05 December 2019

EPA One Step Closer to Updating Ethylene Oxide Regulations

The White House Office of Management and Budget completed its review on November 26 of the United States Environmental Protection Agency’s (EPA or Agency) advance notice of proposed rulemaking (ANPRM) that will outline potential Agency approaches to updating the Maximum Achievable Control Technology (MACT) standard for emissions of ethylene oxide (EtO) from sterilization and fumigation facilities. EtO emissions have generated intense and focused debate for federal and state environmental regulators after recent controversial changes to EPA’s risk value and the National Air Toxics Assessment (NATA) report. The ANPRM will solicit public comment on calculating and controlling fugitive EtO emissions, improving EtO monitoring technologies and categorizing the differences among medical sterilization facilities. EPA has also pledged to use its Clean Air Act (CAA) section 114 authority to gather more information directly from sterilization facilities about their facility specifications, work practices and costs of emissions control devices.