EDF Health

Seven ways we can turn off the tap on PFAS pollution

This blog is adapted from an Op-Ed originally published by Environmental Health News on Nov. 23 and is authored by Lauren Ellis, Research Analyst and Maricel Maffini, consultant.

Per- and polyfluoroalkyl substances (PFAS) are a group of highly persistent chemicals used in hundreds of products. Many PFAS are toxic and have been detected in the bloodstream of virtually all Americans. It’s an ongoing public health and environmental emergency that requires immediate and comprehensive action.

The good news is the White House recently outlined its plan to tackle PFAS pollution already in our water, air and food.

These are worthy efforts, and EDF commends the Biden-Harris Administration for taking these important steps. In addition to these initial actions aimed at addressing legacy pollution, it is also crucial to prevent additional PFAS from entering commerce and further polluting our environment.

In an Op-Ed published today by Environmental Health News, EDF Environmental Health Research Analyst Lauren Ellis and EDF consultant Maricel Maffini laid out seven steps the federal government should take to address PFAS in commerce and help turn off the tap on new PFAS pollution. The recommendations range from adopting a comprehensive definition for PFAS and taking a class-based approach to regulating the chemicals to phasing out all but essential uses of the substances. Read More »

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Industry-requested risk evaluation for D4 under TSCA: EPA has improved its scoping approach, but must go further

Lauren Ellis, Research Analyst, Environmental Health

Earlier this week, EDF submitted comments to EPA on the agency’s draft scope for the manufacturer-requested risk evaluation of D4 under the Toxic Substances Control Act (TSCA). This is EPA’s first draft scope under the Biden Administration – providing an opportunity to see where improvements have been made and where challenges still exist (see EDF’s and others’ comments on the last set of draft scopes under the Trump Administration).

In our comments, we applaud the agency for developing a more comprehensive chemical risk evaluation plan than EPA provided in past scopes. For instance, in its draft scope document, EPA indicated its intent to assess exposure occurring via environmental release to capture fenceline exposures – a necessary step toward addressing environmental justice considerations under TSCA. EPA also indicated it would not assume the use of personal protective equipment (PPE) when evaluating and making determinations on potential risks to workers – a highly problematic approach taken in the past. However, the draft D4 scope also revealed areas still needing further improvement, including greater detail on how the agency will approach differential risks across the population and address combined exposures from different sources.

Last year, the Silicones Environmental, Health and Safety Center (SEHSC), on behalf of Dow Silicones Corporation, Elkem Silicones USA Corporation, Evonik Corporation, Momentive Performance Materials, Shin-Etsu Silicones of America, Inc., and Wacker Chemical Corporation, asked EPA to evaluate D4, or octamethylcyclotetrasiloxane, under TSCA’s provisions governing manufacturer-requested risk evaluations. In October 2020, EPA granted that request. Critically, when conducting manufacturer-requested risk evaluations, EPA must adhere to the same requirements under TSCA as EPA-initiated risk evaluations, including consideration of all reasonably available information and use of the best available science.

D4 is a high production cyclic siloxane chemical, with an annual U.S. production volume of 750 million to 1 billion pounds. It has widespread industrial, commercial, and consumer uses, including as a reactant to make other silicone chemicals; in adhesives, paints, and plastic products; and in food packaging, personal care products (e.g., hair, skin, and nail products), over-the-counter medications (e.g., anti-gas drugs), and medical devices (e.g., breast implants).

D4 hazard, exposure, and risk has been considered by the Government of Canada and the European Chemicals Agency, among others. In 2009, a Health Canada screening assessment concluded that D4 is harmful to the environment and its biodiversity. In Europe, D4 is currently restricted in wash-off cosmetics (concentration limit of 0.1 % w/w); and recently, the European Chemicals Agency proposed further restrictions on D4 in other consumer and commercial uses due to potential risk. Notably, here in the U.S., EPA has received 39 separate “substantial risk reports” on D4 under TSCA Section 8(e), highlighting health concerns such as reproductive toxicity and immunotoxicity. Given the results of previous risk assessments on D4, and the significant number of risk reports provided to the agency, EPA must comprehensively assess the potential risk of D4 in all relevant uses to best protect public health.

Despite EPA’s movement toward a more comprehensive, public health protective approach to risk evaluation (see EDF’s Re-visioning TSCA after the Trump years blog series), the draft D4 scope highlights significant issues that remain, including:

  • Insufficient indication of specific “potentially exposed and susceptible subpopulations” that will be included in the risk evaluation;
  • Absence of a revised systematic review method and a specific systematic review protocol for D4;
  • Inadequate plan to use information authorities under TSCA to fill the extensive data gaps identified;
  • Failure to consider combined exposures to D4 in the workplace (e.g., when a worker is engaged in multiple activities involving potential exposure to D4);
  • Failure to consider combined exposures to individuals who fall into multiple receptor categories (e.g., individuals exposed to D4 in both the workplace and as resident of a fenceline community);
  • Insufficient commitment to consider relevant “background exposures” of D4 that may fall outside of TSCA’s direct regulatory authority but are relevant to evaluating risks from “TSCA uses” (e.g., exposures from food packaging, personal care products, and medical applications); and
  • Insufficient detail on how EPA plans to assess and incorporate uncertainty associated with the use of modeled or surrogate data when evaluating potential D4 risk.

EDF commends EPA for improvements made from previous scopes, and urges the agency to address the identified deficiencies in the final D4 scope.

See EDF’s comments for more detail.

Posted in EPA, Health Policy, Health Science, Public Health / Tagged , , | Comments are closed

New Study Highlights Lead in Water at Child Care Facilities and Holes in Current EPA Rule

Lindsay McCormick, Program Manager

This month, EDF published an article along with collaborators from Auburn University and Mississippi State University, based on a pilot we conducted in partnership with local organizations[1] to comprehensively test and remediate lead in water at 11 child care facilities in Illinois, Michigan, Mississippi and Ohio.

The study found that while over 75% of first draw samples contained lead levels under the 1 ppb level recommended by the American Academy of Pediatrics, 10 of 11 child care facilities produced at least one sample above that level. We fixed problems at the facilities, including replacing 26 contaminated fixtures and two lead service lines. Read More »

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FDA reinstates ban on lead added to hair dyes

Tom Neltner, Chemicals Policy Director

On October 7, FDA announced that it is reinstating its ban on lead acetate as the active ingredient in hair dyes that hide grey hair when used regularly. In 1980, the agency approved the chemical for hair dyes. In response to a color additive petition from the Environmental Defense Fund and others, in October 2018, the agency revoked its approval. Combe Inc, the maker of Grecian Formula, objected and forced the FDA to suspend its decision. With this new action, the FDA reinstates its decision effective January 6, 2022 and gives companies one year to reformulate lead acetate out of their products.

Grecian Formula reportedly stopped using lead acetate shortly before the FDA acted in 2018. From our searches, Youthair is the remaining brand that uses the chemical.

We applaud the FDA’s affirmation of its 2018 decision where it determined these products are not safe. The agency soundly rejects Combe’s arguments that low levels of lead are safe and concludes that “we have determined that there is no known level of exposure to lead that does not produce adverse effects” in adults. These adverse effects include heart and kidney damage.

People should not be spreading lead on their head! It gets through the skin where it can hurt their body in myriad of ways. While we applaud the decision, we don’t see anything in the record that explains why FDA took almost three years to reaffirm the obvious and allow consumers to unknowingly continue using the unsafe product. Therefore, it is even harder to understand why FDA chose to give Youthair another year – until January 2023 – to remove the product from the shelves.

The FDA has known for more than forty years that the lead in these hair dyes is absorbed through the scalp, especially when used every day to hide grey hair, but previously thought there was a safe level. Other federal agencies acknowledged a decade ago there is no known safe amount of exposure to lead in adults or children. The FDA’s action in 2018, reaffirmed today, brings it in line with the scientific consensus.

Beyond lead acetate hair dyes, the FDA needs to do more to drive down consumer’s exposures from all sources of lead in food and cosmetics by tightening limits on this heavy metal in common ingredients. To protect kids and adults, it needs to translate its recognition that there is no known safe level of lead exposure by updating its outdated standards for food additives, bottled water, metal cans, and brass faucets as we demanded in a petition last year. The agency’s Closer to Zero Action Plan for children’s foods is critical but not sufficient to protect adults.

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Not goodbye, but see you later

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

After nearly 35 years at EDF, I am retiring this week.

While I have had the privilege of working on many things in my time at EDF, for the last 20+ years my main focus has been on the Toxic Substances Control Act: making the case for why reform was so badly needed; helping shape what that reform should look like; traversing every twist and turn on the long and winding road to get the Lautenberg Act finally enacted; and providing EPA with our advice on how to get strong and lawful implementation of the law off the ground.

I don’t know that any of us who worked so hard on all of the above imagined what a tragic turn all of that work would take with the arrival of the Trump administration.  They simply handed over the keys to the chemical industry and its bevy of law firms, trade associations, and consultants, who quickly shattered the fragile consensus and good will that had allowed the reform to happen, and then systematically undermined the intent of the law in a manner that actually made many things worse than before.  EDF’s and my role necessarily shifted to one of vociferous opposition, documenting and challenging how EPA political appointees were thwarting the law, science, and the agency’s mission to protect health and the environment, including those at greatest risk.

Considerable damage was done to EPA, including to its most valuable resource, the career staff.  Considerable time will be needed to right the ship.  I am hopeful about the corrective actions that have already been taken by new EPA leadership and what they are signaling is still to come.

It is vital not only that the damage be fixed, but also that EPA work to realize a broader vision for what TSCA can be and must do to fully account for and protect those most exposed or susceptible to chemical risks – including fenceline communities, workers, and children.  Earlier this year we published a series of posts to this blog titled “Re-visioning TSCA” that lays out some of our thinking about why and how this work should begin immediately.

Enormous tasks lie ahead.  EDF has had and will continue to have a strong team working on TSCA, and we will shortly be announcing a new member who will lead this work.

I plan to take a break and return at a later point to continue to advise our team on this important work.

Finally, a note about the EDF Health blog:  Our program started it in February 2008 to be able to weigh in and talk about our work back then to ensure the safety of nanomaterials.  Some 820 posts later, we now regularly address a range of issues we work on relating to chemicals and health.  We also strive to do more than just opine on the issues – often using the blog to present the results of our research and analysis of problems and detailed recommendations for how they should be tackled.

I was startled to see that, over these years, I have contributed about 475 posts, more than 350 of them directly focused on TSCA.  That is a lot of words, but I hope they can still serve as a resource, and a window into what we believe can and needs to be done to protect everyone from toxic chemicals.

For now, I’ll just say, not goodbye, but see you later.

Posted in EPA, Health Policy, Public Health, TSCA Reform, Worker Safety / Read 5 Responses

Broken GRAS: Undermining the safety of dietary supplements and food

Tom Neltner, Chemicals Policy Director and Maricel Maffini, consultant

Over the years, we have seen a disturbing approach being taken by some dietary supplement companies to circumvent the Food and Drug Administration’s (FDA) oversight. Their strategy undermines both dietary supplement safety and food safety. These companies are leveraging FDA’s decision to allow manufacturers to secretly self-certify food chemicals as Generally Recognized as Safe (GRAS) in order to:

  1. Bypass mandatory new dietary supplement ingredient (NDI) notice requirements; and
  2. Expand their market from dietary supplements into conventional food.

We have long-challenged FDA’s interpretation of the GRAS exemption in the Food Additives Amendment of 1958 because it results in the agency being unable to fulfill its statutory duty to ensure food is safe.[1] When Congress passed the amendment, the GRAS exemption was expected to be for common substances like oils and vinegar. In this blog, we explain how the agency’s flawed approach to GRAS also undermines the safety of dietary supplements. Read More »

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