COVINGTON, Ga. — Scientists and medical industry advocates are speaking out against what's being described as "public hysteria" over the use of ethylene oxide in a Metro Atlanta medical device sterilization facility.
Industry leaders also warn of a public health crisis should sterilization plants continue to shut down in the U.S., even on a temporary basis.
State leaders are calling for the temporary closure of the B.D. Bard plant, following air quality results commissioned by Covington leaders that showed heightened levels of the toxic gas. There are also concerns about a September gas leak, and how the company handled the response.
A complaint filed by the state Attorney General is pending in Newton County Superior Court.
But the plant, through the assessment of nonprofit toxicologists, says leaders are not weighing mitigating factors and putting the results that have alarmed the public into proper context.
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"I can assure people with unequivocal and as strong as I can make this as a toxicologist that the concentrations that are in the area are safe," said Dr. Michael Dourson, a career toxicologist, former EPA employee and scientist with the nonprofit organization Toxicologoy Excellence for Risk Assessment, or TERA.
Dourson and others have worked with B.D. Bard since August, attending a Covington community town hall to hear residents' concerns about exposure to the gas over time. They've been commissioned to assess air quality, and say any results need to be modeled, and take mitigating factors, like weather, into consideration over time.
In reading risk assessments for lifetime exposure, Dourson says the public should not equate these to cancer assessments.
"Well the people say ‘above EPA's value.' That's true. But the values don't indicate cancer risks. They're for screened out areas that we (EPA) don't worry about anymore."
Dourson cites the Texas Commission on Federal Environmental Quality and their recent research regarding ethylene oxide evaluations.
"Their new science says the safe level, continuous exposure for seven years is seven micrograms per liter, but the average concentrations in Covington are on average, are like in the 1 to 2. They're not seven," said Dourson. "And if you have an exceedance in one day, which there were some exceedances, it's the average over 7 years constant exposure that results in the upper level cancer risks.
"So bottom line, I'm not concerned with the concentrations of ethylene oxide in Covington," Dourson continued. "Would I like to see more data? Of course, we would like to see that data to keep confirming this, but from what we have now, there's no concern from a health point of view."
Meanwhile, a half-dozen medical groups have written a letter to the FDA, warning regulators against limiting the use of ethylene oxide without an immediate plan to address alternate, affordable sterilization methods for the basics used in surgical rooms.
AdvaMed, a Washington, D.C.-based medical device trade association, points out that the gas is used to sterilize produce and cosmetics, but Bard makes up one of 34 medical sterilization plants processing 25 billion medical devices annually.
"If you move through what we call a rolling series of shutdowns, not only in Georgia and Illinois, but perhaps in other states, now you're talking about a public health pandemic," said Greg Crist, chief advocacy officer for AdvaMed. "Our argument to any lawmaker and any local official is how can we get the scientists in the room to have that non-passionate that the public and lawmakers need in order to govern."
The medical group that wrote the letter is set to present to an FDA committee in early November.
Cox Media Group
