EPA moves to weaken pollution limits on chemical used to sterilize medical equipment

WASHINGTON (AP) — The Environmental Protection Agency proposed Friday to weaken air pollution limits on a chemical used to sterilize medical equipment, a move that would reverse a Biden administration finding of high cancer risks at manufacturing facilities that use ethylene oxide to clean medical devices like catheters and syringes.

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

Ethylene oxide plays a crucial role in sterilizing lifesaving medical devices, including pacemakers and syringes, but long-term exposure can cause leukemia and other types of cancer among people who work at medical sterilization facilities or live nearby.

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 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.

The proposal is the latest in a series of moves by the EPA under President Donald Trump to relax pollution limits and lower costs for industry. In February alone, the agency weakened restrictions on mercury from coal-burning power plants and repealed a scientific finding that served as the central basis for U.S. action to regulate greenhouse gas emissions and fight climate change.

An EPA rule finalized in 2024 was intended to reduce ethylene oxide emissions by about 90% by targeting nearly 90 commercial sterilization facilities across the country. The Biden-era rule also required companies to test for the antimicrobial chemical in the air and ensure their pollution controls are functioning properly.

The American Lung Association hailed the 2024 rule as an important step to protect human health from cancer caused by ethylene oxide emissions. People who live near commercial sterilization facilities are more likely to develop cancer over their lifetimes, the group said.

Environmental justice advocates 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 roughly half of all medical devices and is also used to ensure the safety of certain spices and other food products. It is used to clean everything from catheters to syringes, pacemakers and plastic surgical gowns. Brief exposure isn’t considered a danger, but breathing it long term elevates the risk of breast cancer and lymphoma, the EPA said.

The EPA first classified ethylene oxide as a human carcinogen in 2016.

In 2022, the EPA laid out the risks faced by residents who live near medical sterilization facilities. In Laredo, Texas, for example, residents and activists fought to clean up a sterilization facility run by Missouri-based Midwest Sterilization Corp. It was one of 23 sterilizers in the United States that the EPA said posed a risk for people nearby.

Sterigenics, a major sterilization company, shuttered a medical sterilization plant in a Chicago suburb after monitoring found emissions spikes in nearby neighborhoods. They eventually settled numerous lawsuits.

Scott Whitaker, president and CEO of the Advanced Medical Technology Association, said medical sterilizers provide a vital service and many devices can’t be sterilized by any other method.

“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.