EDF Health

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

By Lindsay McCormick / Published: October 27, 2021

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 »

Posted in Lead / Tagged , | Comments are closed

FDA reinstates ban on lead added to hair dyes

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: October 8, 2021

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.

Posted in FDA / Comments are closed

Not goodbye, but see you later

By / Published: September 29, 2021

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 Health policy, Public health, TSCA reform, Worker safety / Tagged | Read 5 Responses

Broken GRAS: Undermining the safety of dietary supplements and food

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: September 27, 2021

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 »

Posted in FDA, GRAS / Tagged , , | Comments are closed

FDA and industry continue to ignore cumulative effects of chemicals in the diet

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: September 24, 2021

Tom Neltner, Chemicals Policy Director and Maricel Maffini, consultant

The Food and Drug Administration (FDA) has made no apparent progress to comply with the legal requirement that it consider the cumulative effect of chemicals in the diet that have similar health impacts when evaluating the safety of an additive. A year ago, on September 23, 2020, EDF and 11 other organizations[1] filed a formal petition with the agency documenting the problem and asking it begin complying with the law.

We reviewed FDA and industry actions since the petition was filed and found that both continued to ignore the requirement 100% of the time in:

  • Generally Recognized as Safe (GRAS) notices in which companies were required to consider the cumulative effect as part of their determination that a substance’s use was safe;
  • FDA’s responses to those GRAS notices where it found “no questions” with the flawed safety determinations; and
  • FDA’s revised guidance to industry on use of recycled plastics in food packaging.

The agency’s only response to our petition was a March 2021 letter saying it “has not reached a decision due to competing priorities” and that the “petition is currently under active evaluation by [its] staff.”

From what we can see, FDA and industry continue to make safety determinations about chemical additives without regard to their overall effect on individuals’ health and their legal obligations. Is it any surprise that consumers continue to rate chemicals in food their #1 food safety concern? Read More »

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

Loosening industry’s grip on EPA’s new chemicals program

By / Published: September 22, 2021

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

[I delivered a shorter version of these comments at the September 22, 2021 webinar titled “Hair on Fire and Yes Packages! How the Biden Administration Can Reverse the Chemical Industry’s Undue Influence,” cosponsored by Public Employees for Environmental Responsibility (PEER), NH Safe Water Alliance, and EDF.  A recording of the webinar will shortly be available here.  The webinar, second in a series, follows on EPA whistleblower disclosures first appearing in a complaint filed by PEER that are detailed in a series of articles by Sharon Lerner in The Intercept.

The insularity of the New Chemicals Program – where staff only interact with industry and there is no real engagement with other stakeholders – spawns and perpetuates these industry-friendly and un-health-protective policies.

I have closely tracked the Environmental Protection Agency’s New Chemicals Program for many years.  Reluctantly, I have come to the conclusion that the program does not serve the agency’s mission and the public interest, but rather the interests of the chemical industry.  Despite the major reforms Congress made to the program in 2016 when it overhauled the Toxic Substances Control Act, the New Chemicals Program is so badly broken that nothing less than a total reset can fix the problems.

Revelations emerging through responses Environmental Defense Fund finally received to a FOIA request we made two years ago, and through the disclosures of courageous whistleblowers who did or still work in the New Chemicals Program, confirm what I have long suspected, looking in from the outside.  The program:

  • uses practices that allow the chemical industry to easily access and hold sway over EPA reviews and decisions on the chemicals they seek to bring to market;
  • has developed a deeply embedded culture of secrecy that blocks public scrutiny and accountability;
  • employs policies – often unwritten – that undermine Congress’ major reforms to the law and reflect only industry viewpoints; and
  • operates through a management system and managers, some still in place, that regularly prioritize industry’s demands for quick decisions that allow their new chemicals onto the market with no restrictions, over reliance on the best science and protection of public and worker health.

Many of the worst abuses coming to light took place during the Trump administration, and it is tempting to believe the change in administrations has fixed the problems.  It has not.  The damaging practices, culture, policies and management systems predate the last administration and laid the foundation for the abuses.  Highly problematic decisions continue to be made even in recent weeks.

I am encouraged by recent statements and actions of Dr. Michal Freedhoff, Assistant Administrator of the EPA office that oversees TSCA implementation.  They clearly are moves in the right direction.  But it is essential that the deep-rooted, systemic nature of the problem be forthrightly acknowledged and forcefully addressed.

Let me provide some examples of each of the problems I just noted.  Read More »

Posted in Health policy, Health science, Industry influence, PFAS, Public health, Regulation, TSCA reform, Worker safety / Tagged , , | Authors: / Comments are closed