EDF Health

EPA should ensure federal funds do not support harmful partial LSL replacements

Tom Neltner, Senior Director, Safer Chemicals Initiative and Roya Alkafaji, Manager, Healthy Communities

Last year, the White House set a goal of eliminating lead service lines (LSLs) by 2032 and worked with Congress to enact the Infrastructure Investment and Jobs Act (IIJA)—also known as the Bipartisan Infrastructure Law—which included critical resources to help meet this goal.

Through IIJA, communities across the United States have access to federal funds to replace an estimated 9 million LSLs, which are the pipes that connect homes to water mains under the street. EDF fully supports the President’s goal and related efforts to protect public health and advance environmental justice.

EPA is off to a good start. The agency:

  • Distributed the first of five years of IIJA funds to state revolving fund (SRF) programs, including $15 billion dedicated to LSL replacement and $11.7 billion in general funding for drinking water infrastructure projects (which may also be used for LSL replacement).
  • Provided guidance to states to help ensure the funds go to “disadvantaged communities” and that the $15 billion is used for full (not partial) replacements.
  • Plans to publish the results of its drinking water Infrastructure Needs Survey and Assessment. That report is crucial to updating the formula by which SRF funds will be allocated to states in subsequent years.

However, as states begin to administer SRF funds from the $11.7 billion in general infrastructure funding, EPA’s lack of clarity on what the funds can and cannot be used for reveals problems. Specifically, some states may allow this funding to pay for partial – as opposed to full – LSL replacements when a utility works on aging water mains that have LSLs attached to them.

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Unleaded Juice: FDA’s challenge of continuous improvement and compliance assurance

Tom Neltner, Senior Director, Safer Chemicals

This is the sixth 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. 

A core tenet of FDA’s Closer to Zero program is the “Cycle of Continuous Improvement” represented by the image below on the program’s webpage. The four-stage, outer ring represents FDA’s process for revising its action levels for food contaminants. The inner, grey ring describes the agency’s on-going monitoring, research, and compliance program.


This approach makes sense, and we fully support it. However, the success of this approach relies on FDA addressing several significant structural weaknesses.

  • Future funding is not guaranteed: In March 2022, Congress appropriated $11 million in Fiscal Year 2022 (FY22) funding for FDA’s maternal and infant health work—in part to support the agency’s efforts to reduce arsenic, lead, and cadmium in children’s foods. Last year’s request and appropriations were a significant increase over previous years, but that funding level is not guaranteed for future years.
  • Action levels are guidance—not legally binding requirements: FDA’s action levels for contaminants in food are established in guidance. The guidance introduction makes it clear that “The contents of this document do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract.” It assumes that the food industry—from the largest multinational corporation to the smallest entrepreneur—will comply.
  • The agency has limited means to monitor compliance: FDA largely relies on physical inspections and market sampling, supplemented by voluntary reporting, to assure compliance with action levels. Inspections at high-risk facilities must occur every three years (but likely have been delayed due to the COVID pandemic). We understand that most facilities will see an inspector once every eight years. This is particularly problematic because FDA says it lacks the authority to require food companies to provide requested documents without the physical inspection, and the agency does not require ongoing testing and reporting by companies for action levels.
  • Action levels must be consistently strong enough to drive research and impact markets: FDA correctly points to its success in setting an action level for inorganic arsenic in infant rice cereal as a model to lower contamination. Unfortunately, the model assumes the action level for a contaminant is set low enough to result in research investments and increased product and ingredient testing and to provide FDA with sufficient information to act on problems. This is not the case for lead in juice.
     
    We explore each of these weaknesses below.

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Unleaded Juice: FDA needs to start with public health—not market impact

Tom Neltner, Senior Director, Safer Chemicals 

This is the fifth 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. 

FDA’s approach to setting draft action levels for lead in juice is based on two ill-conceived presumptions:

  • Action levels should not impact more than 5% of the market. Unfortunately, FDA does not appear to consider market trends or whether the products were made using best practices shown to reduce contamination.
  • Action levels should help ensure 90% of young children have a dietary intake of lead that is below FDA’s Interim Reference Level, the maximum daily intake from food. Unfortunately, this effectively ignores the top 10% or 2.4 million of the most-exposed young children.[1]

To its credit, the agency has shown it is willing to go beyond the 5% impact for three types of juices (grape at 12%, pomegranate at 6%, and prune at 6%),[2] and it has proposed the most protective lead-in-juice standards in the world. However, for a heavy metal like lead where relatively short-term exposures can result in long-term harm to young children’s developing brains, the current approach has serious weaknesses.

We think the agency should evaluate alternatives that impact more than 5% of the market and protect more than 90% of children. And when FDA evaluates impacts, it should assess the socioeconomic benefits of the alternatives. For substances like lead (and arsenic), these societal benefits can be quantified using established methods. In a previous blog, we showed that reducing young children’s overall dietary intake of lead by just 6% would yield $1 billion a year in benefits. The agency should compare these benefits to the investments that industry would need to make to achieve these action levels using best practices.

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Successful Denver Water Lead Reduction Program Seeks 12-Year Extension

Roya Alkafaji, Manager, Healthy Communities and Lindsay McCormick, Senior Manager, Safer Chemicals

Denver Water has one of the most successful lead service line (LSL) replacement programs in the country. Since it began the program in 2020, the utility has replaced nearly 14,000 LSLs—prioritizing lines to buildings serving vulnerable populations, such as child-care facilities. Denver Water has also distributed over 102,000 filters to local residents. EPA should continue to support their innovative approach.

Watch this video to learn more about Denver Water’s Lead Reduction Program.

In 2019, we blogged about a novel program that Denver Water designed to address the estimated 64,000 to 84,000 LSLs in its system. These lead pipes connect buildings to water mains under the street.  At the time, the water utility proposed to fully replace all LSLs in their entirety within 15 years under its Lead Reduction Program.

The utility decided to fund the work through water rates and bonds, hydropower production, and other sources. In addition, they proposed to provide filters to residents until six months after replacement of the LSL.

Critically, the program includes a comprehensive effort to engage local partners to reach all members of the community. For example, Denver Water partnered with CREA Results, a local community-based organization that is helping to engage and educate Spanish-speaking and immigrant communities on the risks of lead in drinking water and to ensure that residents understand the steps involved with LSL replacement in their neighborhoods. Denver Water’s program has emerged as a national model and its success is recognized by the Lead Service Line Replacement Collaborative and EPA (including its recent service line inventory guidance).

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

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.

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Unleaded Juice: Getting Credible Lab Results is Essential

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.

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