EDF Health

Exhibit PV29: Why this EPA can’t be trusted to forthrightly assess chemical risks under TSCA

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

I blogged last week about the Environmental Protection Agency’s (EPA) illegal and hypocritical decision to deny the public access to health and safety studies conducted on the first chemical to undergo a risk evaluation under the reformed Toxic Substances Control Act (TSCA).  In its draft risk evaluation, now out for public comment, EPA relied on these secret studies to assert that the chemical, commonly known as Pigment Violet 29, or PV29, is safe, so EPA’s denial of public access matters a great deal.

EPA asserts that these studies are entitled to protection as confidential business information (CBI) under TSCA, when in fact TSCA explicitly does not extend CBI protection to such studies.  The only health and environmental information on this chemical that is public are brief summaries of those studies that were prepared by the companies that make the chemical, and were submitted to the European Chemicals Agency (ECHA) when the chemical was registered under the European Union’s REACH Regulation.  (EPA erroneously states that the studies were “summarized by ECHA.”  This is simply not the case:  Registrants, not ECHA, develop the summaries that are then made available in the registration “dossiers” for REACH chemicals.)

As we review EPA’s draft risk evaluation for PV29, we are finding that EPA’s assertions cannot be trusted even about what these summaries state are the findings of the underlying studies.  I’ll discuss one such case in this post.   Read More »

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FDA reduces maximum daily limit for lead in children’s food by half

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

On September 27, 2018, the Food and Drug Administration (FDA) reduced the maximum allowed daily intake of lead for children from 6 to 3 micrograms per day (µg/day). It has also set a limit for adults of 12.5 µg/day, to protect against possible fetal exposure in women who are unaware they are pregnant and to reduce infant exposure during nursing. The agency now refers to these limits as the “Interim Reference Level” to match the Centers for Disease Control and Prevention’s (CDC) terminology for elevated blood lead levels that warrant action. FDA reports that the new level for children is the amount of lead in food expected to result in a blood lead level of 5 µg/deciliter, with a 10-fold safety factor to account for differences across the population.

This change is a major step in FDA’s new push to limit heavy metals in food to protect children’s neurological development. In April 2018, FDA explained that its Toxic Elements Working Group is “looking at all the [heavy] metals across all foods rather than one contaminant, one food at a time,” and that “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.”

As the agency indicated earlier this year, the next step for the Working Group is to “begin reevaluating the specific lead levels that FDA has set for a variety of foods.”

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Also posted in FDA, Food, Health Policy, lead, Public Health, Regulation / Tagged , , | Comments are closed

EDF files extensive comments critical of EPA’s problem formulations for the first 10 chemicals being reviewed under TSCA

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

Last night, Environmental Defense Fund (EDF) submitted more than 200 pages of comments providing a detailed critique of each of the “problem formulations” EPA issued in June for the first 10 chemicals in commerce undergoing risk evaluations under the Toxic Substances Control Act (TSCA).  EDF also delivered 45,000 comments to EPA from members of the public across the country echoing our concerns.

The EPA documents lay out the scope of each of the risk evaluations EPA will conduct.  They are highly flawed and deviate in numerous ways both from what TSCA requires and from use of the best available science.   Read More »

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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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Also posted in FDA, Food, GRAS, Health Policy, perchlorate, PFAS, Public Health / Tagged , , , , , , , | Comments are closed

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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Also posted in EPA, Health Policy, Industry Influence, Public Health / 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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Also posted in Drinking Water, FDA, Health Policy, PFAS, Public Health / Tagged , , , | Comments are closed