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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FDA Acknowledged Ortho-Phthalates Could Be Grouped Into Classes For Safety, Then Punted

Maricel Maffini, consultant and Tom Neltner, Chemicals Policy Director

In May, FDA decided to allow continued use of nine ortho-phthalates in food packaging and processing equipment but punted on deciding whether or not using those phthalates is safe. We’ve written about the petitions that resulted in the decision, along with the agency’s decision to “abandon” the use of 19 other phthalates (here, here, here, and here). We’ve also written about how phthalates that industry and FDA say are no longer on the market are showing up in our food (here and here). Today, however, we focus on whether those nine phthalates are a class of related substances—and the implications for public health if they are.

FDA’s obligation to evaluate related chemicals as a class

FDA’s regulations state that additives “that cause similar or related pharmacological effects will be regarded as a class, and in the absence of evidence to the contrary, as having additive toxic effects.” In denying our petition, FDA acknowledged that some phthalates could be in a class of related substances. For example, FDA described studies showing that seven phthalates reduced testosterone production – an effect called antiandrogenicity – during fetal development. This caused malformation of the male reproductive system (primarily malformed genitals in male infants). The agency balked at declaring all phthalates anti-androgenic because four of them did not show that effect.[1]

But rather than move forward with a safety assessment of the use of the antiandrogenic phthalates as a class of chemicals with similar toxicity, FDA dropped the issue, implicitly sending the message the chemicals are safe. This is contrary to the agency’s obligation. When making a final decision on a food additive petition that allows the use of a substance, FDA must explicitly decide the use is safe after considering the cumulative effect of it and related substances in the diet.[2]

In contrast to FDA’s failure to act, the Consumer Product Safety Commission, responding to safety concerns, took action five years earlier and banned use of antiandrogenic phthalates in children’s products.

A phthalate scorecard: Where we stand on which phthalates can be used and their health effects

The table below provides a scorecard for the nine phthalates that remain in use. Of those substances, studies showed that seven were associated with developmental effects, including four which have antiandrogenic effects. Two phthalates were never studied for developmental effects.

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Consumers continue to rate chemicals in food as top food safety concern

Tom Neltner, Senior Director, Safer Chemicals

For the eighth year in a row, consumers rated chemicals as their top food safety concern according to the annual industry survey of consumer perspectives on food issues. In the survey conducted in March 2022, 48% of consumers rated chemicals as their top category of food safety concern – about the same as 2021 – compared to 22% for foodborne illness from bacteria. The chemicals category includes: cancer-causing chemicals (15%); pesticides (13%); food additives and ingredients (11%); and heavy metals (9%).

Last year, we examined the International Food Information Council’s (IFIC) 2021 Food and Health Survey in detail. Our takeaway was that consumers continue to be concerned about chemicals in food, partly because they lack confidence that the federal government is actually ensuring additives—like artificial sweeteners—are safe. (Nearly 70% didn’t know that’s the government’s role).

As a result, consumers do their best to protect their health and safety by avoiding ingredients that sound like chemicals—the only way they see to control the perceived risk. In reaction to consumer concerns, some food companies have undertaken “clean label” programs, which, according to a 2017 analysis by Center for Science in the Public Interest, either remove these ingredients (which can be helpful if the removed ingredients are unsafe) or use names that do not sound like chemicals (which obscures the facts and can be misleading).

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ICYMI: EDF Cumulative Risk Assessment Framework Webinar

On Wednesday, September 7, 2022, Sarah Vogel, EDF’s Senior Vice President for Health, welcomed over 150 attendees to a webinar on EDF’s new Cumulative Risk Assessment Framework (CRAF). The event featured presentations by:

  • Lariah Edwards, PhD, EDF post-doctoral fellow and Associate Research Scientist, Department of Environmental Health Sciences, Mailman School of Public Health, Columbia University.
  • Devon Payne-Sturges, DrPh, Associate Professor, Maryland Institute for Applied Environmental Health, School of Public Health, University of Maryland.
  • Deborah Cory-Slechta, PhD, Professor of Environmental Medicine, Pediatrics, Public Health Sciences, and Neurosciences, University of Rochester Medical Center.

EDF staff developed this new tool to provide a practical pathway for applying comprehensive, cumulative chemical risk evaluations within the framework of the Toxic Substances Control Act (TSCA).

The tool is designed to support EPA’s mandate under TSCA to provide: 1) A holistic consideration of chemical risks, and 2) Special consideration of those who may be at greater risk because they are more susceptible to a chemical’s effects or more highly exposed.

The framework begins with the evaluation of a single chemical and moves toward an approach that takes into account multiple chemical exposures, as well as other, non-chemical stressors—like racism, poverty, and lack of access to health care. In combination, these factors lead to higher risks of disease and disability from cancers and heart disease to poor birth outcomes and childhood asthma.

For more information on the Framework, visit our new CRAF webpage, where you can download the in-depth report on the development of the framework and watch a recording of the webinar.

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Broken GRAS: FDA must declare abandoned uses of ortho-phthalates are not GRAS.

Maricel Maffini, EDF consultant and Tom Neltner, Chemicals Policy Director

This blog is the sixth 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.

In May, FDA removed its approval for all uses of 19 ortho-phthalates (aka phthalates) and some uses for two more because it agreed with the industry petition claiming the uses had been abandoned. During the comment period when the petition was filed and again when the decision was published, Earthjustice, EDF, and others warned FDA that despite the removal of approvals, a company could still use any of the abandoned phthalates without the agency’s knowledge by determining on its own that the use was Generally Recognized as Safe (GRAS).

In its decision, FDA implicitly acknowledged that this could indeed happen. After explaining what a GRAS safety determination[1] entails and how its voluntary GRAS notification program[2] works, the agency said:

In the future, if a manufacturer wishes to establish safe conditions of use for one or more of these substances in food contact applications, we expect the manufacturer to submit either a food additive petition or a food contact substance notification prior to market entry because these intended uses were previously authorized under section 409 of the FD&C Act.[3]

Since the agency has no way of knowing that a company determined a substance’s use was GRAS or that it was actually in use, FDA’s expectation is little more than a hope. The agency’s own studies show that the abandoned phthalates show up in food and in food contact materials. Many other studies have shown the same thing, including one that found an unapproved phthalate in fast food.

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