January 14, 2025
Contact Information
EPA Press Office (press@epa.gov)
WASHINGTON – Today, Jan. 14, the U.S. Environmental Protection Agency released the Interim Decision for Ethylene Oxide (EtO) – a pesticide used on 50 percent of all sterilized medical devices in the United States and on approximately 30 percent of dried herbs and spices. EtO is known to cause cancer, including lymphocytic leukemia, breast cancer, non-Hodgkin lymphoma and myeloma in people. Workers who use EtO and people who work, live, or go to school or daycare near facilities that use EtO may breathe in emissions at levels that can increase cancer risk. The greatest risk is for people who work for their entire careers at facilities directly handling EtO with insufficient worker protections in place.
The Interim Decision includes mitigation measures that, in addition to the measures included in the 2024 EtO National Emissions Standards for Hazardous Air Pollutants (NESHAP), will reduce exposure to workers and nearby communities. Together, these two EPA actions provide a comprehensive approach to addressing EtO pollution concerns, including cancer risk, that will increase safety in communities and for workers while supporting ongoing supply chain needs for sterilized medical equipment. This decision advances President Biden’s commitment to ending cancer as we know it as part of the Cancer Moonshot, as well as the Administration’s commitment to securing environmental justice and protecting public health, including for communities that are most exposed to toxic chemicals.
“EPA continues to make important strides to protect people from dangerous chemicals like ethylene oxide,” said Assistant Administrator for the Office of Chemical Safety and Pollution Prevention Michal Freedhoff. “These protections will reduce EtO exposures to workers and communities, while also ensuring that the chemical remains available to provide sterile life-saving medical supplies.”
Ethylene Oxide
EPA regulates EtO’s use as a pesticide under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). EtO has both antimicrobial uses, such as sterilization of medical devices, and conventional uses, such as fumigation of dried herbs and spices. In some instances, such as with sterilization of medical devices like surgical kits, EtO is the only available option, making it essential for protecting human health. Every 15 years, EPA evaluates potential human health and environmental effects associated with the use of a pesticide through the registration review process. As part of EtO’s registration review, the agency assessed cancer risk from working in sterilization and health care facilities that use EtO, living in communities near EtO facilities, and consuming dried herbs and spices treated with EtO.
After a 75-day public comment period with over 60 stakeholder meetings with industry, other federal agencies, unions, and nonprofit organizations, EPA identified a broad set of protections under FIFRA that aim to reduce exposure to all EtO sterilization facility workers and to others who work, live, or go to school near sterilization facilities. Specifically, the Decision includes a reduced EtO concentration rate limit for new medical device sterilization cycles to reduce levels of exposure for workers; a lowered worker exposure limit of 0.5 ppm after three years, 0.25 ppm after five years, and 0.1 ppm after 10 years (compared to the current Occupational Safety and Health Administration standard of 1 ppm); phased cancellation of the use of EtO on specific dried herbs and spices; and cancellation of the use of EtO when safer and effective alternatives are available.
Interim Decision
Some of the highlights of the Interim Decision include:
Commercial Sterilizers
Lowered worker exposure limit of 0.5 ppm by 2028, 0.25 ppm by 2030, and 0.1 ppm by 2035, as compared to the 1984 OSHA limit of 1 ppm. Any workers who could be exposed to concentrations of EtO above these limits would need to wear additional respiratory protection.
Finalizing the ban of use for museum, library and archival materials; cosmetics; musical instruments; and beekeeping equipment.
Immediate cancellation of the use of EtO for specific dried herbs and spices for which its use is not considered critical for food safety, and phased cancellation for specific dried herbs and spices for which EtO use is considered critical for food safety but have potential alternatives to EtO.
Establishing a concentration limit of 600 mg/L for new medical device sterilization cycles within 10 years. If a device requires a concentration of EtO greater than 600 mg/L due to the device design, the facility must maintain records to justify the increased application rate.
Separation of HVAC systems for areas where EtO is used and areas where EtO is not used, to reduce EtO exposure in areas such as offices.
Requiring respirators to protect workers involved in certain high EtO exposure tasks, such as connecting and disconnecting EtO containers from sterilization process equipment.
Continuous EtO concentration monitoring throughout sterilization facilities, including on-site storage facilities.
Data requirements to monitor breathing zone worker exposure to EtO within commercial sterilization facilities and warehouses that store sterilized materials, both on and off-site.
Healthcare Facilities
Require abatement devices for healthcare facilities that use more than 10 lbs. of EtO/year by comparison – c commercial sterilizers typically release tons of EtO annually.
Ventilation of EtO through exterior ventilation stacks to reduce exposure to healthcare facility workers. Exposure to communities from EtO used in healthcare facilities is expected to be minimal because the amount of EtO used at healthcare facilities is orders of magnitude lower than at commercial sterilization facilities.
Next Steps
EPA expects that registrants will submit label amendments that include the changes outlined in the Interim Decision within 60 days after publication. The agency plans to quickly review the label amendments so that products sold and distributed by registrants will include the changes outlined in the Interim Decision. The timing for implementation for individual mitigation measures ranges from two years to 10 years, taking into consideration the costs, technology availability, potential impacts to the medical device supply chain and other logistical elements. Additionally, EPA will issue a Data Call-In (DCI) to gather information on worker exposure. Specifically, the DCI will require submission of worker exposure data for commercial sterilizers and warehouses in order to understand the worker exposure impacts of complying with EPA’s Clean Air Act EtO commercial sterilization NESHAP and implementing the mitigation measures identified in this Interim Decision. EPA will reevaluate this Interim Decision within eight years, earlier than the typical 15-year cycle, based on the submitted worker exposure data, in order to identify further opportunities to reduce EtO exposures.
To view all documents related to EtO’s registration review, visit docket EPA-HQ-OPP-2013-0244.
Read the full article.
