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.
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?