CHA News

EPA Proposes to Tighten Standards on Chemicals Used to Sterilize Equipment

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The Environmental Protection Agency (EPA) has released a proposal focused on emission standards for ethylene oxide’s (EtO) use in commercial sterilization facilities. EtO is a type of gas used to sterilize certain medical devices that cannot be sterilized using alternative methods.  

The proposal focuses on stricter emission and control standards and worker protection. The proposal would cut EtO’s emissions to the air from commercial sterilization facilities by 80% per year. It would also introduce new safeguards to protect workers. They include reducing the amount of EtO that may be applied for medical device sterilization while meeting applicable standards for sterility assurance and mandating personal protective equipment in sterilization facilities when EtO is detected.  

The EPA also announced a proposal to significantly reduce emissions of toxic and other harmful air pollution from chemical plants, including EtO. It would significantly strengthen and update several Clean Air Act regulations, which apply to a variety of equipment and processes used to make synthetic organic chemicals and a variety of processes used in polymers and resins production, including neoprene production.  

The proposal is intended to reduce air toxics-related cancer risks for people who live near approximately 200 plants across the country that make synthetic organic chemicals. Additional information is available in an EPA fact sheet.  

The EPA will host a public webinar on May 1 at 5 p.m. (PT) to provide an overview of the proposed actions.