Dorothy: “Don’t you know the Wizard’s going to give you some courage?” Cowardly Lion: “I’d be too scared to ask him for it.”

In an article that will soon be published in the Seattle Law Review, I take a look at food safety through the lens of the “pink slime” controversy and question whether the lack of real transparency that characterizes food safety regulation, especially with regard to meat and poultry, is more intentional strategy of agencies and industry than byproduct of the public not simply wanting to think about just how unsafe food can be.In the article, I compare the U.S. Department of Agriculture (USDA) and the meat industry to the Wizard of Oz, an entity that Dorothy, her traveling companions, and those living in Oz all thought was “great and powerful” — that is, until he was revealed to be a huckster who was fooling everyone through trickery and special effects. But, in reading some recent remarks by Brian Ronholm, Deputy Under Secretary at USDA’s Food Safety and Inspection Service, another comparison for USDA and its regulation of meat and poultry quickly came to mind: the Cowardly Lion. As reported by Food Safety News, Ronholm was appearing last week at the 2015 National Food Policy Conference in Washington, D.C., when asked about the agency’s policy on declaring Salmonella an “adulterant” under the Federal Meat Inspection Act (FMIA). According to the article:

Ronholm explained that the interpretation of why E. coli is an adulterant in ground beef but Salmonella isn’t adulterating poultry stems from past court cases. “There are several ways to cook a burger: rare, medium, well-done. In the court’s mind, because there are several ways, it’s possible to not cook E. coli out of a burger,” Ronholm said. “Now look at poultry. In the court’s mind, there’s only one way to cook a chicken. You cook it to 165 degrees and it kills the Salmonella.” “Because ordinary cooking is able to kill Salmonella, in the court’s mind, it cannot be declared an adulterant,” he added.

Cowardly LionThe court (and court case) he is referring to is one with which I am exceedingly familiar, not only because I have been an attorney handling food-related cases for more than 20 years, but because I also a professor of food law and policy, and this semester my students and I spent several hours of class time both unpacking this particular case and also the historical evolution of USDA policy on adulterants in meat. And although I readily admit that there are grounds for reasonable disagreement when interpreting any court case, I am nonetheless 100-percent confident in asserting that Ronholm is either telling a big fat lie or the attorneys at USDA are telling their bosses what they want to hear to justify continuing and cowardly inaction on the Salmonella front. Like so much that USDA does, it wants to appear busily in action, convincing the public that, “We are on it!” and, “No need to worry!” At the same time, they repeatedly trot out this line of defense with regard to Salmonella in meat, claiming that, “Our hands are tied!” and blaming it on the courts. But all of this is clearly subterfuge, and I would be shocked if Ronholm and other higher-ups at USDA were unaware of the real duplicity at work here. Because no court has tied USDA’s hands. Instead, USDA is sitting on its hands while millions are infected with Salmonella and injured each year. So, let’s look at this case that Ronholm cites — American Public Health Association v. Butz, a 1974 decision of the D.C. Circuit Court of Appeals. This decision stemmed from a lawsuit that APHA, one of the leading public health associations in the United States, had filed against USDA. In the lawsuit, APHA accused USDA of “misbranding,” a violation of the FMIA because the agency was placing the mark of inspection (“USDA inspected and passed”) on meat and poultry in a way that was false and misleading and by failing to warn against the dangers of Salmonella. APHA further argued that USDA had abused its discretion in refusing to add a warning and instructions for proper preparation and storage to the mark of inspection. The warning that APHA sought read as follows: “Caution: Improper handling and inadequate cooking of this product may be hazardous to your health. Despite careful government inspection, some disease-producing organisms may be present. Consult your local health department for information on the safe handling and preparation of this product.” Of course, a similar warning now does appear on all meat and poultry products, an indication of just how much has changed since 1974. And it is that change that matters so much when seeking to understand just how disingenuous USDA is being now when it points to the APHA v. Butz decision as evidence that the court more than 40 years ago tied its hands, and that its hands remain tied today, preventing it from taking more effective action against the illnesses and death caused by Salmonella-contaminated meat and poultry. At the time of the APHA lawsuit, USDA did not consider pathogens in raw meat to be adulterants — any pathogens, including E. coli O157:H7. USDA was still in the “poke-and-sniff” era of meat inspection that had commenced with the passage of the FMIA in 1906. But plainly the USDA position changed in the wake of the 1993 Jack in the Box E. coli outbreak, and today we have both warning and instruction labels on meat, but we also have USDA declarations that certain pathogens are “adulterants” within the meaning of the FMIA when present on raw meat. And recall, USDA was sued when it made these declarations, and USDA fought in court and won. That is the nature of the beast when it comes to USDA imposing stricter regulations. A lawsuit is like the sun rising in the morning and setting in the evening: inevitable. And, while there was a time when USDA appeared to have the courage of its convictions, that time seems to have passed in a decision way. But back to the APHA decision and USDA’s present dissembling. Ronholm claims that, in its decision affirming dismissal of the APHA’s lawsuit, the court specifically decided that, “Because ordinary cooking is able to kill Salmonella, … it cannot be declared an adulterant.” That claim is untrue. First, note that the position of USDA in front of both the trial court and on appeal was that “since ‘there are numerous sources of contamination which might contribute to the overall problem’ it would be ‘unjustified to single out the meat industry and ask that the Department require it to identify its raw products as being hazardous to health. Such an act would have to apply to any and all sources of salmonellae in order to be fairly administered.’” USDA was defending the meat industry’s interests here and the USDA inspection policy overall, which was, as noted above, premised on the notion that there was no such thing as an “adulterant” in raw meat, and that meat was, as a byproduct of how it was slaughtered, inevitably going to be contaminated, thus making such contamination “inherent” to meat. But USDA no longer accepts this premise as true. The agency’s position has changed. If it had not changed, then E. coli O157:H7 could not be declared an adulterant either. Second, the observation about “ordinary cooking” is not an observation that the court made; it is an observation that USDA made. Here is what the court decision actually states (emphasis added):

As the Department said in its letter of August 18, 1971 ‘the American consumer knows that raw meat and poultry are not sterile and, if handled improperly, perhaps could cause illness.’ In other words, American housewives and cooks normally are not ignorant or stupid and their methods of preparing and cooking of food do not ordinarily result in salmonellosis.

Of course, the somewhat sexist “in other words” rephrasing of USDA’s position is the court speaking, but most first-year law students could easily explain that is not the court’s holding in the case and, as a result, it has no precedential or binding power. Thus, Ronholm was plainly wrong when he asserted ”in the court’s mind, [Salmonella] cannot be declared an adulterant.” No — in 1974, that was in USDA’s mind and, apparently, it still is. But please don’t blame it on the court. Third, and also apropos of the “customary methods of preparing food for the table,” which is the phrase that ends the majority opinion in this case, the issue before the court with regard to consumer knowledge of the risk of Salmonella related to APHA’s attempt to require a warning label on meat and poultry. Whether Salmonella could be declared an adulterant was an issue not before the court. In ruling on the issue of the warning label, the court did nothing more than defer to the agency’s discretion. As the court explained:

After carefully considering the appellants’ proposals the Secretary concluded that warning labels were not the answer to the problem and that the solution was a consumer education program which the Department proposed to undertake. We cannot say that this conclusion was unreasonable; certainly we may not substitute our judgment for that of the Secretary.

Finally, on the question of whether the court decided anything with regard to Salmonella’s presence being an adulterant, it must be remembered that the issue before the court was whether the USDA mark of inspection was “false and misleading” for stating that the meat was “passed and inspected” even though Salmonella might be present. On that central issue, what the court decided was about the method of USDA inspection, a method that, as the court noted, APHA had conceded was reasonable:

As alleged in the complaint, and established by the record, “The inspection procedures now required by the Wholesome Meat Act and the Wholesome Poultry Products Act do not include any investigation to detect the presence of salmonella in meat or poultry, because no such microscopic examination is considered feasible as a routine matter.” The reason for this situation is apparent: a poultry inspector, for example, may conduct post mortem examinations of more than 10,000 birds in one day. Microscopic examination of each bird would obviously be impractical. Recognizing and accepting this fact the appellants do not seek revision of inspection techniques.

Accordingly, against the backdrop of the APHA concession, which the court accepts, the court then confronted the issue of whether, despite this conception, the mark of inspection constituted “misbranding” for the USDA having placed it on meat that was contaminated with Salmonella. The court said no, and here is why:

In construing both the Wholesome Meat Act and the Wholesome Poultry Products Act we are mindful that the presence of salmonellae can be detected only by microscopic examination. No one contends that Congress meant that inspections should include such examinations. We think it follows therefore that Congress did not intend the prescribed official legends to import a finding that meat and poultry products were free from salmonellae.

In other words, because the FMIA does not require “microscopic examination” of meat as the method of inspection, and because only such examination can reveal the presence of Salmonella, the mark of inspection is not “false and misleading” as a result of there being the possibility that Salmonella might be present on the meat sold. And who can really quibble with such logic? Not me. But here is the problem. USDA now tests for the presence of Salmonella, and USDA inspection is built upon the foundation of the microscopic examination of meat and poultry. So, let me ask you this: Flash forward the APHA v. Butz case to the present. Do you think the court would now reach the same decision? For a clue, let’s look at what the dissenting judge in the case wrote:

My colleagues try to support their holding by the claim that Congress “did not intend the prescribed official legends to import a finding that meat and poultry products were free from salmonellae.” That observation, I submit, is wide of the mark. Congressional intent is not helpful in determining whether the labels are misleading; the relevant inquiry is the understanding of consumers. Appellants proffer evidence tending to show that consumers in large numbers understand the challenged labels to mean that the Federal Government has inspected the labeled food products for the presence of salmonellae. That indication is false, for no such inspections are ever made, and labeled products are “passed” even if they contain salmonellae.

In the end, what is so untenable and troubling about USDA’s position on all of this, is how much it rests on a view of meat and meat inspection that was supposed to have gone away after the tragedy of the Jack in the Box outbreak. There was a time when it seemed that USDA was going to embrace its public health mission and choose to fight for safer meat, even in the face of threatened lawsuits. But, alas, it seems to now be back to its old ways — a Cowardly Lion, afraid of its own self-made shadows. 1 See Denis Stearns, PAY NO ATTENTION TO THAT MAN BEHIND THE CURTAIN: Concealment and Revelation and the Question of Food Safety; OR, How “Pink Slime” Tells You All That You Need to Know about Food in the United States, 38 Seattle L. Rev. ___ (2015) (publication pending).

  • heavyhanded

    Entertaining and informative piece!

  • MaryFinelli

    Until the government has the integrity to address the problem at its source: the pathogen-producing conditions that hens (and other animals) are subjected to, people will continue to sicken and die. Hens are prone to disease from the start due to intensive selection for egg production traits at the expense of their immunity. It’s outrageous but not surprising that the USDA turns a blind eye to it though, given its dual and conflicting mission of promoting agriculture and safeguarding the food supply.

  • Excellent piece. Agree, 100%. But I am left wondering: what can we do? The USDA maintains its cowardly stance in this regard, regardless of who is President, or what party is in charge. It is one of the most obstinate of the alphabet agencies…entrenched to a degree that can seemingly withstand even political winds.

    We can’t start a petition on, threaten not to elect (or elect) a Congressional rep or President, and even lawsuits seem to hit the agency and bounce off.

    I’m active in the animal welfare community and we’ve had the same frustrations with the USDA and the AWA (APHIS). Recently a puppy miller in Missouri put a dog into a kennel with its food dish on the other side of a dropped door, without showing the dog how to use the door. He then ignored it until an inspector from the USDA stopped by and noted the dog was starving to death, and needed immediate attention. Now, this is a dog with its nose inches away from food, starving to death. Most sane people would consider this to be cruelty.

    The puppy miller had the dog euthanized and the inspector noted that compliance with the AWA was satisfied (the dog was no longer starving to death, it was dead), and the puppy miller was not fined, or even chastised.

    How does one fight an agency that can make a decision such as the above, or make statements like the following, when it is surrounded by laws that literally give us no opening to force them into doing better?

    “Because ordinary cooking is able to kill Salmonella, in the court’s mind, it cannot be declared an adulterant”

    Anyway, excellent piece, and thank you for writing it.

  • Food Microbiologist

    So, looks like Rondholm hasn’t read the decision, American Public Health Association v. Butz. He’s just listened to the hacks that quote the USDA allegation that, “American housewives and cooks normally are not ignorant or stupid and their methods of preparing and cooking of food do not ordinarily result in salmonellosis.” He should read the rest of that decision.

    That USDA allegation reflected politics. Earlier, in 1970, the Microbiological Subgroup of the USDA Food Safety Committee published, “A Review of the NAS-NRC Report. An Evaluation of the Salmonella Problem”. The Subgroup, composed of members from the USDA ARS and the USDA Consumer Marketing Service (Which became APHIS, then FSQS and now FSIS) concurred or agreed with every recommendation. However, the under the Nixon administration, the future FSIS managers “got religion” and thus, implementation of those recommendations didn’t happen. I was there and heard some of those managers crow, “Just cook it” as if it was a mantra that would send all Salmonella to the nether regions.

    But, what is Rondholm’s excuse? Should we apply Hanlon’s Razor? Since 1974, there have been numerous scientific studies showing ordinary consumer’s inability to handle raw meat or poultry contaminated with virulent pathogens. The epidemiology shows that virulent strains of Salmonella are ordinarily injurious to health in the hands of consumers. Thus, according to the law, 21 USC 453(g)(1) and 21 USC 601(m)(1), that meets the definition of an adulterant.

    Perhaps the lack of action is a matter of “training”. I kidded a friend, John, after he entered the SES by asking him if they pithed their brains during SES training. He replied, “No, but they made us more politically aware.” Thus, does political awareness trump consumer protection in the Meat and Poultry Inspection Acts? In my last years at FSIS, we in OPHS often laughed at the claim that “FSIS is science based”. Yeah, “Political Science” we smirked.

    When I worked for FSIS, some former inspectors had 21 USC 602 framed and posted on their office walls. “Unwholesome, adulterated, or misbranded … products impair the effective regulation of … products in interstate or foreign commerce, are injurious to the public welfare, destroy markets for wholesome, not adulterated, and properly labeled and packaged … products, and result in sundry losses to … producers and processors of … products, as well as injury to consumers.” Thus, FSIS’ inaction not only affects consumers but also puts the honest conscious industry members at an economic disadvantage.

  • Mike_Mychajlonka_PhD

    Indeed, consumers are neither ignorant nor stupid. Too often, however, they remain uninformed. How many politically-appointed heads of FSIS have left their regulatory duties to take lucrative positions with some of the same companies it had been their responsibility to regulate? Given that proclivity, are such leaders really cowardly or are they merely looking ahead and preparing their credentials for a post-government-job sinecure in the private sector?

    • doc raymond

      Mike, please give us just one example of a “politically-appointed head of FSIS that have left their regulatory duties to take lucrative positions”…: Just one please.

      • Mike_Mychajlonka_PhD

        Let’s begin with yourself. Your
        departure from USDA is given variously as early as October of 2008
        and as late as January 2009. Immediately after your departure, you
        were a consultant for the Elanco Animal Health Branch, a division of
        the pharmaceutical company Eli Lilly. This division markets a number
        of products for the veterinary market (in the U.S. And other
        countries) all containing Narasin (an ionophore): 3Nitro, Maxiban,
        Monteban (several different formulations), Roxarsone and Tylan.
        Roughly two years ago, on this same forum, I tried to educate you
        about a paper then recently published showing that resistance to
        Narasin co-selected for Vancomycin resistance in enterococci so as to
        construct Vancomycin Resistant Enterococci (VRE). As you yourself
        are well aware, the pharmaceutical industry has not been inundating
        the world with new antibiotics so as to keep pace with the
        development of microbial resistance. Vancomycin has long been an
        antibiotic of last resort, reserved for critically-ill patients. The
        inconvenient truth that Narasin exacerbates development of Vancomycin
        resistance is something you have ignored by your insistence that
        ionophores are OK because they have never been nor ever will be
        prescribed to humans. In 2008, Eli Lilly’s Elanco paid Monsanto $300
        million for the rights to recombinant bovine growth hormone (rBGH),
        also called recombinant bovine somatotropin (rBST). In July of 2009,
        you were the lead author of a non-peer-reviewed document entitled:
        “Recombinant bovine somatotropin (rbST): a safety assessment,”
        presented at the July, 2009 joint annual meeting of the American
        Dairy Science Council, the Canadian Society for Animal Science and
        the American Society of Animal Science in Montreal, Canada. This
        document claimed endorsement of rBGH by 20 leading health
        organizations including the American Academy of Pediatrics, the
        American Cancer Society and the American Medical Association. Later,
        one of your co-authors, another paid consultant for Eli Lilly,
        admitted that such endorsements were “technically untrue” and
        that “We counted endorsement as failure to oppose rBGH.” In
        2011, during the Australian Meat Industry Conference held August 24 –
        25 you were the speaker for Session 2, your talk entitled: “Food
        Safety in America – What Australia has to do to maintain market
        access.” During that talk you were reported to have said: “Any
        product recall in the US was basically a public relations issue,
        rather than a public health issue.” On November 8th,
        2011, you were welcomed as senior counselor within APCO Worldwide’s
        Health Advisory Board by Robert Schooling, then global head of APCO’s
        health care practice (and current president). Of course, some
        remember APCO Worldwide from another context. In December 1992, the
        US Environmental Protection Agency published a 500-page report
        entitled: “Respiratory Health Effects of Passive Smoking.” In
        February 1993, the Philip Morris tobacco company (now calling itself
        Altria) engaged APCO Worldwide as the public relations firm to
        discredit EPA’s findings. By September, 1993, APCO Worldwide had
        formed a plan for the launch of “the Advancement of Sound Science
        Coalition” (TASSC). The rest is controversial history. As for
        other examples, let’s see: Your temporary replacement at FSIS,
        Elizabeth Johnson departed for a job as Senior Vice President for
        Public Affairs for the National Restaurant Association. The latest
        departure, Dr. Elisabeth Hagen, left FSIS/USDA for the consultancy
        Deloitte & Touche, LLP where she apparently runs a consumer
        products practice as a food safety senior advisor.

  • billmarler

    I do expect that FSIS will also argue that a court in Supreme Beef v USDA also made a holding that Salmonella was not an adulterant. That too is untrue – see footnote 21 – “The USDA agrees in this case that Salmonella is not an adulterant per se, meaning it is not a 601(m)(1) adulterant.” FSIS could, if it chose, deem Salmonella, like E. coli O157:H7 and the “Big Six” an adulterant.

    • Steve Gendel

      Thanks for mentioning the Supreme Beef case. I have had the impression that this is viewed as the more important impediment by USDA. I would be interested in seeing a similar analysis of that case.

  • Anonymous

    This article might not have been critical enough.

    Not all strains of Salmonella are pathogenic.

    Yes, E. coli O157:H7 has been considered an adulterant by the USDA. But there are other strains of E. coli that are pathogenic that have not been considered adulterants by the USDA, such as the non-O157 STECs. While they are not considered adulterants by USDA, USDA has verification in place (which the article mentioned – testing) to address those pathogens. USDA should consider declaring those as adulterants as well.

    Consumer education is important. I think it is a mistake to rely completely on the government because, as the article said, the government has tied their own hands. It is not possible to completely eliminate all pathogens in meat and poultry, especially if it is raw and not “ready-to-eat.” For raw products, It is possible to reduce the pathogen load so that by the time it is cooked, the pathogens can be eliminated (or reduced to very low levels that will not cause illness). But it doesn’t mean that government can be lax – by law, the USDA must ensure that misbranded and adulterated product be prevented from entering commerce.

    I agree that there are many issues that USDA needs to address, and I understand everything that this article is saying. But this article could have been more sophisticated if it provided more solutions on how USDA can address issues instead of providing more criticism than solutions. This article sounded like a blame game. This article sounded like the USDA was pointing fingers at the consumer while this article pointed fingers at the USDA. We cannot solve anything with a blame game, but we can solve problems with collaboration to find solutions. The only solution I found provided in this article is to declare Salmonella an adulterant – with feisty and whiny commentary saying that the USDA is too coward in declaring it as such, which might be true, but I think this article just missed the whole point. The whole point is to prevent illnesses, so this article should have provided more solutions on how to get there – in collaboration with USDA.

    I agree that the USDA should declare pathogenic Salmonella strains as adulterants. I also think that the USDA should provide more aggressive educational programs for consumers. I think USDA should also encourage or require industry to provide more information in their labels about characteristics of the product (such as if the product is non-intact because it is ground, mechanically tenderized, etc.) and how to properly cook product. I think pressure from the public and communication between the public and the USDA are necessary so that more effective regulations and policies can be developed to prevent illnesses, which is the overall goal here.

  • billmarler

    E. coli 026, 0111, 0103, 0121, 045 and 0145 have been adulterants in hamburger since September 2012 –

  • Jerry Segers

    This problem exists in the FDA as well. In Great Britain they require chickens to be vaccinated against salmonella. This process has allowed the entire country to quit refrigerating eggs. They just place them on the shelves beside other items in the grocery. Meanwhile, there is no vaccination program in the US because it cost money and the FDA does not require it. So why do they not require it? According to a quote in the Huffington post

    ‘Data on the vaccine’s effectiveness in field trials conducted in real world conditions “was insufficient to support a mandatory vaccination requirement,” the agency said in the text of new rules requiring increased inspections and testing of eggs.’

    So a vaccine in a closed chicken house where the farmers in Great Britain add the vaccine to the drinking water is not effective, but with the other side of their mouth they claim that vaccination of children is totally effective with only minuscule side effects. That is totally illogical either vaccines work or they don’t. For the chickens in Great Britain they seem to work.

    If the FDA or the USDA would require the vaccinations of chickens, there would soon be no need for this discussion about salmonella If the flocks were vaccinated and salmonella existed it would be because of contamination and so far as I know the actions regarding contamination seems to be pretty well defined.

    The real problem with going this route is where do you stop with the vaccinations. First it is salmonella then several forms of E.coli as noted by Bill Marler, and the bird flu. Next we have random other pathogens from an ever growing list like we have for children.

    What we really need is to direct our efforts at cleaning up our agricultural processes, but as noted by Shelly Powell that is not likely to happen because of the insulation between the government agencies and the real world. At the moment they seen untouchable and until that changes, we are doomed to continue to write about obscure court rulings and blathering of the government agencies that were supposedly created to protect public health.

    At times like this I am in favor of abolishing both the FDA and the USDA then make their budgets available to lawyers that represent people that have been harmed by the actions of our food and drug producers. I think that would clear the problem pretty quickly, but perhaps I am a bit naive about how the real world works.