Over the past two years, Madeline Beal has heard frustration and even bewilderment during public meetings about ethylene oxide, a cancer-causing gas that is used to sterilize half of the medical devices in the U.S.

Beal, senior risk communication adviser for the Environmental Protection Agency, has fielded questions about why the agency took so long to alert people who live near facilities that emit the chemical about unusually high amounts of the carcinogenic gas in their neighborhoods. Residents asked why the EPA couldn’t close those facilities, and they wanted to know how many people had developed cancer from their exposure.

“If you’re upset by the information you’re hearing tonight, if you’re angry, if it scares you to think about risk to your family, those are totally reasonable responses,” Beal told an audience in Laredo, Texas, in September 2022. “We think the risk levels near this facility are too high.”

There are about 90 sterilizing plants in the U.S. that use ethylene oxide, and for decades companies used the chemical to sterilize medical products without drawing much attention. Many medical device-makers send their products to the plants to be sterilized before they are shipped, typically to medical distribution companies.

But people living around these facilities have been jolted in recent years by a succession of warnings about cancer risk from the federal government and media reports, an awareness that has also spawned protests and lawsuits alleging medical harm.

The EPA is expected to meet a March 1 court-ordered deadline to finalize tighter safety rules around how the toxic gas is used. The proposed changes come in the wake of a 2016 agency report that found that long-term exposure to ethylene oxide is more dangerous than was previously thought.

But the anticipated final rules — the agency’s first regulatory update on ethylene oxide emissions in more than a decade — are expected to face pushback. Medical device-makers worry stricter regulation will increase costs and may put patients at higher risk of infection from devices, ranging from surgical kits to catheters, due to deficient sterilization. The new rules are also not likely to satisfy the concerns of environmentalists or members of the public, who already have expressed frustration about how long it took the federal government to sound the alarm.

“We have been breathing this air for 40 years,” said Connie Waller, 70, who lives with her husband, David, 75, within two miles of such a sterilizing plant in Covington, Georgia, east of Atlanta. “The only way to stop these chemicals is to hit them in their pocketbook, to get their attention.”

The EPA says data shows that long-term exposure to ethylene oxide can increase the risk of breast cancer and cancers of the white blood cells, such as non-Hodgkin lymphoma, myeloma, and lymphocytic leukemia. It can irritate the eyes, nose, throat, and lungs, and has been linked to damage to the brain and nervous and reproductive systems. Children are potentially more vulnerable, as are workers routinely exposed to the chemical, EPA officials say. The agency calculates the risk based on how much of the gas is in the air or near the sterilizing facility, the distance a person is from the plant, and how long the person is exposed.

Waller said she was diagnosed with breast cancer in 2004 and that her husband was found to have non-Hodgkin lymphoma eight years later.

A 2022 study of communities living near a sterilization facility in Laredo found the rates of acute lymphocytic leukemia and breast cancer were greater than expected based on statewide rates, a difference that was statistically significant.

Beal, the EPA risk adviser, who regularly meets with community members, acknowledges the public’s concerns. “We don’t think it’s OK for you to be at increased risk from something that you have no control over, that’s near your house,” she said. “We are working as fast as we can to get that risk reduced with the powers that we have available to us.”

In the meantime, local and state governments and industry groups have scrambled to defuse public outcry.

Hundreds of personal injury cases have been filed in communities near sterilizing plants. In 2020, New Mexico’s then-attorney general filed a lawsuit against a plant in Santa Teresa, and that case is ongoing. In a case that settled last year in suburban Atlanta, a company agreed to pay $35 million to 79 people who alleged ethylene oxide used at the plant caused cancer and other injuries.

In Cook County, Illinois, a jury in 2022 awarded $363 million to a woman who alleged exposure to ethylene oxide gas led to her breast cancer diagnosis. But, in another Illinois case, a jury ruled that the sterilizing company was not liable for a woman’s blood cancer claim.

Greg Crist, chief advocacy officer for the Advanced Medical Technology Association, a medical device trade group that says ethylene oxide is an effective and reliable sterilant, attributes the spate of lawsuits to the litigious nature of trial attorneys.

“If they smell blood in the water, they’ll go after it,” Crist said.

Most states have at least one sterilizing plant. According to the EPA, a handful, like California and North Carolina, have gone further than the agency and the federal Clean Air Act to regulate ethylene oxide emissions. After a media and political firestorm raised awareness about the metro Atlanta facilities, Georgia started requiring sterilizing plants that use the gas to report all leaks.

The proposed rules the EPA is set to finalize would set lower emissions limits for chemical plants and commercial sterilizers and increase some safety requirements for workers within these facilities. The agency is expected to set an 18-month deadline for commercial sterilizers to come into compliance with the emissions rules.

That would help at facilities that “cut corners,” with lax pollution controls that allow emissions of the gas into nearby communities, said Richard Peltier, a professor of environmental health sciences at the University of Massachusetts-Amherst. Stronger regulation also prevents the plants from remaining under the radar. “One of the dirty secrets is that a lot of it is self-regulated or self-policed,” Peltier added.

But the proposed rules did not include protections for workers at off-site warehouses that store sterilized products, which can continue to emit ethylene oxide. They also did not require air testing around the facilities, prompting debate about how effective they would be in protecting the health of nearby residents.

Industry officials also don’t expect an alternative that is as broadly effective as ethylene oxide to be developed anytime soon, though they support researching other methods. Current alternatives include steam, radiation, and hydrogen peroxide vapor.

Increasing the use of alternatives can reduce industry dependence on “the crutch of ethylene oxide,” said Darya Minovi, senior analyst with the Union of Concerned Scientists, an advocacy group.

But meeting the new guidelines will be disruptive to the industry, Crist said. He estimates companies will spend upward of $500 million to comply with the new EPA rules and could struggle to meet the agency’s 18-month timetable. Sterilization companies will also have difficulty adjusting to new rules on how workers handle the gas without a dip in efficiency, Crist said.

The Food and Drug Administration, which regulates drugs and medical devices, is also watching the regulatory moves closely and worries the updated emissions rule could “present some unique challenges” if implemented as proposed, said Audra Harrison, an FDA spokesperson. “The FDA is concerned about the rule’s effects on the availability of medical devices,” she added.

Other groups, like the American Chemistry Council and the Texas Commission on Environmental Quality, the state’s environmental agency, assert that ethylene oxide use isn’t as dangerous as the EPA says. The EPA’s toxicity assessment has “severe flaws” and is “overly conservative,” the council said in an emailed statement. Texas, which has several sterilizing plants, has said ethylene oxide isn’t as high a cancer risk as the agency claims, an assessment that the EPA has rejected.

Tracey Woodruff, a researcher at the University of California-San Francisco who previously worked at the EPA, said it can be hard for the agency to keep up with regulating chemicals like ethylene oxide because of constrained resources, the technical complications of rulemaking, and industry lobbying.

But she’s hopeful the EPA can strike a balance between its desire to reduce exposure and the desire of the FDA not to disrupt medical device sterilization. And scrutiny can also help the device sterilization industry think outside the box.

“We continue to discover these chemicals that we’ve already been exposed to were toxic, and we have high exposures,” she said. “Regulation is an innovation forcer.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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In Pawtucket, Rhode Island, near a storefront advertising “free” cellphones, J.R. sat in an empty back stairwell and showed a reporter how he tries to avoid overdosing when he smokes crack cocaine. KFF Health News is identifying him by his initials because he fears being arrested for using illegal drugs.

It had been several hours since his last hit, and the chatty, middle-aged man’s hands moved quickly. In one hand, he held a glass pipe. In the other, a lentil-size crumb of cocaine.

Or at least J.R. hoped it was cocaine, pure cocaine — uncontaminated by fentanyl, a potent opioid that was linked to about 75% of all overdose deaths in Rhode Island in 2022. He flicked his lighter to “test” his supply. He believed that if it had a “cigar-like sweet smell,” he said, it would mean that the cocaine was laced with fentanyl. He put the pipe to his lips and took a tentative puff. “No sweet,” he said, reassured.

But this method offers only false and dangerous reassurance. A mistake can be fatal.

It is impossible to tell whether a drug contains fentanyl by the taste or smell. “Somebody can believe that they can smell it or taste it, or see it … but that’s not a scientific test,” said Josiah “Jody” Rich, an addiction specialist and researcher who teaches at Brown University. “People are going to die today because they buy some cocaine that they don’t know has fentanyl in it.”

The first wave of the long-running and devastating opioid epidemic began in the United States with the abuse of prescription painkillers in the early 2000s. The second wave involved an increase in heroin use, starting around 2010. The third wave began when powerful synthetic opioids such as fentanyl started appearing in the supply around 2015. Now experts are observing a fourth phase of the deadly epidemic.

The mix of stimulants such as cocaine and methamphetamines with fentanyl — a synthetic opioid 50 times as powerful as heroin — is driving what experts call the opioid epidemic’s “fourth wave.” The mixture of stimulants and fentanyl presents powerful challenges to efforts to reduce overdoses because many users of stimulants don’t know they are at risk of ingesting opioids, so they don’t take overdose precautions.

The only way to know whether cocaine or other stimulants contain fentanyl is to use drug-checking tools such as fentanyl test strips — a best practice for what’s known as “harm reduction,” now embraced by federal health officials in combating drug overdose deaths. Fentanyl test strips cost as little as $2 for a two-pack online, but many front-line organizations also give them out free.

Nationwide, illicit stimulants mixed with fentanyl were the most common drugs found in fentanyl-related overdoses, according to a study published in 2023 in the scientific journal Addiction. The stimulant in the fatal mixture tends to be cocaine in the Northeast, and methamphetamine in the West and much of the Midwest and South.

“The No. 1 thing that people in the U.S. are dying from in terms of drug overdoses is the combination of fentanyl and a stimulant,’’ said Joseph Friedman, a researcher at UCLA and the study’s lead author. “Black and African Americans are disproportionately affected by this crisis to a large magnitude, especially in the Northeast.”

Friedman was also the lead author of another new study, published in the American Journal of Psychiatry, that shows the fourth wave of the opioid epidemic is driving up the mortality rate among older Black Americans (ages 55-64) and, more recently, Hispanic people. Friedman said part of the reason street fentanyl is so deadly is that there’s no way to tell how potent it is. Hospitals have safely used medical-grade fentanyl for surgical pain because the potency is strictly regulated, but “the potency fluctuates wildly in the illicit market” Friedman said.

Studies of street drugs, he said, show that in illicit drugs the potency can vary from 1% to 70% fentanyl.

“Imagine ordering a mixed drink in a bar and it contains one to 70 shots,” Friedman said, “and the only way you know is to start drinking it. … There would be a huge number of alcohol overdose deaths.”

Drug-checking technology can provide a rough estimate of fentanyl concentration, he said, but to get a precise measure requires sending drugs to a laboratory.

It’s not clear how much of the latest trend in polydrug use — in which users mix substances, such as cocaine and fentanyl, for example — is accidental versus intentional. It can vary for individual users: a recent study from Millennium Health found that most people who use fentanyl do so at times intentionally and other times unintentionally.

People often use stimulants to power through the rapid withdrawal from fentanyl, Friedman said. And the high-risk practice of using cocaine or meth with heroin, known as “speedballing,” has been around for decades. Other factors include manufacturers’ adding the cheap synthetic opioid to a stimulant to stretch their supply, or dealers mixing up bags.

Researchers say many people still think they are using unadulterated cocaine or crack — a misconception that can be deadly. “Folks who are using stimulants, and not intentionally using opioids, are unprepared to respond to an opioid overdose,” said Brown University epidemiologist Jaclyn White Hughto, “because they don’t perceive themselves to be at risk.” Hughto is a principal investigator in a new, unpublished study called “Preventing Overdoses Involving Stimulants.”

Hughto and the team surveyed more than 260 people in Rhode Island and Massachusetts who use drugs, including some who manufacture and distribute stimulants such as cocaine. More than 60% of the people they interviewed in Rhode Island had bought or used stimulants that they later found out had fentanyl in them. And many of the people interviewed in the study also use drugs alone. That means that if they do overdose, they may not be found until it’s too late.

In 2022, Rhode Island had the fourth-highest rate of overdose deaths involving cocaine in 2022, after Washington, D.C., Delaware, and Vermont, according to the Centers for Disease Control and Prevention.

The fourth wave is also hitting stimulant users who choose pills over what they perceive as more dangerous drugs such as cocaine in an effort to avoid fentanyl. That’s what happened to Jennifer Dubois’ son Cliffton.

Dubois was a single mother raising two Black sons. The older son, Cliffton, had been struggling with addiction since he was 14, she said. Cliffton also had been diagnosed with attention-deficit/hyperactivity disorder and a mood disorder.

In March 2020, Cliffton had checked into a rehab program as the pandemic ramped up, Dubois said. Because of the lockdown at rehab, Cliffton was upset about not being able to visit with his mother. “He said, ‘If I can’t see my mom, I can’t do treatment,’” Dubois recalled. “And I begged him” to stay in treatment.

But soon after, Cliffton left the rehab program. He showed up at her door. “And I just cried,” she said.

Dubois’ younger son was living at home. She didn’t want Cliffton doing drugs around his younger brother. So she gave Cliffton an ultimatum: “If you want to stay home, you have to stay drug-free.”

Cliffton went to stay with family friends, first in Atlanta and later in Woonsocket, an old mill city that has Rhode Island’s highest rate of drug overdose deaths.

In August 2020, Cliffton overdosed but was revived. Cliffton later confided that he’d been snorting cocaine in a car with a friend, Dubois said. Hospital records show he tested positive for fentanyl.

“He was really scared,” Dubois said. After the overdose, he tried to “leave the cocaine and the hard drugs alone,” she said. “But he was taking pills.” Eight months later, on April 17, 2021, Cliffton was found unresponsive in the bedroom of a family member’s home.

The night before, Cliffton had bought counterfeit Adderall, according to the police report. What he didn’t know was that the Adderall pill was laced with fentanyl. “He thought by staying away from the street drugs and just taking pills, he was doing better,” Dubois said.

A fentanyl test strip could have saved his life.

This article is from a partnership that includes The Public’s Radio, NPR, and KFF Health News.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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