Monthly Archives: January 2022

Did your kids have a hyper holiday? Why those vibrantly colored treats need a warning label

Terry Hyland, Communications Manager

Many parents have experienced that foreboding sense of what might come next as they watch their child indulge in a decadent treat at a holiday gathering or birthday party. All that sugar means things are about to get a little crazy, right?

While sugar has its own issues, perhaps the source of that burst of hyperactivity is another ingredient: the synthetic dyes that brighten many of our sweet treats, and many of the not-so-sweet ones too.

Last year, California government scientists at the Office of Environmental Health Hazard Assessment (OEHHA) released a report finding that commonly used synthetic food dyes can lead to hyperactivity and other neurobehavioral problems in children, with some reacting very strongly to relatively small amounts of colorants. Children’s exposure is also higher compared to adults.

That stands to reason. According to OEHHA, the most common food items associated with food dye exposures include icings, fruit-flavored and juice drinks, sodas, and breakfast cereals. And it is not only the more than 6 million children diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) that may be particularly sensitive to synthetic dyes; kids without pre-existing behavioral disorders can also be affected. Read More »

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In latest act of leadership, Cincinnati votes to cover the cost of replacing lead pipes for all residents

Tom Neltner, Chemicals Policy Director

The Cincinnati City Council has voted unanimously to authorize Greater Cincinnati Water Works (GCWW) to pay 100% of the cost of replacing private lead service lines (LSLs) that bring drinking water to customers’ homes and other buildings. The Council’s December vote supports its larger strategy to “provide quality healthy housing for all income levels.” More broadly, the action is the latest act of leadership from the city as it works to address the environmental justice issues in its communities.

The ordinance gives GCWW the authority to help more customers pay to fully replace LSLs as the utility conducts infrastructure work on drinking water mains that connect to the lead pipes. Since 2017, the utility has subsidized up to 40% of a customer’s replacement cost through grants, and allowed customers to take a 10-year, interest-free loan.

Despite these incentives, the utility recognized that the cost of replacement was an obstacle for many customers, especially for low-income residents. About 60% of customers declined to participate, leaving them with partial LSL replacements that left lead pipes on private property in place. These partial replacements create higher short-term spikes in lead levels in drinking water and do not reliably reduce the risk of lead exposure over the long-term, as full replacement does. This is an important step for Cincinnati, as it ends LSL replacement practices that force customers to share in the costs that can lead to environmental justice and civil rights issues. Read More »

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Civil rights complaint draws attention to the discriminatory impacts of common lead pipe replacement practice

Jennifer Ortega, Research Analyst, Environmental Health

This past Wednesday, Rhode Island’s Childhood Lead Action Project (CLAP) led a coalition of groups in submitting a civil rights complaint to the Environmental Protection Agency (EPA) against the Providence Water Supply Board (Providence Water), pursuant to the Civil Rights Act of 1964.

The administrative complaint highlights the discriminatory effects that can result when utilities require customers to share the cost of replacing the lead pipes that feed into their homes. The complaint was submitted as part of CLAP’s larger Lead-Free Water RI campaign, which calls “for an equitable, statewide plan for full, free lead pipe replacements for all Rhode Islanders.”

In the complaint, CLAP, South Providence Neighborhood Association, Direct Action for Rights and Equality, National Center for Healthy Housing, and EDF allege that the water utility’s process of replacing lead service lines (LSLs) — the lead pipes that run from the water main to the water meter in homes — has a disparate impact on Black, Latinx, and Native American residents in violation of Title VI of the Civil Rights Act of 1964 and EPA’s implementing regulations. Read More »

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EPA’s Significant New Use Rules under TSCA must reflect its policy goals

Lauren Ellis, Research Analyst, Environmental Health 

We recently submitted comments to the Environmental Protection Agency (EPA) on a subset of proposed Significant New Use Rules (SNURs) published by the New Chemicals program under the Toxic Substances Control Act (TSCA). We commend EPA for issuing these proposed SNURs. Our review of some of the SNURs, however, raised concerns about chemical releases to the environment, risks to consumers, and the absence of worker protections. We believe EPA can address many of these concerns by following through on its stated policy goals. 

For all the chemicals in this batch, EPA had previously issued “consent orders” – which impose restrictions on a new chemical – because the agency found at the time of their initial review for market entry that the chemical substances may present an unreasonable risk to health or the environment. We strongly support EPA’s use of SNURs to follow up on consent orders it issues, as a consent order only applies to the original company that submitted a premanufacture notice (PMN) to EPA to domestically manufacture or import a new chemical. 

A SNUR is a separate action that requires any company seeking to engage in a “significant new use” identified in the SNUR to notify EPA at least 90 days before beginning that use, triggering EPA’s review of the potential new use. For new chemicals that received orders, a SNUR can conform to the order – meaning it mirrors the conditions in the consent order for the chemical – or it can apply more broadly to activities or uses that are beyond the scope of the consent order. Either way, SNURs enable the agency to review potentially risky uses prior to their commencement. 

In our comments, we call for four major changes to a subset of the proposed SNURs: 

Read More »

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Broken GRAS: It’s time for FDA to wake up and protect consumers from dubious ingredients

Maricel Maffini, consultant and Tom Neltner, Chemicals Policy Director

This blog is the third in our Broken GRAS series where we explore how the Food and Drug Administration’s Generally Recognized as Safe (GRAS) voluntary notification system for novel chemicals added to food works in practice and why it is broken.

In this blog, we examine another voluntary GRAS notice submitted to the FDA, this one for Venetron, an extract of Apocynum venetum leaves. It is marketed for sleep improvement and anti-stress and used as a dietary supplement and food ingredient. Documents obtained through a Freedom of Information Act (FOIA) request reveal that FDA scientists raised safety concerns about Venetron. Under the broken GRAS system, however, the company that manufactures the ingredient was able to withdraw its notification and continue to market the chemical as GRAS, despite the questions raised by the agency.

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Japanese company Tokiwa Phytochemical (Tokiwa) voluntarily notified the Food and Drug Administration (FDA) in August 2014 that it had determined its extract of Apocynum venetum leaves was Generally Recognized as Safe (GRAS). The extract, called Venetron, would be an “ingredient in food” at levels up to 100 mg per day, the company said in the notice (GRN 530). Tokiwa indicated that Venetron could be incorporated into “health food product[s], such as tablet[s] or capsule[s],” but did not identify specific foods to which the substance might be added.

In support of its GRAS determination, the company presented results of preclinical and clinical investigations that examined the safety of the extract in mice and healthy adult male volunteers. They also reported data on the effectiveness of Venetron to treat individuals with mild depression. It convened a panel of three experts ‒ Drs. Veronika Butterweck (Univ. of Applied Sciences and Arts, Northwestern Switzerland), Sansei Nishibe (Health Sciences Univ. of Hokkaido), and Kuo-Hsiung Lee (Univ. North Carolina at Chapel Hill) ‒ to review the studies, as well as a “history of human intake” of Rafuma [another name for A. venetum] leaf extract and its use as a dietary supplement in Japan and as a drug in China to treat insomnia, kidney disease, hypertension and heart palpitations.

Tokiwa said the panel “unanimously concluded that VENETRON™, when used in foods in general at levels providing a daily total intake of 100mg/person/day, is safe,” and that the GRAS determination was based on “scientific procedures supported by a history of safe use.” Read More »

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An environmental justice case study: how lead pipe replacement programs favor wealthier residents

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.  Read More »

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