The Trump EPA is moving to roll back recent restrictions on ethylene oxide, a carcinogen
The Trump administration on Friday moved to roll back Biden’s term limits on emissions of ethylene oxide, a cancer-causing chemical commonly used to sterilize medical devices.
The Environmental Protection Agency said the repeal of the rules, which fall under the National Emissions Standards for Hazardous Air Pollutants, “will protect the supply of critical medical equipment” – saving companies about $630 million over 20 years. California is home to about a dozen such institutions.
The government said the release is part of protecting people from “deadly or debilitating diseases that can result without properly sterilized medical equipment.”
“The Trump EPA is committed to ensuring that life-saving medical services remain available in critical care for America’s children, adults, and all patients without unnecessary exposure to communities,” EPA Director Lee Zeldin said in a statement.
An estimated 50% of sterile medical devices in the US are treated with ethylene oxide, or EtO, especially those that cannot be cleaned using steam or radiation. The colorless gas is also used to make chemicals found in products such as antifreeze, detergents, plastics and adhesives.
But EtO poses health risks. Short-term exposure by 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 cancers of the white blood cells, such as non-Hodgkin lymphoma, and breast cancer. A now-removed page on the EPA website said, “EtO is a human carcinogen. It causes cancer in humans.”
Friday’s proposal takes aim at revised EtO emission regulations passed by the Biden administration in 2024 following pressure from environmental justice groups, particularly those in heavily industrialized Louisiana’s “Cancer Alley.” This change sought to reduce the amount of EtO released from commercial disinfectants by 90% and reduce risks to nearby communities.
The strict rules were based in part on the EPA’s own scientific study that found it to be 60 times more carcinogenic than previously thought, which the agency now says should be retested.
If finalized, the program will give facilities a choice between installing real-time monitoring systems for EtO emissions or complying with modified emissions control requirements for facilities that emit more than 10 tons per year, the EPA said.
The proposal follows other moves by the Trump administration to roll back regulations it says are burdensome and costly to industry, such as those that regulate emissions from coal-fired power plants. Last month, the EPA overturned the findings on the endangerment, which confirmed the dangers of the emissions and upheld the agency’s ability to regulate those emissions from vehicles.
The action surrounding ethylene oxide could affect about 90 commercial sterilization facilities owned and operated by about 50 companies. Three California companies applied for a presidential exemption and received their EtO exemption last July.
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 exemption in federal court. The lawsuit from the Southern Environmental Law Center and the Natural Resources Defense Council says the technology exists for agencies to comply with the tougher Biden-era standards without raising costs, and many agencies are already using them.
“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. “Repeal of this law, which is proven to significantly reduce air pollution exposure and cancer risk, will expose many people who work, live, and send their children to schools near these facilities to harm that is entirely preventable.”
Sterilization and chemical industry groups support the plan.
“The EPA’s rule regarding the use of ethylene oxide in the commercial market threatens to severely limit access to important medical products across the country,” the American Chemistry Council said in a statement. “We commend the EPA for its commitment to reevaluating these policies.”
EPA will hold a 45-day comment period on the proposal after it is published in the federal register. A final decision is expected sometime this year.
