EDF Health

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.

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

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

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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EPA’s three new service line notices: Critical to transparency and accelerating lead pipe replacement

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

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

This is the second in a series of blogs evaluating various aspects of EPA’s December 2020 revisions to the Lead and Copper Rule (LCR) and what they may mean for accelerating lead service line (LSL) replacements. The blogs cover: 1) new service line inventory; 2) three new LSL notices; 3) environmental justice implications; 4) communicating health effects of lead; 5) economic implications; and 6) sampling and trigger/action level.

Note that President Biden’s Executive Order on Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis directs agencies to review the former administration’s regulations and actions, including the Lead and Copper Rule. 

Three new notices required by the revised LCR from water systems to people with known or potential LSLs provide critical opportunities to build public support for LSL replacement by helping individuals better understand their situation and specific actions they should take. However, we recognize that, like all notices, many people may simply ignore them, especially if only delivered as an insert to a monthly or quarterly bill. We anticipate that notices will be most effective when coupled with broader outreach efforts and requirements that property owners share the notice with potential buyers and tenants.

As explained in a previous blog on the new service line inventories, water systems must assign all service lines to one of four categories. The rule treats three categories – “Lead,” “Galvanized Requiring Replacement,” and “Lead Status Unknown” – as known or potential service lines containing lead. People receiving water from a service line in any of these three categories must receive three new types of notices designed to prompt them to take steps to address the risk of lead in their drinking water pursuant to 40 CFR § 141.85(e) to (g). The three types of notices are:

  1. An annual notice;
  2. A notice of disturbance to service line; and
  3. A notice if trigger or action levels exceeded.

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Posted in Drinking water, Health policy, Lead, Public health, Regulation / Tagged , , , , , | Authors: / Comments are closed

EPA’s new service line inventory: The good, the bad, and the absurd

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: January 19, 2021

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

This is the first in a series of blogs evaluating various aspects of EPA’s December 2020 revisions to the Lead and Copper Rule (LCR) and what they may mean for accelerating lead service line (LSL) replacements. The blogs cover: 1) the new service line inventory; 2) three new LSL notices; 3) environmental justice implications; 4) communicating health effects of lead; 5) economic implications; and 6) sampling and trigger/action level. 

Note that President Biden’s Executive Order on Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis directs agencies to review the former administration’s regulations and actions, including the Lead and Copper Rule. 

The backbone of the revised LCR is a new service line inventory[1] that all public water systems, whether large or small, rural or urban, must develop by January 2024 unless they can demonstrate that they have no LSLs. If properly designed and implemented, the inventory should transform how utilities, communities and states approach LSLs by moving from rough estimates to a data-driven approach that allows water systems to identify what is known and not known about the service lines, communicate that information to the public, and establish LSL replacement priorities.

Unfortunately, EPA has included an unfortunate and absurd new detail in the inventory that requires systems to categorize service lines that contain a two-foot piece of lead pipe, often known as a gooseneck, as “Non-lead.” We anticipate that the absurdity of calling a lead pipe “Non-lead” will undermine the inventory’s credibility and effectiveness.

What is the new service line inventory and how is it used?

By January 2024, water systems must submit a service line inventory to the state and make it publicly accessible pursuant to 40 CFR § 141.84(a). To develop the inventory, they must assign all service lines, regardless of ownership, for the portions on public or private property to one of four categories:

  1. Lead: where a portion of the service line is made of lead (excluding lead connectors, such as goosenecks, as explained below). We presume this includes lead-lined pipe.
  2. Galvanized Requiring Replacement: where a portion of the service line is galvanized iron or steel.[2] If the system can determine that the galvanized pipe was never downstream of an LSL (or lead connector, such as a gooseneck[3]), then it is essentially a galvanized pipe not requiring replacement and can be categorized as “Non-lead.”
  3. Non-lead: where the line is determined not to be “Lead” or “Galvanized Requiring Replacement” (see discussion below for lead connectors). Our understanding is that systems could assume service lines installed after the 1986 federal ban on lead pipe are “Non-Lead.”
  4. Lead Status Unknown: where it has not been determined if the service line met the SDWA Section 1417 definition of “Lead-free” at 42 U.S.C. § 300g-6. We presume this means that solder or flux must be less than 0.2% lead and other wetted surfaces must be less than 8% from 1986 to 2013 and less than 0.25% for 2014 to present.[4]

Under these requirements, a service line is classified as an LSL if it is in the “Lead” or “Galvanized Requiring Replacement” categories.[5]

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Getting lead out of brass and bronze food equipment

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: January 12, 2021

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