EPA Finalizes Worker and Community Protections from Uses of Ethylene Oxide
EPA has imposed new restrictions on uses of ethylene oxide (EtO), a pesticide used primarily to sterilize medical devices. The restrictions include the cancellation of certain uses and the establishment of an occupational exposure limit for EtO in commercial sterilization facilities of 0.5 ppm as an eight-hour time-weighted average (TWA). This OEL, which takes effect in 2028, will be lowered to 0.25 ppm by 2030 and 0.1 ppm by 2035. The current OSHA permissible exposure limit for EtO is 1 ppm, which was established in 1984.
Both EPA and the U.S. National Toxicology Program classify EtO as a known human carcinogen. Other health effects from exposure to EtO include lung irritation, headaches, memory loss, numbness, nausea, and vomiting, according to the Agency for Toxic Substances and Disease Registry.
EPA’s restrictions are part of an “interim decision” the agency reached during its review of EtO to determine whether it still meets the registration criteria under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The agency says it tries to conduct FIFRA reviews of substances every 15 years. When more data on occupational exposures become available, EPA may reevaluate its interim decision.
The interim decision terminates the use of EtO for museum, archival, and library materials; cosmetics; musical instruments; and beekeeping equipment. It limits the concentration of EtO used to sterilize new medical devices to 600 mg/L by 2035, and it requires areas where the substance is used to be serviced by a separate HVAC system. Workers involved in some high-exposure tasks must wear respiratory protection, and continuous monitoring is required throughout sterilization facilities. Healthcare facilities where EtO is used must ventilate it through exterior stacks to reduce exposure to workers.
About half of all sterilized medical devices in the United States each year are sterilized with EtO. The substance is also used to sterilize approximately 95 percent of all surgical kits. An estimated 14 million pounds of EtO are used for sterilization each year in the U.S.
Documents related to EPA’s interim decision on EtO are available in the docket on Regulations.gov. The interim decision itself can be downloaded as a PDF. For more information, see EPA’s news release and the agency’s EtO webpage. ATSDR’s toxicological profile for EtO is published as a PDF on the agency website.
