The U.S. Environmental Protection Agency (EPA) has extended the comment period on proposed revisions to federal ethylene oxide (EtO) standards for commercial sterilization facilities, with comments now due May 15. The proposal would reconsider parts of a 2024 rule that the U.S. Small Business Administration’s Office of Advocacy warned could drive small sterilization providers out of the market, disrupt medical device supply chains and affect manufacturers that rely on sterilized products.

EPA’s proposal would revise standards for new aeration room vents, give facilities a choice between parametric monitoring and continuous emissions monitoring, and rescind the permanent total enclosure requirement. EPA estimates the changes could reduce costs by roughly $43 million to $48 million a year from 2026 to 2046.

“Environmental rules need to protect communities without breaking the supply chains that patients, workers and manufacturers depend on,” said James Lee, managing director of public policy services for the Ohio Manufacturers’ Association. “EPA’s proposal is a reminder that technical feasibility, cost and real-world implementation have to matter in federal rulemaking.” 5/5/2026