The U.S. Environmental Protection Agency is tightening ethylene oxide (EtO) emissions rules for facilities that use the chemical to sterilize medical devices.
The agency announced these amendments under the Clean Air Act standards for hazardous air pollution emissions on March 14 as part of the President Biden’s ongoing environmental justice initiative. The final rule includes requirements for air-pollution controls that will cut emissions by more than 90% at commercial sterilization facilities, the EPA said in a news release.
This final rule for commercial sterilizers is one of several actions the EPA is taking to reduce EtO exposure. The agency is currently working on a rule to strengthen EtO standards in chemical facilities.
The amendments will address emissions at nearly 90 commercial sterilization facilities owned and operated by approximately 50 companies.
The final rule includes new standards for unregulated emissions like building leaks and chamber exhaust vents, stronger standards for sterilization chamber vents and aeration room vents and requirements for continuous emissions monitoring and quarterly reporting. Sterilizers will also be subject to emission standards during startup, shutdown and malfunction periods to ensure continuous clean air protection. Other updates include technical and electronic reporting revisions.
The EPA said it will provide facilities with sufficient time and flexibility to comply with the new standards, while minimizing any potential impacts to the medical device supply chain.
