GRAND RAPIDS — While state environmental regulators and a company have reached a tentative agreement to stop sterilizing medical devices at a Grand Rapids plant, officials say their work tracking a pollutant from the facility and elsewhere is far from over.
On Wednesday night, the Michigan Department of Environment, Great Lakes and Energy (EGLE) took public comments in Grand Rapids on a proposed consent order with Viant Medical Inc., which has had multiple air pollution violations over the past year.
The facility near downtown Grand Rapids is a hub for sterilizing medical equipment and uses ethylene oxide in the process.
Last year, the state found the Viant facility was the No. 1 source of concern for ethylene oxide emissions in the state. Elevated levels of the carcinogen have been tested multiple times at and around the facility over the past year. The facility is subject to both state and federal air regulations.
“We obviously took notice,” Chris Ethridge, a field operations manager in EGLE’s Air Quality Division, said of a recent federal report’s findings about the facility. “Modeling analysis done for Viant did show some significant concerns offsite with the concentration of ethylene oxide, particularly in surrounding residential areas.
Ethylene oxide is a known carcinogen. The man-made, flammable, colorless gas could increase the risk of developing blood and breast cancers if breathed in over many years. It’s used mostly to make other chemicals and sterilizing medical equipment.
Emissions from the Viant facility are now part of a ongoing broader cancer review by the Kent County Health Department.
Following a series of onsite inspections and air pollution monitoring as part of an “escalated enforcement,” the state and Viant agreed last month to settle compliance violations that would end its medical device sterilization processes by Dec. 31. The company also agreed to pay a $110,000 fine, which critics said Thursday was insufficient. Viant — a global medical device manufacturing company — was formed last year after a merger between MedPlast and an Integer Holdings subsidiary. The company and its predecessors have been at the location for nearly 30 years.
The state will continue monitoring emissions around the plant through February.
The state Department of Health and Human Services (DHHS) also completed a study this year on whether exposure to ethylene oxide was affecting cancer rates in the surrounding area, which included portions of Grand Rapids, Walker and Wyoming. While the state saw fewer cases of breast cancer in women than expected, it found slightly higher cases of multiple myeloma than rates expected in Kent County.
Still, the state can’t say definitively based on research limitations whether the plant caused higher rates of cancer, said Laura Abington, an environmental epidemiologist at DHHS.
Officials also note the technology limitations in measuring ethylene oxide in the air, a subject gaining increasing attention across the U.S.
More to come
Since ethylene oxide is not a persistent toxin like lead or PFAS, emissions from the facility won’t linger long in air, water or soil after sterilization stops.
However, residents expressed concern about the company potentially continuing sterilization onsite after the agreement. State officials say the company could be hit with fines of up to $10,000 per day if the process continues after Dec. 31.
Additionally, state officials said the Viant site sparked a broader look into the sources of ethylene oxide pollution statewide. While Viant was using the most ethylene oxide in the state, “many” more medical sterilization operations exist, Ethridge said.
He added that across the U.S., ethylene oxide is being detected, even in places without medical device sterilization activity nearby. Ethridge said the state next will look at chemical manufacturing plants as a source of ethylene oxide pollution.
“Clearly something else is contributing to emissions of ethylene oxide beyond just industries using it,” Ethridge said. “There’s going to be a lot more to come as we get into the weeds and data to figure out what in particular could be causing the emissions.”
As more facilities, including hospitals, stop medical device sterilization operations because of concerns related to ethylene oxide, Ethridge said that raises additional questions about where devices can be sent for sterilization. It’s currently unclear where facilities who sent their products to Viant will turn to for sterilization.
“The (Food and Drug Administration) is now saying there’s a shortage of medical device sterilization services because so many businesses are getting out of it,” Ethridge said. “It’s a bit of a concern to us where the equipment is going to go.”
EDITOR’S NOTE: This story has been updated to note the public hearing took place on Wednesday, not Thursday.