EDF Health

Selected tag(s): PFAS

Toxic Chemicals: Regulatory exemptions prioritize industry wants over safety needs

By / Bio / Published: December 2, 2022

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.
Posted in Industry Influence, Public Health, TSCA, Uncategorized / Also tagged , , , , , , | Comments are closed

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

By / Published: October 19, 2022

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.

Posted in Emerging Science, Regulation / Also tagged , , | Comments are closed

Companies are not withdrawing PFAS exemptions on their own; EPA should

By / Bio / Published: June 13, 2022

Samantha Liskow, Lead Counsel, Healthy Communities; and Lauren Ellis, Research Analyst, Environmental Health

EPA has committed to address the urgent issues presented by PFAS, a harmful class of human-made chemicals that are used widely in everyday products. Last July, as part of this effort, EPA called on companies to voluntarily withdraw some 600 PFAS that were previously allowed onto the market through a fast-track exemption process known as a “low volume exemption” (LVE).

Nearly a year later, however, less than 3% of these low volume per- and polyfluoroalkyl substances (PFAS) have been pulled from the market. That means manufacturers in the U.S. could still be making PFAS that never went through a full safety review – possibly millions of pounds each year. Read More »

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Understanding PFAS: Why a broad, transparent PFAS Testing Strategy is needed

By / Bio / Published: March 2, 2022

Maria Doa, Senior Director, Chemicals Policy; Lauren Ellis, Research Analyst; and Lariah Edwards, Post-Doctoral Fellow

EDF this week sent EPA a letter identifying opportunities for the agency to improve the effectiveness and transparency of its strategy for testing per- and polyfluoroalkyl substances (PFAS).

EPA unveiled its National PFAS Testing Strategy (Testing Strategy) last fall, laying out its plan to better understand the class of chemicals and inform its future regulatory efforts. PFAS are a large group of synthetic chemicals used to impart water, oil, grease, and stain resistance to various materials, and they are used in hundreds of everyday products, from water-proof clothing to grease-proof food packaging. By its own count, EPA says there are more than 12,000 individual PFAS.

In their letter to EPA, EDF analyst Lauren Ellis and post-doctoral fellow Lariah Edwards commended the agency for developing a strategy to address some of the significant data gaps that exist around PFAS and committing to use its authority under the Toxic Substances Control Act (TSCA) ‒ the country’s main chemical safety law ‒ to require manufacturers to provide toxicity data on the chemicals.

As the letter points out, however, in its current state, the Testing Strategy lacks sufficient detail and is too narrow to fulfill the agency’s intended purpose to understand and regulate PFAS in a way that is protective of both human health and the environment. Read More »

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Seven ways we can turn off the tap on PFAS pollution

By / Published: November 23, 2021

This blog is adapted from an Op-Ed originally published by Environmental Health News on Nov. 23 and is authored by Lauren Ellis, Research Analyst and Maricel Maffini, consultant.

Per- and polyfluoroalkyl substances (PFAS) are a group of highly persistent chemicals used in hundreds of products. Many PFAS are toxic and have been detected in the bloodstream of virtually all Americans. It’s an ongoing public health and environmental emergency that requires immediate and comprehensive action.

The good news is the White House recently outlined its plan to tackle PFAS pollution already in our water, air and food.

These are worthy efforts, and EDF commends the Biden-Harris Administration for taking these important steps. In addition to these initial actions aimed at addressing legacy pollution, it is also crucial to prevent additional PFAS from entering commerce and further polluting our environment.

In an Op-Ed published today by Environmental Health News, EDF Environmental Health Research Analyst Lauren Ellis and EDF consultant Maricel Maffini laid out seven steps the federal government should take to address PFAS in commerce and help turn off the tap on new PFAS pollution. The recommendations range from adopting a comprehensive definition for PFAS and taking a class-based approach to regulating the chemicals to phasing out all but essential uses of the substances. Read More »

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Beyond paper, part 2: PFAS intentionally used to make plastic food packaging

By / Published: August 12, 2021

Tom Neltner, Chemicals Policy Director; Maricel Maffini, consultant; and Tom Bruton with Green Science Policy Institute

Since 2002, FDA has authorized the use of four types of per- and polyfluorinated alkyl substances (PFAS) to make plastic food packaging, one as recently as 2016. The PFAS are allowed in plastic at levels up to 2000 parts per million (ppm); although lower than those used to greaseproof paper, these levels still contaminate food. The PFAS are added to facilitate the production of articles such as bottles and wraps. They reportedly improve polymer extrusion, reduce build-up on the injection mold, and improve surface roughness among other technical effects.

EDF submitted a Freedom of Information Act (FOIA) request for seven food contact substance notices (FCNs) that FDA has authorized. From FDA’s response[1], we learned that these PFAS can contaminate food in contact with the packaging. In one case the overall amount of the PFAS in the diet would be as high as 41 ppb (see pages 31-32 of FOIA response) – much more than is tolerated for some PFAS in drinking water.

These plastic processing aids, along with fluorinated polyethylene, are the latest additions to a growing list of sources of ‘forever chemicals’ in the diet. They join environmental contamination and greaseproofed paper and cardboard as sources that food companies must consider in order to keep PFAS out of their products and respond to consumer demand for safer food. Given the evidence, FDA needs to move forward pursuant to our June 2021 citizens petition to evaluate the safety of PFAS taking into account the cumulative effect of these chemicals in the diet from many sources.

Read More »

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