EPA Proposes Rolling Back 2024 Ethylene Oxide Limits for Device Sterilizers

The US Environmental Protection Agency has formally proposed rolling back key parts of its 2024 emission standards for commercial sterilizers that use ethylene oxide, the gas used to sterilize about half of US medical devices, in a proposed rule published in the Federal Register on March 17.

The proposal would rescind the risk-based standards in the 2024 rule, revise the standard for new aeration room vents that came out of the agency's technology review, revise compliance demonstration requirements and rescind a related requirement, according to the Federal Register notice. The EPA said it announced its reconsideration of the 2024 rule on March 12, 2025.

EPA frames it as a supply chain issue

In a fact sheet, the EPA said ethylene oxide is used to sterilize 50 percent of all medical devices in the US every year, which it put at 20 billion devices, "with no viable alternative on the market." The agency listed heart valves, pacemakers, surgical kits, gowns, drapes, ventilators, syringes and catheters among the equipment that relies on the method.

The EPA argued that the previous administration lacked statutory authority under the Clean Air Act to conduct a second risk review of the standards, and said the 2024 rule set emission limits facilities could not meet before compliance deadlines. It noted that the previous administration set up a presidential exemption process in January 2025 because of that concern.

The agency estimated the proposal would save about $630 million over 20 years, or about $43 million a year. It also said it is seeking public comment on new information about ethylene oxide exposure and toxicity, to help decide whether the 2016 toxicity value it used to estimate risk remains suitable.

Environmental groups object

Earthjustice, which represented groups whose 2022 lawsuit led to the 2024 standards, said on March 13, when the EPA announced the proposal, that the rollback would let facilities emit more of the gas. Based on the EPA's own data, the proposal would subject at least 85,000 more people to unacceptable cancer risks compared with the 2024 rule, the group said.

"The 2024 standards would have delivered enormous public health benefits," said Earthjustice senior attorney Deena Tumeh. "EPA has no basis to repeal this well-supported rule."

The group said the 2024 regulations required most sterilizer facilities to reduce emissions and install continuous emissions monitoring systems by April 6, 2026, and that the administration had exempted more than 40 percent of US sterilizers from complying for two years.

Comment period and hearing

The Federal Register notice says comments must be received on or before May 1, 2026, and that the EPA will hold a virtual public hearing on April 1. Comments on the rule's information collection provisions are best assured of consideration if the Office of Management and Budget receives them by April 16, the notice says.

The EPA said that, if finalized as proposed, its action "will ensure a strong domestic supply chain of commercial sterilized medical equipment." Any final rule would follow the comment period.