EDF Health

The Chemical Industry Hid Evidence of Harm from PFAS: 3 Takeaways

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

Yesterday, The Guardian published a powerful story by reporter Tom Perkins detailing how chemical manufacturers hid evidence of dangerous health impacts from certain types of PFAS and the Food and Drug Administration (FDA) did not take sufficient and swift action to protect the public.

The story is largely based on data revealed in the FDA’s response to a Freedom of Information Act request by EDF and Environmental Working Group. The analysis showed that two major PFAS manufacturers, Daikin and DuPont, withheld safety information from the agency both by 1) not submitting it when the agency was considering whether the chemical should be on the market, and 2) not alerting the FDA when later analysis revealed a problem.

The companies’ failures are disturbing. What FDA did (or, more precisely, failed to do) after finding out is also disconcerting. While the agency’s scientists have taken strides to more fully understand the harm posed by PFAS, management has failed to adequately translate the science into timely action to protect people from toxic chemicals like these in their food.

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California water utilities fear the unknown when it comes to lead service lines

Tom Neltner, Chemicals Policy Director.

Last month, two California trade associations submitted disconcerting comments to the Environmental Protection Agency (EPA) as the agency considers what to do with the revised Lead and Copper Rule (LCR) published in the waning days of the Trump Administration. The associations – the Association of California Water Agencies (ACWA) and the California Municipal Utilities Association (CMUA) – represent 90% of the state’s drinking water utilities.

The trade associations are asking EPA to allow water utilities to tell the agency, the state, their customers, and the public that they have no lead service lines (LSLs) even when they know it may well be false. This would seriously undermine one of the most important positive aspects of the revised LCR – the service line inventory. California’s unusual definition of a “user service line” has been a long-running problem: it does not include the portion of the service line on private property. This definition is narrower than the federal one – and even the state’s definition of an LSL that has been in place for more than a quarter century.

Under EPA’s revised LCR, utilities can only claim that they have no LSLs – and thus avoid the need to comply with the rule’s more protective sampling and corrosion control requirements for systems with LSLs – if they are confident there are no LSLs based the entire length of the service line, including the portion on private property. The two state trade associations are asking EPA to put the burden of determining the composition of this portion of the service line entirely on the customer, allowing a utility to ignore a lead pipe if the customer does not provide the information. This approach will render the inventory effectively useless and misleading.

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Michigan embraces predictive tools to develop a lead service line inventory

Tom Neltner, Chemicals Policy Director.

Earlier this year, the Michigan Department of Environment, Great Lakes, and Energy (EGLE) released ground breaking guidance to help utilities in the state develop their “Complete Distribution System Materials Inventory” (CDSMI) that is due in 2025. The guidance is important because it explicitly allows utilities to use predictive tools to prepare an accurate materials inventory that is essential to effective lead service line (LSL) replacement efforts. Because the Environmental Protection Agency’s (EPA) service line inventory in its revised Lead and Copper Rule (LCR) has many elements in common with Michigan’s inventory, we encourage EPA and other states to look closely at Michigan’s guidance as a model to help all utilities develop accurate service line inventories.

Michigan’s inventory requirement and guidance

Michigan’s version of the LCR requires utilities to fully replace all LSLs – the portion on both public and private property – at an average rate of 5% per year by 2040.[1] The key to compliance is an accurate CDSMI that must be submitted to EGLE and made public by January 1, 2025.

EGLE states that the CDSMI’s purpose “is to characterize, record, and maintain a comprehensive inventory of distribution system materials, including service line materials on both public and private property.” It supports effective asset management planning, LSL replacement efforts, and notification of those served by an LSL.

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Reversing the last administration’s TSCA new chemicals policies needs to be a priority for this one

Richard Denison, Ph.D., is a Lead Senior Scientist.

Reprinted by permission from The Environmental Forum®, May/June 2021. MAY/ JUNE 2021 | 55
Copyright © 2021, Environmental Law Institute®, Washington, D.C. www.eli.org.

[NOTE:  This post is my contribution to a debate on TSCA implementation published by ELI.  I wrote this piece, which ELI titled “Reversing New Chemicals Program a Priority,” in late March.]

As with so much else these past four years, implementation of the 2016 reforms to the Toxic Substances Control Act was not normal.

Despite bipartisan support for TSCA’s overhaul and the chemical industry’s acknowledgment that it needed a stronger federal system to restore public confidence in its products, this progress evaporated virtually overnight with the ascendance of the most anti-environmental and anti-public health administration in our lifetimes.

Nowhere was this more apparent than in the Trump EPA’s systematic undermining of the new TSCA’s enhancements of safety reviews for the hundreds of new chemicals entering commerce each year. The chemical industry, its army of law firms, and its political plants inside EPA went for broke.  Read More »

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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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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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