EPA: Chemicals in medical device cleaners pose cancer risk

WASHINGTON– The Environmental Protection Agency is warning residents who live near medical sterilization plants in 13 states and Puerto Rico of potential health risks from emissions of ethylene oxide, a chemical widely used in their operations.

Laredo, Texas; Ardmore, Oklahoma; and Lakewood, Colorado, are among the communities most at risk from ethylene oxide emissions, the EPA said.

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. More than half of the sites on the EPA’s watch list are in majority-minority or low-income communities.

Laredo, one of the communities targeted by the EPA advisory, is a border town where the vast majority of residents are Latino and more than a quarter live in poverty. Missouri-based Midwest Sterilization Corp. operates a sterilization facility in Laredo. The company also has a plant in Jackson, Missouri, which is on the EPA watch list.

More than 40% of Laredo’s nearly 70,000 school children attend campuses in high cancer risk areas due to ethylene oxide emissions from the Midwest plant, according to an analysis by ProPublica and the Texas Tribune.

A spokesperson for the Midwest declined immediate comment. But the company told ProPublica and the Tribune last December that the cancer risk at its Laredo plant was overstated. Emissions reported to the EPA are “worst-case scenarios,” rather than specific pollution levels, the company said.

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 no practical alternative currently available 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.

Scott Whitaker, president and CEO of the Advanced Medical Technology Association, another industry group, applauded the EPA “for being candid about what it knows and doesn’t know” about EtO, but added “It’s critical that the EPA get it right.”

A potential closure of medical device sterilization facilities “due to ill-informed political pressure, as well as uncertainty about the regulations with which facilities must comply…would be disastrous for public health,” Whitaker said in a statement. E-mail.

At least seven sterilizers on the EPA’s watch list are members of AdvaMed, including the two Midwest plants and two owned by industry giant Becton, Dickinson and Co., also known as BD.

In addition to medical cleaners, EtO is used in a range of products including antifreeze, textiles, plastics, detergents and adhesives. It was 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 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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