Publisher’s Platform: Mr. Bill goes to Washington again, and again, and again
Last week the USDA Food Safety and Inspection Service (FSIS) announced a recall of ground turkey products due to “possible” Salmonella contamination. According to the press release, “Cargill Meat Solutions Corporation, a Springdale, Ark. establishment, is recalling approximately 36 million pounds of ground turkey products that may be contaminated with a multi-drug resistant strain of Salmonella Heidelberg.”
The release goes on: “This recall follows a July 29, 2011 FSIS Public Health Alert that was initiated due to concerns about illnesses caused by Salmonella Heidelberg that may be associated with use and consumption of ground turkey. A total of 79 persons infected with the outbreak strain of Salmonella Heidelberg have been reported from 26 states between March 1 and August 3, 2011. The outbreak strain of Salmonella Heidelberg is resistant to several commonly prescribed antibiotics.”
This recall was, for me, surprising but positive news — surprising, and somewhat inexplicable, given the USDA’s long-held position that Salmonella is not an adulterant per se in raw meat. You see, the meat industry got a court to invalidate Salmonella performance standards that the USDA tried to implement as part of the Pathogen Reduction, HACCP regulations adopted in 1996.
So when I read about this recall, my first thought was to wonder why Cargill agreed to it. (Remember: USDA’s Food Safety and Inspection Service lacks the statutory authority to compel a recall.) And my second thought was: I wonder if the meat industry will sue the USDA to try to prevent the agency from seeking a recall in the future based on possible Salmonella contamination.
I obviously cannot answer either of these questions. But I can provide some useful background information about why this particular recall is so surprising, and so inexplicable. (And, by the way, by inexplicable I mean it is nearly impossible to explain how FSIS could take this action in light of 25 years worth of policy and court decisions that would appear to suggest it has no authority to do what it did. The recall is certainly NOT inexplicable from a public health and safety perspective, which is certainly ironic given the fact that the FSIS has the term “safety” in its name, and doing something in favor of safety should not be inexplicable.)
So now on to some history:
In 1971, the American Public Health Association (APHA) sued the USDA on the grounds that its mark of inspection (“inspected for wholesomeness”) was misleading because, even though the USDA had put its stamp of approval on meat — literally — it did not, for example, test the meat for bacteria. Moreover, APHA argued that raw meat was commonly contaminated with Salmonella, which posed a risk to the public health. According to APHA, the USDA should instead require that meat carry both a warning label and cooking instructions. The USDA opposed the APHA, helped ably (and predictably) by the meat industry. As quoted by Marion Nestle in her great book, “Safe Food,” the USDA’s position was that, given how many foods are contaminated with Salmonella, “it would be unjustified to single out the meat industry and ask that the [USDA] require it to identify its raw products as being hazardous to health.” (Note to readers: No, really, I am not making this up.)
In 1974, the D.C. Circuit Court of Appeals upheld the position of the USDA and the meat industry, doing so in a way that was as nonsensical as it was sexist. The court stated that: “The presence of salmonellae on meat does not constitute adulteration within this definition [of ‘adulterated,’ provided in 21 U.S.C. ¬ß 601 (m)]….As it 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.’” APHA v. Butz, 511 F.2d 331, 334 (1974).
This remained the position of the USDA and the meat industry until 1994 when, in an act of both commonsense and bravado, Michael Taylor, then FSIS Administrator, announced that E. coli O157:H7 would be deemed an adulterant in raw ground beef. The Agency did not, however, change its tune with regard to any other pathogens, especially Salmonella. Indeed, in 1999, when FSIS announced its inane distinction between E. coli O157:H7 in “intact” meat versus “non-intact” meat, the Agency continued to focus on how a given meat was “customarily cooked” as a chief determinant of whether the pathogen must be treated as an adulterant. Thus, for example, because it decided that “intact steaks and roasts are customarily cooked in a manner that ensures that these products are not contaminated with E. coli O157:H7,” there was no need to treat this deadly pathogen as an adulterant on intact cuts of meat. Of course, this FSIS policy is also one that appears to have been silently jettisoned by the Agency of late.
The Agency’s position on Salmonella and meat came back to haunt it in a big way when FSIS tried to shut down Supreme Beef Processors, Inc. for repeatedly failing Salmonella performance standards that, according to the Agency, were proof that the ground beef being made there was being processed under “insanitary conditions.” Supreme Beef sued the USDA and not only won an injunction, but it succeeded in having the Salmonella regulations struck down as being “beyond the authority granted the Secretary [of the USDA] by the Federal Meat Inspection Act.” Supreme Beef v. USDA, 275 F.3d 432, 434 (5th Cir. 2001).
Explaining its holding, the Court wrote:
The difficulty in this case arises, in part, because Salmonella, present in a substantial proportion of meat and poultry products, is not an adulterant per se, meaning its presence does not require the USDA to refuse to stamp such meat “inspected and passed.” This is because normal cooking practices for meat and poultry destroy the Salmonella organism, and therefore the presence of Salmonella in meat products does not render them “injurious to health” for purposes under the law. Salmonella-infected beef is thus routinely labeled “inspected and passed” by USDA inspectors and is legal to sell to the consumer.
Not surprisingly, the court in this case was quick to cite the decision in APHA v. Butz, and to note that even now the “USDA agrees that Salmonella is not an adulterant per se.”
In my view, the Supreme Beef decision is poorly reasoned and ill-informed. (For example, it is impossible for meat to be “infected” with Salmonella; the proper term here is “contaminated.”) But the real lesson of Supreme Beef is that the USDA was, and continues to be, an Agency that is unable to decide whose side it is on. Sometimes it puts on its public safety hat, and sometimes — actually, most often — it puts on its pro-meat industry hat. And, unfortunately, these roles are too often contradictory. That is why USDA policy, when it comes to meat safety, is also too often contradictory.
So how does the USDA square last week’s recall of Salmonella-contaminated meat with the last 25 years of Agency policy on meat adulteration standards? It cannot. But let us hope that if the meat industry decides to sue to scuttle what appears to be a new and better policy on Salmonella in meat, that this time the USDA decides to stand with the public on the side of meat safety.
Or, perhaps it is just time for the FSIS to take the position that all pathogens in meat that can kill are adulterants. Let the meat industry sue you. I know a good lawyer to defend you.
Or, as I have said before:
Personally, as I said to the Los Angeles Times some time ago, “I think that anything that can poison or kill a person should be listed as an adulterant [in food].”
Ignoring Salmonella in meat makes little, if any, sense. Even after the Court’s twisted opinion in Supreme Beef v. USDA, where it found Salmonella “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.
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 United States. Of those cases, 95 percent are related to foodborne causes. Approximately 220 of each 1,000 cases result in hospitalization, and 8 of every 1,000 cases result in death. About 500 to 1,000 deaths – 31 percent of all food-related deaths – are caused by Salmonella infections each year.
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, like Salmonella) 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. I would pay to watch it.
Being in Washing D. C. this week (in November 2021) made me wonder – what the hell have we been doing for the last decade?
It is time to take the gloves off – FSIS, the petition to deem 31 Salmonella as adulterants is long past due – FSIS-2020-0007-0001_attachment_1
The alternative is a lawsuit that you will lose – Letter to Ms. Eskin 11.12.21 – FINAL
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