This article has been updated with a statement from Sterigenics.
A judge in Illinois has approved the consent agreement between the state and Sterigenics that could enable the company to reopen its Willowbrook medical device sterilization plant.
DuPage County Circuit Court Judge Paul Fullerton gave the nod to the agreement that the state attorney general and Sterigenics reached in July. The llinois Environmental Protection Agency abruptly shut down the company’s ethylene oxide (EO) medtech sterilization plant in February, citing excess emissions of the carcinogenic sterilant gas.
The parties inked the consent agreement in July, weeks after the state passed a tough new law regulating the discharge of the gas. The plant processed millions of medical devices annually, and its sudden closure caused some device shortages and a push by the FDA to come up with different methods to replace and improve EO sterilization.
Under the terms of the consent agreement, Sterigenics will install additional emission capture and control equipment that will enable the Willowbrook facility to meet the state’s new, more stringent standards. The Illinois EPA said it would have to approve the upgrades before the plant could reopen.
The net effect will be to reduce the EO emissions from Sterigenics’ Willowbrook facility to no more than 85 pounds per year. This compares with Sterigenics’ reported annual emissions from 2006 to 2018, which ranged from 2,840 pounds to 7,340 pounds per year, according to the state EPA.
“When our offices partnered to file a lawsuit against Sterigenics in 2018, we called upon and gave the Illinois General Assembly time to strengthen our state’s laws regulating sterilization facilities that emit ethylene oxide,” Illinois Attorney General Kwame Raoul said in a news release. “With nearly unanimous support, the Legislature this spring passed the nation’s strictest requirements on ethylene oxide emissions at sterilization facilities, which were quickly signed into law by the governor. The consent order entered today mirrors and goes even further than the new law.
“The consent order gives our offices the tools to act quickly to protect the community and hold Sterigenics accountable for any future violations of Illinois’ new ethylene oxide restrictions or other state environmental laws. To be clear, nothing within the consent order guarantees that the Willowbrook facility will reopen in the immediate future – or that it will reopen at all. Under the consent order, Sterigenics’ Willowbrook facility is strictly prohibited from resuming sterilization operations until it constructs new emissions control systems that have been reviewed and approved by the Illinois EPA. The attorney general’s office, the state’s attorney’s office and the court will be closely monitoring each step Sterigenics takes to potentially reopen.”
“Court approval of this agreement resolves all current litigation between the state of Illinois and its
representative agencies and Sterigenics, with no finding of liability or fault against either side and with
no imposition of penalties,” Sterigenics said in a news release on Friday. “During today’s proceedings, the court noted that the state has acknowledged that there is no uncertainty that Sterigenics has operated in compliance with federal standards regarding its ethylene oxide (EO) emissions. Further, the State indicated in its briefing that compliance with the consent order and the new Illinois law regarding EO sterilization ‘will ensure that [EO] emissions from the [Willowbrook] site are negligible and not a public health hazard.’ Sterigenics has always operated safely, and we are pleased that the State has acknowledged the safety of these new controls. The company will continue to work to complete the permitting process regarding the enhancements detailed in the consent order.”
Sterigenics, which is owned by Sotera Health, applied in June for permits to upgrade emissions controls at the Willowbrook plant. The company still faces more than 40 lawsuits filed by residents who live near the Willowbrook plant, seeking damages for illnesses that they claim stem from EO exposure.