EPA’s Focus on Ethylene Oxide
The Environmental Protection Agency issued a final rule on March 14 that will require significantly reduced emissions from commercial facilities that sterilize medical devices and other equipment using ethylene oxide gas (“EtO Rule”). The EtO Rule amends the National Emission Standards for Hazardous Air Pollutants (“NESHAP”), 40 C.F.R. Part 63, Subpart O, and is projected to reduce EtO emissions by over 90 percent nationwide for commercial sterilizers. The impetus for the Rule is a complaint filed by Earthjustice on December 14, 2022, in which the non-governmental organization (“NGO”) requested both injunctive and declaratory relief based upon its claim that the Environmental Protection Agency (“EPA”) had violated Section 112(d) of the Clean Air Act for the past 16 years by failing to review and revise air toxics standards for commercial sterilizers.
Emissions Controls and Reporting
The EtO Rule imposes strengthened standards for EtO emissions from the proposed rule following the receipt of public comments. It requires continuous emissions monitoring and quarterly reporting for most commercial sterilizers to ensure that emissions are controlled. Notably, the EtO Rule establishes revised standards for existing sources such as sterilization chamber vents and aeration room vents, as well as for previously unregulated emissions that escape via building leaks and chamber exhaust vents.
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