The U.S. Environmental Protection Agency seeks input information from industry and the public on strategies for further reducing ethylene oxide emissions from commercial sterilization and fumigation operations. This is part of a suite of actions the EPA is taking related to ethylene oxide, including reviewing and updating regulations for sources that emit ethylene oxide, and working closely with state and local agencies to better understand and address ethylene oxide emissions at facilities.
Background on ethylene oxide
Ethylene oxide is one of 187 hazardous air pollutants regulated by the EPA. Ethylene oxide is a flammable, colorless gas used to make other chemicals that are used in making a range of products, including antifreeze, textiles, plastics, detergents and adhesives. Ethylene oxide also is used to sterilize equipment and plastic devices that cannot be sterilized by steam, such as medical equipment.
According to the Food and Drug Administration, about half of all medical devices, more than 20 billion, are sterilized using ethylene oxide each year. As the EPA works to evaluate options for reducing air emissions from commercial sterilizer operations, the agency is coordinating closely with FDA and other federal partners.
“Today’s action is another step in the Trump Administration’s efforts to address ethylene oxide emissions across the country and soliciting feedback from citizens and stakeholders is an important step in the process,” EPA Administrator Andrew Wheeler said. “Medical device sterilization is vital to protecting public health. As EPA takes steps to reduce ethylene oxide emissions from facilities we are committed to working with our federal partners as they are working to advance medical device sterilization.”
The EPA is soliciting nominations for representatives for small entities potentially subject to a future rulemaking to advise a Small Business Advocacy Review Panel that would focus on rule development seeks input from commercial sterilization companies on facility characteristics, control devices, work practices and costs for emission reductions.
EPA’s actions on ethylene oxide
EPA is taking a two-pronged approach to address ethylene oxide emissions: reviewing Clean Air Act regulations for industrial facilities that emit ethylene oxide and working closely with state and local air agencies to get additional information on facility emissions to determine whether more immediate emission reduction steps are needed.
The Clean Air Act requires EPA to regulate emissions of hazardous air pollutants from industrial facilities and to control these emissions by developing and implementing standards and guidelines.
More information about ethylene oxide can be found at epa.gov/hazardous-air-pollutants-ethylene-oxide.