Trump moves to repeal regulation of cancer-linked ethylene oxide
Many medical devices must 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 makers are turning 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, about half of all medical devices in the country are sterilized with ethylene oxide, or EtO, making it a mainstay of the medical device industry.
There’s just one problem: EtO is a toxic gas that has been linked to breast and lymph node cancers. About 90 facilities across the country use this chemical for sterilization. These nondescript facilities often resemble warehouses and are located in residential neighborhoods and near schools.
In 2022, the Environmental Protection Agency found that dozens of these facilities posed an unacceptable cancer risk to surrounding communities. Two years later, the federal agency, led at the time by the Biden administration, announced new regulations aimed at limiting the amount of the chemical released into the air. The rule required sterilization facilities to install equipment to capture and burn ethylene oxide and would have reduced 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 restrictive, the newly elected Trump administration began to repeal it. Last year, Trump exempted many establishments from having to comply with this rule. And this week, the EPA decided to repeal the rule altogether.
“This proposed rule demonstrates EPA’s strong commitment to protecting people’s health while maintaining a stable domestic medical supply chain,” EPA Administrator Lee Zeldin said in a press release. “Trump’s EPA is committed to ensuring that life-saving medical devices remain available for the critical care of children, seniors, and all American patients, without unnecessary exposure to communities. »
The unregulated link in a toxic supply chain
When the Biden administration formalized the sterilization rules in 2024, companies began taking steps to meet the compliance deadline of April 2026. In fact, 7 of 88 sterilization facilities across the country already met the standards at the time they were adopted. Others have begun 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 “significant efforts to implement industry-leading upgrades, enabling continued and safe use of EtO to meet and even exceed regulations.”
Still, the industry was eager to find a way around the regulations. After the EPA created a special inbox last year to receive requests for exemptions from several provisions of the Clean Air Act, including rules related to ethylene oxide emissions, the sterilization industry flooded it with petitions. Trump ultimately granted exemptions to about 40 facilities last year. A group of environmental nonprofits and community groups sued Trump and the EPA over the decision.
“We always knew that the presidential exemptions granted last year were part of a broader plan to put the interests of corporate polluters ahead of the health and well-being of American families,” Maurice Carter, president of Sustainable Newton, a Georgia-based environmental advocacy group, said in a press release. “But we will not stop fighting to protect our community by demanding reasonable, common-sense measures.”
The EPA said its latest action was necessary to protect the nation’s supply chain for critical medical equipment. In a press release announcing the proposal, the agency said it was committed to ensuring its “regulations will not put countless lives at risk,” noting that there are currently no viable alternatives to ethylene oxide.
While it is true that there is currently no alternative to ethylene oxide, sterilizers have several other options to reduce emissions while still using the gas. In some cases, facilities tend to apply too much ethylene oxide in a process called “overkill” to ensure a high safety margin. This method is designed to exceed the level necessary to meet sterility standards. Reducing these doses can lead to a reduction in emissions. Facilities have also largely adapted to stricter regulations by installing permanent total enclosures. This technology traps ethylene oxide inside the building and routes 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 statements, the industry has said PTEs are technically difficult to install and expensive. Ultimately, the EPA rule “will jeopardize the availability of sterile medical devices and supplies” and “will likely result in significant disruption and crisis in public health care,” industry group AdvaMed said in a 2023 letter.
“With hundreds of thousands of surgeries and other medical procedures performed every day in the United States, the ability to meet these demands is critical,” AdvaMed President Scott Whitaker said in a statement sent to Grist. “We appreciate EPA’s efforts to listen and understand the importance of providing safe and sterile medical technologies without interruption while protecting employees and communities near sterilization facilities.”
In its latest proposal, the EPA also questions 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 believed in 2016. That finding prompted a series of actions to educate the public about the risks posed by sterilizers and ultimately led to the 2024 standards. But the Trump administration now appears to be questioning the underlying toxicity data that was used to justify tougher regulations.
In its press release, the agency said that ethylene oxide is “produced in the body through normal processes and also from tobacco smoke or other combustion processes” and that “new information” about the chemical continued to emerge. The agency also plans to “consider comments” regarding the Texas Commission on Environmental Quality’s assessment of ethylene oxide toxicity. The Texas agency has long maintained that the chemical is far less toxic than EPA assessments.
