Risk Evaluation for Formaldehyde
In December 2024, EPA released the final risk evaluation under the Toxic Substances Control Act (TSCA) for formaldehyde.
Formaldehyde’s use as a pesticide is also undergoing a separate review under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The FIFRA risk assessment, which addresses the pesticidal uses of formaldehyde, was released earlier in 2024 on docket EPA-HQ-OPP-2015-0739.
Find other information about other chemicals undergoing risk evaluations under TSCA.
On this page:
- Risk Evaluation Findings
- Background on Formaldehyde
- Uses of Formaldehyde
- Recent Activities and Opportunities for Public Comment
- Risk Evaluation and Supporting Documents
On another page:
Risk Evaluation Findings
EPA has determined that formaldehyde presents an unreasonable risk of injury to human health under its conditions of use (COU) because of acute inhalation and dermal exposures. EPA also identified cancer and other chronic risk due to long-term inhalation of formaldehyde. EPA notes that these risks may not apply to everyone, everywhere and describes some of the uncertainties in EPA’s findings. However, EPA has high confidence in the overall conclusions of the risk evaluation.
Due to its many and varied sources, people are routinely exposed to formaldehyde in indoor and outdoor environments, often from more than one source at a time. Studies in people demonstrate that exposure to formaldehyde for a short period of time, such as for 15 minutes (called an acute exposure) cause sensory irritation such as eye and respiratory inflammation. Sensory irritation effects go away when exposure stops. Inhaling formaldehyde for longer "chronic" periods of time can reduce lung function and increase asthma and allergy-related conditions, and cancer. Skin contact with products containing formaldehyde can also cause allergic reactions. Formaldehyde is not expected to persist in water or soils based on its physical and chemical properties; therefore, it is not expected in groundwater or surface water used for drinking water.
EPA’s risk evaluation focused on formaldehyde sources involved in the manufacturing, processing, distribution in commerce, use, and disposal of formaldehyde and formaldehyde-containing products and articles that are subject to TSCA. These may include composite wood articles, plastics, paints, adhesives, and sealants. The highest releases of formaldehyde from articles occur when new.
EPA found that workers who are in workplaces where formaldehyde is used are at the most risk from formaldehyde exposure, particularly if workers are not wearing personal protective equipment. Workers may be exposed to formaldehyde in air during manufacturing, processing, or use of formaldehyde and products and articles containing formaldehyde. Workers can also be exposed to formaldehyde by making skin contact with formaldehyde-containing materials. Most of the risk to workers is because of acute inhalation and dermal exposures. Cancer risk to workers under many conditions of use also supports the risk determination.
EPA also found that people who frequently use consumer products that contain formaldehyde such as automotive care products, crafting supplies, and leather goods are also at high risk from formaldehyde due to short term inhalation and dermal exposures, particularly when articles are new.
EPA also identified some risk from chronic exposure to ambient air for people living near facilities that release formaldehyde. EPA did not determine that ambient air contributes significantly to the unreasonable risk determination. This is in part because modeling does not account for atmospheric degradation of formaldehyde, which may reduce concentrations, in part because there remain uncertainties with regard to the cancer hazard assessment associated with formaldehyde, and in part because of extremely conservative assumptions included in EPA’s model (for example that people located within 100 to 1,000 meters of a facility releasing formaldehyde are exposed to the same high-end concentrations for the entire duration of their life (i.e., 78 years). Furthermore, additional regulatory measures already promulgated but not yet implemented under the Clean Air Act (e.g., regulations expected to reduce emissions from combustion sources such as vehicles as well as oil, gas, and other facilities), as well as regulatory steps EPA expects to promulgate under TSCA to address the unreasonable risk to workers and consumers would be expected to also reduce ambient exposures to the general population. As such, all of these considerations led the Agency to find that general population exposures from ambient air emissions under the conditions of use of formaldehyde do not significantly contribute to the unreasonable risk of formaldehyde.
EPA did not identify risk of injury to the environment that would contribute to the unreasonable risk determination for formaldehyde. Formaldehyde concentrations in air are much lower than the concentrations needed to produce negative effects to the environment, and formaldehyde does not last long in water, sediment, or soil, resulting in lower exposure risks to plants, animals, and the environment.
Background on Formaldehyde
Formaldehyde is a colorless, flammable gas at room temperature and has a strong odor. Formaldehyde is found nearly everywhere. People and animals produce and release formaldehyde. Formaldehyde is produced when organic material including leaves, plants, and woodchips decay. Formaldehyde is also produced and released into the air when things burn, such as when cars emit exhaust, when furnaces and stoves operate, and through forest fires, burning candles, and smoking. Finally, formaldehyde is used to make many products including composite wood products and other building materials, plastics, pesticides, paints, adhesives, and sealants. Information from the 2016 Chemical Data Reporting (CDR) for formaldehyde indicates that the reported production volume is between 1 billion and 5 billion lbs/year (manufacture and import).
Uses of Formaldehyde
In the final scope, EPA identified conditions of use associated with the importing; processing; distribution in commerce; industrial, commercial and consumer uses; and disposal of formaldehyde, for example:
- Adhesive and sealants;
- Pesticides and agricultural chemicals;
- Lawn and garden products;
- Personal care products;
- Plastic materials;
- Resins, glues, and binders;
- Paper manufacturing;
- Various petrochemical processes and products;
- Wood product manufacturing; and
- Textiles, apparel, and leather.
The above listed conditions of use are ways that a person or the environment could be potentially exposed to this chemical. However, when conducting a risk evaluation, EPA also considers the hazards (i.e. health effects or environmental impacts) that could occur from coming in contact with a chemical.
Recent Activities and Opportunities for Public Comment
On March 15, 2024, EPA released the draft risk evaluation for this chemical for public comment and peer review. EPA accepted public comments on the draft risk evaluation for 60 days following publication in the Federal Register via docket EPA-HQ-OPPT-2023-0613 at regulations.gov.
EPA held a virtual peer review public meeting for of the Science Advisory Committee on Chemicals (SACC) to discuss the draft risk evaluation from May 20-23, 2024. EPA also held a virtual preparatory public meeting for the SACC and the public to consider and ask questions regarding the scope and clarity of the draft charge questions on May 7, 2024. View the SACC website for more information on the May 2024 meetings.
In August 2020, EPA published a final scope document outlining the hazards, exposures, conditions of use, and the potentially exposed or susceptible subpopulations the agency expects to consider in its risk evaluation. The agency released the draft scope in April 2020 and took public comments on the draft document.
- Read the final scope of the risk evaluation for this chemical and EPA’s response to comments on the draft scope.
- View the dockets for this chemical, EPA-HQ-OPPT-2023-0613 and EPA-HQ-OPPT-2018-0438 on regulations.gov.
As EPA continues to move through the risk evaluation process there will be additional opportunities for public comment, including a public comment period on the draft risk evaluation. In addition to public comment periods, EPA will continue to engage with stakeholders as it refines the risk evaluation and stakeholders should reach out to EPA via the staff contact to engage with the agency.
Risk Evaluations and Supporting Documents
Read the Federal Register notice.
View the supporting documents in docket EPA-HQ-OPPT-2018-0438.
- Risk Evaluation for Formaldehyde: Environmental Risk Assessment (pdf)
- Risk Evaluation for Formaldehyde: Chemistry, Fate, and Transport Assessment (pdf)
- Risk Evaluation for Formaldehyde: Environmental Release Assessment (pdf)
- Risk Evaluation for Formaldehyde: Environmental Exposure Assessment (pdf)
- Risk Evaluation for Formaldehyde: Environmental Hazard Assessment (pdf)
- Risk Evaluation for Formaldehyde: Executive Summary (pdf)
- Risk Evaluation for Formaldehyde: Human Health Hazard Assessment (pdf)
- Risk Evaluation for Formaldehyde: Conditions of Use (pdf)
- Risk Evaluation for Formaldehyde: Human Health Risk Assessment (pdf)
- Risk Evaluation for Formaldehyde: Occupational Exposure Assessment (pdf)
- Risk Evaluation for Formaldehyde: Consumer Exposure Assessment (pdf)
- Risk Evaluation for Formaldehyde: Indoor Air Exposure Assessment (pdf)
- Risk Evaluation for Formaldehyde: Ambient Air Exposure Assessment (pdf)
- Risk Evaluation for Formaldehyde: Unreasonable Risk Determination (pdf)
- Risk Evaluation for Formaldehyde: Nontechnical Summary (pdf)
- Risk Evaluation for Formaldehyde: Response to Comments (pdf)