Body
The U.S. Environmental Protection Agency proposed to weaken air pollution limits on ethylene oxide, a chemical used to sterilize medical equipment, setting up a fight between the agency’s industry-leaning rationale and health advocates’ warnings about cancer risk. The proposal, announced Friday, would reverse a Biden administration finding that elevated health risks for people living near or working at ethylene oxide sterilization facilities.
EPA Administrator Lee Zeldin said the agency’s approach balances public health protections with what he characterized as the need for a reliable U.S. supply chain for essential medical devices. In a statement, Zeldin said, “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.”
The EPA said the current Biden-era standards would hinder sterilization operations and limit manufacturers’ ability to keep medical supplies available. In describing the rationale for the change, the agency said the existing rules “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, also known as EtO, is used to sterilize roughly half of medical devices, the EPA said, including equipment such as catheters and syringes, as well as pacemakers. The EPA also said ethylene oxide is used to treat certain food products, and it said brief exposure is not considered dangerous while breathing it long term elevates health risks.
The Biden-era rule the EPA seeks to roll back was designed to cut ethylene oxide emissions by about 90% by targeting nearly 90 commercial sterilization facilities across the country. The EPA said that rule also required companies to test for the antimicrobial chemical in the air and ensure their pollution controls were working properly, in contrast to the standards the agency now proposes to weaken.
The EPA said ethylene oxide was first classified as a human carcinogen in 2016. It said long-term exposure raises the risk of leukemia and other cancers for people who work at sterilization facilities or live nearby, and it said risks include breast cancer and lymphoma.
Advocates and public health groups condemned the proposal. The American Lung Association called the change unacceptable and said the science shows both short-term and long-term exposure to ethylene oxide is dangerous for health. “The science shows that both short-term and long-term exposure to ethylene oxide is dangerous for health,” said Laura Kate Bender, vice president of the association. “People who live near many commercial sterilization facilities are much more likely to develop cancer over their lifetimes. No one should have to live with elevated cancer risk because of air pollution in their community.”
Environmental justice advocates said many ethylene oxide sterilization facilities are located in minority communities and that Black and Brown residents have been exposed to cancer-causing levels of the chemical. The EPA’s proposal came as part of what AP described as a series of moves by the Trump administration EPA to relax pollution limits and reduce costs for industry, including actions affecting mercury emissions from coal-burning power plants and greenhouse gas regulations.
Industry groups supporting sterilization capacity said the process is essential for medical devices. Scott Whitaker, president and CEO of the Advanced Medical Technology Association, said sterilizers provide a vital service and that many devices cannot be sterilized through other methods. In an email, Whitaker said the group “appreciate[s] 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.”
Some local officials also criticized the agency’s proposal. Los Angeles County Supervisor Janice Hahn, who has said she raised concerns about emissions at a Sterigenics facility southeast of Los Angeles, said Friday that “the EPA is moving in the wrong direction and putting more Americans’ health on the line.”