Weekly Policy Blog: Ethylene Oxide – EPA’s Proposed Rules 

Ethylene Oxide (EtO or EO) is a colorless gas used commercially in a wide variety of ways. It is one of the most common and proven ways to sterilize medical devices. EtO’s proven effectiveness means this method sterilizes approximately 50% of all medical devices — 20 billion — in the U.S. each year. Other methods of sterilization include ionizing radiation, steam (autoclaving), and chemical agents (such as hydrogen peroxide or peracetic acid), but these methods pose challenges which hinder their usability and effectiveness for the sterilization of many medical devices and supplies — which has led innovators in the MedTech community to work on alternative methods for sterilization. Many devices cannot currently be effectively sterilized by methods other than EtO sterilization, though, so EtO is crucial to ensuring patient access to life-saving medical technologies and other medical products. 

EtO sterilization is a highly regulated process. Device manufacturers, hospitals, and third-party sterilizers follow rigorous controls established by the Food and Drug Administration (FDA), the Environmental Protection Agency (EPA), the Occupational Safety and Health Administration (OSHA), and other government agencies to protect patients, workers, and the environment. 

The EPA is performing a risk assessment and updating guidance and proposing new regulations pertaining to workers’ and communities’ exposure to EtO emissions. In April 2023, the EPA announced two proposed changes to EtO emission standards. The first proposed rule, under the National Emission Standards for Hazardous Air Pollutants (NESHAP), would impose new EtO emissions standards for sterilization facilities by implementing Section 112 of the Clean Air Act. The second change, a proposed interim decision under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), would lower the amount of EtO used per sterilization cycle for medical devices at sterilization facilities as well as require updates in engineering controls and personal protective equipment (PPE) at commercial sterilization facilities. 

CBSA, the MedTech industry, and our member companies that use EtO sterilization have demonstrated a long-standing safe sterilization process that protects employees and the communities surrounding sterilization facilities and maintains an uninterrupted supply of billions of pieces of sterile medical technologies and supplies on which patients and physicians depend. We are concerned that patient access will immediately be at risk if the regulations, as proposed, are finalized too quickly. According to AdvaMed’s data, finalization of the proposals as written would lead to a reduction in device sterilization of 30-50% nationwide, and 70% at some facilities. 

We strongly urge the EPA to embrace technology-neutral solutions to meet new emissions targets. Multiple technologies could be necessary to achieve regulatory goals; regulations that are unnecessarily restrictive might foreclose options that would keep sterilization facilities open and operating safely while serving American patients nationwide. Innovators in the MedTech community are working to develop alternative methods for sterilization, but EtO sterilization is still — and will continue to be — crucial to maintaining the medical device supply chain. 

How is CBSA Engaging? 

CBSA submitted a comment letter to the NESHAP and FIFRA dockets during the open comment period for the proposed changes that closed on June 27, 2023. We advocated for a longer comment period as well as alternative solutions to meet the EPA’S new emissions standard goals while allowing facilities to continue their sterilization operations and ensure uninterrupted access for patients to these critical, life-saving medical technologies and supplies. 

CBSA and national partners are continuing to follow this activity very closely and working with the life sciences ecosystem to make sure the information being shared about the safety of EtO is accurate. CBSA will continue advocating for the life sciences ecosystem and patients. 

Learn More 

Read about CBSA’s recent engagement on EtO.  

To learn more about EtO and its role in our healthcare system, as well as what sterilization companies are doing to control emissions, please visit the resource section on “Ethylene Oxide & Sterilization” developed by our national partner, AdvaMed. 

Categories: CBSA News