EPA Completes Final TSCA Risk Evaluation for FormaldehydeEPA Completes Final TSCA Risk Evaluation for Formaldehyde

In its final Toxic Substances Control Act (TSCA) risk evaluation for formaldehyde, EPA determined that formaldehyde presents an unreasonable risk of injury to human health under its conditions of use because of acute inhalation and dermal exposures. The agency also identified cancer and other chronic risk due to long-term inhalation of formaldehyde.

EPA stated 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.

Studies in people found that exposure to formaldehyde for a short period of time, such as for 15 minutes (called an acute exposure) causes sensory irritation like eye and respiratory inflammation. The 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 can also cause allergic reactions.

The EPA said that formaldehyde is not expected to stay 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.

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The American Chemistry Council shared a statement that overall, the ruling could jeopardize domestic production and critical American industries. The statement goes on to read:

“While ACC acknowledges EPA made several important adjustments in the final risk evaluation, concerns remain about the agency’s continued disregard for statutory requirements on scientific quality, peer reviews, and engagement with public and interagency comments. TSCA requires that EPA reviews and regulates a chemical based on the best available science. 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 US economy and key sectors that support health, safety and national security.

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“Government agencies like Department of Defense, Department of Agriculture, the Centers for Disease Control and Prevention, and the Small Business Administration and EPA-selected expert peer reviewers have raised concerns about the shortened timeline, scientific shortcomings, and potential devastating effects of a flawed TSCA risk evaluation. Ignoring these concerns could result in overly restrictive regulation of this building block chemistry, handicapping America’s economy and creating reliance on overseas production."

The statement said that despite some improvements, 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."

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The ACC ends the statement saying that formaldehyde is necessary to modern life and that businesses and families rely on the products it enables. Without it, ACC says the US could face increased product prices, reduced economic output, and a loss of the US competitive edge. The association plans to collaborate with formaldehyde users hoping to engage the next Administration and keep access to the chemical.