EPA Releases Interim Decision for Ethylene Oxide to Protect Workers and Communities

In January 2025, the U.S. Environmental Protection Agency (EPA) released an Interim Decision for Ethylene Oxide (EtO)¹. This Interim Decision includes mitigation measures that will reduce exposure to EtO for workers and nearby communities and will work in conjunction with the April 2024 Final Air Toxics Rule for EtO sterilization facilities².

Exposure in nearby communities is mainly to people who live, work, or play near sterilization facilities and breathe in EtO from the air⁴. There is no information to suggest that there are health risks associated with EtO in soil or water near these sterilization facilities, but EtO is on the EPA method 8260 compound list and is analyzed by Purge and Trap (P&T) with a detection limit around 20-100 parts per billion (ppb)³.

EtO is known to cause cancer, including leukemia, breast cancer, non-Hodgkin lymphoma, and myeloma. Workers who use EtO and people who live in communities near industries that use it may breathe in emissions at levels that can increase the cancer risk. The greatest risk is to those workers who have worked their entire careers in industries that directly handle EtO with poor worker protections¹.

Highlights of the Interim Decision for Commercial Sterilizers and Healthcare Facilities include¹:

• Lowered worker EtO exposure limits, down to 0.1 ppb by 2035 compared to the 1984 Occupational Safety and Health Administration (OSHA) limit of 1 ppm. Any workers who could be exposed to limits of EtO greater than this will need to wear additional respiratory protection.
• Ban of use for museum, library, and archival materials, cosmetics, musical instruments, and beekeeping equipment.
• Ban of use of EtO for specific dried herbs and spices. EtO is a pesticide used on about 30% of dried herbs and spices¹.
• New concentration limit for medical device sterilization cycles. EtO is used in the United States on 50% of all sterilized medical devices¹.
• Separation of HVAC systems for areas where EtO is used and areas where it is not used.
• Continuous EtO monitoring in sterilization facilities with data requirements to monitor breathing zone worker exposure to EtO.
• Require abatement devices for healthcare facilities that use more than 10 pounds/year of EtO.
• Ventilation of EtO through exterior ventilation stacks to reduce exposure to healthcare workers.

EPA expects label amendments to the Interim Decision, but those will be quickly reviewed and changes incorporated into the Decision. EPA also expects two to 10 years for implementation of individual mitigation measures, taking into consideration the costs, technology available, potential impacts to the medical device supply chain and other logistical factors¹.

With already established low detection limits for EtO, will detection limits continue to be lowered due to its potential health risks, even if these risks are not known or studied enough in soil and water? Either way, with just a few method modifications, your Tekmar P&T can prepare your sample for parts per trillion (ppt) analysis. Be sure to reach out to our technical support team at TekmarSupport@Teledyne.com if you need assistance.

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Resources

1. United States Environmental Protection Agency. (2025, January 14). “EPA Finalizes Protections for Workers and Communities from Cancer-Causing Ethylene Oxide Pollution.” EPA Finalizes Protections for Workers and Communities from Cancer-Causing Ethylene Oxide Pollution | US EPA
2. United States Environmental Protection Agency. (2024, April 9). “Ethylene Oxide Emissions Standards for Sterilization Facilities: National Emission Standards for Hazardous Air Pollutants (NESHAP).” Ethylene Oxide Emissions Standards for Sterilization Facilities: National Emission Standards for Hazardous Air Pollutants (NESHAP) | US EPA
3. United States Environmental Protection Agency, Office of Solid Waste. “Volatile Organic Compounds by Gas Chromatography/Mass Spectrometry (GC/MS).” SW-846 Method 8260C, Revision 3, August 2006.
4. United States Environmental Protection Agency. “What is EtO? What are the Risks.” What is EtO and What are the Risks?