FDA asks state to reopen Sterigenics plant

Sterilizing company could help shortage of protective medical gear.

The federal Food and Drug Administration sent a letter to Gov. Brian Kemp this week urging Georgia to allow a controversial sterilization plant in Cobb County to reopen amid the ongoing COVID-19 pandemic.

Sterigenics, near Smyrna, has been shuttered since last summer. It is one of a handful of facilities permitted to use the carcinogenic gas ethylene oxide to sterilize single-use medical devices.

The letter, which was obtained a nd published by the Cook County Record in Illinois, cites the current shortage of “personal protective equipment,” (PPE) such as gowns, respirators, masks and gloves, as a compelling reason to allow the plant to resume operations.

“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 during the COVID-19 outbreak has been further limited,” it reads. “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.”

Sterigenics originally closed in order to install new pollution controls following a public outcry over its ethylene oxide emissions. Later, the county pulled its building and occupancy permits, allegedly for being out of compliance with fire code.

A spokesman for the Georgia Environmental Protection Division said Sterigenics’ ability to proceed with testing required by the state to reopen is dependent on Cobb County’s approval. A planned test of new emission controls was called off last month after local elected officials objected.

Cobb spokesman Ross Cavitt wrote in a statement Friday that the county is in “ongoing discussions” with representatives from FDA, the governor’s office and Sterigenics “concerning the COVID-19 virus and our desire to do anything to help stop or slow the spread of the disease.”

“Those discussions continue and we hope to come up with an agreement on a path forward soon,” he added.

Tony Adams, a resident who lives near the plant and an active member of Stop Sterigenics Georgia, said his group was sympathetic to the shortage of medical equipment.

“But we also don’t want a company to twist the truth and take advantage of a crisis situation just to get back open, which is what we suspect is going on,” he said. “I don’t know what to think about the FDA nicely asking the state to get involved in this.”

In a statement posted on its website, Sterigenics said its Atlanta facility could immediately assist with the sterilization backlog for items needed to combat the novel coronavirus outbreak.

“New controls further reduce ethylene oxide (EO) emissions beyond already safe levels protecting employees and the community,” it said.