Subject: National Emission Standard for Hazardous Pollutants

EPA’s Final EtO Rule Has Landed: What Now?


The U.S. Environmental Protection Agency (EPA) recently released their long-awaited final rule regulating ethylene oxide (EtO) emissions from commercial sterilizers. The final rule comes after five years of development, over 1,000 comments, and with estimated compliance costs for industry of up to $900 million.

The final rule differs significantly from EPA’s initial proposed rule. See initial proposal back in April 2023. The changes result in a still restrictive and costly rule, but with more time and options for compliance. These changes come after significant interagency discussions, including discussions with the U.S. Food and Drug Administration (FDA) about the impact of these rules on the medical devices, about half of which are currently sterilized by EtO. According to EPA, there will be no need for companies to revalidate their medical devices due to this final rule. It seems likely, however, that a facility’s ability to comply with the new regulation ultimately may affect sterility validation, so revalidation concerns should not be completely discounted just yet.

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Ethylene Oxide Alert: Where Is Your Warehouse?


For over a year now, the U.S. Environmental Protection Agency (EPA) has been focused on reducing or eliminating ethylene oxide (EtO) emissions from industrial sites, commercial sterilizing facilities, and even hospitals. After a brief extension, the comment period for new proposed Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and National Emission Standards for Hazardous Air Pollutants (NESHAP) regulations closed at the end of June with over 1,000 unique written comments.  It is anticipated that EPA is going to take some time to sort through those comments before issuing final rules, which are expected in March 2024.  At the same time, EPA has forecasted releasing a proposed rule specific to hospital sterilizers in early 2024.

Next up on EPA’s agenda appears to be warehouses that store products sterilized with EtO.  The looming question appears to be “where is your warehouse?”  Onsite warehouses are the first to be in EPA’s crosshairs, but in classic agency style they are leaving the option to expand that focus open for the time being.  Meanwhile, environmental groups are asking EPA not to wait to expand that focus, and states like California and Georgia are taking matters into their own regulatory hands.

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