EPA Puts New Limits on Ethylene Oxide Due to Cancer Risks

Ruling comes after Sterigenics reached a $400 million settlement with residents and workers exposed to increased cancer risks following ethylene oxide leaks.

Following serious health concerns caused by several high-profile ethylene oxide leaks and exposure lawsuits, federal environmental regulators have issued a final rule meant to help protect communities living near commercial sterilization facilities.

The U.S. Environmental Protection Agency (EPA) announced this week that it has finalized amendments to the National Emission Standards for Hazardous Air Pollutants for Ethylene Oxide Commercial Sterilizers, which the agency says are the strongest measures yet to reduce ethylene oxide risks, and may help reduce the lifetime risk of cancer for nearly 13 million residents across the U.S.

Ethylene oxide (EtO) is a potent cancer-causing chemicals, which is used to sterilize some medical devices, including metals, glass, and other products with multiple layers and small crevices. While other methods are used to sterilize equipment, EtO is used to sterilize about half the medical equipment made in the U.S.

A number of serious and life-threatening health risks have been linked to ethylene oxide exposure. Inhaling the gas can irritate the lungs, throat, eyes, and nose. It’s linked to breast and lymphoid cancers, and research indicates it can cause damage to the brain and nervous system.

The final rule approved this week would put in place controls that will reduce air pollution from commercial sterilization facilities by more than 90%, according to the EPA.

It addresses emissions at 90 commercial sterilization facilities owned and operated by 50 companies across the U.S. The rule will:

• Establish standards for unregulated emissions and chamber exhaust vents.
• Strengthen standards for sterilization chamber vents and aeration room vents.
• Require continuous air emissions monitoring and quarterly reporting for commercial sterilization plants.
• Ensure sterilizers are subject to emission standards during startup, shutdown, and malfunction.

“We have followed the science and listened to communities to fulfill our responsibility to safeguard public health from this pollution – including the health of children, who are particularly vulnerable to carcinogens early in life,” EPA Administrator Michael S. Regan said in a press release.

Ethylene Oxide Leaks

The EPA first proposed new ethylene oxide standards in 2023, following several high-profile EtO plant shutdowns that suffered massive gas leaks, flooding the areas with the toxic gas.

Ethylene Oxide leaks occurred in 2019 at the Sterigenics plant in Illinois and other facilities in Michigan and Georgia. The facilities were shut down temporarily to address the leaks, but multiple lawsuits were subsequently filed over health risks from exposure to the toxic gas.

Following the leaks, the FDA began hosting a series of town hall meetings to discuss restrictions on EtO use, alternative sterilization methods, and reducing EtO use overall.

Lawsuits filed over ethylene oxide leaks at Sterigenics facilities allege workers and nearby residents developed breast cancer, non-Hodgkin’s lymphoma and other health problems due to exposure. The lawsuits resulted in a $408 million settlement last year from residents in surrounding communities.

The EPA believes the new rule will put into place proven and achievable air pollution controls for EtO. The agency worked with the Department of Health and Human Services to review the latest science to inform the rule, agency officials indicate.

The rule will become effective once it is published, sometime later this month. Then, facilities will have two years to enact measures to come into compliance.

The agency notes that this rule is one of a series of actions the EPA plans to take to reduce exposure to EtO.