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On December 3, 2025, the U.S. Environmental Protection Agency (EPA) released for public comment an Updated Draft Risk Calculation Memorandum that will be used to inform a Revised Draft Risk Evaluation for Formaldehyde under the federal Toxic Substances Control Act (TSCA). Comments are due by February 2, 2026.
EPA designated formaldehyde as a high-priority substance for TSCA risk evaluation in December 2019, and work to evaluate the risks posed by formaldehyde has been ongoing since 2020. EPA's Updated Draft Risk Calculation Memorandum is a revision to the agency's final risk evaluation for formaldehyde just released in January 2025 by the previous administration.
EPA's updated assessment maintains the current determination that formaldehyde poses an unreasonable risk of injury to human health but proposes changes to certain technical elements. Specifically, EPA is considering a revised acute inhalation point of departure and potential impacts to the related margin of exposure and risk determination for formaldehyde. EPA is also proposing a revised draft occupational exposure value for the chemical.
One of the key changes EPA proposed in the Updated Draft Risk Calculation Memorandum is to drop consideration of the recently finalized chronic non-cancer reference concentration (RfC) and cancer inhalation unit risk (IUR) developed by the Integrated Risk Information System (IRIS). As support for this decision, EPA cites two federal advisory committees—the Human Studies Review Board and the Science Advisory Committee on Chemicals—as raising concerns that the IRIS values failed to meet TSCA's requirements of applying "best available science" and a "weight of scientific evidence" approach. EPA is now proposing to use sensory irritation as the basis for the acute inhalation point of departure.
EPA also cited President Donald Trump's May 2025 Executive Order 14303, titled "Restoring Gold Standard Science," as providing a basis for reevaluation. EPA is separately proposing a number of TSCA regulatory updates (90 Fed. Reg. 45690 (Sept. 23, 2025)), including incorporating the "Restoring Gold Standard Science" definition of "weight of scientific evidence" directly into TSCA's regulations. TSCA's statutory language (at 15 U.S.C. § 2625(i)) requires use of a "weight of scientific evidence" approach but does not provide a definition.
EPA's approach to reevaluating the draft risk calculation for formaldehyde—applying the principles of "Restoring Gold Standard Science" and references to various federal advisory committees—provides a key glimpse into how the current administration will conduct TSCA evaluations and other human health risk assessments moving forward.
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