EPA Strengthens Rules for Ethylene Oxide Emissions

Compliance with new, stricter air toxics standards for ethylene oxide (EtO) used in commercial sterilization facilities will reduce EtO emissions from these sites by 90%, EPA says. About 90 facilities will be impacted by amendments to the relevant National Emission Standards for Hazardous Air Pollutants (NESHAP), finalized on March 14, 2024.

See EPA's news release.

One goal of this rulemaking is to reduce the lifetime cancer risk for populations living near commercial sterilization facilities. EtO can be particularly harmful to children and communities that are already overburdened by pollution.

After reviewing input from public hearings and more than 40,000 comments, EPA is finalizing the following amendments to the NESHAP: 

• Establish standards for currently unregulated emissions, such as building leaks and chamber exhaust vents.

• Strengthen standards for sources such as sterilization chamber vents and aeration room vents.

• Require continuous emissions monitoring and quarterly reporting for most commercial sterilizers.

• Ensure that sterilizers are subject to emission standards during periods of startup, shutdown, and malfunction so there is continuous clean air protection.

• Other clarifying items, including electronic reporting and technical revisions.

Two-Year Exemption for Special Circumstances

A two-year exemption is available (in special circumstances) to help a facility achieve compliance with the NESHAP when the technology to implement the standard is not available and there are national security considerations. The President is prepared to exercise authority "to protect the medical supply chain and a commercial sterilizer is working in good faith to come into compliance with the rule," EPA says.

EPA is also working to strengthen standards to reduce EtO and other toxic pollutants from chemical plants. Other actions to address EtO emissions and advance EtO research include investigation additional sources of EtO (e.g., stand-alone warehouses, conducting more research, and enforcing existing regulations.

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Tags: Clean Air Act, e, EPA, ethylene oxide