EDF Health

Eight steps to strengthen FDA’s Closer to Zero plan to reduce toxic metals in children’s food

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: December 21, 2021

Tom Neltner, Senior Director, Safer Chemicals

EDF this week submitted comments to the Food and Drug Administration (FDA), applauding the agency’s recent activities related to its Closer to Zero Action Plan for reducing toxic elements in children’s food and outlining specific steps to strengthen the FDA’s action.

The agency’s November 18 public meeting on the action plan included excellent presentations by scientists as well as an extended public comment period and an opportunity to provide written follow-up comments. We also appreciate the December 1 colloquium focusing on the latest evidence showing the significant risks posed by arsenic to the development of children’s nervous and immune systems.

Our primary takeaways from these meetings are that:

  • There is an urgent need for FDA and industry to do more to reduce lead, arsenic, and cadmium levels in food that children eat, given the evidence that there are no safe levels of exposure;
  • FDA faces a challenge in effectively communicating to the public about the risks from even relatively low-level, short-term exposure to lead and arsenic;
  • Folic acid and iron play an important role in reducing – but not eliminating – the harm from these toxic elements; and
  • The U.S. Department of Agriculture (USDA) and the Environmental Protection Agency (EPA) play a critical supporting role in the overall effort to protect children from these toxic elements.

The Closer to Zero plan is a step forward because it commits FDA to specific actions and general deadlines for the first time. In our comments, we identify eight areas for improvement with specific suggestions for each that we think the agency can and should adopt to strengthen its efforts. These are:

  • Reduce the maximum daily intake level / IRL for lead from 3 to 2 µg per day for children and from 12.5 to 9 µg per day for adults as the next step towards the Closer to Zero goal.
  • Reverse the flawed practice of evaluating lead content of each food in isolation and allowing those with high levels to remain in commerce. Instead, FDA should focus on comparing the product to other lot numbers or private brand to its competitors as recommended by 22 state attorneys general.
  • Release the Total Diet Study results for 2018-19 cycle and investigate outliers.
  • Define “as low as possible” based on best performing ingredients or products in a class.
  • Define “children’s food” to include foods commonly consumed by children younger than six years of age.
  • Be consistent on public health messaging and avoid phrases like “no immediate health hazard.”
  • Move up deadlines for arsenic and cadmium action levels.
  • Add milestone for compliance verification with action levels and preventive controls.

We look forward to continuing to work with FDA to ensure that levels of toxic metals in children’s food really do get closer to zero.

Posted in FDA, Food / Comments are closed

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

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: April 22, 2021

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.
Posted in FDA, Food, GRAS, Health policy, PFAS, Public health, Regulation / Tagged , , | Comments are closed

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

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: April 21, 2021

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.

Read More »

Posted in FDA, Food, Lead, Public health / Tagged , , , , , | Comments are closed

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

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: January 11, 2021

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.

Read More »

Posted in FDA, Food, Lead / Tagged , , , | Comments are closed

When it comes to testing heavy metals in food, the result is only as good as the lab.

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: January 23, 2020

Tom Neltner, J.D., Chemicals Policy Director and Boma Brown-West, Senior Manager.

[pullquote]

“Even though the levels of a metal in any particular food is low, our overall
exposure adds up because many of the foods we eat contain them in small amounts.”

 

Dr. Conrad Choiniere, leader of FDA’s Toxic Elements Workgroup on April 20, 2018

[/pullquote]

Heavy metals such as arsenic, cadmium, and lead are present in most foods, whether conventional or organic, usually as the result of environmental contamination. Because heavy metals pose significant threats even at low levels, the Food and Drug Administration (FDA) has made reducing cumulative exposure a priority. The Baby Food Council – consisting of Beech-Nut Nutrition Company, Happy Family Organics, Earth’s Best, and Gerber Products Company and supported by Healthy Babies Bright Futures (HBBF), Cornell University and EDF – shares this goal and seeks to reduce heavy metals in the companies’ products to as low as reasonably achievable using best-in-class management practices.

Through the Council, EDF is coordinating a proficiency testing program to enable retailers, food manufacturers, ingredient suppliers, and others to identify laboratories that are capable of measuring arsenic, cadmium, and lead at levels in the low parts per billion (ppb). The Council has arranged for FAPAS, a leading proficiency testing provider for the food and water testing industries, to manage the testing program.

Read More »

Posted in FDA, Food, Health science, Lead / Tagged , , , , , | Comments are closed

EDF joins court challenge of FDA’s refusal to ban use of perchlorate in food contact materials

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

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.

Read More »

Posted in Emerging science, Health policy, Health science, Public health, Regulation / Tagged , , , | Authors: / Comments are closed