The Georgia Environmental Protection Division (EPD) has opened an investigation into Becton Dickinson’s (NYSE:BDX) medical device sterilization plant in Covington, Ga. following an eight-day leak of the sterilant gas ethylene oxide (EO).
The EPD notified BD this week that it was dissatisfied with the company’s reporting of the valve leak that released 54 lbs. of ethylene oxide into the air between Sept. 15 and Sept. 22, according to an email statement to Medical Design & Outsourcing. BD has said that it closed the valve as soon as it discovered it was the source of the leak, and that it notified the city of Covington and the EPD.
The EPA 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, according to the EPD.
The city of Covington had a third-party testing company to measure EO levels in the air immediately outside the plant, in surrounding neighborhoods and in more distant locations for comparison from Sept. 17 to Sept. 24. Those tests revealed that the plant had released 54 lbs. of ethylene oxide into the air between Sept. 15 and Sept. 23, according to a City of Covington incident report. Citing “particularly high levels of ethylene oxide in the neighborhoods adjacent to your facility,” Covington Mayor Ronnie Johnston wrote a letter to BD asking the company to temporarily close the plant until emissions updates are installed. BD had previously pledged to voluntarily spend $8 million to upgrade emissions controls at its EO plants in Covington and Madison, Ga.
“The City of Covington’s air testing results are deeply troubling,” the Georgia EPD wrote to BD this week. “Based on these results, EPD will deploy more equipment to double testing frequency and determine what regulatory action may be necessary for the surrounding community’s safety. The Governor and EPD are working together to name an environmental task force of stakeholders and subject-matter experts for recommendations on the regulation of medical sterilization companies and ethylene oxide use in Georgia.”
In a detailed response, the company said it was “surprised and deeply concerned” by the EPD’s “new position that BD did not properly disclose the unintended release of ethylene oxide… That is simply not accurate and misleading based on our prior communications with EPD and other stakeholders.” The company provided an extensive timeline of its interactions with city and state officials from November 2018 through this week, and said it verbally notified the city of Covington and the EPD of the leak on Sept. 25 and in an official written report on Sept. 27.
“Our highly educated and skilled Covington employees, with the full support of BD corporate resources, operate a facility that is safe for both employees and the community,” the company added. “We would not operate a facility that was not in compliance with all laws and regulations.”
BD had the air on its property in Covington tested by a different company on the same dates that the city’s contractor conducted its tests. The company also said it provided both BD’s and the city of Covington’s air monitoring results to three independent toxicologists for review. The toxicologists agreed that the most appropriate way to analyze the results from this very limited sample is to average all measurements from any single monitoring location to get a view of average exposure levels for that location, according to BD.
“To scientifically compare risk levels to regulatory limits or risk screening values, scientists look at the average (typically a geometric mean) of all points at the same location,” the company added. “That’s because long-term risk is defined as consistent exposure 24 hours per day, 365 days a year for a lifetime, which is defined as 70 years. Taking only one value from one location, high or low, and comparing to regulatory limits is not grounded in science… Neither the City of Covington nor Georgia EPD provided any scientific explanation as to why they are raising concerns with the same data that was reviewed by our toxicology experts. This is a complex issue and needs more context than soundbites. The residents of Covington and Georgia deserve the facts.
“What has not received enough attention is the millions of patients that rely on BD devices that are sterilized in Georgia,” BD concluded. “We would not trade employee or community safety for patient safety but knowing that the science has revealed the safety of our operations, we must advocate for the patients around the world who use the more than 250 million devices each year that are sterilized by BD in Georgia. Creating public hysteria with no basis in science does not serve the public interest and is putting millions of patients at risk worldwide.”