EPA Concludes That Formaldehyde Poses an Unreasonable Risk to Human Health
The U.S. Environmental Protection Agency (EPA) has finalized its risk evaluation for formaldehyde under the Toxic Substances Control Act (TSCA). According to the final assessment published in December 2024, EPA determined that formaldehyde presents an unreasonable risk of injury to human health under certain conditions of use.
The evaluation covers exposures occurring during the manufacturing, processing, distribution, use, and disposal of formaldehyde and formaldehyde-containing products.
General Information on Formaldehyde
Formaldehyde is a colorless, flammable gas with a strong odor at room temperature. It is found widely in both natural and industrial environments. Formaldehyde is produced naturally by humans, animals, and plants, and is released during the decay of organic matter. It is also emitted through combustion processes such as vehicle exhaust, heating systems, forest fires, tobacco smoke, and burning candles.
In addition, formaldehyde is used in the production of composite wood products, building materials, plastics, pesticides, paints, adhesives, and sealants. According to EPA’s Chemical Data Reporting (CDR), annual production and import volumes range between 1 and 5 billion pounds.
Key Findings of the EPA Risk Evaluation
EPA concluded that formaldehyde poses unreasonable risks to human health primarily due to acute inhalation and dermal exposure. Short-term exposure can cause sensory irritation, including eye and respiratory tract inflammation. These effects generally subside once exposure ends.
However, long-term inhalation exposure has been associated with reduced lung function, asthma, allergic conditions, and cancer. Skin contact with formaldehyde-containing products may also cause allergic reactions.
EPA stated that while risks may not apply equally to all individuals or environments, the Agency has high confidence in the overall conclusions of the risk evaluation.
Risks Identified for Workers
Workers in facilities where formaldehyde is manufactured, processed, or used were identified as the most highly exposed and at-risk group. Exposure may occur through inhalation of formaldehyde in the air or through direct skin contact with formaldehyde-containing materials, particularly in the absence of appropriate personal protective equipment (PPE).
EPA determined that acute inhalation and dermal exposures are the primary contributors to worker risk, and that cancer risk under several conditions of use further supports the unreasonable risk determination.
Consumer and General Population Exposure
EPA also identified risks for consumers who frequently use products containing formaldehyde, such as automotive products, crafting materials, and leather goods. Exposure risks are higher for newly manufactured products due to higher emission levels.
While EPA evaluated long-term exposure from ambient air for people living near facilities releasing formaldehyde, it concluded that ambient air exposure does not significantly contribute to the unreasonable risk determination. This conclusion reflects modeling uncertainties, conservative assumptions, and the expectation that existing and forthcoming regulatory measures will reduce overall emissions.
Environmental Risk Assessment
EPA did not identify risks to the environment that would contribute to the unreasonable risk determination. Formaldehyde does not persist in water, soil, or sediment, and environmental concentrations are generally well below levels expected to cause adverse effects to plants or wildlife.
Uses of Formaldehyde
EPA identified the following conditions of use as part of the final scope:
Adhesives and sealants
Pesticides and agricultural chemicals
Lawn and garden products
Personal care products
Plastic materials
Resins, glues, and binders
Paper manufacturing
Petrochemical processes
Wood product manufacturing
Textiles, apparel, and leather products
Recent Developments and Public Comment Opportunities
In December 2025, EPA released an Updated Draft Risk Calculation Memorandum for formaldehyde for public comment. This document does not alter EPA’s determination that formaldehyde poses an unreasonable risk to human health, particularly for workers and consumers, but strengthens the scientific basis for acute inhalation exposure assessments.
Public comments on the updated draft are accepted until February 2, 2026.