EDF Health

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

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: August 5, 2019

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

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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).

[/pullquote]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 / Tagged , , | Read 1 Response

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, PFAS / Tagged , , | Comments are closed

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

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: June 3, 2019

[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 / Tagged , , | Read 2 Responses

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, PFAS, Public health, Regulation / Tagged , , | Comments are closed

FDA-approved PFAS: A serious breakdown in assessing food additive safety

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: November 4, 2018

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

This blog is the fourth in a series describing information we discovered in reviewing thousands of pages from the Food and Drug Administration’s (FDA) response to our Freedom of Information Act (FOIA) of the agency’s approval of 31 Food Contact Substance Notifications (FCNs) from 2002 to 2016 submitted by six companies for 19 distinct chemical mixtures of per- and poly-fluorinated substances (PFAS).

In this blog, we identify one company’s serious breach of its obligation to provide FDA with all relevant toxicology data. While hindsight is 20/20, we have reason to believe that if FDA had had all relevant information, it would have demanded more studies potentially revealing risks that are only now coming to light with related chemicals. Though we have not completed a similar review for the other companies, we think this inadequate approach to chemical safety is not unique to a single company, and FDA should reassess all its reviews given what is now known about PFAS chemicals.

Safety assessment requirements for food additives – including food contact substances

When a company seeks FDA’s approval of food additives (including food contact substances), it is required to provide the agency with all relevant chemistry, toxicology and environmental data so it can conduct a safety assessment. While the agency typically conducts a literature search of its own and of public databases, the company that is claiming the chemical’s use is safe is obligated to include any data that is inconsistent with the company’s conclusion.

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Posted in Drinking water, FDA, Food, Health policy, PFAS, Public health, Regulation / Tagged , , , , | Read 1 Response

FDA-approved PFAS and drinking water – Q & A on analytical measurements

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: June 29, 2018

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

On May 2018, we released a blog highlighting paper mills as a potentially significant source of drinking water contamination from 14 Food and Drug Administration (FDA)-approved poly- and per-fluorinated alkyl substances (PFASs) used to greaseproof paper. We showed that wastewater discharge could result in PFAS concentrations in rivers in excess of the Environmental Protection Agency (EPA)’s 70 parts per trillion (ppt) health advisory level for drinking water contamination for PFOA and PFOS, the most studied of the PFASs. Readers of the blog have asked some important questions highlighted below. We provide our best answers based on EDF’s FOIA request to FDA. See also our Q & A blog on textile mills and environmental permitting. 

Question 1: Would EPA’s analytical method for PFASs actually measure any of the FDA-approved PFASs in rivers and drinking water?

The answer is “likely no.” To understand why, we first need to explain which chemicals FDA approved and compare those chemicals to the list of 18 specific perfluorinated alkyl acids measured by Method 537, the EPA-approved analytical method used to report on PFASs in drinking water. Acids are only one of many functional groups that can be attached to the fully fluorinated carbons in the alkyl chain.

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Posted in Drinking water, FDA, Health policy, Health science, PFAS, Public health / Tagged , , | Comments are closed