“This is a critical problem for patients, and as a result the stakes are high. Ethylene oxide sterilization facilities are at capacity,” said Scott Whitaker, president and chief executive of AdvaMed, which says it is the world’s largest medical technology association. “If new EPA regulations force sterilization facilities to close, patients could experience delays in treatment as sterile technology supplies—such as pacemakers and surgical equipment—fail.”
However, environmental groups and EPA officials say tougher rules are needed because too many Americans are burdened by ethylene oxide pollution, which the EPA says is a carcinogen.
Agency Administrator Michael Regan, who has placed an emphasis on taking on deadly pollution in minority and poor communities, was in Louisiana on Thursday to announce the plans.
In an analysis this year, the Union of Scientists reported that 14 million people within 5,000 commercial sterilizers and other majors emit ethylene oxide, and that more than 48 percent of those people are of color. About 32 percent are poor. It also found that while there are only about 100 of these facilities nationwide, they are often interconnected, causing cancer risk hot spots, typically in urban areas, including Los Angeles, Minneapolis-St. Paul and Baltimore.
As with other sterilizers, ethylene oxide is in high demand for health benefits, but chronic exposure has been linked to cancers — especially lymphoma — and other ills. Fights over these health effects have led to production plant shutdowns in recent years, and the Food and Drug Administration has warned of potential shortages of sterile medical devices. That could get worse if the EPA rule changes prove too aggressive, industry trade groups say.
As part of his plans, he announced Thursday, the EPA will invest stricter limits on the emissions of “hazardous organic substances” which includes the economy. The measure is aimed at manufacturers, including producers of synthetic organic chemicals and polymers, primarily to limit worker and community exposure to these carcinogenic chemicals as they are produced.
The proposal would establish new monitoring requirements for ethylene oxide and a host of other chemicals — including chloroprene, benzene, 1,3-butadiene, ethylene dichloride and vinyl chloride, the EPA said. Businesses would have air polluting monitors on their premises, and when the chemicals exceeded concentration levels set by the agency, businesses would have to take action to find the source and stop the emissions.
The agency also plans to announce rule changes specifically for ethylene oxide, more stringent standards for businesses that use it and suppliers that plan to sell it. The EPA is also proposing to analyze other sources of ethylene oxide, including polyethylene production, hospital sterile plants, and smaller chemical manufacturers known as “area sources.”
The agency undertook a community risk assessment as part of the effort, which concluded that in communities surrounding chemical plants, the number of people with an elevated cancer risk could drop by 96 percent if the EPA’s proposal were implemented. It also found ethylene oxide to be the biggest driver of the remaining risk, the agency said.
“For generations, our vulnerable communities have borne the unfair burden of breathing unsafe, polluted air,” Regan said in a statement. “Every child in this country deserves to breathe clean air, and EPA has every tool available to make that vision a reality.”
Regan announced the first changes in the region among local environmentalists and government officials. He had visited the same area, St. John the Baptist Parish, in 2021 on his “Journey of Justice” along the Gulf Coast. He then promised that the Biden administration would work to help poor and minority communities, which are disproportionately harmed by pollution, and said Thursday that he had taken these steps to fulfill part of that pledge.
A local St. John’s Citizens’ Concern group says the highest risk of cancer in the region comes from naval landfills, chemical plants and other industrial sites across the region. The group targeted ethylene oxide as one of the most destructive carcinogens.
In the same month that Regan visits in 2021, these groups and the Sierra Club asked Regan to ask the EPA to better regulate the production of polymers and resins, of which ethylene oxide is one of the many products.
He fought in the compound for centuries. Ethylene oxide has been used as a sterilizer since the 1930s, and the EPA has been under pressure to better regulate it since at least the 1980s.
Federal agencies and groups estimate that about half of all medical devices interact with ethylene oxide, about 50 million devices a day in the United States. They say they include personal protective equipment that was in high demand during the coronavirus pandemic, including simple items such as wound dressings and syringes, as well as specialized items such as stents and tracheotomy tubes for adults and children.
The battles have escalated in recent years, especially after the EPA completed a new review in 2016. It was concluded that ethylene oxide was 60 times more toxic than previously estimated.
Following that analysis, the Chicago Tribune revealed high rates of cancer near a production site in suburban Chicago, and the resulting uproar led to multimillion-dollar lawsuits and the closing of the plant. Other shutdowns followed in Illinois and Georgia, and in October 2019, the FDA said There were medical threats to cleaning supplies.
Industry lobbyists say many states have been waiting for the EPA’s decision to pursue their own potential regulations, and that the increase could lead to further growth in an industry where spare capacity is already minimal. Several industries were preparing to push back against the EPA even before the time of the formal announcement.
The chemical manufacturers’ council American Chemistry said the 2016 findings were flawed and opposed rule changes made by the EPA based on those findings.
“We support strong, science-based standards for ethylene oxide,” the trade group said in a statement. “But we are concerned that the EPA appears to be rushing its work into significant regulatory packages that reach across multiple species and could set important precedents.”