A north Arkansas industrial facility is cutting emissions of a cancer-causing chemical after reporting some of the highest releases of ethylene oxide nationwide in recent years.
Baxter International recorded an estimated 65% decrease in its emissions of the gas at its Mountain Home plant last year, according to spokeswoman Lauren Russ.
The company recently invested $50 million in reducing its releases of the gas at the Arkansas facility, which manufactures medical devices. Baxter has also worked with state environmental regulators to adopt new emission restrictions that in some cases are significantly more restrictive than federal benchmarks.
Leading up to the decrease in emissions, however, the Mountain Home facility, which operates as Baxter Healthcare Corp., lagged behind a nationwide reduction in the release of the gas.
In 2020, the facility reported the third-highest emissions of the chemical, which is known to cause certain cancers and reproductive problems, in the U.S. The year before, the plant recorded its highest release of the gas since the company ramped up production in 2015, according to data from the U.S. Environmental Protection Agency.
Ethylene oxide is a critical gas for Baxter -- and the health care industry as a whole -- as it is the only chemical capable of sterilizing certain medical equipment. The U.S. Food and Drug Administration estimates half of all sterile medical devices in the U.S. are treated with ethylene oxide.
Mounting concerns about the chemical's toxicity have nevertheless led to a recent increase in scrutiny of the gas.
Baxter's five-year spike in emissions began as facilities nationwide reported lowering their releases of the chemical. It continued as lawmakers, regulators and community activists in other parts of the country started pressuring other major emitters to limit or even cease their emissions of the gas.
While Baxter boosted its production, two Mountain Home residents alleged in court that historic emissions from the facility caused their cancers and claimed the company was continuing to subject residents to elevated health risks.
The EPA estimated the lifetime cancer risk due to toxic air pollutants near the Mountain Home facility to be three times higher than the agency's upper limit of acceptable risk, using data from 2017. The risk for this area was driven primarily by ethylene oxide emissions from the facility, according the agency's 2017 Air Toxics Screening Assessment.
This latest available federal assessment means that if a million people were continuously exposed to the level of air pollutants recorded in 2017 over a lifetime of 70 years, 300 of them would likely contract cancer due to the pollution.
The cancer risk estimates near the facility were by far the greatest in Arkansas.
Surrounded by neighborhoods, Baxter Healthcare Corp. shares a fence with dozens of homes. Hundreds more, along with churches and businesses, lie within a few miles of the plant. Roughly 5,000 people lived in the area the EPA estimated as having an elevated lifetime cancer risk at the time of the 2020 census.
The 2017 estimates do not reflect Baxter's current operations or planned reductions, according to the state Division of Environmental Quality.
Baxter's reported emissions from 2021 are still higher than figures it recorded in 2014, when the EPA estimated lifetime cancer risks near the facility to be almost three times higher than the national average.
State environmental officials pointed to the 2014 cancer estimates and Baxter's rising emissions when it issued an order last year that significantly restricted the amount of ethylene oxide the facility was allowed to emit. In light of EPA's analysis and the federal agency's intention to revise standards, Baxter voluntarily agreed to reduce and monitor its emissions of ethylene oxide, according to the order.
The EPA uses lifetime cancer risk estimates to highlight areas that might benefit from additional public health studies. The agency does not rely on this screening tool as the basis for key decisions due to uncertainty in air emission data.
Citing disagreement among scientists, Russ said Baxter officials don't believe ethylene oxide emissions are putting Mountain Home residents at risk of developing cancer.
"There are some different opinions among health agencies, scientists, et cetera about whether environmental exposure of this nature presents any risks to human health," she said.
Russ pointed to a 2019 op-ed written by toxicologist Gail Charnley. In the piece, Charnley argued that environmental regulators had overestimated the toxicity of ethylene oxide.
"No new science was used, just new math," she wrote. "Whether that change was justified is debated by scientists."
Charnley has a doctorate in toxicology from Massachusetts Institute of Technology and has served on multiple government and industry advisory panels, according to her curriculum vitae. In her op-ed, Charnley wrote the Advanced Medical Technology Association, a medical device trade association, asked her to clarify issues surrounding ethylene oxide exposure.
Phone calls to a number registered to Gail Charnley went unanswered over the weekend.
Public health officials have long suspected ethylene oxide of causing short- and long-term health effects, according to Dr. Peter Orris, chief of occupational and environmental medicine at the University of Illinois in Chicago.
As early as 1981, the National Institute of Occupational Safety and Health recommended classifying the gas as a potential occupational carcinogen. The World Health Organization followed suit, determining ethylene oxide was carcinogenic to humans and labeling the chemical with its highest risk classification.
By 2016, EPA found the gas to be 30 times more carcinogenic to adults than previously suspected and changed its description of the chemical from "probably carcinogenic to humans" to "carcinogenic to humans."
"The quality of a known carcinogen ... is that we cannot tell you a lowest dose that doesn't have some impact," said Orris.
LAWSUITS FILED
At least two Mountain Home residents, who lived within 5 miles of the facility for more than 30 years, have alleged that Baxter Healthcare's emissions caused their cancers.
Tamara Knight and Gary Beck accused Baxter of significantly elevating cancer risks near their homes in lawsuits consolidated in the U.S. District Court for the Western District of Arkansas.
"Individuals living and working near the Baxter facility face some of the highest long-term cancer risks in the United States," plaintiff attorneys wrote in a legal document filed in March 2020. "These individuals have been unknowingly inhaling ethylene oxide on a routine and continuous basis for decades. Now they are suffering from a variety of cancers, reproductive issues, birth defects and other life-altering health effects from their continuous exposure to ethylene oxide."
Along with the facility's recent increase in emissions, attorneys pointed to earlier records that indicate Baxter emitted significantly more ethylene oxide before 2000. In the 1980s, the facility reported emitting up to 16 times the amount of ethylene oxide it released in 2020.
Attorneys representing Baxter argued that it was unclear to what extent the plaintiffs were exposed to ethylene oxide emissions and if other factors predisposed the plaintiffs to their cancers.
A federal judge granted a motion by Baxter Healthcare's attorneys to dismiss three of the complaints in the case last year but denied the dismissal of a fourth. In an opinion, Judge Timothy L. Brooks determined Baxter Healthcare's argument that it had not violated its state-issued permit was not enough to immunize the company from a negligence claim.
"From the Complaints, the Court can infer that a reasonably careful user of [ethylene oxide] might have taken more precautions than Baxter," wrote Brooks.
The judge was also unconvinced by Baxter Healthcare's claim that it didn't have a duty to warn residents of the dangers of gas since the information was already publicly available. The judge signaled that the company wasn't necessarily doing enough by providing emissions data to regulatory agencies.
"A sophisticated internet user with enough understanding of the situation to know what information to look for and where to look might have been able to find data regarding Baxter Healthcare's emissions," wrote Brooks. "But that does not necessarily relieve Baxter of a duty to warn."
Baxter still considers its reports to state and federal regulators its primary means of updating the public on its use of the chemical, according to Russ. The company also communicates regularly with the mayor and others in Mountain Home about work at the facility and emissions.
Last year, Baxter settled the case out of court paying the plaintiffs an unspecified amount, according to a financial document the company filed with the U.S. Securities and Exchange Commission.
"The settlement of these claims does not preclude potential future lawsuits," company officials wrote in the 2021 annual financial report.
A woman who answered a phone call to a number registered to Tamara Knight in Mountain Home declined to comment on the case. Phone calls to a number registered to Gary Beck went unanswered. Benjamin Richman, one of the plaintiff attorneys, declined to comment on the case for this article.
Out-of-court settlements often include confidentiality clauses that prevent plaintiffs from discussing the details of the case.
ALTERNATIVES EXPLORED
Since the EPA designated ethylene oxide as a known carcinogen, hundreds of plaintiffs have leveled accusations against other major emitters of the gas. Lawmakers in Georgia and Illinois tightened regulations of the chemical. In Congress, a bipartisan task force with representatives from Georgia, Illinois and Pennsylvania pushed the EPA to tighten emission regulations.
The backlash prompted some facilities to reduce their releases of the gas or temporarily close. At least one sterilization plant in Illinois shut down in 2019 after facing pressure from community members and restrictions from state officials.
As sterilization facilities scaled back their use of ethylene oxide, the FDA anticipated potential shortages in important medical devices. While facilities may use several methods to sterilize medical equipment, ethylene oxide is often the only chemical effective at killing microbes on devices with multi-layered packaging or equipment that is sensitive to heat or moisture.
"In short: this method is critical to our health care system and to the continued availability of safe, effective and high-quality medical devices," Dr. Norman Sharpless, acting commissioner of food and drugs, said in a 2019 FDA news release.
The FDA has since started a program aimed at finding alternative ways of sterilizing medical devices.
As an ongoing effort to reduce ethylene oxide emissions, Baxter's research and development teams are exploring ways of using less of the gas in the facility's sterilization process. The company might be willing to adopt other methods of sterilizations that become available in the future.
"Everything is under consideration," said Russ.
Few if any Mountain Home residents have raised concerns about ethylene oxide emissions, according to Mayor Hillery Adams. Most complaints regarding the facility are due to noise or construction work.
Baxter Healthcare Corp. is the second-largest employer in the community behind Baxter Regional Medical Center, according to Adams.
Baxter's facility was the only significant emitter of ethylene oxide in Arkansas to report emissions of the gas within the past 10 years of available data. Clean Harbors in El Dorado, which recorded emissions of one pound in 2019 and 2020, was the only other facility in the state to report releases to the EPA during this time.
Dr. Bala Simon, deputy chief medical officer for the state Department of Health, was unaware of any investigations by the department into potential cancer clusters in the Mountain Home area.
As part of an upcoming revision of the EPA's ethylene oxide regulations, federal officials are considering a new round of public outreach, according to Joe Robledo, an EPA spokesman.
While the agency has yet to finalize its list of communities to be included in the outreach, Robledo said in a statement that the effort could include Mountain Home.