EDF Health

Selected tag(s): PFAS in food

FDA scientists push back on an industry-funded analysis about bioaccumulation and toxicity of short-chain PFAS

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: April 1, 2020

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

Note to readers: As we all grapple with the grave global health challenge from COVID19, we want to acknowledge the essential services that professionals at the Food and Drug Administration (FDA) and in the food production, processing and retail industries provide in continuing to deliver food. In the meantime, we are continuing to work towards improved health protections – including reducing chemicals in food. We’ll plan to keep sharing developments that may be useful to you. In the meantime, please stay safe and healthy.

Last year, we reported on a sophisticated analysis performed by FDA’s scientists showing that 5:3 acid, a breakdown product of a short-chain PFAS known as 6:2 fluorotelomer (6:2 FTOH) was slow to be eliminated by the body. The authors concluded that the metabolite was an important biomarker for assessment of long-term exposure to 6:2 FTOH and showed potential bioaccumulative (aka biopersistence[1]) properties. The chemical 6:2 FTOH is a common starting substance in the manufacture of many PFAS polymers, including those used to greaseproof paper and paperboard. As a result, it is a major impurity in, and degradation product of, these polymers.

We are now reporting on two recent publications by the same group of FDA scientists (Kabadi et al.[2] and Rice et al.)[3] in which they not only confirmed their initial findings but also produced new evidence on the behavior of short-chain PFAS when they enter the body. The new evidence highlights:

  • Bioaccumulation: 6:2 FTOH is transformed by the body into several metabolites; one of them, called 5:3 acid, bioaccumulates, and the bioaccumulation is greater with lower exposure to 6:2 FTOH.
  • Toxicity: The toxicity of 6:2 FTOH is concerning and its risk to human health may have been significantly underestimated previously. Data on perfluorohexanoic acid (PFHxA), the industry’s proposed reference chemical for the short-chain PFAS class are not appropriate for assessing the potential health effects of 6:2 FTOH.

The FDA’s scientists reached these important conclusions after reviewing “recently received additional data on 6:2 FTOH and 5:3 acid” and more than a dozen reports on oral toxicity studies that “had been conducted and submitted by industry in support for food contact uses” of short-chain PFAS in addition to a study by the National Toxicology Program. They also called out flaws in industry-funded analyses that reached different conclusions.

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Posted in FDA, Health policy, Industry influence / Also tagged , | Comments are closed

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.

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Posted in FDA, Food / Also tagged , , | 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

[pullquote]

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.

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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.

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Posted in FDA, Food, Health science / Also tagged , , , | 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.

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Posted in FDA, Food, Health policy / Also tagged , , | Comments are closed

The elephant in the room: potential biopersistence of short-chain PFAS

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

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

In January 2018, US Food and Drug Administration (FDA) scientists published a peer-reviewed journal article stating a commonly used raw material to make greaseproof paper is likely to persist in the human body. FDA scientists’ sophisticated analysis and remarkable conclusion raises questions about the broad assumption that short-chain perfluorinated alkyl substances (PFAS), as a class, did not accumulate.

Strangely, two recent reviews funded by the FluoroCouncil, ignored FDA scientists’ study even though it was published ten months before the industry group submitted their analysis for peer-review. The peer reviewers appear to have missed the omission as well. As a result, the industry evaluations continue to perpetuate the flawed assumptions, concluding that perfluorohexanoic acid (PFHxA) and related short-chain PFAS “present negligible human health risk” and that this substance alone is a suitable marker for the “safety of fluorotelomer replacement chemistry.”

In this blog, we discuss the differences between the studies and the implications of the discordance between FDA’s and industry’s conclusions for the safety assessment of short-chain PFAS.

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Posted in Drinking water, FDA, Health policy, Health science, Public health, Regulation / Also tagged , , | Comments are closed