EDF Health

Too many young children get too much perchlorate from food

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: January 27, 2017

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

On January 9, we described a new Food and Drug Administration (FDA) report showing that perchlorate exposure to infants and toddlers increased 34% and 23% respectively between the years around 2005 and 2010. Young children were the most exposed age groups. FDA compared the exposure to a “safe dose” established in 2005 and saw no cause for concern. We respectfully disagree and find the levels alarming. First, we now know that the 2005 “safe dose” is no longer sufficient to protect children’s brains from the irreversible harm that can result from even transient exposures to perchlorate. Second, many young children may be over the “safe dose.” Read More »

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FDA finds more perchlorate in more food, especially bologna, salami and rice cereal

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: January 9, 2017

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

Last month, the Food and Drug Administration’s (FDA) scientists published a study showing significant increases in perchlorate contamination in food sampled from 2008 and 2012 compared to levels sampled from 2003 to 2006. The amount of perchlorate infants and toddlers eat went up 34% and 23% respectively. Virtually all types of food had measurable levels of perchlorate, up from 74%. These increases are important because perchlorate threatens fetal and child brain development. As we noted last month, one in five pregnant women are already at great risk from any perchlorate exposure. The FDA study doesn’t explain the increase in perchlorate contamination. Yet, it’s important to note that there is one known factor that did change in this time period: FDA allowed perchlorate to be added to plastic packaging.

Reported perchlorate levels in food varied widely, suggesting that how the food was processed may have made a significant difference. The increase in three foods jumped out to me:

  • Bologna: At a shocking 1,557 micrograms of perchlorate per kilogram (µg/kg), this lunchmeat had by far the highest levels. Another sample had the fifth highest levels at 395 µg/kg. Yet a quarter of the other bologna samples had no measurable perchlorate. Previously, FDA reported levels below 10 µg/kg.
  • Salami: One sample had 686 µg/kg giving it a third ranking. Other samples showed much lower levels and six of the 20 had no detectable levels of perchlorate. Previously, FDA reported levels below 7 µg/kg.
  • Rice Cereal for Babies: Among baby foods, prepared dry rice cereal had the two highest levels with 173 and 98 µg/kg. Yet, 15 of the 20 samples had non-detectable levels of perchlorate. Previously, FDA reported levels less than 1 µg/kg.

The increases are disturbing in light of the threat posed by perchlorate to children’s brain development and the emerging science showing the risk at lower levels is greater than thought a decade ago. The risk is particularly significant for children in those families loyal to those brands with high levels. Unfortunately, FDA’s study does not identify the brand of food tested. Read More »

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

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: December 15, 2016

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.

Also posted in Drinking water, Emerging science, FDA, General interest, Health policy, Perchlorate, Regulation / Tagged , , , , , , , , | Comments are closed

Lost opportunity for safer food additives

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: August 12, 2016

[pullquote]In DC, “Take Out the Trash Day” refers to federal agencies releasing unpopular decisions on Friday when the media and public are not watching.  It is especially common around the holidays or in August when many people, especially those in Congress are on vacation.  On Friday, August 12, FDA took out the trash by issuing a final rule regarding chemicals added to food more than two weeks before a court ordered deadline[/pullquote]

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

On August 12, the Food and Drug Administration (FDA) issued a final rule defining how companies should voluntarily notify the agency when they conclude that a chemical added to or used to make food is “Generally Recognized as Safe” (GRAS).

The decision is a lost opportunity to close a widely-abused loophole that allows chemicals to be approved for use in food with no notification to or review by FDA. The rule allows the industry to continue making secret decisions about what we eat without the agency’s – or the public’s – knowledge.  The agency has the legal authority to significantly narrow the GRAS loophole to prevent companies from deliberately avoiding FDA’s safety review process.

Just two years ago, the senior FDA official overseeing food safety acknowledged that the agency “cannot vouch for the safety of many of these chemicals” as a result of the GRAS loophole. Read More »

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Protecting our most TENDR: Experts Call for Reducing Children’s Exposure to Neurodevelopmental Toxicants

By Jennifer McPartland / Published: July 1, 2016

Jennifer McPartland, Ph.D., is a Senior Scientist with the Health Program.

Today, a prominent group of health care professionals, scientists, and advocates including EDF published a consensus statement highlighting the significant scientific evidence linking impacts on children’s brain development to exposures to certain toxic chemicals.

Beginning in utero, children are particularly vulnerable to the effects of toxic chemicals and exposures occurring early in development can result in lasting, later life outcomes. The TENDR (Targeting Environmental NeuroDevelopmental Risks) Consensus Statement, published in Environmental Health Perspectives, outlines troubling statistics on the high incidences of neurological disorders in children, ranging from ADHD and other behavioral disorders to reduced IQ. Some  of the exemplar chemicals featured in the statement include the PBDE flame retardants, phthalates, air pollution, and lead—all harmful chemicals that EDF has blogged about and been working to address through policy improvements, better exposure monitoring tools, and market action.

A number of factors contribute to neurological disorders, but exposure to neurodevelopmental toxicants is preventable. The TENDR statement calls on government, the business community, and health professionals to all redouble efforts to reduce children’s exposures to neurodevelopmental toxicants. We applaud the broad set of individuals and organizations that came together to develop and support the TENDR consensus statement, and hope that it will catalyze actions to protect children from chemicals that adversely impact their brain development.

 

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FDA accepting public comments on the safety of ortho-phthalates

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: May 19, 2016

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

Today, the Food and Drug Administration (FDA) announced it was accepting public comment on a food additive petition asking the agency to reconsider the safety of 30 toxic chemicals known as ortho-phthalates, which are used as additives in food packaging and handling materials.

The announcement, to be published in tomorrow’s Federal Register, comes shortly after a new study by Dr. Ami Zota published in the journal Environmental Health Perspectives found that individuals who consume large amounts of fast food have higher levels of exposure to two of the most commonly-used phthalates—diethylhexyl phthalate (DEHP) and diisononyl phthtlate (DiNP). Because the study was about fast food, final food packaging is less likely to be a major source than food handling equipment, including gloves. Read More »

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