EPA Rule Cuts Cancer Risks in Lakewood From Ethylene Oxide

Ethylene oxide emissions from Terumo Blood and Cell Technologies (BCT) in Lakewood have been identified as a cancer risk, according to multiple studies, including several from the Environmental Protection Agency.

The EPA has mandated a reduction of those emissions by at least 90 percent. Announced on March 14, the rule will require new and stronger methods for pollution control at commercial sterilization facilities such as Terumo BCT.

Ethylene oxide is used to sterilize medical equipment because it breaks down DNA — but that’s also what makes it cause cancer. In a 2023 supplement to a 2018 ethylene oxide study identifying Terumo BCT as a high-risk facility, the EPA found heightened levels of breast cancer and Hodgkin's lymphoma in subjects over a twenty-year period. Cancer risk from ethylene oxide is based on long-term exposure of 24 hours per day over seventy years.

“The final amendments to the air toxics standards for ethylene oxide commercial sterilization facilities put in place the strongest measures in U.S. history to reduce emissions of ethylene oxide, one of the most potent cancer-causing chemicals,” says Kerry Hicks, an environmental engineer in the Air Toxics, Partnerships, and Program Support Branch of the EPA. “Once the rule is in full effect, no person will be exposed to ethylene oxide at levels that correspond to a lifetime cancer risk of greater than 100-in-1 million," a metric specified by the Clean Air Act.

Commercial sterilization facilities like Terumo BCT emit ethylene oxide because they must be sure products are perfectly sterile before releasing them to hospitals. Terumo BCT manufactures and distributes blood-related medical devices globally.

Terumo BTC has a venting system that captures ethylene oxide before it goes into the air, but the EPA's new rule establishes standards for controlling ethylene oxide emissions from building leaks and chamber exhaust vents for the first time. The new rule also requires facilities to use stronger control measures for sterilization chamber vents and aeration room vents in addition to implementing continuous emissions monitoring.

“There are some parts of the new rule that we think are very positive, and there's some parts of it that we wish were different and we wish were stronger,” says Marvin Brown, an attorney with environmental law firm Earthjustice. “Overall, I do think it's a good step forward, but it's not the end of the fight to protect communities from ethylene oxide emissions.”

In 2022, Earthjustice sued the EPA for failing to review air toxics rules for commercial sterilizers, which it had last done in 2006. Legally, the agency is supposed to review those rules every eight years; the new rule is a consequence of that lawsuit.

Terumo BCT faces lawsuits filed by Coloradans who claim the facility’s ethylene oxide emissions contributed to their cancers. Most of those lawsuits are making their way through the Jefferson County District Court, with judges grouping several plaintiffs together to simplify proceedings. The number of lawsuits ramped up five years ago, after the EPA identified the facility as creating a cancer risk.

One notable case is that of Blake Darnell, who claims that Terumo BCT caused his cancer and other health problems he still experiences by exposing him to ethylene oxide through his high school years as a Lakewood resident. Darnell's legal team did not respond to a request for an update on his case.

While developing the new rule, the EPA held a meeting with Lakewood residents to discuss the chemical and its impact there.

Terumo BCT has been working to reduce its emissions since 2018, when it was first identified as causing increased cancer risk in Lakewood. The facility has told the EPA it will complete additional updates on its system this year.

“At this time, EPA and Terumo BCT are evaluating what changes need to be made at the facility in order to comply with the new regulation and how their current projects fit into those changes,” Hicks says.

Terumo BCT has two years to comply with the new regulations. According to Brown, that two-year timeline is one aspect of the rule that displeases advocates. Many of them had hoped that eighteen months would be the maximum length of time companies had to comply, he says.

“If you're a community who's been living next to a sterilizer facility for the past thirty years under weak regulations, an additional few years is a lot to ask for in terms of patience," Brown argues.

Christine Romero, Terumo BCT’s external communications manager, says company officials are examining the EPA rule.

In a statement, Terumo BCT says that it complies with all current health and safety regulations. “Terumo’s current advanced emissions control system already captures and destroys more than 99 percent of ethylene oxide emissions,” the statement adds.

Terumo BCT also notes that ethylene oxide is one of the only proven ways to sterilize medical equipment properly, so the company is working toward ways to use less in the process while still maintaining sterilization standards.

“No one is arguing that we do not need to sterilize medical products,” Brown says. “What we are arguing is that we should not sacrifice communities in that process, that there are safer and better alternative ways of sterilizing medical products than the ways that we have been doing it in the past, and we should be working towards that future where no one is getting cancer from a device that is meant to save their life.”