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People who live near plants that use ethylene oxide to clean medical equipment have been pushing for regulators to address their dangerous emissions for years. Residents in communities from Laredo, Texas, to Willowbrook, Illinois, have tried various methods to shut down these facilities, taken legal action against them, and advocated for air-sampling studies to measure their exposure to the cancer-causing substance.
The Environmental Protection Agency has finally taken notice.
Last week, the agency finalized issued new regulations that will require dozens of medical sterilization companies to adopt procedures and technologies that it claims will reduce emissions of the toxic chemical by 90 percent. The rule will take effect within two to three years, a longer timeline than advocates of the change hoped for. Still, regulators and community advocates alike hailed the change.
“We have followed the science and listened to communities to fulfill our responsibility to safeguard public health from this pollution—including the health of children, who are particularly vulnerable to carcinogens early in life,” said EPA Administrator Michael Regan in a press release.
According to the Food and Drug Administration, more than 50 percent of the nation’s medical equipment is sterilized using ethylene oxide. The nondescript buildings where this fumigation occurs came under scrutiny in 2016, after the EPA revised its risk assessment of the chemical, finding it 30 percent more toxic to adults and 60 percent more toxic to children than previously known. Over the years, studies have linked exposure to the chemical to cancers of the lungs, breasts, and lymph nodes.
The medical sterilization industry has recently warned that too stringent regulations risk disrupting the supply of medical equipment.
“The industry supports updated standards while ensuring the technology patients rely on around the clock is sterile and well supplied,” wrote the Advanced Medical Technology Association, a trade group, in a February press release.
After the agency published a 2019 analysis indicating unusually high levels of cancer risk near sterilizers, people around the country rallied against the facilities in their communities, with a Chicago suburb even managing to shut one down. Federal data indicate that more than 96 of these businesses operate in 32 states and Puerto Rico and are concentrated near Latino communities.
Marvin Brown, an attorney at Earthjustice who advocated for stronger oversight of toxic emissions from commercial sterilizers, applauded the new rule, noting that EPA regulations were last revised in 1994, long before the agency was aware of the true risk of ethylene oxide.
“Overall, it’s definitely a victory for our clients in terms of getting EPA to finally revise and increase regulations on an industry that’s really been operating with a lack of controls for the past 30 years,” he told Grist in an interview.
The rule will rely upon several measures to achieve an estimated 90 percent reduction in toxic emissions. It requires companies to install air monitors inside their facilities to continuously track the level of ethylene oxide and report their results to the EPA on a quarterly basis. Brown considers these continuous monitoring systems important, because they capture pollutants escaping through leaks and cracks in the sterilization chambers, providing a more comprehensive assessment of the facility’s emissions.
The regulation also mandates both big and small sterilizers to install “permanent total enclosures,” which create negative pressure in a building to prevent air from escaping. Instead of being released into the atmosphere and putting nearby residents at risk, any emissions are directed to a device that burns them.
However, despite its benefits, Brown mentioned that the new regulation omits several important protections that residents and advocates had fought for. The EPA extended the rule’s implementation from 18 months for all sterilizers to two years for large facilities and three years for smaller ones, a change attributed to industry pressure. He said the decision will disappoint residents who were hoping for more immediate relief.
Importantly, the new regulations do not mandate companies to monitor the air near their facilities, making it challenging for communities to assess the concentrations of ethylene oxide near their homes. The agency argues that such a provision is excessive given the new monitoring requirements inside facilities, but advocates of the change point out that internal monitors do not detect leaks that occur outdoors, such as from trucks carrying newly sterilized equipment.
Concerns are mounting over ethylene oxide emissions from warehouses where medical equipment is stored after sterilization. After fumigation, these items can contain traces of the chemical that evaporate for days or weeks afterward. Officials in Georgia’s Environmental Protection Division discovered that this off-gassing can lead to significant concentrations of the chemical in the air, and a recent Grist investigation found that dozens of workers at one warehouse in Lithia Springs experienced nausea, headaches, rashes, and seizures after being exposed to these fumes. The EPA’s new regulations do not address such emissions, a gap that Brown described as “unfortunate.” Brown said of the new rule, “There’s still a lot more work to be done. But this is a positive step in terms of stricter emission controls and new emission controls that did not exist before.”
Editor’s note:
Earthjustice is an advertiser with Grist. Advertisers have no role in Grist’s editorial decisions. This article originally appeared in
https://grist.org/accountability/epa-finally-cracks-down-on-the-carcinogen-used-to-sterilize-medical-equipment/ Grist at Even though the rule will reduce ethylene oxide emissions by about 90 percent, “there’s still a lot more to be done.”.
