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EPA Inspector General Report Could Exacerbate Medical Supply Shortages

As hospitals struggle to access sterile medical supplies, the U.S. Environmental Protection Agency (EPA) Inspector General (IG) released a report on March 31 that could make things worse. The report alleges that EPA officials failed to warn people of cancer risks associated with ethylene oxide (EtO) emissions from medical sterilization plants—a claim that holds no water. The IG’s allegations are based on flawed science, but the fear they generate could undermine operations at these facilities.

EtO is a gas that has been used for decades to sterilize medical equipment. Most of the EtO gas that plants use is recaptured, but the plants may emit trace levels into the air. Until recently, there was little concern about EtO emissions because they are too low to have any impact, and the emissions are regulated to ensure they remain insignificant.

Yet, a highly flawed EPA study released in 2016 stoked fears about the risks—and the IG relies on it in its alarmist report. For more details about EtO, see my recent Inside Sources op-ed as well as toxicologist Gail Charnley’s article and paper on the topic. 

During 2019, several states and localities shut down medical supply sterilization plants because of similar fearmongering set off by the EPA’s flawed research. The Food and Drug Administration (FDA) issued repeated warnings last year—in March, September, and October—that these closures could lead to shortages of medical supplies, which could become serious, particularly if a medical emergency were to arise.

In fact, long before we knew about COVID-19 there was a shortage of pediatric breathing tubes in April 2019, resulting from the closing of a sterilization plant in Willowbrook, Illinois. After that, another Illinois plant also closed, as well as facilities in Georgia and Michigan.

Last November, as worries about shortages mounted, the FDA assembled an advisory meeting with a panel of experts from its Devices Advisory Committee at which participants expressed grave concerns. The sterilization plant closures, explained San Juan Regional Medical Center physician Robert Burr, promises to produce a “major medical logistical failure”—and that was before he knew about COVID-19.

Faced with the COVID-19 emergency, the FDA asked these companies to reopen plants to help deal with severe medical supply shortages—and threatened legal action against one local government to make it happen. A facility located in Cobb County, Georgia, which the county shut down in August 2019, managed to get a court order to reopen this past week. A plant in Waukegan, Illinois that voluntarily shut down last December to upgrade emission controls has also reopened.

The Willowbrook facility remains closed, which the company announced last year would be permanent. Ironically, a Willowbrook nursing home reported cases of COVID-19 a couple of weeks ago. It is a heartbreaking development because of the high risks this virus presents to older Americans, and it has already led to a number of deaths at that nursing facility.

Yet journalists at the Chicago Tribune—which peddled hype and junk science that led to the shuttering of the Willowbrook plant—fail to offer balanced reporting. They don’t bother to address the real risks associated with plant closures and medical supply shortages. Instead, the Tribune writers simply present the nursing home case as just another unfortunate event that has affected that community, while noting the alleged cancer risk from the Willowbrook plant as another. Meanwhile, there are fewer medical supplies available, in part, because of the shutdown in Willowbrook. The plant, according to the FDA, was “a large facility” that sterilized nearly 600 different types of products.

EtO is now becoming a larger part of the solution to medical supply shortages, with plants ramping up sterilization, yet the IG report provides pushback in the wrong direction. States and localities probably won’t shut down these plants in the near term, but what about the future? Who knows how long these facilities will be allowed to continue operating when government bodies, such as the EPA’s IG office, continue to spew misinformation about the risks?

But the fact remains: After COVID-19 gets under control, medical sterilization plants will continue to be crucial components in ensuring a stable supply of sterile medical products. There are no good substitutes for EtO when it comes to the many products that need sterilization. EtO is used to sterilize more than 20 billion medical products—more than half of all sterile medical products in the United States. The FDA notes that “ethylene oxide may be the only method that effectively sterilizes and does not damage” certain devices.

The IG report only makes things more difficult, and its timing couldn’t be worse. EPA officials have been working for more than a year with communities where these plants are located to address concerns and ensure emissions remain low and pose insignificant risks. That may explain why EPA administrator Andrew Wheeler expressed dismay about the IG report. He commented in a press statement earlier this week:

The tone and substance of this report indicates a disconnect in the U.S. EPA IG’s office. … Most surprising is that in our final meeting with the IG’s office on this matter they provided no indication that there would be any unresolved issues. As a result, we are formally requesting the EPA IG rescind the report so it can be appropriately updated.

The IG has refused to comply with Wheeler’s protest, and apparently that means there will be some sort of dispute process, according to Inside EPA. Hopefully reason will prevail.

It’s irresponsible for EPA’s IG to release this faulty report, particularly now. Clearly, they should use common sense and rescind this report, because it only makes a difficult situation worse, and it could contribute to long-term medical supply shortages.