EPA: Chemicals in medical device cleaners pose cancer risk

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An area in Lakewood around a medical sterilization plant is among those facing the highest potential risk from ethylene oxide emissions, the EPA said.

WASHINGTON DC, DC – The Environmental Protection Agency is warning residents who live near medical device sterilization plants in 13 states – including Colorado – and Puerto Rico of potential health risks from greenhouse gas emissions. 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, said the EPA.

The agency has notified 23 commercial sterilizers — 19 in the continental United States and four in Puerto Rico — that their operations pose a high risk of cancer and other ailments. The advisory follows a recent survey of emissions data from nearly 100 commercial sterilizers nationwide.

Ethylene oxide is used to clean everything from catheters to syringes, pacemakers and plastic surgical gowns.

Although short-term or infrequent exposure to ethylene oxide does not appear to pose a health risk, the EPA has stated that long-term or lifetime exposure to the chemical could lead to various effects. on health, including lymphoma and breast cancer. The EPA said it is working with commercial sterilizers to take appropriate steps to reduce emissions.

“Today, the EPA is taking action to ensure communities are informed and engaged in our efforts to address ethylene oxide, a potent airborne toxicant that poses serious health risks in the event of a long-term exposure,” EPA Administrator Michael Regan said in a statement Wednesday.

The EPA will conduct public awareness campaigns in each of the communities where elevated risks have been found, including a webinar on August 10.

The EPA said it will also host a community meeting for Lakewood-area residents on Oct. 25. Registration for the meeting can be found here.

Lakewood Facility

Terumo BCT manufactures products to collect and process blood and cells, and uses EtO to sterilize its products. The company said Wednesday that its use of EtO is strictly regulated and meets or exceeds state and federal standards.

“ETO is the only viable and effective option for sterilizing many medical products, including most of what we produce,” the company said in a press release.

The facility does not violate any regulatory air pollution control requirements, according to the EPA.

An EPA map of the Terumo facility and surrounding Lakewood area shows lifetime cancer risk estimates, which decrease with distance from the facility.

According to the EPA, “the area in blue shows estimated lifetime cancer risks of 100 in a million or more from breathing air containing EtO emitted from the facility, the same as a case extra cancer in 10,000 people.

“A lifetime cancer risk of 100 in a million means that if 1 million people were exposed to that level of EtO in the air 24 hours a day for 70 years, 100 people would have to develop cancer from that exposure. .”

Emissions from the Lakewood facility are below limits set by the EPA and the Colorado Department of Public Health and Environment, Terumo said in a press 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 statement.

In 2018, the CDPHE said it found no evidence of more cancer in the community around Terumo than in surrounding areas, but predicted cancer risks were above EPA guidelines for a level. acceptable risk. The CDPHE said it could be decades before data shows whether there is a real rise 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 statement said. “We are committed to operating our Lakewood facility safely and continuing to meet the needs of patients who rely on our lifesaving 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 healthcare community to sterilize a wide variety of medical devices and equipment. Over 20 billion healthcare products are sterilized each year in the United States alone.

In many cases, there is currently no practical alternative to ethylene oxide, the group said, adding that using less effective cleaning methods “could introduce the real risks of increased morbidity and mortality” in hospitals across the country.

The EPA has called medical sterilization “an essential function that ensures a safe supply of medical devices for patients and hospitals.” operate safely in communities while providing sterilized medical supplies.”

Proposed rules to update controls for toxic air emissions from commercial sterilizers and facilities that manufacture EtO are expected by the end of the year, with final rules likely next year. said the EPA.

In addition to medical cleaners, EtO is used in a range of products including antifreeze, textiles, plastics, detergents and adhesives. It is also used to decontaminate certain food products and spices.

Two of the 23 facilities targeted by the EPA – in Hanover and Jessup, Maryland – are used to sterilize spices. Both are operated by Jessup-based Elite Spice.

Other commercial sterilizers cited by the EPA are located in Laredo, Texas; Ardmore, Okla.; Groveland, Florida; Salisbury, Maryland; Taunton Mass; Columbus, Nebraska; Linden and Franklin, New Jersey; Erie and Zelienople, Pennsylvania; Memphis and New Tazewell, Tennessee; Athens, Texas; Sandy Utah; and Richmond Virginia.

Four factories are Puerto Rico: Anasco, Fajardo, Salinas and Villalba.

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