Amid chemical industry lobbying, Trump EPA reconsiders risk of cancer-causing ethylene oxide

Amid chemical industry lobbying, Trump EPA reconsiders risk of cancer-causing ethylene oxide

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Sterigenics building

Sterigenics, a medical supply sterilization company linked to increased cancer rates in the Willowbrook area, has been closed since it was barred in February from using ethylene oxide. 

CHICAGO — Facing tougher restrictions, companies that manufacture and use ethylene oxide are pushing the Trump administration to undercut federal scientists and adopt a dramatically weaker standard for the cancer-causing gas.

The dispute pits Dow Chemical, Shell and other industry giants against the Environmental Protection Agency’s career staff, its scientific advisers and academic researchers, who concluded during the past decade that ethylene oxide is far more dangerous than previously thought.

Trade groups representing chemical companies -- and Chicago-area customers including Medline Industries and Sterigenics -- are lobbying President Donald Trump’s political appointees to throw out the EPA’s rigorous, peer-reviewed evaluation in favor of industry-funded research rejected by two panels of independent scientists.

Heavy lobbying by industry appears to be working, despite a growing clamor for action from community groups and lawmakers from both political parties.

As recently as May, a top administration official vowed the White House would back EPA scientists while drafting new regulations intended to protect more than a half-million Americans living near sources of ethylene oxide pollution in Illinois and 13 other states.

The Trump EPA abruptly backed away from that promise in November, signaling it will reconsider the industry claims.

Number of parties suing Sterigenics jumps to 73

If the administration ends up siding with industry groups, the decision would effectively erase a 2018 EPA report that identified dozens of communities where the toxic gas is responsible for alarmingly high cancer risks, including neighborhoods near a Medline facility in Waukegan and a former Sterigenics plant in Willowbrook.

Redrafting the EPA’s assessment to deem ethylene oxide less harmful would make those risks abruptly disappear on paper. Chemical companies and their customers would avoid government mandates to spend millions of dollars on pollution-control equipment, or perhaps stop using ethylene oxide altogether.

“It’s a choice between objective science and purposeful science fiction,” said Richard Peltier, an environmental health researcher at the University of Massachusetts Amherst who closely follows the issue.

Dawn Dolcimascolo learned the hard way what could be at stake.

After the Chicago Tribune first reported in November 2018 that southwest Waukegan is among the communities at risk, Dolcimascolo and her husband considered selling the house they had bought a decade earlier. She worried about their two young sons playing in the backyard less than a mile from Medline’s sterilization facility off Skokie Highway and Pulaski Drive.

In August, Dolcimascolo’s fears morphed into a mix of sheer terror and anger. Doctors diagnosed her 3-year-old son, Samuel, with leukemia.

“I dropped to my knees when they told me,” Dolcimascolo said in a recent interview. “How could this have happened? He’s always been a healthy kid. We try to avoid all the things you read about being harmful to children. Samuel and his brother eat organic, and they are active, happy boys.”

It is difficult, if not impossible, to determine why cancerous cells suddenly develop in people. But Dolcimascolo can’t help but wonder if Medline’s pollution contributed to Samuel’s leukemia.

“Now these industry people are trying to say the EPA and all of those scientists are wrong?” she said. “Why should we believe them?”

An unexpected partner

The industry campaign to fend off more stringent regulation is part of a decadeslong effort by chemical manufacturers and their customers to raise doubts about the dangers of ethylene oxide.

By the end of 2016, it appeared their strategy had faltered. A panel of independent scientists -- the second convened for this one chemical -- reviewed the evidence and endorsed an EPA safety limit intended to protect Americans from breast cancer, leukemia and lymphomas caused by breathing the toxic gas.

Since then, Trump and his industry-backed appointees have provided another opening.

Soon after the Republican president took office, the American Chemistry Council -- the chief trade group for Dow, Shell and other chemical companies -- launched another effort to overturn the EPA’s conclusions, according to emails, meeting notes and other confidential industry documents obtained by the Tribune.

The trade group was joined by Medline, Sterigenics and other members of the Ethylene Oxide Sterilization Association, the records show.

This time the trade groups enlisted an unexpected partner: a taxpayer-funded Texas state agency created to shield the public from environmental hazards.

Under plans outlined in the documents obtained by the Tribune, the industry groups paid corporate scientists to “develop an alternative risk assessment” to counter the EPA. The Texas Commission on Environmental Quality, which during discussions with the chemistry council “indicated its receptiveness” to challenging the EPA, followed through in June by proposing a legal standard 3,500 times weaker than the federal agency’s safety limit.

To amplify their position, medical device manufacturers and sterilization companies spent more than $1 million during the past year lobbying Congress and the EPA on ethylene oxide issues, according to federal records.

Dow and other chemical companies have an even bigger presence in the nation’s capital. By the end of September, records show, the American Chemistry Council had spent more than $5.2 million this year conveying its views to lawmakers and Trump administration officials.

'Best available science’

Northfield-based Medline is permitted to use ethylene oxide, also known as EtO, to sterilize medical products.

The company declined to answer a detailed list of questions from the Tribune. In a statement, Medline called for “clear national standards based on sound science that both protects public health and ensures patients don’t suffer from a lack of available sterile medical products cleaned with EtO.”

Another contributor to the industry defense is Oak Brook-based Sterigenics, operator of facilities that use the gas to sterilize medical products in seven U.S. cities including suburbs of Atlanta and Los Angeles.

Sterigenics permanently closed its Willowbrook plant in September, citing an unstable regulatory landscape and a failure to broker a new deal on its lease amid concerted opposition from community groups and local politicians. The company declined to comment for this story.

Echoing Medline’s statement, the American Chemistry Council said it supports “using the best available science in regulatory decision-making.”

“We understand and appreciate the concerns that people have about the air they breathe,” the trade group’s Ethylene Oxide Panel said in a statement. “We’re constantly using what we’ve learned to improve our practices, striving to minimize emissions every day.”

Changing the cancer risk

Less stringent regulation would spare the chemical industry from making major improvements at plants in Texas and Louisiana owned by Dow, Huntsman, Shell and Union Carbide, a subsidiary of Dow. The companies use ethylene oxide to synthesize ethylene glycol, a raw material in antifreeze, polyester and plastics.

A weaker federal standard also could help deter state and local regulators from cracking down on emissions from commercial sterilization facilities, a once-obscure industry that during the past year has been subjected to intensive scrutiny.

Absent federal action, Illinois Gov. J.B. Pritzker ordered a temporary shutdown of the Sterigenics facility in Willowbrook seven months before the company opted to close it permanently; the company’s plant in Smyrna, Georgia, northwest of Atlanta, remains indefinitely shuttered under orders from local officials.

State officials in Georgia sought a court order to shut down two other ethylene oxide sterilizers east of Atlanta owned by Becton, Dickinson and Co., a medical products manufacturer. The company ended up agreeing to install new pollution-control equipment. On Wednesday, state regulators cited the company for excessive emissions from a warehouse where it stores fumigated equipment.

In Michigan, state officials cited the EPA’s latest assessment of ethylene oxide last year when they took action against a Grand Rapids sterilization plant accused of violating the state’s clean air regulations. The facility’s owner decided to close the facility by the end of this month.

By contrast, federal officials have largely resisted calls from the public and elected officials to investigate the industry.

Andrew Wheeler, the EPA administrator, told a congressional committee in September the agency is relying on its 2016 evaluation of ethylene oxide while drafting new federal rules for chemical plants and commercial sterilization facilities. Later in the same testimony, Wheeler hedged his earlier statement, saying the agency plans to use “all available science.”

Two months later, when the EPA unveiled its proposed rule for chemical plants, the agency altered the way it typically determines whether additional steps need to be taken to address cancer risks from toxic air pollution.

For nearly every other chemical, the EPA considers it to be unacceptable if more than 100 cancer cases are diagnosed for every 1 million people exposed during their lifetimes. The national average is 32 people in a million.

Neighbors of ethylene oxide producers are treated differently under the Trump EPA proposal. Between 200 and 300 cancer cases for every 1 million people exposed to the toxic gas is acceptable, according to the agency’s regulatory filing.

Among the EPA’s justifications in its filing: The American Chemistry Council asked the agency to reconsider the science. And Texas claimed ethylene oxide is far less dangerous than the EPA concluded after more than a decade of review.

The agency defended its decision in a brief statement, saying the proposed regulations “likely overestimate” health risks posed by ethylene oxide.

Lawmakers who follow the issue are livid.

“The EPA reveals who it really answers to when it throws its own dedicated civil servants under the bus and invites corporate interests to trash” the agency’s scientific evaluation, U.S. Sens. Dick Durbin and Tammy Duckworth of Illinois said in a statement.

Others calling for more aggressive action include nonprofit environmental groups and attorneys general from 16 states, led by Kwame Raoul of Illinois.

'No “safe” level’

Determining the health risks posed by any chemical is a process fraught with uncertainties. People respond differently to exposure. With cancer, factors including chance, genetics and exposure to other substances can play a role.

Since most testing of humans is illegal or unethical, the EPA and other regulatory agencies typically rely on workplace studies where employee exposures and health are tracked.

EPA scientists based their 2016 conclusions about ethylene oxide on decades of animal research and a study of more than 18,000 sterilization plant workers conducted by the National Institute of Occupational Safety and Health. They adjusted their safety limit to account for people in the general population who are particularly sensitive to chemical exposures.

For the first time, the EPA applied additional safety factors to protect children, who are more susceptible to cellular damage caused by cancer-causing chemicals when exposed early in life.

Jennifer Jinot, a former EPA scientist who led the assessment of ethylene oxide, said the agency’s safety limit reflects what is “necessary to ensure the protection of the public’s health from cancer risks.”

“There is no ‘safe’ level of exposure to this chemical,” Jinot wrote in comments filed with Texas officials co-signed by three colleagues including Tracey Woodruff, a University of California at San Francisco researcher who studied toxic substances at the EPA for more than a decade.

Adopting a significantly weaker legal standard would “leave the public, especially women, at unacceptable risk of developing and dying from cancers caused by ethylene oxide,” the researchers wrote.

Trust Texas

American industries have a long history of financing their own research to block or delay public health protections.

With ethylene oxide, the chemical industry added another wrinkle to its defense.

Asked why federal or state regulators should base decisions on studies bankrolled by companies with a financial stake in the outcome, industry lobbyists and scientists have a quick answer: Trust Texas.

“You don’t have to trust me. I’m asking you to reach out to another state,” Kimberly Wise White, an American Chemistry Council toxicologist, told an Illinois House committee in October, mentioning Texas a dozen times while urging lawmakers to reject a bill that would ban Medline and other sterilization operations from using ethylene oxide in densely populated areas or near schools.

“The saddest thing about this whole situation is the fear and mistrust that is so unnecessary,” said Gail Charnley, another industry-connected scientist who testified on behalf of AdvaMed, a trade group representing manufacturers of medical products.

White and Charnley suggested tougher regulations would do little to protect public health. They peppered their testimony with references to the Texas Commission on Environmental Quality, an agency that also has fought federal attempts to regulate dangerous substances such as benzene, mercury, smog and soot.

In June, Michael Honeycutt, the commission’s chief toxicologist, proposed the standard for ethylene oxide that is 3,500 times weaker than the approach taken by the EPA.

The proposal came after meetings with representatives of the American Chemistry Council, according to emails and meeting notes. Honeycutt, who was appointed to lead the EPA’s board of scientific advisers in the Trump administration, also briefed chemical manufacturers on the weaker standard before making it public, emails show.

While Honeycutt called his proposal a “reality check,” he relied on statistical methods rejected by the EPA and its independent scientific advisers during the Obama administration, several of whom were ousted by Trump appointees in favor of researchers with close ties to industry.

“There’s no reason to use that (statistical) model except to get the results they want,” Jinot, the former EPA scientist, said in an interview.

The Texas scientists eliminated breast cancer risks in their assessment. They threw out the EPA’s conclusion that cancer risks from ethylene oxide increase dramatically at lower levels of exposure and flatten out at higher concentrations.

Instead, the Texas scientists concluded, the chemical is only dangerous at higher levels of exposure. They further undercut the EPA’s safety limit by discounting childhood exposure when calculating lifetime cancer risks, and by comparing the general population to workers, who generally are healthier.

“What (the Texas agency) has done here violates the principles of scientific integrity and doesn’t meet the bare minimum of what the federal government normally would consider the starting point for any kind of regulatory process,” said Emma Cheuse, an attorney for the nonprofit group EarthJustice who represents national and state environmental groups challenging the weaker standard.

Environmental groups also are suing the Texas agency for refusing to comply with a ruling by the state’s attorney general ordering the release of documents related to the ethylene oxide rule.

In a statement, the Texas agency said it is the EPA’s peer-reviewed report that is flawed. The agency denied coordinating its work with the chemical industry.

“TCEQ is on the side of the best available science,” the agency said. “We ultimately evaluate and weigh all relevant scientific information on our own and based on our guidelines to arrive at our own decisions.”

Confusion in Illinois

Throwing out the EPA safety limit in favor of the Texas proposal would meet goals summarized by the American Chemistry Council in a March presentation to Medline, Sterigenics and other sterilization companies.

Makers and users of ethylene oxide must ensure states “adopt industry-supported measures” instead of banning the chemical, one of the slides reads. They also need to prevent the EPA from using its evaluation of the chemical when crafting new national regulations, the trade group urged.

In November, when it came time for an Illinois Senate committee to vote on the legislation banning Medline from using ethylene oxide in Waukegan or other urban areas, several lawmakers appeared to be confused, if not swayed, by testimony from industry lobbyists.

“I don’t know if any of us feels expert enough to evaluate (the EPA and Texas safety limits) critically,” said Sen. Don Harmon, an Oak Park Democrat who chairs the panel.

Harmon said lawmakers were “suffering from dueling scientists.” Then his committee killed the legislation.

Given the slow process of federal rule-making, there is a strong chance the Trump administration’s chemical-plant regulations won’t be finalized during the president’s term.

New standards for Medline, Sterigenics and other sterilization companies will take even longer to adopt. After promising to propose rules for commercial sterilizers during the summer, the EPA announced last month it won’t release them for comment until sometime next year.

By then it will have been 35 years since ethylene oxide was added to the federal list of carcinogens. And more than a decade since EPA scientists first concluded it is far more dangerous than previously thought.

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