EDF Health

Selected tag(s): PFAS

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

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

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, EPA, FDA, Food, Health Policy, PFAS, Public Health, Regulation / Also tagged , , , | Read 1 Response

American Academy of Pediatrics calls for “urgently needed reforms” to fix broken food additive regulatory system

Tom Neltner, J.D. is Chemicals Policy Director

Today, the American Academy of Pediatrics (AAP) released a “Food Additives and Child Health” policy statement calling for “urgently needed reforms to the current regulatory process at the US Food and Drug Administration (FDA) for food additives.” The policy applies to chemicals deliberately added to food or to food packaging or food processing equipment that get into food. These substances are used to flavor, color, preserve, package, process and store our food, but many never appear among the list of ingredients. AAP’s statement calls specifically for the following:

  • “Greatly strengthening or replacing the GRAS [Generally Recognized as Safe] determination process;
  • Updating the scientific foundation of the FDA’s safety assessment program;
  • Retesting all previously approved chemicals; and
  • Labeling direct additives with limited or no toxicity data.”

EDF applauds AAP’s policy statement and its decision to add its influential voice to the rising call for reform of the process by which FDA and food manufacturers decide additives are safe. AAP, a professional society representing 67,000 pediatricians, develops policy statements regarding federal, state, and community policies that affect children through an extensive, deliberative process that draws on tremendous scientific expertise. As with past policies, such as those concerning lead toxicity and fruit juice consumption, this statement on chemicals in food presents a well-reasoned assessment of the problem and clear recommendations for reform.

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Posted in FDA, Food, GRAS, Health Policy, Health Science, perchlorate, PFAS, Public Health / Also tagged , , , , , , , , | Comments are closed

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

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

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, EPA, FDA, Food, Health Policy, Health Science, PFAS, Public Health, Regulation, States / Also tagged , , , , | Comments are closed

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

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, EPA, FDA, Health Policy, PFAS, Regulation / Also tagged , , , , , , | Read 2 Responses