EPA Sets Tough Limits For EtO Sterilizers But Eases Compliance Options

EPA has released its long-awaited final rule setting tougher limits on emissions of the solvent ethylene oxide (EtO) from commercial sterilizers, tightening existing limits, setting new limits, eliminating exemptions for facility startup and shutdown -- but also offering a two-year compliance extension, and finalizing “site-wide” flexible compliance options. The rule will tighten standards for “on the books” sources such as sterilization chamber vents and aeration room vents, and add new limits for unregulated emissions, such as building leaks and chamber...