Companies that use ethylene oxide to sterilize medical products would have to significantly reduce employee and community exposure to the carcinogenic chemical under a proposed rule the Environmental Protection Agency announced Tuesday.
Ethylene oxide, or EtO, is a colorless gas used to sterilize medical equipment such as syringes, catheters, infusion pumps, surgical kits and pacemakers. Companies prefer this highly effective, versatile sterilization method, but research links long-term EtO exposure to lymphohematopoietic cancers, non-Hodgkin’s lymphoma, Hodgkin’s disease, leukemia, and cancers of the stomach, esophagus, rectum, liver, breast, pancreas, prostate, bladder, kidney and brain. Short-term exposure can cause difficulty breathing, blurred vision, dizziness, nausea, headache, convulsions, blisters and vomiting.
The EPA estimates the additional lifetime cancer risk associated with workplace exposure to EtO for 8 hours a day, 240 days a year, over 35 years in an occupational setting is between 1 in 25 employees at sterilization plants and 1 in 12 employees who use ethylene oxide in healthcare facilities.
The agency proposes to limit the amount of ethylene oxide that can be used for medical device sterilization while maintaining standards for sterility. If finalized, EtO emissions from sterilization facilities would decline 80% per year, improving community health, according to the EPA.
“Together [the proposals] would significantly reduce worker and community exposure to harmful levels of ethylene oxide,” EPA Administrator Michael Regan said in a news release. “EPA will continue to use every available tool to safeguard our nation’s communities, including workers, from exposure to toxic chemicals and to deliver important public health protections.”
Several states enacted ethylene oxide rules while waiting for the EPA to develop federal standards.
Sterigenics, a leading medical supply sterilization company, faces multiple lawsuits alleging it exposed people to ethylene oxide who later developed cancer. The cases include one brought in 2018 by then-Illinois Attorney General Lisa Madigan (D). Last year, an Illinois jury ordered the company to pay $363 million to a woman who lived near one of its facilities and contracted cancer.
The EPA will accept comments for 60 days after the proposed rule appears in the Federal Register.