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Pick Your Poison

The hidden dangers of boosting PPE production

Last July, Jessica K., a forty-two-year-old learning specialist at a private school in Atlanta, received a text from one of her best friends. “Hey, you realize where you live?” The message linked to an article posted on WebMD, the medical information website, about emissions of ethylene oxide, a chemical linked to elevated risk of developing cancer. The story included a map of Cobb County, where Jessica lives. She could see her own home, ringed by a yellow line indicating a zone where aboveground concentrations of EtO were higher than the national average. It turned out that half a mile away, a company called Sterigenics operated a plant that used the gas to sterilize medical equipment. To Jessica, who had always thought that the air she breathed was “as fresh as it could be in the city of Atlanta,” this came as a surprise. Not only was she unaware of the danger the plant posed, she hadn’t even known the facility existed at all.

Jessica considered moving; she even started house hunting. Shortly thereafter, however, she began to reconsider. Local activists, rallying under the name Stop Sterigenics-Georgia, had stepped up a vocal campaign to close the plant, attending public meetings, launching a letter-writing campaign, and handing out bright-orange flyers that read, “eto must go.” Hoping that her family might be able to safely remain in their home, Jessica and her ten-year-old daughter canvased the neighborhood. In August, after a week of independent air-quality monitoring, Sterigenics agreed to voluntarily shut down the plant to install equipment that would limit emissions. Two months later, county officials deemed the plant an “industrial high hazard” facility—meaning that it was now out of compliance with fire and building codes—and threatened to issue a stop-work order.

The campaign to shutter the plant for good seemed likely to succeed. But nearly six months later, in late March, as Jessica entered her third week of sheltering-in-place from the coronavirus, she learned that federal officials were pressuring the state to reopen the Cobb County plant in order to meet the growing demand for personal protective equipment (PPE). Sterigenics subsequently announced that it would resume sterilization operations as early as April. Soon, COVID-19 would be joined by an entirely different invisible threat, lurking in the bright spring air.

The news of the reopening had also dredged up memories about Jessica’s first daughter, who had died from unknown causes at the age of two. “You can’t go down the rabbit hole of, well, was it because we lived here?” she said. Still, Jessica could not bear the thought of losing another child, and once again had to confront the fact that her family had unwittingly chosen to live in the shadow of a sterilization plant that was “pumping cancerous and carcinogenic air into our lungs,” as she put it. “We would have never chosen that. And no one around us would have.”

Some in the community viewed the reopening of the Sterigenics facility as a business nobly answering the call to duty amid a dire threat. But others saw the federal government’s request as a reckless handout to private industry disguised as a public service. In that sense, the Sterigenics story is part of a broader trend: in late March, for instance, the Environmental Protection Agency announced that it would indefinitely curtail enforcement of numerous pollution laws and allow facilities like Sterigenics to self-monitor and self-report any violations. EPA administrator Andrew Wheeler said that the decision would ensure that “under the current, extraordinary conditions … facility operations continue to protect human health and the environment.” The agency also fast-tracked implementation of the Strengthening Transparency in Regulatory Science rule, a proposal that critics worry will narrow the criteria for scientific studies allowed to be consulted when drawing up federal environmental regulations. Among other things, the rule could preclude the use of private, anonymized health data already being used to link air pollution with increased risk of viral respiratory infection. Were these measures in the midst of a pandemic really intended to fight COVID-19, or were communities being asked to make sacrifices that had little to do with public health and everything to do with a political gambit that would put vulnerable lives at risk?

By mid-March, as Sterigenics sought to reopen its Cobb County facility, shortages of PPE, including gowns, gloves, and medical-grade N95 respirators—the iconic white polypropylene face masks that filter out 95 percent of airborne particles—had been reported across the country. Doctors and nurses pleaded for donations. Community organizers mobilized sewing brigades to make cloth masks. Public health officials warned that demand was so dire that any quick solution was unlikely, given widespread disruptions in the supply chain. Further complicating matters was the fact that certain PPE, like surgical garb, is ordinarily required to be sterilized before it reaches health workers. And one of the chief methods of sterilization is EtO.

EtO is a colorless and extremely combustible gas that, in high concentrations, is said to have a sweet, ether-like odor. It is also a known human carcinogen, and acute exposure has been linked to numerous health issues, including respiratory illness. But at the right concentrations, and for the right length of time, the gas can function as a powerful sterilizing agent. Essentially, it rips apart the coating around bacterial and viral pathogens, such as the one that causes COVID-19, inactivating these disease-causing microbes and preventing them from spreading. According to data from AvaMed, a trade group, more than twenty billion medical devices are sterilized in the United States each year using EtO.

Debates over EtO’s safety have raged for over three decades, but they reignited at the federal level not long before COVID-19 hit American shores. In 2016, an updated EPA assessment found that the lifetime risk of developing cancer from inhaling EtO was nearly thirty times greater than previous estimates. As the news about the exposure risk spread, the report sparked a series of lawsuits and protests. Following pressure from local activists, state regulators effectively shut down a Sterigenics facility in Willowbrook, Illinois, in February 2019. A second EtO plant in Waukegan, Illinois, closed shortly thereafter, as did facilities in Michigan and Georgia. These closures were so significant that, in late 2019, a senior Food and Drug Administration official claimed that they had jeopardized the supply of sterilized medical equipment, and warned that “a shortage—especially of life-saving, life-sustaining, or other critical devices—can be a detriment to public health.”

On March 19, FDA commissioner Stephen Hahn sent a letter to Georgia governor Brian Kemp in which he invoked those same concerns with regard to the sudden need for PPE, and urged the governor to work with Sterigenics to reopen the Cobb County plant. Sterigenics, which operates eighteen EtO facilities worldwide, then issued a fact sheet in which it claimed to have one million protective gowns awaiting processing in Cobb County alone. The company claimed that the facility met all state and federal environmental regulations, and added that Sterigenics had “developed a safe method for rapid mask sterilization in China at the request of the Chinese Government. That solution can be replicated in Atlanta.” (A company spokesperson confirmed that this method has not yet been used in Georgia.) All that Sterigenics needed to reopen, and to begin processing equipment that protected frontline health care workers and patients, was a sign-off from local officials.

Under pressure from federal authorities, county leaders initially stood their ground. “We understand the gravity of the current situation,” then-county manager Rob Hosack said in a statement posted online, “but we also need to ensure the safety of our residents and with that in mind we need to carefully move forward.” Just days later, though, the county backed down, granting permission for Sterigenics to operate for twenty-one days, but solely for the purpose of sterilizing gowns, masks, and other equipment designed to protect health care workers against COVID-19.

Despite the county’s concessions, Sterigenics argued that limiting its operations to PPE—and thus excluding ventilator tubing, IV sets, catheters, and other medical devices that the company typically sterilized—fell “woefully short of the measures needed to protect public health.” The company filed a legal complaint against the county in federal court on March 30, arguing that it had already complied with fire and safety regulations. Sterigenics’ operations, read a statement, were “in the interest of protecting public health.” Those remarks explicitly referred back to the alarm sounded by the FDA in 2019, noting that, amid the pandemic, its concern about equipment shortages had a prophetic ring: “Unfortunately, the validity of the FDA’s warning is now clear.”

Just as momentum seemed to be shifting in Sterigenics’ favor, however—only one day after the company had announced its lawsuit and resumed limited operation of the Cobb County facility—the EPA’s watchdog, the Office of Inspector General, issued a report about insufficient community outreach in “high-priority ethylene oxide-emitting facilities.” It included an urgent notice: “The EPA needs to inform residents who live near facilities with significant ethylene oxide emissions about their elevated estimated cancer risks so they can manage their health risks.” Many of those facilities are commercial sterilizers. (“The report’s timing with the reopening of EtO facilities,” a public affairs officer in the OIG’s office confirmed, “was purely coincidental.”) The release of the report, at any rate, had little effect on the Cobb County plant’s reopening. Wheeler, the EPA administrator, promptly asked for the report to be rescinded. Only a week earlier, he had claimed that protecting “heroic healthcare workers and their patients” took precedence over the risks posed by EtO exposure. While EtO could take a lifetime to cause harm, Wheeler had said, “COVID-19 poses an immediate threat to our nation during this crisis.” By early April, after at least one other previously shuttered sterilization facility had come back online, a federal court ruled that Sterigenics could resume unrestricted operations indefinitely. The plant was finally open for business.

Janet Rau, the president of Stop Sterigenics-Georgia, is an elementary school teacher who lives less than three miles from the Cobb County plant. She doesn’t deny that there is a legitimate shortage of PPE—when she isn’t teaching, in fact, she helps coordinate Atlanta Beats Covid, a grassroots effort to 3-D-print masks and collect donated equipment. But Rau and other organizers I spoke with argued that the shortage was born of manufacturing and distribution problems, not reduced sterilization capacity. FDA guidelines, as Rau pointed out, mandate sterilized garb for invasive surgeries, including the elective procedures that hospitals have put on hold, but not for the kind of barrier protection that workers doing intake or performing diagnostic testing require. Sterilizing such PPE for frontline workers, Rau argued, would only create unnecessary delays. She told me that if the Georgia plant had any stockpiles of new PPE in storage, she’d be willing to deliver them to nearby hospitals and health care facilities herself.

Sterigenics, of course, rejects the idea that its sterilization of PPE is unnecessary. “Any notion that Sterigenics customers would incur the time and expense to sterilize products that do not require sterilization is misinformed at best,” a spokesperson said by email. The company continues to highlight its role in supplying critical medical supplies and, by its own estimates, sterilizes 25 percent of the world’s gowns, masks, and gloves. The activists remain skeptical. “At the end of the day,” Sri Rao of an Illinois group called Stop Sterigenics, told me, “you don’t need ethylene oxide to sterilize this PPE. It doesn’t need to be sterile. It just doesn’t.”

Back in Cobb County, Rau worried over the children of essential workers who had been left at a daycare facility less than a mile from the plant, and wondered why state regulators had temporarily removed metal canisters in recent weeks that were used to monitor ambient air pollution. “They’re continuing to poison our community. They’re not being held accountable,” she said, “And we’re just saying, ‘It’s okay to trade lives?’” Her concerns extended to other vulnerable fenceline communities—many of which are economically depressed—which disproportionately suffer from illnesses linked to emissions from similar plants. “They already have preexisting conditions. They’re the ones most vulnerable to COVID virus, too,” Rau said. “On top of this, the ethylene oxide is cranking back up again. It’s just… The pain in this community is palpable.”

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December 2015

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