EPA Says Formaldehyde Unreasonable Risk, Chemistry Council Says Evaluation is Flawed

On January 2, the EPA released its final risk evaluation for formaldehyde conducted under the Toxic Substances Control Act (TSCA). The agency said it has determined that formaldehyde presents an unreasonable risk of injury to human health, specifically to workers and consumers, under its conditions of use.  

The 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 new. 

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

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 agency noted that in addition to workplace, 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.

The American Chemistry Council took issue with the agency's evaluation. "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 U.S. economy and key sectors that support health, safety and national security.

Furthermore the ACC notes that 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." And it ponts out that 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." 

From a larger perspective, the ACC is concerned that “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.

“Formaldehyde is integral to modern life, and businesses and families rely on the important products it enables. Without robust formaldehyde manufacturing in the United States, we could face increased product prices, reduced economic output, and a loss of the U.S.’s competitive edge. 

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."

Next Steps 

EPA 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. 

Conditions of Use that Significantly Contribute to the Unreasonable Risk:

• Manufacturing (domestic manufacture); 
• Manufacturing (import); 
• Processing – as a reactant in: 
• adhesives and sealant chemicals in plastic and resin manufacturing; wood product manufacturing; paint and coating manufacturing; and basic organic chemical manufacturing; 
• an intermediate in pesticide, fertilizer, and other agricultural chemical manufacturing; petrochemical manufacturing; soap, cleaning compound, and toilet preparation manufacturing; basic organic chemical manufacturing; plastic materials and resin manufacturing; adhesive manufacturing; chemical product and preparation manufacturing; paper manufacturing; paint and coating manufacturing; plastic products manufacturing; synthetic rubber manufacturing; wood product manufacturing; construction; and agriculture, forestry, fishing, and hunting; 
• a functional fluid in oil and gas drilling, extraction, and support activities; 
• processing aids specific to petroleum production in all other basic chemical manufacturing; 
• bleaching agent in wood product manufacturing; 
• agricultural chemicals in agriculture, forestry, fishing, and hunting; 
• Processing – incorporation into an article, in:  
• finishing agents in textiles, apparel, and leather manufacturing;  
• paint additives and coating additives not described by other categories in transportation equipment manufacturing (including aerospace);  
• additive in rubber product manufacturing;  
• adhesives and sealant chemicals in wood product manufacturing; plastic material and resin manufacturing (including structural and fireworthy aerospace interiors); construction (including roofing materials); and paper manufacturing; 
• Processing – incorporation into a formulation, mixture, or reaction product, in:  
• petrochemical manufacturing; petroleum, lubricating oil and grease manufacturing; fuel and fuel additives; lubricant and lubricant additives; petroleum and coal products manufacturing; and basic organic chemical manufacturing;  
• asphalt, paving, roofing, and coating materials manufacturing;  
• solvents (which become part of a product formulation or mixture) in paint and coating manufacturing;  
• processing aids, specific to petroleum production oil and gas drilling, extraction, and support activities; chemical product and preparation manufacturing; and basic inorganic chemical manufacturing;  
• paint additives and coating additives not described by other categories in paint and coating manufacturing and plastic material and resin manufacturing;  
• an intermediate in basic chemical manufacturing; chemical product and preparation manufacturing; plastic material and resin manufacturing; oil and gas drilling, extraction, and support activities; and wholesale and retail trade;  
• solid separation agents in miscellaneous manufacturing;  
• agricultural chemicals (nonpesticidal) in agriculture, forestry, fishing, and hunting; pesticide, fertilizer, and agricultural chemical manufacturing;  
• surface active agents in plastic material and resin manufacturing;  
• ion exchange agents in adhesive manufacturing and paint and coating manufacturing;  
• lubricant and lubricant additive in adhesive manufacturing;  
• plating agents and surface treating agents in chemical product and preparation manufacturing;  
• soap, cleaning compound, and toilet preparation manufacturing;  
• laboratory chemicals;  
• adhesive and sealant chemical in adhesive manufacturing;  
• bleaching agents in textile, apparel, and leather manufacturing;  
• Processing – repackaging - sales to distributors for laboratory chemicals;  
• Processing – recycling;  
• Distribution – distribution in commerce;  
• Industrial use (non-incorporative activities):  
• as a process aid in oil and gas drilling, extraction, and support activities; process aid specific to petroleum production, hydraulic fracturing;  
• used in: construction;  
• oxidizing/ reducing agent; processing aids, not otherwise listed;  
• Industrial use – chemical substances in industrial products:  
• paints and coatings; adhesives and sealants; lubricants;  
• aerospace use in: paints and coatings; adhesives and sealants; lubricant; and foam insulation;  
• Commercial use in:  
• floor coverings; foam seating and bedding products; furniture & furnishings including stone, plaster, cement, glass and ceramic articles; metal articles; or rubber articles; cleaning and furniture care products; leather conditioner; leather tanning, dye, finishing, impregnation and care products; textile (fabric) dyes; textile finishing and impregnating/surface treatment products;  
• water treatment products; 
• laundry and dishwashing products;  
• adhesives and sealants; paint and coatings;  
• construction and building materials covering large surface areas, including wood articles; construction and building materials covering large surface areas, including paper articles; metal articles; stone, plaster, cement, glass and ceramic articles;  
• machinery, mechanical appliances, electrical/electronic articles; other machinery, mechanical appliances, electronic/electronic articles;  
• construction and building materials covering large surface areas, including metal articles;  
• automotive care products; lubricants and greases; fuels and related products;  
• lawn and garden products;  
• explosive materials;  
• arts, crafts, and hobby materials;  
• ink, toner, and colorant products; photographic supplies;  
• laboratory chemicals;  
• Consumer use in:  
• floor coverings; foam seating and bedding products; cleaning and furniture care products; furniture & furnishings including stone, plaster, cement, glass and ceramic articles; metal articles; or rubber articles;  
• fabric, textile, and leather products (clothing);  
• adhesives and sealant; paint and coatings;  
• construction and building materials covering large surface areas, including wood articles; construction and building materials covering large surface areas, including paper articles; metal articles; stone, plaster, cement, glass and ceramic articles;  
• automotive care products; lubricants and greases; fuels and related products;  
• paper products; plastic and rubber products; toys, playground, and sporting equipment;  
• arts, crafts, and hobby materials;  
• ink, toner, and colorant products; photographic supplies; and  
• Disposal. 

Conditions of Use that Do Not Significantly Contribute to the Unreasonable Risk:

• Commercial use in paper products; plastic and rubber products; toys, playground, and sporting equipment;  
• Consumer use in water treatment products;  
• Consumer use in laundry and dishwashing products;  
• Consumer use in machinery, mechanical appliances, electrical/electronic articles; other machinery, mechanical appliances, electronic/electronic articles; and 
• Consumer use in lawn and garden products.