Tom Neltner, J.D., is Chemicals Policy Director
At the end of March, EDF, represented jointly by counsel from Earthjustice and the Center for Food Safety (CFS), asked a federal district court judge to decide as a matter of law that the Food and Drug Administration’s (FDA) Generally Recognized as Safe (GRAS) regulation is unlawful. The GRAS Rule allows food manufacturers to make secret safety determinations for chemicals added to food without notifying FDA or the public and to use such chemicals. If the judge agrees to our request, this would vacate the rule. Two years ago, EDF and others challenged the legality of the GRAS Rule in the Federal District Court for the Southern District of New York. Last September, the court ruled that plaintiffs EDF and the CFS have standing, setting the stage for a decision on the merits of the case.
In the Motion for Summary Judgment, we identify the following four ways in which FDA violated the law in the GRAS Rule. FDA has until May 28 to respond to our motion.
- FDA unlawfully delegated to food manufacturers its authority to determine the safety of chemicals added to our food.
When Congress enacted the Federal Food Drug and Cosmetic Act (FFDCA) of 1938, it gave FDA the responsibility to ensure the nation’s food is safe and free from harmful substances. To implement this responsibility, it provided the agency broad authority to adopt necessary regulations.
Unfortunately, in the GRAS Rule, instead of fulfilling its responsibility to keep food safe, FDA formally and unlawfully outsourced its responsibility to the regulated entities themselves – namely, for-profit additive manufacturers – allowing them to decide for themselves, in secret, whether the chemical substances they have manufactured can be added to food. This unlawful delegation – made without express statutory authorization – makes it all but impossible for FDA to fulfill its obligations under the FFDCA.
As a result, the GRAS Rule impermissibly allows regulated, private companies with obvious conflicts of interest to self-certify the use of their chemical additives as GRAS without notifying FDA. This is not a case where FDA is seeking legitimate outside input to gather factual information or advice and make policy recommendations. Here, FDA retains no oversight over these secret GRAS determinations that directly affect the safety of our food and thus render it impossible for the agency to fulfill its statutory mandate to keep our food safe.
By delegating its authority in the GRAS Rule, the agency violated Constitutional principles, the FFDCA, and the Administrative Procedures Act (APA). The rule effectively insulates the agency from democratic accountability for food safety decisions and denies citizens their right to seek judicial review of decisions about the safety of substances that may be added to food.
- The GRAS Rule makes it impossible for FDA and food manufacturers to consider the cumulative effect of related substances in the diet despite a legal requirement.
When making food additive safety determinations, the FFDCA requires FDA to consider “the cumulative effect of such additive in the diet of man or animals, taking into account any chemically or pharmacologically related substance or substances in such diet.”[1] Because the GRAS Rule makes it impossible for FDA to know all of the substances added to food and every use of those substances, the agency cannot determine what substances that may be chemically- or pharmacologically-related already are used in food or evaluate the combined health effects.
In addition, FDA’s regulations[2] require that companies make the same assessment of cumulative effect of related substances when making GRAS determinations. If the companies, like FDA, do not have access to the GRAS safety determinations made by other food manufacturers, they cannot adequately comply with their legal obligation.
- FDA ignored evidence in the record that documented serious weaknesses in the program.
The final GRAS Rule largely failed to address the extensive evidence in the docket showing the shortcomings of the proposed rule that FDA had almost 20 years of experience implementing. The final GRAS Rule is substantially the same as the proposed rule. Specifically, the agency did not meaningfully grapple with the problems identified by the Government Accountability Office in 2010 documenting that FDA is not systematically ensuring the continued safety of current GRAS substances and does not help ensure the safety of all new GRAS determinations.
- The GRAS Rule lacks sufficient criteria to ensure compliance with the FFDCA.
Even if FDA could delegate its food safety responsibility to food manufacturers by allowing secret GRAS safety determinations (which it cannot), the GRAS Rule lacks sufficient criteria to ensure that GRAS determinations comply with the FFDCA. The agency cannot realistically conduct spot checks and random audits of food manufacturers when it has no idea if a GRAS determination was made or a GRAS substance is being used. And the rule fails to require a food manufacturer to maintain any written documentation of the decisions. So even if the agency knew of the determination, it could not evaluate the basis of the decision.
Specifically, the GRAS Rule:
- Fails to include sufficient criteria to ensure that the data, information, and methods upon which manufacturers base their GRAS determinations are “generally recognized” going so far as to allow a decision to be based on unpublished data.
- Does not include criteria to ensure that manufacturers’ GRAS determinations are free from conflicts of interest.
- Does not contain any criteria to ensure manufacturers do not self-certify substances as GRAS after FDA raises safety concerns about them.
- Fails to include criteria clarifying that carcinogenic substances can never be deemed safe for use in food.
For these reasons, FDA cannot fulfill the FFDCA’s core purpose[3] of ensuring food safety.
We hope that the agency will recognize the flaws and fix the rule. As we said when the agency issued the final rule in 2016, FDA lost an opportunity to ensure safer food additives. With this challenge, we move one step closer to correcting that failure and achieving a safer food supply.
[1] See 21 U.S.C. § 348(c)(5)(B).
[2] See 21 C.F.R. § 170.3(i)(2).
[3] See 21 U.S.C. § 393(b)(2).