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DuPage judge OKs Sterigenics consent order; Company can begin regulatory process to reopen Willowbrook plant

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By Cook County Record | Sep 6, 2019

Sterigenics

Editor's note: This article has been revised from a previous version to include statements from Sterigenics.

A DuPage County judge has signed off on an agreement that would end a court fight over actions taken by the state of Illinois to shut down a Willowbrook medical device sterilization plant over claims the plant emitted an allegedly cancer-causing chemical into the air.

On Friday, DuPage County Circuit Judge Paul Fullerton approved the so-called consent order between medical device sterilizer Sterigenics on one side and the Illinois Attorney General’s Office and DuPage County State’s Attorney’s Office on the other.


Illinois Attorney General Kwame Raoul

The consent order would end the legal action launched against Sterigenics last fall by then-Attorney General Lisa Madigan and DuPage County State’s Attorney Robert Berlin over Sterigenics’ alleged emissions of ethylene oxide (EtO.)

The consent order would also end Sterigenics’ lawsuit against the state over the shutdown imposed on its Willowbrook facility by the Illinois Environmental Protection Agency, an order Sterigenics called unconstitutional and illegal.

In a statement released following Judge Fullerton’s ruling, Illinois Attorney General Kwame Raoul and DuPage State’s Attorney Berlin said the consent order would ensure Sterigenics complies with strict new EtO emissions rules required under a new state law, signed by Gov. JB Pritzker earlier this summer.

“The consent order entered today mirrors and goes even further than the new law,” the state attorneys said in their joint statement.

Under the consent order, Sterigenics would be required to install new emissions control systems, and then show the IEPA the system works to capture all EtO emissions. 

The company must secure permits from the IEPA and “multiple certifications required by the new law” before it can resume operations at its Willowbrook plant, according to the Attorney General’s statement.

The statement said the “net effect” of the consent order would be “to reduce the EtO emissions from the Willowbrook facility to no more than 85 pounds per year.”

Under the state permit held by Sterigenics and reapproved as recently as 2015, the facility was allowed to emit up to 36,400 pounds of EtO per year.

Since 2001, however, Sterigenics had averaged emissions of 4,800 pounds per year, about 13 percent of what the state had permitted.

The consent order did not assign liability, and the state would impose no penalties on Sterigenics for any alleged violations.

"Sterigenics has always operated safely, and we are pleased that the State has acknowledged the safety of these new controls," Sterigenics said in a statement following the ruling. "The company will continue to work to complete the permitting process regarding the enhancements detailed in the consent order."

Sterigenics has said EtO is essential to its method of sterilizing surgical instruments and other medical devices, including catheters, surgical kits, stents and other medical implants. Sterigenics’ claims have largely been echoed by medical device trade groups and the U.S. Food and Drug Administration, who have asserted there is no effective substitute for EtO sterilization for many medical devices. Should sterilization plants that use EtO be shut down, they say, the infection risk in U.S. hospitals and medical facilities would rise.

Sterigenics had consistently noted for months its emissions never came close to exceeding the emissions levels allowed under its permit or state and federal emissions rules.

In a statement following the judge's ruling, Sterigenics noted Judge Fullerton said the state has "acknowledged that there is no uncertainty that Sterigenics has operated in compliance with federal standards regarding its ethylene oxide emissions."

Nonetheless, the Attorney General and DuPage State’s Attorney’s offices launched a legal action last fall in response to public outcry over a report from the federal Agency for Toxic Substances and Disease Registry, which claimed to show an increased cancer risk for people living near Sterigenics’ Willowbrook facility. The agency pinned the blame for that risk on EtO emissions from Sterigenics.

In the legal action, the state never accused Sterigenics of violating emissions rules. Rather, the state argued the company still violated the law by creating a “public nuisance” by emitting EtO at all.

Sterigenics asserted this and a number of private personal injury lawsuits filed against the company since last summer, which similarly allege the company created a “nuisance,” amount to an attempt to use civil litigation to rewrite federal and state air rules without the legislative or rulemaking processes normally required.

The state, however, heightened tensions when the IEPA, under Gov. Pritzker, slapped a so-called seal order on the Willowbrook plant in February, forbidding Sterigenics from using its stores of EtO and shutting down the plant ever since.

Sterigenics responded with a lawsuit against the state, calling the seal order unconstitutional and indefensible.

After Pritzker signed the new state EtO rules into law, Sterigenics and the state announced the consent order to end all the litigation between the state and Sterigenics.

Sterigenics must still face a growing number of lawsuits filed by a group of personal injury lawyers representing people who claim Sterigenics’ EtO emissions caused cancer and other health conditions.

A group of activists have also pledged to continue their fight to keep Sterigenics’ Willowbrook plant closed, and have also pushed for legislation to ban the use of EtO in Illinois.

They have been joined in that effort by state lawmakers from DuPage County and elsewhere, who have asked Gov. Pritzker to call a special session of the Illinois General Assembly to vote on such a ban.

Three of those lawmakers had filed a legal brief in DuPage County court, asking Fullerton to not approve the consent order because they had drafted the law specifically to target Sterigenics. They argued the Attorney General's office lacked the authority to settle the lawsuit the Attorney General's office had filed. 

Willowbrook and other neighboring city and village governments had also opposed the consent order.

On Friday, Illinois House Republican Leader Jim Durkin, R-Western Springs, announced he had filed legislation to give local communities the option of sidestepping IEPA control and banning the use of EtO within their borders. Durkin called the court decision "disappointing."

":Sterigenics continues to prove they cannot be trusted and have no place in our region,” Durkin said in a statement announcing the legislation. “If the Illinois EPA continues moving forward in issuing permits, then we must do everything we can to empower our local municipalities in their fight to keep Sterigenics closed for good.”

Durkin said the village of Willowbrook supported the legislation.

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Organizations in this Story

Illinois Environmental Protection AgencyCircuit Court of Dupage CountyIllinois Attorney GeneralSterigenicsIllinois Governor J.B. PritzkerDupage County State's AttorneyIllinois State Representative Jim DurkinVillage of Willowbrook

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