The Environmental Protection Agency on Friday unveiled a proposal to roll back air‑pollution limits for ethylene oxide, a gas essential to sterilizing medical devices such as catheters, syringes, and pacemakers. The change would reverse a 2024 rule that cut emissions by roughly 90 % at nearly 90 commercial sterilization plants and would dilute a 2016 classification of ethylene oxide as a human carcinogen.
EPA Administrator Lee Zeldin said the agency was “committed to ensuring life‑saving medical devices remain available … without unnecessary exposure to communities.” He added that the existing standards “actively threaten” manufacturers’ ability to sterilize equipment and jeopardize a “secure domestic supply chain of essential medical equipment.”
The 2024 rule required facilities to monitor ethylene‑oxide levels continuously, test the air for the chemical, and keep pollution controls functioning. It was designed after the agency’s 2022 risk assessment, which linked long‑term exposure to leukemia, lymphoma, breast cancer and other cancers among workers and nearby residents.
Environmental‑health groups slammed the proposal. Laura Kate Bender, vice president of the American Lung Association, said, “The science shows that both short‑term and long‑term exposure to ethylene oxide is dangerous for health.” She warned that people living near the roughly 23 sterilization plants identified as high‑risk are “much more likely to develop cancer over their lifetimes.”
Advocates for environmental justice noted that many facilities sit in minority neighborhoods, exposing Black and Brown communities to heightened cancer risks. Los Angeles County Supervisor Janice Hahn warned, “The EPA is moving in the wrong direction and putting more Americans’ health on the line.”
Industry representatives defended the chemical’s role. Scott Whitaker, president and CEO of the Advanced Medical Technology Association, said medical sterilizers provide a vital service and that many devices cannot be sterilized by any other method. He thanked the EPA for “listening to … the importance of supplying safe, sterile medical technology without interruption while protecting employees and communities.”
The proposal follows a pattern of regulatory rollbacks under the Trump administration, including a February move that weakened mercury‑emission limits on coal‑burning power plants and a repeal of a scientific finding that underpinned U.S. action on greenhouse‑gas emissions.
If finalized, the new rule would allow higher ethylene‑oxide releases, raising concerns that communities surrounding sterilization facilities could face increased cancer risks. The agency has opened a comment period, inviting stakeholders to weigh in on the balance between medical‑device supply security and public‑health protection.