EDF Health

EDF joins court challenge of FDA’s refusal to ban use of perchlorate in food contact materials

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: October 29, 2019

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

Today, EDF, represented by Earthjustice, joined with other public health advocates in filing a lawsuit to overturn the Food and Drug Administration’s (FDA) May 2017 decision, reaffirmed in April 2019 that allows the continued use of perchlorate[1], at concentrations up to 12,000 parts per million, in plastic packaging and processing equipment in contact with dry food. Perchlorate exposure is particularly dangerous for fetuses, infants, and young children, as it has been linked to developmental delays, reduced growth, and impaired learning capabilities. FDA relied on flawed reasoning while entirely ignoring important evidence developed by its own scientists revealing potentially serious risks resulting from ongoing use of perchlorate. We maintain that the intentional and unnecessary use of perchlorate in food contact materials should end.[2]

As with any litigation, we take this action reluctantly. We have long questioned FDA’s decisions that ignore evidence that endocrine disruptors like perchlorate can cause harm at levels the agency systematically dismisses as trivial. We have also pushed back on FDA’s decisions that allow toxic chemicals to be used in packaging and processing equipment that contact food ingredients multiple times from the farm to the grocery store shelf when the exposure estimate is based solely on the amount of the chemical that may migrate into food from the final product packaging. Agency assertions that its estimates are based on worst-case assumptions are misleading when they only consider a single contact. While FDA’s initial decision in November 2005 allowing the use of perchlorate-containing plastic raises all of these problems, the agency’s failure to address its own data and accompanying analysis by its own scientists that was published a decade later has left us with little choice but to act.

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Posted in Emerging science, Health policy, Health science, Public health, Regulation / Tagged , , , | Authors: / Comments are closed

EPA distorts the scientific evidence and fails to protect kids’ brains in its proposed limit for perchlorate in drinking water

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: May 24, 2019

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

Today, the Environmental Protection Agency (EPA) proposed a Maximum Contaminant Level (MCL) of 56 parts per billion (ppb) for perchlorate in drinking water – more than three times less protective than an interim health advisory level set in 2008. To justify this increase, EPA turned its back on scientific evidence showing that this potent neurotoxin undermines childrens’ motor development and control and can increase their anxiety and depression. The agency’s reasoning is inconsistent with its own analysis published in a draft report in late 2017 and the findings of a peer review panel it convened last year to review that report.

If the agency had used the most protective scientific study and the most sensitive endpoint evaluated in the proposed rule, the MCL would likely be 4 ppb – more than three times more protective than the current health advisory. As a result, the agency fails to adequately protect children from a lifetime of harm. With this MCL, EPA is allowing pregnant women to be exposed to perchlorate in the first trimester of pregnancy at levels that pose much greater risk of impaired neurodevelopment in their children.

The proposed MCL – and how the agency reached it – was both a disappointment and a surprise to us. In late 2017, we applauded the agency’s scientists for developing an innovative model connecting a mother’s perchlorate exposure in the first trimester to fetal harm. We were not alone – in early 2018, EPA’s peer review panel congratulated the agency’s scientists on their analysis. We also complimented EPA’s population-based approach to developing an MCL by estimating the percent of pregnant women, and their children, with borderline thyroid dysfunction due to low iodine intake.

So how did EPA abruptly change course and estimate an MCL less protective than the current health advisory? By altering its analysis in three subtle but significant ways:

  1. Rejecting five epidemiology studies showing harm at even lower exposure levels in favor of one IQ study by Korevaar et al. in 2016.
  2. Choosing an MCL that allows an IQ loss of 2 points even though the study showed a 1 point loss was statistically significant.
  3. Dismissing an alternative, population-based method that EPA proposed in 2017 that reinforces the need for a more protective standard.

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Posted in Drinking water, Health policy, Health science, Perchlorate / Tagged , , , | Read 1 Response

EPA’s safety standard for perchlorate in water should prioritize kids’ health

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: May 7, 2019

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

The Environmental Protection Agency (EPA) will soon propose a drinking water standard for perchlorate. The decision – due by the end of May per a consent decree with the Natural Resources Defense Council (NRDC)— will end a nearly decade-long process to regulate the chemical that has been shown to harm children’s brain development.

In making its decision, EPA must propose a Maximum Contaminant Level Goal (MCLG) “at the level at which no known or anticipated adverse effects on the health of persons occur and which allows an adequate margin of safety.”[1] It must also set a Maximum Contaminant Level (MCL) as close to the MCLG as feasible using the best available treatment technology and taking cost into consideration.

To guide that decision, EPA’s scientists developed a sophisticated model that considers the impact of perchlorate on the development of the fetal brain in the first trimester when the fetus is particularly vulnerable to the chemical’s disruption of the proper function of the maternal thyroid gland. As discussed more below, the model was embraced by an expert panel of independent scientists through a transparent, public process that included public comments and public meetings.

In April, a consulting firm published a study critiquing EPA’s model. The authors acknowledged the model as a valuable research tool but did not think it is sufficient to use in regulatory decision-making due to uncertainties. Therefore, the authors concluded that EPA should discard the peer-reviewed model and rely on a 14-year old calculation of a “safe dose” that does not consider the latest scientific evidence and has even greater uncertainties. They didn’t offer other options such as using uncertainty factors to address their concerns about the model’s estimated values.

Given the importance of the issue and the risk to children’s brain development, we want to explain EPA’s model, the process the agency used to develop it, and the study raising doubt about the model.

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Posted in Drinking water, Health policy, Health science, Industry influence, Perchlorate / Tagged , , , | Read 2 Responses

FDA is dragging its feet while children continue to be exposed to perchlorate in food

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: January 11, 2019

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

It has been more than 18 months since EDF and other advocates challenged the Food and Drug Administration’s (FDA) May 2017 decision to continue allowing perchlorate in dry food plastic packaging and food handling equipment.

While Congress gives FDA 180 days to act on food additive petitions, FDA must act “as soon as possible” on a challenge such as ours. However, the agency has yet to complete a review of its May 2017 decision in light of our concerns and evaluate whether to either stand by it, or reverse it. We did not expect FDA would take three times longer to review a decision already made, especially since our objection is largely based on the agency’s own data.

In the meantime, perchlorate in food continues to threaten children’s brains. The chemical, a component of rocket fuel, disrupts the thyroid gland’s normal function and reduces production of the thyroid hormone needed for healthy fetal and child brain development. FDA’s own studies show increased levels of perchlorate in foods such as baby food dry cereal, indicating the chemical’s intentional use in dry food packaging is the likely source of increased exposure for young children.

How FDA got it wrong

In FDA’s May 2017 decision to continue allowing intentional use of perchlorate in contact with dry food, the agency largely relied on flawed science to assess dietary exposure. Its three central errors were:

  1. Ignoring its own data showing significantly increased exposure for children;
  2. Woefully underestimating exposure based on a flawed migration test; and
  3. Unrealistically assuming that perchlorate-laden plastic would only contact food once.

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Posted in FDA, Food, Health policy, Health science, Perchlorate, Public health / Tagged , , | Comments are closed

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

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: May 31, 2018

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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Posted in Drinking water, EPA, FDA, Food, Health policy, Health science, Perchlorate, Public health / Tagged , , | Comments are closed

EPA’s latest analysis shows perchlorate risks to fetal brain development

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: November 20, 2017

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

Pursuant to a consent decree with the Natural Resources Defense Council (NRDC), the Environmental Protection Agency (EPA) is developing drinking water regulations to protect fetuses and young children from perchlorate, a toxic chemical that inhibits the thyroid’s ability to make the hormone T4 essential to brain development. The rulemaking is part of a long process that began in 2011 when the agency made a formal determination that Safe Drinking Water Act standards for perchlorate were needed. Under the consent decree, EPA should propose a standard by October 2018.

In the latest step in that process, EPA’s scientists released a draft report in September that, at long last, answers questions posed by its Science Advisory Board in 2013: does perchlorate exposure during the first trimester reduce production of T4 in pregnant women with low iodine consumption? Does reduction in maternal T4 levels in these women adversely affect fetal brain development? According to EPA’s scientists, the answers are Yes and Yes.

For several years, EPA and the Food and Drug Administration (FDA) have developed and refined a model that would predict the effect of different doses of perchlorate on levels of T4 in pregnant women. The latest version of the model addresses women during the first trimester, especially those with low iodine intake. This is important because iodine is essential to make T4 (the number four indicates the number of iodine atoms present in the hormone); perchlorate inhibits its transport from the blood into the thyroid. The risk of perchlorate exposure to fetuses in the first trimester is greatest because brain development starts very early and is fully dependent on maternal T4. If the mother gets insufficient iodine to offset the perchlorate inhibition, she will not produce enough T4 for the fetal brain to develop properly. When free T4 (fT4) levels are low but without increase in thyroid stimulating hormone (TSH), the condition is known as hypothyroxinemia. When T4 production is lowered further, the pituitary gland releases TSH to increase T4 production by a feedback loop mechanism.

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Posted in Drinking water, Emerging science, FDA, Food, Health policy, Perchlorate, Public health, Regulation / Tagged , , , , , , , , , , | Authors: / Comments are closed