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  • Press Release

SEHSC Welcomes EPA Release of Final Scope for D4 Evaluation

Charlotte Anthony

WASHINGTON (March 8, 2022) – Members of the Silicones Environmental, Health, and Safety Center (SEHSC), a sector group of the American Chemistry Council (ACC), today welcomed U.S. Environmental Protection Agency’s (EPA) release of the Final Scope of the Risk Evaluation for D4. In October, SEHSC submitted comments on EPA’s Draft Scope, which identified several areas that merited attention to help ensure that the Agency’s D4 risk evaluation will fully satisfy statutory and regulatory requirements. In the comments, SEHSC reiterated its support for the 2016 amended Toxic Substances Control Act (TSCA), which requires EPA to assess D4 risks on a use-by-use basis, known commonly as Conditions of Use.  

“While EPA’s Final Scope touched on key elements outlined in the Agency’s Risk Evaluation Procedural Rule, SEHSC looks forward to receiving much more detailed information from EPA about its assessment of D4,” said Karluss Thomas, Senior Director of SEHSC, ACC’s Chemical Products and Technology Division (CPTD). “There are still many unknowns about how EPA intends to assess D4 exposures, effects, and risk. Those specifics will be critical to ensuring a timely, thorough, transparent, and scientifically sound risk evaluation for D4, as Congress prescribed in the bipartisan passage of the amended TSCA statute.” 

SEHSC was one of several parties whose comments on the Draft Scope supported EPA conducting a probabilistic risk assessment of D4, and who urged EPA for more clarity around proposed changes to its systematic review protocols. 

“It remains unclear how EPA plans to evaluate and integrate available information through the recently-released draft Systematic Review Protocol,” Thomas said. “While the silicones industry submitted comments on this draft, it is imperative that SEHSC fully understands the implications of the Agency’s updated Systematic Review Protocol before EPA uses the approach to assess the risks associated with D4.”

In October 2020, EPA granted SEHSC’s request for a risk evaluation of D4, an opportunity Congress afforded chemical manufacturers in the amended TSCA statute. The amended TSCA statute was passed with bipartisan support and was broadly supported by industry and environmental organizations. SEHSC’s request for an assessment of D4 also included a comprehensive human health and environmental risk evaluation, prepared in accordance with EPA guidance. This risk evaluation includes results from the rigorous D4 environmental monitoring program the silicones industry designed and executed in collaboration with EPA from 2014 to 2017. An independent, peer-reviewed risk assessment that incorporated the monitoring results concluded that D4 poses negligible risk to the environment.

“SEHSC looks forward to working collaboratively with EPA as it has done for many years across both Democratic and Republican administrations,” said Thomas. “This includes continuing to serve as a technical resource and providing EPA with additional information, as needed, to complete a rigorous science-based evaluation of D4.” 

Greater than 99 percent of D4 is used as an intermediate to produce silicone polymers.  These silicone polymers are used in a variety of products that provide vital societal benefits in a range of industries, including transportation, building and construction, health care, and electronics. A number of these products, such as solar panels and wind turbines, are essential for improvements in energy efficiency and will be critical for the US to accomplish its ambitious carbon neutrality goals.

To learn more, view these frequently asked questions or visit americanchemistry.com/sehsc.

American Chemistry Council

The American Chemistry Council (ACC) represents the leading companies engaged in the multibillion-dollar business of chemistry. ACC members apply the science of chemistry to make innovative products, technologies and services that make people's lives better, healthier and safer. ACC is committed to improved environmental, health, safety and security performance through Responsible Care®; common sense advocacy addressing major public policy issues; and health and environmental research and product testing. ACC members and chemistry companies are among the largest investors in research and development, and are advancing products, processes and technologies to address climate change, enhance air and water quality, and progress toward a more sustainable, circular economy.

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