EDF Health

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

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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EPA sets interim limits on hypochlorite bleach to reduce degradation to perchlorate

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

On May 1, 2018, Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) made an interim pesticide registration decision[1] for hypochlorite bleach used to disinfect drinking water. The office decided to require the “Precautionary Statements” section of the bleach’s pesticide label to include advisory best management practices to minimize the formation of chlorate and perchlorate. The new label will state:

"The following practices help to minimize degradant formation in drinking water disinfection:

  • It is recommended to minimize storage time.
  • It is recommended that the pH solution be in the range of 11-13.
  • It is recommended to minimize sunlight exposure by storing in opaque containers and / or in a covered area. Solutions should be stored at lower temperatures. Every 5º C reduction in storage temperature will reduce degradant formation by a factor of two.
  • Dilution significantly reduces degradant formation. For products with higher concentrations, it is recommended to dilute hypochlorite solutions with cool, softened water upon delivery, if practical for the application."

EDF submitted comments in November 2017 supporting OPP’s proposed label changes and requesting specific changes to the language including making the advice to users mandatory. We also asked the agency to extend the changes to hypochlorite bleach used to treat produce and to disinfect food handling equipment.

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

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 2nd, 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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FDA details its new push on heavy metals in food

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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Heavy metals in food: Carrageenan as an example of the need to improve ingredient quality

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

Arsenic, cadmium and lead levels in carrageenan varied widely but were within international standards. This is not reassuring since current specifications for the heavy metals are inadequate. Food manufacturers can and should set tighter limits to better protect their customers. Consumers, especially those buying from internet-only retailers, need to ask the ingredient supplier how much of the heavy metals is acceptable.

In the fall of 2013, the Food and Drug Administration (FDA) bought 10 samples of carrageenan from 5 companies sold through internet-only retailers to test for three heavy metals – lead, arsenic (total and inorganic), and cadmium. The agency published the results on its combination metals testing webpage in September 2016.

Each of these metals are carcinogens. In addition, lead and inorganic arsenic are widely acknowledged as harming children’s brain development even at low levels of exposure. EDF found that more than one million children consume lead in amounts that exceeds the maximum exposure level set by FDA in 1993, a level that subsequent research shows is of great risk to children’s health. Further, recent research has strengthened evidence of the relationship between low levels of lead exposure in adults and cardiovascular deaths. In 2011, the Joint FAO/WHO Expert Committee on Food Additives (JECFA) took the extraordinary step of withdrawing its previous tolerable intake level for lead because it could not determine a safe level of exposure for children.

In light of these risks, we must make every effort to reduce the levels of these heavy metals in food to the greatest extent possible – without undermining other food safety measures or compromising quality. A key step to success is examining the levels of heavy metals in all ingredients used to make a food since the risk is based on the cumulative exposure – even if the amounts in individual additives are small. With this in mind, we revisited FDA’s analysis of carrageenan.

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