In a proposal announce last week, the U.S. Environmental Protection Agency (EPA) could loosen limits on emissions of ethylene oxide used in the sterilization of some medical devices. Breathing the gas has been linked to cancer in reports and labeled as a carcinogen by the EPA in 2016.

Currently, ethylene oxide is used to sterilize about half of all medical devices in the United States and the proposal would ease pollution rules for about 90 commercial sterilization facilities nationwide through a roll-back of parts of the 2024 rules issued under the Biden administration. These current rules required some sterilization plants to install stronger pollution controls and monitor emissions constantly, but EPA now says some of those requirements may be too difficult for these facilities to meet.

Reports claim the medical device industry and EPA have been in ongoing debate over balancing the need for sterile medical equipment with concerns about pollution near sterilization plants.

The new rule could save companies about $43 million a year in compliance costs, according to Agency estimates which also stated, “The Trump EPA is committed to ensuring lifesaving medical devices remain available for the critical care of Americans without unnecessary exposure to communities.”

While medical device manufacturers say the gas is essential because it sterilizes without damaging delicate materials, opponents claim the Trump EPA is “systematically looking for ways to let polluters off the hook.” MedicalExpress.com reported that Sarah Buckley, a senior attorney with the Natural Resources Defense Council claims, “If this abuse of authority is left unchecked, communities will pay the price in higher cancer risks.” The EPA, however, says there is no widely available alternative that can sterilize these devices.

Medical device industry group, AdvaMed, has welcomed the proposed new rule in a statement by its CEO, Scott Whitaker, “We appreciate the EPA’s efforts in listening to and understanding the importance of supplying safe, sterile med tech without interruption while protecting employees and communities near sterilization facilities.”