Brenda Goodman is a senior news writer for WebMD. Andy Miller is editor and CEO of Georgia Health News.
Oct. 29, 2019 -- 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, a process that might have taken months.
Instead, the company will stop production for a week between Oct. 30 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 isn’t being done. That testing could help tell whether ethylene oxide levels around the plant are significantly different whether it is in operation or not. The company says ethylene oxide comes from many sources in the environment, not just sterilization.
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, also limits production at the BD Covington facility to 75% to 80% 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 additional pollution control equipment at both plants. The equipment would control “fugitive” emissions -- the ethylene oxide gas that escapes the pressurized sterilization system through leaks, off-gassing of sterilized products, and other means.
Until that equipment is installed next spring, the agreement limits the company to releasing 30 pounds of ethylene oxide as fugitive emissions a month, based on a 90-day rolling average. That means the company can emit significantly more in spikes as long as it later reduces those emissions to make up for the increase.
“Most of us don’t breathe in 90-day rolling averages, we breathe minute to minute,” says Ron Sahu, PhD, an environmental engineer from Alhambra, CA, who reviewed the state’s consent order with BD.
Kurt Ebersbach, an energy and air quality attorney at the Southern Environmental Law Center in Atlanta, who reviewed the consent order, says that while state environmental regulators are holding BD to a 30-pound-per-month average, Sterigenics, in Cobb County, has pledged that its new pollution controls will limit fugitive emissions to 40 pounds per year. That means even with reductions, BD’s emissions would be almost 10 times higher.
The BD facility’s releases of ethylene oxide 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.
In 2016, the U.S. Environmental Protection Agency (EPA) ruled that ethylene oxide was a more potent carcinogen than previously known, and it lowered a key risk threshold for exposure to the gas, which is used to fumigate about half of all sterile medical products in the U.S.
According to an analysis by the Chicago Tribune, more than half a million Americans are exposed to toxic air pollution above the EPA’s threshold for concern. Most of that risk is driven by exposure to ethylene oxide.
The Ethylene Oxide Sterilization Association and medical device manufacturers hotly dispute the EPA’s determination of danger from ethylene oxide.
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 says it sterilizes 250 million medical devices annually at its facilities in Covington and Madison.
Late last week, the FDA warned that further shutdowns of sterilizers could lead to shortages of medical devices. Two other sterilizing plants in the U.S. -- which are operated by 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 8-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 less than 30 pounds a month, on average.
- Explain to state regulators how it calculates fugitive emissions.
- Estimate emissions at its product warehouse, also in Covington. According to the EPD, BD is not currently required to limit emissions of ethylene oxide from its warehouse, because no sterilization takes place there, only off-gassing of recently sterilized products.
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 also 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, saying it had no violations and was in full compliance on its emissions.
“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 call the agreement a positive step but also were skeptical about the provision that BD will be providing emission data to the state.
“The 30 pounds of fugitive emissions -- who’s checking that?” says Cindy Jordan of the group.
“For decades, ethylene oxide has been emitted,” she says, adding that many area residents have cancer.
“The only thing that’s acceptable is zero ethylene oxide” emitted, Jordan says. “There are other [sterilization] methods they can use.”
Michael Geoffroy, an attorney representing area residents with cancer, says, “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, says the city had been successful in getting the EPD, the governor’s office, and the EPA involved in the ethylene oxide matter. He says 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 says.