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New EPA rule to slash cancer-causing emissions from sterilization facilities

The Midwest Sterilization Corporation in Laredo on May 13, 2021.
The Midwest Sterilization Corporation in Laredo on May 13, 2021. Credit: Miguel Gutierrez Jr./The Texas Tribune

The U.S. Environmental Protection Agency on Thursday issued a rule to slash toxic emissions from commercial sterilization facilities that have posed an increased lifetime cancer risk to residents who live near them. These facilities release fumes of ethylene oxide, labeled by the federal agency as “one of the most potent cancer-causing chemicals.”

Ethylene oxide, a flammable, colorless gas, is used to sanitize medical and dental equipment to reduce the risk of infection, and fumigate certain food products. Long-term exposure to ethylene oxide can cause irritation of the eyes, skin, nose, throat and damage to the brain and reproductive system.

The new rule will place stricter limits on how much ethylene oxide commercial sterilizers can release into the outside air, eventually eliminating about 90% of ethylene oxide emissions nationwide, according to the EPA. An analysis by the environmental group Union of Concerned Scientists, found about 13 million people live near these facilities, and these emissions pose a disproportionate risk to poor and minority communities. In Texas, residents say a plant in Laredo has contributed to the city’s elevated rates of cancer.

Facilities would be required to install pollution-control equipment, conduct continuous emissions monitoring and file quarterly reports to the EPA.

Reducing cancer in communities exposed to toxic air pollution has been a prime focus of the Biden administration’s environmental agenda. The new rule will address emissions at nearly 90 commercial sterilization facilities, including some in Texas, that are owned and operated by approximately 50 companies.

Prior regulations on commercial sterilizers that use ethylene oxide did not account for the EPA’s latest research. In 2016, the agency concluded that ethylene oxide was 30 times more carcinogenic than previously thought.

“We have followed the science and listened to communities,” EPA Administrator Michael Regan said in a press release. “We’ve arrived at a historically strong rule that will protect the most exposed communities from toxic air pollution while also ensuring that there will be a process that safeguards our nation’s critical supply of sterilized medical equipment.”

A 2021 investigation by ProPublica and The Texas Tribune revealed the EPA’s yearslong failure to inform communities, including Laredo, a city of 254,000 on the Texas-Mexico border, of their risks to the cancer-causing chemical. The Texas Department of State Health Services conducted two cancer assessments in 2022 examining cancer rates from 2006 to 2019 in Laredo and found a higher rate of acute lymphocytic leukemia, breast cancer and non-Hodgkin lymphoma compared to cancer rates elsewhere in the state.

“We were completely unaware. And to this day, I think many still are not fully aware of what's right there and how dangerous this chemical is,” said Tricia Cortez, a Laredo resident and executive director of the environmental nonprofit Rio Grande International Study Center on Thursday.

“The ones who suffer most are our everyday people who live and work right next to these facilities.”

Cortez said that her community has been waiting a long time for EPA’s new rule and that their decision to reduce emissions means a lot to her and her community.

In 2022, Earthjustice sued the EPA on behalf of environment and community groups including the Rio Grande International Study Center for not updating the rules in nearly a decade and leaving communities unaware of the risks.

Following news reports, the EPA revisited its rules last year to limit the toxic chemical. The federal agency conducted public hearings, webinars and meetings to hear from communities and their health concerns. It also published an analysis of the industry’s self-reported emissions data that showed about a quarter of the nearly 100 commercial sterilizers, including the one in Laredo, were exposing nearby residents to unacceptable cancer risks from ethylene oxide. The agency also published risk maps and other information online for each of the high-risk facilities.

“Overall, I am pleased this rule will protect the health of communities while still considering the importance of medical sterilization devices to hospitals, doctors, and patients,” said U.S. Rep. Henry Cuellar, D-Laredo, in a press release.

Scott Whitaker, president and CEO of the Advanced Medical Technology Association, a group that lobbies for the interests of medical device manufacturers, said in an email Thursday the group is still examining the new rule’s full impact, but warned that new regulations could cause problems for patients by creating treatment and surgical delays.

“There are three broad areas we have emphasized throughout the rulemaking: adequate time to implement, flexibility in technologies to remove emissions, and the ability to achieve EPA targets that would not force resubmission of medical devices for FDA approval,” Whitaker wrote.

EPA is assuring the medical industry that these new rules will not impact access to sterilized medical equipment. Harold Wimmer, president and CEO at the American Lung Association, praised the federal agency for striking a balance between new measures for limiting pollution and the need for safe and clean medical supplies.

“No one should have to live with elevated cancer risk because of air pollution in their community,” Wimmer said in a press release.

The new rule will evaluate if facilities are complying based on their cap or allowable amount of emissions they can release into the air per pollutant as stated in their state permits.

“What we know is that these facilities are often releasing more than what they are stating. [The EPA’s] revised its risk assessment to look at how much a facility is allowed to emit and as a result is more stringent standards, which we think is a major positive,” said Marvin C. Brown IV, a senior attorney at the nonprofit Earthjustice.

While Brown sees EPA’s new rules as a great first step, he said he was disappointed to see that the agency will not require commercial sterilization facilities to obtain a Title V source permit, which requires a review from federal regulators in addition to state regulators and more opportunities for public participation.

The rules go into effect shortly after it is published in the Federal Register. Facilities will have two years to install monitoring and pollution controls and another 180 days to demonstrate compliance. If facilities need more time they can petition states and the EPA for an extension.

In the past, the state’s environmental regulator, Texas Commission on Environmental Quality, has disagreed with the EPA’s science assessment of ethylene oxide’s dangers to health and the environment. The agency launched its own review of the chemical in 2020, which ruled that it was significantly less toxic than the federal agency had found. TCEQ attempted to enact a new standard that could allow plants to emit more of the chemical, but the EPA rejected the standard in 2022.

Richard Richter, a spokesperson for the TCEQ, said the agency will implement the new standard and facilities will be required to comply with the new rule.


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