EDF Health

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

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: November 20, 2019

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.

Posted in FDA, Food, PFAS / Tagged FDA, PFAS in food, PFOS | Read 1 Response

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

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: November 13, 2019

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

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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.

[/pullquote]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.

Posted in FDA, Food, GRAS, PFAS / Tagged FCNs, FDA, PFAS in food | Read 1 Response

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

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: August 9, 2019

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.

Posted in FDA, Food, GRAS, Health science, PFAS / Tagged Chemours, FDA, PFAS in food | Read 2 Responses

FDA concluded PFAS in food are safe. Now it has to show how it reached that conclusion.

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: August 1, 2019

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

In June, the Food and Drug Administration (FDA) posted a webpage that serves as a helpful starting place to learn about the agency’s efforts and plans regarding per- and poly-fluoroalkyl substances (PFAS) in food. The webpage explains that FDA is “assessing food for PFAS through sampling” and is “reviewing the limited authorized uses of PFAS in food contact applications.” In a statement accompanying the webpage’s release, FDA’s acting and deputy commissioners assured the American people that the agency “does not have any indication that these substances are a human health concern, in other words a food safety risk in human food, at the levels found in this limited sampling.”

We were surprised by FDA’s statement that all is fine given the results the agency published and the evidence about the array of health risks posed by PFAS at extremely low levels. Although the information posted is useful, we found it confusing and vague in some important aspects. Therefore, we are taking the opportunity here to raise some issues concerning FDA’s statements and planned next steps on PFAS. Additionally, in another 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.

Posted in FDA, Food, Health policy, PFAS / Tagged EPA, FDA, PFAS in food | Comments are closed

Washington State takes action to eliminate use of PFAS in food packaging

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: March 8, 2018

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

Around 1990, driven by a concern to keep heavy metals out of recycled products, many states adopted laws prohibiting the intentional addition of arsenic, cadmium, lead, and mercury to packaging and limited their total concentration to 100 parts per million. Manufacturers and suppliers of packaging and packaging components in these states were also both required to furnish a Certificate of Compliance to the packaging purchaser and provide a copy to the state and the public upon request. The Toxics in Packaging Clearinghouse currently reports that 19 states have adopted this type of legislation.

Out of concern about consumer’s health and contamination of compost, on February 28, 2018, Washington State extended its heavy metal packaging law in a groundbreaking way. The legislature passed HB-2658 banning the intentional use of “perfluoroalkyl and polyfluoroalkyl substances” (PFAS) in food packaging made from plant fibers, pending a determination by the Washington Department of Ecology that safer alternatives are available. The law defines PFAS as “a class of fluorinated organic chemicals containing at least one fully fluorinated carbon atom.”

The ban goes into effect in 2022 or two years after the Department makes the safer alternative determination, whichever is later.[1] If, after evaluating the chemical hazards, exposure, performance, cost, and availability of alternatives, the Department does not find safer alternatives by 2020, it must update its analysis annually. We anticipate that this approach will spur innovation among companies offering alternatives and provide a thoughtful and rigorous review of the options.

Posted in FDA, Food, Health policy, Health science, PFAS, Public health / Tagged FDA, Food packaging, PFCs, States, Washington State | Comments are closed

Beyond paper, part 2: PFAS intentionally used to make plastic food packaging

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: August 12, 2021

Tom Neltner, Chemicals Policy Director; Maricel Maffini, consultant; and Tom Bruton with Green Science Policy Institute

Since 2002, FDA has authorized the use of four types of per- and polyfluorinated alkyl substances (PFAS) to make plastic food packaging, one as recently as 2016. The PFAS are allowed in plastic at levels up to 2000 parts per million (ppm); although lower than those used to greaseproof paper, these levels still contaminate food. The PFAS are added to facilitate the production of articles such as bottles and wraps. They reportedly improve polymer extrusion, reduce build-up on the injection mold, and improve surface roughness among other technical effects.

EDF submitted a Freedom of Information Act (FOIA) request for seven food contact substance notices (FCNs) that FDA has authorized. From FDA’s response [1], we learned that these PFAS can contaminate food in contact with the packaging. In one case the overall amount of the PFAS in the diet would be as high as 41 ppb (see pages 31-32 of FOIA response) – much more than is tolerated for some PFAS in drinking water.

These plastic processing aids, along with fluorinated polyethylene, are the latest additions to a growing list of sources of ‘forever chemicals’ in the diet. They join environmental contamination and greaseproofed paper and cardboard as sources that food companies must consider in order to keep PFAS out of their products and respond to consumer demand for safer food. Given the evidence, FDA needs to move forward pursuant to our June 2021 citizens petition to evaluate the safety of PFAS taking into account the cumulative effect of these chemicals in the diet from many sources.

Posted in FDA, Food, PFAS / Tagged FDA, PFAS in food | Comments are closed

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