EPA curbs toxic ethylene oxide used to sterilize medical devices – The Washington Post – The Washington Post

The Environmental Protection Agency on Thursday announced tougher limits on a cancer-causing gas used to sterilize medical equipment, a move aimed at helping disadvantaged communities across the country reduce their exposure to a toxic pollutant.

Some environmental and public health advocates criticized the final rule as too weak, saying it would not adequately protect low-income and minority communities that are disproportionately affected. At the same time, the medical device industry warned that the rule could disrupt the supply of safe medical equipment at hospitals and clinics nationwide.

The rule targets emissions of ethylene oxide, an odorless, colorless gas that has been linked to several types of cancer, particularly lymphoma and leukemia. It illustrates the tensions between two of the Biden administrations signature priorities: promoting environmental justice and bolstering domestic supply chains.

Michael Regan, the first Black man to serve as EPA administrator, has put an emphasis on curbing deadly pollution in communities of color and low-income neighborhoods. He announced the proposed rule last year in Louisiana, where an 85-mile-long area between New Orleans and Baton Rouge is known as Cancer Alley because of numerous polluting facilities, including those that produce ethylene oxide.

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, Regan said in a statement Thursday.

The rule will apply to nearly 90 sterilization facilities that are owned and operated by roughly 50 companies, according to the EPA. Those facilities will have to reduce ethylene oxide emissions by more than 90 percent, the agency said.

In response to requests from the medical technology industry, however, facilities will have significantly more time to meet the requirements.

Under the proposed rule, all facilities would have 18 months to comply. But under the final rule, larger facilities will have up to two years, while smaller facilities will have up to three years, with the option to request a one-year extension.

In an analysis last year, the Union of Concerned Scientists found that roughly 14 million people live within five miles of facilities that emit ethylene oxide, and that nearly 60 percent are people of color. Nearly 31 percent are low-income.

Darya Minovi, a senior analyst at the Union of Concerned Scientists, an environmental group, said she was disappointed by the delayed compliance deadlines.

In our comments to the agency, we requested for these deadlines to be shortened, Minovi said. They actually went in the opposite direction and lengthened them. And we know who will be most impacted.

Yet medical technology lobbying groups have warned that a strong rule could have devastating impacts on sterilization facilities and patients access to lifesaving products. In public comments, AdvaMed and the Medical Device Manufacturers Association wrote that the proposed rule could force many sterilization facilities to shutter or pause their operations, potentially leading to shortages of medical equipment.

We just have to get this rule right or theres going to be a huge I would even say catastrophic impact on the health care system, said Scott Whitaker, president and chief executive of AdvaMed.

Whitaker said he and his group were still reviewing the rule. But in general, he said the coronavirus has illustrated the importance of strong supply chains for medical devices, including the personal protective equipment in high demand during the pandemic.

You cant make high-risk regulatory moves that could result in supply chain issues or shortage issues because if were hit with another crisis, well be in really bad shape, Whitaker said. So EPA has to factor that into their thinking because you cant predict when the next pandemic or public health event will occur.

Ethylene oxide is used to sterilize about half of all U.S. medical supplies, including billions of syringes, heart valves, pacemakers, and feeding and breathing tubes. In January, the Food and Drug Administration announced that it also considers vaporized hydrogen peroxide to be a safe method of sterilization for medical devices.

Yet ethylene oxide has a unique ability to penetrate porous surfaces without causing any damage, according to the FDA. For many medical devices, sterilization with ethylene oxide may be the only method that effectively sterilizes and does not damage the device, the agency says on its website.

Although medical sterilization facilities are scattered across the country, one plant in a Chicago suburb has sparked especially intense backlash. In 2018, a Chicago Tribune investigation revealed high cancer rates near the Sterigenics facility in Willowbrook, Ill. The resulting uproar led to a multimillion-dollar settlement and the closure of the plant in 2019.

Illinois Democrats in 2018 asked the EPA to investigate whether the Trump administration had obstructed inspections of the Sterigenics plant. On Thursday, Sen. Tammy Duckworth (D-Ill.) cheered the tougher restrictions on ethylene oxide, also known as EtO.

For too long, EtO emissions from commercial sterilization facilities have damaged public health in surrounding communities and significantly increased the risk of nearby residents developing cancer in their lifetimes, Duckworth said in a statement.

She added that the new EPA rule will help us reduce these toxic emissions, advance environmental justice and change the fate of health outcomes in disadvantaged communities.

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