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Feds threaten action against Cobb County if it doesn't expand sterilization order

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You are the owner of this article.Welcome,COBB COUNTY, Ga. (CBS46) -- Cobb County Chairman Mike Boyce “stands by his order” after a top federal official in Washington blasts him for limiting Sterigenics’ capability to sterilize medical equipment in the wake of the COVID-19 outbreak.&nbsp;Chairman Boyce signed the emergency order earlier this week, at the urging of the US Food and Drug Administration (FDA), an agency within the Department of Health and Human Services (HSS). The order allowed for Sterigenics to temporarily reopen, for the sole purpose of sterilizing personal protection gear like masks, gloves, gowns, and respirators – exactly as the FDA had requested.The FDA initially reached out to Cobb County and Governor Brian Kemp about the matter on March 19th. FDA Commissioner Stephen Hahn said in a letter, there was a shortage of those specific items, which he claims require sterilization. The federal agency believes reopening Sterigenics, could help meet that need.“I know that Secretary Azar needs that plant open,” Governor Kemp told CBS46. “There’s a lot of medical supplies that they need to move to the marketplace and as he told me, this is a national public health emergency we need that plant open.”However, Sterigenics has been shut down since August 2019. The plant is one of dozens around the country that uses a highly toxic carcinogen, ethylene oxide, to sterilize medical equipment. With so many other plants that are already operational, why the FDA would choose to focus on Sterigenics, in particular, is unclear. The controversial plant, located on Olympic Industrial Blvd, near Smyrna came under intense public scrutiny after a report was released last July linking the facility’s use of EtO to higher rates of cancer in the surrounding area. The plant voluntarily closed weeks later to install new emission control systems that it claimed would reduce the amount of toxic air being released into the atmosphere. Cobb County later mandated that Sterigenics remain shut down after discovering it did not have proper permits to operate as a high hazard facility. An investigation was launched, and there has been infighting between the company, the Georgia Environmental Protection Division (EPD), the State, the County, and the residents who live nearby… ever since. Also during that same time frame, local media and concerned citizens submitted dozens of Freedom of Information Requests for documents related to the plant’s use of ethylene oxide, which revealed a history of reported and un-reported chemical leaks and spills. The company had been allowed to self-report the amount of ethylene oxide it was emitting into the air for decades, leaving residents worried they may never truly know the ‘actual’ amount of EtO seeping into the air they breathe.Despite all of that, Cobb County still agreed to comply with the FDA’s request, and allowed the plant to resume operation for the duration of the Coronavirus emergency, to sterilize the personal protection equipment the FDA said it needed.Although Sterigenics has been eager to reopen for the last 7 months, on the same day Cobb County issued the order, the company released a statement objecting to the provisions set forth in it.“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.”Within hours of Sterigenics vocalizing its objections, a federal official with the U.S. HHS, stepped in to echo similar sentiments, even going so far as to seemingly threaten action against the county, if it did not expand the emergency order.CBS46 learned that HHS official, whose name was not specified, sent an email to the Office of Governor Kemp, which was subsequently forwarded to Chairman Boyce at 2:26pm Thursday afternoon.The email states:From HHS:"We are heartened about the progress with the BD facility and thank you very much for work done on that plant.On Sterigenics, we at HHS have reviewed the Cobb County consent decree issued last night regarding Sterigenics and briefed the Secretary this morning.Their decision to only allow the company to sterilize PPE items is too limited.The Secretary does NOT think it is sufficient to respond to the nation’s needs for the medical components that are required to TREAT COVID-19 patients – and other patients who will be impacted by the increased demand.Second, it is only for 21 days, the needs will extend significantly beyond that.Third, PPE was only about 20% of what was being sterilized at Sterigenics, and other items like catheters, syringes, IV sets and ventilator components like tubes, filters, and masks are critical to helping patients.Finally, we don’t think that one county should be allowed to jeopardize the nation’s response to an unprecedented national pandemic. My understanding is that this particular plant represented 4% of the total U.S. capacity for Ethylene Oxide Sterilization. If it remains shuttered, there are national implications.We hope you will use whatever communication channels you have to encourage the county to expand the decree to full production of all medical items and extend it until the nation’s threat and need is over.Conversations on next steps from the Federal Government are occurring at the highest levels, should the situation not change."It’s unclear why the FDA would request Sterigenics be allowed to sterilize specific personal protection gear for the fight against COVID-19, and then once the County obliged, demand the plant be allowed to sterilize beyond those items. It’s also unclear what action the HHS might take if the order is not expanded. But Chairman Boyd has said, he “stands by his order”.The nature of the White House’s involvement in this issue has raised concern for Georgia Representative Erick Allen, a democrat who represents Smyrna.“This afternoon I received the text of a letter that appeared to come from HHS by way of the Governor’s office. It would have been good to know who within HHS was sending the letter and if that person understands the bullying tone of the note.It is clear that someone at HHS is parroting the desires of Sterigenics and applying pressure on Cobb County. The chairman has already done more than I think he should and to be bullied into allowing Sterigenics to begin full operation is unthinkable.”Cobb County Commissioner, Lisa Cupid is also encouraging Chairman Boyce to stand his ground.“The more this situation evolves the more it looks orchestrated to allow Sterigenics to fully operate again. It is not our role in this pandemic to facilitate that beyond what is necessary to address COVID-19. I have yet to see compelling evidence that, but for Sterigenics operating, medical facilities and service providers will lack necessary PPE. If the state and HHS remain convinced, let them make the order. Cobb does not need to be complicit in circumventing protections the county and EPD put in place for the health, safety and welfare of our citizens while clear exigence is lacking.”Residents who live near the Sterigenics plant also reacting to the threatening tone of the email sent to the chairman. Janet Rau, the President of Stop Sterigenics Georgia says when it comes to Sterigenics, somehow the goal post always seems to move.“The story that the public is given by Sterigenics (and those who advocate for them) is constantly changing. We heard their CEO tell us about their safety record… and then uncovered repeated evidence of the opposite. They said that they couldn’t possibly close to make improvements and then as soon as the city and county began air testing, they suddenly closed. This is a disingenuous corporate entity led by people who seemingly are only out for the almighty dollar. If the county allows the reopening beyond the stance already taken, it will be virtually impossible to shut them back down afterwards. If the federal government wants them open, let them make that call and as soon as this pandemic is behind us, and normal rule of law is back in balance, the county will have every right to keep them closed.”Everyone CBS46 interviewed for this story said they fully support the Administration’s efforts to prevent the spread of the COVID-19 virus. However, as one resident put it, “what we don’t understand, is creating one public health emergency, to try to solve another. We’re already worried about the Coronavirus, now we have to be worried about ethylene oxide poisoning our kids and loved ones, too.”Meanwhile, as federal and local officials argue over how much or how little Sterigenics is going to be allowed to sterilize, a number of Georgia-based companies, and other local nonprofits, are busy manufacturing and delivering life saving masks and other personal protection devices, directly to hospitals and healthcare workers on the front lines.On Friday, alone… an Alpharetta nonprofit called “Send Relief” donated 20,000 masks and 25,000 protective suits to hospitals and nursing homes across the state.And a mattress company in Floyd County, called Heritage Sleep Concepts, tried making masks… instead of mattresses to help alleviate the shortage. Dr. John Cowan, a local neurosurgeon helped facilitate the endeavor. “As of today, they have the capacity to make 24-masks every minute and a half. So we’re really going to be able to ramp up our number of masks to provide to the general population and to hospitals very quickly.” Dr. Cowan says he was confused by the FDA’s request to have Sterigenics sterilize personal protection equipment, he said, in the context of fighting coronavirus, it’s not necessary to have those items sterile.“PPE is a big category of barrier devices, so the items I use in surgery, when I’m operating on somebody’s brain or spine, are obviously sterilized, and the instruments we use, some of them may be sterilized with ethylene oxide or other methods, but what we’re talking about, the acute need, for PPE right now, really refers to non-sterile items; Items that create a physical barrier from aerosolized material or liquid material that may go from a patient to a health care provider, or health care provider to patient, that is barrier we’re looking for now, and that does not require sterility to the level that ethylene oxide might create,” said Dr. Cowan.In the FDA’s original letter to Governor Kemp, it stated: “Much of the PPE also requires certain sterilization.” In response to that statement, Dr. Cowan said, “That’s a vague statement - if you’re asking a doctor what does that sentence mean, I don’t really understand what that sentence means, I mean much of PPE that’s used for surgery, I think yes. The PPE used on the front line…. doesn’t; It is not a sterile item. Whether in the manufacturing process, they run it through some sterilization process so that (it’s sterile) when they package it, but the second we open that package, start pulling it out of the bags, it’s not sterile anymore because we’re not using sterile technique to put it on. So, yeah - I think the sentence is a little vague and doesn’t really help what we’re trying to achieve.”What Dr. Cowan, and others, are trying to achieve, he says - is simply getting PPE in the hands of health care providers on the front lines. He is proactively working to collect donations from the public and private sectors to do it.The conflicting logic regarding whether PPE requires sterilization, is one of the primary reasons State Representative, Erick Allen is skeptical of the Government’s request. “The items they (the FDA) listed are level 1 sterilization - which is clean; Not level 4 - which requires EtO, or deep sterilization. You’ve got people using 3D printers to make face shields, you’ve got people making masks at their kitchen tables by just staying they’ve got a sterile environment and hospitals are accepting them, so I find it a little interesting that the FDA would say all of a sudden ethylene oxide is needed to sterilize equipment that’s being made at people’s kitchen tables.”Further complicating the FDA and the HHS argument to need items sterilized with ethylene oxide, is new research, showing less toxic, less controversial methods are available. In the event an item, such as a mask needs to be reused, and thus sterilized, new research out of Duke University shows hydrogen peroxide can effectively decontaminate masks. According to the research, leaving N-95 masks in a room with equipment that turns hydrogen peroxide into a fine mist, decontaminates the masks, so they can be used again. Researchers say the mist permeates the layers of the mask to kill germs, including the new coronavirus. This method has been used on other lab equipment, but this is the first-time researchers have used it on masks.Stay with CBS46 for updates on this story.Copyright 2020 WGCL-TV (Meredith Corporation). All rights reserved.×××Keep it Clean. Please avoid obscene, vulgar, lewd,racist or sexually-oriented language.PLEASE TURN OFF YOUR CAPS LOCK.Don't Threaten. Threats of harming anotherperson will not be tolerated.Be Truthful. Don't knowingly lie about anyoneor anything.Be Nice. No racism, sexism or any sort of -ismthat is degrading to another person.Be Proactive. Use the 'Report' link oneach comment to let us know of abusive posts.Share with Us. We'd love to hear eyewitnessaccounts, the history behind an article.© Copyright 2020 (A Meredith Corporation Station), 425 14th Street NW Atlanta, GA&nbsp;| &nbsp;| &nbsp;|Powered by from .

You are the owner of this article.Welcome,COBB COUNTY, Ga. (CBS46) -- Cobb County Chairman Mike Boyce “stands by his order” after a top federal official in Washington blasts him for limiting Sterigenics’ capability to sterilize medical equipment in the wake of the COVID-19 outbreak.&nbsp;Chairman Boyce signed the emergency order earlier this week, at the urging of the US Food and Drug Administration (FDA), an agency within the Department of Health and Human Services (HSS). The order allowed for Sterigenics to temporarily reopen, for the sole purpose of sterilizing personal protection gear...

Feds threaten action against Cobb County if it doesn't expand sterilization order

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