UPDATE: September 9, 2019: DuPage County Circuit Court Judge Paul Fullerton Friday approved the consent order between Sterigenics and Illinois, creating an opening for the company to gain permission to reopen its Willowbrook sterilization plant if it receives a permit from the Illinois Environmental Protection Agency.
Sterigenics Tuesday filed a joint motion to enter a consent order alongside Illinois that would allow the company to resume medical device sterilization at its Willowbrook facility pending approval from the DuPage County Circuit Court.
Under the agreement, commercial ethylene oxide sterilization would not be permitted to resume until Sterigenics installs new emissions capture and control systems that capture 100% of the gas within the facility with a control efficiency of 99.9% or 0.2 parts per million. The Illinois Environmental Protection Agency must approve the systems before Willowbrook operations resume.
The closure of the Willowbrook plant caused millions of dollars of losses for major medical device manufacturers including Medtronic, Boston Scientific and Smiths Medical.
Regulators have been seeking alternatives sterilization methods since a federal EPA report found the gas, known as EtO, to be carcinogenic and linked to breast cancer, lymphoma and leukemia. Roughly half of all medical devices in the U.S. use this method.
Earlier this week, FDA launched two innovation challenges to encourage the development of alternative sterilization methods and the reduction of EtO emissions.
An agency spokesperson told MedTech Dive it is aware of the Sterigenics agreement, but is still monitoring the supply of devices "sterilized in facilities that have closed or that may close."
"The FDA believes that there is merit in encouraging development of new types of sterilization processes as well as improving the efficiency and capacities of existing processes to improve availability of sterile devices and promote public health," the spokesperson said in an email.
Illinois argued the consent order would force Sterigenics to reduce the lifetime cancer risk from EtO emissions to close to 1 in 1 million, which it argued would be "negligible and not a public health hazard."
"Through implementing these requirements, IEPA will be able to ensure that the Site's EtO emissions are well below the amount of EtO that testing shows already exists in ambient air," Illinois state attorneys wrote.
Sterigenics said the new equipment will increase the number of emission control stages to boost EtO capture and combine all existing emission stacks into one. Under the pending consent order, the company also agreed to set aside $300,000 for community projects in the Willowbrook community to improve the environment.
Sterigenics said the consent agreement's controls are the strictest EtO regulations for any facility in the country.
"We are pleased to have reached this agreement, which creates a path for our Willowbrook facility to resume its safe operation and includes no finding of wrongdoing on the company's part nor the imposition of any financial penalties," Sterigenics President Philip Macnabb said in a statement.
The medical device trade lobby declined to comment on the consent order. "That was something they were working on independent of us," Greg Crist, AdvaMed executive vice president of public affairs, told MedTech Dive. "We'll have to study the specifics of that agreement, assuming it gets ratified."
One wild card is what steps the EPA will take when it publishes two proposed rules, set for release soon. The forthcoming rules are aimed at addressing emissions from commercial EtO sterilizers and a review of the maximum achievable control technology for emissions from the manufacturing of the gas.