EPA Must Complete Work by March 2024 on Ethylene Oxide Rules

The Environmental Protection Agency (EPA) must complete its work on the final rule governing commercial sterilization using ethylene oxide (EtO) by March 1, 2024, following the government’s signature on a consent decree that settles a complaint against the EPA filed by multiple groups in December 2022.

Five groups, including the Sierra Club and the Union of Concerned Scientists, signed onto a lawsuit Dec. 14, 2022, alleging the EPA violated the Clean Air Act when it “failed to perform its non-discretionary duties” to review the National Emission Standards for Hazardous Air Pollutants (NESHAP) for Commercial Sterilization Facilities “at least every eight years,” noting that it has been 16 years since the standards were last reviewed.

While EtO usage has decreased over time, it continues to be the most widely used gaseous sterilization agent in the world and is used to sterilize roughly 50 percent of reusable medical devices in the U.S. today — about 20 billion items annually.

Read the consent decree here.

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