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10 ways the incoming FDA Commissioner should protect people from toxic chemicals in food

Tom Neltner, Chemicals Policy Director.

The FDA’s critical role in the COVID-19 pandemic has brought intense interest in whom President Biden will nominate to lead the agency as its new commissioner.

While COVID-19 is the priority, the FDA obviously has many vital other responsibilities. Though it doesn’t get that much attention, one of the important roles of the agency is to protect the public from unsafe chemicals in food. Frankly, their record has been disappointing, but the new administration has an opportunity to fix some key problems that scientists and doctors have been warning us about for years.

Here are ten things the new FDA Commissioner should do to keep unsafe chemicals out of our food. The list ranges from actions on specific chemicals to broader reforms.

  1. Stop letting industry decide for themselves, in secret, whether chemicals are safe and can be added to food. EDF, represented by Earthjustice, and the Center for Food Safety, have sued the agency to close the dangerous “Generally Recognized as Safe” loophole.
  2. Systematically reassess dangerous food chemicals it has allowed to be used in food based on new information. The FDA approved the use of many chemicals in food decades ago, and we now have evidence that some of these are unsafe. A chemical shouldn’t be given a forever approval. There needs to be a systematic process to review the scientific evidence, especially when new risks come to light.
  3. Ban the use of perchlorate, an ingredient in rocket fuel, from use in plastic packaging and equipment that comes into contact with food. Perchlorate gets into food, and exposure is particularly dangerous for pregnant women, infants, and young children, as it has been linked to developmental delays, reduced growth, and impaired learning abilities. We’ve sued the FDA to get this chemical out of food, and the case is pending.
  4. Comply with its 60-year-old Congressional mandate to look at the cumulative effect of chemical exposures people have when deciding whether to approve the use of related chemicals in food. EDF’s investigation of 900 approval decisions found that just one followed this common-sense mandate. The reality is that no one is exposed to just one chemical – so the agency shouldn’t be analyzing chemicals’ safety as if that were the case. FDA must respond to a petition filed by EDF and other organizations demanding that the agency follow the law and assess chemicals as classes.
  5. Drive down levels of heavy metals in food. Over the last decades, evidence has emerged of concerning levels of lead, arsenic, and cadmium in food consumed by children, such as rice, juice, and root crops like sweet potatoes and carrots. The FDA should move quickly and aggressively on its new commitment to set limits on heavy metals in food children eat and should also set limits for other food.
  6. Use modern science when evaluating if a chemical poses a health risk. The FDA is stuck in the past by relying on outdated, less accurate scientific methods and ignoring the evolving information we now know about chemical exposure. You wouldn’t insist on driving a car the Flintstones drove just because that was the first car ever.
  7. Prohibit lead from being added to materials that contact food, such as the tin that lines metal cans, and tighten limits for lead in bottled water. EDF’s analysis of FDA data found lead in 98% of certain canned fruits compared to 3% in fresh or frozen types. We’ve sent a formal petition to FDA requesting it immediately take action to ban these harmful and unnecessary uses of lead. Though it’s not a food safety issue, the FDA should also reject a challenge to its decision to ban lead acetate in hair dye. That challenge has put the FDA decision on hold, meaning that people are literally still putting lead on their head!
  8. Prohibit ortho-phthalates from being added to food packaging and processing equipment. These chemicals are known to disrupt hormones and harm brain development. The FDA is significantly overdue in meeting its legally required deadline to make a decision based on a petition from 2016 by EDF and nine other consumer, public health, and environmental groups to ban these chemicals.
  9. Be more transparent about the decisions it is making on chemicals in food. Information about FDA decisions should be publicly available without a Freedom of Information Act request and a months-long wait to learn more about agency actions on the chemicals in our food supply.
  10. Take aggressive action on harmful PFAS in food packaging and processing equipment. PFAS (Per- and poly-fluorinated alkyl substances) can provide water and grease resistance to paper and paperboard and can also leach into food. Growing evidence links PFAS to a wide range of serious health effects – from developmental problems to cancer. And now we know that many types of PFAS bioaccumulate in the body.
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EDF joins court challenge of FDA’s refusal to ban use of perchlorate in food contact materials

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

Today, EDF, represented by Earthjustice, joined with other public health advocates in filing a lawsuit to overturn the Food and Drug Administration’s (FDA) May 2017 decision, reaffirmed in April 2019 that allows the continued use of perchlorate[1], at concentrations up to 12,000 parts per million, in plastic packaging and processing equipment in contact with dry food. Perchlorate exposure is particularly dangerous for fetuses, infants, and young children, as it has been linked to developmental delays, reduced growth, and impaired learning capabilities. FDA relied on flawed reasoning while entirely ignoring important evidence developed by its own scientists revealing potentially serious risks resulting from ongoing use of perchlorate. We maintain that the intentional and unnecessary use of perchlorate in food contact materials should end.[2]

As with any litigation, we take this action reluctantly. We have long questioned FDA’s decisions that ignore evidence that endocrine disruptors like perchlorate can cause harm at levels the agency systematically dismisses as trivial. We have also pushed back on FDA’s decisions that allow toxic chemicals to be used in packaging and processing equipment that contact food ingredients multiple times from the farm to the grocery store shelf when the exposure estimate is based solely on the amount of the chemical that may migrate into food from the final product packaging. Agency assertions that its estimates are based on worst-case assumptions are misleading when they only consider a single contact. While FDA’s initial decision in November 2005 allowing the use of perchlorate-containing plastic raises all of these problems, the agency’s failure to address its own data and accompanying analysis by its own scientists that was published a decade later has left us with little choice but to act.

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EPA distorts the scientific evidence and fails to protect kids’ brains in its proposed limit for perchlorate in drinking water

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

Today, the Environmental Protection Agency (EPA) proposed a Maximum Contaminant Level (MCL) of 56 parts per billion (ppb) for perchlorate in drinking water – more than three times less protective than an interim health advisory level set in 2008. To justify this increase, EPA turned its back on scientific evidence showing that this potent neurotoxin undermines childrens’ motor development and control and can increase their anxiety and depression. The agency’s reasoning is inconsistent with its own analysis published in a draft report in late 2017 and the findings of a peer review panel it convened last year to review that report.

If the agency had used the most protective scientific study and the most sensitive endpoint evaluated in the proposed rule, the MCL would likely be 4 ppb – more than three times more protective than the current health advisory. As a result, the agency fails to adequately protect children from a lifetime of harm. With this MCL, EPA is allowing pregnant women to be exposed to perchlorate in the first trimester of pregnancy at levels that pose much greater risk of impaired neurodevelopment in their children.

The proposed MCL – and how the agency reached it – was both a disappointment and a surprise to us. In late 2017, we applauded the agency’s scientists for developing an innovative model connecting a mother’s perchlorate exposure in the first trimester to fetal harm. We were not alone – in early 2018, EPA’s peer review panel congratulated the agency’s scientists on their analysis. We also complimented EPA’s population-based approach to developing an MCL by estimating the percent of pregnant women, and their children, with borderline thyroid dysfunction due to low iodine intake.

So how did EPA abruptly change course and estimate an MCL less protective than the current health advisory? By altering its analysis in three subtle but significant ways:

  1. Rejecting five epidemiology studies showing harm at even lower exposure levels in favor of one IQ study by Korevaar et al. in 2016.
  2. Choosing an MCL that allows an IQ loss of 2 points even though the study showed a 1 point loss was statistically significant.
  3. Dismissing an alternative, population-based method that EPA proposed in 2017 that reinforces the need for a more protective standard.

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EPA’s safety standard for perchlorate in water should prioritize kids’ health

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

The Environmental Protection Agency (EPA) will soon propose a drinking water standard for perchlorate. The decision – due by the end of May per a consent decree with the Natural Resources Defense Council (NRDC)— will end a nearly decade-long process to regulate the chemical that has been shown to harm children’s brain development.

In making its decision, EPA must propose a Maximum Contaminant Level Goal (MCLG) “at the level at which no known or anticipated adverse effects on the health of persons occur and which allows an adequate margin of safety.”[1] It must also set a Maximum Contaminant Level (MCL) as close to the MCLG as feasible using the best available treatment technology and taking cost into consideration.

To guide that decision, EPA’s scientists developed a sophisticated model that considers the impact of perchlorate on the development of the fetal brain in the first trimester when the fetus is particularly vulnerable to the chemical’s disruption of the proper function of the maternal thyroid gland. As discussed more below, the model was embraced by an expert panel of independent scientists through a transparent, public process that included public comments and public meetings.

In April, a consulting firm published a study critiquing EPA’s model. The authors acknowledged the model as a valuable research tool but did not think it is sufficient to use in regulatory decision-making due to uncertainties. Therefore, the authors concluded that EPA should discard the peer-reviewed model and rely on a 14-year old calculation of a “safe dose” that does not consider the latest scientific evidence and has even greater uncertainties. They didn’t offer other options such as using uncertainty factors to address their concerns about the model’s estimated values.

Given the importance of the issue and the risk to children’s brain development, we want to explain EPA’s model, the process the agency used to develop it, and the study raising doubt about the model.

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Posted in Drinking Water, EPA, Health Policy, Health Science, Industry Influence, perchlorate / Also tagged , , | Read 2 Responses

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

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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American Academy of Pediatrics calls for “urgently needed reforms” to fix broken food additive regulatory system

Tom Neltner, J.D. is Chemicals Policy Director

Today, the American Academy of Pediatrics (AAP) released a “Food Additives and Child Health” policy statement calling for “urgently needed reforms to the current regulatory process at the US Food and Drug Administration (FDA) for food additives.” The policy applies to chemicals deliberately added to food or to food packaging or food processing equipment that get into food. These substances are used to flavor, color, preserve, package, process and store our food, but many never appear among the list of ingredients. AAP’s statement calls specifically for the following:

  • “Greatly strengthening or replacing the GRAS [Generally Recognized as Safe] determination process;
  • Updating the scientific foundation of the FDA’s safety assessment program;
  • Retesting all previously approved chemicals; and
  • Labeling direct additives with limited or no toxicity data.”

EDF applauds AAP’s policy statement and its decision to add its influential voice to the rising call for reform of the process by which FDA and food manufacturers decide additives are safe. AAP, a professional society representing 67,000 pediatricians, develops policy statements regarding federal, state, and community policies that affect children through an extensive, deliberative process that draws on tremendous scientific expertise. As with past policies, such as those concerning lead toxicity and fruit juice consumption, this statement on chemicals in food presents a well-reasoned assessment of the problem and clear recommendations for reform.

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