EPA seeks to loosen rules on cancer-causing gas used at Long Island site

To reduce cancer rates, the Environmental Protection Agency under President Joe Biden imposed stricter rules and regulations on a cancer-causing gas used to sterilize medical devices.

Eighty-eight facilities in the United States, including one in Hauppauge, would be required to continuously monitor their outputs of ethylene oxide. Required technology upgrades would reduce emissions by 80% to 99%.

The Trump administration this month proposed rescinding those rules entirely, calling them "unfeasible and unattainable." The EPA's announcement said ethylene oxide "is the only safe and effective sterilization method available for many medical devices" and argued the Biden rules would threaten the domestic supply chain of medical equipment.

The plan is the latest in a series of efforts to ease regulations on  industries and weaken standards on air pollution, including fine particulate matter, mercury and greenhouse gases.

Long Island Sterilization and its parent company, Busse Hospital Disposables, operate at two addresses at an industrial park in Hauppauge, employing 260 people. The company manufactures, sterilizes and sells 18 million medical devices a year, including surgical drapes, trays and suction products, which are used in hospitals, doctors' offices and nursing homes, according to the company's email to the EPA.

Company executives did not respond to multiple requests for comment for this story.

Last year, Long Island Sterilization, at the invitation of the Trump administration, requested a reprieve of at least two years from the rules. It argued in an email to the EPA obtained by the nonprofit Environmental Defense Fund that the upgrades "will be quite costly for our company" and the purchases would need to be made in stages. 

Long Island Sterilization released about 3 pounds of ethylene oxide emissions in 2022, 2023 and 2024, according to the EPA’s facility report for the company. Darya Minovi, a senior analyst at the nonprofit Union of Concerned Scientists, said this is a small amount compared with other facilities, where emissions can be in the hundreds or thousands of pounds.

But even small levels of exposure are a concern, because "we're not exposed to one chemical contaminant at a time," she said. "There's a very complex mix of things we might be exposed to." 

She also noted that without continuous monitoring, which is considered more accurate than estimates based on snapshot measurements and not required under New York State regulations, it's hard to know if self-reported emissions are accurate.

In 1992, Busse pleaded guilty to failing to install mandated emissions control equipment at its plant, then located on Arkay Drive in Hauppauge, Newsday reported at the time. The company paid $675,000 in fines — at the time the largest criminal penalty in New York for air pollution violations.

Sterilizing medical equipment

Ethylene oxide is used to sterilize about half of all medical equipment in the country, including bandages, sutures and stents — items that would be damaged if exposed to high heat or steam. It’s also used to fumigate spices, herbs and some cosmetics, according to the U.S. Food and Drug Administration. Hospitals, dentists' offices and veterinarians also use ethylene oxide to sterilize equipment, but these were not subject to the stricter regulations. 

The agency said reversing the rules, which were finalized in January 2025, would save  industries $43 million a year.

The EPA, the National Toxicology Program and the World Health Organization’s cancer research agency all classify ethylene oxide as a human carcinogen, causing cancers such as lymphocytic leukemia, breast cancer, non-Hodgkin lymphoma and myeloma. Between 1 in 17 and 1 in 10 workers who handle ethylene oxide at sterilization facilities will develop cancer if exposed to the chemical throughout their careers, according to an EPA study from 2016.

The EPA last year invited companies subject to Clean Air Act regulations to ask for exemptions from pollution rules, and has already granted 180 such exemptions to coal plants, chemical manufacturers, sterilizers and other industries, according to the Environmental Defense Fund's records, which the nonprofit obtained under a Freedom of Information Act request. Long Island Sterilization was not among those granted an exemption and is therefore still subject to the more stringent rules, which are scheduled to go into effect next month.

Minovi said in a statement the rule "was long overdue." Industries would "use proven pollution-control technologies to protect workers and fence line communities from unnecessary cancer risk."

Nearly 14 million people live within 5 miles of a sterilization facility, according to Minovi’s analysis for UCS, a research and advocacy organization.

She also found that sterilization facilities are disproportionately located in low-income areas and communities of color. Many are clustered close together, subjecting residents to high levels of emissions. 

The distance the gas can travel varies according to concentration, wind and other factors, Minovi said in an interview. The risk of living near facilities emitting an amount as low as Long Island Sterilization is therefore difficult to calculate but Minovi said, "I think it's information that people should have, if this is operating in their community." 

The Trump administration has made it increasingly difficult to get information about ethylene oxide and other toxins — including where they are being released and what the hazards are. The EPA has taken down its webpages on 23 high-risk facilities, on the risk to workers who handle the gas and on hospitals, dental offices and veterinarians that use the compound.

The EPA did not respond to a request for information about these facilities, but pointed to a news release that said the Biden rules were burdensome for the supply of vital medical devices.

Industry groups such as the American Chemistry Council applauded the EPA's decision to revisit the Biden rules, arguing the requirements threatened critical medical equipment supply chains and national security. The group referred questions on the rollbacks to the Ethylene Oxide Sterilization Association, which did not reply to a request for comment.

State regulation

Ethylene oxide is one of roughly 60 on New York State's list of "high toxicity air contaminants." Facilities that use the compound are required to seek permits from the state Department of Environmental Conservation and to comply with the state's air toxics regulations. Long Island Sterilization's permit renewal, which is now under review at the agency, will include requirements "that will serve as a backstop if the federal government rescinds" the regulation, the DEC told Newsday in an email. 

The state "has always required a greater degree of control for ethylene oxide commercial sterilizer than the federal government," DEC spokesperson Lori Severino said. 

The DEC requires facilities to meet its more stringent emissions standards that it considers protective of human health; the Biden rules mandate specific emissions control technologies such as sterilization chamber vents that the state doesn't specifically require.

Public health experts have strongly criticized the Trump administration’s proposed rollbacks.

Contrary to the administration's claims, there are alternatives to ethylene oxide, Minovi said, such as vaporized hydrogen peroxide, which has been approved by the FDA for sterilizing medical equipment. 

Many public health groups, including the American Lung Association, supported the Biden rules and oppose their repeal.

"This proposal would roll back standards that protect people from a toxic air pollutant," said Laura Kate Bender, vice president for advocacy and public policy at the Lung Association.

The proposal will be open for public comment until April 16.