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.
The bottom line is that the regulations focused on EtO are gaining momentum, and EPA’s scope continues to widen. Commercial sterilizers, industry, hospitals, and those in the supply chain will need to continue to stay on top of these developments.
For a more detailed description of current rulemaking efforts, timelines, and anticipated next steps, see https://www.faegredrinker.com/en/insights/publications/2023/8/ethylene-oxide-where-are-we-now-and-what-next
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