Nine months ago, residents of the Chicago suburb of Willowbrook, Illinois, scored a major victory in their fight to prevent emissions of a dangerous gas, ethylene oxide, into the air they breathe. In fact, their victory appeared to have ripple effects in other communities. But like so many other aspects of life in the midst of a pandemic, things changed in a hurry.
The U.S. Environmental Protection Agency (EPA) classified ethylene oxide, or EtO, as a human carcinogen in December 2016. According to the agency, exposure via inhalation increases the likelihood of developing certain cancers and other respiratory and neurological ailments. EPA has not established a reference dose, or maximum acceptable dose, for EtO, but the U.S. Agency for Toxic Substances and Disease Registry’s (ATSDR) Cancer Risk Evaluation Guide (CREG) estimates concentrations of a carcinogen at which there is an elevated risk of one additional cancer case in one million people exposed over a lifetime. ATSDR’s CREG for ethylene oxide is 0.00021 µg/m3.
Despite being classified as harmful, EtO is used to sterilize nearly half of all medical devices that require sterilization in the United States. EPA’s 2016 Toxics Release Inventory identified more than 100 facilities in the United States that emit ethylene oxide into the air. Many of the communities exposed to this carcinogen are made up of primarily Black, Brown, and low-wealth families.
In August 2018, a group of Willowbrook residents came together in response to mounting evidence that EtO emissions from a nearby medical device sterilization facility, owned by a company named Sterigenics, was a threat to their health. That month, ATSDR published an analysis concluding that “an elevated cancer risk exists for residents and off-site workers in the Willowbrook community surrounding the Sterigenics facility.” All of the five-year modeled and 12-hour measured EtO concentration averages exceeded ATSDR’s CREG for EtO. According to the agency, the residential sample location had an additional lifetime risk of 6.4 cancer cases per 1,000 people, which greatly exceeds EPA’s acceptable cancer risk threshold of 100 cases per 1 million.
In 2019, facing pressure from the newly formed grassroots group Stop Sterigenics, the Illinois Department of Public Health published a study revealing an elevated incidence of non-Hodgkin's lymphoma and breast cancer in the census tracts near the Willowbrook facility. Each piece of new information added fuel to residents' campaign to eliminate EtO emissions. In June, state lawmakers passed SB1852, requiring plants to reduce ethylene oxide emissions by 99.9 percent. Then just three months later, in September 2019, Sterigenics decided to permanently shut down the facility due to an “unstable legislative and regulatory landscape.”
The achievement was not only a win for residents of Willowbrook, but helped launch a successful campaign to close a similar plant in Lake County, Illinois, where blood samples from 93 people living within half a mile from a medical device sterilization facility had EtO levels 50 percent greater than those living farther away, whose results closely resembled background levels. Similarly, in Cobb County, Georgia, one of the five medical device sterilization plants operating in the state closed indefinitely after it was unable to comply with additional safety regulations imposed by the county. By the start of 2020, dozens of lawsuits had been filed against Sterigenics by Willowbrook residents seeking justice for years of exposure to the toxic gas.
Then came the coronavirus.
As COVID-19 cases started to climb and hospitals became increasingly concerned about the impending influx of patients and supply shortages, sterilization facilities were once again in demand. While the Willowbrook plant remains closed, the Lake County facility reopened in March. The plant in Cobb County also reopened following arm-twisting by the U.S. Food and Drug Administration (FDA). And while these facilities have installed emission controls, residents are understandably skeptical. Last month, the Lake County Health Department released EtO air monitoring data but has yet to publish its analysis.
Recognizing that the demand for sterilization facilities was on the rise, in March 2020, the EPA Office of Inspector General issued an alert that the agency was not adequately informing people who live near EtO facilities about elevated cancer risks. The Centers for Disease Control and Prevention (CDC), Occupational Safety and Health Administration (OSHA), and 3M also caution against using EtO to disinfect N95 masks. CDC warns that the sterilized masks may give off EtO vapors that will be inhaled by health care workers wearing them. Instead, the agency recommends using safer sterilization alternatives, like hydrogen peroxide.
Such concerns notwithstanding, Charlie Mills, CEO of Medline Industries, another medical device sterilization company, is pressuring FDA to authorize plants to disinfect N95 masks.
This debate over EtO underscores a question public health experts have asked themselves for decades: Should we address one public health crisis by potentially creating another?
It is beyond question that medical device sterilization operations are necessary. And identifying a safe alternative to EtO for mass medical device sterilization requires time, a luxury we unfortunately don’t have in the midst of this pandemic. However, rather than bend to the will of sterilization companies seeking to regain power and money, FDA should continue seeking safer alternatives to EtO and limit reopened facility operations to critical medical equipment that cannot be adequately sterilized with hydrogen peroxide. EPA should update its regulation for EtO emissions and include cancer risks in its review, and it should require companies to monitor and report emissions. They can be sure that the communities who will bear the brunt of their decisions are watching.
UPDATE (8/18/20): If you're interested in learning more about COVID-19 and ethylene oxide, check out a new factsheet from Coming Clean. It highlights key talking points on the issue and what federal agencies can do to protect communities and health care workers from harm.
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Darya Minovi | July 13, 2020
Nine months ago, residents of the Chicago suburb of Willowbrook, Illinois, scored a major victory in their fight to prevent emissions of a dangerous gas, ethylene oxide, into the air they breathe. In fact, their victory appeared to have ripple effects in other communities. But like so many other aspects of life in the midst of a pandemic, things changed in a hurry.
Michael C. Duff | July 2, 2020
Workers' compensation was created as a means to an end and not an end in itself. It addressed the outrageous frequency of workplace injury and death caused by railroads in the late 19th/early 20th century. The unholy trinity of employers' affirmative tort defenses – assumption of the risk, contributory negligence, and the fellow servant rule – meant that workers or their survivors were not being compensated adequately or, in many cases, not at all. For this reason, expert American investigators were dispatched to Europe between 1909 and 1911 to study the existing workers' compensation systems there. Our current system was the result.
Alice Kaswan | July 1, 2020
When California adopted its first-in-the-nation regulations requiring truck electrification on June 25, the state took a step (or drove a mile) toward reducing pollution in the nation's most vulnerable communities. The new regulation exemplifies a key feature of California's approach: its integration of climate goals, clean air goals, and, at least in this case, environmental justice goals.
Katie Tracy | June 19, 2020
Until this week, laws in a majority of U.S. states permitted some form of employment discrimination based on sexual orientation or gender identity. On Monday, the law changed – dramatically, sweepingly, historically – when the U.S. Supreme Court made clear that in this respect the 1964 Civil Rights Act's anti-employment discrimination provisions mean exactly what they say. The Court's ruling in Bostock v. Clayton County, Georgia makes clear that it is illegal to base employment decisions – hiring and firing, the allocation of work, the grouping of employees, compensation practices, harassment – on sexual orientation or identity. The prior patchwork of state laws – most of which permitted some type of employment discrimination based on orientation or identity – is no more.
William Buzbee | June 19, 2020
On June 18, the U.S. Supreme Court struck down the Trump administration's rescission of the Obama administration's immigration relief program known as Deferred Action for Childhood Arrivals (DACA). In explaining and then defending its DACA rollback, the Trump administration had raised an array of claims that, if accepted, would have undercut numerous regulatory rule of law fundamentals. Instead, the Court strengthened these longstanding requirements. Department of Homeland Security (DHS) v. Regents will become central to battles over the many Trump administration rollbacks and reversals of environmental and other regulations.
Daniel Farber | June 18, 2020
On June 16, the D.C. Circuit Court of Appeals decided two cases that add to the legal difficulties the Trump EPA will face in court. The difficulties relate to two proposed EPA rules that attempt to hamstring future efforts to impose tighter restrictions on pollution. Both EPA rules rely on vague, general grants of rulemaking authority from Congress. That just became more tenuous.
Darya Minovi | June 18, 2020
A blog post published last month by the Chesapeake Bay Program, a collaborative partnership focused on Bay restoration, addressed the many ways that the climate crisis will affect farms in the region. Data from the program shows temperatures on Maryland’s Lower Eastern Shore, home to a high concentration of industrial poultry farms, increased between 2 to 2.5 degrees Fahrenheit, on average, between 1901 and 2017. By 2080, temperatures in the Chesapeake Bay watershed are projected to increase by 4.5 to 10 degrees, posing a serious risk of heat stress to farmworkers and livestock.
Thomas McGarity | June 17, 2020
Governments and industries are "reopening" the economy while COVID-19 continues to rage across the United States. At the same time, the lack of effective, enforceable workplace health and safety standards puts workers and the general public at heightened risk of contracting the deadly virus. In a new report from the Center for Progressive Reform, Sidney Shapiro, Michael Duff, and I examine the threats, highlight industries at greatest risk, and offer recommendations to federal and state governments to better protect workers and the public.
Katlyn Schmitt | June 16, 2020
On June 9, the House Energy and Commerce Committee's Subcommittee on Environment and Climate Change held a remote hearing, “Pollution and Pandemics: COVID-19’s Disproportionate Impact on Environmental Justice Communities.” The Center for Progressive Reform, joined by Fair Farms, Sentinels of Eastern Shore Health (SESH), and the Sussex Health and Environmental Network submitted a fact sheet to subcommittee members outlining the impacts of COVID-19 on the Delmarva Peninsula, along with a number of recommendations for building a more sustainable model for the region. The area is home to a massive poultry industry, hit hard by the coronavirus pandemic. We addressed several of the most severe problems in our fact sheet.