EPA Issues Draft Risk Evaluation for Formaldehyde
Released March 15, 2024
Today, the U.S. Environmental Protection Agency (EPA) released its draft risk evaluation for formaldehyde under the Toxic Substances Control Act (TSCA) for public comment and peer review. In the draft risk evaluation, EPA preliminarily finds that formaldehyde poses unreasonable risk to human health. The risk evaluation notes that these risks may not apply to everyone, everywhere and describes some of the sources of uncertainties in EPA’s findings.
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. Over time, formaldehyde may be released from these products and people may inhale it.
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.
This draft risk evaluation attempts to understand whether the risks from those uses contribute to the unreasonable risk presented by formaldehyde. EPA assessed exposure for 62 TSCA conditions of use of formaldehyde, using many scenarios, considering multiple human life stages (e.g., childhood, adulthood) and how people might be exposed outdoors in the open air, in their homes or other buildings, at workplaces that use formaldehyde, and in communities located close to industrial sources of formaldehyde.
In evaluating these exposures, EPA faces a unique challenge: the formaldehyde released from commercial activities and products is mixed in with the naturally formed formaldehyde. It is often difficult to estimate how much of the formaldehyde a person is exposed to comes from a given source at any given time. Similarly, EPA’s finding of unreasonable risk does not mean that a single exposure to formaldehyde will result in adverse health effects.
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.
Next Steps
Upon publication of the Federal Register notice, EPA will accept public comments on the draft risk evaluation for 60 days via docket EPA-HQ-OPPT-2023-0613 at www.regulations.gov. The draft risk evaluation will also be reviewed by the Agency’s Science Advisory Committee on Chemicals (SACC). Following a call for nominations in December 2023, the biographical sketches of the candidates under consideration as prospective peer reviewers were posted for public comment in February 2024.
EPA will hold a virtual public meeting for the SACC to discuss the draft risk evaluation from May 20-23, 2024. Registration instructions for the meeting will be announced on the SACC website in April 2024, including information about how to register to present oral comments during the meeting. For additional information, please see the Federal Register notice or contact the Designated Federal Official, Tamue Gibson at [email protected].
In addition, a preparatory virtual public meeting will be held on May 7, 2024, for the SACC and the public to consider and ask questions regarding the scope and clarity of the draft charge questions. EPA will also announce instructions for registering for that meeting on the SACC website.
EPA will use feedback received from public comments and the SACC to inform the final risk evaluation.