IL EPA orders Sterigenics plant shut down; Sterigenics will seek to reverse 'indefensible' action

By Jonathan Bilyk | Feb 15, 2019

Editor's note: This article has been revised from an earlier version to include a statement from Sterigenics reacting to the IEPA regulatory action.

Illinois state environmental regulators have issued an order essentially closing down a medical device sterilization facility in suburban Willowbrook accused of emitting cancer-causing chemicals into the air.

Late Friday, the Illinois Environmental Protection Agency announced it had issued a seal order on the facility run by Sterigenics, restricting the ability of the company to continue using the chemical known as ethylene oxide to sterilize surgical tools and other health care devices.

In a release, the IEPA said the order was needed “to prevent the commencement of any new sterilization cycles using ethylene oxide to prevent emissions which present an imminent and substantial endangerment to residents and off-site workers in the Willowbrook community.”

The IEPA said the seal order was precipitated by “recent elevated” air monitoring results conducted both the U.S. Environmental Protection Agency and the village of Willowbrook, and “Sterigenics’ refusal to voluntarily suspend operations.”

The IEPA did not indicate it believes the plant is in violation of any air pollution regulations, nor that it had violated the operating permit issued to it by the IEPA in 2015, at the time granting it permission to release EO into the air.

In response to the seal order, Sterigenics called the IEPA action "indefensible." 

In a statement, Sterigenics said it would both "comply with the order" but would "take all legal actions necessary to reverse this decision."

In the statement, Sterigenices said:"Sterigenics Willowbrook has consistently complied with all state permits and regulations and Sterigenics has been in ongoing cooperation with the Illinois EPA and other officials regarding the safe operation of the facility. Unilaterally preventing a business that is operating in compliance with all state permits and regulations from carrying out its vital function sets a dangerous precedent. 

"The Illinois EPA’s decision will place the health and lives of thousands of patients who rely on the critical medical products sterilized at Willowbrook at risk. In addition, we are in the process of reviewing the air monitoring results released today from the Village of Willowbrook. These results are inconsistent with all prior monitoring results. We will be analyzing these results closely to understand the cause for such inconsistency from all prior samples taken to date."

In recent days, pressure has mounted against new Illinois Gov. JB Pritzker to take action against the facility, including from the state’s two U.S. Senators, Dick Durbin and Tammy Duckworth, and members of Congress. They have responded to calls from many residents and local government officials in Willowbrook and surrounding communities, who have insisted the facility is emitting too much EO, which they blame for incidences of cancer among area residents.

They pointed to a report completed last summer by the U.S. Agency for Toxic Substances and Disease Registry, which asserted Sterigenics’ EO emissions presented an increased risk for incidences of cancer in the region.

The ATSDR relied on emissions data supplied by the U.S. EPA. Since then, subsequent EO monitoring data released by the U.S. EPA has revealed what the agency called elevated EO levels in the air near the Sterigenics facility.

Sterigenics noted EO levels in nearby residential levels were equivalent to typical EO levels throughout the Chicago area. And the company noted the U.S. EPA had indicated it believed more monitoring and assessment was needed.

However, Friday the IEPA said monitoring data from sampling “conducted by U.S. EPA and the Village of Willowbrook has consistently found outdoor ambient levels of ethylene oxide in commercial and residential areas as high or higher than the levels used by the ATSDR.”

The IEPA release said the seal order will remain in place until it is lifted by Acting IEPA Director John J. Kim, who was appointed by Pritzker.

Sterigenics has said it uses the EO to sterilize essential medical devices. It has asserted more than half of all medical devices and 90 percent of surgical kits used in operating rooms in the U.S. are sterilized using EO. It has warned without EO, infection risks in American hospitals “would soar,” as alternative sterilization methods using heat and radiation can weaken the devices and surgical materials and compromise their effectiveness.

The IEPA decision comes as Illinois Attorney General Kwame Raoul and DuPage County State’s Attorney Robert Berlin continue to seek a court order shutting down the Sterigenics Willowbrook facility.

The action is currently in federal court, as Sterigenics has argued the state’s actions represent an attempt to bypass federal pollution control authority and use the courts to rewrite federal air quality rules.

Sterigenics has contended from the beginning of the public controversy that its emissions have always complied with state and federal clean air rules, and the terms of the permit issued by the IEPA.

The state has argued the plant represents a public health threat, and can be shut down under state nuisance laws.

Friday, U.S. District Judge John Z. Lee asked the two sides to submit further arguments, as he attempts to decipher whether the law requires the case to be heard in federal court or in DuPage County Circuit Court.

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