This article has been updated with comments from AdvaMed.
The Georgia Environmental Protection Division (EPD) filed a motion yesterday with Newton County Superior Court for a temporary restraining order to halt operations at BD’s Covington, Ga. plant, which uses ethylene oxide (EO), a known carcinogen, to sterilize millions of medical devices annually.
The EPD claims that BD violated its state air quality permit during an eight-day valve leak in September that released 54.5 lbs. of EO into the air. The leak produced a 97.3% reduction of EO in one of the sterilizer chamber vents, below the 99% reduction required by the permit. The EPD also claims that the BD plant violated another permit by “willfully or negligently allowing” EO emissions of 555.7 lbs. per year.
BD failed to immediately alert the EPD to the September leak, but rather mentioned it in a routine weekly call and initially said that only 2 lbs. of EO had been released, according to the state’s complaint. The state also claims that BD “acted negligently or in bad faith” when it told the city of Covington that the plant was operating normally during the time the leak occurred, which overlapped with a city contractor’s air-quality tests near the plant.
BD pledged in August to install $8 million worth of emissions-control equipment at its two Georgia EO plants, but the state alleges the company has been dragging its feet. The EPD asked the court to shut down the plant until BD:
- Trains all technicians on the proper operation of all valves in the facility.
- Completes corrective action to prevent a future release from all vacuum exhaust valves at the facility.
- Installs necessary pollution control equipment to capture fugitive EO emissions and route them to a control device with at least 99% efficiency.
“Today’s action by the state of Georgia is a result of BD’s lack of response to these recent violations, which is in stark contrast to the response that Governor Kemp and EPD have gotten from other similar medical commercial sterilizers in Georgia that have complied with EPD’s requests and are progressing in their efforts to reduce ethylene oxide emissions,” the state said in a news release. The other medical sterilizers are Sterigenics and Sterilization Services of Georgia, which each operate an EO plant in Atlanta. BD also has an EO plant in Madison, Ga.
In response, BD claimed it is operating safely and in full compliance with its permits and has “proactively adopted the most advanced and best available technology and is emitting a fraction of its allowable limit.”
“The Attorney General’s action is an unnecessary move given the company’s high level of cooperation and is inconsistent with our continued dialogue with the state to implement voluntary improvements at our Covington facility,” BD said in a news release. “We are concerned about the risk the State of Georgia’s actions poses to the patients our products serve in Georgia and nationwide.”
BD pledged to vigorously defend the company and patients from harm posed by “unnecessary decisions by the State of Georgia that are not based on sound legal or scientific grounds,” the company said. “Governor Brian Kemp, the Georgia EPD and (Covington 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.” Last week, Johnston asked BD to suspend operations in light of the September EO leak.
The federal Environmental Protection Agency considers EO a carcinogen and is expected to update its regulations of the gas by March 2020. Meanwhile, the state of Illinois tightened its regulations in June and now Georgia officials will look into strengthening their own, the EPD said last week in announcing an investigation of the Covington plant.
The technology used in the Covington plant “represents the best available and was recently validated by a third-party testing firm to have a 99.999% destruction efficiency,” the company added. “As BD stated in a letter to Governor Kemp last week, the EPD has aided consistent misunderstanding and misplaced public hysteria about ethylene oxide. This letter was the latest in BD’s many attempts over the past several months to work productively with the Governor, EPD and local officials to engage in open, productive and transparent discussions around our shared commitment to public and employee safety.”
Trade group AdvaMed said Georgia’s move for a restraining order puts more than 1 billion medical devices at risk.
“Governor Kemp’s attempt to shut down another medical device sterilization plant in the state is very alarming, and sets Georgians and many Americans down a potentially dangerous path with serious public health consequences,” AdvaMed president & CEO Scott Whitaker said in a statement to Medical Design & Outsourcing. “If the BD Covington plant shuts down, there will be three facilities in two states unable to sterilize critical medical devices.
Sterigenics recently decided not to reopen its EO plant in Willowbrook, Ill. following Illinois state officials’ move to shutter it temporarily in February. The company also voluntarily shut down its Atlanta plant in August for improvements to its emissions-control equipment. The Georgia EPD recently told Sterigenics to test that equipment and to report its findings to the division.
“With these three facilities closed, procedures for urological conditions, cardiothoracic and lung cancer surgeries, retinal detachments and tumor ablations are now in jeopardy because, for these devices, there is no other way to sterilize them properly for the patients who need them,” Whitaker added. “Even those entering intensive care units (ICUs) in the coming days could see delays in their care or lack of availability because every patient requires a catheter that must be sterilized with (EO).”
Companies that use EO to sterilize medical devices “take their responsibility to protect workers and surrounding communities extremely seriously, Whitaker said. “Experts in toxicology confirm that this is the case, and that living near a medical device sterilization plant that properly destroys ethylene oxide, as BD has thoroughly demonstrated it does, poses no risk to public health. We worry that failure to listen to and engage with these scientific experts is the true risk to public health here.”