EDF Health

Selected tag(s): PFAS

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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Posted in FDA, Food, GRAS, Health Science, PFAS / Also tagged , , | Read 2 Responses

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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Posted in FDA, Food, GRAS, Health Science, PFAS / Also tagged , , | Read 1 Response

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

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 EPA, FDA, Food, Health Policy, PFAS / Also tagged , | Comments are closed

FDA finds surprisingly high levels of PFAS in certain foods – including chocolate cake

[Update: FDA has published a webpage on PFAS and released the data for the studies discussed in this blog].

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

As reported by the Associated Press today, at a conference last week in Helsinki, Finland, the U.S. Food and Drug Administration (FDA) presented the results of three studies it conducted of 16 per- and poly-fluoroalkyl substances (PFAS) in various foods. A friend who attended the conference sent us photos of the poster. The results for samples of meat and chocolate cake purchased by the agency in October 2017 as part of its ongoing Total Diet Study (TDS) jumped out at us as surprisingly high and worth further investigation:

  • 17,640 parts per trillion (ppt) of perfluoro-n-pentanoic acid (PFPeA) in chocolate cake with icing. These levels suggest that the cake was contaminated from the intentional use of the chemical to greaseproof paper that contacted the cake rather than from an environmental source. We cannot find any evidence that FDA ever reviewed the safety of PFPeA as a food contact substance – meaning the manufacturer may have secretly designated it as Generally Recognized as Safe (GRAS). We also found little evidence – good or bad – of the health risks posed by this PFAS. We have reached out to FDA to learn more, but as of this blog posting the agency has not yet responded. This chemical was also found in chocolate milk at 154 ppt.
  • Nearly half (10 of 21) meat samples had quantifiable levels of perfluoroctanesulfonate (PFOS) with concentrations ranging from 134 ppt in a frankfurter to 865 ppt in tilapia. Unlike the chemical in chocolate cake, PFOS has been extensively studied because of widespread environmental contamination, especially around the facilities in Alabama and Minnesota where it was previously produced. It is associated with increased cholesterol, thyroid disease, testicular cancer, and decreased birth weight. While comparisons are complicated, the PFOS levels found in some of these meats were far greater than the 70 ppt health advisory set by the Environmental Protection Agency (EPA) for drinking water in May 2016. Two years later, the Centers for Disease Control and Prevention (CDC) proposed limits that are almost 7 times more protective than EPA’s, partly because more recent studies indicate the chemical may undermine the effectiveness of vaccines. Production of PFOS in the United States reportedly ended in 2002, though it is still made overseas and may have been imported paper. In 2016, FDA removed its approval to greaseproof paper with PFOS.

FDA’s poster also showed testing results from food produced around two PFAS contaminated areas. FDA found most of the 16 PFAS at varying levels measured in produce sold in farmer’s markets downstream of a PFAS production facility in the Eastern U.S. – presumably Chemours’ plant in North Carolina. The highest produce sample had 1,200 ppt and was purchased within 10 miles downstream of the production plant and short-chain PFAS were prevalent.

The other contaminated area was a dairy farm near an air force base in New Mexico. FDA found many of the 16 PFAS in the water and silage used to feed the cows but PFOS was the most prevalent among a few PFAS measured in the milk with levels higher than 5000 ppt. The agency also detected several PFAS in cheese produced by the farm in lower amounts than the milk. Many of the PFAS are likely from aqueous film forming foam (AFFF) used to fight fire and conduct firefighting training at the Air Force base.

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Posted in FDA, Food, GRAS, PFAS, Public Health / Also tagged , , | Read 2 Responses

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

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, PFAS, Public Health, Regulation / Also tagged , | Comments are closed

The Trump EPA’s actions on formaldehyde can be summed up in one word: Corrupt

Richard Denison, Ph.D.is a Lead Senior Scientist.

Today, Heidi Vogt at the Wall Street Journal reported on the systematic efforts by the Trump Administration to derail chemical assessments under the Environmental Protection Agency’s (EPA) Integrated Risk Information System (IRIS).   

Decisions are being made as I write by conflicted EPA political appointees, not only to derail the beleaguered IRIS assessment for the carcinogen formaldehyde, but to transfer any further assessment of the chemical to be under the control of those same political appointees.

The WSJ article cites an upcoming report by Congress’ Government Accountability Office (GAO) that notes “EPA leadership in October directed the heads of the agency’s various programs to limit the number of chemicals they wanted IRIS to study or continue researching.  Nine of 16 assessments were then dropped, including one that looked at whether exposure to formaldehyde increases the risk of leukemia that ‘has been drafted and is ready to be released for public comment.’ ”  The chemical industry has long sought to undermine the findings of numerous governmental authorities that have identified the dangers posed by formaldehyde, one of the industry’s biggest cash cows.

IRIS itself has also long been a target of the chemical and allied industries, including those well represented by EPA political appointees who are now able to drive the assault on IRIS from inside the agency.

This post will provide more of the backstory to the WSJ’s excellent reporting.  It reveals additional decisions being made as I write by conflicted political appointees, not only to derail the beleaguered IRIS assessment for formaldehyde, a known human carcinogen, but to transfer any further assessment of the chemical to be under the control of those same political appointees.  What is happening here we believe is ripe for further investigation.   Read More »

Posted in EPA, Health Policy, Health Science, Industry Influence, TSCA Reform / Also tagged , , | Comments are closed