EPA moves to reduce ethylene oxide emissions

Washington — The Environmental Protection Agency intends to significantly reduce emissions of ethylene oxide – a gas used to sterilize medical devices that’s been linked to cancer and neurological problems – under a new final rule.

In a March 14 press release, the agency says people who live, work or attend school near sterilization facilities that use EtO may face an elevated cancer risk. The rule will require commercial sterilization facilities and other plants that use EtO to install available and proven technologies, practices and procedures that have been shown to reduce EtO emissions. EPA claims the move will cut EtO emissions from commercial sterilizers by 90%.

“Once the rule is in full effect, no individual will be exposed to EtO at levels that correspond to a lifetime cancer risk of greater than 100 in 1 million, which is the benchmark for elevated cancer risk under the Clean Air Act,” Tomás Carbonell, deputy assistant administrator for stationary sources in EPA’s Office of Air and Radiation, says in an EPA video discussing the rule.

EPA – under the Federal Insecticide, Fungicide, and Rodenticide Act of 1947 – is also “reevaluating how EtO is used within sterilization facilities, with the goal of reducing risks to workers who handle EtO” and anyone otherwise exposed, Carbonell adds.

The rule will increase requirements for continuous monitoring at facilities and regular emissions reporting.

In a separate press release, American Lung Association President and CEO Harold Wimmer calls on the agency to move forward with additional safeguards, “including measures to protect workers from ethylene oxide and final chemical plant rules that will further reduce these emissions. Other federal agencies must take steps to collaborate to find more alternative sterilizers.”

In April, EPA issued separate proposals – one aimed at workers and the other focused on the general public – to reduce annual EtO emissions at sterilization facilities.