Trump Administration Rolls Back Emissions Limits on Cancer-Causing Chemical Used in Medical Device Sterilization
WASHINGTON – The Trump administration moved Friday to weaken Obama-era regulations on ethylene oxide, a gas classified as a human carcinogen and widely used to sterilize medical equipment. The rollback, announced by the Environmental Protection Agency, aims to reduce costs for companies and “safeguard the supply of essential medical equipment,” according to EPA Administrator Lee Zeldin.
The proposed rule targets updated emissions standards for ethylene oxide, or EtO, implemented by the Biden administration in 2024. Those standards, spurred by pressure from environmental justice groups, sought a 90% reduction in EtO released from commercial sterilizers, particularly impacting communities near facilities.
The EPA now says it will reassess its previous finding that EtO is 60 times more carcinogenic than previously thought. The agency will offer facilities a choice between installing real-time monitoring systems or complying with modified pollution control requirements for those emitting more than 10 tons a year.
Approximately 50% of sterile medical devices in the U.S. rely on EtO for sterilization, as alternatives like steam or radiation aren’t suitable for all materials. The gas is also used in the production of antifreeze, detergents, plastics, and adhesives.
However, exposure to EtO poses significant health risks. Short-term inhalation can cause headaches, dizziness, and respiratory irritation. Long-term exposure is linked to increased risks of cancers of the blood and breast.
The move is part of a broader pattern by the Trump administration of easing regulations deemed burdensome to industry. Earlier this year, the EPA loosened restrictions on emissions from coal power plants and repealed an affirmation of the dangers of greenhouse gas emissions.
The action affects around 90 commercial sterilization facilities operated by approximately 50 companies. Three facilities in California – located in Ontario and Vernon and operated by Sterigenics – previously received exemptions for their EtO emissions.
A coalition of environmental and community groups has already challenged the EtO exemptions in federal court, arguing that existing technology allows facilities to meet stricter standards without significant cost increases.
“Repealing this rule…will subject even more people who work, live, and send their children to schools located near these facilities to harm that is entirely preventable,” said Irena Como, senior attorney at the Southern Environmental Law Center, in a statement.
Industry groups, including the American Chemistry Council, have praised the EPA’s move, stating the previous regulations threatened access to vital medical products.
The EPA will accept public comments on the proposal for 45 days after it is published in the Federal Register, with a final decision expected later this year.
