This EPA Regulation Is Literally Making People Sick Ross Marchand
As the deadly coronavirus takes its toll on countless families, healthcare workers are doing their best to get patients the medicine and equipment they desperately need.
But medical devices can do more harm than good unless properly sterilized and disinfected by applying agents such as Ethylene Oxide (EtO) gas. And, because of deeply flawed federal studies and subsequent state and local actions based on this shoddy science, production of sterilizing agents such as EtO has been put on the backburner. Policymakers must examine all the evidence at hand and keep patients safe from COVID-19 contamination.
As any of the nearly 500,000 coronavirus patients in the U.S. can attest, COVID-19 is highly contagious and can spread easily on shared surfaces, making sterilization critical. The Advanced Medical Technology Association notes, “Ethylene Oxide (EtO) gas is the most common way to sterilize medical devices, a process which is critical for preventing infections and ensuring patients have safe surgeries and medical treatments…For many medical devices, due to their size, shape, complexity or material composition, EtO is the only option for sterilization.”
Hospitals need ample supplies of sterilized equipment now more than ever. But hospitals face the prospect of shortages due to irresponsible Environmental Protection Agency (EPA) risk reporting.
The culprit behind the shortage and misinformation is an obscure research program within the agency called the Integrated Risk Information System (IRIS) which monitors the risks associated with a host of chemicals and issues reports on toxicity.
In 2016, IRIS found that EtOs start to pose harm to human health at the infinitesimally low level of 100 parts per quadrillion, or approximately 19,000 times lower than the amount of EtO found in the human body.
That’s right: according to the EPA, humans are exposed to sky-high EtO risks just by being alive and producing EtO internally. This isn’t the first time that IRIS has pedaled junk science.
As Competitive Enterprise Institute senior fellow Angela Logomasini points out, “In 2011, a National Academies of Sciences (NAS) report on IRIS’ draft assessment on formaldehyde sharply rebuked IRIS’ science. It criticized the program for ‘recurring methodologic problems,’ including repeated failures to provide ‘clarity and transparency of the methods.’”
But that hasn’t stopped states and localities from taking IRIS’ fearmongering at face value and forcing the closures of EtO plants across the country. For example, in September 2019, one Illinois plant shuttered operations after claiming that they faced an “unstable legislative and regulatory landscape” related to the phony science behind the IRIS risk value for EtO.
In December, a Michigan production plant ceased sterilization after being strong-armed by Michigan’s Department of Environment, Great Lakes, and Energy to cut its EtO activities and pay a $110,000 fine.
Even before the start of the coronavirus pandemic, the Food and Drug Administration (FDA) began to realize that all of these closures were putting unsustainable strains on the healthcare system.
Suzanne Schwartz, director of FDA’s Office of Strategic Partnerships and Technology Innovation, expressed concern at the end of 2019 that if another facility were to shut down, “We will start to see spot shortages; there is no question about that. In terms of a more catastrophic national impact, with two facility shutdowns, it is almost a certainty.”
Now that the “catastrophic national impact” is here, the EPA is finally starting to take notice. Due to the heightened risks of transmission and infection at America’s 7,200 hospitals, agency administrator Andrew Wheeler has made it a priority to “increase the nation’s capacity to sterilize critically needed life-saving medical equipment and protect our heroic healthcare workers and their patients.”
EPA Administrator Wheeler’s cautious recommendation that facilities use EtO to sterilize medical devices has provoked the ire of the EPA’s inspector general, who recently accused EPA officials of failing to disclose EtO’s cancer risks. But these disclosures would be based on the same flawed IRIS reporting that led to the irresponsible closures of EtO plants and destabilized the U.S. healthcare system.
The EPA needs to disavow this flawed risk requirement once and for all and work with state and local regulators to reopen or keep sterilization plants operating. The stakes are simply too high for patients to go without clean, sanitized medical equipment.
Ross Marchand is the director of policy for the Taxpayers Protection Alliance.
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