The battle over the sterilization agent ethylene oxide began like a sequel to “Erin Brockovich” — local activists shut down big chemical plants over cancer fears — and then the coronavirus hit.
Now the story has veered off script as the Food and Drug Administration, which warned repeatedly last year that the closures could lead to shortages of critical medical supplies, scrambles to reopen the plants amid a surge in demand for sterilized equipment to fight the pandemic.
“I am quite concerned that the unscientific opposition to [ethylene oxide] is imperiling public health by impeding our ability to provide equipment needed to counter COVID-19,” said toxicologist Gail Charnley of HealthRisk Strategies.
Angela Logomasini, senior fellow at the free market Competitive Enterprise Institute, said that “misguided activist efforts to close plants meant that we were even less prepared for COVID-19 when the virus struck.”
She issued a policy memo last week challenging the “unwarranted fearmongering” over ethylene oxide, a gas used to sterilize more than 50% of U.S. medical equipment, about 20 billion products annually, that “may be the only method that effectively sterilizes and does not damage the device,” according to the FDA.
“FDA officials along with advisers from the medical community expressed grave concerns about shortages of sterile medical supplies back in November well before the COVID-19 crisis began,” said Ms. Logomasini. “Fortunately, reopening of plants to address severe shortages helped mitigate the damage, but activists could create more problems in future if they are able to shut down plants again by peddling misinformation about EtO risks.”
Local activists who have fought to shut down the plants argue that the shortages were caused by a lack of equipment, not a bottleneck in the sterilization process, and that even the manufacturing giant 3M has advised against using the gas on its N95 masks over concerns about the lengthy post-contamination aeration process.
“Frankly, this is all complete hogwash,” said Lauren Kaeseberg, a leader of the Illinois-based advocacy group Stop Sterigenics. “You do not need to sterilize all this [personal protective equipment]. This is another tactic and a strategy by this lobbying effort and these companies who are trying to make money and trying to exploit a pandemic and a tragedy for their own monetary gain.”
Under pressure from the FDA, officials in Cobb County, Georgia, issued an emergency order in March to temporarily reopen a Sterigenics plant to sterilize masks, gowns and other personal protective equipment.
A Medline Industries facility in Waukegan, Illinois, reopened in March after making $10 million in upgrades after the state raised its standards on ethylene oxide emissions. A Sterigenics plant in Willowbrook, Illinois, remains closed after being shut down last year by Attorney General Kwame Raoul.
“Illinois has already acted to significantly reduce ethylene oxide emissions, but there is an urgent need for the EPA to strengthen national EO standards to protect communities throughout the country,” Mr. Raoul said in a February 2019 press release.
Using ‘new math’
As far as the sterilizer’s defenders are concerned, however, the EPA was the problem. Ethylene oxide has been used since 1938 in a wide variety of products, including shampoo, detergents, plastics and antifreeze, but it wasn’t until the agency changed its standard in 2016 that the outcry began.
The Environmental Protection Agency’s Integrated Risk Information System program published its final finding on the cancer risks of ethylene oxide in December 2016, shortly before President Trump took office, concluding that exposure to a concentration of 0.1 parts per trillion represented a safe level for those continuously exposed to the gas.
That is far smaller than the 0.2 to 0.4 parts per billion found in suburban and urban air. By contrast, the Occupational Safety and Health Administration’s standard for those exposed to the gas eight hours a day in a five-day workweek is one part per million.
“Ethylene oxide is suddenly getting attention because an office within the EPA changed the way it calculated the amount it considers safe to breathe. No new science was used, just new math,” said Ms. Charnley, who has a doctoral degree in toxicology from the Massachusetts Institute of Technology.
She said the Integrated Risk Information System standard was “nearly 20,000 times lower than the amount produced naturally in the human body, 5,000 times lower than levels normally found in suburban air” and more than five million times more stringent than other U.S. and global regulatory limits.
“The IRIS assessment for EO is scientifically flawed and significantly overestimates cancer risk,” the Ethylene Oxide Sterilization Association said in a statement. “These grossly inflated risk factors, recently relied upon by EPA, have resulted in inaccurate results, caused undue concern, and are misleading the public.”
Even so, the EPA inspector general issued a report in March accusing the agency of failing to warn communities of the cancer risk, based on the Integrated Risk Information System assessment, which prompted a rebuke from EPA Administrator Andrew Wheeler.
“The tone and substance of this report indicates a disconnect in the US EPA IG’s office,” Mr. Wheeler said in a March 31 statement. “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.”
Lawsuits are on the upswing. In December, five women who worked at a high school near the Willowbrook plant filed a lawsuit alleging that they developed cancer from exposure to the facility’s emissions. Sterigenics has disputed the claim.
Shawn Collins of the Collins Law Firm in Naperville, Illinois, who represents the women, has developed a specialty in ethylene oxide litigation. He advertises on his website that his firm is “investigating and filing toxic tort lawsuits for people who developed cancer after living or working within 3 miles of the Sterigenics plant.”
“There has to be another way to clean medical equipment rather than poisoning the rest of us in the United States or wherever they’re doing it,” plaintiff Peg Vahldieck, a former teacher, told CBS.
Other methods of sterilization are available, but experts say ethylene oxide gas is unique in being able to penetrate delicate, hard-to-reach surfaces without damaging equipment, raising fears that the crackdown may prove more perilous to public health than the gas itself.
“If COVID-19 teaches us anything, it is that we need to remain prepared for emergencies,” said Ms. Logomasini. “Shutting down critical operations such as medical supply sterilization plants, without justification, is dangerous.”
