IHMM Comments

Federal Register

Deadline: May 1, 2026

EPA has proposed to reconsider its 2024 ethylene oxide rule for commercial sterilization facilities. The proposal would rescind the 2024 rule’s risk-based standards under Clean Air Act section 112(f)(2), relax some control and monitoring requirements, remove the permanent total enclosure requirement, and retain certain technology-based standards. EPA says the changes would reduce compliance costs and help protect medical-device sterilization capacity, but it also acknowledges increased ethylene oxide emissions and resulting health disbenefits. IHMM’s comments support technical fixes and practical compliance flexibility, while opposing unjustified rollbacks and urging legally durable, science-based protections that safeguard workers, nearby communities, and the environment.

IHMM outlines the roles of AHMMs, CHMMs, CHMPs, CSHMs, and CSMPs in implementing this proposed rule and in environmental and workplace safety and protection.