WASHINGTON (November 14, 2024) – The American Chemistry Council (ACC) and its member companies are disappointed that the final risk evaluation for 1,4-dioxane under the Toxic Substances Control Act (TSCA) continues to rely on outdated risk assessment methods. Moreover, the risk evaluation fails to meet the scientific standards of TSCA by failing to apply an updated and transparent systematic review of new research and data.
EPA’s finding that 1,4-dioxane poses an unreasonable risk to human health or the environment is deeply flawed. As has been shown both domestically and abroad, 1,4-dioxane exposure does not occur with a frequency, or at levels, that present an unreasonable risk to human health or the environment. This has been recognized by the EPA Office of Water and in assessments conducted by other regulatory authorities including Health Canada, and the World Health Organization. In this regard, the TSCA risk evaluation is an outlier and fails to meet the scientific requirements of TSCA and the Information Quality Act (IQA).
In December 2023 and subsequently in July 2024, ACC, along with other industry stakeholders, asked EPA to correct scientific information in the 2020 risk evaluation for 1,4-dioxane. EPA’s IQA guidelines require the agency to reexamine its conclusion regarding 1,4-dioxane based on a systematic review of literature published between the December 2020 draft 1,4-Dioxane Risk Evaluation and the July 2023 Draft Supplement to the Risk Evaluation for 1,4-Dioxane. We urged EPA then, and urge EPA now, to reconsider its approach for this risk evaluation since EPA failed to take into account significant new peer-reviewed research that has been published since December 2020 evaluating the potential effects of 1,4-dioxane exposure.
Along with the new research and the conclusions of other regulatory bodies, the National Academies of Science, Engineering, and Medicine (NASEM) issued a consensus document criticizing the underlying guidance, which the Agency used as a foundation for drafting the risk evaluation and stating that EPA’s approach to systematic review of data “does not adequately meet the state-of-practice.”
The safety of the public, workers, and the environment is an essential priority for ACC, and we believe that a clear, consistent and transparent approach to determining and applying the best available science in the TSCA risk evaluation process is critical. Such an approach promotes a thorough and accurate risk assessment and prevents biased or outlier studies from disproportionately and inappropriately influencing the evaluation process. We look forward to continuing to work with the Agency in addressing the underlying science consistent with the requirements of TSCA and the IQA.
