EDF Health

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

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

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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