The US Environmental Protection Agency (EPA) has proposed weakening air pollution limits on ethylene oxide, a chemical used to sterilise medical equipment such as catheters and syringes. The move would reverse a Biden administration finding of high cancer risks at facilities that use the gas.
The EPA, now under President Donald Trump, said it fears the current Biden-era standards 'actively threaten' manufacturers' ability to sterilise equipment and jeopardise the domestic supply chain for essential medical devices. Ethylene oxide is crucial for sterilising life-saving items like pacemakers and syringes, but long-term exposure can cause leukaemia and other cancers.
EPA Administrator Lee Zeldin said the proposed rule shows the agency's commitment to protecting health while maintaining a stable medical supply chain. However, environmental advocates note that many ethylene oxide facilities are located in minority communities, where residents face higher cancer risks.
The 2024 Biden rule required a 90% reduction in emissions from nearly 90 commercial sterilisation facilities and mandated air testing. The American Lung Association had hailed that rule as an important step to protect human health.
Ethylene oxide, classified as a human carcinogen by the EPA in 2016, is used to sterilise roughly half of all medical devices and some spices. Brief exposure is not considered dangerous, but long-term inhalation elevates the risk of breast cancer and lymphoma.
Scott Whitaker, head of the Advanced Medical Technology Association, welcomed the EPA's efforts to ensure an uninterrupted supply of sterile medical technology while protecting employees and communities.
