EPA Releases Proposal for Commercial Sterilizers to Safeguard the Supply of Life-Saving Medical Tools

EPA Releases Proposal for Commercial Sterilizers to Safeguard the Supply of Life-Saving Medical Tools

March 13, 2026

WASHINGTON - Today,U.S. Environmental Protection Agency (EPA) proposed amendments to the Biden-era 2024 National Emissions Standards for Hazardous Air Pollutants (NESHAP) for Ethylene Oxide (EtO) Commercial Sterilization Facilities to ensure consistency with the law and gold standard science. EtO is the only safe and effective sterilization method available for many medical devices, making it indispensable for life-saving medical equipment including heart valves, pacemakers, surgical kits, gowns, drapes, ventilators, syringes, and catheters-medical equipment that newborns, the elderly, and Americans undergoing surgery rely on daily to survive. EPA is concerned that the current Biden-era EtO emission standards actively threaten facilities' ability to sterilize equipment and jeopardize one of America's only options for a secure domestic supply chain of essential medical equipment. EPA is committed to a rulemaking process that follows the law, ensures that regulation will not put countless lives at risk, and advances the agency's core mission of protecting human health and the environment, including minimizing Americans' unnecessary exposure to EtO.

"This proposed rule shows EPA's strong commitment to protecting people's health while maintaining a stable domestic medical supply chain," said EPA Administrator Lee Zeldin. "The Trump EPA is committed to ensuring life-saving medical devices remain available for the critical care of America's children, elderly, and all patients without unnecessary exposure to communities."

Congress deliberately designed CAA section 112 with detailed implementation timelines and requirements for residual risk reviews of Maximum Achievable Control Technology (MACT) standards in NESHAP rules. In 2024, however, the Biden-Harris EPA took the unprecedented step of conducting a second, "discretionary" residual risk review despite already completing the residual risk review required by law within eight years of promulgating the NESHAP. This second risk review, done in apparent contravention of the best reading of the statute using an almost decade old risk-based value for EtO, led to the 2024 EtO Commercial Sterilizer Final Rule (2024 NESHAP). During and following the promulgation of the Biden-Harris Administration's 2024 NESHAP, the medical community, industry stakeholders and other federal agencies, including the U.S. Food and Drug Administration, raised serious concerns. These concerns included the feasibility of complying with the more stringent EtO emission standards and the significant impacts the requirements would have on maintaining a strong domestic supply chain for sterilized medical equipment essential to saving American lives. Commercial sterilizers utilize EtO to sterilize 50 percent of all medical devices in the U.S. every year-or 20 billion medical devices-with no viable alternative on the market.

As a result of the 2024 NESHAP, the Biden-Harris Administration was forced in January 2025 to establish a Presidential exemption process from the administration's own rule due to facilities' inability to meet required standards before compliance deadlines, and the grave risk that the closures of these facilities posed to American lives. In response to legal, scientific and policy concerns, including the critical medical supply chain issue the U.S. faced due to the 2024 NESHAP rule, the Trump EPA issued a press release on March 12, 2025, announcing its reconsideration of the 2024 NESHAP, and on March 21, 2025, formally granted voluntary reconsideration.

With this rule, EPA is proposing that section 112(f)(2) of the CAA prevents EPA from conducting more than the one risk review EPA completed in 2006. Therefore, the second risk review the Biden EPA conducted in 2024 violated the CAA and should never been completed. In line with congressional intent, EPA is proposing to remove the risk-based CAA section 112(f)(2) standards which justified the 2024 NESHAP. EPA is also proposing to change other requirements that were promulgated from the standards, including the requirement to use continuous emission monitoring systems, technology review standards for new aeration room vents (ARV), and requirements for permanent total enclosure. If finalized as proposed, the Trump EPA's rule would give facilities the choice between installing a new monitoring system or making adjustments to the 2024 EtO standards for technology review standards for new ARV where EtO is greater than ten tons per year. These changes better reflect the complexity of facilities and give them the flexibility to work to use safe and effective equipment to sterilize medical tools and devices without compromising clean air for all Americans. EPA is proposing to keep the 2024 NESHAP standards consistent with the CAA and that result in facilities installing attainable emission controls consistent with the latest required technology review. The Trump EPA is committed to following the law exactly as it is written, while also ensuring standards effectively protect human health and the environment.

Since 2016, new information, including new epidemiological studies, advancements in statistical methods related to dose-response modeling have continued to emerge. It is known that EtO is produced within the body via normal processes and additionally from tobacco smoke or other combustion processes. As part of this rulemaking, EPA is seeking comment on new information related to these sources of EtO exposure. EPA anticipates this information would be useful for updating the agency's understanding of EtO exposure and toxicity and determining whether the 2016 EtO IRIS value remains suitable for estimating risk to inform regulatory decision-making, including the proposed amendments announced today. The agency will also consider comments regarding the Texas Commission of Environmental Quality's 2020 finalized alternative assessment of EtO's toxicity and potential to cause cancer or other alternative values not yet considered by the agency.

EPA estimates that this proposed action would save approximately $630 million in costs over 20 years, or about $43 million annually, not including the immeasurable value of the countless lives that would be saved from lethal or significantly debilitating infections that would result without properly sterilized medical equipment.

EPA will accept public comments on this proposal for 45 days after it is published in the Federal Register. If requested,EPA will hold a virtual public hearing for this proposed action 15 days after publication in the Federal Register.

Find more information about this rulemaking and further details about the public hearing.

Background

EtO is a colorless gas that is critical to the medical device supply chain. The EtO Commercial Sterilization NESHAP regulates EtO emitted from commercial sterilization facilities. Commercial sterilization covers the sterilizer process that uses EtO to sterilize or fumigate materials such as medical equipment and supplies, spices, and other miscellaneous products and items. This process is designed to eliminate microorganisms including bacteria, viruses, fungi, and protists from products to ensure they are safe for human use and consumption.

EtO sterilization plays a key role in the medical device supply chain, sterilizing a variety of devices ranging from general health care items, such as wound dressings, to specialized devices, such as stents. For many heat- and moisture-sensitive products, EtO sterilization is the only method that effectively sterilizes a product without damaging it.

Today, there are about 90 commercial sterilization facilities owned and operated by approximately 50 companies. EPA issued the original NESHAP under section 112(d) of the CAA in 1994, establishing emission limits for sterilization chamber vents, ARVs, and catalytic oxidizer vents (CEVs). In 2001, EPA revised the NESHAP to remove requirements for CEVs due to equipment failure. In 2006, EPA finalized a residual risk and technology review under CAA sections 112(f)(2) and (d)(6) with no further changes. On April 5, 2024, EPA finalized amendments to the EtO Sterilizers NESHAP based on the results of a residual risk and technology review outside the scope of CAA statutory authority.