This article has been updated to include comments from Sterigenics.
Medical device sterilization plants in two Atlanta suburbs have come under scrutiny from neighbors and state officials following the publication of an investigative report by Georgia Health News and WebMD.
Ethylene oxide plants owned by Sterigenics in Smyrna, Ga. and BD Bard in Covington, Ga. reported having emitted thousands of pounds of the cancer-causing gas into the air in excess of federal environmental limits, according to the report.
Many such plants received state permits before the federal EPA lowered its limits on ethylene oxide emissions in 2016, the report said.
The Illinois EPA ordered a Sterigenics ethylene oxide plant in Willowbrook, Ill., closed in February, citing excessive emissions of the sterilant. In June, the state passed a tough new law regulating the discharge of the gas. The plant processed millions of medical devices annually, and its sudden closure caused some device shortages and a push by the FDA to come up with different methods to replace and improve ethylene oxide sterilization. Last week, Sterigenics said it has reached an agreement with the state to reopen the plant.
Data compiled by the Georgia Comprehensive Cancer Registry show that the incidence of “at least one of the cancers tied to ethylene oxide, non-Hodgkin lymphoma, has risen significantly over the last decade, especially among men, in the 30014 ZIP code around the sterilizing plant in Covington,” the report said.
Male workers at ethylene oxide plants have had more cases of non-Hodgkin’s lymphoma and other “lymphoid” cancers than female workers, according to a U.S. Environmental Protection Agency risk review.
Sterigenics is installing new pollution control equipment in its Smyrna plant, the Georgia Health News and Web MD report said. The company did not immediately respond to a request for comment.
The report said that state data showed “ethylene oxide emissions exceed the state’s annual safe level by an average of 23 to 34 times,” with an average concentration of ethylene oxide in one neighborhood near the Bard plant “97 times higher than the state’s safe level” in 2015. In an email to MassDevice, a BD spokesman called the Georgia Health News/WebMD report “misleading because it states that our emissions are in excess of state standards/regulations and that is simply not true.”
In a separate statement, BD said it has installed the best available emission control technology at the Covington plant and that it “achieve(s) greater than 99.95% destruction of ethylene oxide in our plant emissions. We verify the effectiveness of emission destruction through stack testing (conducted by an independent third-party), in accordance with permit requirements,” the company said. “BD meets or exceeds all local, state and federal ethylene oxide emission standards in Covington, including the National Emission Standards for Hazardous Air Pollutants (NESHAP), and our ethylene oxide levels are well below all requirements under the Clean Air Act.”
Sterigenics said its Atlanta facility “safely operates in compliance with permits and regulations established by the Georgia Environmental Protection Division (EPD) and the United States Environmental Protection Agency (US EPA).
“As part of our commitment to ongoing improvement, we have consistently taken voluntary steps to reduce emissions of ethylene oxide (EO) from the facility resulting in a 90% reduction in EO emissions over the past five years,” the company said. “In addition, we are working with the Georgia EPD regarding additional voluntary enhancements that are consistent with changes being undertaken in other Sterigenics facilities and which will further reduce EO emissions from the facility to negligible levels. We anticipate completing the enhancements over 12 to 24 weeks following receipt of the necessary permits.”
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