EDF Health

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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EPA proposes limits on hypochlorite bleach to reduce degradation to perchlorate

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: November 17, 2017

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

Every 15 years, the Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) reviews the safety of registered pesticides. The current cycle ends in 2022. As part of that process, the agency is evaluating the safety of hypochlorite bleaches. In January 2017, EPA decided it would consider the risks posed by degradation of the hypochlorite into perchlorate.

This is important for two reasons: 1) degraded bleach is less effective as a pesticide, and 2) perchlorate is a chemical that interferes with the production of thyroid hormone, a critical hormone for fetal and infant brain development.

On September 22, EPA proposed changes to the pesticide label to minimize the degradation for hypochlorite bleach used to disinfect drinking water, and the agency is accepting comments until November 21, 2017. The label would advise users to:

  • Minimize storage time;
  • Maintain pH of the solution between 11 to 13;
  • Minimize exposure to sunlight;
  • Store at lower temperatures; and
  • If practical, dilute with cool softened water upon delivery.

EDF submitted comments to EPA supporting EPA’s proposal and requesting specific changes to the proposed language, including making the advice to users mandatory. We also asked the agency to extend the label requirements to hypochlorite bleach used to treat produce and to disinfect food handling equipment. Bleach appears to be one of several significant sources of perchlorate contamination of food. Improving management conditions will reduce degradation and preserve effectiveness regardless of the whether the bleach is used in drinking water or to treat vegetables.

EPA’s proposal is an interim decision. We also were pleased to see that OPP is committed to continue working with EPA’s Office of Water (OW) in its assessment of the risks of perchlorate to pregnant women and young children. We asked OPP to incorporate the OW’s findings in additional interim registration decisions for all uses of hypochlorite bleaches.

 

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Little follow-up when FDA finds high levels of perchlorate in food

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: November 2, 2017

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

[pullquote]FDA’s apparent lack of follow-up when faced with jaw-dropping levels of a toxic chemical in food is disturbing.[/pullquote]

For more than 40 years, the Food and Drug Administration (FDA) has conducted the Total Diet Study (TDS) to monitor levels of approximately 800 pesticides, metals, and other contaminants, as well as nutrients in food. The TDS’s purposes are to “track trends in the average American diet and inform the development of interventions to reduce or minimize risks, when needed.” By combining levels of chemicals in food with food consumption surveys, the TDS data serve a critical role in estimating consumers’ exposure to chemicals.

From 2004 to 2012 (except for 2007), FDA collects and tests about 280 food types for perchlorate, a chemical known to disrupt thyroid hormone production. This information is very important, because for the many pregnant women and children with low iodine intake, even transient exposure to high levels of perchlorate can impair brain development.

The agency published updates on food contamination and consumers’ exposure to perchlorate in 2008 (covering years 2004-2006) and in 2016 (covering 2008-2012). On its Perchlorate Questions and Answers webpage, FDA says it found “no overall change in perchlorate levels across foods” in samples collected between 2008 and 2012 compared to those collected between 2005 and 2006. It also notes that there were higher average levels in some food and lower in others between the time periods and suggests that a larger sampling size or variances in the region or season when the samples were collected may account for the differences.

FDA’s Q&A webpage masks the most disturbing part of the story

FDA’s attempt at providing consumers with information about the presence of a toxic chemical in food and what it means for their health falls short. By focusing on the similar average level of perchlorate across foods, FDA masks the disturbing fact that children are consuming increasing amounts of perchlorate: 35% for infants, 23% for toddlers and 12% for children between 2 and 6 from 2004-2006 to 2008-2012. The agency’s webpage notes the exposures in 2008-2012 but fails to mention the increase reported by its own scientists.

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EPA to consider perchlorate risks from degradation of hypochlorite bleach

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: February 3, 2017

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

Virtually all types of food contain measurable amounts of perchlorate. Young children are the most highly exposed, and they consume levels that may be unsafe. Reducing exposure to perchlorate is of public health importance because it presents a risk to children’s brain development

One potentially significant source of the toxic chemical in food is hypochlorite bleach that, when not well managed, degrades to perchlorate. Bleach is used to sanitize food manufacturing equipment or to wash or peel fruits and vegetables. Thanks to a recent decision by Environmental Protection Agency’s (EPA) Office of Pesticide Programs, we will better understand the risk posed by perchlorate-contaminated bleach and whether standards are needed to improve the management of bleach.

Reduce perchlorate exposure by improving bleach management

In 2011, an excellent report by the American Water Works Association (AWWA) and the Water Research Foundation documented that hypochlorite bleach degrades into perchlorate. The report also included guidelines on better management of hypochlorite to preserve its effectiveness for drinking water utilities using it to disinfect water.

Most of AWWA’s recommendations are equally relevant to food manufacturers and anyone using bleach to disinfect food contact surfaces. The key recommendations are:

  • Dilute hypochlorite solutions on delivery. Cutting the concentration in half decreases the degradation rate by a factor of 7.
  • Store hypochlorite solutions at lower temperatures. Reducing temperature by 5oC decreases degradation rate by a factor of 2.
  • Keep pH between 11 and 13 even after dilution.
  • Avoid extended storage times, and use fresh hypochlorite solutions when possible.

The objective is not to reduce the use of bleach. Rather it is to preserve its effectiveness by preventing degradation to perchlorate through careful management.

Bleach: a food additive and a pesticide

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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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