More suits, EPA review seen after chemical emissions case (1)

Medical Sterilization Plant’s Multi-Million Dollar Loss in Court Over Carcinogenic Effects of Ethylene Oxide Sets Stage for Influx of Similar Cases, Puts EPA’s Actions on Chemical potentially carcinogenic under investigation.

Neighboring communities around the fences of facilities that use ethylene oxide – a compound used primarily to sterilize medical equipment – say emissions from the sterilization process have adverse short- and long-term health effects. , including cancer.

Those claims may have been bolstered by a Cook County, Illinois jury that ruled Sept. 19 that the Willowbrook plant of the Sterigenics medical sterilizer emitted toxins that contributed to plaintiff Sue’s breast cancer. Kamuda for three decades. The plaintiff argued that the company was aware of the health risks of the chemical, but failed to notify the community.

The $360 million victory, which is the first jury verdict for such cases, could spur even more residents to file lawsuits against ethylene oxide emitters, according to David Fusco, associate at the K&L Gates LLP office in Pittsburgh.

“The risk is real for various entities and the expected verdict will likely lead to increased 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 rules on sterilizers. report that found the agency delayed disclosure of critical risks to areas near sterilization facilities.

Case landscape

There is a growing list of more than 700 ethylene oxide, or EtO, personal injury and medical surveillance claims in court across the United States, including Pennsylvania, Georgia, Illinois and New Mexico.

Companies using EtO advocated for the importance of medical sterilization of the chemical at the height of the Covid-19 pandemic, when hospitals were struggling under the weight of mass illnesses and shortages of personal protective equipment.

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

The panel blasted Sterigenics’ recent verdict as an “unfortunate example of bad science with real-world implications.”

“We believe this verdict should be a wake-up call to EPA officials, and we look forward to continuing to engage on this important issue in support of strong, science-based regulations that protect human health and our environment,” the statement said. panel.

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

The agency has not updated airborne toxicity standards for EtO since they were established in the 1990s, but released a risk assessment in 2016 that found the chemical was 60 times more toxic than we didn’t initially think so.

This risk assessment has likely spurred litigation around the chemical, but further investigation is needed, according to Fusco. Without further scrutiny, “very low level broadcasts” could be subject to legal action, he noted.

“It’s an ongoing process for the EPA, and I think the uncertainty creates an open door for potential litigation,” Fusco said.

Community concerns

As litigation progresses, communities on the outskirts of ethylene oxide facilities are demanding damages and tougher regulations in an area they say has been sickening residents and killing them for years .

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

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

The Rio Grande International Study Center existed for 28 years before concerns about the plant’s EtO emissions hit its radar in 2021, according to executive director Tricia Cortez.

“What we found was really shocking,” she told Bloomberg Law. “We didn’t know we were at the highest level of cancer risk in the United States for industrial air pollution, according to the EPA, we just didn’t know any of that.”

According to a statement from Midwest Sterilization, the facility did not wait 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 exceed current emissions requirements under the Clean Air Act,” the company said in a statement.

Some members of Congress joined the communities to express their concern. The House and Senate have introduced bills (HR 3631, S. 1903) that would require the EPA to update its ethylene oxide standards.

Risk visit

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

Cortez and his organization were thrilled that Laredo was one of the stops on the EPA tour, but are disappointed with the agency’s delay in crafting tougher rules and raising awareness.

“We are disheartened by the length of this extraordinary delay, solely because of the toxicity and carcinogenicity of this chemical, and this threat that much of our community lives under unknowingly,” she said. .

Sheila Serna, director of climate science and policy at the Rio Grande International Study Center, used to investigate issues such as ethylene oxide for the Texas Commission on Environmental Quality. She said she remains skeptical of facilities self-reporting their emissions when local air regulators and the EPA don’t do their own monitoring.

“We repeatedly asked them for air monitoring of the fences and only air monitoring of the community in general, and we did nothing with it,” according to Serna.

The EPA did not immediately respond to a question for comment.