Chemical in medical device cleaner – used in Lehigh Valley – poses cancer risk, EPA says

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The U.S. 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.

The Lehigh Valley is home to one of the commercial sterilizers, but it’s not among the top 23 facilities of concern, according to the EPA. The EPA defines elevated cancer risk at these nearly two dozen sites as 100 or more additional cancer cases per million people exposed to ethylene oxide emissions from each site.

B. Braun Medical Inc. uses ethylene oxide at its 901 Marcon Blvd. manufacturing facility outside of Allentown in Hanover Township, Lehigh County. The chemical, sometimes called EtO, is used by manufacturers to clean everything from catheters to syringes, pacemakers and plastic surgical gowns.

A Philadelphia law firm, Kline & Spectre, sued B. Braun on behalf of people with cancer, or their families, who lived, worked, or spent significant time near the plant.

“Best in class” emissions controls outside of Allentown

B. Braun began using new ethylene oxide emission controls at the Marcon Boulevard facility in September 2020, according to documents filed with the Pennsylvania Department of Environmental Protection. December 2020 tests submitted to DEP showed an average reduction of 99.98% in ethylene oxide emissions, which exceeds the compliance standard of at least 99% in its largest sterilization chamber ; testing in the plant’s vent room showed emissions of 0.701 parts per million dry volume, which is within the compliance range of less than 1 ppmvd, according to DEP documents.

Ethylene oxide is essential for the proper sterilization of instruments manufactured at the B. Braun site to ensure the safety of patients and healthcare providers and to meet standards set by the US Food and Drug Administration. United, the company says in DEP records.

“B. Braun Medical is dedicated to the safe production of life-saving medical products and to protecting the health of our employees and the community,” said Alli Longenhagen, spokesperson for B. Braun Medical Inc., based in Bethlehem, at lehighvalleylive.com last week. “We operate in full compliance with federal and state regulations, and emissions from our Allentown facility are well below the levels permitted in our operating license.

“We have also made voluntary investments in new technology, including a world-class emissions control system at our Allentown plant. Last May, the Pennsylvania Department of Health conducted an analysis of cancer rates near the B. Braun facility, which confirmed that people living in municipalities around the B. Braun facility do not are no more likely to develop the types of cancer potentially linked to EtO exposure than people in other areas of Pennsylvania.

“We are pleased that the EPA’s latest report shows that we are safely and responsibly delivering sterilized medical products to hospitals and other healthcare facilities across the country.”

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

U.S. Environmental Protection Agency Administrator Michael Regan speaks during a news conference May 5, 2022 at the Department of Justice in Washington. The EPA is warning residents of 13 states and Puerto Rico of potential health risks from emissions of ethylene oxide, a chemical widely used to sterilize medical equipment and decontaminate spices.AP File Photo/Patrick Semansky

“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.

Sites on the EPA’s Watch List in Underprivileged Communities

EPA will conduct public awareness campaigns in each of the communities where elevated risks have been found, including a webinar scheduled for Wednesday, 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 factory 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 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.” The agency said it is committed to addressing pollution issues associated with EtO, “in a comprehensive way that ensures facilities can 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 is critical that the EPA get this right.”

A potential closure of medical device sterilization facilities “due to ill-informed political pressure, as well as uncertainty about what regulations facilities must adhere to … would be disastrous for public health,” Whitaker said in an e-mail. 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.

Ethylene oxide used to make many products

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, Maryland 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, MA; 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 located in Puerto Rico: Anasco, Fajardo, Salinas and Villalba.

The EPA’s announcement highlights the health threats sterilization facilities pose to millions of Americans, said Raul Garcia of the environmental group Earthjustice.

“Now that the EPA has new information on the precise location of the worst health threats, the agency must use its full authority to…require fencing monitoring at these facilities (and) issue a tough new rule,” did he declare. “No one should catch cancer in facilities that are used to sterilize equipment in the treatment of cancer.”

LEARN MORE

Visit epa.gov to register and learn more about ethylene oxide hazards from certain commercial sterilizers during the August 10, 2022 webinar hosted by the U.S. Environmental Protection Agency.

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The Associated Press and supervising reporter Kurt Bresswein contributed to this report. Join it at [email protected].

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