Risk Evaluation for Formaldehyde

General Information for Formaldehyde

Chemical Group: N/A

CASRN: 50-00-0

Risk Evaluation Initiated: December 2019

Docket: EPA-HQ-OPPT-2018-0438

Staff Contact: Jeffrey Putt
[email protected]
(202) 564-3703

On March 15, 2024, EPA released the draft risk evaluation under the Toxic Substances Control Act (TSCA) for formaldehyde for public comment and peer review. 

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, will be released in 2024 on docket EPA-HQ-OPP-2015-0739.

Find other information about other chemicals undergoing risk evaluations under TSCA. 

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Risk Evaluation Findings

EPA preliminarily finds that formaldehyde poses unreasonable risk to human health. However, EPA notes that these risks may not apply to everyone, everywhere and describes some of the sources of uncertainties in EPA’s findings.

Due to its varied sources, people are routinely exposed to formaldehyde in indoor and outdoor environments, often from more than one source at a time. High levels of exposures to formaldehyde can cause health problems when inhaled and if it is absorbed into the skin. Inhaling high levels of formaldehyde for a short period of time can cause sensory irritation such as eye irritation. Inhaling formaldehyde for longer periods of time can damage the lungs and increase asthma and allergy-related conditions, sensory irritation, reproductive toxicity, and cancer. Skin contact with products containing formaldehyde can also cause allergic reactions.

In the draft risk evaluation, EPA evaluated the risks that arise from ways in which people may be exposed to formaldehyde from the production and use of products that are subject to TSCA - as opposed to exposures from those products that are excluded from TSCA (such as pesticides and exposures from sources of formaldehyde that are biogenic such as breathing and the decomposition of leaves) and exposures from other sources of formaldehyde.

EPA found that workers who are in workplaces where formaldehyde is used are at the most risk from formaldehyde exposure. Workers may be exposed to formaldehyde by inhaling it after it is released into the air or by making skin contact with formaldehyde-containing materials. EPA made these conclusions without assuming that worker protections, such as wearing protective equipment, were in place, although EPA is aware that many employers do take measures to protect the safety of their workers.

EPA also found that people who frequently use certain consumer products that contain formaldehyde are at risk. These products included car waxes, some crafting supplies, and fabrics or leather goods treated with formaldehyde. However, a person’s risk from these products depends on how long and how frequently the products are used, and in many cases, exposures from these products are at the same or lower levels than exposures from other sources of formaldehyde in the home such as candles or cooking. People may also be exposed to more formaldehyde in their homes if the homes are newer or contain newer furniture because building products and furniture can release formaldehyde at higher levels when newly formulated. Lastly, people living near facilities releasing formaldehyde may have higher exposures than those located further away.

EPA also evaluated formaldehyde’s impact on the environment and found that formaldehyde is not expected to last long in water, sediment, or soil based on its physical and chemical properties. EPA did not identify risk of injury to the environment that would contribute to the unreasonable risk determination for formaldehyde.

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 will accept 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 will hold 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 will also hold 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.

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.

Draft Risk Evaluations and Supporting Documents

The draft risk evaluation has a different structure compared to previous risk evaluations released by EPA. Rather than one document, the risk evaluation for formaldehyde includes several documents that culminate in an environmental risk assessment, human health risk assessment, and unreasonable risk determination. 

Read the Federal Register notice.

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Last updated on October 18, 2024