EPA Eases Ethylene Oxide Rules for Medical Devices

The Environmental Protection Agency announced a proposal to weaken air pollution limits on ethylene oxide, a gas used to sterilize medical equipment. This move reverses a prior standard aimed at reducing emissions by about 90% from nearly 90 commercial sterilization facilities. Ethylene oxide exposure elevates cancer risks for workers and residents nearby, directly affecting community health and safety.

Ethylene oxide causes lymphoma, myeloma, lymphocytic leukemia, and breast cancer with long-term exposure, as stated by the EPA. People living near facilities face higher lifetime cancer risks, with environmental justice advocates highlighting impacts on Black and Brown communities. In Laredo, Texas, residents challenged a sterilization plant operated by Midwest Sterilization Corp. for its emissions.

The EPA expressed concerns that current standards threaten manufacturers' ability to sterilize essential devices like catheters, syringes, and pacemakers. EPA Administrator Lee Zeldin described the proposal as a commitment to a stable domestic supply chain for medical equipment. Scott Whitaker, president and CEO of the Advanced Medical Technology Association, noted that many devices rely on ethylene oxide for sterilization, ensuring uninterrupted access to safe products.

The American Lung Association deemed the proposal unacceptable, citing science that links both short-term and long-term ethylene oxide exposure to serious health dangers. Laura Kate Bender, the association's vice president, emphasized that no community should endure elevated cancer risks from air pollution. Sterigenics, a major company, previously shut down a plant in a Chicago suburb after emission spikes led to lawsuits and neighborhood concerns.

Facilities using ethylene oxide often sit in minority areas, exacerbating cancer threats for local families. The 2024 rule had required companies to test air for the chemical and maintain pollution controls, a safeguard now at risk. This change could mean ongoing exposure for workers and neighbors, potentially increasing health care burdens in affected regions.