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It’s Time to Move on non-O157:H7 STECs

Editor’s Note: This opinion piece was written by Carol L. Tucker-Foreman and Richard A. Raymond, M.D. [1]


It’s Time to Move the Needle on non-O157:H7 STECs

The massive 1993 Jack in the Box E. coli O157:H7 foodborne illness outbreak was a seismic event that moved the food safety needle toward greater public health protection. It caused over 650 illnesses and four deaths, introduced the public to the dangers of this previously little-known pathogen, proved foodborne illness was more than “just a stomach ache,” and resulted in the U.S. Department of Agriculture declaring that any amount of the pathogen in ground beef rendered the product adulterated.

  

E. coli O157:H7 is different from other common foodborne pathogens.  The powerful substance it exudes, called Shiga toxin, causes bloody diarrhea.  As few as 50 bacteria can be infective.  The illnesses  progress to Hemolytic Uremic Syndrome (HUS) in 8 percent of its victims and brings death to too many of our children and other vulnerable individuals.

The USDA’s Food Safety and Inspection Service (FSIS) quickly adjusted to the reality of this new pathogen and, in 1994, issued an interpretive rule  declaring that any amount of E. coli O157:H7 rendered ground beef adulterated.  The rule required that the adulterated product be removed from commerce and be diverted to cooked product or destroyed. The agency also began  testing for E. coli to assure process controls were effective. Industry invested time, money and creativity in the effort to find E. coli O157:H7 and keep it out of ground beef.   Together, industry and FSIS moved the needle toward safer meat.

 

But our ground beef is still not safe enough.  We now know that other species of E. coli also produce the powerful Shiga toxin, are similar to O157 in virulence, and are much more prevalent than we once thought. These newly emerging pathogens are known, collectively, as non-O157:H7 Shiga-toxin producing E. coli, or non-O157 STECs.  Six of them, O26, O111, O103, O45, O121 and O140, are responsible for foodborne illnesses that have developed into Hemolytic Uremic Syndrome (HUS). These are often referred to as “The Big Six”.

 

Like E. coli O157:H7 in 1993, the dangers presented by the “Big Six” STEC serotypes aren’t well-known.  Most Americans are completely unaware of them.

 

The Centers for Disease Control and Prevention (CDC) did not begin analyzing and reporting illnesses caused by the non-O157 serotypes in the Morbidity and Mortality Weekly Report (MMWR) until 2004.  Now that they are reported, it is increasingly clear that the non-O157 STECs contribute to a significant amount of foodborne illness.

 

The non-O157 STECs may be new and emerging pathogens, but it is also possible that they’ve been out there for years, causing people to get sick and die but were invisible because no scientists or laboratories were  looking for them.

 

What we do know now is that the CDC’s annual reports on the incidence of foodborne illness in the U.S., published in the Mortality and Morbidity Monthly Report (MMWR), reveal an increase in  non-O157 STEC illnesses in nearly every year from 2000 thru 2007, as follows :

INCREASE IN REPORTED CASES OF NON-O157 STECs (2)

Year   Number of illnesses  Rate of Illnesses per 100,000 population

2000           51                            0.12

2004         106                            0.23

2006         209                            0.46

2007         260                            0.57

The CDC report numbers reflect only the FoodNet catchment areas that represent 15 percent of the U.S. population. The total number of documented cases across the country is larger.  Unfortunately, the CDC estimates that, even now, fewer than 10 percent of laboratories test for these pathogens. As a result, most of the illnesses continue to go unrecognized.  It’s unlikely that the number of cases of non-O157 STECs will decline if there is no organized program to prevent and control them.

 

After Jack in the Box, we often referred to E. coli O157:H7 as “the rare but virulent” pathogen but once laboratories were required to test for it we found it was not so rare.

  

Still, many people, including author and attorney Shawn Stevens, have the misconception that non-O157 STEC illnesses are uncommon. He wrote recently in Meatingplace.com that the “other non-O157 strains such as O111 and O145 which, though rare, (emphasis added) can … cause illness” [3]

The evidence shows  these pathogens are far more common and cause more illness than previously recognized.

● The January 2011 CDC report updating data on foodborne illness in the U.S. illustrates that public perceptions lag behind reality.  The annual case rate for E. coli O157:H7 is 63,000 and for Listeria Monocytogenes, it is 1,591.  Both of these are far lower than the so-called rare non-O157 STECS that cause 113,000 cases of foodborne illness each year. [4]

    

●The most recent CDC FoodNet Report for the year 2009 reveals that, at several of the FoodNet sites, non-O157 STECs are found to cause illnesses more frequently than the declared adulterant E. coli O157:H7. [5]

  

●The rate of foodborne illnesses caused by non-O157 STECs and O157 is now about the same in children less than 4 years of age, perhaps our most vulnerable population. These are nasty pathogens, not to be taken lightly. And they are not rare.

In 2007, USDA’s Undersecretary for Food Safety was informed that some state public health labs were seeing as many non-O157 STEC infections as they were O157 illnesses. In response, FSIS, along with FDA and CDC, held a day-long information gathering session on the importance of non-O157 STECs and the public’s health. During that meeting, it became clear that two hurdles prevented FSIS from moving forward:  the agency had no solid numbers on the rate of non-O157:H7 STECs contaminating ground beef and  commercially available tests for these pathogens were not yet fully developed.

After this revelation, the FSIS immediately began joint efforts with the USDA’s Agricultural Research Service to speed the development of consistent and convenient testing methodologies for non-O157 STECs. The two agencies recently completed test development and testing kits and protocols are available for all of the Big Six non-O157 STECs.  They were preparing to move the needle toward more public health protection.

  

Soon aft
er the 2007 meeting, FSIS began testing ground beef for non-O157 contamination, but the agency has not  made the results public.

  

However,  Dr. Mansour Samadpour of IEH Laboratories and Consulting Group in Seattle reported at the “7th International Symposium on Shiga Toxin Producing E. coli” that his lab tested approximately 5,000 samples of ground beef purchased at retail stores and found non-O157 STECs in 1.9 percent of the samples. One positive out of every 50 packages sampled suggests a high rate of contamination. It is more proof that the pathogens exist in our food supply and make people sick.

  

The USDA Meat Animal Research Center, located in Clay Center, NE, has also done extensive testing not only for non-O157 STECs in ground beef but also on the relative virulence of the serotypes found.  Their most recent research results, published in March, 2011, can be found at: www.ncbi.nlm.nih.gov/pubmed/21257806.

We expected that, with the completion of the research and development work, the agency would be ready to move quickly to declare these pathogens to be adulterants and to begin testing for them, but there has been no further action.  We were encouraged in our belief by President Obama’s March 14, 2009 speech in which he pledged new attitudes and policies to address weaknesses in the national food safety system. “…there are certain things that we can’t do on our own,” he said. “There are certain things only a government can do. And one of those things is ensuring that the foods we eat, and the medicines we take  are safe and don’t cause us harm.

The FSIS  acted to carry out the President’s pledge. It prepared a rule declaring non-O157 STECs adulterants in ground beef and requiring  testing for them.  We’re confident that the kind of preventive action proposed by FSIS is far better than waiting until  problem with non-O157 STEC foodborne illness reaches seismic proportions, like another Jack in the Box.

 

The truth is that, if you don’t look for these pathogens, you will not find them until after they’ve already made people sick. The numbers cited earlier indicate at least the potential for another seismic event, a large outbreak and needless illnesses and deaths. The difference now, as compared to 1993, is that we are forewarned.

However, the FSIS’s effort to follow through on the President’s pledge has not been approved by the White House Office of Management and Budget.  It is opposed by the American Meat Institute and some of our trading partners.  In the case of AMI, its position is consistent with its opposition to declaring E. coli O157:H7 an adulterant.  The AMI strongly opposed testing for O157 when it began and now opposes requiring meat companies to test for the “Big Six” non-O157 STECs.

  

Some foreign countries may be concerned because, while they haven’t found much E. coli O157:H7 in ground beef and trim, they have had occasional findings of  Non-O157 STECs.

  

We think it is just good sense for anyone who has an interest in promoting the sale and use of ground beef to do everything possible to assure that it is free of pathogens, especially the virulent Shigatoxin producing E. coli serotypes. Anyone who opposes using every tool available to fight these virulent pathogens should try explaining their position of opposition to the parents of a child suffering kidney failure after contracting HUS from one of those strains of E. coli, or to the family of a Korean War veteran who lost their father to the poisoning.

   

There are real people whose lives have been tragically altered by the presence of virulent pathogens in meat that bears the USDA seal of inspection.  These pathogens are considered adulterants as defined by the Federal Meat Inspection Act. Currently, the U.S. government is not meeting either the letter of the law nor the societal expectation that our food will not make us sick.  We urge the President, his appointees and the industry to join us in supporting FSIS’s efforts to get non-O157 STECs out of our ground beef. 

——————————–

[1] Carol L. Tucker-Foreman was USDA Assistant Secretary for Food and Consumer Services, 1977-81. Her responsibilities included the Food Safety and Inspection Service, the Food and Nutrition Service and elements of the Agricultural Marketing Service.  Richard A. Raymond, M.D., was USDA Undersecretary for Food Safety, 2005-2008.


[2] CDC. 2010. Preliminary FoodNet Data on the Incidence of Infection with Pathogens Transmitted Commonly Through Food — 10 States, 2009 Report. Mortality and Morbidity Weekly Report (MMWR). Ap 16;59(14) 418-422. 

Accessed at www.cdc.gov/foodnet/reports.htm


[3] April 4, 2011, Meatingplace.com blog Accessed at  www.meatingplace.com/MembersOnly/blog/BlogDetail.aspx?blogID=37

[4] Scallon, et al. 2011. Foodborne Illness acquired in the U.S.–major pathogens. Emerging Infectious Disease


[5] CDC Ibid.

© Food Safety News
  • Brad

    Well said Dr. Raymond and Mrs. Tucker-Foreman. That’s just more proof that the AMI cares more about money than they do public health.

  • http://www.foodborneillness.org pbuck

    Thank you Carol and Dr. Raymond for an excellent presentation about the current status on the non-O157 STECs. Our country needs to start addressing this problem now! To continue to ignore the potential harm to American consumers, especially its children, is unacceptable. The “Big Six” need to be declared adulterants in food — we have adequate proof and testing procedures in place — all we need is the will to demand what is right.
    Sincerely,
    Pat Buck
    Director of Outreach & Education
    Center for Foodborne Illness Research & Prevention
    http://www.foodborneillness.org
    724-458-0767

  • jmunsell

    No one will contend that non-O157:H7 STEC’s should be allowed to remain in meat. My perception is that whether these six STEC’s are classified as “adulterants”, “contaminants”, or any other title, the primary reason for ongoing outbreaks is that FSIS endorses the right of source slaughter plants to ship these STEC’s into commerce, with full agency approval. Huh? FSIS allows source slaughter plants to ship into commerce intact cuts of meat which are “ONLY” surface-contaminated with E.coli O157:H7, since O157:H7 (according to FSIS) is but a mere “contaminant” at that time, a relatively feckless bug ostensibly incapable of causing consumer sicknesses. But in a furtive sleight of hand, FSIS then states that when the downstream further processing facilities and retail meat markets cut those intact cuts into steaks, roasts, stew, ground beef etc, then those heretofore harmless “contaminants” supernaturally transmorgriphy themselves into lethal “adulterants”. I suggest that public health would more benefit from FSIS’ implementing enforcement actions at the true SOURCE of STEC-contamination of meat, and to consider STEC’s as pathogens at all stages of meat production, not simply after the intact cuts have been further processed. This means that FSIS should consider all STEC’s as injurious to health starting in the beef chill cooler, immediately after the kill floor. If the STEC is discovered on carcasses in the chill cooler, or on intact boxed beef cuts, in trim as well as in ground beef, FSIS must treat the bug with equal disrespect in whatever form the bug is detected. FSIS disagrees with me.
    For what it is worth, I suggest that public health may not necessarily benefit merely by FSIS coyly declaring that these 6 STEC’s be classified as “adulterants”. Who cares about a name change, when the agency allows the pathogen, whatever it is named, to be shipped into commerce bearing the official USDA Mark of Inspection, with full agency endorsement?
    John Munsell

  • Tony Corbo

    This is an excellent piece. I sure hope that OMB is paying attention so that any inter-agency squabbling on this issue is put to rest.

  • http://www.marlerblog.com bill Marler

    Thanks Dr. and Carol. For those that want a bit more information see this link and download my Petition:
    http://www.marlerblog.com/lawyer-oped/it-is-past-time-for-the-usdafsis-to-deem-the-big-six-e-coli-as-adulterants/

  • http://www.consumerfed.org Carol L. Tucker-Foreman

    Responding to John Munsell’s comment
    John, CFA agrees with you that:
    1. FSIS should trace any E. coli O157:H7 positive back to the slaughter house, not just those associated with outbreaks. Doing so would reduce the amount of E. coli O157:H7 moving in commerce and might identify companies that are not as vigilant as they should be.
    2. Declare pathogenic E. coli in mechanically tenderized beef an adulterant, require companies to test their mechanically tenderized products, and do their own testing as part of the regulatory process.
    You suggest that FSIS should also declare pathogenic E. coli serotypes adulterants in whole pieces of meat (steaks, roasts, etc). You may know of cases where people have gotten sick from eating E. coli contaminated steaks or roasts. FSIS would probably need such records in order to withstand the inevitable court challenge to such an action. It has been assumed that pathogens present on whole pieces of meat are not a risk because they are on the surface and quickly killed by cooking heat. However, surface pathogens do create a risk of cross-contamination.

  • http://www.foodborneillness.org Patricia Buck

    Thank you Carol and Dr. Raymond for an excellent presentation about the current status on the non-O157 STECs. Our country needs to start addressing this problem now! To continue to ignore the potential harm to American consumers, especially its children, is unacceptable. The “Big Six” need to be declared adulterants in food — we have adequate proof and testing procedures in place — all we need is the will to demand what is right.
    Sincerely,
    Pat Buck
    Director of Outreach & Education
    Center for Foodborne Illness Research & Prevention
    http://www.foodborneillness.org
    724-458-0767

  • John Munsell

    No one will contend that non-O157:H7 STEC’s should be allowed to remain in meat. My perception is that whether these six STEC’s are classified as “adulterants”, “contaminants”, or any other title, the primary reason for ongoing outbreaks is that FSIS endorses the right of source slaughter plants to ship these STEC’s into commerce, with full agency approval. Huh? FSIS allows source slaughter plants to ship into commerce intact cuts of meat which are “ONLY” surface-contaminated with E.coli O157:H7, since O157:H7 (according to FSIS) is but a mere “contaminant” at that time, a relatively feckless bug ostensibly incapable of causing consumer sicknesses. But in a furtive sleight of hand, FSIS then states that when the downstream further processing facilities and retail meat markets cut those intact cuts into steaks, roasts, stew, ground beef etc, then those heretofore harmless “contaminants” supernaturally transmorgriphy themselves into lethal “adulterants”. I suggest that public health would more benefit from FSIS’ implementing enforcement actions at the true SOURCE of STEC-contamination of meat, and to consider STEC’s as pathogens at all stages of meat production, not simply after the intact cuts have been further processed. This means that FSIS should consider all STEC’s as injurious to health starting in the beef chill cooler, immediately after the kill floor. If the STEC is discovered on carcasses in the chill cooler, or on intact boxed beef cuts, in trim as well as in ground beef, FSIS must treat the bug with equal disrespect in whatever form the bug is detected. FSIS disagrees with me.
    For what it is worth, I suggest that public health may not necessarily benefit merely by FSIS coyly declaring that these 6 STEC’s be classified as “adulterants”. Who cares about a name change, when the agency allows the pathogen, whatever it is named, to be shipped into commerce bearing the official USDA Mark of Inspection, with full agency endorsement?
    John Munsell

  • jmunsell

    Thank you Carol for your comments. I suggest that risk associated with cross-contamination is greatly understated. Is a rattlesnake only lethal when in the wild? It is lethal wherever it is found……same with E.coli O157:H7 and the other six non-O157:H7 STECS. Bottom line: AFTER a carcass exits the kill floor, the pathogen should be considered lethal, regardless of which form in which it resides.
    John Munsell

  • doc raymond

    John, you know I agree. That boxed beef will eventually end up to a degree as trim and some will go into ground beef. And the steak? As you said, cross contamination will always occur, despite our best efforts. I am tiring of treating beef of any cut as a toxic visitor to my kitchen counter.

  • John Munsell

    Thank you Carol for your comments. I suggest that risk associated with cross-contamination is greatly understated. Is a rattlesnake only lethal when in the wild? It is lethal wherever it is found……same with E.coli O157:H7 and the other six non-O157:H7 STECS. Bottom line: AFTER a carcass exits the kill floor, the pathogen should be considered lethal, regardless of which form in which it resides.
    John Munsell

  • http://www.consumerfed.org Carol L Tucker-Foreman

    John, Dick and I agree that meat contaminated with pathogenic E. coli presents a serious risk of cross contamination. The dangers of cross contamination are a given. “Avoid cross contamination” is one of 4 basic food safety education messages.
    The problem of getting from there to a policy decision is lack of data. No one has attempted to quantify the number of steaks and roasts contaminated with pathogenic E. coli, the number of illnesses caused by contaminated whole pieces of meat, or how often a STEC-related illness is the result of other foods, such as fresh produce, being contaminated by contact with whole cuts of meat that contain pathogenic E. coli. (For example, there was a large outbreak of E. coli O157:H7 illness several years ago, traced initially to lettuce and, ultimately, back to E. coli contaminated raw steak that had been stored above the lettuce and dripped contaminated blood and juices on it. The lettuce was used in a salad bar.)
    USDA sponsored research has usually specifically ignored the risk of illness created by cross contamination. In 2002, the FSIS released a risk assessment that asserted ground beef did not create a high risk of E. coli poisoning, if it was cooked properly. The risk assessment completely ignored cross contamination. The same flaw has been built into studies of the risk presented by mechanically tenderized whole pieces of meat.
    My bottom line is that we and others need to urge FSIS, FDA and CDC to do those studies, trace back the illnesses, and gather the data needed to present an unimpeachable case for declaring that whole pieces of meat contaminated with pathogenic E. coli are adulterated.
    John, there is no justification for FSIS continuing to reject our argument that all E. coli O157:H7 positives found by FSIS personnel in regulatory sampling should be tracked back to the slaughter plant from which the meat originated.

  • Micky

    So stop eating meat already! It’s proven to be a dangerous product and consuming it is unnecessary. There are many beautiful plant proteins that don’t relate to animal slaughter. Why risk your life or the lives of your loved ones for a hamburger….a glorified term for ground up animal corpses?

  • jmunsell

    Mickey: even your “beautiful plant proteins” frequently harbor lethal pathogens, and have caused many outbreaks, recalls, and deaths.
    Carol, I am encouraged by your comment that E.coli O157:H7 positives should be traced back to the slaughter plant from which the meat originated. Let’s get to the point quickly here: WHY is FSIS unwilling to trace back to the slaughter plant? I suggest for two reasons:
    1. The FSIS is paralyzed with fear of litigation from the big packers if the agency were ever bold enough to (a) trace back to the packers, and (b) attempt to initiate meaningful enforcement actions at the big packing establishment. Why is the agency fearful of litigation?
    2. Because the FSIS truly deregulated the largest packers when it introduced FSIS-style HACCP. Realizing that the agency promised our industry that the agency’s role under HACCP would be “Hands Off”, that the agency would no longer police us, that the FSIS would disband its previous command and control authority, and that the FSIS could not tell plants what must be in their HACCP Plans, any subsequent attempt by the agency to reassume any of those functions would constitute a breaking of its contract with the industry, and is illegal. The agency can’t have it both ways. Furthermore, realizing that many FSIS retirees go to work in the industry after retiring from FSIS, agency bureaucrats are unwilling to initiate enforcement actions against their future employers.
    Carol, I respectfully submit to you that FSIS-style HACCP is the most formidable obstacle to Food Safety which is facing us today. I submit to you that we should go back to the original organoleptic-based meat inspection system we had, and couple with it microbial testing of products (like you suggest above), along with Pillsbury-style HACCP activities such as a Hazard Analysis, CCP’s, SSOP’s, etc. Plants which make RTE products which have been exposed to a kill step, and whose microbial test results validate that their Kill Steps are truly efficacious, do qualify for deregulation. Plants producting raw meat & poultry do not qualify for deregulation, and must submit to the combination of organoleptic and HACCP meat inspection requirements as I suggest above. It is essential that inspectors and their supervisors are again empowered with authority to police plants, coupled with command and control authority.
    Frankly, our government must maintain a meaningful oversight of meat production, but FSIS-style HACCP disagrees. Until agency bureaucrats are willing to make such common sense mid-course corrections in its failed HACCP Hoax, we will continue to experience an inappropriately high incidence of outbreaks.
    “Who’s on first”? Not the FSIS, by intentional agency design.
    John Munsell

  • John Munsell

    Mickey: even your “beautiful plant proteins” frequently harbor lethal pathogens, and have caused many outbreaks, recalls, and deaths.
    Carol, I am encouraged by your comment that E.coli O157:H7 positives should be traced back to the slaughter plant from which the meat originated. Let’s get to the point quickly here: WHY is FSIS unwilling to trace back to the slaughter plant? I suggest for two reasons:
    1. The FSIS is paralyzed with fear of litigation from the big packers if the agency were ever bold enough to (a) trace back to the packers, and (b) attempt to initiate meaningful enforcement actions at the big packing establishment. Why is the agency fearful of litigation?
    2. Because the FSIS truly deregulated the largest packers when it introduced FSIS-style HACCP. Realizing that the agency promised our industry that the agency’s role under HACCP would be “Hands Off”, that the agency would no longer police us, that the FSIS would disband its previous command and control authority, and that the FSIS could not tell plants what must be in their HACCP Plans, any subsequent attempt by the agency to reassume any of those functions would constitute a breaking of its contract with the industry, and is illegal. The agency can’t have it both ways. Furthermore, realizing that many FSIS retirees go to work in the industry after retiring from FSIS, agency bureaucrats are unwilling to initiate enforcement actions against their future employers.
    Carol, I respectfully submit to you that FSIS-style HACCP is the most formidable obstacle to Food Safety which is facing us today. I submit to you that we should go back to the original organoleptic-based meat inspection system we had, and couple with it microbial testing of products (like you suggest above), along with Pillsbury-style HACCP activities such as a Hazard Analysis, CCP’s, SSOP’s, etc. Plants which make RTE products which have been exposed to a kill step, and whose microbial test results validate that their Kill Steps are truly efficacious, do qualify for deregulation. Plants producting raw meat & poultry do not qualify for deregulation, and must submit to the combination of organoleptic and HACCP meat inspection requirements as I suggest above. It is essential that inspectors and their supervisors are again empowered with authority to police plants, coupled with command and control authority.
    Frankly, our government must maintain a meaningful oversight of meat production, but FSIS-style HACCP disagrees. Until agency bureaucrats are willing to make such common sense mid-course corrections in its failed HACCP Hoax, we will continue to experience an inappropriately high incidence of outbreaks.
    “Who’s on first”? Not the FSIS, by intentional agency design.
    John Munsell