Federal Partnerships Related to Ethylene Oxide (EtO)
As EPA works to decrease EtO exposure nationwide, we have and will continue to partner closely with federal agencies and the private sector to maintain the essential medical supply chains needed for lifesaving care. In addition to EPA, the agencies below play a special role in understanding and addressing EtO risk and in maintaining the safety of medical devices, spices and other products.
Centers for Disease Control
- The Agency for Toxic Substances and Disease Registry (ATSDR) provides scientific and health effects information on EtO. One resource is ATSDR’s Toxicological Profile for Ethylene Oxide and accompanying information sheet ToxFAQsTM.
- The National Institute for Occupational Safety and Health (NIOSH) is a research agency focused on assuring safe and healthy working conditions. Access NIOSH resources on EtO.
The Food and Drug Administration (FDA)
EPA has been and will continue to work with FDA to reduce risk from EtO exposure while providing a path to maintain a robust supply chain for sterilized medical equipment.
Before medical devices labeled “sterile” go onto the market, FDA reviews the sterilization information provided in regulatory submissions. FDA also inspects facilities that sterilize medical devices to make sure the sterilization processes have been validated. The sterilization processes are commonly validated using FDA-recognized consensus standards. FDA is conducting innovation challenges to identify new sterilization methods and technologies and to reduce ethylene oxide emissions. Learn more on the innovative challenges.
The Occupational Safety and Health Administration (OSHA)
OSHA’s mission is to ensure safe and healthful working conditions for workers. OSHA sets workplace standards for EtO exposure and provides other resources for employers. Read a fact sheet from OSHA (pdf).
EPA and OSHA have worked closely together on reducing exposure from EtO and will continue to work together as proposed solutions to reduce risk to workers are implemented.