EPA Restricts EtO Emissions From Medical Device Sterilizers

Final rule requires a 90% reduction in ethylene oxide emissions from commercial medical device sterilization facilities

On March 14, the Environmental Protection Agency announced final amendments to the Clean Air Act standards to reduce ethylene oxide (EtO) emissions from medical device sterilization facilities by 90%, one of the most stringent measures to reduce EtO emissions in U.S. history. This reduction is even more stringent than EPA's April 2023 proposal, which called for an 80% reduction of EtO emissions to outdoor air from commercial sterilizers.

EtO is used to sterilize about half of all medical equipment in the U.S.; however, EPA has concluded that EtO is a human carcinogen with a high estimated cancer potency based on data from a study of sterilization workers. That estimate has been challenged, as the Texas Commission on Environmental Quality (TCEQ) estimated a substantially lower cancer potency using the same data. The National Academies of Sciences,