EPA’s Final Formaldehyde IRIS Assessment Ignores Peer Reviews and Best Available Science

WASHINGTON (August 19, 2024) – Today, the American Chemistry Council's (ACC) Formaldehyde Panel issued the following statement on the U.S. Environmental Protection Agency’s (EPA) Final Integrated Risk Information System (IRIS) Assessment of Formaldehyde:

"As required under the Toxic Substances Control Act (TSCA), any assessment of formaldehyde must begin with the best available science. This assessment fails that test and is therefore unfit for regulatory decision-making. EPA’s final assessment fails to reflect fundamental criticism from multiple peer review bodies or public comments provided by hundreds of experts, stakeholders, and other agencies. The Agency is on a path to ignore applicable scientific standards and procedural requirements, and issue unscientific and legally unsound regulatory actions based on this flawed assessment under TSCA and other laws later this year.

“If EPA continues on its current path, formaldehyde manufacturing and many of its downstream uses could be severely restricted or potentially banned in the U.S., with an overwhelmingly negative impact on the environment, human health, national security, and the economy.

Any assessment of formaldehyde must begin with the best available science and the fact that formaldehyde is an ever-present part of the natural world. Backed by decades of responsible innovation and regulation, formaldehyde is essential to goods including contributing to a sustainable future for wood products, electric vehicles, lifesaving vaccines, and medical devices.

“The toxicity values produced by EPA’s IRIS Assessment are significantly out of step with international authorities, such as global health agencies and regulators, including the World Health Organization (WHO) and the European Chemicals Agency, which have used decades of scientific evidence by universities and independent scientists to support a safe threshold for formaldehyde exposure and no causal association with leukemia. 

“The Formaldehyde Panel has extensively commented on the numerous procedural and scientific flaws with EPA’s assessment, most recently outlined in a July 2024 letter to EPA Administrator Regan. Unfortunately, the final assessment does not meaningfully address key scientific, legal, peer review, and procedural issues with the underlying IRIS Assessment, which requires the Agency to go back to the drawing board on this assessment. 

“The IRIS program has a troubling history of being out of step with the best available science and methods, lacking transparency, and being unresponsive to peer review and stakeholder recommendations. In recent years, bipartisan Members of Congress have raised concerns about IRIS, a program that has never been authorized by Congress.

“Formaldehyde is extensively regulated to protect human health and the environment. Decades of scientific evidence support a safe level of formaldehyde exposure at current regulatory levels."

Additional background:

EPA’s IRIS assessment fails to demonstrate the best available science and is deficient in many ways, including:

• U.S. Department of Agriculture noted that formaldehyde is “very important in agriculture,” and that “an overly conservative toxicological assessment of formaldehyde... could have a net adverse impact on human health and the environment.” USDA also raised concerns that “recent reviews of formaldehyde are missing” from the assessment and the Agency on Toxic Substances and Disease Registry argued that EPA has failed to incorporate or address key peer review recommendations and public comments.
• Failure to identify, incorporate, and address highly relevant peer review comments from committees of the National Academies of Sciences (NAS), including formaldehyde-focused reports from 2011 and 2023, as well as recommendations from EPA’s Human Studies Review Board (HSRB) in 2023, and the most recent August 2024 Science Advisory Committee on Chemicals (SACC) report.
  • The Science Advisory Committee on Chemicals’ (SACC) peer reviewers found the TSCA program’s reliance on the IRIS assessment inappropriate. In particular, the report stated:
    • On chronic noncancer endpoints: ‘Concerns were raised by some Committee members regarding studies selected by ORD IRIS for chronic non-cancer hazards. These studies are mainly observational and unreliable for identifying a point of departure. The studies identified by ORD IRIS for the weight of evidence for chronic human health non-cancer hazard do not adequately address the chosen endpoint.’
    • On cancer endpoints: ‘Many Committee members recommended not using the IUR published in the 2022 Draft Formaldehyde IRIS Assessment' with these members recommending use of 'a mode of action approach where there is a threshold concentration below which no cancer is anticipated.’  
• Failure to incorporate and respond to the significant public comments received by EPA, NAS, HSRB, and SACC since 2021.
• Failure to conduct a full, open, and documented interagency consultation process on the draft or final assessment. Consistent with calls from a group of dozens of bipartisan members of Congress, Executive Order 12866 and other White House guidance, and interagency requirements under environmental statutes, this coordination should last at least 60 days and include all federal agencies.
• Failure to fix fundamental methodological and procedural defects with the assessment. For example, EPA’s June 2024 IRIS Outlook confirms that, contrary to the Agency’s 7-step IRIS process, IRIS handbook, statutory or regulatory requirements, and clear peer review recommendations, formaldehyde is the only IRIS Assessment which has not issued and/or taken public comments on a pre-established systematic review protocol.
• Failure to fully incorporate the latest peer-reviewed publications on formaldehyde. Just this year, several important studies and reviews have been published that are highly relevant to the assessment. The Formaldehyde Panel has identified over 100 publications relating to important scientific issues including sensory irritation, formaldehyde modeling, weight of evidence, dermal exposure, and systematic review methods that have all been excluded.
• EPA appears to have doubled down on key scientific and procedural issues despite a long record of fundamental concerns raised by hundreds of public commenters as well as independent peer reviewers who have evaluated EPA’s formaldehyde conclusions under IRIS and TSCA over the last 15 years, including: 
  • National Research Council Committee to Review EPA's Draft IRIS Assessment of Formaldehyde (2011)
  • EPA’s Human Studies Review Board on EPA’s TSCA Weight-of-Evidence Approach (2023)
  • National Academies of Science, Engineering, and Medicine (NASEM) Committee on Review of EPA’s 2022 Draft Formaldehyde Assessment (2023)
  • EPA’s TSCA Science Advisory Committee on Chemicals (2024)
  • SciPinion Independent Expert Panel Review on Human Health Risk Assessment Issues for Formaldehyde (2024)

This unscientific assessment will be the basis for several midnight regulations in late 2024, including risk evaluations under TSCA and FIFRA for formaldehyde.

Formaldehyde is a critical building block for essential applications including agriculture, food safety, medical devices, semiconductors, automobiles/electric vehicles, and affordable housing. Formaldehyde technologies have broad roles in the economy, supporting 987,000 jobs and $552.7 billion in sales in 2022 in the United States.