Lystn LLC, which does business as Answers Pet Food, is suing the FDA along with numerous other defendants over zero-tolerance Salmonella standards applicable to pet food. Answers is challenging the FDA’s authority to promulgate binding rules through the issuance of purportedly nonbinding guidance materials. If the FDA prevails, the practical result would be a significant broadening of the agency’s rulemaking authority. That, in turn, could have wide-ranging repercussions for food companies.
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Explore This IssueOctober/November 2019
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Answers is seeking declaratory and injunctive relief. Declaratory relief is, in short, a judicial declaration stating what the law is. In this case, Answers wants the court to declare that the FDA has no authority to enforce the zero-tolerance Salmonella standard. Injunctive relief seeks to stop (or enjoin) something from happening. Answers is asking the court to enjoin the FDA from enforcing the zero tolerance Salmonella standard.
Answer’s arguments, as set forth in their legal complaint, are proffered in a colorfully worded and legally complex tapestry of jurisdictional issues, statutory analysis, constitutional principles, and allegations of regulatory overreach. In simple terms, however, the arguments can be summarized as follows: The FDA’s enforcement of the Salmonella rule is unconstitutional because the rule was created through the promulgation of guidance materials, which, as a matter of federal law, the agency has no legal authority to enforce. Put differently, the FDA overstepped its authority. There are important constitutional principles underpinning the allegations by Answers.
In drafting the U.S. Constitution, the Founding Fathers were principally concerned with limiting the power of the federal government. To prevent tyranny, they sought to divvy up governmental power between multiple branches with competing interests. Accordingly, Article 1 of the Constitution grants the U.S. Congress the ability to pass laws, Article 2 grants the executive branch the ability to enforce the laws, and Article 3 grants the judiciary the ability to interpret the laws. This is often referred to as the “separation of powers” and is intended to prevent the consolidation of power in any single branch of government. Those limits would be meaningless if federal agencies, as part of the executive branch, could both create and enforce their own legally binding rules. Yet, despite the limitations, it is administratively necessary for federal agencies to be able to create some types of regulations. This inherently creates a gray area.
As a matter of law, the FDA’s rulemaking authority is generally limited to developing and implementing regulations that are necessary to administer or enforce the laws passed by Congress (e.g., the Food Safety Modernization Act and the Food Drug and Cosmetic Act). What is “necessary,” however, is itself a subjective determination (the gray area). The FDA and the entities it oversees naturally have very different viewpoints on what constitutes “necessary.” The Administrative Procedure Act (APA), a federal statutory scheme that governs the process and limitations by which federal agencies create regulations, further constrains the FDA’s authority and serves as an important check on executive authority.
Formal vs. Informal Rules
Ultimately, effective rulemaking is about striking a balance. In the case of the FDA, that balance encompasses granting the agency authority to efficiently and effectively enforce the laws, but not such expansive authority that it can violate the constitutionally mandated separation of powers.
The APA is comprised of numerous individual statutes. The APA’s rule-making statute, 5 U.S.C. § 553, grants federal agencies such as the FDA the authority to make two types of rules: formal and informal. Suffice it to say that formal rules are vastly more onerous to enact than informal rules. Formal rules typically take years—or even decades—to enact. Informal rules, on the contrary, are nonbinding and do not create legally enforceable responsibilities. This is perfectly logical inasmuch as enforceable rules should be more difficult to create. Importantly, the rule-making statute exempts “interpretative rules, general statements of policy, or rules of agency organization, procedure, or practice” from the requirements. Here again is the gray area alluded to earlier: When does a statement of policy become a formal rule?
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.
Fortunately, we have an independent judiciary composed of thoughtful and remarkably intelligent jurists who look at the law and render judgment on the merits of the respective arguments. It will be interesting to see what happens.
Chappelle is a food industry lawyer and consultant at Food Industry Counsel, LLC. Reach him at firstname.lastname@example.org. Stevens, also a food industry attorney, is a founding member of Food Industry Counsel, LLC. Reach him at email@example.com.