EPA Move to Scale Back 2024 Ethylene Oxide Safeguards

The Environmental Protection Agency has proposed rolling back key parts of a 2024 air toxics rule that tightened limits on emissions of ethylene oxide, a carcinogenic gas used by commercial sterilizers to disinfect medical devices and some food products.

The proposal would amend the National Emissions Standards for Hazardous Air Pollutants for Ethylene Oxide Commercial Sterilizers, finalized in 2024 under the Clean Air Act. EPA is seeking to remove the “residual risk” standards that underpinned the 2024 rule, arguing that the agency lacked authority to conduct a second risk review beyond one completed in 2006.

The agency also proposes to revise or relax several technical requirements adopted in 2024, including mandates for continuous emissions monitoring systems, standards for new aeration room vents, and permanent total enclosure of certain operations. If finalized, the rule would give facilities flexibility either to install new monitoring technology or adjust how they meet standards for high‑volume ethylene oxide use.

In March 2024, EPA issued a final rule requiring nearly 90 commercial sterilizers to reduce ethylene oxide emissions, targeting a 90 percent cut nationwide by 2027. The agency said the rule would significantly reduce lifetime cancer risks for roughly 14 million people living near sterilization plants. The EPA has previously estimated that millions of people near sterilizers face cancer risks far above the agency’s usual threshold for unacceptable risk, even with partial controls in place.

The 2024 rule tightened limits on previously less‑regulated sources such as building leaks and chamber exhaust vents and required continuous monitoring and quarterly public reporting at most facilities.

According to EPA’s new proposal, medical providers, sterilization companies and other federal agencies raised concerns that the 2024 standards could disrupt the supply of life‑saving devices if facilities could not install required controls in time. The Trump administration has already used presidential authority to grant two‑year compliance exemptions for dozens of sterilization plants while EPA reconsiders the rule.

Industry groups, including the Ethylene Oxide Sterilization Association and the American Chemistry Council, have pressed EPA to narrow the scope of the 2024 rule and revisit the 2016 toxicity assessment that drove the stricter risk calculations. They argue that some provisions are unnecessary for larger, well‑capitalized companies and potentially devastating for smaller operators.

The proposal will be published in the Federal Register and opened for public comment, giving industry, health groups, local officials and residents near sterilization plants an opportunity to weigh in. EPA could finalize revisions before key 2024 rule compliance deadlines arrive.