the U.S. Environmental Protection Agency (EPA) is issuing an Advance Notice of Proposed Rulemaking (ANPRM) to solicit 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 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.

EPA recognizes the important role of ethylene oxide in sterilizing medical devices. According to the Food and Drug Administration (FDA), about half of all medical devices, more than 20 billion, are sterilized using ethylene oxide each year. As 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,” said EPA Administrator Andrew Wheeler. “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.”

Today’s ANPRM offers industry and the public the opportunity to comment on the potential approaches that EPA could take in the development of a future rulemaking for commercial sterilization facilities. EPA is also taking two additional actions in preparation for a potential future rulemaking for these facilities:

• 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 the rule development.
• EPA is issuing a request for information under CAA section 114 to gather information from several 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. Ethylene oxide – a hazardous air pollutant – is emitted from several types of industrial facilities that are regulated by EPA. The agency has begun its review of its air toxics emissions standards for miscellaneous organic chemical manufacturing (often referred to as the “MON”), and recently issued proposed amendments to the MON that would reduce ethylene oxide emissions from this sector by 93 percent. EPA also plans to take a closer look at its rules for other types of facilities, beginning with emission standards for commercial sterilizers.

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. In 2016, EPA updated its risk value for ethylene oxide.