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EPA’s TSCA Risk Evaluation for Formaldehyde

The U.S. Environmental Protection Agency (EPA) has released multiple updates to its Toxic Substances Control Act (TSCA) risk evaluation for formaldehyde, including the final risk evaluation issued in December 2024 and an Updated Draft Risk Calculation Memorandum published in December 2025. 

EPA’s 2025 Risk Calculation Memorandum incorporates feedback from independent peer reviewers, revisiting key scientific inputs, specifically inhalation exposures, and refining the scientific support for its risk determinations. The Agency continues to move forward on proposed risk management rulemaking. EPA has started that process by convening its Small Business Advocacy Review Panel to solicit input from impacted small entities on risk management options. 

ACC’s Position

The American Chemistry Council’s Formaldehyde Panel commends EPA’s recent efforts to strengthen scientific rigor by reconsidering critical elements of the risk evaluation. In our response to the updated draft analysis, we highlight the following:

  • Any evaluation of formaldehyde must be grounded in the best available science and aligned with TSCA requirements.
  • EPA’s revised approach reflects meaningful consideration of the recommendations from the Science Advisory Committee on Chemicals (SACC), the Human Studies Review Board (HSRB), and other authoritative bodies, and strengthens alignment with TSCA’s requirements to use the best available science and the weight of scientific evidence.
  • The final 2024 risk evaluation for formaldehyde did not fully align with statutory requirements for scientific quality, peer review, or engagement with public and interagency comments. It relied heavily on an assessment from EPA’s Integrated Risk Information System (IRIS) program, which has faced questions about its transparency, authorization, and scientific methods. A flawed evaluation may lead to regulations that are more restrictive than necessary for this important chemistry, with potential implications for the U.S. economy and domestic production.

ACC supports EPA’s decision to incorporate key scientific principles, including:

  • Recognition of a portal-of-entry threshold mode of action.
  • Identification of sensory irritation as the most sensitive and protective endpoint,
  • Acknowledgment that formaldehyde does not follow Haber’s Law because effects are driven by concentration rather than duration,
  • Greater weight on controlled human exposure studies, which offer greater scientific rigor than observational epidemiology.
  • ACC Comments on the EPA’s Draft 2025 Risk Calculation Memorandum is available at: Regulations.gov

The Importance of Formaldehyde Across Critical Sectors

Formaldehyde is a building-block chemistry foundational to numerous industries. Its properties enable essential applications in:

  • Aerospace: Chemicals and polymers derived from formaldehyde are used in aerospace applications because of their flame resistance, thermal protection, and impact resistance. Learn more in our aerospace infographic 
  • Agriculture: Formaldehyde helps American families access safe meat, poultry, and aquaculture products. Learn more in our agriculture infographic 
  • Automotive: Formaldehyde-based technologies are used to make interior molded and under-the-hood components. Learn more in our automotive infographic
  • Building & Construction: Formaldehyde-based resins are used to make plywood, particleboard, and fiberboard along with numerous other applications for the housing industry. Learn more in our building and construction infographic 
  • Energy: Formaldehyde is used in the oil and gas industry, supporting a wide range of activities from production and drilling to safety and waste management. Learn more in our energy infographic
  • Medicine: Formaldehyde is used in the influenza, polio, and hepatitis vaccines to inactivate viruses and detoxify bacterial toxins.  Learn more in our medicine infographic 
  • National Security: Formaldehyde is used to make munitions and ballistics along with lightweight durable military equipment. Learn more in our national security infographic
  • Science & Preservation: Formaldehyde is used in biological research, microscopy, anatomical and forensic studies along with the preservation of specimens in museums. Learn more in our science and preservation infographic 
  • Semiconductors: Formaldehyde is used in electrolytic copper plating, chemical mechanical planarization slurry formulations, lithography formulations, and mold compounds used for plastics packages. Learn more in our semiconductors infographic

These technologies collectively support over 1.5 million jobs and $1.6 trillion in economic output in the United States.

ACC’s Call for a Science-Based Path Forward

ACC advocates for a TSCA process that:

  1. Upholds statutory requirements for scientific quality, transparency, and stakeholder engagement.
  2. Ensure risk evaluations reflect current, robust, peer‑reviewed science rather than outdated or uncertain assumptions.
  3. Ensures protection of public health while also recognizing the importance of maintaining critical supply chains and the many societal benefits provided by formaldehyde-based technologies.

These updates move EPA closer to a scientifically robust and transparent risk evaluation framework. ACC will continue working with EPA, scientific experts, and stakeholders to advance a risk evaluation that is scientifically sound, transparent, and consistent with TSCA’s mandate to use the best available science.

ACC Comments on EPA’s Formaldehyde TSCA Risk Evaluation

Evaluation Not Based On Best Science And Sets Up Unachievable Workplace Limits That Threaten Vital Industries

EPA Building from Below

Over 200 Comments Submitted

A diverse group of stakeholders, experts, and peer reviewers have identified major issues with EPA’s draft Formaldehyde Risk Evaluation under TSCA.

Read the article

EPA Formaldehyde TSCA Risk Evaluation Key Dates

January 2025

Final TSCA Risk Evaluation

December 2025

Updated Draft Formaldehyde Risk Calculation Memorandum 

  • 60 Day Public Comment Period

February 2026

Small Business Advocacy Review Panel  

Estimated by May 2026

Propose risk management rule(s) for any unreasonable risk determinations found in the final risk evaluation

Estimated by April 2027

Finalize risk management rule(s) for any unreasonable risk determinations found in the final risk evaluation

* Dates listed for future events are projections based on current information and should be considered estimates. Actual timing may vary.

FAQs

TSCA requires the use of the best available science, meaning that information must be of the highest quality in order to be included in the review. This type of evidence includes information on the hazard and exposure potential of the chemical substance; persistence and bioaccumulation; potentially exposed or susceptible subpopulations; the conditions of use or significant changes in the conditions of use of the chemical substance; and the volume or significant changes in the volume of the chemical substance manufactured or processed.

EPA has made clear that designation as a high priority chemical “does not constitute a finding of risk” and should not be cause for concern. Formaldehyde plays an integral role in a wide variety of industrial applications across the automotive, aviation, textile, energy, and building and construction sectors. The U.S. Department of Labor's Occupational Safety and Health Administration (OSHA) has standards for workplace exposures to formaldehyde. These comprehensive health standards include limits on permissible exposures, requirements for monitoring employee exposures in the workplace, protective measures—including engineering controls, medical surveillance and communication—and training about hazards. Current standards, such as the OSHA Formaldehyde Standard, 29 C.F.R. § 1910.1048, protect the health of millions of workers and provide effective workplace controls for the production, storage, handling, and use of this important chemical.

A $1.35 million fee for each EPA-initiated risk evaluation will be divided among companies that have manufactured or imported the chemical substance in any volume in the past five years, including companies that have imported articles containing that substance.

After years of study, and hundreds of peer-reviewed scientific publications, the weight of the scientific evidence supports the conclusions that formaldehyde does not cause leukemia and there are clearly defined safe thresholds for formaldehyde exposure. These thresholds have been utilized by international scientific and regulatory bodies to develop risk-based exposure levels.