A Georgia county agreed to lift restrictions on a medical sterilizer plant that uses ethylene oxide, after White House pressure to help satisfy the growing demand for clean and safe medical equipment to fight the coronavirus pandemic.
The Cobb County Board of Commissioners signed an emergency order late Wednesday that “temporarily” permits Sterigenics U.S. LLC to restart its currently shuttered sterilization plant “for the sole purpose of sterilizing PPE (personal protective equipment) necessary to combat the COVID-19 pandemic,” referring to the infection caused by the deadly new coronavirus.
Cobb County took the action the same day Georgia’s Environmental Protection Division said it modified a legal settlement with another company,
Becton Dickinson, Sterigenics, and other companies have been at the center of growing national concern over sterilization plants that allow fugitive emissions of ethylene oxide, which can cause cancer, to escape into residential neighborhoods in Illinois, Georgia, and elsewhere.
But those concerns are clashing against the immediate pressure regulators feel to ensure proper protection for health workers fighting Covid-19.
“While we must take into account the risks from emissions of ethylene oxide, and addressing those risks remains a major regulatory priority for the agency, it’s important to bear in mind those risks are linked to exposure over an entire lifetime, however COVID-19 poses an immediate threat to our nation during this crisis,” EPA Administrator Andrew Wheeler said in a statement Wednesday.
Cobb County has been under pressure from the state and the White House since last week to reopen the Sterigenics plant, which had been shut down since August, in part for the company to install upgraded emissions controls to capture fugitive releases of ethylene oxide into the neighboring community.
Cobb County commissioners said they allowed the plant to reopen only after the Georgia Environmental Protection Division reassured them the company’s recently installed emissions controls were “deemed safe” to reduce ethylene oxide releases, and emphasized the resumption was temporary.
“Washington has asked us to reopen the plant in the national interests, and we have to respond,” Mike Boyce, the Republican chairman of the County Board of Commissioners, said in an interview earlier on Wednesday. “This is a high-level national crisis and we will respond, as that is what responsible governments do.”
In a statement on Wednesday, Sterigenics said it will take “immediate steps” to start sterilizing personal protective equipment for health workers.
But the company said the temporary Cobb County order “falls woefully short of the measures needed to protect public health, as well as the FDA’s request for assistance,” and excludes the company from sterilizing other “vital” medical products and devices.
The EPA in 2016 concluded ethylene oxide—a toxic, flammable, and faintly sweet-smelling gas—was 30 times more carcinogenic than previously understood, prompting citizen activism to limit releases of the gas from the commercial sterilizer industry.
In response to the cancer finding, the EPA is seeking to update its toxic air emissions standards for commercial sterilization plants, including the Sterigenic and Becton facilities in Georgia.
The toxic gas gas is found naturally in ambient air. But prolonged exposure to higher concentrations of the gas can hurt eyes and lungs, harm the brain and nervous system, and potentially cause lymphomas, leukemia, and breast cancer.
Becton uses ethylene oxide to sterilize catheters, used for delivering antibiotics and for others purposes. The Sterigenics plant in suburban Atlanta sterilizes intravenous sets, breathing tubes, and other personal protective gear.
A number of Covid-19 patients are so sick that they require intravenous infusions of medicine and other forms of nutrition, David Jamison, an executive director at ECRI, a nonprofit patient safety group.
“We are hearing that patients on average are using up to four sets of intravenous sets,” which means hospitals need a significant number of sterilized needles, tubing, and pumps that seem to be in short supply, Jamison said in an interview Wednesday.
Personal protective gear such as masks, gowns, and gloves need to be disinfected, but not necessarily sterilized, Jamison said.
The state’s consent decree with Becton, reached in October 2019, restricted the amount of medical equipment the company could sterilize and required state-of-the-art emissions controls for ethylene oxide.
State officials said the modifications allowing an increase in sterilization operations announced Wednesday were temporary and would only last for two weeks after Gov. Brian Kemp (R) lifts the state’s first-ever public health emergency due to the coronavirus. Kemp declared this emergency March 16.
Citizen activists were relieved Cobb County didn’t allow the company to fully restart operations.
“We get that this is temporary and once the declaration of emergency expires, the plant will be shut down again,” Tony Adams, the vice president of Stop Sterigenics Georgia, said in an interview.
—With assistance from Chris Marr in Atlanta.