EPA Proposes Easing Ethylene Oxide Emission Rules

The Environmental Protection Agency proposed on Friday to ease air pollution restrictions on ethylene oxide, a carcinogenic gas essential for sterilizing about half of all medical devices in the United States, reversing a stricter 2024 rule aimed at reducing emissions from roughly 90 commercial facilities nationwide.

The proposal addresses concerns that the existing standards, finalized under the previous administration, could disrupt manufacturing and threaten the domestic supply chain for critical equipment such as pacemakers, catheters, syringes and surgical gowns. Ethylene oxide, or EtO, is a colorless gas used to treat devices that cannot withstand steam or radiation sterilization. While short-term exposure poses minimal risk, long-term inhalation has been linked to increased chances of cancers including leukemia, lymphoma and breast cancer, particularly for workers at facilities and residents nearby. The EPA first classified EtO as a human carcinogen in 2016 and detailed elevated risks to communities in a 2022 assessment.

Under the new plan, facilities emitting more than 10 tons of EtO annually would have options to comply, such as adjusting aeration room vents or...