U.S. EPA Releases Draft Update on Formaldehyde Risk Calculation, Seeks Public Comments

Time: Dec 12, 2025
美国
TSCA
Risk Assessment

On December 4, 2025, the U.S. Environmental Protection Agency (EPA) has published a Memorandum on the Draft Update to Formaldehyde Risk Calculations, conducted under the Toxic Substances Control Act (TSCA). The agency is now soliciting public comments on the draft.

Key Updates

The memorandum revises the acute inhalation risk assessment for formaldehyde, adopting a new Point of Departure (POD) of 0.3 ppm and an uncertainty factor of 1 (UF=1). The Margin of Exposure (MOE) was recalculated for workers, consumers, and the general population. Key findings include:

1. Worker Exposure

  • In certain manufacturing and processing scenarios (e.g., adhesives, sealants, paper products), median exposure risks remain below the safety threshold (MOE < 1).
  • Risks in some industrial/commercial uses (e.g., automotive care products, water treatment chemicals) remain elevated.
  • In a few scenarios, risks shifted from "exceeding limits" to "acceptable" due to the updated POD.

2. Consumer Exposure

  • When using formaldehyde-containing products (e.g., adhesives, coatings, building materials), most scenarios show MOE < 1, indicating acute inhalation risks.
  • Conclusions align with the final risk assessment: Consumer use of formaldehyde-containing products poses unreasonable health risks.

3. Indoor/Outdoor Air

  • Indoor air: Most scenarios show MOE > 1, indicating lower risks.
  • Outdoor air: Residents near emission sources (e.g., industrial combustion) may face MOE values near or below 1, suggesting potential risks.

Conclusion

Despite adopting a less conservative POD (0.3 ppm + UF=1), formaldehyde continues to pose acute inhalation health risks across multiple exposure scenarios. Thus, EPA reaffirms that formaldehyde presents an unreasonable risk to human health.

The public may submit comments via the Federal Register within 60 days (by February 2, 2026). EPA will subsequently release a proposed rule outlining specific regulatory measures.

 

Further Information

EPA

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