WASHINGTON — The Environmental Protection Agency is imposing stricter limits on a chemical used to sterilize medical equipment after finding a higher-than-expected cancer risk at facilities that use ethylene oxide to clean billions of devices, including catheters and syringes.
A rule finalized Thursday will reduce ethylene oxide emissions by about 90% by targeting nearly 90 commercial sterilization facilities across the country, the EPA said. The companies will also have to test for the antimicrobial chemical in the air and ensure their pollution controls are working properly.
The new rule will “protect public health from this pollution – including the health of children, who are particularly vulnerable to carcinogens at young ages,” said EPA Administrator Michael Regan. “We have reached a historically strong rule that protects the communities most exposed to toxic air pollution while… protecting our nation’s critical supply of sterilized medical equipment.”
The American Lung Association called the rule an important step forward to protect human health from cancer caused by ethylene oxide emissions.
“The science on the health risks of ethylene oxide shows that exposure is hazardous to health in both the short and long term,” said Harold Wimmer, president and CEO of the group.
People who live near commercial sterilization facilities are more likely to develop cancer throughout their lives, Wimmer said, adding, “No one should have to live with an increased risk of cancer because of air pollution in their community.” ‘
Patients with lung disease and other health problems “also need access to safe and clean medical facilities,” he said. “We appreciate the work EPA has done to ensure that this final rule both cleans up harmful emissions and ensures continued access to sterilized medical equipment.”
Darya Minovi, a senior research analyst at the Union of Concerned Scientists, called the EPA action overdue.
“For far too long, communities across the country – especially Black and brown people and those who do not speak English as their native language – have been exposed to the cancer-causing chemical ethylene oxide,” Minovi said in a statement.
“Make no mistake: Politically powerful industries sought to weaken the rule’s health protection standards, but the public health benefits this action will bring to communities are a testament to the efforts of grassroots advocates and experts in the field public health who didn’t let that happen. in their demands,” she added.
The strengthened safeguards are driven by the EPA’s better understanding that the threat from ethylene oxide is serious, Regan said. The chemical is classified as a pesticide. A worker in a medical sterilization plant could see his risk increase by as much as one additional case of cancer for every ten people exposed over the course of his career. The generally acceptable increase in lifetime cancer risk according to the EPA is 1 in 10,000.
Ethylene oxide is a gas used to sterilize about half of all medical devices and is also used to ensure the safety of certain spices and other foods. It is used to clean everything from catheters to syringes, pacemakers and plastic surgical gowns. Brief exposure is not considered a hazard, but long-term inhalation increases the risk of breast cancer and lymphoma, the EPA said.
In 2016, the EPA updated its assessment of the hazard of ethylene oxide based on information about exposed workers in sterilization facilities, finding the chemical to be many times more threatening than previously known. An analysis released by the agency two years later found that the risk of cancer was too high near some medical sterilization plants and some other facilities that release ethylene oxide.
In 2022, the EPA outlined the risks facing residents living near medical sterilization facilities. For example, in Laredo, Texas, residents and activists fought to clean up a sterilization facility operated by Missouri-based Midwest Sterilization Corp. It was one of 23 sterilizers in the United States that the EPA said posed a risk to people nearby.
Sterigenics, a major sterilization company, has closed a medical sterilization plant in a Chicago suburb after monitoring found emissions spikes in nearby neighborhoods. They eventually settled numerous lawsuits.
Many facilities have significantly reduced ethylene oxide emissions in recent years, but those that have not will now have to meet stricter requirements, the EPA said.
The EPA said it has worked closely with the Department of Health and Human Services and other agencies to develop a final rule that focuses on public health. The rule provides sufficient time and flexibility for commercial facilities to comply, while providing strong public health protections for nearby communities and minimizing potential impacts to the medical device supply chain, officials said.
Health and Human Services Secretary Xavier Becerra called the rule a victory for workers and communities stuck at the border, who continually face the dangers of ethylene oxide pollution.
Scott Whitaker, president and CEO of the Advanced Medical Technology Association, said medical sterilizers provide an essential service and many devices cannot be sterilized otherwise.
The industry group appreciates EPA’s update and will review the rule, Whitaker said in a statement Thursday. Industry has emphasized the need for sufficient time to implement the rule, “flexibility in technologies to remove emissions, and the ability to meet EPA goals that would not force resubmission of medical devices for FDA approval,” Whitaker said.
He said he remains hopeful the rule “will not have a negative impact on the health care system or the patients we serve.”
