The EPA wants new ethylene oxide rules to measure and reduce emissions from chemical plants that make, store or use EtO, which is the most common method of medical device sterilization.
The agency said its proposal would reduce annual EtO emissions by 58 tons and decrease the number of people with an elevated cancer risk due to their proximity to chemical plants by 96 percent.
Facilities that make, store, use or emit EtO — as well as chloroprene, benzene, 1,3-butadiene, ethylene dichloride or vinyl chloride — would be required to monitor air pollutant levels at the site’s fenceline.
If those sensors detect 0.2 micrograms of EtO per cubic meter of air, the facility owner and operator would need to identify and fix the source. That monitoring data would also be publicly available through the EPA’s WebFiRE database tool.
“The proposal would reduce cancer risks from breathing in toxic air pollutants that are emitted from the specific processes and equipment covered under the rules,” the EPA said in a news release. “These pollutants are linked to a number of cancers, including lymphoma, leukemia, breast cancer and liver cancer, among others. EPA also expects the proposal to benefit children, who are more susceptible to the effects of EtO and chloroprene.”
The agency said the proposed new ethylene oxide rules are based on similar Clean Air Act requirements for identifying and reducing benzene emissions from petroleum refineries.
The EPA said it plans to announce proposed updated regulations for commercial sterilization facilities that emit EtO. The agency is also developing proposed rules for other EtO sources, such as polyether polyols production, hospital sterilizers and smaller chemical manufacturers.
The FDA and medical device industry are working on safer ways to use EtO and alternative means of sterilization. Sterilization facilities are already at capacity, and industry association AdvaMed has voiced concerns that new EtO regulations could lead sterilization companies to close facilities and cause device shortages.