The Environmental Protection Agency on Tuesday proposed limiting the use of the chemical ethylene oxide after finding a higher than expected cancer risk at facilities that use it to sterilize billions of medical devices each year.
The EPA says its proposal will reduce ethylene oxide emissions by roughly 80% by targeting 86 medical sterilization facilities across the United States. The companies will also have to test for the antimicrobial chemical in the air and make sure their pollution controls are working properly.
“EPA’s number one priority is protecting people’s health and safety,” EPA Administrator Michael Regan said in a statement. The agency’s proposals “would significantly reduce worker and community exposure to harmful levels of ethylene oxide,” he said.
Darya Minovi, a senior research analyst with the Union of Concerned Scientists, called the action overdue by “almost a decade” and said it should have gone further to require monitoring at facility fence lines so people know what is entering their neighborhoods.
“I’m relieved and pleased that the EPA has finally issued proposed standards that are based on their own scientists’ recommendations on an updated, higher cancer risk value,” Minovi said in a statement.
The tightened safeguards are driven by the EPA’s better understanding that ethylene oxide’s threat is severe. The chemical is classified as a pesticide. A worker in a medical sterilizing plant, over the course of a career, could see their risk shoot up by as much as one extra case of cancer for every 10 people exposed. The EPA’s generally acceptable increase in lifetime cancer risk is 1 in 10,000.
Ethylene oxide is a gas used to sterilize roughly half of all medical devices and is also used to ensure the safety of certain spices and other food products. It is used to clean everything from catheters to syringes, pacemakers and plastic surgical gowns. Brief exposure isn’t considered a danger, but breathing it long term elevates the risk of breast cancer and lymphoma, according to the agency.
In 2016, the EPA updated its assessment of ethylene oxide’s danger based on information about exposed workers at sterilizing facilities, finding the chemical was many times more threatening than previously known. Analysis released by the agency two years later found that cancer risk was too high near some medical sterilization plants and some other facilities that release ethylene oxide.
“That set off a regulatory alarm bell,” said Marvin Brown, an attorney at the environmental group Earthjustice.
Public concern grew. Sterigenics shuttered a medical sterilization plant in a Chicago suburb after monitoring found emissions spikes in nearby neighborhoods. They eventually settled numerous lawsuits. (ABC)