Companies responsible for cleaning doctors’ surgical kits and syringes have been placed under a microscope by Southern California’s air quality monitor, which has found that at least three located in Southern California are emitting alarming levels of a cancer-causing gas used in the sterilization process.
The South Coast Air Quality Management District plans to investigate 15 facilities permitted to use the gas known as ethylene oxide, or EtO, in Los Angeles, Orange, Riverside and San Bernardino counties in light of a growing national concern about the toxicity of the chemical.
Air monitoring at three of the five facilities tested so far has shown the cancer risk in the immediate vicinity could be as much as 20 times higher than allowable, according to the South Coast AQMD. The colorless and odorless gas can cause lymphoid and breast cancers and reproductive damage.
One of the three facilities in violation, Parter Sterilization Services in Carson, is within 700 feet of a residential neighborhood and 2,000 feet away from a school, but air samples have yet to be collected at those locations to determine how far the emissions might have traveled. The other two, Sterigenics facilities in Vernon and Ontario, are being reviewed because of their potential risk to nearby workers and are not believed to pose any risks to neighborhoods.
The three facilities, which are among the largest users of ethylene oxide in the region, are currently taking up the “full capacity” of the South Coast AQMD’s air monitoring resources, according to a spokesperson. The list of facilities that the agency plans to investigate in the future includes the Los Angeles Zoo, UCLA and Mt. San Antonio Community College, as well as other medical device sterilizers in Riverside, Irvine, Brea and Fountain Valley.
More than half of the medical equipment in the United States, or approximately 20 billion devices, is sterilized with ethylene oxide because of the chemical’s ability to penetrate plastics and other materials to destroy bacteria without melting or weakening the device. Locally, the Vernon facility alone is responsible for cleaning 45 million medical devices and supplies per year.
What has changed
The toxicity of ethylene oxide has been debated nationally for decades, but federal regulators have moved at a glacial pace. A draft assessment from the U.S. EPA in 2006 determined the chemical was significantly more carcinogenic than previously believed, according to ProPublica. Yet, the final assessment wasn’t published until a decade later.
Now, regulators and residents across the country are pushing back against companies — including Sterigenics facilities in other states — over their ethylene oxide emissions. The U.S. EPA released a list of 23 facilities with elevated risks in early August. None in California made the cut.
California first listed ethylene oxide as cancer causing in 1987 and as damaging to reproductive systems in 2009. The long-standing listing of ethylene oxide as a carcinogen has prompted some critics, including Los Angeles County Supervisor Janice Hahn, to question why the regional air monitor wasn’t more proactive.
The South Coast AQMD began to scrutinize ethylene oxide users earlier this year after the EPA announced it would revisit its own regulation of the chemical in an effort to reduce emissions.
“When the EPA began reevaluating its rules and risk analysis for EtO, looking at potentially more stringent risk levels, many agencies began reviewing their individual rules and regulations as a result,” said Nahal Mogharabi, a spokeswoman for the local air quality regulator. “As such, South Coast AQMD decided to take a closer look at EtO facility operations as well as potential rulemaking, recognizing U.S. EPA’s work regarding toxicity of EtO.”
In the 1980s, doctors and dentists used ethylene oxide in-house to sterilize their own equipment, but as the evidence against it grew in subsequent years, the chemical became more tightly controlled and required more advanced technologies to contain, said Richard Jackson, professor emeritus of environmental health sciences at the UCLA Felding School of Public Health. Jackson served as California’s public health officer under Gov. Arnold Schwarzenegger and previously as director of the CDC’s National Center for Environmental Health.
Early concerns about the chemical were primarily focused on workers and pregnant women. Over time, the concerns shifted as scientists realized the chemical’s reach could extend beyond an industrial park’s chain-link fences.
“Imagine, if this can kill microorganisms on a dirty scalpel, what it can do to your nasal cavities and lungs,” Jackson said. “It is not something you want to be breathing.”
The evidence of ethylene oxide’s damaging effect has increased in recent decades, he said. Studies on animals found the chemical alters and “breaks” chromosomes, according to Jackson.
Jackson attributed the delay in widespread concern about ethylene oxide to the need to develop more advanced computer models and air monitoring techniques, and to an overall shift in public perception around environmental health, particularly in the lower income neighborhoods where many of the worst polluters were often located and faced little political backlash.
“As the ability to detect chemicals has gone up, the public’s acceptance of these levels has gone down,” he said.
Calls to shut down operations
In Los Angeles County, Supervisor Hahn has called for the shuttering of the Sterigenics facility in Vernon in part because of the cumulative impacts to nearby residents in Maywood and other communities who have suffered from lead contamination and other pollutants from the nearby Exide battery recycling plant.
A hearing on a petition by the South Coast AQMD to force Sterigenics to correct its issues, or to shut down, is scheduled for Tuesday, Aug. 9. Hahn, Assemblyman Miguel Santiago and other local community leaders plan to gather the day before to renew their call for the closure of Sterigenics.
In a statement, Hahn said it is alarming that these high levels of emissions may have gone unnoticed for years.
“I don’t think enough is being done,” Hahn said. “SCAQMD has used the same, reactive approach for too long and it isn’t working.”
Proactive air monitoring should “be the status quo” at every facility that uses ethylene oxide, she said.
Industry warns of catastrophe
Scott Whitaker, president and CEO of the Advanced Medical Technology Association, which represents medical sterilization companies, in a statement last week in response to the release of the EPA’s list of risky companies, warned that the shuttering of medical device sterilization facilities could be “catastrophic.”
“The shutdown of medical device sterilization facilities due to misinformed political pressure, as well as the uncertainty regarding which regulations the facilities must adhere to as EPA works to update the federal rule, would be disastrous to public health under the best of circumstances; it could be catastrophic, in light of the fragile global supply chain, which hospitals are already strained to address,” Whitaker stated.
Parter Sterilization Services did not return a request for comment. Sterigenics provided a statement through a spokesperson that described ethylene oxide as essential to the U.S. health care system and encouraged the EPA to adopt “new standards that are better aligned with the best EO (ethylene oxide) control technologies currently available.”
The company has committed to implementing additional protection measures at its Vernon facility to “further enhance our already safe operations.” South Coast AQMD’s reviews have not found any risks to nearby residents in Vernon or Ontario, the spokesperson stressed.
“Stergienics is confident in the continued safety of our employees and the surrounding communities near our Vernon and Ontario facilities,” the spokesperson stated. “Sterigenics has been fully cooperating with SCAQMD and has addressed the alleged SCAQMD violations at each facility.”