EDF Health

Unleading Baby Food: FDA’s proposed limits are a positive step, but…

Tom Neltner, Senior Director, Safer Chemicals

What Happened: FDA recently released draft action levels for lead in foods intended for babies and young toddlers.1 Action levels represent the point above which FDA is likely to regard food as adulterated – essentially unsafe – and seek a recall. This is a key step in implementing FDA’s Closer to Zero Action Plan.

  • Lead limits would be 10 parts per billion (ppb) for most foods.
  • Limits would be 20 ppb for dry infant cereals and single-ingredient root vegetable products, because these products may have greater lead contamination levels. (Root vegetables are primarily carrots and sweet potatoes.)

The new action levels do not apply to juices; FDA proposed limits on those in April 2022.

Why It Matters: There is no safe level of lead in the diet.

For young children living in homes without lead pipes or lead paint, diet is the primary source of their lead exposure. FDA makes clear in the proposal that:

“Even low lead exposure can harm children’s health and development, specifically the brain and nervous system. Neurological effects of lead exposure during early childhood include learning disabilities, behavior difficulties, and lowered IQ. Lead exposures also may be associated with immunological, cardiovascular, renal, and reproductive and/or developmental effects. Because lead can accumulate in the body, even low-level chronic exposure can be hazardous over time.”

Lead can enter the food chain through multiple sources, including crops grown in contaminated soil and/or irrigated with contaminated water, atmospheric deposition from industrial activities, and old food-processing equipment that contains lead. The objective is to get exposure closer to zero.

Our Take: We applaud FDA’s proposed limits, which are more protective than the European Union’s 2021 standards. BUT…on the flip side:

  • FDA failed to set action levels for popular grain-based snacks, like teething biscuits and snack puffs. The agency needs to rectify this failure with all deliberate speed.
  • More protective action levels are achievable, especially for non-rice cereals and for foods that don’t contain rice or root vegetables.
  • Proposed action levels do not apply to multiple categories of foods, including:
  • FDA’s justification for the draft action levels lacks transparency—undermining both credibility of the levels and the likelihood industry will comply with them.

In addition, USDA and industry need to expand their support for research on the methods for growing, harvesting, and processing root vegetables, rice, and quinoa to further reduce lead contamination in these important foods. Research should include both store-bought and homemade baby foods.

Go Deeper: Visit our new Deep Dives blog to see our 3-part series, which provides a more detailed analysis of FDA’s proposal—including our recommendations for setting more protective limits and improving the transparency and credibility of the agency’s process of setting action levels.

NOTES
1 FDA’s guidance refers to babies and young children. Younger than two is a very narrow definition of young children, especially since children up to age six are particularly vulnerable to the harm that lead causes to their brains. Other federal agencies set standards for this broader age range. Toddlers are generally considered to be between 1 and 3 years of age. Therefore, we use the term “young toddlers” to avoid confusion.

Revised on March 21 to correct quote.

Also posted in Deep Dives, FDA, Health Science, Public Health, Unleaded Juice / Read 1 Response

Introducing Deep Dives—EDF’s New Platform for In-Depth Scientific & Policy Analyses on Environmental Health

What’s New? Today we’re launching a new digital channel for the die-hard science and policy wonks in our midst! Deep Dives is a new, long-form blog site that will offer readers in-depth scientific analyses, hard data, and practical policy prescriptions from our top environmental health experts. The authors are Environmental Defense Fund experts in air quality, chemistry, epidemiology, law, public health, and more.Illustration of a pink brain wearing glasses on a bright yellow background

Why It Matters: We have multiple audiences for our content—and data tell us they have very different information needs and preferences about format.

We are committed to giving everyone the information they want in the format they prefer—and that led us to create Deep Dives.

Here’s the Deal: On average, only about 5% of web visitors read to the bottom of any particular piece of internet content. That’s why we have moved this blog to short-form content that tells you what’s happening and why it’s important from the jump. We give you the gist, and we try to keep it under 500 words.

But we also have a specialized audience of scientists, policymakers and implementers, academics, and advocates who value the policy nuances and scientific details. The people in this group want the meaty content and all the details—and, if they are interested in the subject, they will read to the end of the post, no matter how long it is.

If that describes you, Deep Dives was conceived and created for you!

What’s Next? We may be creating a new space for the self-described geeks and wonks, but we’ll continue to give you the skinny here—and all visitors are welcome in both spaces! Be sure to subscribe to this blog to receive email notifications of new Deep Dives blogs.

Last one in is a rotten egg!


Illustration of two French bulldogs under water, wearing swimming goggles, surrounded by a colorful coral reef.

Welcome to our new Deep Divers!

Also posted in Deep Dives, Health Science, Public Health / Comments are closed

The Case of the Missing PFAS

By Lauren Ellis, MPH, Research Analyst, Environmental Health and Samantha Liskow, Lead Counsel, Health

NOTE: In a recent blog post, EDF called for EPA to revoke PFAS approved through the agency’s “low volume exemption” (an LVE is an exemption from a full safety review for new chemicals produced in quantities less than ~10 tons) and to instead require all PFAS to undergo a full safety review under the Toxic Substances Control Act (TSCA). Last month, EDF and other groups, represented by Earthjustice, formally petitioned EPA to do just that.

What Happened: We recently discovered that EPA is withholding the names of over 100 PFAS chemicals approved as LVEs—claiming that releasing that information would reveal “confidential business information” (CBI).

Why It Matters: PFAS causes harm to both the environment and to human health—including reproductive, developmental, and cancer-related effects. Given growing concerns about the risks of PFAS, the public has the right to know if they are being exposed to PFAS, especially those approved through exemptions to EPA’s new chemical safety review process.

Our Take:

  • EPA should reveal the identities of the missing PFAS LVEs. If doing so would reveal CBI, EPA should work with PFAS manufacturers to craft a name that clearly communicates PFAS class membership.
  • EPA should require full safety review for all PFAS, including those previously approved through exemptions.

GO DEEPER… Read More »

Also posted in Industry Influence, Public Health, Regulation / Tagged , , | Read 1 Response

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.

Read More »

Also posted in Civil rights, Public Health / Tagged , , , , , , , | Comments are closed

Sperm Concerns: Sons Affected by Mom’s Exposure to Forever Chemicals

Illustration of gray sperm swimming toward a dark purple egg on a light purple background

By Lauren Ellis, MPH, Research Analyst, Safer Chemicals

What’s New: A peer-reviewed study by Danish researchers found that a male fetus who is exposed to PFAS (per- and polyfluoroalkyl substances—also known as “forever chemicals”) during early pregnancy is more likely to have lower sperm quality in early adulthood.

It’s the first study to explore the impact of exposure to more than two PFAS compounds (as measured in maternal blood samples during early pregnancy) on adult male reproductive hormones and sperm quality.

Why It Matters: Poor sperm quality is directly related to male infertility. In addition, it has been linked to other health problems such as testicular cancer, heart disease, and all-cause mortality.

This study adds to decades of literature linking environmental chemical exposures to negative impacts on reproductive health.

Key Lessons from the Study:

  • Women who were pregnant 20+ years ago had multiple types of PFAS in their blood. The study used data on a group of Danish women who were pregnant between 1998-2003. The women gave blood samples, which were then frozen and stored; 95% of those samples were taken in the first trimester of pregnancy.
  • In 2020-2021, researchers tested those maternal samples for 15 different PFAS compounds. They found 7 of the 15 in the bloodstream of nearly 90% of mothers in the study. The seven were: PFHxS, PFHpA, PFOA, PFOS, PFNA, PFDA, and PFUnDA.
  • Exposure to PFAS during pregnancy decreases the sperm quality of adult male offspring. Researchers found that both combined and single exposure to maternal PFAS concentrations during early pregnancy had a negative effect on the sperm quality—particularly sperm count, concentration, and movement—of adult male offspring.

Our Takeaway: The new study presents a startling finding—developmental exposures to chemicals are associated with long lasting harm, including impacts that can affect future generations. It also adds to the growing evidence of PFAS health risks and demonstrates the urgent need for more health-protective PFAS policies and regulations.

Next Steps: EDF and our partners are pushing EPA to revoke existing PFAS exemptions and require those PFAS (and new PFAS coming to market) to undergo a full safety review under the Toxic Substances Control Act, our nation’s primary chemical safety law.

It is critical that these evaluations also consider the cumulative risk of exposure to PFAS mixtures in the environment.

Note: In June 2021, EDF, with a group of health, environmental, and consumer organizations, sent a formal petition to FDA asking the agency to ban all PFAS  that accumulate in the body. That petition is still under review.

Also posted in Emerging Science, Regulation / Tagged , , , | Comments are closed

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.

Posted in Health Policy / Tagged , , , , , | Comments are closed