A syringe is prepared at a clinic in Norristown, Pa., Dec. 7, 2021. The Environmental Protection Agency is warning residents in 13 states and Puerto Rico about potential health risks from emissions of ethylene oxide, a chemical widely used to sterilize medical equipment and decontaminate spices.AP File Photo/Matt Rourke

The U.S. Environmental Protection Agency is warning residents who live near medical sterilizing plants in 13 states and Puerto Rico about 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 facing the highest risk from ethylene oxide emissions, EPA said.

The agency has 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.

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

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

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

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

Ethylene oxide is critical to proper sterilization of the instruments manufactured at the B. Braun site to ensure the safety of patients and health care providers and to meet standards set by the U.S. Food and Drug Administration, the company says in the DEP records.

“B. Braun Medical is dedicated to safely producing life-sustaining medical products and protecting the health of our employees and community,” Alli Longenhagen, spokeswoman for Bethlehem-based B. Braun Medical Inc., told lehighvalleylive.com last week. “We operate in full compliance with federal and state regulations, and emissions from our Allentown facility are far below the allowable levels in our operating permit.

“We also have made voluntary investments in new technology, including a best-in-class emission control system in our Allentown plant. This past 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 B. Braun’s facility are no more likely to develop the types of cancer potentially related to EtO exposure than people in other areas of Pennsylvania.

“We are pleased that the EPA’s latest report shows we safely and responsibly deliver 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 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 is working with commercial sterilizers to take appropriate steps to reduce emissions.

U.S. Environmental Protection Agency administrator Michael Regan speaks at a news conference May 5, 2022, at the Department of Justice in Washington. The EPA is warning residents in 13 states and Puerto Rico about 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, 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 a webinar set for Wednesday, Aug. 10. More than half the sites on EPA’s watch list are in predominantly minority or low-income communities.

Laredo, one of the communities targeted by the EPA notice, is a border city where the vast majority of residents are Latino and more than a quarter live in poverty. Missouri-based Midwest Sterilization Corp. operates a sterilization plant in Laredo. The company also owns a plant in Jackson, Missouri that is on EPA’s watch list.

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

A spokesperson for Midwest declined immediate comment. But the company told ProPublica and the Tribune last December that cancer risk from its Laredo plant is overstated. Emissions it 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 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 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.

Scott Whitaker, president and CEO of the Advanced Medical Technology Association, another industry group, applauded EPA “for its forthrightness about what it does and doesn’t know” about EtO, but added: “It is critical that the EPA get this right.”

A potential shutdown of medical-device sterilization facilities “due to misinformed political pressure, as well as uncertainty regarding which regulations the facilities must adhere to ... would be disastrous to public health,” Whitaker said in an email.

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

Besides medical cleansers, EtO is used in a range of products, including antifreeze, textiles, plastics, detergents and adhesives. It also used to decontaminate some food products and spices. Two of the 23 facilities targeted by 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 EPA are located in 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 in Puerto Rico: Anasco, Fajardo, Salinas and Villalba.

EPA’s announcement shines a light on health threats that sterilizer facilities pose to millions of Americans, said Raul Garcia of the environmental group Earthjustice.

“Now that EPA has new information on precisely where the worst health threats are, the agency must use its full authority to ... require fenceline monitoring at these facilities (and) issue a strong new rule,” he said. “No one should get cancer from facilities that are used to sterilize equipment in the treatment of cancer.”

Visit epa.gov to sign up to learn more about ethylene oxide risks from some commercial sterilizers during the Aug. 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. Reach him at kbresswein@lehighvalleylive.com.

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