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EPA identifies elevated cancer risk due to facility's chemical in Lakewood neighborhood

Terumo BCT Sterilization Service, Inc.
Posted at 10:53 AM, Aug 05, 2022
and last updated 2022-08-09 13:30:51-04

LAKEWOOD, Colo. — Scientists with the U.S. Environmental Protection Agency (EPA) identified an elevated cancer risk in an area of Lakewood due to a nearby company that emits ethylene oxide into the air.

Terumo BCT Sterilization Service, Inc., located at W. Collins Avenue and Simms Street in Lakewood, is a medical device manufacturing company that uses ethylene oxide to sterilize its equipment and materials, according to the EPA. It began operations in 2000.

Ethylene oxide is a flammable, colorless gas that is used to make antifreeze, plastics, detergents, and adhesives, and to sterilize devices, according to the EPA. The Food and Drug Administration reports that about 50% of sterile medical devices are treated with ethylene oxide. It is a human carcinogen and constant exposure over many years increases the risk of cancers of the white blood cells, including non-Hodgkin lymphoma, myeloma, and lymphocytic leukemia, plus breast cancer in women, according to the EPA. Ethylene oxide is also produced naturally in the body when metabolizing ethylene, which is easily lost through exhalation, the EPA said.

The scientists and analysts with the EPA, in an effort to understand the impacts of ethylene oxide emissions from Terumo BCT Sterilization Service, Inc. and the cancer risks to its neighbors, completed a risk assessment on the singular chemical.

Based on the data collected and results, the EPA determined that there is an elevated cancer risk in that area of the Lakewood community. This risk information is current as of July 27, 2022 and may be updated.

The map below shows the EPA's estimates of lifetime cancer risks. The facility is labeled by the orange square.

EPA cancer risk map for Terumo BCT Sterilization Service, Inc

The light blue area shows an estimated lifetime cancer risk of 100 in a million or greater if a person breathes the air containing ethylene oxide, according to the EPA. In other words, it means that if one million people were exposed to that level of ethylene oxide 24/7 for 70 years, 100 people would develop cancer due to that exposure. The dark blue area increases the risk level to 600 in a million, or six in 10,000.

The EPA said this is a "worst-case scenario that assumes a person stays in the highest risk area 24 hours a day continuously for 70 years," according to the agency. It added that Terumo BCT Sterilization Service is not violating air pollution control regulatory requirements.

There isn't a simple answer to how far away is far enough to avoid these risks, the EPA said. This depends on various factors, including how far the chemical can travel and how long it stays concentrated in the air.

The EPA is now working with state and local agencies, facilities and the community to reduce the risk. It will determine if additional air pollution controls are needed.

In a statement to media, Terumo BCT Sterilization Service explained how it uses ethylene oxide because it is the "only viable, effective option to sterilize many medical products, including most of what we produce." It's use of ethylene oxide is strictly regulated, the company said.

"The EPA states that its risk assessment information represents potential, not actual, risk," the statement continues. "It is the most conservative estimate of potential risk; the EPA cautions that it should be used as a screening tool to identify areas for much more study for determining actual health risks for facility employees and local communities. Terumo BCT supports EPA’s nationwide review of EtO use and emission levels and its efforts to engage the community on new risk information.... State and federal regulators have identified no increased cancer rates in neighborhoods surrounding Terumo BCT’s Lakewood facility."

Jessi Done, senior plant manager for sterilization at Terumo BCT, said its emissions are well below the permitted limits.

"When Colorado looked at the cancer registry data, they found no increase in the actual cancer rates around Terumo compared to the rest of the state," Done said. "We care deeply about our employees, the community we’ve called home for 55 years and the patients who rely on our healthcare products.”

The EPA has offered ways adults and children can take care of their health, plus a community meeting in the fall to learn more about this specific case.

Adults should keep up with routine doctor visits and should contact their healthcare provider if they have concerns related to ethylene oxide exposure. The Agency for Toxic Substances and Disease Registry, at 888-232-6348, can provide the location of occupational and environmental health clinics. The parents of children who may be affected by this can contact the Pediatric Environmental Health Specialty Unit in their area. Children are more sensitive to the chemical than adults, according to the EPA.

While a Lakewood-specific community meeting, hosted by the EPA, is scheduled for Oct. 25, the EPA is holding a national public webinar on ethylene oxide-emitting facilities on Aug. 10 at 6 p.m. Click here to register for the August meeting.

Agency personnel will present the results of their 2022 ethylene oxide risk modeling analysis for the facility during the October meeting. To sign up to attend, click here and scroll down to the "Register to Attend the Community Meeting" banner. Residents can read a letter from the company addressing the community here.

Previously, the company and state officials evaluated and reduced the ethylene oxide risk in 2018, and this meeting will include new information and resolutions to those actions. The 2018 control measures reduced community risk by 50 to 75%, according to the Colorado Department of Public Health and Environment.

Terumo BCT Sterilization Service said next year, it plans to further reduce emissions with a new $22 million system that will convert ethylene oxide to water vapor and carbon dioxide.

Later this year, the EPA plans to propose strengthening the current regulations for ethylene oxide commercial sterilizers.