EPA moves to roll back recent limits on ethyene oxide, a carcinogen

The Trump administration moved Friday to roll back Biden-era limits on emissions of ethylene oxide, a cancer-causing chemical often used in the sterilization of medical devices.

The Environmental Protection Agency said the rules that fall under the protection have been repealed. National Emission Standards for Hazardous Air PollutantsIt will “secure the supply of essential medical equipment” and save companies approximately $630 million over 20 years. california about one a dozen facilities like this.

The government said the emissions were part of protecting people from “fatal or significantly debilitating infections that could occur without properly sterilized medical equipment.”

“Trump EPA is committed to ensuring that life-saving medical devices remain available without unnecessary exposure to communities for the critical care of America’s children, the elderly, and all patients,” EPA Administrator Lee Zeldin said in a statement.

An estimated 50% of sterile medical devices in the United States, especially those that cannot be cleaned using steam or radiation, are treated with ethylene oxide, or EtO. The colorless gas is also used to make chemicals found in products such as antifreeze, detergents, plastics and adhesives.

But EtO carries health risks. According to federal law, short-term exposure through inhalation may cause headache, dizziness, nausea, fatigue, respiratory irritation and other adverse health effects. Agency for Toxic Substances and Disease Registry.

Long-term exposure increases the risk of breast cancer, as well as white blood cell cancers such as non-Hodgkin’s lymphoma. A. now deleted page “EtO is carcinogenic to humans. It causes cancer in humans,” the EPA’s website states.

Friday’s proposal targets updated EtO emissions rules adopted by the Biden administration in 2024 following pressure from environmental justice groups, especially those in Louisiana’s heavily industrialized “Cancer Alley.” The change was intended to reduce the amount of EtO released from commercial sterilizers by 90% and reduce hazards to nearby communities.

The stricter rules were based in part on EPA’s own scientific study. 60 times more carcinogenic than previously thought, the agency now says this needs to be re-evaluated.

EPA said the plan, if completed, would allow facilities to choose between installing continuous real-time monitoring systems for EtO emissions or complying with modified pollution control requirements at facilities that emit more than 10 tons per year.

The proposal follows other moves by the Trump administration to repeal regulations it says are burdensome and costly for industries such as those that regulate emissions from coal plants. Last month, the EPA rescinded its finding of danger that confirmed the dangers of greenhouse gas emissions and bolstered the agency’s ability to regulate those emissions from vehicles.

The impact around ethylene oxide will affect approximately 90 commercial sterilization facilities owned and operated by approximately 50 companies. Three California companies applied for and received a presidential exemption for EtO emissions in July.

They are located in Ontario and Vernon and are operated by Sterigenics, a company that 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. case A report from the Southern Environmental Law Center and the Natural Resources Defense Council argues that the technology is available to allow facilities to comply with 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,” Southern Environmental Law Center senior attorney Irena Como said in a statement Friday. “Repealing this rule, which has been proven to significantly reduce pollution exposure and cancer risk, would expose more people who work, live and send their children to schools located near these facilities to completely preventable harm.”

Sterilization and chemical industry groups support the plan.

“The EPA 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 reevaluating these policies.”

EPA will maintain a 45-day comment period on the proposal after it is published in the federal register. The final decision is expected to be made this year.