Foodborne pathogens have been a major news topic in recent weeks. Notably, on October 19, 2021 the Food Safety Inspection Service (FSIS), an agency housed in the United States Department of Agriculture (USDA), announced it is taking steps to reduce illness caused by the Salmonella microbe by 25%. USDA’s press release announcing these new efforts explains that “[d]espite consistent reductions in the occurrence of Salmonella in poultry products, more than 1 million consumer illnesses due to Salmonella occur annually, and it is estimated that over 23% of those illnesses are due to consumption of chicken and turkey.” Thus, FSIS is seeking input on ways to reduce rates of illness from Salmonella which has remained at a consistent level despite declining amounts of the bacteria on raw poultry products.

Although Salmonella can be found on many foods including fruits and vegetables, not all foods are regulated by the same agency. The reason FSIS announced it is taking steps to combat Salmonella particularly in poultry, and not onions or other types of produce, is because FSIS only has jurisdiction over meat, poultry, and some egg products. Therefore, FSIS’s food safety jurisdiction accounts for about 22% of the food supply. The Food and Drug Administration (FDA) has food safety jurisdiction over the other 78% of the food supply.

Although Salmonella is not the only foodborne pathogen that causes health concerns, FSIS treats other pathogens, such as Listeria Monocytogenes and E. coli in beef, as “adulterants”. FSIS has yet to identify Salmonella as an adulterant. This blog post explains what the term adulterant means as it is applied to meat, poultry, and some egg products. This blog post also outlines why Salmonella is treated differently than E. coli in beef. A later blog post will explore how the FDA defines the term adulterated and the way FDA deals with pathogen outbreaks in the rest of the food supply.

What Is the Definition of “Adulterated”? 

For FSIS to take any regulatory action Congress must first delegate authority to the agency. Congress delegated FSIS the authority to inspect meat, poultry, and egg products through three main acts: the Federal Meat Inspection Act (FMIA), the Poultry Products Inspection Act (PPIA), and the Egg Products Inspection Act (EPIA). The main purpose of each of these acts is to ensure that the food supply will not cause illness or injury. For example, the first section of the PPIA, which is the Congressional statement of findings, states “it is essential in the public interest that the health and welfare of consumers be protected by assuring that poultry products distributed to them are wholesome, not adulterated, and properly marked, labeled, and packaged.” Very similar language is found in the FMIA and EPIA. Each act directs the Secretary of Agriculture to create regulations and procedures designed to detect and remove harmful meat, poultry, and egg products from the food supply.

However, there has been some debate about what exactly causes a product to become “adulterated” despite each of the three acts having almost identical definitions for the term. In each act there are eight main ways a product can become adulterated. Meat or poultry is considered adulterated if:

1. It contains a poisonous or deleterious substance that when consumed ordinarily causes injury.
2. It contains an unapproved pesticide, food additive, or color additive that makes the meat or poultry unfit for food.
3. It is putrid or otherwise unfit for food.
4. It is prepared in an insanitary facility.
5. The animal dies of a disease or before arriving at a slaughter facility.
6. The container or packaging of the meat or poultry is unsafe or injurious.
7. The meat or poultry has been exposed to radiation.
8. It is branded in a way that describes the product as being worth more than it really is.

This definition is found in the PPIA at 21 U.S.C. § 453(g), in the FMIA at 21 U.S.C. § 601(m), and in the EPIA at 21 U.S.C. § 1033(a).

Applying the Definition to Foodborne Pathogens

Originally under the FMIA, PPIA, and EPIA, courts and FSIS only considered macro-contaminants such as glass and dirt to be adulterants. Thus, foodborne pathogens such as Listeria, E. coli, and Salmonella were not considered adulterants. This was first challenged in the case, American Public Health Association v. Butz, 511 F.2d 331 (D.D.C. 1974). In this case the plaintiffs, a public health advocacy group, filed suit to stop FSIS from including the language “U.S. Passed and Inspected” or “U.S. Inspected for Wholesomeness” on meat and poultry products that contained Salmonella. Since FSIS placed this seal of inspection on products that passed inspection despite the products containing Salmonella, the plaintiffs wanted the agency to also include a warning label so consumers would understand that the seal of inspection did not mean the products are Salmonella free. The plaintiffs argued that including the seal of inspection without a warning label on meat and poultry containing Salmonella was false and misleading. As explained in the case, FSIS included the seal of inspection on products containing Salmonella because it philosophized foodborne pathogens “can be handled most effectively at the consumer level where all contributing factors converge—where the final preparation of food takes place.” Ultimately, the court agreed with FSIS and held that the seal of inspection without a warning label was not false and misleading because Salmonella is inherent in meat and poultry. As an inherent component of meat and poultry, the court determined Salmonella was not an adulterant under the statutory definition.

However, in 1987, FSIS identified Listeria Monocytogenes as an adulterant in cooked and ready to eat meat without challenge. Then in 1994, in response to an E. coli outbreak linked to ground beef sold at Jack in the Box restaurants, FSIS established an E. coli sampling program which treated E. coli as an adulterant. Shortly thereafter, in the case Texas Food Industry Association v. Espy, 870 F.Supp. 143 (W.D. Tex. 1994), supermarkets and meat industry organizations challenged FSIS’s authority to establish the sampling program. The plaintiffs argued FSIS did not have the authority to treat E. coli as an adulterant under the FMIA because E. coli contaminated ground beef “is only injurious to health if improperly cooked”. The court disagreed and found that “in light of common cooking practices of most Americans, there is at least a rational basis for treating E. coli differently than other pathogens” and that “many Americans consider ground beef to be properly cooked rare, medium rare, or medium”. However, E. coli in ground beef is usually only killed off when cooked medium-well to well done. Ultimately, the court held that because E. coli “is a substance that renders ‘injurious to health’ what many Americans believe to be properly cooked ground beef” E. coli in ground beef “fits the definition of an adulterant under the FMIA.”

In 1996, after the Espy case, FSIS published a final rule that required all meat and poultry facilities to adopt Pathogen Reduction, Hazard Analysis and Critical Control Point (HACCP) systems. This regulation, which still exists, requires meat and poultry facilities to put a plan in place to reduce harmful bacteria like E. coli and Salmonella on raw meat and poultry. To enforce HACCP, the regulation calls for FSIS to conduct performance standards and test for levels of E. coli and Salmonella on the finished products.

In the case Supreme Beef Processors, Inc. v. U.S. Dept. of Agric., 275 F.3d 432 (5th Cir. 2001), a beef processing facility sued FSIS on the grounds that the agency did not have the authority to render its facility insanitary because FSIS found Salmonella on its end products. The beef processing facility argued that because Salmonella is not an adulterant per se, like E. coli, FSIS did not have the authority to prevent it from selling meat containing Salmonella. The court held that FSIS’s “regulation fails, but not because it measures Salmonella levels and Salmonella is a non-adulterant. The performance standard is invalid because it regulates the procurement of raw materials.” In other words, the court refused to treat Salmonella in ground beef as an adulterant because the beef came into the processing facility already containing Salmonella.

The Supreme Beef court also explained “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 of [the first definition of adulterant]. Salmonella-infected beef is thus routinely labeled ‘inspected and passed’ by USDA inspectors and is legal to sell to the consumer.”

Most recently in 2018, the parents of a boy who became ill from Salmonella-infected chicken sued the chicken producer in the case Craten v. Foster Poultry Farms Incorporated, 305 F.Supp.3d 1051, 1060 (D. Ariz. 2018). The court in Craten relied on the Btuz, Espy, and Supreme Beef cases and found that these cases “suggest[] that Salmonella on raw poultry is not an adulterant per se, and that its mere presence does not in and of itself show that a product was produced under insanitary conditions, these cases do not entirely foreclose the possibility that Salmonella may be deemed an adulterant under the PPIA when products contaminated with the bacteria are associated with an illness outbreak.”

These four cases apply many of the statutory definitions of “adulterated” to different scenarios. However, read together the cases pave a winding path directing us to what is considered an adulterant under the law and what is not. Under these cases, only E. coli (specifically the strain E. coli 0157:H7 and 6 others) found in ground beef is an adulterant. E. coli found in other beef cuts or poultry, and Salmonella found on any meat or poultry products are not considered adulterants unless enough people become ill from consuming the pathogens that an outbreak ensues. It is important to note that none of these cases are binding on FSIS as they were decided in district and circuit courts. Nevertheless, each case references the earlier cases although the earlier cases were not directly binding precedent. This offers FSIS insight on how best to apply the definition of adulterant to foodborne pathogens.

Conclusion

This murky landscape of courts and FSIS considering only certain pathogens adulterants, but only if they are on certain meats, has spurred a lot of debate. During the past couple of years a few interested people and organizations have submitted petitions to FSIS asking the agency to reevaluate its policy on foodborne pathogens, specifically Salmonella. On October 22, 2021, in a letter responding to a requested status update regarding one of these petitions, FSIS stated it will consider the issues raised in recent petitions as it considers approaches to reduce Salmonella caused illness by 25%. The response letter and the announced effort to reduce Salmonella caused illness does not change the law, but these actions indicate there may be future regulatory changes.

To read the Press Release announcing FSIS new Salmonella efforts, click here.

For more National Agricultural Law Center resources on food safety, click here.

For more National Agricultural Law Center resources on the EPIA, click here.

To read the Federal Register Notice identifying Listeria Monocytogenes as an adulterant, click here and locate page 7464.

To read the chapter in the Code of Federal Regulations entitled “Control of Listeria monocytogenes in post-lethality exposed ready-to-eat products”, found at 9 C.F.R. § 430.4, click here.

To view the case American Public Health Association v. Butz in its entirety, click here.

To view the case Texas Food Industry Association v. Espy in its entirety, click here.

To view the case Supreme Beef Processors, Inc. v. U.S. Dept. of Agric. in its entirety, click here.

To view the case Craten v. Foster Poultry Farms Incorporated in its entirety, click here.

**This article was written by former NALC Staff Attorney Jana Caracciolo.