Final Amendments to Strengthen Air Toxics Standards for Ethylene Oxide Commercial Sterilizers
March 17, 2024
On March 14, 2024, EPA announced final amendments to the National Emission Standards for Hazardous Air Pollutants (NESHAP) for Ethylene Oxide Commercial Sterilizers. Since 2019, EPA has been gathering information about how to reduce people’s risk from exposure to ethylene oxide (EtO). This rule is one of the most important measures EPA is taking to reduce emissions of EtO while mitigating and managing any potential supply chain impacts. The Clean Air Act standards EPA is finalizing will reduce lifetime cancer risks associated with EtO emissions from commercial sterilizers down to or below the benchmark of 100 cancer cases per million people exposed. And the number of people with a potential risk of greater than or equal to one in one million will be reduced by approximately 92 percent.
Regulatory Documents
- Final Air Toxics Rule for EtO Sterilization Facilities (pdf)
- Regulatory Impact Analysis for the Final Air Toxics Standards for EtO Sterilization Facilities (pdf)
- Rule History
Additional Information
Recent News
- bioMérieux strengthens its next-generation sequencing capabilities with the acquisition of Day Zero Diagnostics solutions and technologies
- DGENTHERA AND NUSANO SIGN LETTER OF INTENT FOR ASTATINE‑211 SUPPLY
- 2025 BIO International Recap
- Halia Therapeutics Completes First-in-Human Phase 1 Study of HT-4253, a Novel LRRK2 Inhibitor Targeting Neuroinflammation
- Nelson Labs to Double Cleanroom Capacity to Support Growing Demand for Sterility Assurance Services
- RATIO THERAPEUTICS AND NUSANO ENTER LONG-TERM, MULTI-ISOTOPE SUPPLY AGREEMENT TO BOOST PRODUCTION OF CANCER RADIOPHARMACEUTICALS
