Pet Food Company Sues FDA Over its Zero-Tolerance Salmonella Standard

At the heart of Answer’s lawsuit is the FDA’s Compliance Policy Guide (CPG) 690.800, “Salmonella in Food for Animals.” The guidance was published in July 2013, and its stated purpose is “to provide guidance for FDA staff on the presence of Salmonella in food for animals.” An explanatory paragraph early in the document affirms that, “FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the FDA’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.” Additionally, the words “Contains Nonbinding Recommendations” is printed at the top of each page of the guidance.

These statements are striking, as their effect seems deliberately intended to diminish the document’s importance. However, the language of the actual guidance could be interpreted as being inconsistent with the disclaimers that precede it. For instance, the FDA asserts that it “considers an animal feed or pet food that may be injurious to health because it is contaminated with Salmonella to be adulterated under [the FDCA].” The FDA justifies this assertion by stating that pet food poses a significant risk to human health when contaminated with Salmonella, because humans come into direct contact with these foods. By that logic, almost all raw meat products containing Salmonella could be considered adulterated. After all, a consumer’s direct contact with the food they eat is almost certainly more frequent than their contact with the food they feed their pets. Consider also that the USDA, which regulates meat and poultry for human consumption, does not deem raw meat adulterated on the singular basis that it contains any serotype of Salmonella. The obvious irony is that, at least for Salmonella, the FDA applies a more stringent standard to pet food than human food.

The most often utilized counterargument is that raw meat produced for human consumption is intended to be cooked, thereby killing any pathogenic bacteria that may be present. However, that argument is problematic for several reasons. For one, pet food is not meant to be consumed by humans in the first place. Another reason is that our contact with the raw meat we consume is almost certainly more substantial than the contact we have with raw pet food. Many consumers wash raw meat and apply rubs, marinades, etc. At least in this regard, the FDA rule seems somewhat illogical, or at least ungrounded.

Conversely, the adulteration standards are nuanced and complex. The federal adulteration statute must incorporate a complicated nexus of enormously important (and often competing) societal interests. Broadly speaking, food safety brings into play social, political, demographic, and economic factors. Effective adulteration laws, in turn, must anticipate and address all possible risks. Salmonella does pose a serious health risk to humans and pets alike. Consequently, many are ambivalent about critiquing the agency for taking a hard line against products contaminated with Salmonella.

An Important Case

Ultimately, the outcome of this specific case has little to do with Salmonella or pet food. This case is really about the rulemaking process and extent of executive authority. If the FDA can create rules simply by issuing guidance that the FDA falsely claims is nonbinding, then where is the ultimate stopping point?

Today, the question is whether the FDA has exceeded its mandate by enacting a binding regulation using an informal rulemaking procedure. How the courts answer that question will likely set a precedent future courts will have to abide by.

On the one hand, the court could significantly expand the FDA’s authority, removing an important check on executive power. On the other hand, if the courts rule that the FDA lacks authority to make adulteration declarations regarding foods contaminated with potentially lethal pathogens, then what? It is certainly a very difficult question, and reasonable minds can differ on which is the desired outcome.