EDF Health

Toxic Chemicals: Regulatory exemptions prioritize industry wants over safety needs

A rubber stamp lies on its side to the right of the photo. To the left, you see the stamped image of a skull and crossbones and the words Toxic Substances

By Maria Doa, PhD, Senior Director, Chemicals Policy

What’s the Issue?

EPA grants exemptions from full safety reviews for approximately half the new chemicals submitted by the chemical industry. Once those exemptions are granted, EPA very rarely revises or revokes them—even in the face of new information.

The Toxic Substances Control Act allows EPA to grant an exemption from a full safety review only if it determines that the chemical will not present an unreasonable risk. That’s a high standard—and one that many exemptions do not meet.

Why it Matters:

  • The chemical industry takes maximum advantage of exemptions given the abbreviated safety review and the industry’s ability to keep their use of new chemicals under the radar. For example, the chemicals that get exemptions don’t go on the national inventory of chemicals that are in use.
  • For years, EPA has granted exemptions for chemicals that can have long-term negative impacts on human health and the environment. They include hundreds of exemptions for PFAS, “forever chemicals” known to contaminate our water supplies and farmland. And it’s not just PFAS. EPA has granted exemptions for other types of persistent, bio-accumulative, toxic (PBT) chemicals that can have lasting impacts on people and the environment.
  • These exemptions often contradict TSCA’s requirement that EPA consider the risks from a chemical throughout its lifecycle. That includes the risks for vulnerable groups who may be more susceptible to the chemical or who are more highly exposed, such as frontline communities.
  • EPA does not typically consider the cumulative impacts of multiple exempted chemicals on frontline communities, consumers, or the environment.

Our Take: EPA has an important opportunity to address overuse of TSCA exemptions.

Next Steps:

  • EPA should revisit the exemptions it has already granted. The agency should determine that chemicals truly do not present an unreasonable risk—particularly to vulnerable populations—throughout their lifecycles. EPA should focus first on chemicals that can have long-lasting impacts on health and the environment, like PFAS and other PBTs.
  • Before granting any new exemptions, EPA should consider the combined impacts throughout the lifecycle of these chemicals on all stakeholders, especially frontline communities. EPA Administrator Regan recently said EPA would be embedding environmental justice into the DNA of EPA. This is another opportunity for EPA to do just that.
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EPA greenlights 21 states’ SRF plans to fund LSL replacement projects

Tom Neltner, Senior Director, Safer Chemicals

What’s New: EPA announced it has awarded $1.16 billion to the State Revolving Fund (SRF) programs in 21 states, the District of Columbia, and three territories to support lead service line (LSL) replacement projects. In order to secure funding, these states developed and submitted Intended Use Plans (IUPs), which included LSL replacement projects that met EPA’s requirements.

Why It Matters: These 25 programs can now begin distributing their share of the first of five years of funding from the $15 billion Congress included in the 2021 Infrastructure Investment and Jobs Act (IIJA) specifically for full LSL replacement projects. The remaining states are working to get their IUPs submitted to EPA.

Read More »

Also posted in Drinking Water, EPA, lead, Public Health, States / Tagged , , , , , | 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 EPA, Industry Influence, PFAS, Public Health, Regulation, TSCA Reform / 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, Drinking Water, EPA, lead, Public Health, States / 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, EPA, PFAS, 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.

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