Georgia Attorney General Chris Carr filed a complaint Monday on behalf of Georgia Gov. Brian Kemp and the Georgia Environmental Protection Division (EPD) to temporarily halt medical manufacturing plant BD Bard’s sterilization operations.
The plant, which has been embroiled in controversy since August over reports of high concentrations of the carcinogen ethylene oxide near the facility, is located about one mile away from Emory’s Oxford campus.
The complaint comes after the city of Covington, Ga., requested on Oct. 16 that the plant temporarily close when city officials determined that results from tests for ethylene oxide conducted by a third party contractor indicated dangerous levels of the chemical.
Ethylene oxide is a colorless and odorless chemical used by BD Bard and other medical equipment manufacturers to sterilize medical products. The U.S. Environmental Protection Agency (EPA) classified the chemical as a definite human carcinogen in 2016 after finding extensive epidemiological and laboratory evidence that it can cause cancer after long-term exposure.
Assistant Vice President of Reputation Management Laura Diamond told the Wheel in an Oct. 18 email statement that the University contracted with a third party to conduct independent testing of the air quality around the Oxford campus. Diamond said the test showed ethylene oxide levels below federal limits.
“Independent test results found that the air quality at the Oxford College campus is safe and the levels of ethylene oxide are significantly below federal limits,” Diamond wrote. “We will continue to monitor the situation and work cooperatively with our community partners as well as local and state officials.”
Diamond declined to comment when asked to further elaborate on the details of the test results and which third-party consultants conducted the tests.
The State's Injunction
The attorney general’s complaint cites the plant’s “negligent” release of 54.5 pounds of ethylene oxide emissions into the air in September.
In August, Georgia EPD requested BD Bard to prove that it had reduced its ethylene oxide emissions, but the plant has taken “few, if any, demonstrable steps” to meet this request, according to the complaint.
On Sept. 24, the plant disclosed to Georgia EPD that as a result of an operator error, the valve on the chamber vent where ethylene oxide is used to sterilize medical devices was discovered to be partially open, releasing the pollutant into the atmosphere over the course of eight days between Sept. 15 and 22.
According to the complaint, the September leakage is a violation of BD Bard’s air quality permit and the Georgia Air Quality Act, which requires that sterilization chamber vents reduce ethylene oxide emissions by up to 99 percent when operating. BD Bard’s chambers only reduced emissions up to 97.3 percent during this period.
BD Bard firmly opposed the state and city governments’ attempted move to shut down the facility in a statement emailed to the Wheel on Monday by BD Bard Senior Director of Public Relations Troy Kirkpatrick. The company argued that state and local officials are failing to accept cooperative dialogue initiated by the company.
“Governor Brian Kemp, the Georgia EPD and [Covington City] Mayor [Ronnie] Johnston are ignoring science and facts and may be creating a risk to the health and safety of patients, including the elderly and children that rely on these devices to deliver critical interventions,” the statement reads. “[Georgia] EPD has aided consistent misunderstanding and misplaced public hysteria about ethylene oxide.”
The statement also says that the company has been working with Georgia EPD to voluntarily implement an $8 million investment to reduce emissions.
The City of Covington's Request
Covington Mayor Ronnie Johnston and the Covington City Council requested in an Oct. 16 letter to BD Bard that the company temporarily shut down the medical manufacturing plant after the city reviewed test results of ethylene oxide levels near the plant.
The city contracted Montrose Air Quality Services to conduct tests for the chemical in 11 locations around the city between Sept. 17 and 23. The results found the average concentration of ethylene oxide to be 1.97 micrograms per cubic meter — higher than the EPA’s acceptable concentration risk of 0.02 micrograms.
The test results showed particularly high concentrations near the Settlers Grove and Covington Mill neighborhoods, according to the city’s press statement.
BD Bard released results of tests for ethylene oxide conducted by independent tester Ramboll, an environmental engineering firm, between Sept. 17 and 23. The results show the period’s median concentration of the chemical, which BD Bard argued is a more applicable measure in this case, was 1.2 micrograms per cubic meter.
“1.2 micrograms of [ethylene oxide] per cubic meter of air, is well below permissible exposure limits set by the Occupational Safety and Health Administration (OSHA) and the Texas Commission on Environmental Quality (TCEQ), but is greater than the screening value set by U.S. EPA, which does not account for background levels,” the statement reads.
Georgia EPD Director of Communications Kevin Chambers called the city’s test results “deeply troubling” in an Oct. 16 press statement and said the agency would double its testing frequency at the plant and “determine what regulatory action may be necessary for the surrounding community’s safety.”
“Due to this leak, EPD has opened an investigation into the Covington BD facility,” the statement reads. “The safety of Georgia families remains the state’s top priority, and BD will be held accountable to the fullest extent available under current law.”
The agency said it is also working with Kemp’s office to form an environmental task force that examines the regulation of medical sterilization companies and ethylene oxide use in Georgia.
Oxford SGA President Rachel Ding (20Ox) told the Wheel in a statement on Tuesday that the body supports the city’s evaluation and that she will discuss the situation and next steps at their Wednesday meeting.
“[Oxford] SGA supports the City of Covington’s statement and the Executive Board concluded that the facility is a community and health concern for students, faculty, and staff,” Ding wrote. “Although the company statement claims that there is no proven harm, the estimated cases of cancer per million is more than double the acceptable EPA standard.”
