Proposed Reconsideration for 2024 Commercial Sterilizer Rule
In response to legal, scientific and policy concerns, including the critical medical supply chain issue the U.S. faces due to the 2024 NESHAP rule, EPA is proposing the repeal of the burdensome Biden-era 2024 final rule for National Emission Standards for Hazardous Air Pollutants (NESHAP) for Ethylene Oxide (EtO) Commercial Sterilization Facilities. EtO is used to sterilize 50 percent of all medical devices in the U.S. every year—that’s 20 billion medical devices. Without EtO, it is impossible to develop a secure domestic supply chain of these critical medical devices that newborns, the elderly, and Americans undergoing surgery rely on daily to survive. If finalized as proposed, EPA’s action will ensure a strong domestic supply chain of commercial sterilized medical equipment. EPA is focused on taking actions that will save lives and protect Americans from unnecessary EtO exposure.
Regulatory Documents
- Proposed Reconsideration for EtO Sterilization Facilities (91 FR 12700)
- Regulatory Impact Analysis for the Proposed National Emission Standards for Hazardous Air Pollutants: Ethylene Oxide Emission Standards for Sterilization Facilities Residual Risk and Technology Review Reconsideration (pdf)
- Historical Actions