A commercial sterilizing plant in Georgia that was shut down last year for storing and using a volatile carcinogenic gas on medical equipment may be closer to reopening to help meet the growing demand for clean masks, gowns, and gloves to fight the coronavirus pandemic.
Sterigenics U.S. LLC moved a step closer to resuming production Monday when officials in Cobb County, Ga. allowed the Illinois-based company to start negative air pressure tests for gaps in ventilation, sealing and insulation at its plant, which uses carcinogenic ethylene oxide for sterilization.
The county’s order came days after Food and Drug Administration Commissioner Stephen Hahn asked Georgia Gov. Brian Kemp (R) to help Sterigenics reopen its suburban Atlanta facility to meet the critical demand for personal protective equipment for health workers and first responders.
Sterigenics, part of Sotera Health, has been at the center of growing national concern over sterilization plants that allow fugitive emissions of ethylene oxide to escape into residential neighborhoods in Illinois, Georgia and other communities. But those concerns are clashing against the pressure regulators feel to ensure health workers are properly protected.
Sterigenics, which began testing on Tuesday, said its tests, known as negative air pressure tests, would “demonstrate the effectiveness of the enhancements we have installed to our emissions control systems.”
Cobb County regulators on Monday cautioned the plant must still comply with several other requirements. The facility has been shuttered since late September while the company updated its building and fire codes to meet county standards.
“We recognize that Sterigenics could assist the community in combating Covid-19,” County Manager Rob Hosack said in a statement. “However, several critical steps must be completed before Sterigenics can safely reopen and comply with fire safety codes and other county ordinances.”
The company said it’s committed to safely resuming sterilization of vital medical products, including intravenous sets, breathing tubes, and other personal protective gear needed to battle Covid-19, the disease spread by the coronavirus.
Ethylene oxide is a flammable, colorless gas with a faintly sweet odor that—in addition to its use to sterilize medical equipment—is a building block for other chemicals to make a range of products, including antifreeze, textiles, plastics, detergents, and adhesives.
Limited Gear Due to Closures
In his March 19 letter letter to Georgia’s governor, Hahn said the closure of some commercial sterilizers, including Sterigenics, has limited the supply of personal protective equipment, or PPE.
“FDA is asking for your assistance in helping to increase the supply of PPE to help protect against Covid-19 by working with Sterigenics to allow for the appropriate sterilization” of personal protective equipment,” Hahn wrote.
A Kemp spokeswoman on Tuesday declined to answer if the governor directly intervened on Sterigenics’ behalf with Cobb County, saying only that it was a “local decision.” She deferred further questions to county officials.
Communities around medical sterilization plants have been raising alarms about the airborne dangers of ethylene oxide after the Environmental Protection Agency in 2016 deemed it to be 30 times more carcinogenic than previously understood. The EPA is now seeking to update its toxic air emissions standards for commercial sterilization plants including the Sterigenic facilities.
This toxic gas gas is found naturally in ambient air. But prolonged exposure to higher concentrations can hurt eyes and lungs, harm the brain and nervous system, and potentially cause lymphomas, leukemia, and breast cancer.
Janet Rau, president of the citizen-led Stop Sterigenics Georgia, questioned the need for sterilized gowns, masks, and gloves for first responders to transport patients, saying this type of gear doesn’t need to be sterilized by ethylene oxide. Only coronavirus test kits do, she said.
“They are opening up a facility to sterilize equipment that is not necessarily needed by frontline workers,” Rau said. “In the meantime, they are exposing the people living around the facility to toxic air.”
The FDA, which is responsible for ensuring the safety of medical devices and equipment, said personal protective gear used in surgeries and other related procedures that require the insertion of tubes and stents, require sterilization by ethylene oxide.
And Sterigenics isn’t reopening immediately, Cobb County spokesman Ross Cavitt said. The company is only running tests that were set for February but delayed by occupancy permit issues.
A third-party expert will determine whether Sterigenics resumes operations after reviewing whether the facility meets county fire codes and other ordinances, Cavitt said.
Georgia State Rep. Erick Allen (D), whose district includes Cobb County, asked the FDA Monday to explain whether it is using the Defense Production Act or any other authority to ask for the reopening of Sterigenics. He also asked FDA whether it is using the same authority to request the reopening of other sterilization facilities.
Allen, who supports a bill that both chambers passed requiring reporting of any amount of unpermitted releases of ethylene oxide, also criticized Cobb County’s reliance on a third-party expert.
“Why is the county abdicating its responsibility to a third party?” Allen said in an interview. “A third party shouldn’t be used to make a decision when we have elected officials.”
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