Trump rolls back Biden’s toughest-ever rule on a gas linked to cancer

EPA proposes loosening a Biden-era health rule

The Trump administration proposed rolling back limits on ethylene oxide emissions on March 13, 2026. The gas is used to sterilize medical equipment at nearly 90 facilities across the country.

The Biden-era rule from 2024 was the strongest measure in U.S. history to control those emissions, requiring cuts of more than 90%.

EPA Administrator Lee Zeldin said the new proposal balances health protection with keeping the medical supply chain stable. The proposal is open for public comment.

What ethylene oxide is and why it matters

Ethylene oxide, also called EtO, is a colorless, flammable gas used to kill bacteria on medical equipment and some food products.

It sterilizes roughly half of all medical devices sold in the United States, about 20 billion devices per year. Pacemakers, heart valves, catheters, syringes, surgical kits, and ventilators all go through the process.

Many of those devices are made of materials that cannot handle steam or radiation-based sterilization. The EPA first classified EtO as a human carcinogen in 2016.

Long-term exposure raises serious health concerns

Brief exposure to EtO is not considered dangerous, but breathing it over long periods is a different story. Long-term exposure has been linked to leukemia, lymphoma, and breast cancer.

Children face especially high risk from the gas. It is also tied to reproductive harm, including a higher chance of miscarriage.

About 14 million people in the United States live within five miles of a commercial sterilization facility, putting them in the zone of potential long-term exposure.

What the 2024 rule required facilities to do

The Biden-era rule required commercial sterilizers to cut EtO emissions by more than 90% using proven air pollution controls.

Facilities had to install continuous emission monitoring systems and report results every three months. The rule also set a goal that no nearby resident would face a lifetime cancer risk greater than 1 in 10,000.

Most facilities had until April 2026 to comply.

Even the Biden administration acknowledged supply concerns and set up an exemption process in January 2025.

The new proposal would roll back key requirements

The Trump EPA’s new proposal would remove the requirement for continuous emission monitoring systems, letting facilities use less rigorous alternatives instead.

It would also eliminate the requirement for permanent total enclosure technology, which captures EtO before it escapes into the air.

The proposal would undo roughly a third of the emissions reductions that the 2024 rule would have achieved. The EPA argues the Biden administration’s 2024 health risk review was not authorized under the Clean Air Act.

Some standards from the 2024 rule that the EPA considers legally sound would stay in place.

The EPA says strict rules threaten medical supply

The EPA says the Biden-era standards threaten manufacturers’ ability to keep sterilizing equipment at the scale the country needs.

The agency warns the stricter rules could put one of America’s only options for a secure domestic medical supply chain at risk.

The medical device industry has said overly tight emissions limits could force some facilities to cut back or close.

The trade group AdvaMed said it supports maintaining a reliable supply of sterile equipment while also protecting workers and nearby communities.

The FDA has also raised concerns about how stricter rules could affect the availability of sterilized devices.

Health groups say millions more people face cancer risk

The American Lung Association called the proposed rollback unacceptable, saying both short-term and long-term EtO exposure is dangerous.

According to Earthjustice, the change could expose at least 85,000 more people to cancer risks above the EPA’s own acceptable threshold of 100 in 1 million.

The Union of Concerned Scientists said more than 10,000 schools and childcare facilities sit within five miles of a sterilization plant.

The Environmental Protection Network, made up of more than 750 former EPA scientists and staff, said the proposal ignores health costs.

A 2025 National Academies of Sciences review also found that an alternative risk assessment promoted by Texas lacked scientific rigor.

Real communities have already paid the price

The effects of EtO exposure are not just numbers. In Laredo, Texas, residents fought for years to clean up a sterilization facility the EPA identified as one of 23 plants in the country posing elevated cancer risk.

In a suburb of Chicago, Sterigenics closed a plant after monitors detected spikes in airborne EtO levels in nearby neighborhoods.

In Covington, Ga., a Becton Dickinson sterilization plant has faced multiple lawsuits from employees and residents who developed cancer.

In Salinas, Puerto Rico, residents learned their community had one of the highest rates of toxic air cancer risk in the country due to EtO.

Minority communities sit closest to the risk

Environmental justice advocates say many EtO facilities are in minority and low-income neighborhoods.

A 2021 EPA study found that nearly two-thirds of EtO facilities contributing to high cancer risks sit in areas that are at least 50% minority or low-income.

The Union of Concerned Scientists found that communities near these plants are disproportionately made up of people of color or those who do not speak English as a first language.

Health advocates say these communities have been unknowingly exposed to EtO for years, and sometimes for decades.

A year of rollbacks led to this proposal

The March 2026 proposal did not come out of nowhere. In March 2025, Zeldin announced the agency would reconsider the 2024 rule.

Then in July 2025, the Trump administration granted exemptions from the rule to about 40 sterilization facilities, roughly 45% of those covered.

The exemptions gave those plants an extra two years to comply.

No president had used the Clean Air Act exemption authority invoked for those waivers in the 55 years since it was enacted.

Environmental groups filed a federal lawsuit challenging the exemptions, arguing the president exceeded his legal authority.

Legal fights are already lined up

The original 2024 rule was already in court. Industry groups and environmental organizations both challenged it in the D.C. Circuit, and the court put that case on hold in April 2025 at the EPA’s request.

A separate lawsuit filed in January 2026 by the Southern Environmental Law Center and NRDC, on behalf of community groups in North Carolina, Georgia, and Virginia, challenges the July 2025 exemptions and asks the court to strike them down.

The March 2026 proposal opens another front in that legal fight, with public comments expected before the EPA moves toward a final rule.

What comes next for the rule

The EPA will accept public comments on the proposal before issuing a final rule.

If it passes as written, the weaker standards would replace the 2024 rule for the roughly 90 commercial sterilization facilities covered.

The April 2026 compliance deadline for the Biden-era rule is approaching fast, leaving facilities in a state of uncertainty while they wait for clarity.

Health and environmental groups have already signaled they will challenge any final rule that weakens protections.

The public comment period gives individuals, scientists, and organizations a chance to weigh in before the EPA acts.

This article was created with AI assistance and human editing.

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