The Environmental Protection Agency has proposed changes to commercial sterilizer regulations that would roll back key provisions of a 2024 emissions rule, citing risks to the domestic medical supply chain.
The rule applies to commercial sterilization facilities that use ethylene oxide, a gas used to sterilize 50% of all medical devices in the U.S., or roughly 20 billion units annually, according to a March 13 news release. The Trump administration said the current standards, finalized under the Clean Air Act last year, relied on an “unauthorized” second risk review and could jeopardize access to critical equipment such as surgical kits, pacemakers and catheters.
The new proposal would eliminate that second risk review, revise compliance measures and offer facilities more flexibility through optional monitoring or adjusted technology standards for high-emission vents. The EPA estimates the proposed changes would save $630 million over 20 years.
EPA Administrator Lee Zeldin said the proposal aims to “protect people’s health while maintaining a stable domestic medical supply chain.” Approximately 90 sterilization facilities are currently regulated under the rule.
The EPA will accept public comment for 45 days after the proposal is published in the Federal Register and will hold a virtual public hearing 15 days after publication.
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