U.S. EPA moves to set stricter rules for plants that manufacture or use ethylene oxide

Regulations would require commercial sterilization operations to reduce EtO emissions by 90%, largely by installing pollution-control equipment already required in Illinois.

Nearly two decades after federal scientists concluded ethylene oxide is far more dangerous than previously thought, President Joe Biden’s administration is moving to dramatically reduce emissions from a small but important industry sector that relies on the cancer-causing gas to fumigate medical products and spices.

Regulations unveiled Thursday by the U.S. Environmental Protection Agency would require commercial sterilization operations to reduce ethylene oxide emissions by 90%, largely by installing pollution-control equipment already required in Illinois and a handful of other states.

The once-obscure industry drew attention in 2018 when the EPA reported some of the nation’s highest cancer risks from toxic air pollution could be found in communities near manufacturers and users of ethylene oxide, also known as EtO. Some of the most alarming results came from west suburban Willowbrook and north suburban Waukegan.

Under pressure from community organizers and a bipartisan group of politicians, Oak Brook-based Sterigenics closed its Willowbrook sterilization plant a year later and took steps to reduce pollution from eight of its other facilities across the country. A state law prompted by Chicago Tribune reporting required Northfield-based Medline to dramatically reduce EtO emissions at its Waukegan facility.

All told the new federal regulations target about 90 sterilization plants in 30 states and Puerto Rico. During a Wednesday teleconference with reporters, EPA officials noted many of the facilities are located near low-income, Black and Latino communities disproportionately impacted by toxic pollution.

“We have followed the science and listened to communities to fulfill our responsibility to safeguard public health from this pollution — including the health of children who are particularly vulnerable to carcinogens early in life,” EPA Administrator Michael Regan said in a statement.

Chemical companies and government health agencies have known since at least the late 1970s that ethylene oxide mutates genes and causes breast cancer, leukemia and lymphomas.

Time and time again, a 2019 Tribune investigation found, the multibillion-dollar chemical industry and its political allies in Washington have thwarted, weakened or delayed efforts to limit exposure to EtO, relying on the same tactics that stalled protections from more well-known hazards such as lead and asbestos.

After reviewing studies of sterilization workers and animals, EPA scientists concluded in 2006 that EtO effectively was dangerous at any level. It took the agency another decade to formally adopt a more protective limit intended to protect plant workers and neighbors.

Two panels of independent scientists generally agreed with the agency’s findings and rejected industry-financed studies that claimed to show EtO isn’t harmful at typical exposure levels. Chemical manufacturers and the sterilization industry continue to cite those studies as proof the new regulations aren’t necessary.

“Scientific studies of real-world data conducted over the past decades consistently have found that low levels of EtO are safe and do not increase the risk of cancer for employees who regularly work around facility levels of EtO, let alone for people who live or work in areas near EtO facilities,” Sterigenics wrote in June after the Biden EPA released a draft of its proposed rules for commercial sterilizers.

When elevated cancer risks near EtO manufacturers and users first came to light in 2018, top aides to former President Donald Trump promised Willowbrook-area residents the federal government would adopt more stringent regulations. The Trump EPA later backed away from those statements amid lobbying from the major producers of ethylene oxide: Dow, Huntsman and Shell, which use the chemical to synthesize ethylene glycol, a raw material in antifreeze, polyester and plastics.

More stringent regulation of EtO manufacturers is pending.

Based on air quality monitoring at parks, schools and homes when Sterigenics still operated in Willowbrook, the EPA concluded the facility’s pollution could trigger more than 10 cases of cancer for every 10,000 people exposed during their lifetimes — a rate 10 times higher than what the agency considers acceptable.

The Willowbrook plant increased the risk of cancer for people living up to 25 miles away, EPA officials said during a 2019 community forum.

In September 2022, a Cook County jury ordered Sterigenics and two corporate predecessors to pay a Willowbrook breast cancer survivor $363 million for exposing her to ethylene oxide. The company later agreed to settle lawsuits filed by nearly 900 other neighbors for $408 million.

Sterilization companies contend they need to continue using ethylene oxide to fumigate about half of the medical devices and related products manufactured in the United States each year.

The Food and Drug Administration has said it is nudging the industry to find safer alternatives. But in response to comments from Sterigenics and other companies, the EPA extended the deadline for commercial sterilizers to comply with its new regulations from 18 months to two years for large operations and up to four years for smaller facilities.

Left unadressed by the EPA regulations are warehouses storing products fumigated with ethylene oxide. In February, an investigation by Grist, a nonprofit news operation, and Atlanta TV station WANF found there has been little scrutiny of storage facilities where residual EtO can escape into workspaces and surrounding neighborhoods, in part because neither the EPA nor state regulatory agencies know where they are located.