EDF Health

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

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: September 22, 2022

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.

Read More »

Posted in FDA, Food, Lead, Unleaded Juice / Tagged , , , , , | Comments are closed

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 »

Posted in FDA, Food, Lead, Unleaded Juice / Tagged , , , , | Authors: / Comments are closed

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 »

Posted in FDA, Food, Lead, Unleaded Juice / Tagged , , , | Comments are closed

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 »

Posted in FDA, Food, Lead, Unleaded Juice / Tagged , , , | Comments are closed

FDA and industry continue to ignore cumulative effects of chemicals in the diet

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: September 24, 2021

Tom Neltner, Chemicals Policy Director and Maricel Maffini, consultant

The Food and Drug Administration (FDA) has made no apparent progress to comply with the legal requirement that it consider the cumulative effect of chemicals in the diet that have similar health impacts when evaluating the safety of an additive. A year ago, on September 23, 2020, EDF and 11 other organizations[1] filed a formal petition with the agency documenting the problem and asking it begin complying with the law.

We reviewed FDA and industry actions since the petition was filed and found that both continued to ignore the requirement 100% of the time in:

  • Generally Recognized as Safe (GRAS) notices in which companies were required to consider the cumulative effect as part of their determination that a substance’s use was safe;
  • FDA’s responses to those GRAS notices where it found “no questions” with the flawed safety determinations; and
  • FDA’s revised guidance to industry on use of recycled plastics in food packaging.

The agency’s only response to our petition was a March 2021 letter saying it “has not reached a decision due to competing priorities” and that the “petition is currently under active evaluation by [its] staff.”

From what we can see, FDA and industry continue to make safety determinations about chemical additives without regard to their overall effect on individuals’ health and their legal obligations. Is it any surprise that consumers continue to rate chemicals in food their #1 food safety concern? Read More »

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

A consequential day in the effort to prevent lead poisoning

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: May 18, 2021

Tom Neltner, J.D., is Chemicals Policy Director

Lead poisoning prevention advocates should mark May 14, 2021 as a consequential day in our collective efforts to protect public health. Last week, two decisions and a preliminary report were issued that lay a solid foundation for further progress. When translated into action, the decisions and report should result in significantly reduced lead exposure for children. These developments were:

  • A court ruling on lead-based paint hazard standards: The U.S. Court of Appeals for the Ninth Circuit directed the Environmental Protection Agency (EPA) to reconsider – and most likely tighten – the agency’s 2019 revisions to its lead-based paint (LBP) hazard standard that define the levels of lead in paint, dust, and soil that are dangerous. The current standards remain in place until EPA revises them to comply with the law and the court’s order. This decision has significant implications for home renovations, real estate disclosures, lead cleanups, and homeowner testing. This welcome step toward stronger protections for children was only possible thanks to Earthjustice and the petitioners that challenged EPA’s flawed rule.
  • Lowered federal elevated blood lead level: The Centers for Disease Control and Prevention’s (CDC) Lead Exposure and Prevention Advisory Committee (LEPAC) unanimously recommended that the agency lower its blood lead reference level (aka “elevated blood lead level” or EBLL) from 5 micrograms per deciliter (µg/dL) of lead in young children’s blood to 3.5 µg/dL. CDC appears ready to act on the recommendation. When it does, the decision will have significant implications for state and local health and housing agencies reacting to blood lead testing results for at-risk children and for action levels for lead in food.
  • New national survey of lead-based paint hazards: The U.S. Department of Housing and Urban Development (HUD) presented to LEPAC the preliminary results of its American Healthy Homes Survey II (AHHS-II), a long-overdue update to its 2006 survey. This survey of lead-based paint hazards serves as the basis for federal agencies to set priorities, assess impacts of policy decisions, and track progress. The results of samples taken in 2018-19 shows modest but significant progress across many demographics including African American households, government-supported households, and households in poverty – most likely an indication that the federal investment to fix low-income housing is paying off.

These actions put added urgency to President Biden’s America Jobs Plan that includes $45 billion in federal funding to fully replace the nation’s 9 million lead service lines and $213 billion for housing – both critical aspects of our nation’s infrastructure that need a lead poisoning prevention-oriented upgrade. We encourage Congress to provide at least $19 billion as part of an investment in housing to reduce lead-based paint hazards in pre-1940 housing, especially by replacing old, single-pane windows to get the combined benefits of safer and more energy efficient homes.

Read More »

Posted in Health policy, Lead, Regulation / Tagged , , , , | Read 1 Response