Today, the U.S. Environmental Protection Agency (EPA) 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 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 consumer products and articles including textiles, foam bedding/seating, semiconductors, resins, glues, composite wood products, paints, coatings, plastics, rubber, resins, construction materials (including roofing), furniture, toys, and various 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. 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 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.
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 extremely 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.
The risk evaluation notes 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.
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.
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.
Read the final risk evaluation for formaldehyde.
Additional Information
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.
