EDF Health

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 »

Posted in EPA, Industry Influence, PFAS, Public Health, Regulation, TSCA Reform / Read 1 Response

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.

Posted in Emerging Science, EPA, PFAS, Regulation / Tagged , , | Comments are closed

EPA’s Significant New Use Rules under TSCA must reflect its policy goals

Lauren Ellis, Research Analyst, Environmental Health 

We recently submitted comments to the Environmental Protection Agency (EPA) on a subset of proposed Significant New Use Rules (SNURs) published by the New Chemicals program under the Toxic Substances Control Act (TSCA). We commend EPA for issuing these proposed SNURs. Our review of some of the SNURs, however, raised concerns about chemical releases to the environment, risks to consumers, and the absence of worker protections. We believe EPA can address many of these concerns by following through on its stated policy goals. 

For all the chemicals in this batch, EPA had previously issued “consent orders” – which impose restrictions on a new chemical – because the agency found at the time of their initial review for market entry that the chemical substances may present an unreasonable risk to health or the environment. We strongly support EPA’s use of SNURs to follow up on consent orders it issues, as a consent order only applies to the original company that submitted a premanufacture notice (PMN) to EPA to domestically manufacture or import a new chemical. 

A SNUR is a separate action that requires any company seeking to engage in a “significant new use” identified in the SNUR to notify EPA at least 90 days before beginning that use, triggering EPA’s review of the potential new use. For new chemicals that received orders, a SNUR can conform to the order – meaning it mirrors the conditions in the consent order for the chemical – or it can apply more broadly to activities or uses that are beyond the scope of the consent order. Either way, SNURs enable the agency to review potentially risky uses prior to their commencement. 

In our comments, we call for four major changes to a subset of the proposed SNURs: 

Read More »

Posted in EPA, PFAS, TSCA Reform / Tagged , , | Comments are closed

Seven ways we can turn off the tap on PFAS pollution

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 »

Posted in PFAS / Tagged | Comments are closed

Industry-requested risk evaluation for D4 under TSCA: EPA has improved its scoping approach, but must go further

Lauren Ellis, Research Analyst, Environmental Health

Earlier this week, EDF submitted comments to EPA on the agency’s draft scope for the manufacturer-requested risk evaluation of D4 under the Toxic Substances Control Act (TSCA). This is EPA’s first draft scope under the Biden Administration – providing an opportunity to see where improvements have been made and where challenges still exist (see EDF’s and others’ comments on the last set of draft scopes under the Trump Administration).

In our comments, we applaud the agency for developing a more comprehensive chemical risk evaluation plan than EPA provided in past scopes. For instance, in its draft scope document, EPA indicated its intent to assess exposure occurring via environmental release to capture fenceline exposures – a necessary step toward addressing environmental justice considerations under TSCA. EPA also indicated it would not assume the use of personal protective equipment (PPE) when evaluating and making determinations on potential risks to workers – a highly problematic approach taken in the past. However, the draft D4 scope also revealed areas still needing further improvement, including greater detail on how the agency will approach differential risks across the population and address combined exposures from different sources.

Last year, the Silicones Environmental, Health and Safety Center (SEHSC), on behalf of Dow Silicones Corporation, Elkem Silicones USA Corporation, Evonik Corporation, Momentive Performance Materials, Shin-Etsu Silicones of America, Inc., and Wacker Chemical Corporation, asked EPA to evaluate D4, or octamethylcyclotetrasiloxane, under TSCA’s provisions governing manufacturer-requested risk evaluations. In October 2020, EPA granted that request. Critically, when conducting manufacturer-requested risk evaluations, EPA must adhere to the same requirements under TSCA as EPA-initiated risk evaluations, including consideration of all reasonably available information and use of the best available science.

D4 is a high production cyclic siloxane chemical, with an annual U.S. production volume of 750 million to 1 billion pounds. It has widespread industrial, commercial, and consumer uses, including as a reactant to make other silicone chemicals; in adhesives, paints, and plastic products; and in food packaging, personal care products (e.g., hair, skin, and nail products), over-the-counter medications (e.g., anti-gas drugs), and medical devices (e.g., breast implants).

D4 hazard, exposure, and risk has been considered by the Government of Canada and the European Chemicals Agency, among others. In 2009, a Health Canada screening assessment concluded that D4 is harmful to the environment and its biodiversity. In Europe, D4 is currently restricted in wash-off cosmetics (concentration limit of 0.1 % w/w); and recently, the European Chemicals Agency proposed further restrictions on D4 in other consumer and commercial uses due to potential risk. Notably, here in the U.S., EPA has received 39 separate “substantial risk reports” on D4 under TSCA Section 8(e), highlighting health concerns such as reproductive toxicity and immunotoxicity. Given the results of previous risk assessments on D4, and the significant number of risk reports provided to the agency, EPA must comprehensively assess the potential risk of D4 in all relevant uses to best protect public health.

Despite EPA’s movement toward a more comprehensive, public health protective approach to risk evaluation (see EDF’s Re-visioning TSCA after the Trump years blog series), the draft D4 scope highlights significant issues that remain, including:

  • Insufficient indication of specific “potentially exposed and susceptible subpopulations” that will be included in the risk evaluation;
  • Absence of a revised systematic review method and a specific systematic review protocol for D4;
  • Inadequate plan to use information authorities under TSCA to fill the extensive data gaps identified;
  • Failure to consider combined exposures to D4 in the workplace (e.g., when a worker is engaged in multiple activities involving potential exposure to D4);
  • Failure to consider combined exposures to individuals who fall into multiple receptor categories (e.g., individuals exposed to D4 in both the workplace and as resident of a fenceline community);
  • Insufficient commitment to consider relevant “background exposures” of D4 that may fall outside of TSCA’s direct regulatory authority but are relevant to evaluating risks from “TSCA uses” (e.g., exposures from food packaging, personal care products, and medical applications); and
  • Insufficient detail on how EPA plans to assess and incorporate uncertainty associated with the use of modeled or surrogate data when evaluating potential D4 risk.

EDF commends EPA for improvements made from previous scopes, and urges the agency to address the identified deficiencies in the final D4 scope.

See EDF’s comments for more detail.

Posted in EPA, Health Policy, Health Science, Public Health / Tagged , , | Comments are closed