Selected category: FDA

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

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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Also posted in Drinking Water, Emerging Science, EPA, Food, Health Policy, perchlorate, Public Health, Regulation| Tagged , , , , , , , , , , , | Leave a comment

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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New EPA model enables comparison of various sources of childhood exposure to lead

Tom Neltner, J.D.is Chemicals Policy Director and Dr. Ananya Roy is Health Scientist

This week, Environmental Health Perspectives published an important article by scientists at the Environmental Protection Agency (EPA) that sheds important light on the various sources of children’s lead exposure. Led by Valerie Zaltarian, the article shares an innovative multimedia model to quantify and compare relative contributions of lead from air, soil/dust, water and food to children’s blood lead level. The model couples existing SHEDS and IEUBK models to predict blood lead levels using information on concentrations of lead in different sources, intake and gut absorption. The predicted blood lead levels compared well with observed levels in the National Health and Nutrition Evaluation Survey population. Given the variety of independent sources of lead exposure, the model provides a critical tool that public health professionals can use to set priorities and evaluate the impact of various potential standards for all children and not just those with the greatest exposure.

This peer-reviewed article builds on a draft report EPA released in January 2017 evaluating different approaches to setting a health-based benchmark for lead in drinking water. The report has provided a wealth of insight into a complicated topic. Earlier this year, we used it to show that formula-fed infants get most of their lead exposure from water and toddlers from food, while the main source of lead for the highest exposed children is soil and dust. In our February blog, we provided our assessment of a health-based benchmark for lead in drinking water and explained how public health professionals could use it to evaluate homes. The information was also critical to identifying lead in food as an overlooked, but meaningful, source of children’s exposure to lead.

The new article reaffirms the analysis in the January 2017 EPA report and highlights that evaluating source contribution to blood lead in isolation versus aggregating across all sources can lead to very different answers and priorities. A health-based benchmark for lead in drinking water could vary from 0 to 46 ppb depending on age and whether all other sources of lead are considered. For example, a health-based benchmark for infants (birth to six months old) would be 4 ppb or 13 ppb depending on whether or not you consider all sources of exposure.

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Also posted in Drinking Water, Emerging Science, EPA, Food, Health Policy, lead, Uncategorized| Tagged , , , , , , , , | Comments are closed

Lead in food – An overlooked, but meaningful, source of children’s exposure to lead

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

By now, it is well known that lead exposure is a significant human health concern, especially for young children. While most of the discussion about lead exposure has involved paint, drinking water, and contaminated soil or dust where young children live, play, and learn, EDF's new report shows reason to pay more attention to another source: our food.

Until recently, we have known very little about the contribution of food to children’s lead exposure. In January 2017, an Environmental Protection Agency (EPA) draft report indicated that food is a meaningful source of children’s exposure to lead. Using EPA’s data, we estimated that over 1 million young children consume more lead than what the Food and Drug Administration (FDA) considers acceptable for children to eat every day. From EPA’s analysis, we calculated that  that if lead in food were eliminated, millions of children would live healthier lives, and the total societal economic benefit would exceed $27 billion a year in increased lifetime earnings resulting from the impact of lead on children’s IQ.

To better understand the issue of lead in food, EDF evaluated over a decade’s worth of data collected and analyzed by the FDA as part of the agency’s Total Diet Study (TDS). Since the 1970s, the TDS has tracked metals, pesticides, and nutrients in up to 280 types of food yearly.

What did we find?

Overall, 20% of 2,164 baby food samples and 14% of the other 10,064 food samples had detectable levels of lead. At least one sample in 52 of the 57 types of baby food analyzed by FDA had detectable levels of lead in it. Lead was most commonly found in the following baby foods:

  • Fruit juices: 89% of 44 grape juice samples contained detectable levels of lead, mixed fruit (67% of 111 samples), apple (55% of 44 samples), and pear (45% of 44 samples)
  • Root vegetables: Sweet potatoes (86% of 44 samples) and carrots (43% of 44 samples)
  • Cookies: Arrowroot cookies (64% of 44 samples) and teething biscuits (47% of 43 samples)

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Also posted in Food, lead, Uncategorized| Tagged | Comments are closed

Toxic secrets in our food? EDF joins in lawsuit aimed at protecting food safety

Today, Environmental Defense Fund joined other groups in challenging a Food and Drug Administration (FDA) rule that allows chemical and food manufacturers to decide for themselves – in secret – what chemicals and food additives can be added to foods. The practice puts our health at risk and does not fulfill Congress’ requirement that FDA determine that chemical additives are safe before they can be used in food.

Americans would be shocked to learn that food companies routinely add novel chemicals to our food without first getting FDA approval. In doing so, the companies are exploiting a loophole exempting ingredients “Generally Recognized as Safe” (GRAS) from formal FDA review and approval.

Originally intended for ingredients like vinegar and olive oil, industry now abuses the GRAS loophole by bypassing FDA review and making safety determinations in secret. The alarming result: even FDA does not know what is in our food. In fact, FDA has no way to know what chemicals are actually being used in which food or in what quantities—even in baby food.

Last year, the FDA issued a final rule formalizing this outrageous practice. We described this decision as a lost opportunity for safer food additives when the decision was made. Today, EDF and our colleagues at the Center for Food Safety (CFS), Breast Cancer Prevention Partners, Center for Science in the Public Interest, and Environmental Working Group, represented by CFS and the environmental law firm Earthjustice, joined in filing suit against the FDA for unconstitutionally and illegally delegating that authority to self-interested food and chemical manufacturers.

It is disappointing that the groups were forced to take legal action. In addition to being a bad policy that doesn’t comply with law, or protect public health, the FDA is oddly out of touch with public sentiment. Just last week an industry funded survey showed overwhelming consumer concern about chemicals in food, including cancer causing chemicals, while showing diminished confidence in the food supply. This continues a trend that has been building for years. Food companies would be wise to take notice: adding secret chemicals without FDA scientific review to our food is no way to improve confidence in their products.

But with thousands of secret chemicals in our food, we can’t wait for industry or FDA to wise up. Today’s lawsuit seeks to force FDA to do what should be common sense—determine that food additives are safe before they can be added to our food.

Also posted in Food, GRAS, Uncategorized| Tagged , | Comments are closed

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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Also posted in Food, GRAS, Health Policy, Markets and Retail, Regulation| Tagged , , , , , , , , , , , | Comments are closed
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