EPA Releases Updated Draft Risk Calculation Memorandum for Formaldehyde under TSCA for Public Comment
Released December 3, 2025
Today, U.S. Environmental Protection Agency (EPA) is releasing an Updated Draft Risk Calculation Memorandum for Formaldehyde conducted under the Toxic Substances Control Act (TSCA) for public comment. This Updated Draft Memorandum informs the Revised Draft Risk Evaluation for Formaldehyde under TSCA and provides risk estimates from acute inhalation exposures based on feedback from independent peer reviewers, enhancing the scientific rigor of the underlying information used to support the risk determination while maintaining EPA’s January 2025 determination that formaldehyde presents an unreasonable risk of injury to human health, specifically to workers and consumers, under its conditions of use. The Agency will simultaneously continue working on a proposed risk management rule for formaldehyde as required by TSCA. EPA plans to expeditiously convene a Small Business Advocacy Review Panel to get input on a proposed rule. The agency will rely on gold standard science and take the Updated Draft Risk Calculations and Revised Draft Risk Evaluation into account when drafting a proposed risk management rule to meet statutory deadlines and ensure health protections.
Under President Trump’s leadership, EPA is committed to following the science and the law to make informed, commonsense decisions. Under the Biden Administration, the Office of Chemical Safety and Pollution Prevention (OCSPP) programs, including the Office of Pollution Prevention and Toxics and the Office of Pesticide Programs (OPP), were directed to rely upon and use the chronic non-cancer reference concentration (RfC) and cancer inhalation unit risk (IUR) that were being developed and were subsequently finalized by the Integrated Risk Information System (IRIS) program. Consistent with statutory obligations and Executive Order (EO) 14303, Restoring Gold Standard Science, EPA is committed to the highest standards of scientific integrity and reliance on the best available scientific information. As such, OCSPP has re-evaluated the use of the IRIS cancer IUR in the formaldehyde risk evaluation. EPA has considered the peer-review record, including comments from the Science Advisory Committee on Chemicals (SACC), the Human Studies Review Board (HSRB), and National Academies of Sciences, Engineering, and Medicine. Following their recommendations and focusing on the science, EPA is issuing this Updated Draft Risk Calculation Memorandum which was used as the basis for the Revised Draft Risk Evaluation for Formaldehyde.
Consistent with the recommendations from the SACC, EPA is supplementing the endpoints used in the TSCA risk evaluation to determine human health effects from formaldehyde. In its review of the draft formaldehyde risk evaluation, the SACC was generally critical of the agency’s reliance on cancer and non-cancer hazard values for formaldehyde inhalation presented in the draft IRIS Toxicological Review of Formaldehyde – Inhalation.
In this Updated Draft Risk Calculation Memorandum and the documents that rely on the information presented in the Updated Draft Risk Calculation Memorandum, EPA is proposing that the best available science supports using sensory irritation as the most sensitive endpoint for determining human health effects from inhalation exposures. Managing risks from acute sensory irritation will be protective against other health effects, including cancer. This approach is supported by the recommendations of the SACC and other federal advisory committees. Because this Updated Draft Risk Calculation Memorandum implements recommendations from the multiple peer review bodies, additional peer review is not necessary.
EPA will accept public comments on the Updated Draft Risk Calculation Memorandum and supporting documents for 60 days until February 2, 2026, in docket EPA-HQ-OPPT-2018-0438 on www.regulations.gov. EPA encourages everyone to read and comment on the Updated Draft Risk Calculation Memorandum.
For more information, please visit EPA's website about the formaldehyde risk evaluation.