The federal Environmental Protection Agency (EPA) is proposing tighter limits on air emissions and new worker protections to reduce exposure to ethylene oxide, a colorless gas used to sterilize medical supplies and some food products that has been linked to cancer and other serious health conditions.
The agency announced the new standards on Tuesday and said they are needed to address the health risks posed by long-term exposure to the gas in communities surrounding sterilization facilities in Georgia and across the country. In 2019, a report on federal modeling of ethylene oxide emissions and potential health impacts triggered outrage in metro Atlanta in neighborhoods near medical sterilization plants.
Some plants that use ethylene oxide have already taken steps to reduce emissions, the EPA said. But the proposal floated by the agency would require all 86 commercial sterilization facilities currently operating in the U.S. — plus any new factories that come online — to begin using new advanced technologies to capture emissions and monitor for leaks.
If fully implemented nationwide, the EPA said the requirements would lead to an 80% reduction in ethylene oxide emissions from the facilities.
The EPA is also proposing a host of new measures to safeguard workers, including requiring the use of state-of-the-art emissions capture technologies, personal protective equipment and, where feasible, ditching ethylene oxide for alternative sterilization techniques.
Ethylene oxide plays a critical role in ensuring medical equipment is safe for use. An estimated 20 billion medical devices and other pieces of equipment are treated with the gas each year.
Still, EPA Deputy Administrator Janet McCabe said the agency was compelled to act given the serious health effects that can be caused by breathing in ethylene oxide.
“Failing to take action to address these risks is simply unacceptable,” McCabe said. “At EPA, we are committed to following the law and following the science to safeguard public health.”
Ethylene oxide is used widely to eliminate E. coli and other bacteria on medical supplies and to kill potentially dangerous microbes lurking in spices, dried vegetables, walnuts and some other food products.
But the gas has been known for years to be dangerous to humans. In 2016, the EPA reclassified ethylene oxide as a human carcinogen and the gas has been linked to breast, lymphoid, leukemia and other types of cancers.
That same year, the EPA determined ethylene oxide is dangerous at much lower levels than previously thought.
Based on its new threshold, EPA air modeling flagged several census tracts in Georgia for potential elevated cancer risks from exposure to ethylene oxide in 2018. But neither the agency nor the state Environmental Protection Division (EPD) alerted the public.
A year later, media reports revealed the potential for increased cancer risk faced by residents in neighborhoods surrounding a plant in Smyrna operated by Sterigenics, one of the country’s largest medical device sterilizers with dozens of facilities around the U.S.
Sterigenics’ Smyrna plant is still in operation, but in recent years, a wave of lawsuits have been filed over the emissions from the facility and a plant in Covington operated by Becton Dickinson (BD). BD also operates a facility in Madison.
Last year, Sterigenics agreed to pay $408 million to settle several lawsuits in Illinois that had accused the company of fouling the air of a suburban Chicago city with the cancer-causing gas. The company has denied wrongdoing and said its decision to settle was a financial one.
In a statement, a Sterigenics spokesperson said the company supports EPA’s mission and has already begun using advanced emissions capture technologies at its Smyrna plant. The company, however, said the EPA’s proposal “contradicts real-world findings” from a federal study of sterilization plant workers and is based on a flawed health risk assessment.
The EPA said Tuesday that the stiffer requirements were “informed by the latest data, science, and extensive outreach and takes full account of the important function of medical sterilization to provide a safe supply of medical devices for patients and hospitals.”
Troy Kirkpatrick, a spokesman for BD declined to comment on the EPA’s new requirements. But Kirkpatrick said BD “has been proactively investing in new innovations to further reduce emissions years before the new proposed rules were issued by EPA.”
Kirkpatrick said the company installed “dry bed” systems at both its Covington and Madison plants in 2020 to capture ethylene oxide emissions from the air, which have reduced emissions by 90% to 95%.
Georgia EPD spokeswoman Sara Lips said the agency had not fully reviewed the EPA’s proposal, but said the new requirements appeared to mirror many of the strategies the state is already using to limit ethylene oxide exposure.
