolytic uremic syndrome (HUS). According to the Oklahoma Department of Health, enterohemorrhagic Campylobacter, Shigella, Salmonella, and Yersinia may cause Hemolytic uremic syndrome (HUS) , a disease that destroys red blood cells and causes kidney failure, primarily affecting children. Furthermore, according to the Department of Health, “Not all cases of HUS are caused by shiga toxin; while uncommon, a variety of viral and bacterial infections, as well as some cancers, can cause HUS” Hospital cost for a HUS victim is about $100,000.00. Between 8% of HUS victims treated without antibiotics and 50% treated with antibiotics die.
    According to Meridian Bioscience, STEC infections are very serious because: 1) Antibiotics increase Shiga toxin release and production and should be avoided: 2) HUS [Hemolytic uremic
    syndrome] develops in 56% of STEC patients treated with antibiotics; 3) HUS develops in only 8% of STEC patients not receiving antibiotics; 4) 38%-61% of patients with STEC infection will develop Hemorrhagic Colitis; 5) 5%-10% of patients with STEC infection will develop HUS; 6)
    Approximately 10% of those with HUS will die or have permanent renal failure; 7) 30%-50% of all STEC infections are caused by E. coli non-O157; 8) 50% of HUS cases are caused by non-
    O157 strains of E. coli; 9) SMAC culture misses as much as half of all O157:H7 and all non-O157 strains of E. coli; and 10) Hospital cost of care for one HUS is approximately $100.000
    http://thewatchers.us/papers/fecal-coliform.html