EPA To Reverse Some Ethylene Oxide Standards Despite Leaks, Lawsuits

Requirements for monitoring and reporting ethylene oxide leaks would be cut, along with more stringent aeration room requirements.

Federal regulators have announced plans to roll back certain ethylene oxide standards adopted after a series of toxic leaks in recent years, citing concerns that medical device sterilization facilities and manufacturers are struggling to meet the requirements.

Ethylene oxide is a gas used to sterilize some difficult-to-clean medical devices, like those made of metal or glass, or that consist of multiple layers and small crevices. While critical in keeping these devices sterilized, the gas can cause lung, throat, eye and nose irritation, and has been linked to increased cancer risks, potential brain damage and damage to the nervous system.

Following a series of ethylene oxide leaks that led to temporary shutdowns at facilities in Illinois, Georgia and Michigan throughout 2019, the U.S. Environmental Protection Agency (EPA) issued new ethylene oxide standards in March 2024. The new rules, affecting 90 commercial sterilization facilities across the U.S. called for standards for unregulated emissions and chamber exhaust vents, stronger requirements for sterilization chamber vents and aeration room vents and continuous air emissions monitoring and reporting. They also required the facilities to ensure sterilizers are subject to emission standards during all phases of operation.

In addition to the new standards, ethylene oxide manufacturers, such as Steris and C.R. Bard, faced a number of ethylene oxide leak lawsuits from workers and residents in surrounding communities, some of whom say they developed cancer and other illnesses from regular exposure to the gas due to air pollution.

In 2023, Sterigenics agreed to pay $408 million to settle claims brought following leaks at facilities in Illinois, Georgia and Michigan after plaintiffs indicated they developed breast cancer, non-Hodgkin’s lymphoma and other ailments. In May 2025, a Georgia jury ordered C.R. Bard to pay $20 million to a man who says he developed non-Hodgkin’s lymphoma due to ethylene oxide leaks from a nearby facility.

However, despite the court victories and leak concerns, the EPA has announced plans to walk the 2024 standards back, according to a press release issued on March 13. The changes under consideration have been incorporated into a proposed rule (PDF) signed by EPA Administrator Lee Zeldin, which will soon be published in the Federal Register.

The proposed rule would remove risk-based standards that led to the 2024 revision, nixing requirements for continuous monitoring of potential toxic leaks and cutting the aeration room vents standards and requirements for total enclosure. According to EPA officials, the Biden-era changes were in violation of the Clean Air Act.

The new rule would allow corporations to choose whether to install a new monitoring system or make adjustments to the 2024 technology review standards, according to the proposal. Regulators claim that keeping the 2024 standards would make it very difficult, if not impossible, for facilities to achieve compliance.

Zeldin notes in the press release that the 2024 ethylene oxide revisions required some companies to seek exemptions due to their inability to meet the new standards before the deadline. The EPA began reviewing the standards last March.

“This proposed rule shows EPA’s strong commitment to protecting people’s health while maintaining a stable domestic medical supply chan. The Trump EPA is committed to ensuring life-saving medical devices remain available for the critical care of America’s children, elderly, and all patients without unnecessary exposure to communities.”

– Lee Zeldin, EPA Administrator

The agency will accept public comments on the proposed rule for 45 days after it is published in the Federal Register. All submissions must reference Docket ID No. EPA-HQ-OAR-2019-0178.

Comments may be submitted online at Regulations.gov, by searching for the docket number. Submissions may also be sent by email to a-and-r-docket@epa.gov or by fax to (202) 566-9744.

Written comments may be mailed to the EPA Docket Center, Docket ID No. EPA-HQ-OAR-2019-0178, Mail Code 28221T, 1200 Pennsylvania Avenue NW, Washington, DC 20460.

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