WASHINGTON D.C., DC — The Environmental Protection Agency is warning residents who live near medical device sterilizing plants in 13 states – including Colorado – and Puerto Rico about potential health risks from emissions of ethylene oxide, a chemical widely used in their operations.
An area of Lakewood around Terumo Blood and Cell Technologies, whose headquarters and campus are at 10811 Collins Ave., is among the communities facing the highest potential risk from ethylene oxide (EtO) emissions, EPA said.
The agency notified 23 commercial sterilizers — 19 in the continental U.S. and four in Puerto Rico — that their operations pose an elevated risk of cancer and other ailments. The notice follows a recent survey of emissions data from almost 100 commercial sterilizers nationwide.
Ethylene oxide is used to clean everything from catheters to syringes, pacemakers and plastic surgical gowns.
While short-term or infrequent exposure to ethylene oxide doesn't appear to pose a health risk, EPA said long-term or lifetime exposure to the chemical could lead to a variety of health impacts, including lymphoma and breast cancer. EPA said it was working with commercial sterilizers to take appropriate steps to reduce emissions.
“Today, EPA is taking action to ensure communities are informed and engaged in our efforts to address ethylene oxide, a potent air toxic posing serious health risks with long-term exposure,” EPA Administrator Michael Regan said in a statement Wednesday.
EPA will conduct public outreach campaigns in each of the communities where elevated risks have been found, including an Aug. 10 webinar.
EPA said it will also host a community meeting for the Lakewood area residents on Oct. 25. Registration for the meeting can be found here.
Terumo BCT makes products to collect and process blood and cells, and uses EtO to sterilize its products. The company said on Wednesday that its use of EtO is strictly regulated and that the company meets or exceeds state and federal standards.
"ETO is the only viable, effective option to sterilize many medical products, including most of what we produce," the company says in a news release.
The facility does not violate any air pollution control regulatory requirements, according to EPA.
An EPA map of the Terumo facility and the surrounding area in Lakewood shows the estimates of lifetime cancer risks, which decrease with distance from the facility.
According to EPA, "The area in blue shows estimated lifetime cancer risks of 100 in a million or greater from breathing air containing EtO emitted from the facility, or the same as one additional cancer case in 10,000 people.
"A lifetime cancer risk of 100 in a million means that, if 1 million people were exposed to this level of EtO in the air 24 hours a day for 70 years, 100 people would be expected to develop cancer from that exposure."
Emissions at the Lakewood facility are below limits set by EPA and the Colorado Department of Public Health and Environment, Terumo said in a news release.
The company plans to further reduce emissions next year with the installation of a $22 million system to convert EtO emissions to water vapor and carbon dioxide, according to the release.
In 2018, CDPHE said it found no evidence of more cancer in the community around Terumo than in surrounding areas but that predicted cancer risks there were above the EPA's guidance for an acceptable risk level. CDPHE said it could be decades before data would show whether there was an actual increase in cancer.
Terumo BCT acquired the Lakewood campus from COBE Laboratories in 2012, and the medical sterilization facility became operational in 2000. The company employs 18 people at its sterilization facility and 2,000 in Colorado.
"Terumo BCT cares deeply about our employees and the surrounding community," the release says. "We are committed to operating our Lakewood facility safely and continuing to meet the needs of patients who rely on our life-saving healthcare products."
Use of ethylene oxide
The Ethylene Oxide Sterilization Association, an industry group, said in a statement that ethylene oxide has been used for decades by the health care community to sterilize a wide variety of medical devices and equipment. More than 20 billion health care products are sterilized each year in the U.S. alone.
In many cases, there are no practical alternatives currently available to ethylene oxide, the group said, adding that use of less effective cleaning methods "could introduce the real risks of increased morbidity and mortality'' at hospitals throughout the country.
EPA called medical sterilization “a critical function that ensures a safe supply of medical devices for patients and hospitals.'' The agency said it is committed to addressing pollution concerns associated with EO, sometimes called EtO, "in a comprehensive way that ensures facilities can operate safely in communities while also providing sterilized medical supplies.''
Proposed rules to update control of air toxic emissions from commercial sterilizers and facilities that manufacture EtO are expected by the end of the year, with final rules likely next year, EPA said.
Besides medical cleaners, EtO is used in a range of products, including antifreeze, textiles, plastics, detergents and adhesives. It is also used to decontaminate some food products and spices.
Two of the 23 facilities targeted by EPA — in Hanover and Jessup, Maryland — are used to sterilize spices. Both are operated by Jessup-based Elite Spice.
Other commercial sterilizers cited by EPA are located in Laredo Texas; Ardmore, Okla.; Groveland, Fla.; Salisbury, Md.; Taunton Mass.; Columbus, Nebraska; Linden and Franklin, New Jersey; Erie and Zelienople, Pa.; Memphis and New Tazewell, Tenn.; Athens, Texas; Sandy Utah; and Richmond Virginia.
Four plants are Puerto Rico: Anasco, Fajardo, Salinas and Villalba.
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