The EPA proposes weaker contamination limits for chemicals used to sterilize medical devices

WASHINGTON (AP) — The Environmental Protection Agency on Friday proposed weakening air pollution limits on a chemical used to sterilize medical equipment, a move that would mirror the Biden administration’s findings of a higher cancer risk at manufacturing facilities that use ethylene oxide to clean medical devices such as catheters and syringes.

The EPA said it was concerned that the current Biden-era standards “effectively threaten” manufacturers’ abilities to sterilize equipment and “jeopardize one of America’s only options for a safe domestic supply chain for essential medical equipment.”

Read more: Advocates warn that the EPA’s rollback of pollution limits could lead to higher health care costs

Ethylene oxide plays a critical role in sterilizing life-saving medical devices, including defibrillators and syringes, but long-term exposure can cause leukemia and other types of cancer among people who work in or live near medical sterile facilities.

EPA Administrator Lee Zeldin said the proposed rule shows the agency’s commitment to protecting people’s health while maintaining a stable domestic medical supply chain.

“The Trump EPA is committed to ensuring that life-saving medical devices remain available for critical care for children, the elderly, and all patients in America without unnecessary exposure to communities,” he said in a statement.

The proposal is the latest in a series of moves the EPA has taken under President Donald Trump to relax pollution limits and cut industry costs. In February alone, the agency eased restrictions on mercury from coal-burning power plants, rescinding a scientific discovery that served as the central basis for US work to regulate greenhouse gas emissions and combat climate change.

The EPA rule finalized in 2024 aims to reduce ethylene oxide emissions by about 90% by targeting approximately 90 commercial sterilization facilities across the country. The Biden-era rule also required companies to test antimicrobial chemicals in the air and ensure their pollution controls are working properly.

The American Lung Association called the proposed rule change unacceptable.

“Science shows that short- and long-term exposure to ethylene oxide poses a health risk,” said Laura Kate Bender, vice president of the association. “People who live near many commercial sterilization facilities are at a higher risk of developing cancer throughout their lives. No one should live with a higher risk of cancer due to air pollution in their community.”

Environmental justice advocates have noted that many ethylene oxide facilities are located in minority communities where black and brown people have been exposed to the cancer-causing chemical.

Ethylene oxide, also known as EtO, is a gas used to sterilize nearly half of all medical devices and is also used to ensure the safety of some spices and other food products. It is used to clean everything from catheters to syringes, pacemakers and plastic surgical gowns. The EPA said brief exposure is not considered dangerous, but long-term breathing increases the risk of breast cancer and lymphoma.

The Environmental Protection Agency first classified ethylene oxide as carcinogenic to humans in 2016.

In 2022, the EPA identified risks faced by residents living near medical sterilization facilities. In Laredo, Texas, for example, residents and activists fought to clean up a sterilization facility operated by Missouri-based Midwest Sterilization Corp. It was one of 23 disinfectants in the United States that the Environmental Protection Agency said posed a risk to people nearby.

Sterigenics, a major sterilization company, closed a medical sterilization plant in a Chicago suburb after monitoring found rising emissions in nearby neighborhoods. They eventually settled several lawsuits.

Medical sterilizers provide a vital service and many devices cannot be sterilized any other way, said Scott Whitaker, president and CEO of the Advanced Medical Technology Association.

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