EDF Health

FDA’s updated results for PFAS in food suggest progress but raise questions about its method

Tom Neltner, J.D.Chemicals Policy Director and Maricel Maffini, Ph.D., Consultant

The Food and Drug Administration (FDA) recently released revised lab results from testing for 16 PFAS in food. Initial results of the testing were announced last June and gained wide attention because the levels of PFAS in certain foods were quite high. Surprisingly, the revised lab results show significantly fewer detections and, in the case of ground turkey and tilapia, concentrations of PFOS that are almost nine times lower than the values initially reported in June. In addition to the revised lab results, the agency also released a validated method for analyzing food for the substances and updated its PFAS webpage.

We were glad to see FDA’s ongoing work on PFAS and have already heard from commercial laboratories who are considering using the validated method as a potential new service to offer their customers. In analyzing the documentation that FDA provided,[1] we have concerns about the agency’s criteria to determine whether a sample had detectable levels of a PFAS. It appears unnecessarily restrictive and effectively underestimates the public’s exposure to PFAS. We are planning to meet with the agency to better understand their rationale for the criteria selection and its implications.

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Think PFAS in food packaging are safe simply because FDA accepted their use? Think again.

Tom Neltner, J.D.Chemicals Policy Director and Maricel Maffini, Ph.D., Consultant

PFAS manufacturers’ claims that the agency demands scientific data, including toxicity and exposure, and conducts a rigorous review before allowing the use of the chemicals in contact with food are not accurate.

Per- and poly-fluorinated alkyl substances (PFAS)—recently dubbed “forever chemicals”—have received a large amount of national attention, mostly due to contamination of drinking water affecting millions of Americans. Since June 2019, when the U.S. Food and Drug Administration (FDA) released its testing results from three studies, questions have arisen about food as a source of PFAS exposure. The main routes by which PFAS enter the food supply are environmental contamination—such as from nearby chemical manufacturing facilities, airports or Department of Defense operations—and from food packaging and processing equipment.

With greater attention on PFAS in food, we’ve noticed several misleading PFAS manufacturers’ talking points asserting that FDA review and acceptance is required for any PFAS to be used in contact with food, and that, due to this review, PFAS that go through this process are safe. However, their claims that the agency demands scientific data, including toxicity and exposure, and conducts a rigorous review before allowing the use of the chemicals in contact with food are not accurate.

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Time for a safer food supply: The legal challenge to FDA’s GRAS Rule

Tom Neltner, J.D.Chemicals Policy Director, Environmental Defense Fund

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.

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Without a food safety overhaul for additives, the innovative food craze could spiral out of control

Tom Neltner, J.D.Chemicals Policy Director

At an FDA-sponsored conference, EDF proposed a new path forward to ensure innovative food ingredients are safe by overhauling how food additives are regulated today.

Every day brings reports of new ingredients that food innovators around the world have developed to meet consumer demands for a healthier and more sustainable food supply. The innovations range from new ways to extract useful additives from existing sources such as algae to bioengineering to make novel ingredients like sweeteners or proteins that can be grown in a tank instead of on a farm.

At EDF, we encourage innovation that helps communities and the environment thrive, especially in the face of the threats posed by climate change. However, an innovator’s bold claims, especially those involving food safety, must be closely scrutinized before the additive hits the marketplace. Given the potential for harm to consumers, we cannot simply take a company’s assertion of safety at face value – there must be transparency and the Food and Drug Administration (FDA) must provide an independent review.

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Chemours asks FDA to suspend its approved uses of PFAS in food packaging

Tom Neltner, J.D.Chemicals Policy Director

Politico reported today that Chemours notified the Food and Drug Administration (FDA) that it had officially abandoned its three approved food packaging uses of per- and poly-fluorinated alkyl substances (PFAS) and asked the agency to withdraw its Food Contact Substance Notifications (FCNs) for those uses. We do not know with certainty what prompted Chemours to abandon its PFAS products for food packaging or whether they were ever used in the United States. Based on past experience, we anticipate that FDA will grant the request.

This action takes us one step closer to reducing people’s exposure to these chemicals linked to an array of health risks posed by PFAS at extremely low levels. Additionally, the action should serve as an incentive for other companies to do the same.

Chemours also has FCNs for six PFAS uses in repeat-use food contact articles like gaskets and seals. The company apparently has not asked the agency to abandon these uses. We suspect that the PFAS-treated gaskets may still be in service even if it has stopped treating new gaskets with the chemicals.

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FDA must abandon its flawed assumptions when reviewing safety of approved PFAS uses in food

Tom Neltner, J.D.Chemicals Policy Director and Maricel Maffini, Ph.D., Consultant

All the PFAS uses allowed by FDA that we reviewed had estimated exposures exceeding the most protective minimal risk level for PFOS proposed by the Centers for Disease Control and Prevention (CDC).

In its June 2019 release of a webpage dedicated to per- and poly-fluoroalkyl substances (PFAS) in food, FDA stated that it is “reviewing the limited authorized uses of PFAS in food contact applications.” As we mentioned in a previous blog, we were pleased to see FDA’s public position on PFAS but we highlighted three major concerns that could impact the ongoing safety review and questioned the conclusion that all is fine. In this blog, we discuss the implications of FDA’s statements on its review of 62 authorized PFAS uses in contact with food and make recommendations to the agency as it proceeds with this promising effort.

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