Climate change solutions
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Tom Neltner, Chemicals Policy Director and Lindsay McCormick, Program Manager
Dr. Karen Baehler and her team at American University’s Center for Environmental Policy, with support from EDF, recently published a peer-reviewed case study highlighting the environmental justice issues that arise when water utilities require property owners to pay when they replace lead service lines (LSLs) that connect homes to the water main under the street. Our experience indicates that the vast majority of the 11,000+ water utilities in the U.S. engage in this practice. Based on the findings, these utilities need to reconsider their programs as they address the more than 9 million LSLs nationwide.
The study found that Washington, DC residents in low-income neighborhoods between 2009-2018 were significantly less likely than those in wealthier neighborhoods to pay for a full LSL replacement and, therefore, had an increased risk of harm from lead exposure from a partial LSL replacement.
The practice of requiring customers to pay for a full LSL replacement also raises civil rights concerns in cities like Washington, DC that have a history of racial segregation, redlining, and underinvestment in neighborhoods predominately comprised of people of color. If a utility that follows this practice also receives federal funding such as state revolving loan funds (SRFs), it may be violating Title VI of the Civil Rights Act of 1964. While Washington, DC largely resolved the issue in 2019 by banning partial replacements and addressing “past partials” left in the ground, this scenario is replicated across the country. (more…)
Maricel Maffini, consultant, and Tom Neltner, Chemicals Policy Director
A federal district court this fall ruled that the Food and Drug Administration (FDA) has the authority to allow food companies to make Generally Recognized as Safe (GRAS) safety determinations for novel chemicals added to food without notifying the agency. The decision followed a lawsuit by EDF and others, in which we challenged this practice. The court agreed, in part, with FDA that an uptick in companies voluntarily choosing to send notices to the agency since the 2016 rule went in effect was a sign that the program was working. We disagree with the court’s conclusion but opted not to appeal.
This blog is the second in our Broken GRAS series where we explore how the voluntary notification system works in practice and why it is broken. The first dealt with a synthetic chemical called apoaequorin and marketed as Prevagen, a chemical found in jellyfish and used in protein shakes. The company claims the substance helps memory, but FDA has repeatedly raised serious questions about its safety. Despite the agency’s concerns the company continues to sell the product as GRAS.
In this blog, we examine another voluntary GRAS notice, this one for GABA, a neurotransmitter naturally produced in the brain and known to slow down certain nervous system activities. It is marketed as a food ingredient despite FDA’s serious concerns with the notice that prompted the company to withdraw it. The agency does not make such information publicly available. We were able to learn of FDA’s concerns through a Freedom of Information Act (FOIA).
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Companies have the option to voluntarily notify FDA when they determine that a use of a new chemical or a new use of an existing chemical is Generally Recognized as Safe, or GRAS. When they do notify FDA, agency scientists then review the data and supporting information and can ask additional questions. In most of the cases, FDA agrees with the company’s determination and publishes a “no questions” letter. In roughly 20% of cases, however, companies ask the agency to stop the process after receiving the scientists’ questions. FDA then stops its review and announces a “cease to evaluate” status in the GRAS notification inventory, and that’s the end of it. There is no public record of as to why the company withdrew the notice. In some cases, a brief summary is included in the agency’s response to the cease to evaluate letter published in its website. The company is free to market and sell the substance if it still believes the chemical’s use is GRAS.
This happened with gamma aminobutyric acid (GABA). As you will see, the GABA case is a prime example of the 1) importance of FDA’s scientific review of safety data, and 2) profound implications for health risks when the agency takes no action in response to safety concerns raised by its own experts. A product with the safety concerns we describe below warrants closer examination, regardless of its current market share. Where serious health effects are found, it is important for FDA to act quickly before a specialty product like this one becomes more popular, and its health risks amplified. (more…)
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:
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:
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.
Ugbaad Ali, Community Environmental Health Tom Graff Fellow
We all deserve to live in a healthy and vibrant community, yet many residents of Flint, Michigan, are overburdened by a lifetime of toxic exposures and environmental injustice. Recently, a coalition of environmental justice groups and community organizers in Flint used their combined power to organize against the siting of a new hot mix asphalt facility.
The Stop Ajax Asphalt Coalition was formed to protect neighboring communities from further environmental harm. The Coalition, which includes residents from Flint and Genesee Township, St. Francis Prayer Center, C.A.U.T.I.O.N, Environmental Transformation Movement of Flint, Flint Rising, Greater Holy Temple Church, Michigan United, R. L. Jones Community Outreach Center Campus, and Mi JustUs, submitted extensive comments and generated hundreds of public comments to contest the state’s permitting of a hot mixed asphalt facility by Ajax Materials Corp. near homes, schools, and parks.
Historically air permit decisions have been made in isolation, ignoring the cumulative impact from surrounding exposure sources. After hearing from the Coalition, the regional office of the Environmental Protection Agency (EPA) – which serves Michigan and five other states – weighed in with a letter that recommended Michigan’s Department of Environment, Great Lakes and Energy (EGLE) “conduct a cumulative analysis of the projected emissions from all emission units at the proposed facility, fugitive emissions from the proposed facility, and emissions from nearby industrial facilities, to provide a more complete assessment of the ambient air impacts of the proposed facility on this community.” It concluded that “because of the environmental conditions already facing this community, and the potential for disproportionate impacts, the siting of this facility may raise civil rights concerns.”
The U.S Department of Housing and Urban Development’s (HUD) regional office also raised serious civil rights concerns in a letter to EGLE, highlighting that the proposed location is near two HUD-assisted communities housing low-income families of color – and expressing concern that EGLE failed to engage HUD on a decision that could impact HUD-assisted residents.
“This isn’t a defeat for the citizens of Flint.
We’re just getting started.”
– Anthony Paciorek, Michigan United (ABC News)
Despite the public comments and federal agency letters, EGLE approved the air permit, but with tightened requirements. The Coalition remains concerned about the siting of the facility and is committed to challenging the state to require additional measures to protect their community. (more…)
Jennifer McPartland, Ph.D., is a Senior Scientist, and Lariah Edwards, Ph.D., is an EDF-George Washington University Postdoctoral Fellow
EPA Administrator Michael Regan recently completed a five-day “journey to justice” tour, highlighting communities across three US states that have been adversely affected by decades of chemical and air pollution. EPA’s focus on protecting those whose health is at greater risk, including communities disproportionately burdened by harmful chemical exposures, must be a priority in its implementation of the Toxic Substances Control Act (TSCA).
This week, EDF submitted comments to EPA to support the agency’s review of nine widely used substances currently undergoing TSCA risk evaluation: 1,3-butadiene, formaldehyde, and seven ortho-phthalates (phthalates). Our comments identify key groups that are at greater risk from these chemicals because they are more susceptible to their effects or are disproportionately exposed from environmental releases. Importantly, while our comments involved a broad review of the public literature, they do not capture all groups potentially at greater risk to exposure from these substances—and we strongly urge EPA to comprehensively identify all such groups using its information authorities as needed. (more…)
The Environmental Protection Agency (EPA) intends to withdraw two answers to frequently asked questions about the responsibilities of property management companies (PMCs) to comply with the agency’s Lead-Based Paint Renovation, Repair, and Painting Rule (RRP). EDF applauds the agency’s action, which is consistent with the intent of the rule. The agency’s Federal Register notice explaining the change also has important implications for improving compliance.
In comments submitted this week, EDF encouraged the EPA to further revise the guidance by replacing the withdrawn answers with the agency’s own detailed explanation to help PMCs – as well as residents, contractors, and landlords – better understand who is responsible for complying with the RRP rule.
