A new Illinois state law, which contains ethylene oxide regulations without peer anywhere else in the country, could make it all but impossible for a now-shuttered sterilization facility to reopen, while essentially closing the state to any medical device sterilizers to open new plants in the state.
And, despite the strict new law, Illinois’ chief legal officer has pledged to continue the state’s legal action to punish the operators of a sterilization facility in Chicago’s western suburbs.
Illinois Gov. JB Pritzker recently signed into law a bill imposing stringent new rules on companies operating plants in Illinois which use the gas known as ethylene oxide (EO) to sterilize a range of surgical tools and other medical devices.
The new law would bar such facilities from operating in Illinois unless 100 percent of all EO emissions are kept within the facility, and emissions tests reveal EO emissions of 0.2 parts per million. Testing will be conducted annually.
Failure of any test would result in immediate shutdown.
Further, the law would require sterilization facilities to acquire certification from the makers of the medical devices they sterilize that use of EO gas is the only safe and reliable method available to sterilize their products.
"Families in affected areas can breathe easy. Illinois now has the strictest safeguards in the nation, and I appreciate the hard work of the General Assembly in developing this bipartisan legislation and bringing it to my desk," said Pritzker in a statement released at the time of the bill signing.
The new law was rushed through the Illinois General Assembly this year with large bipartisan support amid concerns over federal reports allegedly linking the use of EO gas at the sterilization plant operated in suburban Willowbrook by Sterigenics to elevated cancer risks in the surrounding communities.
Those reports first prompted state action in the form of a lawsuit filed by then-Attorney General Lisa Madigan and DuPage County State’s Attorney Robert Berlin, ostensibly on behalf of the Illinois Environmental Protection Agency, asking the court to order Sterigenics’ facility closed.
In response to the lawsuit and other state actions since, Sterigenics has stressed its operations remained in compliance with the operating permits issued to them by the IEPA.
However, the state has argued the company violated state rules and state law by creating a “public nuisance” by emitting EO at all.
Within days of Pritzker’s inauguration as Illinois governor, replacing Bruce Rauner, the IEPA, which is under the governor’s supervision, imposed a so-called “seal order” on the Sterigenics Willowbrook plant. The order forbids Sterigenics from using its stores of EO gas, which is essential to the sterilization operations they perform at the plant.
Sterigenics says it uses the gas to sterilize a wide array of surgical equipment and medical devices at the plant, including surgical tools it says would be damaged by other sterilization methods, such as heat or radiation.
Sterigenics has challenged the seal order in court, asserting the action was illegal and unconstitutional.
Sterigenics has further said in court filings its “customers are deeply concerned about their ongoing ability to supply hospitals and other healthcare providers with vital tools and devices.”
Across the country, medical device industry representatives have expressed similar concerns, with groups such as AdvaMed, the Advanced Medical Technology Association, noting 56% of all medical devices in the U.S. are sterilized using EO. That includes 80% of all pre-prepped surgical tray kits.
Brad Babcook, legislative affairs director for the Chemistry Industry Council of Illinois, said the new law will exacerbate such concerns.
He noted the new law not only imposes the strict new emissions control rules on existing sterilization facilities, but also imposes even further burdens on any facility which has been subjected to a state seal order.
“There’s all sorts of extra hoops to jump through for them,” Babcook said. “At this point, I think it would be almost impossible for Sterigenics to reopen.”
Further, Babcook noted the law imposes geographic requirements on where new sterilization facilities can be located, forbidding any sterilization facility using EO from being within 10 miles of a park or school in a county with a population of more than 50,000. That limit would be 15 miles for any county with a population of less than 50,000.
“We don’t believe anyone’s going to come to Illinois to open any new sterilization facilities,” Babcook said.
The new regulations also drew the ire of the American Chemistry Council trade group, which called them “misguided,” as they are based on a “severely flawed” standard from the U.S. EPA.
The ACC said that standard “dramatically overestimates the potential hazard of EO, deeming it unsafe at levels far below levels found in the environment and ignoring the natural levels of EO in humans created by normal breathing.”
“In fact,” the ACC said, “the EO cancer value derived from EPA’s modeling is 19,000 times lower than the normal, naturally-created levels of EO in the human body.”
The ACC noted industries use EO to make a range of products, including “plastics, adhesives, antifreeze, safety glass and textiles.” Industries relying on EO account for more than 45,000 jobs and pump $3.5 billion into the U.S. economy, the ACC said.
“The flawed EO (standard) has created unnecessary alarm and has led the (U.S. Food and Drug Administration) to announce possible shortages of medical devices that are sterilized with this important chemical,” the ACC said.
Despite the threat of medical device shortages just from the shuttering of the Sterigenics Willowbrook plant, pressure has also mounted for the state to take similar action against Illinois’ other sterilization plant operated by Medline in Lake County.
That pressure comes despite assertions from Medline that it is working with the state to install a so-called “zero pressure” system to capture and scrub its EO emissions.
The new law would give Medline 180 days to comply with the new state EO regulations.
In a statement, Sterigenics said it “has been recommending potential emission control improvement options to regulators for several months.”
Sterigenics said it believes “these measures will not only enable us to comply with the new Illinois law … but will also establish our Willowbrook facility as the strongest emission control environment for EO sterilization in the country and provide further reassurance to the public.”
For now, the seal order also remains in place on the Sterigenics Willowbrook facility.
The company is continuing to contest that order in DuPage County court, and is defending against the state’s legal action, which has been continued under current Illinois Attorney General Kwame Raoul.
Despite the new state law, a spokesperson for Raoul’s office said the Attorney General intends to continue the state’s lawsuit seeking an injunction against Sterigenics.
“While the new law will improve regulations of these facilities in the future, its existence does not ensure compliance,” Raoul spokesperson Annie Thompson said in a statement. “Our litigation is ongoing, and we continue to seek an enforceable court order to ensure future compliance.”