Sterigenics has filed suit against Cobb County in federal court, seeking to resume operations on a permanent basis.

Background

The Sterigenics plant became a focus of community concern in Smyrna and surrounding areas after an article jointly published by Georgia Health News and WebMD reported that three census tracts, two in the Smyrna area and one in Covington, had unacceptable levels of cancer risk by EPA standards, due to elevated amounts of ethylene oxide in the air.

The site has been the subject of community organizing and protests.

In February scheduled testing at the plant was canceled, and last Monday the previously canceled testing was resumed.

In response to a request from the FDA, Cobb BOC Chairman Mike Boyce issued an emergency order reopening the facility on a temporary basis.

Sterigenics then made a statement objecting to the temporary nature of the reopening.

This afternoon Sterigenics issued the press release below announcing their lawsuit against the county.

Press release from Sterigenics

The press release is reprinted in full below:

March 30, 2020 – Atlanta, GA – Sterigenics, a leading provider of mission-critical sterilization services to the healthcare industry, today filed a complaint in the United States District Court for the Northern District of Georgia against Cobb County, Georgia and Cobb County officials, Nicholas Dawe and Kevin Gobble.

In the complaint, Sterigenics seeks immediate and permanent relief to resume normal operation of its facility in Atlanta in order to sterilize essential medical products and devices in the interest of public health.

In connection with the filing, Sterigenics issued the following statement:
“Cobb County officials have manufactured baseless certificate of occupancy claims in order to close a longstanding, lawfully operating facility.

The County’s actions are illegally prohibiting a facility that
outperforms both state and federal regulatory standards from operating, preventing millions of essential and lifesaving medical products from reaching health care providers for use in patient care.

The County’s unlawful actions and the critical need for those products, most recently demonstrated by the ongoing battle against the COVID-19 pandemic, leave Sterigenics with no choice but to take legal action in order to resume safe and vital operations at our facility.

“The facts are clear:

• Sterigenics’ Atlanta facility is safe and fully prepared to return to its role in sterilizing critical medical products and devices to protect health care providers and patients.
• The Sterigenics Atlanta facility has been industry leading, consistently outperforming regulatory standards for decades. In 2019, with the approval of the Georgia EPD and the County, the company invested significant resources to install voluntary enhancements to its emission control systems at the facility. These enhancements have established the facility as one of the most advanced sterilization facilities in both Georgia and around the world in terms of emission control, as demonstrated by the successful test of the negative pressure system on March 24, 2020.
• Cobb County has consistently certified that the Sterigenics facility complied with applicable County fire and building codes in connection with approved expansions and developments. The facility holds appropriate certificates of occupancy and the assertion that the facility only holds a storage certificate of occupancy is false.
• Sterigenics has fully complied with the third party fire and safety review required by Cobb County, in the face of attempts by County officials to manipulate that process to support the unlawful closure of the facility. That review, delivered to the County on March 23, 2020, states that the County should allow the facility to resume normal operations, further demonstrating that the facility is in compliance and safe.

“Sterigenics has met the demands of public officials by further enhancing a state-of-the-art facility to deliver even higher levels of safety. Limited operations have begun at the facility to sterilize personal protective equipment previously validated for sterilization at the facility under the recently issuedCounty Emergency Order, which expires April 15.

Unfortunately, legal action is now necessary to put an end to the County’s baseless and politically motivated claims and allow the facility to be re-opened on a permanent basis for full operation to meet the urgent needs facing health care workers and patients.”

In its complaint, Sterigenics noted that in late 2019, the FDA recognized “there are no readily available processes or facilities that can serve as viable alternatives to those that use ethylene oxide to sterilize these devices. In short: this method is critical to our health care system and to the continued availability of safe, effective and high-quality medical devices.”

Furthermore, in October 2019 the FDA warned that patients’ “care could be negatively affected” by the closure of the Sterigenics Atlanta facility, and that “a shortage – especially of life-saving, life-sustaining, or other critical devices can be a detriment to public health.” Unfortunately, the validity of the FDA’s warning is now clear.