Overview
- Friday’s proposal would scale back the Biden-era 2024 rule that required roughly 90 facilities to cut ethylene oxide emissions by about 90% and install continuous monitoring by April 2026.
- EPA officials argue the revision complies with the Clean Air Act and question a second risk review used to support the 2024 standards within an eight-year window.
- The draft rule would let high‑emitting facilities—those over 10 tons per year—choose either continuous real‑time monitoring or modified controls on aeration room vents.
- The agency estimates savings of about $43 million per year, or roughly $630 million over two decades, and says flexibility is needed because EtO sterilizes about half of U.S. medical devices.
- Environmental and community advocates warn the rollback would heighten cancer risks near sterilizers, citing EPA data that at least 85,000 more people could face unacceptable risk, and they are already challenging earlier exemptions granted to dozens of plants.