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TSCA Risk Evaluation

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Sahar Osman-Sypher
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EPA’s Formaldehyde Risk Evaluation Puts Critical Industries in Jeopardy

The U.S. Environmental Protection Agency (EPA) has released its final risk evaluation for formaldehyde under the Toxic Substances Control Act (TSCA).  While we acknowledge 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.

In developing unrealistic toxicity values for formaldehyde based on flawed data and science, the EPA is targeting a building-block chemistry essential to producing many of the products we rely on every day. If EPA continues on its current path, formaldehyde manufacturing and many of its downstream uses would be severely restricted or banned in the U.S.

  • Aerospace: Chemicals and polymers derived from formaldehyde are used in aerospace applications because of their flame resistance, thermal protection, and impact resistance. Learn more in our aerospace infographic 
  • Agriculture: Formaldehyde helps American families access safe meat, poultry, and aquaculture products. Learn more in our agriculture infographic 
  • Automotive: Formaldehyde-based technologies are used to make interior molded and under-the-hood components. Learn more in our automotive infographic
  • Building & Construction: Formaldehyde-based resins are used to make plywood, particleboard, and fiberboard along with numerous other applications for the housing industry. Learn more in our building and construction infographic 
  • Energy: Formaldehyde is used in the oil and gas industry, supporting a wide range of activities from production and drilling to safety and waste management. Learn more in our energy infographic
  • Medicine: Formaldehyde is used in the influenza, polio, and hepatitis vaccines to inactivate viruses and detoxify bacterial toxins.  Learn more in our medicine infographic 
  • National Security: Formaldehyde is used to make munitions and ballistics along with lightweight durable military equipment. Learn more in our national security infographic
  • Science & Preservation: Formaldehyde is used in biological research, microscopy, anatomical and forensic studies along with the preservation of specimens in museums. Learn more in our science and preservation infographic 
  • Semiconductors: Formaldehyde is used in electrolytic copper plating, chemical mechanical planarization slurry formulations, lithography formulations, and mold compounds used for plastics packages. Learn more in our semiconductors infographic

Many recently completed peer-reviewed studies have meaningfully advanced the body of scientific evidence related to understanding formaldehyde produced by the body versus inhaled formaldehyde generated from other sources. Given the numerous peer-reviewed scientific articles that have already been published and chemical reviews that have been conducted by federal and international agencies, evaluations must rely upon the highest quality and most relevant, recent information when determining risk.

If EPA followed the required science protocols in conducting a transparent risk evaluation of formaldehyde, using the best available, highest quality, and most relevant data, it would find that the responsible uses of formaldehyde, and any potential exposures, continue to be properly managed.

ACC Comments on EPA’s Formaldehyde TSCA Risk Evaluation

Evaluation Not Based On Best Science And Sets Up Unachievable Workplace Limits That Threaten Vital Industries

EPA Building from Below

Over 200 Comments Submitted

A diverse group of stakeholders, experts, and peer reviewers have identified major issues with EPA’s draft Formaldehyde Risk Evaluation under TSCA.

Read the article

EPA Formaldehyde TSCA Risk Evaluation Key Dates

December 2024

Final TSCA Risk Evaluation Released

Summer 2025

Small Business Advocacy Review (SBAR) Panel

December 2025

Propose risk management rule(s) for any unreasonable risk determinations 

December 2026

Finalize risk management rule(s) for any unreasonable risk determinations 

December 2026 to 2031

Establish mandatory compliance date(s) for restrictions or the start of a ban or phase-out based on final risk management rules.

* Dates listed for future events are projections based on current information and should be considered estimates. Actual timing may vary.

FAQs

TSCA requires the use of the best available science, meaning that information must be of the highest quality in order to be included in the review. This type of evidence includes information on the hazard and exposure potential of the chemical substance; persistence and bioaccumulation; potentially exposed or susceptible subpopulations; the conditions of use or significant changes in the conditions of use of the chemical substance; and the volume or significant changes in the volume of the chemical substance manufactured or processed.

EPA has made clear that designation as a high priority chemical “does not constitute a finding of risk” and should not be cause for concern. Formaldehyde plays an integral role in a wide variety of industrial applications across the automotive, aviation, textile, energy, and building and construction sectors. The U.S. Department of Labor's Occupational Safety and Health Administration (OSHA) has standards for workplace exposures to formaldehyde. These comprehensive health standards include limits on permissible exposures, requirements for monitoring employee exposures in the workplace, protective measures—including engineering controls, medical surveillance and communication—and training about hazards. Current standards, such as the OSHA Formaldehyde Standard, 29 C.F.R. § 1910.1048, protect the health of millions of workers and provide effective workplace controls for the production, storage, handling, and use of this important chemical.

A $1.35 million fee for each EPA-initiated risk evaluation will be divided among companies that have manufactured or imported the chemical substance in any volume in the past five years, including companies that have imported articles containing that substance.

After years of study, and hundreds of peer-reviewed scientific publications, the weight of the scientific evidence supports the conclusions that formaldehyde does not cause leukemia and there are clearly defined safe thresholds for formaldehyde exposure. These thresholds have been utilized by international scientific and regulatory bodies to develop risk-based exposure levels.