EDF Health

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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EDF Calls on EPA to Withdraw Censored Science Proposal

Experts for Environmental Defense Fund (EDF) called on the Environmental Protection Agency (EPA) today to withdraw the “censored science” proposal – a proposed rule that would bar the agency from considering some of our most important public health studies in making decisions about vital protections for human health and the environment.

EPA held an all-day public hearing on its proposal at its Washington, D.C. headquarters today. EDF Senior Health Scientist Jennifer McPartland was among the more than 100 Americans who were expected to testify.

“EPA’s proposed rule represents a total disregard for the agency’s core mission: protection of human health and the environment,” said McPartland in her testimony. “If finalized the rule will erode critical public health protections, and with them, the scientific integrity and public trust of the agency.”

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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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New report: Tackling lead in drinking water at child care facilities

Lindsay McCormick, Project Manager, Sam Lovell, Project Specialist and Tom Neltner, J.D.Chemicals Policy Director

Recent crises around lead in drinking water have focused national attention on the harmful effects of children’s exposure to lead. While the particular vulnerability of children to lead is well understood by most – what might be surprising is that the majority of child care facilities are not required to test their water for lead.

Only 7 states and one city have such regulations on the books. And while the Environmental Protection Agency (EPA) has provided a voluntary guidance, the “3Ts for Reducing Lead in Drinking Water,” for schools and child care, the document has significant gaps in the child care setting – including an outdated action level of 20ppb and little emphasis on identifying and replacing lead service lines.

Given the critical need for more investigation in this area, we conducted a pilot project to evaluate new approaches to testing and remediating lead in water at child care facilities. EDF collaborated with local partners to conduct lead in water testing and remediation in 11 child care facilities in Illinois, Michigan, Mississippi, and Ohio. We have previously blogged about some early takeaways from testing hot water heaters and our preliminary findings from the project. Today, we released our final report, which provides the full results of the pilot and recommendations to better protect children moving forward.

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Also posted in Drinking water, Emerging testing methods, Health policy, Lead, Public health, Regulation / Tagged , , , , , | Comments are closed

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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Also posted in Drinking water, FDA, Food, Health policy, PFAS, Public health, Regulation / Tagged , , , , , , , | Authors: / Comments are closed

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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