On Friday, the Trump administration moved to roll back Biden-era limits on emissions of ethylene oxide, a carcinogenic chemical often used in the sterilization of medical devices.
The Environmental Protection Agency said repealing the rules, which fall under the National Hazardous Air Pollutant Emission Standards, would “safeguard the supply of essential medical equipment,” saving companies about $630 million over 20 years. California is home to about a dozen such facilities.
The government said contamination is an inevitable part of protecting people against “lethal or significantly debilitating infections that would occur without properly sterilized medical equipment,” arguing that the technology does not exist to meet the stricter rules.
“The Trump EPA is committed to ensuring that lifesaving medical devices continue to be available for the critical care of America's children, seniors, and all patients without unnecessary exposure to communities,” EPA Administrator Lee Zeldin said in a statement.
Supporters of the Biden rule reject that argument, saying companies could have complied using existing technology and the public was not at risk of losing sterile equipment.
An estimated 50% of sterile medical devices in the US are treated with ethylene oxide or EtO, particularly those that cannot be cleaned with steam or radiation. The colorless gas is also used to make chemicals found in products such as antifreeze, detergents, plastics and adhesives.
EtO poses health risks. Short-term exposure through inhalation can cause headaches, dizziness, nausea, fatigue, respiratory irritation and other adverse health effects, according to the federal Agency for Toxic Substances and Disease Registry.
Long-term exposure increases the risk of white blood cell cancers, such as non-Hodgkin lymphoma, as well as breast cancer. A now-deleted page from the EPA website said: “EtO is a human carcinogen. It causes cancer in humans.”
Friday's proposal specifically targets updated rules for EtO emissions that were approved by the Biden administration in 2024 after pressure from environmental justice groups, particularly those in Louisiana's highly industrialized “Cancer Alley.” The change sought to reduce the amount of EtO released by commercial sterilizers by 90% and reduce dangers to nearby communities.
The stricter rules were based in part on the EPA's own scientific study that found it was 60 times more carcinogenic than previously thought, which the agency now says should be reevaluated.
If finalized, the plan would give facilities the choice between installing real-time continuous monitoring systems for EtO emissions or complying with modified pollution control requirements at facilities that emit more than 10 tons per year, the EPA said.
The proposal follows other moves by the Trump administration to rescind regulations it says are burdensome and costly for industries, such as those governing emissions from coal-fired power plants. Last month, the EPA overturned the hazard finding, which affirmed the dangers of greenhouse gas emissions and supported the agency's ability to regulate those emissions from vehicles.
The ethylene oxide action would affect about 90 commercial sterilization facilities owned and operated by approximately 50 companies. Three California companies applied for and received presidential waivers for their EtO emissions in July.
The Sterigenics facility, downtown, in Vernon, pictured in 2022.
(Myung J. Chun / Los Angeles Times)
They are located in Ontario and Vernon and are operated by the company Sterigenics, which provides industrial sterilization technology for medical devices and other commercial products.
In January, a coalition of environmental and community groups challenged the EtO exemptions in federal court. The lawsuit by the Southern Environmental Law Center and the Natural Resources Defense Council argues that technology exists to bring facilities into compliance with the stricter Biden-era standards without increasing costs, and many facilities are already using it.
“EPA’s 2024 rule was an important and overdue step to reduce toxic ethylene oxide pollution and protect communities,” Irena Como, senior staff attorney at the Southern Environmental Law Center, said in a statement Friday. “Repealing this rule that has been shown to significantly reduce pollution exposure and cancer risks will expose even more people who work, live, and send their children to schools located near these facilities to harms that are entirely preventable.”
Chemical and sterilization industry groups support the plan.
“EPA's rule on the use of ethylene oxide in commercial sterilizers threatens to severely restrict access to vital medical products across the country,” the American Chemistry Council said in a statement. “We commend EPA for its commitment to reevaluate these policies.”
EPA will maintain a 45-day comment period on the proposal after its publication in the federal register. A final decision is expected sometime this year.
