FDA letter to Kemp a preview of the hard choices that will come with the pandemic
By Tom Baxter
Last Wednesday, Cobb County Manager Rob Hosack met with representatives of the Federal Drug Administration, and the following day FDA Commissioner Stephen M. Hahn sent a letter to Gov. Brian Kemp. That letter is a good example of the hard choices that await the country in the wake of the COVID-19 pandemic.
In the letter, Hahn asks Kemp to cooperate with Sterigenics, the company which owns the Smyrna facility which closed last summer amid a big controversy over its emissions of the cancer-causing gas ethylene oxide.
“Due to the recent challenges with the closure of some commercial sterilizers, such as the Sterigenics facility located in Cobb County, the supply of critical PPE (personal protective equipment) during the COVID-19 outbreak has been further limited,” Hahn wrote. “FDA is asking for your assistance in helping to increase the supply of PPE to help protect against COVID-19 by working with Sterigenics to allow for the appropriate sterilization of PPE.”
At a time when healthcare workers are desperately pleading for the equipment they need to protect themselves and fight the pandemic, Sterigenics has a powerful argument. It says on its website that the Smyrna plant sterilized “thousands of gowns and hundreds of thousands IV tubing sets per day when it was open, and stands ready to focus on sterilizing the most needed supplies when it reopens.
Sterigenics also says on its website that the plant has always operated safely, which is where we get into those hard choices.
An EPA study showed that the area around the Sterigenics Smyrna plant and a similar facility in Covington operated by Beckton, Dickinson (BD) had levels of ethylene oxide in the air which increased residents’ cancer risk. The study stayed on the shelf for a while, but when Georgia Health News and WebMD reported on it last year, angry residents filled town hall meetings, and state and local officials reacted with uncharacteristic urgency.
Under government pressure, Sterigenics agreed to close temporarily and install new emission controls at the Smyrna plant. But the county later pulled the building permit for the plant, county and last month state officials called off a planned test of the new equipment. It’s the logjam created by the permit and the test which is probably what prompted the FDA letter.
Legislation that would tighten the testing and reporting requirements at the plant was introduced in this year’s session, but that, like everything else the General Assembly had on its plate, is currently in suspended animation due to the pandemic.
Sterigenics faced an even tougher reaction in Illinois, where it operated a plant in the Chicago suburb of Willowbrook. After failing to reach an agreement with state and local officials there, it announced last fall that it was permanently closing that plant.
There has been no indication that Sterigenics has any intention of reversing that decision, or that the FDA has approached Illinois Gov. JB Pritzker about that facility. Interestingly, however, the news of the letter to Kemp surfaced last week in a Chicago newspaper, the Cook County Record.
Hahn doesn’t mention the Covington plant in his letter, but probably felt no need to do so. If Cobb County and the state have been frustrated with Sterigenics’ response, BD has been even less cooperative. A valve leak last year resulted in the accidental release of 54 pounds of ethylene oxide.
In response to a request for a temporary shutdown by the City of Covington, it argued there are “absolutely no short- or long-term risks that would necessitate any reduction in operations at the site.” BD subsequently agreed to a temporary shutdown after Attorney General Chris Carr filed for a temporary restraining order, but it has resumed operations.
In this crisis, it may be necessary to make a trade-off between the long-term cancer risks of this carcinogenic gas and the dire need for medical equipment. But this won’t be the last time governments will be asked to relax environmental standards because of the pandemic. It’s not too much to ask that Sterigenics be held to its commitment to address shortages directly. Or that when it comes back the legislature passes a good bill to insure these companies’ transparency.