EDF Health

Perchlorate regulation: Critical opportunities for EPA and FDA to protect children’s brains

Tom Neltner, J.D.is Chemicals Policy Director

All Americans who have been tested have perchlorate in their bodies. Perchlorate threatens fetal and child brain development by impairing the thyroid’s ability to transport iodine in the diet into the gland to make a thyroid hormone, known as T4, that is essential to brain development. Both the Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA) are scheduled to make decisions in 2017 that could significantly reduce exposure to this hazardous chemical.

Based on statements in a new report by EPA, we estimate that at least 20% of pregnant women are already iodine deficient, resulting in T4 levels that put the fetuses’ developing brains at risk. For this population of pregnant women, any perchlorate exposure results in an even greater risk of impaired brain development in their children and potentially a lifetime of behavioral and learning difficulties.

This is why it is critical that our public health agencies take actions to reduce exposure to perchlorate with a focus on this vulnerable population. There are three key decisions to be made in the coming year:

  1. EPA will decide in January 2017 whether hypochlorite bleach, an antimicrobial pesticide, degrades to perchlorate in significant amounts. If EPA agrees it does, the agency must set standards to limit that degradation as part of its 15-year update to the pesticide’s registration. Bleach is a widely-used disinfectant in food manufacturing facilities and likely a significant source of perchlorate in contaminated foods. Research shows that reducing hypochlorite concentration limits degradation and this, coupled with expiration dates on the product would significantly reduce exposure to perchlorate.
  2. FDA will decide whether perchlorate should continue allowing perchlorate to be added to plastic packaging for dry food at levels up to 12,000 ppm to reduce buildup of static charges. The agency has evidence that the perchlorate migrates from the packaging into food, especially when it flows in and out of the container. In response to a lawsuit filed by public interest organizations, FDA told a court that it aims to make a final decision by the end of March 2017. A 2008 report by FDA indicated that almost 75% of all food types are contaminated with perchlorate.
  3. EPA told a court that it will complete external peer review of a dose-response model in October 2017 and sign a proposed rule to regulate perchlorate in drinking water a year later. This model is a critical step in establishing a drinking water standard for perchlorate pursuant to its 2011 determination that an enforceable standard was necessary under the Safe Drinking Water Act. The perchlorate is most likely from contaminated source waters (e.g. from military and defense industry activities and some fertilizer use in agricultural regions) or from degradation of hypochlorite bleach used to disinfect water. EPA acted in response to a lawsuit by the Natural Resources Defense Council.

To guide their decision-making, FDA and EPA collaborated to develop a biologically-based dose-response model to predict T4 levels in pregnant women, fetuses, and infants exposed to perchlorate. EDF and NRDC submitted joint comments on the model and the summary report requesting that EPA ensure protection of fetuses during the first two trimesters for pregnant women with serious iodine deficiencies.  These fetuses are particularly vulnerable because their thyroids is not yet functioning. The current fetal model only considers the third trimester when the fetus has a functioning thyroid. The current model fails to adequately protect their vulnerable subpopulations, falling shot of both the EPA’s Science Advisory Board recommendation and the Safe Drinking Water Act requirements.

For decades, federal agencies have been charged with protecting children from environmental health risks with the recognition that they are uniquely vulnerable to chemical exposures. The upcoming decisions on perchlorate present critical opportunities to protect what many of us value the most—our children’s health and their ability to learn and thrive to their fullest potential.

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FDA sued for delay in deciding perchlorate food additive petition

Tom Neltner, J.D.is Chemicals Policy Director.

At the end of 2014, FDA agreed to consider a food additive petition from NGOs to ban perchlorate – a chemical that can impair a child’s brain development – as an additive to food packaging. The agency had 180 days to act, but fifteen months later, the petitioners are still waiting for a response. Today, they sued.

It’s been 15 months since a group of environmental, consumer, and public health advocates petitioned the Food and Drug Administration (FDA) to remove the agency’s approval of perchlorate uses in packaging.

Traditionally, FDA’s food additive petition process has been the exclusive purview of food manufacturers seeking approval to use new chemicals or expand uses of already approved chemicals in food production. However, nothing in the law prohibits the public from using the process to ban or restrict the use of certain chemicals. Read More »

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New study demands far more than a pregnant pause: Expectant women carry dozens of toxic chemicals in their bodies

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

A long-awaited study documenting the presence of multiple toxic chemicals in the bodies of pregnant women was published today in Environmental Health Perspectives.  The study, conducted by researchers at Program on Reproductive Health and the Environment at the University of California, San Francisco, analyzed the most recent comprehensive biomonitoring data collected by the Centers for Disease Control (CDC) as part of its national human biomonitoring program.

The new study found widespread exposure of pregnant women to a large fraction of the chemicals for which biomonitoring is conducted, including chemicals that are currently in widespread use, such as brominated flame retardants (known as PBDEs) used in furniture foam and plastics, perfluorinated chemicals (PFCs) used in everything from packaging to textiles, and a pervasive environmental contaminant used in rocket fuel (perchlorate).

In particular the study noted:  “Certain PCBs, organochlorine pesticides, PFCs, phenols, PBDEs, phthalates, polycyclic aromatic hydrocarbons (PAHs) and perchlorate were detected in 99 to 100% of pregnant women.” (emphasis added)  Read More »

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