EDF Health

Selected tag(s): TSCA Reform

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.

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Righting the ship: A new chance for stronger protections against toxic chemicals

Richard Denison, Ph.D.is a Lead Senior Scientist.

In June 2016, Congress passed historic, bipartisan legislation overhauling the Toxic Substances Control Act, the country’s main chemical safety law, to better protect the public from harmful exposure to toxic chemicals. The Trump administration has spent the last four years working to undermine TCSA by driving its implementation dangerously off the rails.

Now, with President-elect Biden set to take the helm in January, there’s a tremendous opportunity not only to repair the damage done by the Trump administration, but also to use the law proactively to ensure that everyone in the country is better protected from hazardous chemicals — with attention to those whose health is most at risk and to communities where exposures are greatest.

Here are five ways to restore sound and legal implementation of the law and strengthen health protections for families across the country.

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5 ways we’re holding the Trump Administration accountable on the TSCA 4-year anniversary

It’s been four years since Congress passed legislation overhauling our chemical safety system to better protect American families. In the time since that bipartisan achievement, the Trump administration has worked to systematically undermine the law and weaken chemical safety.

But we’re not sitting idly by, and we have the law on our side. This year, on the anniversary of the legislation’s passage, we’re highlighting some of the victories we’ve had and ways we’re fighting back to demand EPA protect the American people from harmful chemicals.

1. Winning important legal cases to hold EPA to the letter of the law

Last year, in response to a challenge from EDF, a federal court delivered a strong rebuke to the Trump EPA’s efforts to undermine the public’s right to know about the chemicals in our homes, schools, and workplaces. The ruling on our lawsuit means that companies can’t hide, and EPA must make public, more information about chemicals in use today.

And a ruling last year in a different case – brought by health, labor and environmental groups, including EDF – has already increased pressure on EPA to stop ignoring known sources of exposure to chemicals when assessing their risks. Conducting the comprehensive risk reviews that the law requires is critical to protecting health, especially for vulnerable populations, like children, pregnant women, and fenceline communities.

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

EPA refuses to extend TCE comment deadline, ignoring requests from Congress, health groups

Joanna Slaney, Legislative Director and Lindsay McCormick, Program Manager. 

Yesterday, in the midst of the COVID-19 national emergency, the Environmental Protection Agency (EPA) closed the comment period on an extremely flawed draft risk evaluation on the toxic chemical, trichloroethylene (TCE).

Due to the many scientific and legal concerns raised by the draft risk evaluation, and its significance for any future regulation of TCE, the draft needs thorough and careful review from experts, the public, and other affected stakeholders. However, EPA refused to delay the deadline for the draft risk evaluation’s comment period, despite the growing hardships and major disruptions resulting from the current COVID-19 crisis.  EPA now seems intent on racing to the finish line with its flawed evaluation, ignoring multiple requests to ensure the document is fully vetted:

  • Congress: In two separate letters from the House and Senate, Members of Congress raised concerns with EPA moving forward with various rulemakings and scientific reviews without sufficient opportunity for expert and public input in light of the pandemic – explicitly referencing the TCE draft risk evaluation as a prime example.
  • Health groups: Health organizations whose staff and members are on the front lines of the pandemic requested that EPA extend the public comment period until after the national emergency is lifted due to severe capacity constraints. EPA did not respond.
  • Impacted communities: In early March, nearly 300 people from communities grappling with TCE contamination asked EPA to hold a public meeting to allow them “to ask questions of the agency and engage in critical dialogue.” EPA denied the request.

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What connects cross country skiing and chemical safety?

Sam Lovell, Project Manager.

An idyllic afternoon gliding through fresh snow may seem as far removed as you can get from Washington, D.C. decision-making about toxic chemicals. However, as recently reported by Outside Magazine, there’s an intriguing connection here that ought to give skiers, and the rest of us, some pause.

Last year, the Environmental Protection Agency (EPA) approved a new chemical for use in ski wax. Just a few months before, the agency had planned to deny the chemical market entry based on the concern, among others, that exposure could “waterproof the lungs” – causing severe, acute harm. Due to the abrupt reversal in EPA’s decision, EDF began looking further into this case and made public records and Freedom of Information Act requests.

The intervening steps that resulted in this chemical getting the green light to market reveal serious problems in EPA’s new chemicals program regarding transparency and industry influence.

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