Selected tag(s): FDA

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

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

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

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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Posted in FDA, Food, Health Policy, Health Science, perchlorate, Public Health| Also tagged , , , , , , , , , , , , , , , , , , , | Read 1 Response

The hidden – and potentially dangerous – chemicals in your diet

Tom Neltner, J.D.is Chemicals Policy Director

While picking up groceries for the week, a shopper may compare brands, prices, and nutritional information to ensure they make economical and healthy choices for their family. Unfortunately, there’s much more to our food than meets the eye – or makes the label.

Approximately 10,000 food additives are allowed in our food. Food additives are substances used to flavor, color, preserve, package, process, and store our food. While some of the chemicals added to food or used in packaging are harmless, others are downright dangerous and linked to health concerns. Certain additives are linked to reproductive problems, developmental issues, and even cancer.

Perchlorate was approved in 2005 as a component of plastic packaging for dry food despite the fact that it is a known endocrine disruptor that impairs infant brain development. Benzophenone – an artificial flavor added to baked goods, dessert, beverages, and candy – is classified as a possible human carcinogen. The list goes on. No matter where you shop, your family’s health may be at risk.

Check out the cupboard below to see what else could be lurking in your food.

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Posted in FDA, Food, GRAS, Health Policy, Markets and Retail, Regulation| Also tagged , , , , , , , , , , | Comments are closed

Dad’s lead-laden hair dye could impact the whole family: FDA to consider barring lead compound in widely-used men’s hair dyes

Jack Pratt is Chemicals Campaign Director

Today, EDF joined a group of advocates in filing a petition that could force a ban on lead in hair dyes. Over the last several decades, we have gone to great lengths to reduce lead exposure—from eliminating the use of lead in gasoline, to tackling legacy uses in paint and water pipes. Yet, somewhat incredibly, lead is still permitted in hair dyes in the United States. Unfortunately, the evidence indicates that use can have an impact not only on the men who use it (it is seemingly exclusive to men’s dyes) but can have an impact on kids in the house too. That’s why FDA should take action and reverse their decades-old approval of lead in hair dyes.

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Posted in FDA, Health Policy, lead, Regulation, Uncategorized| Also tagged | Comments are closed

Too many young children get too much perchlorate from food

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 »

Posted in Drinking Water, FDA, Food, Health Policy, perchlorate, Regulation| Also tagged , , , , , , | Comments are closed

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

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 »

Posted in Emerging Science, FDA, Food, Health Policy, perchlorate, Regulation| Also tagged , , , , , , | Comments are closed

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.

Posted in Drinking Water, Emerging Science, EPA, FDA, Food, Health Policy, perchlorate, Regulation, Uncategorized| Also tagged , , , , , , , | Comments are closed
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