Regulatory Insights

EPA Recognizes Industry Concerns In Final Rule To Reduce Ethylene Oxide Emissions

March 14, 2024

Today the U.S. Environmental Protection Agency (EPA) announced a final rule aimed at reducing emissions of ethylene oxide (EtO) from commercial sterilization facilities. EPA listened to feedback from HIDA and other industry stakeholders in developing the final rule by including strong statements on their commitment to ensuring supply of sterile critical products. Specifically, the timeline to comply with the new regulations has been extended to 2-3 years from the original proposed 18-month timeline with tools available to receive additional time. The agency plans to publish additional guidance and offer technical assistance.

HIDA will provide a more detailed summary soon.

EPA Fact Sheet EPA Final Rule

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