EPA's Formaldehyde U-Turn Sparks Battle Over Science and Safety

Formaldehyde may trigger memories of fetal pigs and frogs from high school biology class. The substance has long been recognized for its use in preservation, but chemical manufacturers have been using it for more than 150 years as a critical ingredient for a wide range of applications, including building materials, polymer production and resins.

Common building materials such as particleboard and fiberboard use formaldehyde-based resins as binding agents. The chemical also functions as an antimicrobial preservative in many consumer products, including soaps, shampoos, hair preparations, deodorants and lotions. In industrial settings, formaldehyde is found in lightweight automotive components, exterior primers and agricultural applications, such as disinfectants used in brooding houses and certain fertilizers.

Formaldehyde is difficult to replace in many of these uses without compromising product quality and performance or significantly increasing costs, according to the American Chemistry Council (ACC).

Its use has emerged as a regulatory flashpoint that highlights the U.S. Environmental Protection Agency’s approach to regulations under the Trump administration (Read “Scientific Battle Between EPA and ACC Enters New Phase Under Trump”). In December, EPA proposed to nearly double the allowable formaldehyde exposure levels to 0.3 ppm for acute sensory irritation in its updated draft risk calculation memorandum for formaldehyde.

This came after the agency issued a finalized Toxic Substances Control Act (TSCA) risk evaluation for formaldehyde in January 2025 during President Biden’s final days in office. The finalized assessment found formaldehyde presents an unreasonable risk of injury to human health, specifically to workers and consumers, under its conditions of use. 

EPA classified formaldehyde as a probable human carcinogen under high or prolonged exposure conditions in 1987, and in 2011 the U.S. National Toxicology Program listed formaldehyde as a known human carcinogen, linking the substance to nasopharyngeal cancer in occupational settings.

However, ACC contends that adequate protections have been in place for decades to keep workers safe. This includes the use of personal protective equipment, as required by the Occupational Safety and Health Administration, to minimize risks.

Regulators Shift Course on Risk Assessment

EPA’s updated draft analysis is a significant departure from its past reliance on Integrated Risk Information System (IRIS) values, wrote Chemical Processing columnist and legal expert Lynn Bergeson, in a memo on the EPA update.

The latest EPA assessment is more closely aligned with other global regulatory agencies and concerns raised by the Science Advisory Committee on Chemicals (SACC), according to Bergeson. 

The SACC review identified areas for improvement, like clearly justifying sensory irritation as an adverse effect, the need for more robust data sets and the consideration of thresholds for assessing cancer risks versus a linear no-threshold approach that assumes any exposure carries some cancer risk. 

“The POD (point of departure) in the January 2025 final risk evaluation was so low and formaldehyde exposures from biogenic and secondary (e.g., combustion) sources are so prevalent, one would expect nasopharyngeal cancers to be much more common than they are,” Bergeson wrote. “Although this POD is quite a bit higher than the one in the original risk evaluation, an occupational exposure limit (OEL) based on this POD is still lower than the Occupational Safety and Health Administration (OSHA) standard, so some workplaces will have to adapt, but the TSCA OEL will no longer be orders of magnitude lower than the OSHA OEL.”

ACC stated the IRIS assessments were flawed, relying on overly conservative values and biased evaluations. ACC has fought EPA efforts to tighten formaldehyde exposure limits since 2010, when EPA released its first IRIS toxicological review of formaldehyde inhalation. 

In 2011, the National Academies of Sciences, Engineering and Medicine (NASEM) reviewed that draft and issued criticisms along with recommendations for improving the IRIS assessment process. ACC has consistently argued that EPA failed to adequately address those 2011 NASEM recommendations in subsequent drafts. ACC welcomed the December draft revision, stating that it finally addressed the earlier peer-review concerns. The full document with redline edits is available on the EPA website.  

However, a former EPA official during the Biden administration said EPA is ignoring sound science and placing politics over worker safety. 

In the latest revised draft, EPA is setting formaldehyde limits based on the prevention of short-term sensory irritation, which has a safe threshold. But this approach ignores EPA's own scientific findings that formaldehyde causes cancer through genetic mutations, for which no safe exposure level exists, said Christopher Frey, who served as assistant administrator of the Office of Research and Development at the U.S. Environmental Protection Agency from 2022 to 2024.  In other words, protecting against irritation doesn't safeguard workers against cancer since any exposure carries some cancer risk, Frey said.

In addition, SACC supported the January 2025 TSCA risk evaluation with a few exceptions, Frey said. 

“Although some members of the SACC, including industry representatives, offered unsolicited comments aligned with ACC positions, the SACC was not unanimous in its advice,” Frey said. 

The unsolicited comments included input from ACC, he said. Frey also said SACC was not charged to conduct a comprehensive peer review of the draft IRIS assessment. That was the responsibility of NASEM. 

Frey's comments seem to align with previous insight from SACC Chair George Cobb. While Cobb wouldn't comment directly on SACC's formaldehyde risk evaluation review in his official capacity, he pointed to peer review excerpts suggesting ACC overstated SACC’s criticism of the EPA assessment. 

'Science First' or Political Gamesmanship?

When the Trump administration returned in 2025, EPA prioritized reforming all regulations. 

The Trump-led EPA claims the agency used flawed analyses under Biden’s leadership in its risk assessment for formaldehyde. 

“Instead of considering all the scientific information, the chemicals team was directed to use one particular analysis instead of considering the entire body of evidence and the comments from external reviewers,” said an EPA spokesperson in an email to Chemical Processing. “This is not gold-standard science. We are correcting the record to reflect the best available science and our core statutory obligations.”

In U.S. House committee testimony on Jan. 8, several ACC representatives called on lawmakers to advocate for what it calls a “science-first approach” to TSCA implementation, warning that EPA's reliance on "precautionary and conservative assumptions, absent real-world exposure data" threatens U.S. competitiveness and innovation.

“Sound, transparent science-driven approaches are vital in chemical evaluations that impact supply chains and long-term investment decisions,” said Kimberly Wise White, ACC’s vice president for regulatory and scientific affairs. “Unfortunately, more Americans lack trust in science. When regulatory decisions are driven by hazard-only assessments that lack real-world context, they undermine regulatory durability and discourage domestic innovation. A science-first, risk-based approach is critical to strengthening domestic manufacturing and maintaining U.S. global competitiveness.”

However, Frey questioned EPA's approach to science, saying its latest formaldehyde assessment created an "unfounded precedent" by using unsolicited opinions from a second advisory panel that introduced no new information beyond the NASEM review.

“EPA is now demonstrating that it will shop around for an answer that favors preferred stakeholders rather than follow established scientific processes and procedures to arrive at a scientifically robust finding,” Frey said in an email to Chemical Processing. “In this regard, the EPA is following the ‘gold standard science’ executive order, which places in the hands of political appointees the ultimate determination of which scientific products will be accepted for use by a federal agency. This is infringement of scientific integrity.”