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Marler Blog Providing Commentary on Food Poisoning Outbreaks & Litigation

Despite being on Colbert the AMI opposes making non-O157:H7 STECS adulterants

I just could not stay awake late enough to watch Colbert have fun with Pat Boyle the other night.  To me it looks like Pat “meat” his match.  Interestingly, the President just made a “recess appointment” of the person who will be part of making the adulterant decision:

Elisabeth Hagen, Nominee for Under Secretary for Food Safety, Department of Agriculture

Dr. Elisabeth Hagen is currently the USDA’s Chief Medical Officer, serving as an advisor to USDA mission areas on a wide range of human health issues. Prior to her current post, she was a senior executive in the USDA’s Food Safety and Inspection Service (FSIS), where she played a key role in developing and executing the agency’s scientific and public health agendas. She has been instrumental in building relationships and fostering coordination with food safety and public health partners at the federal, state, and local level. Before joining the federal government in 2006, Hagen taught and practiced medicine in both the private and academic sectors, most recently in Washington, DC. She holds an M.D. from Harvard Medical School, and a B.S. from Saint Joseph’s University. Dr. Hagen completed her specialty medical training at the University of Texas Southwestern and the University of Pennsylvania, and is board certified in infectious disease.

Below the video is the AMI’s position on non-O157’s as adulterants and mine.  I would love to hear your comments.

The Colbert Report Mon – Thurs 11:30pm / 10:30c
Better Know a Lobby – American Meat Institute

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Here is the AMI’s position on non-O157’s

Designating non-O157:H7 shiga-toxin producing Escherichia coli (STEC) as adulterants would result in a regulatory program that will do more harm than good, the American Meat Institute said in a letter to USDA Secretary Tom Vilsack.

There have been discussions within USDA and pressure from some legislators to broaden the adulterant criteria on E. coli in various ways, including expanding the list of pathogens considered adulterants on some beef products to include at least six of the many non-O157:H7 strains of E. coli.“Non-O157:H7 STECs in beef products may be a reason forpotential public health concern, but it is not a public health emergency,” AMI said in a news release in which it outlined eight actions it suggested USDA take to combat STECs in the beef supply.

1. Focus on Prevention: Any new regulatory programs that USDA contemplates should be addressed within the framework of the existing Hazard Analysis Critical Control Point regulation. USDA should commission a group of qualified experts to review the current science related to the development of a comprehensive farm-to-table preventative strategy for non-O157:H7 STECs in beef products and report their finding to USDA and other stakeholders.

2. Conduct a Comprehensive Public Health Risk Assessment: Conducting a public risk assessment that is subjected to public review before regulators embark on any regulatory program to control non-O157:H7 STECs in raw beef products will provide a better understanding of the public health issues association with non-O157:H7 STECs. For example, why have no confirmed outbreaks associated with beef products occurred in the U.S.? Why have non-O157:H7 STEC outbreaks occurred in other foods, but not in beef products? Why have non-O157:H7 STEC outbreaks associated with beef products occurred in other countries, but not in the U.S.?

3. Validate Analytical Laboratory Test Methods: USDA should openly share with the meat and poultry industry, testing laboratories and test kit manufacturers the sampling and analytical methods that the agency will use to implement any regulatory program and ensure that the analytical methods are peer-reviewed before any regulatory program is initiated. An accurate, validated rapid analytical test must be available to the industry to effectively implement any regulatory program that would make it illegal to enter product containing non-O157:H7 STECs into commerce.

4. Conduct a Baseline Survey of Non-O157:H7 STECs on Beef Products: It is imperative that FSIS conduct a baseline survey of beef products to include beef carcasses, ground beef and the raw materials used to manufacture ground beef in order to assess the impact of any new regulatory program that the agency may be contemplating. The baseline survey design and sampling and analytical methods should be published for public comment to solicit the advice and counsel of scientific and technical experts before proceeding with any such survey. A very limited amount of research has been conducted to assess the prevalence of non-O157:H7 STECs on beef products.

5. Measure Progress Based on the Public Health Outcome: If FSIS decides to further regulate non-O157:H7 STECs, it is prudent to evaluate the success or failure of any such initiative by actual illness reductions. In the case of beef, however, this is nearly impossible given that no non-O157:H7 STECs illness outbreaks have been confirmed in the U.S. This lack of documented outbreaks associated with beef products is remarkable given that approximately 95 percent of the public health laboratories reported in a recent survey that they are screening for non-O157:H7 STECs. If regulatory efforts to reduce non-O157:H7 STECs in beef products cannot generate measurable, positive public health outcomes, the underlying point of the exercise must be drawn into serious question.

6. Expedite Approval of New Microbial Interventions: USDA should convene a joint task force of all federal agencies that are involved in the approval of new microbial intervention technologies and the affected meat and poultry industry to identify approval roadblocks and to develop a better, expedited approval process that can rapidly move new technology to commercialization. New preventive technologies that are effective against all STECs are needed to control these pathogens before USDA considers making non-O157:H7 an adulterant on beef products.

7. Determine Impact on International Trade: USDA, the U.S. Trade Representative, and the Department of State should commission a study to determine the impact on international beef trade that would result from declaring non-O157:H7 STECs an adulterant on beef products. Such a policy shift will be viewed by our trading partners as erecting a non-tariff trade barrier to prevent entry of beef products into the U.S.

8. Provide an Open and Transparent Public Policy Process: If FSIS decides to further regulate non-O157:H7 STECs in beef products, it should only be done through notice and comment rulemaking. The questions surrounding non-O157:H7 STECs demand a disciplined, open, and transparent regulatory process. Any new regulatory program to control non-O157:H7 STECs will likely impose significant financial and regulatory burdens on the meat industry and these costs must be weighed against any public health benefit.

Here is my position on it:

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.

  • Sam

    “If we trust science…” Therein lies the root of the issue.
    As America becomes more ignorant, and less educated, science is increasingly viewed with hostility. As long as people like Sarah Palin and Glen Beck make it cool to be stupid, and uncool to be informed, science will take a back seat to greed and emotion.

  • doc raymond

    Bill, I am on your side on this as you know. And many within the Agency (FSIS) are beginning to also lean in your direction. The AMI list of 8 things that must be done before protecting American lives is laughable at best. Like we need to determine if our trading partners would like this or not? Come on. We made the decision to start testing trim coming into this country during my tenure, New Zealand did not like it, but we found contaminated trim and recalled it. And AMI’s call for more testing, research, public hearings and rule making would effectively delay implementation of calling non-0157 STECs as adulterants by at least ten years, and by then J Pat will be retired and soaking up the Sun somewhere saying I prevented this from happening under my watch.
    When 0157 was declared an adulterant, we did not have testing available to get results back in 8 hours. That evolved and so can testing for these pathogens. We just need someone at FSIS (like and Undersecretary) to push ARS to prioritize the research like we did for Bird Flu and Melamine.

  • JM

    Increased monitoring is only one aspect of a viable solution. The root causes as well as potential preventative measures (ie. kill steps such as phage, high pressure pasteurization, irradiation, etc.) need to be examined by a cooperative contingent representing industry, academia, and regulatory. The key word being “cooperative”. As long as individuals insist on making these issues political, the solutions will evade us and more people will be injured.
    The comment by Sam is a good example of what is wrong with this country. The left-right paradigm is one that needs to be retired in exchange for a more enlightened view. IF synergy can prevail, we just may have a chance at improving this situation.