The US Environmental Protection Agency (EPA) has proposed two much-anticipated rules that would restrict how much ethylene oxide (also referred to as EO or EtO) medical device sterilizers are allowed to use and release into the environment, and how much of it workers can be exposed to. The agency said its aim is to reduce cancer risk for workers and communities adjacent to EtO sterilization plants.
Years in the works, EPA announced the two proposed rules on 11 April, alongside the US Food and Drug Administration’s (FDA) announcement of a pilot project to help manufacturers of class III devices move their sterilization processes away from EtO. EPA also consulted the Occupational Health and Safety Administration (OHSA) when developing the rules…
