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More Suits, EPA Scrutiny Seen After Chemical Emissions Case (1)

Oct. 5, 2022, 9:30 AMUpdated: Oct. 5, 2022, 3:31 PM

A medical sterilizer plant’s multi-million dollar loss in court over the carcinogenic effects of ethylene oxide sets the stage for an influx of similar cases and puts EPA actions on the potentially cancerous chemical under scrutiny.

Neighboring communities at the fence lines of facilities who use ethylene oxide—a compound used primarily to sterilize medical equipment—claim that emissions from the sterilization process cause short and long-term adverse health impacts, including cancer.

Those claims may have gotten a boost from a jury in Cook County, Ill., which ruled on Sept. 19 that medical sterilizer Sterigenics’ Willowbrook plant emitted toxins that contributed to plaintiff Sue Kamuda’s breast cancer over three decades. The plaintiff argued the company knew of the health hazards from the chemical, but didn’t warn the community.

The $360 million win, which is the first jury verdict for these types of cases, could galvanize even more residents to file lawsuits against ethylene oxide emitters, according to David Fusco, partner at the K&L Gates LLP Pittsburgh office.

“The risk is real for variety of entities and the expected verdict is likely to lead an increase in litigation,” Fusco told Bloomberg Law.

The Environmental Protection Agency is also facing legal action, with environmental groups threatening to sue the agency for missing a self-imposed deadline to revise existing sterilizer rules.The EPA has been touring the U.S. to inform communities about ethylene oxide risks, following an independent watchdog report that revealed the agency delayed critical risk disclosures for areas neighboring sterilization facilities.

Landscape of Cases

There’s a growing list of more than 700 ethylene oxide, or EtO, personal injury and medical monitoring claims in courts across the US, including Pennsylvania, Georgia, Illinois, and New Mexico.

Companies using EtO argued for the chemical’s medical sterilization importance during the height of the Covid-19 pandemic, when hospitals were struggling under the weight of mass illness and personal protective equipment shortages.

An estimated 50% of all medical devices are sterilized with EtO, the American Chemistry Council’s Ethylene Oxide Panel said in an emailed statement to Bloomberg Law.

The panel lambasted the recent Sterigenics verdict as an “unfortunate example of bad science having real world implications.”

“We believe this verdict should raise alarms with EPA officials and look forward to continuing to engage on this important issue in support of strong, science-based regulations that are protective of human health and our environment,” the panel said.

The EPA regulates EtO as an air toxic, and promised this year to review Clean Air Act regulations for other options to stem emissions from commercial sterilizers.

The agency hasn’t updated air toxics standards for EtO since they were established in the 1990s, but released a risk assessment in 2016 that revealed the chemical to be 60 times more toxic than originally thought.

That risk assessment likely pushed the uptick in litigation around the chemical, but there is a need for further investigation, according to Fusco. Without further scrutiny, “very low level emissions” could be targeted for legal action, he noted.

“It’s an ongoing process for the EPA, and I think that uncertainty creates an open door for potential things to be litigated,” Fusco said.

Community Concerns

As litigation proceeds, communities at the edge of ethylene oxide facilities are pushing for damages and tougher regulations within a sector they claim has been sickening and killing residents for years.

The Rio Grande International Study Center—a potential plaintiff in the intent to sue lodged against the EPA in September—is located in Laredo, Texas, one of the stops on a recent EPA tour to inform residents of EtO risks from neighboring facilities.

For residents of Laredo, it took years to become aware of the EtO emissions from a local Midwest Sterilization Corporation plant. An EPA risk assessment for areas surrounding the Laredo facility found “elevated cancer risk” for the area—which “decreases with distance from the facility.”

The Rio Grande International Study Center was around for 28 years before concerns about EtO emissions from the plant reached its radar in 2021, according to Executive Director Tricia Cortez.

“What we discovered was really shocking,” she told Bloomberg Law. “We didn’t realize we were at the highest level of cancer level risk in the US for industrial air pollution, according to the EPA, we just did not know any of this.”

According to a statement from Midwest Sterilization, the facility hasn’t waited for EPA changes to EtO rules to make “voluntary process improvements,” and remains in compliance with state and federal regulations.

“As a result, Midwest continues to go above and beyond current emissions requirements under the Clean Air Act,” the company said in a statement.

Some in Congress have joined the communities in expressing concern. Both the House and Senate have introduced bills (H.R. 3631, S. 1903) that would require the EPA to update its ethylene oxide standards.

Risk Tour

The EPA’s community engagement effort was launched in August, which includes a “phased outreach” campaign to inform the American public about EtO risks and individual community visits.

Cortez and her organization were pleased that Laredo was one of the stops on the EPA’s tour, but are disappointed by the agency’s delay in more stringent rulemaking and outreach.

“We feel disheartened by the length of this extraordinary delay, only because of how toxic and carcinogenic this chemical is, and this threat that so much of our community has been living under unknowingly,” she said.

Sheila Serna, Climate Science and Policy Director at Rio Grande International Study Center, used to investigate issues like ethylene oxide for the Texas Commission on Environmental Quality. She said she remains skeptical about facilities self-reporting their emissions when local air regulators and EPA don’t conduct their own monitoring.

“We’ve asked them repeatedly for fenceline air monitoring and just community air monitoring in general, and we have just gotten nowhere with that,” according to Serna.

The EPA didn’t immediately respond to a question for comment.

(Updated with a statement from Midwest Sterilization.)

To contact the reporter on this story: Jennifer Hijazi in Washington at jhijazi@bloombergindustry.com

To contact the editor responsible for this story: Zachary Sherwood at zsherwood@bloombergindustry.com