The state of Georgia and BD have reached a last-minute agreement to stem emissions of cancer-causing ethylene oxide gas at the company’s medical sterilizing facilities east of Atlanta.
The agreement came just moments before a judge was set to hear arguments on the state’s motion for a temporary restraining order and injunction against BD.
The restraining order would have shut down the company’s sterilization operations until new pollution control equipment could be installed.
Instead, the company will stop production for a week between Oct. 30 (this Wednesday) and Nov. 7. In a written statement issued Monday, BD said the weeklong shutdown would give the state Environmental Protection Division (EPD) time to test the air around the facility when sterilization activity is not being conducted.
BD operates two sterilizing facilities in Georgia — one in Covington in Newton County, about 35 miles east of Atlanta, and another in Madison in Morgan County, which is east of Covington.
The consent order, approved by a Newton County judge Monday, limits production at the BD Covington facility to 75 percent to 80 percent of its current workload. The plant will now be limited to sterilizing 600 lots per month, when it would normally sterilize 750 to 800 lots, according to the EPD.
The agreement also imposes deadlines for BD to install pollution control equipment at both plants.
The facility’s releases of ethylene oxide (also known as EtO) have provoked rising concern among political leaders and community members in the Covington area. Independent air testing around the Covington plant in September found high levels of ethylene oxide, especially in two neighborhoods close to the facility.
BD had called the state’s legal action “an unnecessary move’’ and said Gov. Brian Kemp, the EPD and Covington Mayor Ronnie Johnston “are ignoring science and facts and may be creating a risk to the health and safety of patients.”
The company said a reduction in medical equipment sterilizations could create a shortage of sterile equipment in the health care industry.
BD said it sterilizes 250 million medical devices annually at its facilities in Covington and Madison.
Late last week, the FDA warned that a shutdown of the Covington plant could lead to shortages of medical devices. Two other sterilizing plants in the U.S. — which are operated by the company Sterigenics and use ethylene oxide — are now shut down. One of those is in Cobb County in suburban Atlanta, where government officials are demanding more safety controls.
BD, under the consent order, is required to:
- Halt production in Covington from Oct. 31 to Nov. 7
- Report all leaks of ethylene oxide to the state EPD, no matter the amount
- Ensure all technicians have training in proper operation of valves (A valve problem at the Covington plant caused a leak of 54 pounds over an eight-day period in September)
- Increase the amount of time the facility takes to air out products after sterilization
- Reduce fugitive emissions of ethylene oxide to fewer than 30 pounds a month, on average
- Explain to state regulators how it calculates fugitive emissions
- Estimate emissions at its product warehouse, also located in Covington
The company must apply for new air quality permits by Thursday for its Covington facility and by Dec. 15 for its Madison facility. It has to demonstrate these new pollution controls in Covington by the end of March 2020.
It has to install new pollution controls to capture fugitive emissions at its Madison facility by May 31, 2020, and start using them by the end of June.
Kemp issued a statement applauding the agreement. “As governor, I have pledged to always put Georgia families first and ensure their safety. This agreement allows for cleaner operations and improved, long-term accountability at BD’s medical sterilization facilities in Covington and Madison,” he said. “I applaud Attorney General Chris Carr and his team for working with us to secure this win for Newton County and the surrounding communities.”
Last month, a BD spokesman had rejected the idea of the company signing a consent order with the state.
“Consent orders are appropriate when there have been regulatory violations or a dispute with the regulator,’’ said the spokesman, Troy Kirkpatrick, in September. “Neither of those conditions apply to BD. We are in full compliance with our permits, operate substantially below our emission allowance within our permits and have voluntarily and transparently committed to make substantial investments in our facilities to even further reduce emissions.’’
The consent order announced Monday contains no state allegation of wrongdoing by BD and no admission by the company of any wrongdoing.
BD’s statement Monday said that as a result of this agreement and the company’s “business continuity efforts, BD does not expect disruption to product availability at this time.’’
The company also said it agreed to not expand production at its Madison plant.
Members of the activist group Say No to EtO – Georgia called the agreement a positive step, but also expressed skepticism about the provision that BD will be providing emission data to the state.
“The 30 pounds of fugitive emissions – who’s checking that?’’ said Cindy Jordan of the group.
“For decades, ethylene oxide has been emitted,’’ she said, adding that many area residents have cancer.
“The only thing that’s acceptable is zero ethylene oxide’’ emitted, Jordan said. “There are other [sterilization] methods they can use.”
Michael Geoffroy, an attorney representing area residents with cancer, said, “I’m not sure I would trust anything with self-reported numbers. I’m not sure this is a good outcome for the people of Covington.’’
Mayor Johnston of Covington, who had pushed for BD to close the facility until more pollution controls were installed, said he was not aware of the consent order prior to the Newton County Court hearing Monday morning.
“The city of Covington stayed on top of this,’’ Johnston said after the hearing. “We’re going to stay on top of this. This is not something we’re going to forget about.”
He said the city had been successful in getting the EPD, the Governor’s Office and the EPA involved on the ethylene oxide matter. Johnston added that the federal Agency for Toxic Substances and Disease Registry is doing “an elaborate study’’ of cancer among residents of the area.
“The game has just got started,’’ he said.
Brenda Goodman is a senior news writer for WebMD. Andy Miller is editor and CEO of Georgia Health News.
