EDF Health

Selected tag(s): PFOA

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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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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FDA-approved PFAS and drinking water – Q&A on textile mills and environmental permits

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: June 21, 2018

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

In 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 (PFAS) 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. We identified 269 paper mills with discharge permits that warrant investigation. Readers of the blog have asked some important questions highlighted below. As with most issues involving PFAS, there are many gaps in what we know. Based on the information provided in response to EDF’s Freedom of Information Act (FOIA) request to FDA, we hope to fill in some of the gaps and highlight key information needed to better understand the risks of PFASs.  

Question 1: Could textile mills also be a source of PFASs in drinking water?

The answer is “probably.” The FDA-approved PFASs can be used in coating paper that contacts food to repel oil, grease, and water. The same or similar FDA-approved PFASs may be used for non-food uses such as coating textiles to resist stains and repel water.

The processes used to coat paper and textiles differ in some aspects that could affect a mill’s environmental releases. For paper, the PFASs are typically added to the wet wood fibers to be made into paper. In contrast, we understand that PFASs are applied to textiles after the water is removed. Therefore, we would suspect that the amount of PFASs, whether as polymers or impurities, released with the wastewater of a textile mill would be lower compared to that of a typical paper mill. However, there is very little data available to assess the potential environmental release of PFASs from textile mills. Unlike with FDA approvals, there is no environmental review of a chemical’s use in non-food consumer products.[1] So, it would be worthwhile to investigate textile mills for use of PFASs in addition to looking at paper mills.

Using an EPA database[2], we identified 66 textile mills (PDF and EXCEL) in the US, two thirds of which are located in North and South Carolina. Based on wastewater flow, the two largest mills are both operated by Milliken. Its largest facility is in Greenville, South Carolina with a water discharge of 72 million gallons per day (MGD). The second largest is in Bacon, Georgia with a water discharge of 15 MGD. DuPont’s Old Hickory facility, near Nashville, Tennessee, had the third greatest flow at 10 MGD. We do not know whether any of the facilities use and discharge FDA-approved PFASs.

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

Paper mills as a significant source of PFAS contamination, but who’s watching?

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: May 21, 2018

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

Update: See June 21, 2018 Q&A blog on PFAS at textile mills and environmental permits

Across the country, communities are grappling with how to manage contamination of drinking water by perfluorinated alkyl substances (PFASs), a class of chemicals widely used in consumer products, industrial processes, and firefighting foams. Concern over the chemicals grew with the Environmental Protection Agency’s (EPA) 2016 release of a 70 parts per trillion (ppt) drinking water health advisory for PFOA and PFOS, two common and well-studied forms of PFASs.

One challenge to effectively evaluating the potential impacts of PFASs as well as cleaning up priority sites is that there is very little information on where these chemicals are being used. Through a Freedom of Information Act (FOIA) request to FDA, EDF obtained documents previously not made public that show that paper mills using PFASs may be a significant source of contamination to water and potentially to air and compost.

In the nearly 900 documents we received from FDA, we found environmental assessments in four Food Contact Substance Notifications (FCNs) submitted in 2009-2010 by two companies, Daikin America and Chemours.[1] FDA approved each notice, allowing the companies to sell their PFASs to make paper and paperboard repel oil and grease in food packaging such as pizza boxes, sandwich wrappers, and microwave popcorn bags. All four assessments based their estimates on what they called a “typical” paper mill that produces 825 tons of PFAS-coated paper per day and discharges 26 million gallons of water per day.[2]

  • Chemours FCN 885 estimated 95 pounds/day of its PFAS[3] in the wastewater discharge at 43,000 ppt.
  • Chemours FCN 1027 – a notification for the same PFAS – increased the amount in paper from 0.42% to 0.8% resulting in 183 pounds per day in the wastewater discharge at 83,000 ppt.
  • Daikin FCN 933 estimated 180 pounds/day of its PFAS[4] in the wastewater discharge at 83,000 ppt.
  • Daikin FCN 1044 estimated 225 pounds/day of a similar PFAS[5] in the wastewater discharge at 103,000 ppt.

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Posted in Drinking water, FDA, Health policy, Regulation / Also tagged , , , , , , , | Authors: / Read 2 Responses

Will we take this best chance ever to fix the law that helped bring about DuPont’s PFOA debacle?

By / Published: January 11, 2016

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

A remarkable exposé in yesterday’s New York Times Magazine documents the “brazen, decades-long” withholding by DuPont of mounting evidence of widespread exposure to and health effects from one of its signature chemicals (nicknamed PFOA) used in manufacture of its line of Teflon brand products.

The article is compelling in many respects, not the least of which is its scathing indictment of the federal laws that are supposed to protect Americans from toxic chemical exposures.  In particular, the article highlights the deep failures of the Toxic Substances Control Act (TSCA) – now limping into its 40th year of existence without ever having been substantially amended.  TSCA is the law that – in principle – regulates most uses of PFOA and other so-called “industrial chemicals,” thousands of which are widely used in everyday consumer products and materials ranging from household cleaners to furniture to paint to electronics.

The article’s focus on TSCA is more than justified:  PFOA is one of 62,000 chemicals that were already on the market when TSCA passed in 1976.  All of these chemicals were “grandfathered” under the law, effectively presumed safe without any requirement that they be tested or reviewed for safety.  And while, as evidence of harm and widespread exposure mounted, the Environmental Protection Agency (EPA) did conduct a review of PFOA (which more than a decade later is still only in draft form), its authority under TSCA is so weak that it has not even attempted to use that authority to restrict any uses of the chemical, instead having to negotiate a gradual voluntary phase-out.  Indeed, EPA hasn’t tried to regulate any existing chemical under TSCA since 1991, when a court threw out its regulation of the known killer asbestos, on the grounds that EPA had not met its burden of proof of harm under TSCA.

Not mentioned in the article, however, is that for the first time ever Congress is on the verge of finally reforming TSCA.  Reform bills have passed both the Senate and the House, and negotiations toward a final reconciled bill are expected to get underway any day now.

While no single law could by itself have prevented the tragic story of PFOA from unfolding, provisions of one or both bills would go a long way to help prevent such events from happening again.  Let me mention some of the most important:   Read More »

Posted in Health policy, TSCA reform / Also tagged , | Read 3 Responses