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Marler Blog Providing Commentary on Food Poisoning Outbreaks & Litigation

So, why is E. coli O157:H7 considered an adulterant, but other shiga-toxin E. coli not? Why is Salmonella not considered an adulterant, even when the Salmonella is antibiotic-resistant Salmonella Newport?

Personally, as I said to the Los Angeles Times a few days ago, “I think that anything that can poison or kill a person should be listed as an adulterant” [in food].

According to the CDC, E. coli O157:H7 is the source of an estimated 73,000 illnesses, 2,000 hospitalizations, and 60 deaths in the United States every year.  Correctly so, USDA/FSIS has considered this nasty pathogen an adulterant on and in beef (at least hamburger) since 1994.

However, despite causing serious injury and death, other shiga-toxin producing E. coli, such as E. coli O111 and E. coli O21:H19 have not been considered an adulterant by the USDA/FSIS.  In fact, we have found pathogenic E. coli in retail hamburger in private lab tests.  So, we know it is there and USDA/FSIS does too.  Ignoring this makes no sense.

Ignoring Salmonella in meat also makes little, if any, sense.   Even after a Court’s twisted opinion in Supreme Beef v. USDA, where it found Salmonella to be “not an adulterant per se, meaning its presence does not require the USDA to refuse to stamp such meat ‘inspected and passed," our government’s failure to confront the reality of Salmonella, especially, antibiotic-resistant Salmonella, is inexcusable.  See, www.foodpoisonjournal.com for a bit(e) of history.  The Wisconsin Supreme Court in Kriefall v Excel called it as it saw it:

“The E. coli strain that killed Brianna and made the others sick is a “deleterious substance which may render [meat] injurious to health.” There is no dispute about this. Thus, under the first part of 21 U.S.C. § 601(m)(1), meat that either “bears or contains” E. coli O157:H7 (the “deleterious substance”) is “adulterated.” That E. coli O157:H7 contamination can be rendered non-“injurious to health” by cooking thoroughly, as discussed below, does not negate this; Congress used the phrase “may render,” not “in every circumstance renders.” Moreover, if the E. coli bacteria is not considered to be “an added substance,” because it comes from some of the animals themselves and is not either applied or supplied during the slaughtering process (although we do not decide this), it cannot be said that the E. coli strain “does not ordinarily render [the meat on or in which it appears] injurious to health.” Accordingly, meat contaminated by E. coli O157:H7 is also “adulterated” under the second part of § 601(m)(1).

Now, why would Salmonella be different?

According to the CDC, it is estimated that 1.4 million cases of salmonellosis occur each year in the U.S.  95 percent of those cases are related to foodborne causes.  Approximately 220 of each 1000 cases result in hospitalization and eight of every 1000 cases result in death.  About 500 to 1,000 deaths – 31 percent of all food-related deaths – are caused by Salmonella infections each year.

Just in the last week, the reality (again) of antibiotic-resistant Salmonella Newport has surfaced (again), this time sickening dozens so far in several states, and leading to the recall of nearly a million pounds of tainted hamburger.  This follows a recall of nearly a half a million pounds of Salmonella-tainted burger in Colorado after sickening several a month ago.

Of course, this is not the first time that antibiotic-resistant Salmonella has hitched a ride in hamburger – there were illnesses in 1999, and it was reported by the CDC in 2002 and a WARNING issued by FSIS in 2007. The New Hampshire Department of Health and Human Services has urged a strategy to combat multidrug-resistant (MDR) Salmonella in ground beef.  The CDC, through NARMS has continued to raise concerns about the over-use of antibiotics in our food supply.  And, there is clearly no question that these bugs are in the cows we get our milk and the meat that we eat. 

The CDC has reported that Salmonella Newport is the third most common Salmonella serotype in the United States. During 1997 – 2001, the number of laboratory-confirmed Salmonella Newport infections reported to CDC increased from 1,584 (5%) of 34,608 reported Salmonella infections to 3,152 (10%) of 31,607 (CDC, unpublished data, 2002). The increasing number of Salmonella Newport infections in the United States appears to be associated with the emergence and rapid dissemination of multidrug-resistant strains of Salmonella Newport.  Since 1996, NARMS has identified an increasing number of Salmonella Newport isolates that are resistant to at least nine of 17 antimicrobial agents tested: amoxicillin/clavulanate, ampicillin, cefoxitin, ceftiofur, cephalothin, chloramphenicol, streptomycin, sulfamethoxazole, and tetracycline. In addition, these isolates exhibit decreased susceptibility (minimal inhibitory concentrations [MIC] ≥ 16mg/ml) or resistance (MIC ≥64mg/ml) to ceftriaxone, an antimicrobial agent commonly used to treat serious infections in children.

So, where do we stand with the existing USDA/FSIS law on adulteration?  Here is the law:

21 U.S.C. § 601(m)(4) – SUBCHAPTER I – INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING – CHAPTER 12 – MEAT INSPECTION – TITLE 21—FOOD AND DRUGS

(m) 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; …

(3) if it consists in whole or in part of any filthy, putrid, or decomposed substance or is for any other reason unsound, unhealthful, unwholesome, or otherwise unfit for human food;

(4) if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health; …

Hmmm, it is hard to read the above and not think that the words in BOLD equate to all E. coli and Salmonella (frankly, all pathogens in food).  I know, I am just a lawyer, but don’t ya think that when food with animal feces (and a dash of E. coli O157:H7) in it is considered an adulterant, that other animal feces (with dashes of other pathogens) in them, should be considered adulterated too?  But, hey, that is just me.

Another odd governmental fact, is that the FDA does not seem to make a distinction between pathogens it considers adulterants or not.  FDA’s enabling legislation – Sec. 402. [21 USC §342] of the Food, Drug & Cosmetic Act also defines “Adulterated Food” as food that is:

(a) Poisonous, insanitary, or deleterious ingredients.

(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 food shall not be considered adulterated under this clause if the quantity of such substance in such food does not ordinarily render it injurious to health;

(2) If it bears or contains any added poisonous or added deleterious substance … that is unsafe within the meaning of section 406;

(3) if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food;

(4) if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health …

It would be interesting, and perhaps entertaining, to have House and Senate hearings focusing on what should and should not be considered adulterants in our food.  I can see panels of scientists from various fields, FDA, USDA and FSIS officials, beef and produce Industry representatives and consumers discussing this. 

Readers, what are your thoughts?

  • Keith Warriner

    My thought is that you need achievable targets. The detrimental effect of the Zero tolerance Listeria policy is a good example how tighter regulations can have negative consequences.
    To play devils advocate, I always feel with meat products that the consumer should share the responsibility. The producers clearly put cooking instructions on packs and if followed will ensure microbiological safety.

  • Sandi

    Absolutely, salmonella and other E.coli should be included in that list of adulterants. I am curious to know why those werent on the list to begin with, is it because FDA knows they would be inundated with recalls….? It would also make sense to me that pet food be included in the food safety bill for numerous reasons, one of them being problems with salmonella and people falling ill after handling the food.

  • Dr Raymond

    The judge in Supreme Beef vs USDA pretty well made it extremely hard for the USDA to go against that ruling and lose another one in court. When judges decide issues about food safety, the real experts’ hands are tied.

  • Keith, I anticipated your comment on ‚Äúblame the consumer‚Äù in a post I did a few days ago: http://www.marlerblog.com/2009/08/articles/lawyer-oped/the-meat-industry-will-never-solve-the-e-coli-o157h7-problem-until-it-stops-blaming-the-consumer/. Even more interesting is a Meat Industry Expert‚Äôs take on your argument:
    James Marsden‚Äôs Op-ed in ‚ÄúMeating Place‚Äù ‚Äì ‚ÄúWhy “just cook it” won’t cut it:‚Äù
    For almost 20 years, I have heard people from the meat industry say, “if consumers would only cook their burgers, the E. coli problem would go away”. Here are 10 reasons why the “just cook it” approach will not work:
    1. E. coli O157:H7 is a unique pathogen. The levels of this organism necessary to cause infection are very low.
    2. The severity of the disease E. coli O157:H7 can cause, especially in children is devastating.
    3. In many cases, parents order hamburgers for their children and rely on restaurants to cook them properly. In restaurants, parents really have no control over whether the hamburgers they order are sufficiently cooked to eliminate possible contamination from E. coli O157:H7.
    4. If consumers unknowingly bring this pathogen into their kitchens, it is almost impossible to avoid cross contamination. Even the smallest amount of contamination on a food that is not cooked can cause illness. Many of the reported cases of E. coli O157:H7 have involved ground beef that was clearly cooked at times and temperatures sufficient to inactivate E. coli O157:H7. Some other vector, i.e. cross contamination was probably involved.
    5. Even if consumers attempt to use thermometers to measure cooking temperature, it is difficult to properly measure the internal temperature of hamburger patties. They would have to use an accurate thermometer and place the probe exactly into the center of the patty. In addition, the inactivation of E. coli O157:H7 is dependent on cooking time and temperature. For example, if they cook to 155 degrees F, they should hold that temperature for 16 seconds. It is not realistic to expect that consumers, many of which are children will scientifically measure the internal temperature of hamburgers.
    6. The way ground beef is packaged, it is virtually impossible to remove it from packages or chubs and make patties without spreading contamination if it is present.
    7. Sometimes ground beef appears to be cooked when it really isn’t. There is a phenomenon called “premature browning” that can make ground beef appear to be fully cooked when in fact it is undercooked.
    8. E. coli O157:H7 may be present in beef products other than ground beef. For example, in non-intact beef products, including tenderized steaks that are not always cooked to temperatures required for inactivation.
    9. There have been many cases and outbreaks of E. coli O157:H7 associated with foods that are not cooked (i.e. fresh cut produce).
    10. As Senator Patrick Leahy said after the 1993 Jack-in-the-Box outbreak – “The death penalty is too strong a punishment for undercooking a hamburger”. He was right –consumers will make mistakes. There needs to be a margin of safety so that undercooking does not result in disease or death.
    For these and many other reasons, the problem of E. coli O157:H7 in ground beef and other food products must be solved. Of course proper cooking is important. However, telling consumers to “just cook it” is not the answer.

  • Ann Q

    Mr. Marler, I’m not a lawyer. Just an outraged food consumer who has looked in the eyes of beings dying from adulterated food through no fault of their own and will never ever forget it.
    Many of our USDA/FDA food safety regulations are currently being made or sponsored by huge global industrial food corporations whose primary concern
    is commodity profit, not food safety. Just look at the mish-mash governing all consumers’ one food supply to benefit the peculiarities of these billion dollar corporations. E. coli and Salmonella classifications would seem to fit that mold.
    To make progress in consumers war for safer food, as safe as humanly possible, it has to become more costly economically for giant industrial food producers to sicken 76 million and kill 5,000 food consumers each and every year. The money fines and jail time imposed on food growers, processors, and even retailers of adulterated foods have to be increased to the point that the costs to these companies are no longer worth the profits of adulterated food.
    Until then the body count in the consumer safe food war is over 5,000 a year and rising. Until then the focus of food production will remain making the maximum buck, not safer food. Consumer demand for safer food and lawyers making changes to the food safety system are our best hopes.

  • Keith Warriner

    Thanks for the reply Bill, I still think the consumer needs to do more given the limited options available to the producer to control pathogens.
    As mentioned, going towards a zero tolerance for all pathogens on all food types would be a disaster. The only other option is to take the African approach and irradiate everything-consumers might have something to say about that.

  • Consumers can always do better. However, study after study shows that, despite the CDC estimated 76 million people getting sick every year from food borne illnesses, the American public still has misconceptions and overconfidence in our Nation’s food supply. According to a study by the Partnership for Food Safety Education, fewer than half of the respondents knew that fresh vegetables and fruits could contain harmful bacteria, and only 25% thought that eggs and dairy products could be contaminated. Most consumers believe that food safety hazards can be seen or smelled. Only 25% of consumers surveyed knew that cooking temperatures were critical to food safety, and even fewer knew that foods should be refrigerated promptly after cooking. Consumers do not expect that things that you cannot see in your food can kill you. Consumers are being blamed, but most lack the knowledge or tools to properly protect themselves and their children.
    The FDA has stated, “unlike other pathogens, E. coli O157:H7 has no margin for error. It takes only a microscopic amount to cause serious illness or even death.” Over the last few years our Government and the Meat Industry have repeatedly told the consumer to cook hamburger until there is no pink. Yet, recent university and USDA studies show meat can turn brown before it is actually “done.” Now the consumer is urged to use a thermometer to test the internal temperature of the meat. However, how do you use one, and who really has one? Many consumers wrongly believe the Government is protecting the food supply. How many times have we heard our Government officials spout “The US food supply is the safest in the world.‚Äù Remember, however, that it was the USDA that sat on positive E. coli tests for over a week that allowed this recent Con Agra E. coli outbreak to spiral out of control.
    Where is the multi-million dollar ad campaign to convince us of the dangers of hamburger, like we do for tobacco? The USDA’s FightBAC and Thermy education programs are limited, and there are no studies to suggest that they are effective. Most consumers learn about food safety from TV and family members – If your TV viewing habits and family are like mine, these are highly suspect sources of good information. The bottom line is that you cannot leave the last bacteria “Kill Step” to a parent or to a kid in a fast food joint. The industry that makes billions off of selling meat must step up and clean up their mess. They can, and someday will, if I have anything to say about it. That day will come much faster if they start working on it now, and stop blaming the victims.

  • Dr Raymond

    Ann Q, it is not the “giant industrial food producers” that sickened all “76 million” consumers. That is a quote from a 1999 paper looking at 96-98 illnesses and we have come a long way since then. And if you read the paper, you will realize that only a small portion of the illnesses they cite are related to the “giant industrial food producers”. By far, the largest number of illnesses in the report are from the Norovirus category which has absolutely nothing to do with the slaughter and processing facilities. And USDA food safety regs are not “made or sponsored” by the industry, I can assure you of that. Now statutes, like the most recent farm bill giving USDA regulatory authority over catfish but no other fish is another story, but that is Congress that is controlled by industry, not USDA.
    Sandi, USDA used to consider Salmonella an adulterant, but a judge ruled against them. For the USDA to do a recall for Salmonella contaminated ground beef is really a watershed moment. We should be congratulating them instead of further bashing them.

  • Certainly, salmonella are deleterious substances when present in sufficient quantity to cause disease. The main differences between hemorrhagic E coli strains and salmonella are infectious dose and the severity of the health effects. E coli are much more infectious and much more severe. This I believe is the rationale that makes most sense in declaring it an adulterant. Its presence in any food makes that food very hazardous. Should we as a society consider any food containing a hemorrhagic strain of E coli adulterated? Should society consider salmonella in any food an adulterant?
    From a very pragmatic view, there should be no pathogens present in a food that creates a hazardous situation for a consumer. The unfortunate reality is that raw meat, whether it is from poultry, beef, pork or fish has the capacity to become contaminated and baring the use of aseptic techniques throughout the slaughtering and manufacturing process it is probably not possible to ensure that pathogens are not present.
    The philosophic argument to make all pathogens an adulterant in any food are somewhat naive. If it were possible then there might be some merit in this argument. The reality is that our ability to test and find pathogens far exceeds our technical ability to prevent their occurrence in a food. Rather then create a constellation of new laws declaring all pathogens in every food product to be adulterants, we should be instead requiring that the residual risks in products at all stages of production be clearly identified so that the next user in the food chain can take measures to reduce the risk. This is the philosophy of ISO22000:2005 and is the best thinking so far as to how to protect the public.
    Does the food handler have a responsibility, of course. The capacity of consumers to protect their food forms the limits of their responsibility. While I do not believe consumers can protect themselves completely from pathogens in their foods, the education and empowerment of the consumer is a very weak point in the safety of the supply chain. Risk reduction at each step in meat production should begin at the farm level. No one is talking very much about how to keep cattle for being infected in the first place. We should begin there to understand how to rear healthy animals so that the next step in the production chain has less residual risk to begin with.
    Again, it is unfortunate that we as a society cannot bring the type of resources to the effort needed. What we face in terms of other needs far exceeds the resources we have left to cope with the problem of contamination in the food supply.
    The bottom line for me as a food safety professional is that we know how to reduce risk, its actually quite easy, sanitation and process controls at each step of the food supply chain. We are a long way from having the preventive measures in place to reduce contamination to the level we could. Before we make every pathogen in every food an adulterant and maybe have to dispose of a majority of our food, let us concentrate on making prevention consistent throughout the supply chain first and then see where we need such drastic measures.

  • Thomas L. Schwarz

    Bill has pointed out that the language in the adulteration section of the Meat Inspection Act is identical to the language in the adulteration section of the Food, Drug, and Cosmetic Act.
    So any court must decide if:
    (1) the substance is “added”
    (2) the quantity is such that it “ordinarily” renders it injurious.
    We know these pathogens are not added intentionally by man, but are they being “added” accidentally? If they are present in the digestive tract of the animal, are they indigenous and therefore not “added” at all?
    The quantitative piece of this regulation covers such ubiquitous pathogens as S. aureus (which requires large numbers to generate toxin production) or L. monocytogenese (which does not grow to disease-causing levels in many foods). If this clause wasn’t extant, foods such as salads, frozen vegetables, honey would not be legal as they always contain low levels of pathogens.
    What if the food is ordinarily cooked or “pasteurized” prior to consumption? Here we have the raw milk issue as well as the in-shell egg argument. Must it be safe when purchased or can a court decide that the consumer/restauranteur has a role in making the food safe?
    As Bill points out to me often, even when the science is clear, the answers aren’t easy.

  • Sandi

    Dr Raymond, I think if you re-read my question, you will see I was not “bashing” USDA. Im not sure why you feel the need to defend USDA to the point of attacking others. I believe you missed my point. It was a honest question, plain and simple.
    My concern is and has been pet food safety. After losing a cat to the 2007 pet food recalls, I have researched til Im blue in the face and wonder how pet food manufacturers keep managing to escape any form of true regulation and accountability. The 2007 pet food recalls showed many for the first time how human food safety is in peril but yet pets get left out of the very bill that their suffering helped bring to light. There was an FDA Amendment Act initiated in 2007 with parts of it set to be established a year ago…where is the early warning system for pet food problems? Where is the truth in labeling? Last I was told, FDA and AAFCO are still working on it…2 years later. Many will say its just pet food. Believe me Ive heard it many times. Ive also seen lots of blame being applied to pet owners as a means to escape the responsiblity that pet food companies should have for safe food. Ive even been verbally attacked in attempts to silence me. But what some may not understand is that you cant have safe human food without having safe animal food. I dont want to have happen to any other pet, what happened to mine. She died a painful, agonizing death in my arms on the way to the emergency clinic. At this point, its a matter of when will the next big pet food recall happen, not if.
    Last I checked Mr Marler’s site allows everyone who wants to, to post their concerns which is what Im doing. While I think its a good thing that perhaps USDA was involved in the beef recall, its like pet food, the idea is to prevent adulerated food from happening before anyone, human or animal, get sick or dies so that recalls dont have to happen. And clarifcation to your statement to Ann Q. might be needed. AAFCO is the organization that basically sets the regulations and standards for pet food and animal feed. Go take a look at who sits on most of the boards for AAFCO. It is FDA and Pet Food Institute as well as the feed industry. I can assure you its not Congress.
    The statement above by Mr Marler says it all: “The industry that makes billions off of selling meat must step up and clean up their mess. They can, and someday will, if I have anything to say about it. That day will come much faster if they start working on it now, and stop blaming the victims.”
    Remove the word “meat” and add “pet food industry”. The same problem applies.

  • 1. The”Just cook it” bunch ignore the probability of kitchen cross contamination. That was a big omission in the American Public Heath Vs Butz.
    2. There is a precedent set in 9 CFR 311 where the Secretary of Agriculture determined that consumers should not be exposed to certain pathogens without first inactivating them by cooking.
    3. With few exceptions, the muscle tissue of animals presented for slaughter is free of pathogenic bacteria (Lymph nodes are an exception). Thus, one can argue that every bacterium on the skinned, eviscerated carcass is “Added”. The counter argument is that contamination is unavoidable. The counter-counter argument is that technology is making contamination far more avoidable than in the past. Thus the current strategy is to provide incentives and disincentives via Performance Standards (Which need updating).

  • Where do I begin?
    1. In my opinion (as a food safety microbiologist), if E. coli O157:H7 is an adulterant in raw meat, then so is any other shiga-toxin producing E. coli. And so is Salmonella!
    2. USDA/FSIS erred in not pushing hard to obtain an amendment to the law in order to remove the ambiguities underscored by the Supreme Beef v. USDA decision and appeal.
    3. USDA erred in not pursuing the appeal process further.
    4. I have to wonder how well USDA and the DOJ attorneys pressed the case against Supreme Beef. When I was with the Canadian government, the attorneys had a tendency to focus on technicalities and poo-poo the science √¢‚Ǩ‚Äú to the detriment of the government’s case.
    5. “Just Cook It” is not a valid answer. While the consumer bears a responsibility to handle and cook raw meat correctly, the meat industry is responsible BY LAW to provide the consumer with an unadulterated product.
    6. Et cetera.

  • Christoffer Nielsen

    I’m not very well known (not known at all) with the US act on food safety, but I still think I can contribute with some thing.
    After reading the 21 U.S.C √Ǭß601 (m) (4) Subchapter I and chapter 12 things seemed clear. It’s my opinion that you have to differ between “added” and “incidentally contaminated”.
    If the carcass is contaminated during devisceration of the animal it is a result of bad craftsmanship. Slaughtering techniques are extremely important and it is possible to skin and deviscerate an animal whiteout to “add” any filth or photogenes on the carcass. You may therefore say contaminations because of “bad craftsmanship” is not incidentally contamination but is “adding” to the carcass or part thereof, meat or meat food.
    Why E. coli O157H and not other photogenes? This because we know for certain that E. coli O157H originate from the bowel the/one of the animal(s) in that “specific package of minced meat which have caused the illness”. The same isn’t prevailing to (nearly all) other photogenes, because the can be added incidentally to the products during the process elsewhere in the production line. The later because of insufficient risk analyses/assessment.
    In an HACCP analyses of a meat products production line the slaughtering process from ante mortem to post mortem have non critical control points (CP), because it is not possible in a certain step in the process to regulate a failure made in the step before. The CP’s is ante mortem (do that specific living animal look fit for human consumption or not) and post mortem (is this specific carcass fit for human consumption or not). If failures happened between ante and post mortem it is because of neglecting the premises for a hygienically production of meat products.
    I think it is very important that you consider if there are a neglecting of the premises for the HACCP in absolute every step of the production. My opinion is that if some one are neglecting the premises of hygienically productions they are “adding” poisonous or deleterious substance to the products and the products is to be “adulterated”.
    I could continue but because of my poor English and my lack in knowledge of US food act I’m ending here
    Christoffer Nielsen
    Senior Inspector/Official Veterinary Inspector
    Norwegian Food Safety Authority