EPA’s updated Draft Risk Calculation Memorandum for Formaldehyde under the Toxic Substances Control Act (TSCA) reflects meaningful input from independent peer reviewers and scientific advisory bodies. These updates strengthen the scientific foundation of the evaluation.
Overall, the revised approach represents an important step toward a more accurate, transparent, and science driven assessment of formaldehyde risks.
A Stronger, Science Driven Approach
EPA’s updated draft incorporates several significant scientific improvements, including:
- Integration of peer review feedback from the EPA Science Advisory Committee on Chemicals (SACC), the Human Studies Review Board (HSRB), and other expert bodies
- An inhalation risk analysis grounded in controlled human exposure data and supported by mode-of-action evidence
- A focus on sensory irritation as the most sensitive endpoint, consistent with recommendations from independent scientific advisors
- Acknowledgement that formaldehyde effects are driven primarily by concentration rather than duration
- Meaningful scientific progress toward greater consistency with TSCA’s statutory requirements, including consideration of the best available science and a weight of the evidence approach
Importantly, EPA’s revised approach recognizes that managing exposures to prevent sensory irritation is protective of more severe health outcomes, including cancer. This framework reflects well established toxicological principles and supports a health protective evaluation grounded in biological relevance rather than overly conservative assumptions.
Independent Experts Reinforce the Scientific Record
Several respected scientists and risk assessment experts submitted public comments supporting a more rigorous, evidence based approach to evaluating formaldehyde under TSCA. These experts bring decades of experience across toxicology, epidemiology, exposure science, and human health risk assessment, including:
- Dr. Debra Kaden: “I applaud USEPA for developing risk evaluations based on use of the best available science, which supports using an acute inhalation POD of 0.3 ppm as protective of all durations and inhalation hazards, including cancer. This approach is consistent with the mode of action (MOA) for formaldehyde.”
- Dr. Dennis Paustenbach,..: “Formaldehyde is one of the most extensively studied industrial chemicals currently in use. Due to its endogenous production and natural presence in human blood (approximately 0.1-0.2 mM) (Heck et al. 1982; Heck et al. 1985), the biochemistry and kinetics of formaldehyde in humans are well documented and understood. Regulatory and authoritative bodies worldwide have conducted comprehensive reviews addressing aspects of formaldehyde's toxicity and its potential for adverse effects.”
- Dr. Pamela Dalton: “…the human chamber studies of formaldehyde by the laboratories at IfaDo and the Monell Center have found their results to be in alignment with the prior studies thus adding considerable weight and confidence to the proposed revisions in the Updated Draft Risk Calculation Memorandum for Formaldehyde. The number of well-conducted controlled exposure trials with no evidence of ocular sensory irritation between 0.3-0.6 ppm provide ample evidence that maintaining exposures at or below these concentrations will provide sufficient protection from sensory irritation, including eye irritation.”
- Dr. Chad Thompson: “Studies in genetically engineered mice indicate that complete enzymatic ablation of formaldehyde detoxification is required to drive formaldehyde levels high enough to cause heritable DNA damage. Such increases have not been demonstrated following inhalation exposure. Sophisticated BBDR models indicate that nasal tumors in rodents can be driven by cytotoxicity alone without contribution from direct mutagenicity. Formaldehyde is one of the most studied chemistries with multiple cancer bioassays and decades of mechanistic and biological modeling research. Based on the current available science, protection against sensory irritation would protect against cancer risk and thus there is no scientific justification for an IUR for formaldehyde.”
- Dr. Robinan Gentry: “The revised 2025 TSCA Risk Evaluation and the Draft Memorandum are now consistent with the science that supports those of the SACC that ’inhaled formaldehyde is not distributed to an appreciable extent beyond the portal of entry (POE) for distal tissues/organs based on the currently available experimental evidence. Consideration of all of the available science results in a POD of 0.3 ppm based on sensory irritation and should be protective for both acute and chronic health effects following inhalation exposure to formaldehyde.”
- Dr. Andrew Maier: “EPA’s revised occupational exposure value (OEV) of 0.3 ppm is adequately health protective. The reliance on a no-observed-effect concentration (NOEC) in high-quality controlled human exposure studies with a composite uncertainty factor of 1 is supported by the best available science."
- Dr. Roger O. McLellan: “I am pleased with the more recent analysis and endorse the conclusions presented in the updated "risk calculation". It is my professional opinion that the conclusions are based on the best available science and provide a sound scientific basis for the EPA Administrator to make the policy judgments authorized and required under the TSCA statutes.”
While representing diverse disciplines and perspectives, these experts consistently emphasized several core scientific principles:
- The importance of real world exposure data in characterizing risk
- The need to prioritize biologically relevant endpoints over overly conservative modeling assumptions
- The value of weight of evidence approaches that integrate human, animal, and mechanistic data
- The necessity of transparent, peer reviewed methodologies in regulatory decision making
Collectively, their comments reinforce a broad scientific consensus: effective regulation depends on accurate, evidence based risk characterization—not hypothetical scenarios detached from real world conditions of use.
What This Means for Science Based Regulation
Formaldehyde is a widely used chemistry that plays an essential role in manufacturing, building materials, medical applications, and many everyday products. EPA’s updated draft continues to fulfill the agency’s responsibility to identify and address risk where it exists, while also:
- Improving scientific accuracy
- Reducing uncertainty in key assumptions
- Providing a clearer foundation for future risk management decisions
EPA continues to identify potential risks for certain conditions of use, particularly for specific worker and consumer scenarios, while also acknowledging uncertainties and refining how those risks are characterized.
This balanced approach reflects the intent of TSCA: protective, science driven regulation grounded in the best available evidence.
Moving Forward
The American Chemistry Council’s Formaldehyde Panel supports EPA’s efforts to strengthen the scientific foundation of its risk evaluation and encourages continued engagement from the scientific and technical community.
As EPA moves toward finalizing the risk evaluation and developing risk management measures, it is critical that decisions remain grounded in:
- Robust, peer reviewed science
- Real world exposure scenarios
- Transparent, reproducible methodologies
A science based regulatory framework helps protect human health while also supporting continued access to essential chemistries that underpin American manufacturing, infrastructure, and innovation.