- The Environmental Protection Agency is considering applying ethylene oxide (EtO) reporting requirements to facilities run by companies including Boston Scientific and Sterigenics.
- EPA has written to the operators of 31 medical device sterilization facilities to outline its plans and request information to inform its final decision. The agency chose the facilities based on the amount of EtO they are estimated to use and other factors such as their proximity to population centers.
- A final decision is due after the 30-day comment period. If EPA puts reporting requirements on some or all of the facilities, it will advance a multi-year effort to balance the risks of the carcinogen against the benefits it brings in the sterilization of medical devices. The move follows an Office of Inspector General report in May that advised EPA to conduct a fresh review of residual cancer risks from EtO emissions.
EPA is under pressure to act against EtO. While FDA has warned the closure of sterilization facilities will cause shortages of medical devices, the Office of Inspector General wants EPA to ensure risks are reduced to an acceptable level "without considering costs." New EPA regulations on commercial sterilizers are unlikely to arrive before the fourth quarter of 2022, though.
In the meantime, EPA is considering using its existing powers to extend Toxics Release Inventory (TRI) reporting requirements to specific facilities. EPA uses TRI to require U.S. facilities to report how much of a particular toxic chemical they release into the environment or manage through recycling, energy recovery and treatment each year. U.S. law empowers EPA to extend the reporting requirements as it deems appropriate.
EPA plans to apply the reporting requirements to 31 facilities that it thinks handle EtO. The proposal covers eight facilities run by Sterigenics, the contract sterilizer that was an early focal point of the pushback against the release of EtO and the subject of a raft of lawsuits. Steris and its Isomedix unit, which it bought in 1997 to move into contract sterilization, run eight of the targeted facilities.
Boston Scientific runs one of the targeted facilities, which it bought from Steris in 2009. The following year, Boston Scientific secured a permit to "increase the allowable emissions of ethylene oxide." The facility has been used to sterilize medical devices including a balloon catheter from Stryker.
All of the letters set out EPA's right to impose additional reporting requirements on the facilities and explain the information plant operators will need to share. AdvaMed CEO Scott Whitaker responded in an emailed statement to the letters.
"For many years, AdvaMed has cooperated and worked with the EPA and state environmental regulators in their efforts to better understand the use and impacts of ethylene oxide, including its important role in sterilizing medical equipment and how contract sterilizers have significantly reduced ethylene oxide emissions over the years.
“Contract sterilizers also continue their commitment to their local communities and employees with significant investments in environmental abatement technology. The industry welcomes the EPA's federal rule on this issue and looks forward to showcasing how proficient contract sterilization facilities are at capturing, abating and removing EtO emissions,” Whitaker said.