EDF Health

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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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 »

Posted in FDA, Food, GRAS / Tagged | Read 1 Response

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 »

Posted in Drinking Water, lead / Tagged , , | Comments are closed

Broken GRAS: Scientists’ safety concerns are hampered by FDA’s inactions on food chemicals

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. Read More »

Posted in FDA, Food, GRAS / Comments are closed

Eight steps to strengthen FDA’s Closer to Zero plan to reduce toxic metals in children’s food

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:

  • There is an urgent need for FDA and industry to do more to reduce lead, arsenic, and cadmium levels in food that children eat, given the evidence that there are no safe levels of exposure;
  • FDA faces a challenge in effectively communicating to the public about the risks from even relatively low-level, short-term exposure to lead and arsenic;
  • Folic acid and iron play an important role in reducing – but not eliminating – the harm from these toxic elements; and
  • The U.S. Department of Agriculture (USDA) and the Environmental Protection Agency (EPA) play a critical supporting role in the overall effort to protect children from these toxic elements.

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:

  • Reduce the maximum daily intake level / IRL for lead from 3 to 2 µg per day for children and from 12.5 to 9 µg per day for adults as the next step towards the Closer to Zero goal.
  • Reverse the flawed practice of evaluating lead content of each food in isolation and allowing those with high levels to remain in commerce. Instead, FDA should focus on comparing the product to other lot numbers or private brand to its competitors as recommended by 22 state attorneys general.
  • Release the Total Diet Study results for 2018-19 cycle and investigate outliers.
  • Define “as low as possible” based on best performing ingredients or products in a class.
  • Define “children’s food” to include foods commonly consumed by children younger than six years of age.
  • Be consistent on public health messaging and avoid phrases like “no immediate health hazard.”
  • Move up deadlines for arsenic and cadmium action levels.
  • Add milestone for compliance verification with action levels and preventive controls.

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.

Posted in FDA, Food / Read 1 Response

EPA’s updated guidance highlights property management companies’ responsibilities under the Lead-Based Paint Rule

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.

Read More »

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