EDF Health

FDA seeks expert panel review of neurodevelopmental risk of inorganic arsenic in food

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: February 25, 2019

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

Updated March 27, 2019 to include a link to EDF’s comments and to Project TENDR’s comments.

The United States has asked the Codex Alimentarius (Codex), the international standard setting body for food, to prioritize inorganic arsenic for evaluation of non-cancer effects such as neurodevelopmental, immunological, and cardiovascular effects. The evaluation would be conducted by an expert panel convened by the Joint Food and Agriculture Organization / World Health Organization Expert Committee on Food Additives (JECFA), on which Codex relies for scientific advice.[1]

EDF will submit comments in support of the proposal and encourages others to do the same.[2] However, FDA should not wait for the review to be finished before incorporating this evidence into its long-awaited standards for inorganic arsenic in rice.

Evidence of harm from inorganic arsenic on children’s neurodevelopment has grown more compelling

Inorganic arsenic is a known water and food contaminant. FDA has measured it in many foods included in its Total Diet Study, but it’s mostly known for its presence in baby and infant foods such as rice and fruit juices. The presence of inorganic arsenic in staples of children’s diets is concerning due to its risk of potential lasting health effects. The risks posed by inorganic arsenic on fetal and child brain development has become increasingly clear since the early 2000s as epidemiological studies began to scrutinize more subtle effects such as learning disorders and epigenetic effects. Earlier studies mostly focused on gross measures such as low body weight or increased stillbirths.

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How and when will FDA rule on ortho-phthalates in food? It’s anyone’s guess.

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: January 29, 2019

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

The Food and Drug Administration (FDA) has yet to decide three overlapping petitions requesting the agency take action on uses of ortho-phthalates in contact with food. Two of the petitions—a food additive petition and a citizen petition—were submitted by EDF, Earthjustice and nine other public health allies. In those petitions, we requested the revocation of all uses of this class of chemicals in food because the agency can no longer conclude that such use is safe. The law required FDA to make a decision by no later than September 2018; that deadline has long since come and gone, and the agency hasn’t acted.

The third petition was submitted by the Flexible Vinyl Alliance, an industry group. It requested that the agency revoke the food additive uses of 26 ortho-phthalates because, according to FDA’s notice, they had been abandoned. The agency agreed to review the petition in July 2018 and invited public comment on it in November 2018.  Public comments were due on January 14, 2019.

In a press release about its petition, the industry group announced that only four ortho-phthalates “remain relevant in food contact applications”:  di(2-ethylhexyl) phthalate (DEHP), diisononyl phthalate (DINP), dicyclohexyl phthalate (DCHP) and diisodecyl phthalate (DIDP).  It also stated that it confidentially provided the agency with exposure and safety data on these four substances. The agency has made neither the industry’s petition nor the safety data on the four ortho-phthalates publicly available. We submitted a Freedom of Information Act (FOIA) request seeking industry’s “confidential” report and more information on the petition.  We await a response.

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FDA is dragging its feet while children continue to be exposed to perchlorate in food

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: January 11, 2019

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

It has been more than 18 months since EDF and other advocates challenged the Food and Drug Administration’s (FDA) May 2017 decision to continue allowing perchlorate in dry food plastic packaging and food handling equipment.

While Congress gives FDA 180 days to act on food additive petitions, FDA must act “as soon as possible” on a challenge such as ours. However, the agency has yet to complete a review of its May 2017 decision in light of our concerns and evaluate whether to either stand by it, or reverse it. We did not expect FDA would take three times longer to review a decision already made, especially since our objection is largely based on the agency’s own data.

In the meantime, perchlorate in food continues to threaten children’s brains. The chemical, a component of rocket fuel, disrupts the thyroid gland’s normal function and reduces production of the thyroid hormone needed for healthy fetal and child brain development. FDA’s own studies show increased levels of perchlorate in foods such as baby food dry cereal, indicating the chemical’s intentional use in dry food packaging is the likely source of increased exposure for young children.

How FDA got it wrong

In FDA’s May 2017 decision to continue allowing intentional use of perchlorate in contact with dry food, the agency largely relied on flawed science to assess dietary exposure. Its three central errors were:

  1. Ignoring its own data showing significantly increased exposure for children;
  2. Woefully underestimating exposure based on a flawed migration test; and
  3. Unrealistically assuming that perchlorate-laden plastic would only contact food once.

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For children’s food, heavy metals require more attention and better standards

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: June 12, 2018

Tom Neltner is Chemicals Policy Director and Michelle Harvey and Maricel Maffini are consultants

In June 2017, EDF released Lead in Food: A Hidden Health Threat. The report examined a decade’s worth of data from the Food and Drug Administration (FDA) and found lead detected in 20% of baby food samples compared to 14% for other foods. Eight types of baby foods, including fruit juices, root vegetables, and teething biscuits, had detectable lead in more than 40% of the samples. We closed the report with the following recommendation:

In the meantime, parents should consult with their pediatrician to learn about how to reduce lead exposure. They should also check with their favorite brands and ask whether the company regularly tests their products for lead, and ensures that, especially for baby food, there is less than 1 ppb of lead in the food and juices they sell.

As described below, we have reason to believe it will take more focused effort on the part of both FDA and food companies to ensure consistently low levels of heavy metals – lead, arsenic, and cadmium in particular – in infant’s and toddler’s diets.

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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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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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