Ethylene Oxide Emissions Standards for Commercial Sterilization Facilities

On April 5, 2024, EPA finalized a rule to significantly reduce the emissions of ethylene oxide (EtO) from commercial sterilization facilities under Section 112 of the Clean Air Act (CAA). The rule was immediately challenged by both environmental groups and industry. The Trump administration said it will reconsider the 2024 rule and invited industry to seek exemptions.
 
EtO is a potent carcinogen. While EtO emissions from sterilization facilities have been regulated since 1994, prior requirements did not apply to several significant sources of EtO, including fugitive emissions (also called “room air emissions”). As a result, communities that live near these facilities — who are disproportionately low-income and communities of color — have suffered from a significantly higher rate of cancer than the rest of the country. If the 2024 final rule were to take effect, EPA anticipated it would reduce annual EtO emissions from commercial sterilizers 90% by 2027 by increasing the stringency of emissions standards, regulating fugitive emissions, and requiring consistent monitoring to ensure compliance with the new standards.
 
This paper summarizes EPA’s EtO final rule for sterilization facilities, discusses the significance of regulating EtO emissions for fenceline communities, and examines how the pollutant has historically been regulated. It also details the rule’s requirements, including changes to prior regulations, and looks at the litigation challenging it and the Trump administration’s anticipated effort to roll it back.