EDF Health

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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A closer look at FDA’s “Closer to Zero” plan to reduce for heavy metals in children’s food

Tom Neltner, J.D. is the Chemicals Policy Director.

This month, the Food and Drug Administration (FDA) released its “Closer to Zero” action plan to reduce exposure to heavy metals in foods for babies and young children. The plan, released in response to a recent House of Representatives Committee on Oversight and Reform report and the introduction of the Baby Food Safety Act in both the House and the Senate, is a step forward since it commits the agency to specific actions and general deadlines for the first time. However, there is room for improvement, specifically the agency should:

  1. Explicitly consider the cumulative effect of heavy metals on neurodevelopment when setting limits.
  2. Move up deadlines for draft action levels for arsenic and cadmium;
  3. Be consistent in messaging that there is no safe level of lead in children’s blood;
  4. Define what “as low as possible” and “children’s food” means as soon as possible;
  5. Be transparent by posting testing data quickly; and
  6. Add milestones for compliance verification with action levels and preventive controls.

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House Oversight Committee draws renewed attention to heavy metals in baby food and calls for FDA to act

Tom Neltner, J.D. is the Chemicals Policy Director.

Last week, the House Committee on Oversight and Reform’s Subcommittee on Economic and Consumer Policy released an important report summarizing baby food testing data submitted by four companies (Beech-Nut, Gerber, Happy Family, and Earth’s Best), finding that “baby foods are tainted with dangerous levels of arsenic, lead, cadmium and mercury.” These heavy metals are widely recognized as harming children’s brain development.

The report found that three of the four companies (all but Gerber) used ingredients that had exceeded limits set in their internal standards. Additionally, the committee cited “grave concerns” that three other companies (Walmart, Plum, and Sprout) did not provide their internal standards and testing results in response to the legitimate request by the House Committee. Their lack of transparency undermines credibility and trust.

Due to the alarming nature of these findings about a food marketed as safe and healthy for infants and toddlers, the report garnered significant attention and has prompted calls for the Food and Drug Administration (FDA) and food manufacturers to do more on this issue.

Importantly, the report provides new insights into industry decision-making processes, highlights the need for greater oversight, and adds urgency to EDF’s ongoing efforts to reduce heavy metals in food.

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Getting lead out of brass and bronze food equipment

Tom Neltner, J.D. is the Chemicals Policy Director.

Many people may not be aware that lead is still added to brass and bronze used to make drinking water faucets and food equipment like coffee brewers and more. This is problematic because lead can leach into the water and beverages from the equipment – putting consumers at risk. As part of EDF’s efforts to reduce exposure to lead from all sources, we have advocated to stop this use of the heavy metal.

Last June, our three-year effort yielded results when the committee responsible for the national consensus standard for plumbing devices, known as NSF/ANSI/CAN 61, made its lead leaching standard five times more protective for endpoint devices – from 5 to 1 parts per billion. Endpoint devices are faucets, drinking water fountains and other devices installed within the last one liter of water distribution systems in a building. For all other plumbing devices, lead is limited to the amount added to the device’s material, 2500 parts per million (ppm) [1], and leaching limit does not apply.

This fall, we turned our attention to lead leaching into drinking water from food equipment such as ice machines, coffee brewers, teapots, and water heaters. We have submitted petitions to NSF International and to the Food and Drug Administration (FDA) asking them to prohibit use of lead in brass and bronze commonly used in these devices.

For food equipment, we leveraged the more protective safety standards for food contact substances in the Food Additives Amendment of 1958. These standards require that additives not be used unless there is a reasonable certainty of no harm from their intended use after taking into account related substances in the diet. It also prohibits use of carcinogens. Lead is unsafe under both these restrictions because it is a carcinogen and no safe threshold has been found for lead in the blood to prevent neurologic development harm in children and heart disease in adults.

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It’s time to eliminate lead from tin coating and solder on metal food cans

Tom Neltner, J.D. is the Chemicals Policy Director.

In October 2019, we reported finding canned foods had a surprising number of samples with lead based on the Food and Drug Administration’s testing results. Almost half of the 242 samples had detectable lead, including a staggering 98% of 70 canned fruit samples.

We suspect that the high lead detection rates are a result of lead in the tin – either added to make an alloy or as a contaminant – used to coat the steel or join steel pieces together in the cans. This lead can then leach from the coating or solder into the food. Light-colored fruits and fruit juices would be more likely to have lead contamination based on a report indicating they are commonly packaged in tin-coated steel cans without a synthetic coating on the inside isolating the food from the tin. The lead detections in the other canned products in FDA’s study could have resulted from flawed synthetic coatings.

In December 2020, EDF and ten health, consumer, and environmental groups[1] petitioned FDA to ban the use of lead in food contact materials such as tin. We also included that FDA should presume that lead was intentionally used when levels in food contact materials are at or above 100 parts per million (ppm) and provided an option for the agency to specifically authorize the use only if:

  • The part of the food contact article that contains added lead does not contact food under intended conditions of use; or
  • No lead migrates into food from the food contact article under intended conditions of use.

Our petition demonstrates that, because lead is a carcinogen that is unsafe at any level in the blood, its use in tin coatings and solder for food cans should be expressly prohibited. The agency posted the petition for public comment and must make a decision how to proceed by June 2021. There is no deadline for comments, but it is best to submit them by April 1 so they can influence the agency’s decision.

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FDA’s Failure on Food Chemical Safety Leaves Consumers at Risk of Chronic Diseases

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

Update: FDA published the citizen petition upon receipt on 9/23, and is requesting public comment.

More than 60 years ago, Congress enacted legislation requiring the Food and Drug Administration (FDA) and the food industry to evaluate the cumulative effects of substances in the diet that have related health impacts when assessing the safety of chemical additives. In our decade of analyzing FDA and industry actions, we have been increasingly concerned that both have ignored this requirement. To figure it out, we investigated all safety determinations contained in Generally Recognized as Safe (GRAS) notifications voluntarily submitted by food manufacturers to FDA since the program began in 1997. We looked at GRAS notices because they are publicly available and because FDA rules explicitly require that food manufacturers include in the notice an explanation of how they considered the requirement. If there was an omission, it would be more easily noticeable.

We found that in only one of 877 GRAS notices did a food manufacturer consider the cumulative effect requirement in a meaningful way. And we found no evidence that the agency either recognized this single attempt to follow the law or had objected to the omissions in the 876 other notices. This failure has significant consequences for public health, particularly for communities who already face significant health and socio-economic disparities, and for children, who are uniquely susceptible to dietary exposures to multiple chemicals.

For this reason, EDF joined with other health, environmental, and consumer groups to file a formal petition to demand FDA and food manufacturers start following the law. The petition requests specific changes to rules designed to reinforce the existing requirement and make it easier to verify compliance. Still, given the lack of transparency in agency reviews, success still largely depends on FDA and the food industry taking seriously the mandate and the food safety implications.

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