New federal rules could cut emissions from sterilization facilities in Virginia

The sign for Sterilization Services of Virginia, Inc. in Henrico County. (Charlie Paullin/The Mercury)

Henrico County resident Beth Kreydatus works with students in an environmental studies group at Varina High School who serve as peer mentors to Montrose Elementary School students. Both schools sit less than four miles from a business known as Sterilization Services of Virginia that sterilizes medical equipment.

On Tuesday, when Kreydatus told the students about the facility emitting ethylene oxide, a toxic chemical linked to increased risk of cancer, into the air they breathe, the students piped up with concern.

"I live less than one mile away from the facility," Kreydatus said one student named Cameron told her. "I’m worried that a lot of my headaches are caused by all of the ethylene oxide in the air."

Now the U.S. Environmental Protection Agency is proposing a rule that, if finalized, would reduce the amount of ethylene oxide emissions that facilities using the chemical could emit. The new rule, which would impact some sterilizers of medical equipment in Virginia, including Sterilization Services, would also require increased monitoring of the emissions.

Several residents living near the Henrico facility say they support the measure and weren't previously aware of the harmful effects studies have found ethylene oxide emissions can cause.

"I remember back in August of 2022 hearing on the news something about the emissions from that plant, but Henrico County didn't issue any statements to the community of concern," said Aileen Rivera, a resident who lives two and a half miles from the facility. "I’m concerned with the people that live closer by or even with the workers there."

Ethylene oxide, or EtO, is a colorless gas with a sweet smell that leaves no residue, making it useful in the sterilization of medical equipment and preservation of documents, according to the Sterilization Services website. EPA's proposal would set more stringent standards for regulated facilities that emit the gas, with the goal of lowering their emissions by 80%, bringing the levels to below the EPA's Clean Air Act benchmark for elevated cancer risk.

The proposal "would significantly reduce worker and community exposure to harmful levels of ethylene oxide," said EPA Administrator Michael S. Regan in a statement. "EPA will continue to use every available tool to safeguard our nation's communities, including workers, from exposure to toxic chemicals and to deliver important public health protections."

In Virginia, the proposal would not only impact Sterilization Services, which in 2022 was documented by the EPA as posing an elevated risk to communities, but also other commercial sterilizers in the state, including Central Virginia Health Network (the parent company of Bon Secours Mercy Health) and LifeNet, which has two facilities in Virginia Beach.

A person who answered the phone for Sterilization Services in Henrico County hung up on a reporter in an initial call from the Mercury. On a later call, the person directed questions to the company's corporate offices in Chicago but refused to give out contact information for them. Internet searches identified a business known as Chatham Corporation as a parent company of the Henrico facility. Chatham did not return a request for comment.

The health concerns voiced by Kreydatus and Rivera are in line with data from the Union of Concerned Scientists, which released a report last month that documents the impacts of ethylene oxide emissions around the U.S., including in Virginia.

"We have known that ethylene oxide is a carcinogen since at least 2016, and we cannot continue to sacrifice the lives of workers and communities – communities that are already disproportionately exposed to toxic pollution – for the sake of continuing to rely on this chemical," said report author Darya Minovi. "Safer chemicals and processes exist and we need to use them where it is safe to do so."

The proposal from the EPA rolls out a slate of changes to how and when facilities are allowed to use ethylene oxide, what safeguards they must put in place to protect humans from exposure and how they must monitor its use.

The new rule would set new requirements for facilities to upgrade equipment to reduce leakage of the toxin into surrounding communities as well as protect the workers within the facilities.

It would also impose prohibitions on using ethylene oxide where alternative technologies exist, such as in document preservation work in museums and archival settings and other uses in beekeeping and the manufacture of some cosmetics and musical instruments.

The proposal calls for using less ethylene oxide to sterilize medical devices at facilities, which the EPA states are "using much higher concentrations of EtO than what is required for sterility assurance, often times double the necessary concentration."

Companies would be required to develop additional worker controls, such as mandating personal protective equipment when ethylene oxide levels cross a certain threshold and using automation to transport sterilized items to limit human exposure.

According to the EPA, employees exposed to ethylene oxide during regular work hours over a 35-year period face heightened risks of developing cancer. Those risks are roughly 1 in 36 in an occupational setting, 1 in 10 for workers who apply ethylene oxide in sterilization facilities, and between 1 in 25 and 1 in 12 for workers who apply ethylene oxide in health care facilities.

Commercial sterilizers would also have to use advanced monitoring to confirm the pollution controls are working and report the results to EPA twice per year.

In addition to working with local, state and tribal partners to reduce ethylene oxide emissions, the EPA is working to identify alternatives to the chemical's use in sterilization, an effort that builds on the U.S. Food & Drug Administration's Innovation Challenge that began in 2019 to identify new sterilization methods and technologies.

According to the EPA, some commercial sterilization facilities have already implemented some of the measures mandated under the new proposal. Facilities would have 18 months to meet the requirements of the rule, which will be final after the proposal is published in the Federal Register and a 60-day public comment period occurs.

In Virginia, the EPA has identified Sterilization Services as a high-risk ethylene oxide emitter. The agency flagged the facility in August as one of 23 nationwide that posed elevated risks to workers and the surrounding community. However, a local health official told WRIC people would need to be "living, breathing in that air 24 hours a day, seven days a week, for 70 years" to be at risk of developing cancer as a result of the plant.

An EPA webpage for the facility includes a map from July showing heightened lifetime cancer risk for people living within a two-mile radius of the plant. But a disclaimer now on the map states that it is no longer current, as Sterilization Services has since installed an additional wet scrubber and catalytic oxidizer to reduce emissions.

The Henrico facility is not the only sterilization facility in the commonwealth that will need to comply with the new rules.

EPA's website also states the federal agency is working with the state to reduce emissions. Patrick Corbett, air toxics coordinator in the Office of Air Permit Programs at the Virginia Department of Environmental Quality, said Bon Secours Mercy Health is a "very small ethylene oxide user." The LifeNet Health commercial sterilization company also has two small facilities that use the chemical in Virginia Beach, but Corbett said they wouldn't be subject to the rule.

A statement from LifeNet Health said the company already uses emission-capture technology to convert 99.9% of its ethylene oxide into carbon dioxide and water vapor before emissions are released into the atmosphere. LifeNet also said it has worker protections in place — for example, sterilization takes place in a separate room that only essential personnel can access.

"To act upon its mission, LifeNet Health uses EtO to sterilize at low temperatures items that would be damaged in steam sterilizers," said the statement. "The items that undergo this sterilization process are used in the recovery and processing of lifesaving tissue. LifeNet Health uses an average of 40 pounds of EtO per month, a fraction of the amount used by commercial sterilizers."

There are also two chemical facilities in Hopewell that use ethylene oxide: Evonik Industries and Ashland Specialty Ingredients. However, since they aren't commercial sterilizers, they aren't subject to EPA's rule.

The EPA's proposal to reduce emissions coincides with the publication by the Union for Concerned Scientists of a report on the harmful effects of releasing ethylene oxide into communities.

The report found that nearly 726,000 Virginians live within five miles of the sterilizers in Henrico County and Virginia Beach, and people of color make up three-quarters of the population near Sterilization Services, where the population of low-income residents is also 10% greater than the county average.

"This doesn't necessarily mean that they are all breathing hazardous levels of ethylene oxide, but [they] may be at a higher risk of being exposed," said Minovi. "This is unfortunately a trend we observed in our report overall and demonstrates how ethylene oxide is an issue of environmental injustice."

The additional controls and monitoring in the proposed rule are a promising development, Minovi added, but she said the rule should be expanded to cover research and development facilities and include fenceline monitoring.

"If implemented and enforced, the rule will no doubt result in a reduction in ethylene oxide emissions in communities with commercial sterilizers," Minovi said. "However, these measures must also be implemented alongside requirements to transition to safer sterilization methods, where possible, and fenceline monitoring to ensure that communities are not exposed to hazardous levels of ethylene oxide."

In addition to more localized data on the health impacts of emissions from facilities, Kreydatus said more awareness of the risks is needed. She pointed to a 2020 report from the EPA's Office of the Inspector General that declared "prompt action" was necessary to inform residents living near ethylene oxide-emitting facilities "about health concerns and actions to address those concerns".

"It's hard news to hear for homeowners and civic community members, but it's not appropriate to just sweep under the rug, especially if there's a chance for us to try and advocate for better regulation of the facility which would really address the problem," Kreydatus said.

EPA spokesperson David Sternberg said the agency hosted a national public webinar on ethylene oxide emissions in August 2022 in an effort to raise awareness.

Education on the matter can go a long way, Rivera said.

"Unfortunately, the medical sterilization is needed; there's just no other way around it," she said. "But as long as I know and am aware there are ways they can tighten up the emissions, as long as they follow through with it … it can be worked out."

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by Charlie Paullin, Virginia Mercury April 24, 2023

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Charles Paullin covers energy and environment for the Mercury. He previously worked for Northern Virginia Daily in the Northern Shenandoah Valley and for the New Britain Herald in central Connecticut. An Alexandria native, Charles graduated from the University of Hartford initially wanting to cover sports. He's received several Virginia Press Association awards for his coverage of crime, local government and state politics.