EDF Health

FDA on Lead in Grape Juice: Too Late, and Way Too Little Improvement

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: March 5, 2018

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

Update on May 12, 2018: Despite the concerns raised, the Codex Committee on Contaminants in Foods decided that lowering the limit for grape juice from 50 ppb to 40 ppb was sufficient.  The fill Commission will make a final decision at its July 2018 meeting.

On March 12, the Food and Drug Administration (FDA) will be leading the U.S. delegation in the Netherlands proposing that the Codex Alimentarius Commission adopt a maximum lead limit of 40 parts per billion (ppb) in grape juice. The current limit, set by Codex in the 1980s, is 50 ppb. While a small step in the right direction, FDA’s proposal falls woefully short of adequately protecting children from lead.

For context, the 40 ppb proposed Codex limit would be 2.6 times greater than the 15 ppb lead action level established for drinking water by the Environmental Protection Agency (EPA) in 1991 and 8 times FDA’s limit of 5 ppb for bottled water. In addition, a child drinking a single 8-ounce serving of juice with a lead concentration of 40 ppb will be exposed to 160% of FDA’s maximum daily intake level of 6 micrograms of lead per day. This level, set in 1993, should be much lower because it does not reflect scientific discoveries of the past 25 years showing harm to children at lower levels.

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New study links PFAS exposure and body weight regulation

By / Published: February 20, 2018

Ryan O’Connell is a High Meadows Fellow

Perfluoroalkyl and polyfluoroalkyl substances (PFAS), sometimes referred to by the broader term “PFCs” (perfluorinated chemicals), are a large class of chemicals used to make products water- or grease-resistant. They can be found in everything from nonstick cookware and clothing to food packaging and adhesives. While PFAS have useful commercial and industrial applications, these chemicals also persist in the environment and in people, and a number of them have been shown to be very toxic.

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Also posted in Health policy, Health science / Tagged | Comments are closed

We are what we eat: New paper outlines how the regulatory gaps in the US threaten our health

By Sarah Vogel / Published: December 20, 2017

Sarah Vogel, Ph.D., is Vice-President for Health.

In a new paper published in PLoS Biology today, Maricel Maffini, Tom Neltner and I detail the regulatory gaps in how the US manages chemicals in food. We explore how failures in our current regulatory system put the public’s health at risk as exemplified in the case of perchlorate, a chemical allowed in food and a well-known endocrine disrupting compound. Perchlorate’s ability to disrupt normal functioning of the thyroid means that even low levels of exposure, especially in those with inadequate iodine intake, can adversely impact the developing brains of infants and children. It is not a chemical that should be in the food of pregnant women, infants and children. And yet it is, and the levels children consume have increased in recent years.

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Good news and bad news for children: FDA’s 2014 to 2016 food testing for lead

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: December 18, 2017

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

In Environmental Defense Fund’s June 2017 “Lead in food: A hidden health threat” report, we evaluated the Food and Drug Administration’s (FDA) publicly available data for 2003 to 2013 from its Total Diet Study (TDS). Since the 1970s, the TDS has tracked metals, pesticides, and nutrients in food. We found that 20% of baby food samples had detectable levels of lead compared to 14% for other foods. We also identified eight food types where more than 40% of samples had detectable lead. Finally, based on an analysis from EPA, we estimated that more than 1 million young children exceeded FDA’s limit for lead and that eliminating lead from food would save society an estimated $27 billion annually.

In November 2017, FDA publicly released TDS data for 2014 and 2015. And this December, the agency provided us with TDS data for 2016 in response to our Freedom of Information Act (FOIA) request. We evaluated the combined information[1] and have an update that is both good news and bad news. The good news is that the overall trends for detectable rates of lead in baby food and other food, especially in 2016, appear to be on the decline. There is a similar downward trend in apple and grape juice, especially the ones marketed as baby food. Unfortunately, there appeared to be stubbornly high rates of detectable lead in teething biscuits, arrowroot cookies, and baby food carrots and sweet potatoes.

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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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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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