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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, PFAS, Public health, Regulation / Also tagged , , , , , , | Authors: / Comments are closed

For children’s food, heavy metals require more attention and better standards

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: June 12, 2018

Tom Neltner is Chemicals Policy Director and Michelle Harvey and Maricel Maffini are consultants

In June 2017, EDF released Lead in Food: A Hidden Health Threat. The report examined a decade’s worth of data from the Food and Drug Administration (FDA) and found lead detected in 20% of baby food samples compared to 14% for other foods. Eight types of baby foods, including fruit juices, root vegetables, and teething biscuits, had detectable lead in more than 40% of the samples. We closed the report with the following recommendation:

In the meantime, parents should consult with their pediatrician to learn about how to reduce lead exposure. They should also check with their favorite brands and ask whether the company regularly tests their products for lead, and ensures that, especially for baby food, there is less than 1 ppb of lead in the food and juices they sell.

As described below, we have reason to believe it will take more focused effort on the part of both FDA and food companies to ensure consistently low levels of heavy metals – lead, arsenic, and cadmium in particular – in infant’s and toddler’s diets.

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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, PFAS, Regulation / Also tagged , , , , , , | Authors: / Read 2 Responses

EDF and others take FDA to court to demand action on carcinogenic flavors petition

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: May 17, 2018

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

FDA’s priority must be resolving safety concerns with
existing chemicals over approval of new ones.

On May 2, EDF and other consumer health advocates filed a lawsuit to force the Food and Drug Administration (FDA) to make a final decision on our food additive petition, which asked the agency to reverse its approvals of seven carcinogenic synthetic flavors. Earthjustice is representing EDF in this petition for a writ of mandamus to the court of appeals. We did not take this action lightly. However, with the statutory deadline for a decision passing more than 20 months ago, we saw little chance that FDA would act without court oversight.

Our food additive petition narrowly focused on one specific issue where the law and science were clear, and laid out our review of both the scientific literature and the law concluding that the seven chemicals were no longer safe. FDA formally accepted the petition for filing – essentially confirming it was complete – which triggered a 180-day deadline under the statute to make a final decision. That deadline passed in August 2016 without a decision by FDA.

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

FDA details its new push on heavy metals in food

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: April 25, 2018

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

In May 2017, the US Food and Drug Administration (FDA) Center for Food Safety and Nutrition (CFSAN) announced it had “established a Toxic Elements Working Group whose mission in part is to develop a strategy for prioritizing and modernizing the Center’s activities with respect to food/toxic element combinations using a risk-based approach.” FDA set a goal of limiting lead “to the greatest extent feasible.”

In April 2018, FDA released an interview with the Working Group’s chair, Conrad Choiniere, providing an update on its activities. An overarching point expressed by Choiniere during the interview is that “these metals [lead, arsenic, cadmium and mercury] can have effects on children’s neurological development.” This affirmation of scientific evidence is a welcome sign from the agency. FDA’s key statements are:

  • Initial scope: Children’s exposure to “metals like lead, arsenic, cadmium, and mercury in foods, cosmetics, and dietary supplements.”
  • Approach: “Looking at all the metals across all foods rather than one contaminant, one food at a time.”
  • Initial findings: “Even though the level of a metal in any particular food is low, our overall exposure adds up because many of the foods we eat contain them in small amounts.”
  • Next steps:
    • “Finalizing the draft guidance that sets an action-level for the presence of inorganic arsenic in infant rice cereals and apple juice.”
    • “Begin reevaluating the specific lead levels that FDA has set for a variety of foods.”

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New Study Says Lead – Even at Low Levels – is Associated with Risk of Premature Death

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: March 15, 2018

Dr. Ananya Roy is Health Scientist and Tom Neltner, J.D. is Chemicals Policy Director

This week, a team of researchers led by Dr. Bruce Lanphear published an important new study on the deadly impact of lead exposure for adults. The researchers examined data on more than 14,000 adults and found that an increase of 1 to 6.7 micrograms of lead per deciliter of blood (µg/dL) was significantly associated with an increase in mortality of 37% for all-causes, 70% for cardiovascular, and 108% for ischemic heart disease. The findings remained significant even after they considered and accounted for other factors that could have explained this effect.

This research fills a gap identified by the National Toxicology Program in 2011 in our understanding of the risk of lead exposure at low levels in adults. And it goes further by providing a quantitative relationship crucial to better evaluating the potential economic benefits of various policy options.

The study also had startling estimates about how many people are hurt by lead exposure. The authors estimated that over 400,000 Americans every year die from lead related illnesses – ten times higher than previous assessments. That’s on par with deaths from smoking cigarettes.

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Posted in Emerging science, Health policy, Health science, Lead, Regulation / Also tagged , , | Read 1 Response