This blog initially was published as a guest column in Chemical Watch on September 9, 2019. After publication, FDA filed its reply brief to the plaintiff’s August 23, 2019 brief. The briefings are complete and the case awaits a decision by the judge.
Litigation is a time-consuming and often inefficient means to fix a broken regulatory system. However, when there is a fundamental disagreement about a regulatory agency’s responsibilities under the law, it is an essential option. Such is the case with the “Generally Recognized as Safe” (GRAS) exemption from the requirement for pre-market approval of food additives in the Federal Food, Drug, and Cosmetic Act (FFDCA). The Food and Drug Administration (FDA) interprets this exemption as allowing companies to determine whether a substance’s use is GRAS in secret without any notice to the agency.
Next year, I anticipate a federal district court will make a final decision on a lawsuit[1] challenging the FDA’s 2016 GRAS Rule that formalized the agency’s broad interpretation of the exemption and its narrow interpretation of its responsibilities under the FFDCA to “protect the public health by ensuring that . . . foods are safe, wholesome, sanitary, and properly labeled . . . .” (21 U.S.C. §393(b)). It would come a decade after the U.S. Government Accountability Office (GAO), the independent, nonpartisan agency that works for Congress, concluded that “FDA’s oversight process does not ensure the safety of all new GRAS determinations.” The GRAS Rule does little to address the shortcomings described by GAO.
Environmental Defense Fund (EDF), represented by Earthjustice, and the Center for Food Safety (CFS) are the plaintiffs in the lawsuit asking the court to declare the GRAS Rule unlawful and vacate the rule. On August 23, we filed with the court our response to the agency’s brief on both parties’ motions for summary judgment. FDA is expected to file a reply in September. Based on these briefs, the court may order oral arguments before making a decision.
The path to reach this stage has been lengthy and complicated, including a previous lawsuit by CFS to force FDA to finalize the 2016 GRAS Rule that the agency proposed in 1997. Rather than walk through the history, I want to focus on the crux of the case – whether FDA may allow companies to determine—in secret—that a substance they have manufactured for use in food is GRAS.
The agency maintains that it “has reasonably chosen to enforce the GRAS provision by issuing regulations that establish criteria for GRAS conclusions and permit, but do not require, manufacturers to notify FDA of their GRAS conclusions.” In its view, “nothing in the statute unambiguously requires that the FDA enforce these standards in a particular way, let alone through the mandatory premarket notification mechanism that Plaintiffs propose.”
In our August 23 response, we explain that FDA is asking the Court to find that the GRAS Rule is somehow consistent with its duties under the FFDCA, the Administrative Procedures Act, and fundamental constitutional principles. “To rule for FDA, the Court would have to find that the Agency is permitted to shift responsibility for key aspects of food safety to food manufacturers without retaining oversight, and allowing manufacturers to secretly self-certify substances as GRAS is consistent with FDA’s food safety duties, and FDA’s vague and lenient criteria for determining GRAS status are legally adequate. None of these findings is supportable.”
FDA’s argument rests on three contentions which we find untenable and inconsistent with the law. The agency contends that:
- FDA’s ability to enforce violations of the FFDCA makes up for the fact that the GRAS Rule allows manufacturers to make GRAS determinations in secret with no agency oversight;
- The supposed impracticability of identifying all substances added to food justifies FDA’s decision not to require notice when manufacturers certify substances to be GRAS; and
- FDA’s decision to outsource food safety decisions to manufacturers is acceptable because it is efficient.
FDA fails to acknowledge the hazards inherent in a regime that allows self-interested manufacturers to make decisions that could threaten public health and safety. But allowing the fox to guard the henhouse can have disastrous results, as evidenced, for example, by the recent tragedies involving defective commercial jets determined to be safe by their manufacturer, Boeing, with little government oversight. As described by the New York Times on July 27, 2019, prior to a series of crashes involving Boeing’s planes, the Federal Aviation Administration handed nearly complete control to Boeing, effectively neutering the oversight authority of the agency. While a plane crash is far more traumatic than we would expect from a GRAS substance, it underscores the fact that when, as here, decisions about safety are made in secret, the agency’s oversight function is eroded. And when it comes to our food that is a problem because, unlike flying, we all eat food every day and should have confidence that that food is safe.
Nor can FDA’s enforcement authority save the GRAS Rule, because the GRAS Rule’s provision for secret GRAS determinations renders that enforcement authority impotent. FDA cannot bring an enforcement action against an unknown company adding an unknown substance to unknown food. In fact, FDA is unlikely to discover violations of the FFDCA before injury occurs. Sentence on Four Loco.
Nothing prevents FDA from designing a GRAS system that ensures FDA has the information necessary to fulfill its statutory duties. FDA’s claims to the contrary rest on two faulty assumptions.
- FDA mistakenly assumes that EDF and CFS demand premarket approval of manufacturers’ GRAS determinations when, in fact, they merely maintain that FDA must receive premarket notice of those determinations. FDA does not explain why it cannot require manufacturers to provide notice of GRAS determinations.
- FDA relies extensively on a sixty-year-old policy statement asserting that it would be impracticable to list all GRAS substances. But FDA misconstrues this statement, which refers only to the impracticability of listing all substances found to be safe through common use in food up to 1958. FDA fails to explain why it cannot keep a running list of novel substances determined to be GRAS through scientific procedures after
Finally, FDA’s argument that the optional notice system is the most efficient use of its resources is unfounded and illogical. It is not “efficient” for FDA to remain in the dark about substances added to food. To the contrary, FDA’s ignorance threatens food safety and prevents the Agency from carrying out its statutory and constitutional responsibilities.
The agency’s position in the litigation stands at odds with statements made in 2014 to the Washington Post by Michael Taylor when he was FDA’s Deputy Commissioner for Foods. He said that “we simply do not have the information to vouch for the safety of many of these chemicals” added to food, and the GRAS Rule’s lack of transparency “is the opposite of what the oversight law [the FFDCA] intended . . . .”
The bottom line is that FDA has the authority and the obligation under the law to ensure the safety of GRAS substances added to food. The GRAS Rule fails because it unlawfully subdelegates to private industry the agency’s statutory obligations to ensure the safety of our food in contravention of the plain language and intent of the FFDCA.
[1] U.S. District Court for the Southern District of New York, Center for Food Safety and Environmental Defense Fund v. Alex M. Azar II, Secretary, Department of Health and Human Services, Ned Sharpless, Acting Commissioner, U.S. Food and Drug Administration, and U.S. Food and Drug Administration, No. 1:17-cv-3833.
By Tom Neltner
Tom Neltner, J.D., Chemicals Policy Director, Environmental Defense Fund
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