Event
New EPA Rule Impacting Medical Device Sterilization: Strict Emissions Control, Compliance Certification, Reporting, Hosted by Strafford
This CLE webinar focused on the US EPA's long-awaited final rule regulating the use of ethylene oxide (EtO) by commercial sterilizers.
The EPA recently released its long-awaited final rule regulating EtO emissions by commercial sterilizers who use the chemical to sterilize medical equipment. The final rule, effective 5 April 2024, differs significantly from the April 2023 proposed rule and results in costly restrictions and compliance obligations for covered entities.
The final rule includes stricter emissions standards for chamber sterilization vents and aeration room vents, as well as new standards for previously unregulated emissions sources such as chamber exhaust vents and room air admissions, also known as "fugitive emissions." However, the standards vary based on the size of the facility, the amount of EtO used, and the date of the startup of the source. The rule also provides for alternative compliance methods through combined emissions streams.
Additionally, the final rule changes the way commercial sterilizers will certify their compliance with emissions control requirements. The rule requires the use of EtO continuous emissions monitoring systems, with exceptions for small users of EtO, and the electronic submission of compliance reports, performance test reports, and performance evaluation reports through the EPA's Central Data Exchange.
The panelists addressed the below questions:
- How does the final EtO rule differ from the April 2023 proposed rule?
- What emissions control standards are set by the final rule?
- How do the emissions control standards vary based on the size of the facility and the amount of EtO used?
- What alternative compliance methods are allowed by the final rule?
- What are the final rule's reporting requirements?
- How can counsel help their clients prepare for compliance now?
