U.S. Environmental Protection Agency Releases Draft Risk Evaluation Under the Toxic Substances Control Act for Formaldehyde

On March 15, 2024, the U.S. Environmental Protection Agency (EPA or the Agency) published its draft risk evaluation under the Toxic Substances Control Act (TSCA) for formaldehyde. This proposal is one of a series of risk evaluations EPA is conducting as required by the 2016 amendments to TSCA.

The draft risk evaluation — posted as 14 separate documents — preliminarily finds that all industrial and many commercial uses of the chemical pose an “unreasonable risk” resulting from certain activities using formaldehyde and formaldehyde-containing products. The evaluation’s executive summary states that most of the 62 activities that were considered are believed to contribute to unreasonable risk due to noncancer effects associated with inhalation or dermal contact with formaldehyde, while only one activity could pose an unreasonable risk due to nasopharyngeal cancer.

EPA proposes to find that the most at-risk group for acute and chronic noncancer inhalation effects from formaldehyde exposure is workers in workplaces where formaldehyde is used. Certain new formaldehyde-containing consumer products present the next highest risk, according to EPA’s draft evaluation.

The Agency will accept public comments on the draft risk evaluation for formaldehyde until May 14, 2024, and then submit the evaluation to its Science Advisory on Chemicals for peer review. In its fiscal year 2025 budget request published on March 11, 2024, EPA shared its plans to finalize the risk evaluation by the end of 2024. If the Agency maintains its unreasonable risk determination, EPA will be required to conduct a further rulemaking to evaluate options for managing the risk, considering a range of factors including the economic effects of further regulation.


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