EPA proposes new rule for managing ethylene oxide in facilities

Certain products containing ethylene oxide (EtO) are considered pesticides under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) because they can be used to kill viruses and bacteria.

For instance, EtO can be used as a pesticide to sterilize certain equipment, including some medical devices like implants and surgical tools that cannot be sterilized using alternative methods such as steam or radiation due to lack of compatibility with certain materials.

However, because regular exposure to EtO over long periods of time can pose cancer risks, the Environmental Protection Agency (EPA) is working to mitigate these risks. The EPA has issued a proposed interim decision with the following recommendations that will impact health care:

Use-rate reduction for medical equipment sterilization. The EPA proposes lowering the amount of EtO used per sterilization cycle for medical devices at sterilization facilities while continuing to meet requirements from the Food and Drug Administration for sterility assurance.

Engineering controls for health care facilities. The EPA proposes requiring health care facilities to implement engineering controls to reduce exposure to EtO, including:  

• Separating EtO sterilization spaces from other work areas to reduce the broader circulation of EtO;  
• Implementing negative air pressure in rooms containing EtO sterilization devices to ensure that air will not flow from a room with a higher EtO concentration into the rest of the health care facility;   
• Using abatement devices (i.e., equipment used to capture polluting substances) that will remove EtO from the exhaust air and reduce discharge to the environment; and  
• Discharging exhaust air from EtO sterilization devices through exterior ventilation stacks after passing through abatement devices to reduce the amount of EtO re-entrained into the building.

Visit the EPA’s website for additional information and a link to submit comments by June 27.