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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Unleaded Juice: Getting Credible Lab Results is Essential

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: August 2, 2022

Tom Neltner, Senior Director, Safer Chemicals

This is the third 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.

FDA’s move to establish action levels on lead in juice – and eventually other foods that young children eat or drink – is an important step forward. While we believe that the action levels need to be tougher, any action level has a limited value if labs that analyze samples for contamination provide results that buyers, regulators, or consumers cannot trust.

We recommend that labs meet four criteria to provide credible results:

  • Be accredited under international standards for testing and calibration of labs (ISO/IEC 17025);
  • Use the analytical method based on FDA’s Method 4.7 [PDF, 1.16MB];
  • Demonstrate proficiency in a third-party, blinded test to quantify lead, arsenic, and cadmium to around 6 parts per billion (ppb); and
  • Provide a written report of results at that level.

Here is the list of labs that met these criteria as of August 2021. See below for our in-depth analysis.

Read More »

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Unleaded Juice: Tougher limits on lead in juice would bring more than a billion dollars in socioeconomic benefits

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: June 7, 2022

Tom Neltner, Senior Director, Safer Chemicals

This is the second 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 its implications for the agency’s Closer To Zero program.

When developing its draft action levels for lead in juice, FDA started with the current 50 parts per billion limit and considered progressively tighter levels, settling on 10 ppb for apple juice and 20 ppb for other juices. FDA did not consider more protective limits despite acknowledging that there is no known safe level of children’s exposure to lead – which can harm a child’s developing brain – and that many in the food industry already meet the lower draft levels.

FDA also failed to quantify the socioeconomic benefits of its action. While this task is difficult in many settings, it is entirely reasonable for lead because the Environmental Protection Agency (EPA) has developed a quantitative model when considering rules to protect children from exposure to lead.[1] Read More »

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FDA takes action to limit lead in juice, proposes significant – but insufficient – limits

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: June 3, 2022

Tom Neltner, Senior Director, Safery Chemicals

The Food and Drug Administration (FDA) recently released draft action levels for lead in juice, proposing to reduce lead limits from 50 parts per billion (ppb) to 10 ppb for apple juice and 20 ppb for all other juices. However, the draft limits don’t go far enough to protect children. They also risk undermining the agency’s broader Closer to Zero effort to drive down children’s exposure to lead, arsenic, and cadmium in food. 

If finalized, these levels would be the most stringent in the world, including current European standards[1] and anticipated international standards.[2] For that FDA deserves credit. Public comments to FDA are due June 28. 

This blog is the first in our Unleaded Juice blog series where we explore these issues. Heavy metals like lead are potent neurotoxicants that can impair children’s brain development. Lead can also result in lower IQs in children.  Read More »

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Environmental Justice and Community Organizing: A conversation with Eric Ini of Michigan United

By Terry Hyland / Published: May 11, 2022

For the better part of the last decade, Eric Ini has worked with communities fighting for environmental justice. Human health is inextricably linked to the environment in which we live. And health disparities exacerbated by local pollutants are often tied to entrenched inequities and injustices. 

As a campaigner with Greenpeace in Africa’s Congo Basin, Eric helped local communities preserve rainforest sought for palm oil plantations. Last year, he joined Michigan United, drawn to the group’s work to protect the health of frontline communities after its members helped pressure Marathon Petroleum Corporation into paying $5 million to buy out residents in the predominantly black neighborhood of Boynton affected by years of pollution from the company’s refinery in southern Detroit. 

Now Michigan United’s environmental justice director, he is part of a coalition opposed to the state’s permitting of an Ajax Materials Corp. asphalt facility near Flint, Michigan and demanding action to protect public health. The state Department of Environment, Great Lakes and Energy (EGLE) granted the permit last year, despite overwhelming opposition and calls from the federal EPA to evaluate the cumulative impact on the surrounding community of emissions from the Ajax facility and the many industrial facilities already in the area. 

I sat down with Eric to hear more about his environmental justice efforts and the lessons he’s learned in his work with communities, governments, and companies on multiple continents.    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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