Many medical devices need to be sterile to be used safely. But sterilizing a pacemaker, catheter, or other device with steam or heat could damage its structural integrity. So medical device manufacturers turn to the chemical compound ethylene oxide, which is highly effective at killing microbes at low concentrations and allows companies to meet the Food and Drug Administration’s strict sterility standards. As a result, roughly half of all medical devices in the country are sterilized with ethylene oxide, or EtO, making it a linchpin of the medical device industry.
There’s just one problem: EtO is a toxic gas that has been linked to cancers of the breast and lymph nodes. Roughly 90 facilities across the country deploy the chemical for sterilization. These nondescript facilities often resemble warehouses and are located in residential neighborhoods and near schools.
In 2022, the Environmental Protection Agency discovered that dozens of these facilities presented an unacceptable cancer risk to surrounding communities. Two years later, the federal agency, led at the time by the Biden administration, announced new regulations to limit the amount of the chemical released into the air. The rule required sterilization facilities to install equipment to capture and burn ethylene oxide and was estimated to cut EtO emissions — and the resulting cancer risk to nearby communities — by more than 90 percent.
But after the sterilization industry protested that the rule was too burdensome, the newly-elected Trump administration began rolling it back. Last year, Trump exempted many facilities from having to comply with the rule. And this week, the EPA moved to repeal the rule altogether.
“This proposed rule shows EPA’s strong commitment to protecting people’s health while maintaining a stable domestic medical supply chain,” said EPA Administrator Lee Zeldin, in a press release. “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.”
When the Biden administration formalized sterilization rules in 2024, companies began taking steps to meet an April 2026 compliance deadline. In fact, 7 of the 88 sterilization facilities across the country already met the standards at the time they were passed. Others began installing equipment to capture ethylene oxide. A spokesperson for AdvaMed, the industry group that represents sterilizers, previously told Grist that, even before the 2024 rule was finalized, sterilizers had undertaken “extensive efforts to implement state-of-the-art upgrades, allowing for continued safe use of EtO in order to meet and even exceed regulations.”
Still, the industry was eager to find a way around the regulations. After the EPA set up a special inbox last year to receive requests for exemptions from several Clean Air Act provisions, including rules for ethylene oxide emissions, the sterilization industry flooded it with petitions. Trump eventually granted exemptions to about 40 facilities last year. A group of environmental nonprofits and community groups has sued Trump and the EPA over the decision.
“We always knew the presidential exemptions issued last year were part of a broader plan to put the interests of corporate polluters above the health and well-being of American families,” said Maurice Carter, president of Sustainable Newton, a Georgia-based environmental advocacy group, in a press release. “But we won’t stop fighting to protect our community by demanding commonsense, reasonable measures.”
The EPA said its latest move is necessary to protect the domestic supply chain of critical medical equipment. In a press release announcing the proposal, the agency said it is committed to ensuring that its “regulation will not put countless lives at risk,” noting that no viable alternative to ethylene oxide currently exists.
While it is true that alternatives to ethylene oxide do not currently exist, the sterilizers have several other options to reduce emissions while continuing to use the gas. In some cases, facilities tend to overapply ethylene oxide in a process called “overkill” to ensure a high margin of safety. This method is designed to exceed the level needed to meet sterility standards. Reducing these doses can lead to lower emissions. Facilities have also largely adapted to the more stringent regulations by installing so-called Permanent Total Enclosures. This technology traps ethylene oxide inside the building and funnels it to an oxidizer that burns the gas before it can escape. It is estimated to be 99 percent effective.
But in letters to the EPA and other public-facing statements, the industry has said PTEs are technically challenging to install and expensive. Ultimately, the EPA rule will “jeopardize the availability of sterile medical devices and supplies” and “will likely result in a significant disruption and public healthcare crisis,” the industry group AdvaMed said in a 2023 letter.
“With hundreds of thousands of surgeries and other medical procedures performed across the United States every day, the ability to meet those demands is essential,” AdvaMed president Scott Whitaker said in a statement sent to Grist. “We appreciate the EPA’s efforts in listening to and understanding the importance of supplying safe, sterile medtech without interruption while protecting employees and communities near sterilization facilities.”
In its latest proposal, the EPA is also questioning the toxicity of ethylene oxide. The EPA found that the chemical was 30 times more toxic to adults and 60 times more toxic to children than previously understood in 2016. That finding prompted a series of actions to inform the public about the risks sterilizers posed and eventually led to the 2024 standards. But the Trump administration now appears to be questioning the underlying toxicity data that was used to justify more stringent regulations.
In its press release, the agency said that ethylene oxide is “produced within the body via normal processes and additionally from tobacco smoke or other combustion processes” and that “new information” about the chemical has continued to emerge. The agency also plans to “consider comments” about the Texas Commission on Environmental Quality’s toxicity assessment for ethylene oxide. The Texas agency has long held that the chemical is far less toxic than the EPA’s assessments.
This story was originally published by Grist with the headline Trump EPA moves to repeal regulation of cancer-linked chemical ethylene oxide on Mar 13, 2026.
