The U.S. Environmental Protection Agency on Wednesday announced plans to “engage and inform” nearly two dozen communities across the country where air pollution from commercial sterilizer plants has significantly increased lifetime cancer risks for nearby residents. The facilities use a toxic gas called ethylene oxide to sanitize medical and dental equipment and fumigate certain food products. The announcement comes after the EPA’s inspector general and news publications including ProPublica and The Texas Tribune highlighted the agency’s yearslong failure to inform communities of their risks.
The EPA said that its analysis of the industry’s self-reported emissions data showed that about a quarter of the nearly 100 commercial sterilizers the agency regulates are exposing nearby residents to unacceptable cancer risks from ethylene oxide. It posted risk maps and other information online for each of the high-risk facilities and announced dates for national and community-specific webinars and in-person meetings in the coming weeks.
“Today EPA is taking action to ensure communities are informed and engaged in our efforts to address ethylene oxide, a potent air toxic posing serious health risks with long-term exposure,” EPA administrator Michael S. Regan said in a statement. “Under my watch, EPA will do everything we can to share critical information on exposure risk to the people who need and deserve this information, and to take action to protect communities from pollution.”
The EPA is also putting the finishing touches on a proposal to place stricter limits on how much ethylene oxide commercial sterilizers can release into the outside air; it plans to unveil the plan later this year. The agency said Wednesday that it is planning to propose limits on ethylene oxide usage inside such facilities to better protect workers who handle the chemical, as well as people who work or attend school nearby.
Existing regulations on commercial sterilizers, as well as other facilities that manufacture or use ethylene oxide, do not account for the EPA’s latest research on the chemical that shows it is far more toxic than the agency knew.
In 2016, the agency concluded that ethylene oxide was 30 times more carcinogenic than previously thought for people who continuously inhale it as adults and 50 times more carcinogenic for those who are exposed since birth. The conclusion fueled a backlash from the chemical and sterilizer industries, which say that the EPA’s findings are deeply flawed. They have made it clear they plan to fight the EPA’s forthcoming regulatory proposals.
The EPA has known since at least 2018 that some of the communities it identified on Wednesday are at risk from ethylene oxide pollution and has even directed regional offices to hold public meetings. Those occurred in many places; in some more affluent and white communities, residents used the information to pressure elected officials to sue and even shutter sterilizer plants and enact stricter regulations of the chemical at the state level.
The EPA played catch-up last year, holding meetings in several additional communities, though it left out others. One of those communities was Laredo, a city of 260,000 on the Texas-Mexico border.
Last year, an unprecedented analysis of five years of industry data by ProPublica and The Texas Tribune found that a 38-year-old commercial sterilizer located in close proximity to an elementary school in Laredo was the most toxic facility of its kind in the country. Yet none of the more than 100 residents contacted by reporters, including local officials, were aware of the risk; all but one said they didn’t even know the plant existed.
The EPA told ProPublica and the Tribune last year that it was holding off on public engagement in certain communities while it gathered more recent emissions data from each of the nearly 100 commercial sterilizers that it regulates. This data collection is a key step in the agency’s work to craft updated regulations of the facilities.
The agency’s analysis of that data served as the basis of Wednesday’s announcement. It found that ethylene oxide emissions from 23 sterilizers across the country created an excess cancer risk for nearby residents of at least 1 in 10,000. That means that if 10,000 people are exposed to that amount of ethylene oxide over their lifetimes, at least one of them would likely develop cancer as a result of the exposure. (That’s in addition to any cancer risk caused by factors like lifestyle and genetics.) The EPA stressed that the amount of ethylene oxide the facilities are emitting is not high enough to pose short-term health risks.
The Laredo facility, owned by Midwest Sterilization Corporation, was one of those 23. So was the company’s other sterilizer plant in Missouri, which the ProPublica/Tribune analysis found to be the second-most toxic sterilizer plant in the country. Midwest, the country’s largest privately owned contract ethylene oxide sterilizer, didn’t respond to a request for comment.
Its Missouri facility moved to reduce ethylene oxide emissions after the EPA identified it as high-risk in 2018, triggering the agency’s regional office to contact the facility and meet with local leaders. Yet its ethylene oxide emissions remained high enough for it to make the EPA’s list of high-risk facilities.
In a news release Wednesday, the EPA noted that “medical sterilization is a critical function that ensures a safe supply of medical devices for patients and hospitals” and that it is “committed to addressing the pollution concerns associated with EtO in a comprehensive way that ensures facilities can operate safely in communities while also providing sterilized medical supplies.”
According to the EPA’s webpage detailing cancer risk at the Laredo facility, the agency will hold a community meeting in that city on Sept. 15.
Last year, Laredo’s lone environmental group, which first learned about the Midwest facility from ProPublica and the Tribune, spearheaded the formation of a clean air coalition that has pushed for emissions reductions and worked to inform residents of the risks associated with ethylene oxide exposure.
The group, the Rio Grande International Study Center, urged the EPA on Wednesday “to go beyond informing the public, and require immediate third-party fence-line air monitoring in neighborhoods and schools that are most impacted by Midwest.”
“Laredo has been a sacrifice zone for long enough,” said Sheila Serna, the group’s new climate science and policy director, who previously investigated a serious complaint against the Midwest facility while working as an inspector for Texas’ environmental agency. “We demand that our voices be heard and that any and all actions be taken to protect the most vulnerable in our community, which means phasing out the emissions of this highly dangerous and carcinogenic air toxin.”
State Study Finds High Cancer Rates in Laredo
On July 19, the Texas Department of State Health Services published the results of a cancer cluster study requested earlier this year by the Laredo health department. (The state health department only conducts cluster studies by request.)
The study examined rates of four different types of cancer that have been linked to ethylene oxide exposure in three different census tracts nearest the Midwest plant, focusing on diagnoses from 2006 to 2019.
It found that rates of one type of cancer associated with ethylene oxide exposure, extranodal non-Hodgkin lymphoma, were “significantly greater than expected” given the population. It also noted higher-than-expected numbers of cases of breast cancer and nodal non-Hodgkin lymphoma, which have also been linked with the chemical, though not at rates that are statistically significant. None of the rates were high enough to trigger an investigation into possible causes, a state health department spokesperson said.
The head of the Texas Cancer Registry told ProPublica and the Tribune last year that cancer rates may be higher in certain areas due to chance alone and that “cluster investigations in a community setting have rarely led to the identification of associations between cancers and environmental exposures” including air pollution.
However, the state study was limited to the areas closest to the Midwest plant, and the ProPublica/Tribune analysis showed the potential risk extends beyond that. It also didn’t examine rates of other types of cancer linked to ethylene oxide exposure, such as acute lymphocytic leukemia, citing the need to protect patient privacy because there were so few cases in the three census tracts examined.
It’s likely that the incidence rates the state examined in its Laredo study were an undercount, as many residents are low-income or uninsured and travel across the border to Mexico to seek more affordable care. (Doctors in Mexico are not obligated to report cancer diagnoses to the Texas registry.) The city, where nearly every resident is Latino, also has limited health care options, with few oncologists and no children’s hospital.
Last year, ProPublica and the Tribune told the stories of two children in Laredo battling acute lymphocytic leukemia: 9-year-old Juan “JJ” Nevares and 15-year-old Yaneli Ortiz.
Ortiz, who lives just outside the census tracts covered in the state’s cluster study, has been in remission since January. However, the steroids she took during treatment led to the deterioration of her hip bone, and she recently had hip replacement surgery.
JJ, who attended the elementary school close to the Midwest facility and lives nearby, was diagnosed four years ago and continues to undergo treatment in San Antonio.
Sara Montalvo Saldaña, JJ’s aunt and one of his primary caregivers, said she hopes officials take a closer look at rates of acute lymphocytic leukemia. She wonders why it has taken so long for federal and state regulators to inform residents of the risk posed by Midwest.
“They don’t have a sense of urgency. They have not seen it firsthand,” Saldaña said.
The results of the state health department study stand in stark contrast to what a toxicologist hired by Midwest told the local environmental group last year during a one-on-one meeting: Rates of all types of cancer in Laredo were below state averages. She assessed data from the entire county, which state officials and health experts have said is too large of an area to draw firm conclusions about the impact of a single industrial plant’s emissions.
On Wednesday, the EPA said it was working with the 23 high-risk sterilizers, as well as state and local agencies and stakeholders, to reduce ethylene oxide pollution. The agency didn’t say whether those conversations had already resulted in any emissions reductions, but information it provided on the individual facilities indicated that some have plans to install controls that will significantly reduce emissions. The Laredo facility is not one of them.
It’s unclear if Texas’ environmental regulatory agency is cooperating with that effort.
While only two of the commercial sterilizers the EPA identified are in Texas, the state is the largest ethylene oxide polluter in the country thanks to the numerous petrochemical manufacturing facilities clustered on the Gulf Coast. The EPA plans to propose updates to the regulations that limit air pollution at those facilities in coming years.
The historically industry-friendly Texas Commission on Environmental Quality has openly challenged the EPA’s latest ethylene oxide science, even launching its own review, which ruled that the chemical was significantly less toxic than the federal agency had found. That resulted in Texas enacting a new standard in 2020 that could allow plants to emit more of the chemical; the EPA in January formally rejected that standard.
“TCEQ fundamentally disagrees with EPA’s exposure estimates and risk characterization associated with sterilization facilities,” the commission said in a statement to ProPublica and the Tribune. “EPA overestimates both the exposure concentration at which ethylene oxide may cause cancer (cancer potency) and the predicted ambient concentrations of ethylene oxide near sterilization facilities.”
The commission did not respond to questions about whether it would cooperate with the EPA’s effort to reduce ethylene oxide emissions at facilities in Texas.
Even so, Saldaña is grateful about this next set of steps. “It gives me hope,” she said. “Instead of being mad or thinking maybe this would have never happened to JJ, I’m hoping that this will make sure others don’t have to go through it.”