EDF Health

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 »

Posted in FDA, Food, GRAS, Health science / Tagged | Authors: / Comments are closed

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 »

Posted in Civil rights, Drinking water, Lead / Tagged , , , , | Comments are closed

Broken GRAS: A scary maze of questions a corn oil producer couldn’t answer

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: March 25, 2022

Maricel Maffini, consultant and Tom Neltner, Chemicals Policy Director

This blog is the fourth in our Broken GRAS series where we explore the Food and Drug Administration’s (FDA) Generally Recognized as Safe (GRAS) voluntary notification system for novel chemicals added to food, how the process works in practice, and why it is broken. Companies voluntarily submit these notices seeking a “no questions” letter from FDA that makes it easier to market the chemical to food companies.

In our latest blog we address a chemical called “COZ corn oil” developed by the Iowa-based company, Corn Oil ONE. We obtained documents from FDA revealing that the agency twice raised significant concerns about the safety of COZ corn oil with the company, which withdrew its notification without addressing the agency’s questions. As with the other examples in the series, FDA did not make its concerns public or take steps to block the chemical’s use in food.  Read More »

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

Good news: Blood lead levels in children resume their downward trend

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: March 16, 2022

Tom Neltner, Senior Director, Safer Chemicals

It is always worth keeping an eye on the latest U.S. data on blood lead levels in children. While no amount of lead is safe, it is nice to see lower levels reported in findings released by the Centers for Disease Control and Prevention (CDC) late last year.

In case you missed it, blood lead levels decreased among the children most exposed to the heavy metal during the most recent two-year cycle, according to a biomonitoring data report released by CDC.

The 2017-18 data comes from the CDC’s National Health and Nutrition Evaluation System (NHANES), and it is a key measure of overall progress towards reducing children’s exposure to lead from all sources.

In April 2019, we reported disturbing news that after six years of sustained and significant progress, the NHANES 2015-16 cycle showed blood lead levels (BLLs) of the most exposed children 1 to 5 years of age increased compared to the previous two years. We saw a similar trend for children 6 to 11 years of age in the 2015-16 data. At the time, we cautioned that the increase was not statistically significant because of the relatively small sample sizes – between 600 and 800 children in each age range – but was still worth watching. Read More »

Posted in Lead, Public health / Tagged , | Comments are closed

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, GRAS, 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 »

Posted in Civil rights, Drinking water, Lead, Public health / Tagged , , , , | Comments are closed