And, why does the FDA consider Salmonella an adulterant in all foods and the USDA/FSIS does not?
According to the FDA, “[p]athogenic bacteria (e.g., Salmonella or Listeria monocytogenes) are considered adulterants in both human and animal food. Although many animals consuming this food may not become sick themselves, they can become carriers and expose their human family members to pathogenic bacteria. This is especially problematic with young children, the elderly, or people who are immunocompromised.”
According to FDA guidance, “[c]”ertain food for animals, such as pet food, poses a significant risk to human health when contaminated with Salmonella, because humans come in direct contact with these foods. Salmonella from such pet food may be ingested directly by humans from their hands or utensils that are contaminated when they feed their pets. Certain vulnerable populations, such as children, the elderly, and individuals with compromised immune systems, are particularly susceptible to acquiring salmonellosis from pet food and may experience more severe symptoms. Additionally, animals may become infected, either asymptomatically or clinically, with Salmonella from the pet food, thus increasing the potential human exposure.
According to the latest tri-agency (CDC, FDA, FSIS) report (published in November 2022), 23.2% of all Salmonellaillnesses are attributable to chicken and turkey (See 2020 PDF p. 9). The CDC “estimates that Salmonella causes more foodborne illnesses than any other bacteria. Chicken is a major source of these illnesses. In fact, about 1 in every 25 packages of chicken at the grocery store are contaminated with Salmonella.” According to the 2019 NARMS report“1,400/8,713 (16%) of Retail Chickens tested positive for Salmonella – up from 4% in 2018
507/4,320 (12%) of Retail Ground Turkey tested positive for Salmonella – up from 8% in 2018 and 50% of “Chicken (Cecal)” tested positive – up from 46% in 2018.
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 – at least with respect to E. coli – but the analysis is spot on for Salmonella as well:
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:
(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; …
Here is the law specifically related to poultry:
Title 21 – FOOD AND DRUGS CHAPTER 10 – POULTRY AND POULTRY PRODUCTS INSPECTION
(g) The term “adulterated” shall apply to any poultry 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 equate to all E. coli as well as 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, poultry, fish and produce industry representatives, and consumers discussing this.
I would pay to watch it.
And so now onto some history to ruin your appetite.
In 1971 the American Public Health Association (APHA) sued the USDA on the grounds that its mark of inspection (“USDA 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.” Nestle at 66. (Note to Reader: No, I am not making this up.)
In 1974, the DC 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. § 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 common-sense 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 regarding any other pathogens, especially Salmonella. Indeed, in 1999, when FSIS announced it 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 it 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, was 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, 21 meaning its presence does not require the USDA to refuse to stamp such meat “inspected and passed.” 22 This is because normal cooking practices for meat and poultry destroy the Salmonellaorganism, 23 and therefore the presence of Salmonella in meat products does not render them “injurious to health” 24 for purposes of § 601(m)(1). Salmonella-infected beef is thus routinely labeled “inspected and passed” by USDA inspectors and is legal to sell to the consumer.
Supreme Beef, 275 F.2d at 438-39. And, of course, 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.” Id. at 439 n. 21.
In my view the Supreme Beef decision is poorly reasoned and ill-informed. (For example, could not someone at the Court figure out that it is impossible for meat to be “infected” with Salmonella, and 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.
Perhaps it is just time for the FSIS to take the position that all pathogens that can kill you in meat are adulterants. You have the authority – you just need to use it.