State investigates Viant for air permit violations

Contract manufacturer Viant Medical Inc. will close its sterilization operation in Grand Rapids, Mich., as an investigation continues into air emissions of a carcinogen.

However, a company spokesman said the closure planned for later this year and the ongoing probe are not directly related.

The sterilization chambers at the plant were included in the purchase of the property in 2015, and are only a small part of the business model, said Viant spokesman John Truscott, who is with the Lansing-based public relations firm Truscott Rossman.

"Viant is getting out of the business and has informed customers that they will need to find alternatives," Truscott told Plastics News.

The customers sell catheters and connectors that Viant manufactures. The medical devices can't be sterilized using steam so a flammable gas called ethylene oxide (EtO) is used to fumigate the products in a chamber. Viant will discontinue the process and focus on its core business of medical device manufacturing and assembly, Truscott said.

With estimated sales of $310 million, Viant ranks No. 28 among North American injection molders.

Viant, formerly MedPlast Inc., and the Grand Rapids site's predecessors (Vention and Medtronic) have been using EtO to sterilize medical equipment at the location for 30 years, according to the Michigan Department of ​ Environmental Quality (MDEQ). EtO was regulated as a probable human carcinogen from 1982-2016, when it was classified as a known human carcinogen. MDEQ restricts emissions of the gas when it issues air permits to companies. Viant's permit requires pollution control equipment to remove EtO before emissions are exhausted to the atmosphere.

In July 2017, Viant reported an emission problem to state regulators related to a faulty rubber seal on a part of the sterilization system. The company says the malfunction was corrected within a day of its discovery.

"We immediately stopped operations and repaired the seal. We later received a notice of violation from the MDEQ as a result of that self-reported incident. Since then, we have worked closely with the MDEQ to test and monitor air quality at the plant," Viant says in a letter to residents who live by the facility, including students at Grand Valley State University.

The letter hit households just ahead of a March 6 community meeting organized by MDEQ, which says it continued its investigation after the seal was repaired because "levels of ethylene oxide emissions associated with the facility were found to be higher than expected."

During a November 2018 inspection, MDEQ environmental engineers said they learned cardboard boxes of the medical products needing sterilization are placed on racks in one of five fumigating chambers. Then, EtO is introduced into the chamber to sterilize the products. A vacuum pump then collects the EtO emissions and pulls them to a small scrubber, which vents to a larger scrubber. After the chamber is evacuated of EtO, the racks are removed and taken to aeration cells to ventilate residual EtO, which also vents to the large scrubber.

"Facility personnel stated that elevated levels of ethylene oxide are measured when racks are transported from fumigation chambers to aeration cells," MDEQ reported.

MDEQ has issued Viant four violations to date: failure to comply with EtO emission limits; failure to maintain a 99 percent emission reduction from the sterilization chamber vents and/or aeration room vents; failure to maintain a minimum capture and destruction efficiency of 99.5 percent by weight for EtO; and failure to meet a performance testing deadline.

Viant disputes some of the MDEQ findings, including results of 24-hour sampling tests done Nov. 29-30, which led to one of the violations. Viant contends the methodology didn't factor in the influence of other sources of EtO, such as exhaust fumes from cars and trucks.

"The company sent a letter to the DEQ detailing the flaws in their methodology. We are hopeful the DEQ will use the [U.S. Environmental Protection Agency] guidelines in their next round of tests," Truscott said.

Viant also says it has taken voluntary steps to reduce fugitive emissions, including elimination of the specific sterilization cycle that produced the majority of the facility's fugitive EtO emissions, and bringing in outside experts to look into routing fugitive emissions to a stack. Viant also is keeping sterilized products in the sterilization chamber for a longer time so additional EtO emissions will vent to the scrubbers.

"Viant is committed to continuing to work cooperatively with MDEQ to identify additional, feasible steps to reduce EtO emissions from the Viant sterilization facility," the company says in a letter to state agency.

In the meantime, some residents and students are worried. About 100 people attended MDEQ's meeting on March 6. Viant's neighbors expressed concerns about whether cancers that killed relatives are related to the facility, whether they should let grandchildren visit, whether it will be safe to eat from their gardens and whether their property values will go down.

In its letter to residents, Viant reminded them that MDEQ Air Toxics Unit Supervisor Robert Sills has said the agency "found no reason to be concerned about short-term health effects at the level of emissions and exposure we think are occurring" and that "we are not recommending that anyone change their behavior or leave the area."

MDEQ sums up the risks in an online issue summary that says breathing very high amounts of ethylene oxide over a short period of time may cause headaches, dizziness, upset stomach, fatigue and respiratory irritation. The amounts of ethylene oxide measured and estimated around Viant do not pose a risk of short-term health problems.

"Breathing ethylene oxide, even at low levels, over a lifetime may increase the risk of developing breast cancer and blood cancers — including multiple myeloma, leukemia, and non-Hodgkins lymphoma — in some people," MDEQ says.

The Kent County Health Department is evaluating available data on cancer incidence in the area.