News Details

On December 3rd, 2025, the U.S. Environmental Protection Agency (EPA) issued an Updated Draft Risk Calculation Memorandum for Formaldehyde under the Toxic Substances Control Act (TSCA) for public comment. This update supports the Revised Draft Risk Evaluation for Formaldehyde and builds on EPA’s January 2025 conclusion that formaldehyde poses an unreasonable risk to human health, particularly for workers and consumers, under its conditions of use. 

Purpose of the Update 

The Updated Draft Memorandum enhances the scientific basis of EPA’s risk evaluation by incorporating feedback from independent peer reviewers. It provides updated risk estimates focused on acute inhalation exposure, while maintaining EPA’s earlier determination of unreasonable risk. 

Key Scientific Revisions 

• Incorporation of peer review input 
  EPA considered recommendations from the Science Advisory Committee on Chemicals (SACC), the Human Studies Review Board (HSRB), and the National Academies of Sciences, Engineering, and Medicine. 

• Revised health endpoint 
  Consistent with these reviews, EPA proposes sensory irritation as the most sensitive endpoint for assessing inhalation-related health effects. 

• EPA concluded that preventing acute sensory irritation would also be protective against more serious outcomes, including cancer. 

• Re-evaluation of IRIS values 
  The Agency reassessed its reliance on certain cancer and non-cancer inhalation values developed under the IRIS program, consistent with statutory requirements and scientific integrity standards. 

Next Steps in Rulemaking 

EPA will use the Updated Draft Risk Calculation Memorandum to inform: 

• The Revised Draft Risk Evaluation for Formaldehyde 

• Development of a TSCA Section 6 risk management rule 

• Engagement with stakeholders through a Small Business Advocacy Review Panel 

Because the updates reflect extensive prior peer review, EPA determined that additional peer review is not required. 

Public Comment Period 

Public comments will be accepted for 60 days, through February 2, 2026, under docket EPA-HQ-OPPT-2018-0438 on regulations.gov.