Earlier this year, the Environmental Protection Agency finalized new regulations to govern the more than 80 industrial facilities across the nation that use ethylene oxide, a highly potent and toxic chemical, to sterilize medical equipment. The rule was announced eight years after the agency discovered that ethylene oxide is 30 times more toxic to adults and 60 times more toxic to children than previously understood. This new rule marked the first time regulations for these sterilization facilities had been revised in three decades.
Now the rule is coming under fire from two directions. In early July, groups representing environmental advocates and the medical-supply industry both filed separate lawsuits against the EPA.
Studies have connected ethylene oxide exposure to cancers of the stomach, breasts, and lungs, and have found that it can alter DNA, causing negative health effects in unborn children. The chemical has the unique ability to disinfect products without damaging their heat-sensitive components, making it an essential part of the medical device supply chain. The FDA estimates that about half of all medical devices manufactured in the U.S. pass through ethylene oxide sterilization facilities, making these plants hotspots of ethylene oxide exposure. (Globally, ethylene oxide is also used to sterilize food products, cosmetics, and textiles.) The EPA’s new rule targets these operations and requires them to install equipment that can capture and destroy more than 99 percent of their ethylene oxide emissions within the next two to three years.
But environmental and community advocates, who’ve long pushed the agency to more carefully scrutinize the sterilization industry, don’t believe the rule goes far enough to protect residents and are trying to force tougher standards in court. They also contend that the compliance deadline is too far off. By giving companies up to three years to comply, the EPA is “illegally and arbitrarily prolonging [residents’] exposure to toxic emissions of ethylene oxide,” their initial court filings argued. The lawsuit was filed on behalf of members of the Sierra Club, California Communities Against Toxics, and the Union of Concerned Scientists as well as community groups in Lake County, Illinois; Laredo, Texas; and Salinas, Puerto Rico — all places where sterilizers release hundreds of pounds of ethylene oxide into the air each year.
The EPA’s rule does not require sterilization companies to monitor the air around their facilities for ethylene oxide — a requirement that could help residents gauge the effectiveness of the emission reduction equipment the EPA is mandating — and continues to consider sterilization facilities “minor” sources of toxic emissions despite their disparate impact on public health. The advocates argue that by refusing to require these added protections, the EPA is denying residents “access to pertinent information about the danger posed by the commercial sterilization facilities in their neighborhoods.”
Meanwhile, in its own legal filings, the Ethylene Oxide Sterilization Association, or EOSA, a trade group representing sterilizers and medical device manufacturers, contends that the EPA’s regulations use inappropriate cancer risk estimates for ethylene oxide, set an unrealistic compliance deadline, and do not adequately consider the cost of installing equipment to capture emissions.
For companies affected by the rule, a key point of contention stems from the EPA’s decision to conduct a second analysis of the cancer risk posed by ethylene oxide. The first standards for ethylene oxide sterilization were promulgated in 1994, and the EPA surveyed the health risk posed by the sector in 2006. According to the Clean Air Act, the EPA is supposed to review the standards for these facilities every eight years, but regulators failed to fulfill this obligation in 2014 and again in 2022, at which point environmental groups sued. The resulting court decision led the agency to include in its new rule a second review of the risk the facilities pose to communities using an updated toxicity value for ethylene oxide. Industry groups claim that the EPA does not have authority to conduct this second review.
The American Petroleum Institute has sought to intervene in both lawsuits, in part because it believes the second risk review — which the EPA rarely, if ever, conducts — sets a precedent that could apply to other petrochemical and industrial facilities.
Both environmental groups and EOSA have filed motions to intervene in the other group’s lawsuit. The cases will be litigated in the D.C. Court of Appeals. Speaking on background, a source with knowledge of the case told Grist that it is in its “very, very early stages,” without a clear timeline for what comes next. What is clear is that the fight to regulate medical sterilization facilities — one the EPA was hoping to put to bed with its new rule — is far from over.
The health of about 14 million people who reside within a 5-mile radius of these facilities may hang in the balance.
