The U.S. Environmental Protection Agency (EPA) recently released the final risk evaluation for formaldehyde conducted under the Toxic Substances Control Act (TSCA). EPA has determined that formaldehyde presents an unreasonable risk of injury to human health, specifically to workers and consumers, under its conditions of use (COUs).  

Formaldehyde is used to make many consumer products and articles including foam, resins, glues, composite wood products, paints, coatings, plastics, rubber, resins, construction materials, and various adhesives and sealants. Over time, formaldehyde may be released from these products and people may inhale it.   

EPA reports that 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 furniture or other articles, plastics, paints, adhesives, and sealants. The highest releases of formaldehyde from articles occur when they are new. 

EPA assessed human exposure for 63 TSCA conditions of use of formaldehyde. Of these, EPA concluded that 58 conditions of use (50 occupational and 8 consumer) significantly contribute to the unreasonable risk determination. EPA stated 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. 

The EPA reports that people who frequently use consumer products that contain formaldehyde such as automotive car 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 the 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. 

According to the EPA, its risk evaluation notes that these risks may not apply to everyone, everywhere and describes some of the uncertainties in EPA's findings. However, EPA stated that it has high confidence in the overall conclusions of the risk evaluation.    

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.  

EPA stated that the agency will now begin the risk management process to address the unreasonable risk presented by formaldehyde. EPA will propose a rule under TSCA section 6 to protect workers and consumers from the identified risks. 

Read the final risk evaluation for formaldehyde. 

In response to the EPA announcement, the American Chemistry Council’s (ACC) Formaldehyde Panel issued a statement that challenged the scientific rigor of EPA’s assessment. In the statement the ACC’s Formaldehyde Panel stated, "This risk evaluation relies on a flawed assessment by EPA’s Integrated Risk Information System (IRIS) program – a program that has never been authorized by Congress, lacks transparency, and is out of step with the best available science and methods. EPA should go back to the scientific drawing board on formaldehyde instead of pursuing unaccountable lame duck actions that threaten the U.S. economy and key sectors that support health, safety and national security." 

The panel went on in its statement to state that reviewers from agencies including the Department of Agriculture, the Department of Defense, and the Centers for Disease Control and Prevention raised concerns about the timeline, scientific shortcomings and "potential devastating effects of a flawed TSCA risk evaluation." The statement went on to accuse the EPA of creating "overly restrictive regulation” of formaldehyde that could handicap America’s economy and lead to reliance on overseas production. 

Stating that while the EPA made "minor improvements" to the final evaluation, the ACC went on to state, "EPA’s final evaluation concludes that virtually all conditions of use contribute to 'unreasonable risk' under TSCA. This includes 58 of 63 subcategories of formaldehyde uses, including subjecting all manufacturing, import, processing, distribution in commerce, recycling, disposal, and industrial use of formaldehyde and formaldehyde-derived products to potential bans or difficult-to-meet standards for some uses.

"EPA’s suggested starting place for workplace limits continue to be inconsistent with the best available science and ignore practices that are already in place to protect workers, including the use of personal protective equipment. These workplace limits are significantly lower than the recently updated European Union occupational limits.

"Any assessment of formaldehyde must begin with the best available science. Formaldehyde is a natural part of our world and, through decades of responsible innovation and regulation, is essential to critical applications for housing, agriculture, transportation, healthcare, and national security. Formaldehyde technologies have broad roles in the economy, supporting over 1.5 million jobs and $1.6 trillion in manufacturing shipments and other economic output in 2023 in the United States.

"Effective implementation of the TSCA program has been plagued with challenges, and the final risk evaluation does not meet EPA’s requirement to use the best available science. If EPA continues on its current path during the two-year risk management phase, formaldehyde manufacturing and many of its downstream uses could be severely restricted or potentially banned in the United States." 

Visit www.americanchemistry.com to learn more about ACC's response to EPA announcements and visit www.epa.gov to learn more about the EPA.