EDF Health

Selected tag(s): TSCA Reform

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

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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The many ways the American Chemistry Council wants to turn back time on TSCA implementation – Part 2

Part 2 of a 2-part series: Unrestricted approvals of new chemicals, with low fees 

Maria Doa, Ph.D., Senior Director, Chemicals Policy

In its recently issued ‘State of TSCA’ report, the American Chemistry Council (ACC) tries to turn back the clock on how EPA assesses and mitigates the risks of toxic chemicals under the Toxic Substances Control Act (TSCA) and in the process leave workers, frontline communities and other vulnerable individuals at risk.  

In my previous blog, I looked at how ACC’s proposals would restrict the EPA’s ability to assess chemical risks and the science behind it. In this second and final part of our blog series looking at the chemical industry trade group’s report, I discuss ACC’s plan to dictate how EPA should assess the safety of new chemicals industry hopes to bring to the marketplace, as well as its effort to let industry avoid paying its fair share of the cost for EPA to evaluate chemical risks.  Read More »

Posted in EPA, Health Policy, Industry Influence, Public Health, TSCA Reform / Also tagged , , | Read 3 Responses

The many ways the American Chemistry Council wants to turn back time on TSCA implementation – Part 1

Part 1 of a 2-part series: Minimizing or ignoring chemical risks

Maria Doa, Ph.D., Senior Director, Chemicals Policy 

In its recently issued ‘State of TSCA’ report, the American Chemistry Council (ACC) tries to turn back the clock on how EPA assesses and mitigates the risks of toxic chemicals. The chemical industry group looks to return to the policies of the Trump years – a time rife with scientific integrity issues and wholesale disregard of risks – particularly those risks to frontline communities, workers and other vulnerable groups: the very groups the Toxic Substances Control Act (TSCA) calls out for special consideration.

This 2-part blog series looks at the six ways ACC hopes to turn back time on chemical safety and looks at the harms that would result if trade group’s self-serving ideas were to be adopted. Part 1 looks at the types of risks ACC wants EPA to exclude from its chemical risk evaluations, the workers and other groups whose health would be affected, as well as the trade group’s goal to have itself appointed as the arbitrator of EPA science. Part 2 looks at ACC’s efforts to dictate the process for assessing new chemicals and industry’s clear goal to avoid paying its fair share of the cost to evaluate the risks posed by some of the most dangerous chemicals already in the marketplace.  Read More »

Posted in EPA, Health Policy, Health Science, Industry Influence, TSCA Reform, Worker Safety / Also 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.

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Getting chemical safety back on track 5 years after TSCA reform

Five years ago, President Obama signed into law the Lautenberg Chemical Safety for the 21st Century Act, which overhauled the country’s chemical safety law to better protect people from toxic chemicals.

In a welcome change to the dismal Toxic Substances Control Act (TSCA) reform anniversaries during the Trump administration, this year we are able to highlight some signs of progress we have seen from the Biden EPA that are getting chemical safety back on track.

Though significant challenges remain and lots of work lies ahead to repair the damage done by the former administration and advance a broader vision of health protection for everyone, here are five ways the Biden administration has started to turn things around on chemical safety:

1. Naming leaders committed to scientific integrity and public health protection

With Michael Regan at the helm of EPA, the agency is already miles ahead of where it stood in the last administration. The critical position for overseeing TSCA implementation at EPA is the leader of the Office of Chemical Safety and Pollution Prevention. Fortunately, a chemist with deep experience on TSCA and other chemical issues from her time on Capitol Hill, Dr. Michal Freedhoff, has been confirmed for the role.

Both Regan and Freedhoff have made strong statements supporting a return to scientific integrity and transparency – which are critical needs to building back trust. Dr. Freedhoff specifically cited how the Trump White House forced EPA scientists to weaken their assessment of the dangerous chemical trichloroethylene, an egregious example of political interference in science-based decision-making.

Read More »

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