December 2, 2021

EPA May Require Contract Sterilization Facilities to Report Ethylene Oxide Releases

EPA has notified 31 contract sterilization facilities that they may soon be required to report releases of ethylene oxide (EtO), a colorless, flammable gas determined to be a human carcinogen and to cause respiratory irritation and other acute health effects. EtO is used to sterilize some medical and dental equipment and other items that cannot be sterilized using steam. In a news release issued on Oct. 13, the agency describes the action as a “critical first step” in efforts to expand the scope of the Toxics Release Inventory (TRI) Program, which tracks the management of chemicals used in U.S. facilities that are known cause cancer, significant acute human health effects, or environmental effects.

Although the 31 facilities were not previously required to report EtO releases, EPA believes them to use the largest amounts of EtO in the contract sterilization sector and to exceed the TRI reporting threshold for the chemical. According to the agency’s press release, EPA also considered factors such as the density of populations living near the facilities and the facilities’ histories of EtO releases in its decision to extend TRI reporting requirements to these facilities. EPA’s notice letters gave each facility 30 days to provide information that may inform its final decision, such as evidence that EtO is no longer used in the facility. Some facilities may also be required to report releases of ethylene glycol, a chemical produced using EtO.

EPA’s TRI Program is intended to incentivize companies to improve environmental performance by making information about industrial toxic chemical management publicly available. EtO has been on TRI’s toxic chemicals inventory since the program’s inception in 1987. To learn more about TRI, visit the program’s webpage.

Related: A consulting industrial hygienist discussed his participation in the sampling of EtO from a release associated with a sterilization facility in Willowbrook, Illinois, via a prerecorded session for AIHce EXP 2020. The health effects associated with EtO exposure are further covered in a draft toxicological profile published by the Agency for Toxic Substances and Disease Registry.