EPA’s proposed changes to its formaldehyde risk evaluation echo chemical industry demands

Main Takeaways:

• EPA sidelines chronic health risks of formaldehyde in a revised formaldehyde risk evaluation.
• The revisions represent a blow to the federal government’s ability to regulate formaldehyde and protect workers and others exposed to the hazardous chemical.
• While EPA maintains that formaldehyde still presents an overall “unreasonable risk” to human health, the Agency’s revisions radically narrow the scientific basis for regulating inhalation exposure.
• If these revisions are finalized, EPA will have prioritized industry interests over protecting health under TSCA.

EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) issued an Updated Draft Risk Calculation Memorandum on December 3 meant to amend the risk evaluation for formaldehyde completed under the Toxic Substances Control Act (TSCA) in January. Despite formaldehyde’s scientifically well-understood health risks, which range from acute irritation of the eyes and respiratory tract to increased cancer risk with chronic exposure, EPA’s updated risk calculation mirrors comments made by lobbyists at the American Chemistry Council (ACC), reducing inhalation risks of the chemical.

An analysis of EPA’s revisions reveals a striking alignment with arguments made by the ACC’s Formaldehyde Panel in May 2024. In a clear-cut case of regulatory and rhetorical capture, the updated draft replaces the Agency’s standard approach with a framework that closely tracks key positions championed by the very industry being regulated.

EPA’s updated risk calculation embraces the ACC’s demands and weakens EPA’s conclusions about the health risks of formaldehyde in at least five critical ways. The memo proposes to:

1. discontinue reliance on the chronic non-cancer Reference Concentration (RfC) and the cancer Inhalation Unit Risk (IUR) for formaldehyde developed by EPA’s IRIS program—values used to determine cancer and chronic non-cancer risk that have been subjected to external peer review by the National Academies of Sciences, Engineering, and Medicine (NASEM);
2. adopt the industry-preferred threshold-based Mode of Action (MOA) for cancer risk that assumes zero cancer risk under a certain level of exposure—a methodology that goes against best scientific practices;
3. adopt the industry position that formaldehyde does not adhere to Haber’s Law, or a scientific principle that the toxicity of a chemical is a function of its concentration and duration of exposure;
4. reduce science-based factors that have been used for decades to account for uncertainty in scientific evidence, to the industry’s preferred standard; and
5. set occupational exposure limit (OEL) at the industry’s advocated 300 ppb (see table) which means the Agency is saying it is okay (it’s not) to inhale higher amounts of this harmful chemical.

If EPA’s industry-driven revised evaluation of formaldehyde goes forward, the Agency will have prioritized commercial interests over eliminating unreasonable risks from chronic exposure to the chemical under TSCA. Additionally, EPA’s new formaldehyde risk memo fulfills the industry’s goals to weaken cancer risk assessment in general and will set the new norm for dismissing known cancer risks. Weakening these assessments will lead to more Americans being exposed to this cancer-causing chemical—and, in turn, to more people getting sick and dying as a result.

About the author

Daniel Akselrad, PhD, is a postdoctoral fellow at the UCSF Center for Tobacco Control Research and Education and the UCSF Center to End Corporate Harm. He received his PhD in Communication from Stanford University.