EPA Proposes Relaxing Limits on Cancer-Linked Chemical in Medical Device Cleaning

The Environmental Protection Agency announced plans Friday to loosen air quality restrictions on ethylene oxide, a chemical linked to cancer but essential for sterilizing medical equipment. The Trump administration says current rules threaten America's medical supply chain, reversing stricter standards put in place last year.

WASHINGTON — Federal environmental regulators announced Friday their intention to roll back air quality restrictions on ethylene oxide, a cancer-causing substance essential for cleaning medical devices, overturning stricter cancer risk protections established during the previous administration.

The Environmental Protection Agency expressed concerns that existing regulations “actively threaten” companies’ capacity to properly sterilize medical equipment and “jeopardize one of America’s only options for a secure domestic supply chain of essential medical equipment.”

While ethylene oxide serves an essential function in sanitizing life-saving medical instruments such as pacemakers and syringes, prolonged contact with the substance can lead to leukemia and additional cancer types in workers at medical sterilization plants and residents in surrounding areas.

EPA Administrator Lee Zeldin stated the recommended changes demonstrate the agency’s dedication to safeguarding public health while preserving a reliable domestic medical supply network.

“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,” he said in a statement.

This announcement represents another action by the EPA under President Donald Trump to ease pollution regulations and reduce industry expenses. During February, the agency loosened mercury restrictions for coal-fired power plants and eliminated a scientific determination that formed the foundation for U.S. greenhouse gas regulation and climate change efforts.

A regulation completed in 2024 aimed to cut ethylene oxide releases by approximately 90% by focusing on nearly 90 commercial sterilization operations nationwide. The previous administration’s policy also mandated companies monitor airborne levels of the antimicrobial substance and verify their pollution control systems operate correctly.

The American Lung Association praised the 2024 regulation as a significant measure to shield public health from cancer risks associated with ethylene oxide releases. Individuals residing close to commercial sterilization operations face higher lifetime cancer risks, according to the organization.

Environmental justice supporters highlighted that numerous ethylene oxide facilities operate in minority neighborhoods where Black and Brown residents have faced exposure to the carcinogenic substance.

Ethylene oxide, or EtO, is a gas that sterilizes approximately half of all medical devices and helps ensure safety for certain spices and food items. The chemical cleans various items from catheters to syringes, pacemakers and plastic surgical garments. Short-term contact poses minimal risk, but long-term inhalation increases breast cancer and lymphoma chances, according to EPA findings.

Federal regulators initially designated ethylene oxide as a human carcinogen in 2016.

In 2022, the EPA outlined dangers for people living near medical sterilization plants. In Laredo, Texas, residents and activists worked to address contamination from a sterilization operation managed by Missouri-based Midwest Sterilization Corp. This facility was among 23 sterilizers nationwide that the EPA determined created risks for nearby communities.

Sterigenics, a leading sterilization company, closed a medical sterilization plant in a Chicago suburb following monitoring that detected emission increases in surrounding neighborhoods. The company later resolved multiple legal cases.

Scott Whitaker, president and CEO of the Advanced Medical Technology Association, emphasized that medical sterilizers deliver essential services and many devices cannot undergo sterilization through alternative methods.

“We appreciate the EPA’s efforts in listening to and understanding the importance of supplying safe, sterile medical technology without interruption while protecting employees and communities near sterilization facilities,” he said in an email.