EDF Health

Over 7 million children exceed FDA’s new daily maximum intake level of lead

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: August 24, 2022

Tom Neltner, Senior Director, Safer Chemicals

This is the fourth in our Unleaded Juice blog series exploring how the Food and Drug Administration (FDA) sets limits for toxic elements like lead, arsenic, and cadmium in food and the implications for the agency’s Closer To Zero program.

In June, after issuing its proposed action levels for lead in juice, FDA tightened its Interim Reference Levels (IRLs) for lead to 2.2 µg/day for children and 8.8 µg/day for females of childbearing age—a drop of 27% from the original IRLs it established in 2018. We estimate this change increased the number of children over the IRL for lead from 1.2 million to more than 7 million.

The agency describes IRLs as daily maximum intake levels for lead in food and beverages. FDA scientists said the change was made to match the Centers for Disease Control and Prevention’s (CDC) October 2021 revised blood lead reference value.  This value is commonly known as the elevated blood lead level (EBLL).[1] FDA uses the “interim” label in recognition that there is no known safe level of exposure to lead and the neurotoxic harm it can cause. FDA anticipates matching the IRLs to future reductions in CDC’s reference value as the U.S. makes progress in reducing children’s exposure to lead.

We applaud FDA’s decision to tighten the IRLs. It is a good example of the type of continuous improvement to which FDA committed in its Closer to Zero Action Plan, which aims to lower levels of lead, cadmium, mercury, and inorganic arsenic in food that babies and young children eat and drink.

The challenge now is to translate the tighter daily maximum intake level into action levels for specific foods. Next steps for FDA should include:

  • Further tightening its recently proposed action level for lead in juice.
  • Using the revised lead IRLs as:
    • The basis for its proposal for foods commonly consumed by babies and young children – currently stuck in the review process at the White House’s Office of Management and Budget (OMB).
    • A model for FDA’s anticipated IRLs for inorganic arsenic and cadmium under its Closer to Zero program.

Read More »

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Our experience with FDA’s food chemical program reinforces alarming findings from Politico investigation

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: April 26, 2022

Tom Neltner, Senior Director, Safer Chemicals and Maricel Maffini, consultant

A powerful investigative article by Politico’s Helena Bottemiller Evich revealed significant structural and leadership problems at the Food and Drug Administration’s (FDA) food program. The article articulated what has been implicitly understood by the food safety community. It led to demands from Congress for Commissioner Robert Califf to take aggressive action and even prompted calls for a new agency focused solely on food safety.

 

“Over the years, the food side of FDA has been so ignored and grown so dysfunctional that even former FDA commissioners readily acknowledged problems. There’s a long running joke among officials: The “F” in FDA is silent.”
—Helena Bottemiller Evich, Politico article

 

In response, FDA leadership has pointed to Congress for failing to adequately fund the program and touted examples of where the agency has taken action on food safety.

Yesterday, 30 groups representing food industry leaders, and consumer groups, including EDF, joined in a call for Califf to unify the FDA’s food program under a deputy commissioner for foods with direct line authority over all food-related programs.

We have been advocating for FDA to improve the safety of chemicals added to our food for more than a decade, often working with FDA officials to push for regulatory reforms. From that narrow but deep perspective on food safety, everything we have seen reinforces the shortcomings highlighted in the Politico article. Read More »

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NEPA requires water utilities to evaluate potential discriminatory effects before starting work that disturbs lead pipes

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: April 21, 2022

Tom Neltner, Senior Director, Safer Chemicals Initiative; and Jennifer Ortega, Research Analyst

Providence Water, Rhode Island’s largest water utility, has applied for state funds to rehabilitate drinking water mains in its service area. Lead service lines (LSLs) are often attached to the mains and carry drinking water to customer’s homes. The utility has requested a “categorical exclusion” from the basic environmental assessment requirement for projects seeking money from the State Revolving Loan Fund (SRF). We believe the exclusion is not appropriate and have sent a letter to the Rhode Island Department of Health (RIDOH) asking it to deny Providence Water’s request.

As part of its work, Providence Water apparently plans to replace LSLs on public property and give customers the option to accept a 10-year interest free loan to replace the LSLs that run under their private property. However, this practice forces customers to choose between paying for a full LSL replacement or risking greater lead exposure from the disturbance caused by a partial LSL replacement. It is also the basis of a civil rights complaint that Childhood Lead Action Project (CLAP), South Providence Neighborhood Association, Direct Action for Rights and Equality, National Center for Healthy Housing, and EDF filed with the Environmental Protection Agency (EPA) in January.

EPA, which allocates grants to SRF programs has begun to investigate the civil rights issues raised by the complaint, which demonstrated that Providence Water’s practices disproportionately and adversely affect the health of low-income, Black, Latinx, and Native American residents by increasing their risk of exposure to lead in drinking water.

Under federal and state National Environmental Policy Act (NEPA) regulations, SRF projects are not eligible for a categorical exclusion where an “extraordinary circumstance” is present. The discriminatory effects of Providence Water’s LSL replacement practices represent such a circumstance, and the utility should not be eligible for a categorical exclusion unless it changes its LSL replacement practices. Read More »

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The new FDA Commissioner has a full plate; here are 3 steps he can take to keep focused on food safety

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: February 15, 2022

Tom Neltner, Senior Director, Safer Chemicals.

The U.S. Senate today voted to return Robert Califf to the role of FDA Commissioner, bringing needed leadership to an agency that plays a vital role in protecting public health. 

While Dr. Califf faces historic challenges in the form of the COVID-19 pandemic and the opioid epidemic, he also has a tremendous opportunity to elevate the agency’s important role in protecting the public from unsafe chemicals in food. 

We put together a list of three things Dr. Califf and the FDA have the authority to do right now to keep problematic chemicals out of our food:  Read More »

Posted in BPA, FDA, Food, Lead, Public health / Tagged , , , , , , | Authors: / Comments are closed

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

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: January 12, 2022

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

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: January 5, 2022

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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