For years, people who live near plants that use ethylene oxide to sterilize medical equipment have pressured regulators to curb their toxic emissions. Residents in communities from Laredo, Texas, to Willowbrook, Illinois, have tried to shut down these facilities, challenged them in court and fought for air sampling studies to measure their exposure to the carcinogen.
The Environmental Protection Agency finally took notice.
Today the agency dealt with new regulations that will require dozens of medical sterilization companies to adopt procedures and technologies they say will reduce emissions of the toxic chemical by 90 percent. The rule will take effect within two to three years, a longer timeline than proponents of the change had hoped. Still, regulators and community advocates praised the change.
“We followed the science and listened to communities to fulfill our responsibility to protect public health from these pollutants — including the health of children, who are especially vulnerable to carcinogens early in life,” EPA Administrator Michael Regan said in said a press release.
According to the Food and Drug Administration, more than 50 percent of the nation’s medical equipment is sterilized with ethylene oxide. The nondescript buildings where this fumigation takes place came under scrutiny in 2016, after the EPA 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 recently warned that overly strict regulations could disrupt the supply of medical equipment.
“The industry supports updated standards while ensuring that the technology patients rely on throughout the day is sterile and well supplied,” the Advanced Medical Technology Association, a trade group, wrote in A February press release.
After the agency published a 2019 analysis indicating unusually high levels of cancer risk near sterilizers, people across the country rallied against the facilities in their communities, with one Chicago suburb even managing to shut one down. Federal data indicates 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 has 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, this is definitely a win for our customers in terms of the fact that EPA is finally revising and increasing regulations on an industry that has really been operating with a lack of controls for the last 30 years,” he said in an interview. said to Grist.
The rule would rely on several measures to achieve an estimated 90 percent reduction in toxic emissions. It requires companies to install air monitors inside their facilities to continuously detect 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 that escape through leaks and cracks in the sterilization chambers, providing a more comprehensive assessment of the facility’s emissions.
The rule also requires both large and small sterilizers to install “permanent total enclosures,” which create negative pressure in a building, preventing air from escaping. Instead of being released into the atmosphere and endangering nearby residents, any emissions are directed to an appliance that burns them.
But for all its benefits, Brown said, the new regulation leaves out several important protections that residents and advocates have fought for. The EPA pushed back the rule’s implementation from 18 months for all sterilizers to 2 years for large facilities and 3 years for smaller ones, a change Brown attributed to industry pressure. The decision will come as a disappointment, he said, to residents who had hoped for more immediate relief.
In particular, the new regulations do not require companies to monitor the air near their facilities, making it difficult for communities to determine the concentrations of ethylene oxide near their homes. The agency has argued that such a provision is excessive given the new monitoring requirements inside facilities, but proponents of the change note that internal monitors do not pick up leaks that happen outside, such as from trucks transporting newly sterilized equipment.
Ethylene oxide emissions from the warehouses where medical equipment is stored after sterilization is a growing concern. After fumigation, these items may contain traces of the chemical that evaporate for days or weeks afterward. Officials in Georgia’s Environmental Protection Department found that this “off-gassing” can create significant concentrations of the chemical in the air, and a recent Grist investigation revealed that dozens of workers at one warehouse in Lithia Springs experienced nausea, headaches, rashes and experienced seizures after being exposed to these fumes at work. The EPA’s new regulations do not cover such emissions, an omission Brown called “unfortunate.”
“There’s still a lot more work to do,” he said of the new rule. “But it’s a good step in terms of tighter emissions controls, and new emissions controls that didn’t exist before.”
