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The Trump administration on Friday announced plans to roll back Biden-era limits on emissions of ethylene oxide, a cancer-causing chemical commonly used to sterilize medical devices.
The Environmental Protection Agency stated that repealing the rules, which fall under the National Emission Standards for Hazardous Air Pollutants, would "safeguard the supply of essential medical equipment" and save companies approximately $630 million over 20 years. California hosts about a dozen such facilities.
The government argued that emissions are an unavoidable part of preventing "lethal or significantly debilitating infections that would result without properly sterilized medical equipment," and claimed that current technology does not readily allow compliance with the stricter rules.
"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," EPA Administrator Lee Zeldin said in a statement.
Supporters of the Biden-era rule dispute this, asserting that companies could comply using existing technology and that the public was not at risk of losing access to sterilized equipment.
About 50% of sterile medical devices in the U.S. are treated with ethylene oxide (EtO), especially those that cannot be sterilized using steam or radiation. The colorless gas is also used to produce chemicals found in antifreeze, detergents, plastics, and adhesives.
EtO poses health risks. Short-term inhalation exposure can cause headaches, dizziness, nausea, fatigue, respiratory irritation, and other adverse effects, according to the federal Agency for Toxic Substances and Disease Registry.
Long-term exposure increases the risk of cancers such as non-Hodgkin’s lymphoma and breast cancer. A now-deleted EPA webpage stated, "EtO is a human carcinogen. It causes cancer in humans."
Friday’s proposal specifically targets updated EtO emission rules passed by the Biden administration in 2024, following pressure from environmental justice groups, particularly in Louisiana’s heavily industrialized "Cancer Alley." The stricter regulations aimed to reduce EtO emissions from commercial sterilizers by 90%, lowering risks to nearby communities.
The tighter standards were partly based on an EPA scientific study that found EtO to be 60 times more carcinogenic than previously estimated, a finding the agency now says should be reassessed.
If finalized, the plan would allow facilities emitting more than 10 tons of EtO annually to choose between installing continuous real-time monitoring systems or complying with modified pollution control requirements, the EPA said.
This proposal follows other Trump administration efforts to rescind regulations deemed burdensome and costly to industry, such as those limiting emissions from coal power plants. Last month, the EPA repealed the endangerment finding that recognized the dangers of greenhouse gas emissions and supported regulating vehicle emissions.
The rollback would affect about 90 commercial sterilization facilities operated by approximately 50 companies. In July, three California companies received presidential exemptions for their EtO emissions. These facilities, located in Ontario and Vernon, are operated by Sterigenics, a company providing industrial sterilization technology for medical devices and other products.
The Sterigenics facility, center, in Vernon is pictured in 2022.
(Myung J. Chun / Los Angeles Times)
In January, a coalition of environmental and community groups filed a federal lawsuit challenging the EtO exemptions. The lawsuit, brought by the Southern Environmental Law Center and the Natural Resources Defense Council, argues that technology exists for facilities to meet the stricter Biden-era standards without increasing costs, and many are already using it.
"EPA’s 2024 rule was an important and overdue step to reduce toxic ethylene oxide pollution and protect communities," said Irena Como, senior attorney at the Southern Environmental Law Center, in a statement Friday. "Repealing this rule that is proven to significantly lower pollution exposure and cancer risks will subject even more people who work, live, and send their children to schools located near these facilities to harm that is entirely preventable."
Industry groups in sterilization and chemicals support the rollback.
"The EPA rule concerning ethylene oxide use in commercial sterilizers threatens to severely restrict access to vital medical products nationwide," the American Chemistry Council said in a statement. "We commend the EPA for their commitment to reevaluating these policies."
The EPA will open a 45-day public comment period after the proposal is published in the Federal Register. A final decision is expected later this year.
