Sterigenics to reopen under emergency order

COBB COUNTY, Ga. — At the urging of the Food and Drug Administration, a controversial medical sterilization plant will reopen to provide COVID-19 response.

Cobb County Chairman Mike Boyce signed an emergency order Wednesday, authorizing the Sterigenics plant to operate on a “limited contingency basis.”

The facility off Atlanta Road has been closed since last August while the county had a third-party investigation into Sterigenics’ operation and fire code compliance.

It became the center of controversy last year when the facility’s use and release of the carcinogen ethylene oxide came into question.

In a statement, county leaders say the limited emergency authorization to reopen the plant expires at the end of the county’s declaration of emergency. It also restricts the amount of ethylene oxide permitted on-site and calls for compliance reporting.

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The reopening order comes six days after FDA Commissioner Stephen Hahn wrote a letter to Gov. NAME Kemp, asking for his help in allowing sterilization operations to resume in Cobb County in order to prepare personal protective equipment for first responders.

“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,” 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. “

In response, state Rep. Erick Allen (D-Smyrna) wrote Hahn on Monday, asking under what authority the FDA was requesting the facility reopen, what other Sterigenics facilities the FDA had ordered or asked to be reopened and why ethylene oxide was required for Level 1 cleansing of PPE.

“Considering the unprecedented times that we are in, I share your concern to have every available resource contribute by supporting our healthcare providers on the frontline,” Allen wrote. “However, I want to make sure that as we do so, we are not using a federal administration to place pressure on a local government to take an action that is not in alignment with its codes nor best interest of its community."

On Wednesday, Allen told Channel 2 investigative reporter Nicole Carr he had not heard back from the agency regarding the request. The FDA did not immediately respond to questions regarding what other facilities it had asked to reopen.

In part of a statement Wednesday, an FDA spokeswoman said:

“We stand steadfast in our commitment to reduce over-reliance on ethylene oxide for medical device sterilization. In the face of this pandemic, there is increased need for certain essential medical devices that require sterilization. We understand that sterile PPE are rapidly falling in short supply. Therefore, the FDA is seeking assistance from state and local governments as well as from facilities to increase the supply of PPE needed for healthcare personnel to protect against COVID-19.”

Before Cobb County’s announcement, Kemp spokeswoman Candice Broce said they’d assisted the FDA by relaying the HHS message to county officials.

“At the state level, the Environmental Protection Division is ready to move forward with testing the new equipment at Sterigenics once Cobb approves the company’s operations,” Broce said.

Sterigenics sent a statement, saying:

“Sterigenics will take immediate steps to resume sterilization of personal protective equipment (PPE) required to protect health care workers battling COVID-19. However, the County’s Order stating that Sterigenics can operate for only 21 days and only for the purpose of sterilizing PPE falls woefully short of the measures needed to protect public health, as well as the FDA’s request for assistance. The Order also excludes sterilization of vital medical products and devices, including ventilator tubing, IV sets, catheters and many other medical products that are essential to patient care. Rather than engage with Sterigenics regarding an appropriate plan for the operation of its facility to protect the public, the County unilaterally issued an Order that omits necessary medical products at a critical time.

“Sterigenics has invested significant resources to install voluntary upgrades to our emission control systems. Those enhancements have established our facility as one of the most advanced sterilization facilityes in the world in terms of emission control, as demonstrated by our successful test on March 24, 2020. In addition, we have fully complied with the fire and safety review required by Cobb County, which is now in the County’s hands. That review required by the County further demonstrates that our facility is in compliance and safe.

“Sterigenics has met the demands of public officials by further enhancing a state-of-the-art facility that is safe. The only thing that remains is for the County to confirm that the facility may be re-opened for full operation to meet the urgent needs facing health care workers and patients. As we resume our operation on a limited basis, we are also working to fully resume all sterilization operations in the interest of protecting public health.”

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