US EPA Issues Final Rule for Ethylene Oxide Sterilization Facilities

On March 14, 2024, the US Environmental Protection Agency (EPA) announced final decisions regarding the regulation of Commercial Sterilization Facilities under the Clean Air Act. This includes defining affected sources, establishing emission standards for previously unregulated sources, and making amendments to address ethylene oxide (EtO) emissions from various vents and room air emissions. Additionally, the EPA is correcting and clarifying regulations related to emissions during startup, shutdown, and malfunction periods, removing exemptions for these periods. 

Owners and operators will now be required to demonstrate compliance using EtO continuous emissions monitoring systems, with exceptions for very small users. These amendments are expected to reduce EtO emissions from this category by approximately 21 tons per year. According to the US EPA, the Clean Air Act standards EPA is finalizing will reduce lifetime cancer risks associated with EtO emissions from commercial sterilizers down to or below the benchmark of 100 cancer cases per million people exposed. 

Click here to view the final rule or visit the US EPA website here for a summary.