In the coming months, the EPA plans to strengthen protocols for manufacturers that emit ethylene oxide. The agency first designated the chemical a human carcinogen in 2016. The impending rule will be its first formal regulation of EtO under the Clean Air Act since 2006.
The rule has major implications for the healthcare industry, which relies on the gas to sterilize medical devices and equipment. Ethylene oxide, or EtO, is used to sterilize 20 billion pieces of medical equipment per year, including syringes, catheters, infusion pumps, surgical kits and pacemakers.
In a delicate supply chain, any disruption could lead to shortages, which could delay patient care. The EPA is having to govern in this environment while taking into consideration another public health priority: emissions from sterilization facilities increase the risk of cancer in nearby communities.
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There is no scalable alternative, so the agency has its eye on reducing emissions. But there may be little more to regulate absent an all-out ban. “When you’re talking about the safe use of a known human carcinogen, in general, government consensus and government agencies believe in reduction to zero, because we don’t think there’s any safe level of known carcinogen exposure to people,” said Dr. Peter Orris, chief of Occupational and Environmental Medicine at University of Illinois Health.