Ethylene Oxide Lawsuit | EtO Exposure Claims

A newly published study in the American Journal of Industrial Medicine reveals widespread and long-standing overexposure to ethylene oxide (EtO) among American workers.

Researchers examined over four decades of OSHA sampling data from 1979 to 2020 and found that 46% of worker air samples exceeded the NIOSH recommended limit of 0.1 ppm.

In addition, 18% of those samples surpassed OSHA’s legal exposure limit of 1 ppm.

The highest exposure levels were recorded in the industrial sterilization sector, where nearly 70% of samples exceeded NIOSH’s limit.

The data also show that this sector has made little progress in reducing exposure levels over the past several decades.

Although overall EtO exposure in the workplace has declined since the 1980s, the study highlights major disparities across different industries.

Sectors like chemical manufacturing and health services lacked post-2000 exposure data, raising red flags about underreporting and incomplete occupational health monitoring.

Given EtO’s classification as a known human carcinogen, the findings call for more rigorous exposure tracking and stronger regulatory enforcement in high-risk work environments.

A federal lawsuit has been filed against Eastman Chemical Company, claiming that years of excessive ethylene oxide (EtO) emissions from its Longview, Texas facility caused severe health consequences, including multiple breast cancer diagnoses among nearby residents.

The complaint, filed in the U.S. District Court for the Eastern District of Texas, includes claims from six individuals—four of whom have been diagnosed with breast cancer.

Plaintiffs allege they were unknowingly exposed to harmful levels of EtO, a toxic, odorless gas used in chemical manufacturing, while living or working near the Eastman plant.

Ethylene oxide has been classified as a “probable human carcinogen” by the U.S. Environmental Protection Agency (EPA) since 2016.

In 2018, the EPA identified the Longview area as having elevated cancer risks specifically tied to emissions from the Eastman facility.

According to the lawsuit, Eastman self-reported releasing more than 565,000 pounds of EtO into the surrounding environment by 2022.

The Eastman Chemical lawsuit includes two counts of negligence for failing to prevent or control the release of dangerous emissions, as well as a loss of consortium claim filed by spouses of affected plaintiffs.

These spouses allege that the health consequences suffered by their partners have had a direct impact on their lives and relationships.

Newly disclosed records reveal that senior administration officials blocked and edited key EPA findings on the cancer risks of ethylene oxide, stalling long-awaited regulations aimed at reducing emissions from commercial sterilization facilities.

The delay, which benefited companies like Sterigenics, came despite repeated warnings from EPA scientists urging immediate action to protect communities near sterilizer plants.

According to a congressional report released July 18, 2024, political appointees at the White House and EPA suppressed a 2020 proposal that would have imposed strict emissions limits under the Clean Air Act.

The draft rule would have required sterilization facilities to reduce ethylene oxide emissions by 80% and notify nearby residents of the elevated cancer risks.

However, after intervention by the White House Office of Information and Regulatory Affairs (OIRA), the EPA withdrew the proposal entirely.

Internal documents show that officials softened or removed language labeling ethylene oxide as a known carcinogen and deleted references to heightened cancer risks affecting dozens of U.S. communities.

This regulatory stall gave the industry years of continued ethylene oxide use under minimal oversight, during which litigation over exposure steadily increased.

The revelations are expected to impact ongoing lawsuits, as plaintiffs argue that both government and industry knowingly failed to act despite clear evidence of long-term health risks.

Proof of political interference may strengthen claims that regulators and corporations prioritized industry interests over public safety.

New air testing in multiple U.S. communities reveals ethylene oxide (EtO) levels much higher than previously reported by the EPA, with some readings reaching hundreds of times above the agency’s cancer risk threshold.

The Spotlight on America team collaborated with the Southwest Research Institute and utilized a mobile air lab to perform real-time monitoring near sterilization facilities.

In one Illinois neighborhood, EtO levels hit 92,000 nanograms per cubic meter—more than 300 times the EPA’s concern threshold.

The findings further undermine the trustworthiness of government air modeling, a key issue in EtO exposure lawsuits.

Plaintiffs claim that long-term exposure to EtO from medical sterilization facilities caused cancer and other serious health issues.

The new data may reinforce claims that residents were unknowingly exposed to harmful levels of EtO due to underreported emissions and insufficient federal oversight.

The Biden administration is evaluating potential rollbacks to the HON (Hazardous Organic NESHAP) rule that could allow chemical plants—particularly those emitting ethylene oxide (EtO) and other hazardous pollutants—to qualify for exemptions from strict emissions limits.

The HON rule is designed to target major industrial polluters and reduce cancer risks for more than 10 million people, especially those living near petrochemical sites.

Under the proposed changes, companies could postpone installing pollution control technologies if doing so is considered technologically or financially impractical, subject to White House approval.

While no formal exemptions have been granted yet, environmental advocates warn that such loopholes could significantly erode protections for communities surrounding facilities with long records of noncompliance.

Ethylene oxide, a toxic chemical classified as a known carcinogen, has been strongly linked to blood and breast cancers. Communities near emitting facilities and workers in high-exposure settings face elevated risks.

According to a recent EPA analysis, some workers in medical sterilization plants may face cancer risks as high as 1 in 10 due to EtO exposure.

Public health experts and environmental groups argue that softening the HON rule would disproportionately harm vulnerable populations and could reverse recent progress in reducing toxic air pollution and cancer-related risks.

Delaware legislators have passed a new bill that significantly raises fines for environmental violations and allocates those funds to communities located within a two-mile radius of the pollution source.

Now awaiting the governor’s signature, the legislation expands the enforcement powers of the state’s Department of Natural Resources and Environmental Control (DNREC), including the ability to challenge Environmental Appeals Board rulings involving repeat offenders.

The bill raises maximum daily penalties by as much as $30,000 for certain infractions—some of which haven’t been updated in over five decades—and establishes a new fund aimed specifically at assisting communities most directly affected by pollution, rather than distributing resources on a statewide basis.

Residents living near long-criticized sites like Croda Inc.’s Atlas Point facility and the Delaware City Refinery welcomed the legislation, calling it a necessary step toward greater accountability and health safeguards.

Environmental groups have long contended that previous fine structures were too minimal to discourage persistent violators, often forcing DNREC to emphasize compliance over enforcement due to the high cost of appeals.

The Delaware State Chamber of Commerce opposed the measure, citing concerns over increased liability exposure and insurance costs stemming from what they characterized as disproportionate penalty increases.

Ethylene oxide (EtO) is a toxic gas used in medical sterilization and chemical manufacturing, and exposure to it has been linked to serious health conditions.

Workers who regularly encounter EtO—especially in sterilization facilities, hospitals, and nearby businesses—face increased risks of developing lymphoma, leukemia, breast cancer, respiratory issues, and reproductive harm.

Exposure often occurs through inhalation or skin contact, particularly in workplaces with inadequate ventilation or safety protocols.

While workers’ compensation may be one avenue for relief, many affected individuals may also have grounds for filing toxic tort or product liability lawsuits against negligent employers or equipment manufacturers.

To support a legal claim, exposed workers should begin collecting:

• Detailed job descriptions and employment history
• Medical records and diagnostic reports
• Workplace exposure logs or monitoring results
• Testimonies from coworkers about unsafe conditions

Employers are obligated to monitor EtO levels, provide protective gear, and ensure proper safety training.

A failure to uphold these responsibilities may open the door to legal action.

Communities throughout North Carolina may be unknowingly exposed to dangerous levels of ethylene oxide (EtO), a toxic gas used to sterilize medical supplies.

A recent WRAL report identified five warehouses across the state storing EtO-sterilized products—one of which is located in Four Oaks, just 1,100 feet from nearby homes.

These warehouses, operated by companies such as Becton Dickinson, Owens & Minor, and Medline, remain largely unregulated despite EtO being classified as a known human carcinogen.

Long-term exposure to the gas has been linked to serious health risks, including breast cancer and non-Hodgkin lymphoma—even at very low concentrations.

While sterilization facilities are subject to federal EtO emission standards, off-site warehouses that store sterilized products are not currently held to the same regulatory oversight.

North Carolina does not monitor emissions from these storage sites, and the EPA has yet to propose rules to address this regulatory loophole.

Residents near the Four Oaks warehouse have voiced concerns about air quality and public health, urging officials to implement more robust monitoring and transparency.

Steris Corporation has agreed to pay up to $48.15 million to settle personal injury lawsuits tied to ethylene oxide (EtO) emissions from its former sterilization facility in Waukegan, Illinois.

The settlement, reached through Steris’s Isomedix subsidiary, is intended to resolve nearly all pending cases in Cook County Circuit Court involving claims of cancer and other serious health issues.

Plaintiffs allege that emissions from the facility, operated between 2005 and 2008, exposed surrounding communities to harmful levels of EtO—a carcinogenic gas used widely in medical sterilization.

Although Steris denies liability and maintains the emissions posed no safety risk, the company agreed to the payout to efficiently resolve litigation.

The deal, disclosed in a March 2025 securities filing, is still subject to court approval and requires a significant number of plaintiffs to opt in.

If these conditions are not met, Steris may withdraw from the agreement and proceed with defense in court.

The EPA continues to flag EtO sterilization plants as high-risk cancer sites, prompting tighter federal regulations and pressure to transition to safer alternatives.

A Georgia judge has declared a mistrial on the issue of punitive damages in a lawsuit involving C.R. Bard, following a recent $20 million compensatory award to plaintiff Gary Walker.

The decision to retry this portion of the case comes after a juror disclosed that they did not personally agree with the original decision but went along with the rest of the jury.

The retrial will focus solely on whether C.R. Bard should be held liable for punitive damages in connection with its sterilization facility in Covington, Georgia.

Walker, a longtime resident of the area and a former delivery driver for the plant, was diagnosed with non-Hodgkin’s lymphoma after years of exposure to ethylene oxide, a chemical commonly used in sterilization processes and known to carry significant health risks.

The jury had initially awarded $50 million in punitive damages, but that award was voided following the juror’s admission.

Judge Emily Brantley has confirmed that a new trial will be scheduled to decide if Bard’s conduct demonstrated intent or conscious indifference—standards that must be met under Georgia law to justify punitive damages.

Jurors, however, will not be informed of any statutory caps that may apply to such damages.

Walker’s case is one of many emerging from growing concerns over toxic emissions from medical sterilization facilities.

The Environmental Protection Agency responded to these concerns in March 2024 by issuing stricter safety regulations, including continuous emissions monitoring and enhanced controls for sterilization equipment.

While alternatives to ethylene oxide have been proposed, the gas remains widely used in the medical industry across the United States, keeping litigation and regulatory scrutiny at the forefront of public health discussions.

A Georgia jury awarded $20 million to Gary Walker, a retired truck driver who claimed exposure to ethylene oxide (EtO) from C.R. Bard’s Covington sterilization plant caused his lymphoma.

The jury found Bard liable for both negligence and nuisance, determining that a second trial phase is necessary to address punitive damages.

That next phase is scheduled to begin on Monday, May 19.

Walker, now in remission, lived roughly 1.5 miles from the Bard facility beginning in 1991 and regularly delivered to the site until his retirement in 1999.

He was diagnosed with lymphoma in 2017 at age 68 and received ten rounds of chemotherapy in addition to a stem-cell transplant.

His attorneys introduced internal documents and regulatory records showing Bard declined to adopt emissions controls for decades despite repeated warnings from both regulators and its ethylene oxide supplier, Union Carbide.

The jury reviewed a 1985 memo from Georgia environmental officials noting that Bard “does not want to control its emissions at this time.”

During closing arguments, plaintiff’s attorney Lindsay Forlines asserted that Bard had the tools to limit emissions but chose not to use them.

Defense counsel Eric Rumanek countered that Walker’s illness was unrelated, pointing out that no physician had directly linked his cancer to EtO exposure.

This case marks the first EtO exposure verdict in Georgia favoring a plaintiff, potentially opening the door to significant legal exposure for Bard.

Judge Emily Brantley will preside over the punitive damages retrial beginning May 19.

A Georgia jury began proceedings Tuesday in a case alleging that C.R. Bard’s Covington sterilization plant exposed a nearby resident to ethylene oxide (EtO) over several decades, leading to his cancer diagnosis.

The plaintiff, Gary Walker, a retired truck driver, claims he developed non-Hodgkin lymphoma due to years of residential and occupational exposure to the chemical.

According to his legal team, the facility released close to 10 million pounds of EtO between 1970 and 2017, operated without emissions controls until 1990, and ignored repeated warnings from both regulators and its EtO supplier, Union Carbide.

Jurors were shown a 1985 memo from Georgia environmental officials stating that Bard “does not want to control its emissions at this time.”

Bard denies any responsibility, asserting that Walker’s illness was caused by a random genetic mutation unrelated to EtO exposure.

The company maintains that it has complied with regulatory standards and adopted safety measures in line with evolving federal guidelines.

Defense attorneys also pointed to the critical role EtO plays in sterilizing more than half of all medical devices used in the United States, and emphasized Bard’s use of emissions monitoring and pollution controls.

This trial marks the first EtO exposure case in Georgia to be brought before a jury.

Similar lawsuits are underway in other states, including recent defense-favorable outcomes in Colorado and Pennsylvania.

Steris Corporation has agreed to a settlement of up to $48.15 million to resolve personal injury lawsuits tied to ethylene oxide (EtO) emissions from its former sterilization facility in Waukegan, Illinois.

The settlement, negotiated through Steris’ Isomedix subsidiary, is intended to resolve nearly all of the active cases filed in Cook County Circuit Court, which allege cancer and other serious health conditions linked to EtO exposure.

Disclosed in a March 2025 securities filing, the agreement follows increasing legal and regulatory attention to EtO, a gas classified as carcinogenic and widely used to sterilize medical devices in the United States.

Plaintiffs claim that emissions from the Waukegan plant posed a health threat to the surrounding community between 2005 and 2008, the years during which Steris operated the site.

Although Steris has not admitted any liability or acknowledged that the emissions posed a health risk, the company stated that the agreement is intended to resolve the litigation efficiently and avoid prolonged legal proceedings.

Steris announced it will record the settlement as a charge in its fiscal 2025 financials but will exclude it from adjusted earnings.

Earlier this year, the first EtO case against Steris concluded in a mistrial, leaving the door open for further litigation.

The proposed settlement is now subject to court approval and requires a significant majority of plaintiffs to agree to its terms; if that threshold is not reached, Isomedix retains the option to withdraw and resume its legal defense.

The Environmental Protection Agency has identified several EtO-emitting sterilization sites across the country as high cancer risk areas, prompting stricter emissions standards.

In response to regulatory pressure, sterilization companies and device manufacturers are exploring alternatives such as vaporized hydrogen peroxide to reduce dependence on EtO.

Steris continues to operate as one of the leading global providers of medical sterilization services through its Applied Sterilization Technologies division, which has since absorbed the Isomedix name.

Medical device manufacturer B. Braun has reached a confidential settlement resolving the majority of lawsuits filed by residents near its Lehigh County, Pennsylvania facility, who alleged harmful exposure to ethylene oxide (EtO), a gas associated with cancer and neurological disorders.

Dozens of individuals had brought legal claims asserting that emissions from the sterilization plant led to increased health risks, including diagnoses of breast cancer, lymphoma, and other serious conditions.

Although B. Braun continues to deny any liability, the company confirmed the settlement this week and stated it will still defend against the remaining unresolved cases.

Details of the agreement have not been made public.

In response to growing legal and public health concerns, B. Braun reported that it voluntarily installed a new emissions control system in 2020 that has reduced EtO emissions by more than 99.9%, exceeding current regulatory requirements.

This settlement comes amid heightened national focus on EtO emissions and their potential health impacts.

In March 2024, the Environmental Protection Agency implemented more stringent rules for commercial sterilization facilities, mandating real-time air monitoring and imposing limits on emissions during start-up and shutdown processes.

These rules apply to roughly 90 sterilization sites across the United States.

The legal actions against B. Braun are part of a broader trend of litigation aimed at companies in the medical sterilization sector.

In 2023, Sterigenics agreed to a $408 million settlement in cases involving EtO exposure in Illinois, Georgia, and Michigan, while Steris is currently facing hundreds of similar lawsuits nationwide.

Although ethylene oxide remains a cornerstone in sterilizing approximately half of all medical devices used in the U.S., mounting pressure from health advocates and legal developments is fueling demand for safer alternatives.

As litigation progresses and regulatory scrutiny intensifies, both manufacturers and policymakers may face increased urgency to transition toward less hazardous sterilization technologies.

Cosmed Group Inc., a sterilization company serving the medical and food industries, has filed for Chapter 11 bankruptcy protection in Houston, Texas, in the face of growing litigation over its use of ethylene oxide (EtO).

The filing comes after the company was named in more than 300 lawsuits, including two class actions, alleging that EtO emissions from its facilities caused cancer and other serious health issues in nearby communities.

Ethylene oxide is a chemical used in sterilizing medical devices and food products, and it is classified as a known human carcinogen.

At a court hearing, Cosmed’s attorney, David Eastlake, stated that the volume and scope of the litigation—spanning multiple jurisdictions and including both active and former facilities—posed a significant threat to the company’s continued operation.

Cosmed filed for bankruptcy alongside its affiliate, Spicey Partners Real Estate Holdings, with both entities reporting liabilities exceeding $100 million.

U.S. Bankruptcy Judge Christopher Lopez approved an emergency motion to allow the company to meet its $65,000 payroll for its 51 employees, while other funding and operational matters will be addressed in subsequent hearings.

This is not Cosmed’s first encounter with environmental compliance issues; in 2005, the company paid $1.5 million to settle a U.S. Environmental Protection Agency investigation into EtO emissions at multiple facilities across six states.

The bankruptcy filing follows a broader pattern of legal and regulatory challenges for sterilization firms, as public and governmental scrutiny of ethylene oxide intensifies.

At this stage, Cosmed has not indicated whether it plans to pursue a global settlement strategy through its bankruptcy proceedings.

Sterigenics, along with its parent company Sotera Health, has reached a $35 million settlement to resolve a set of lawsuits alleging that emissions from its medical sterilization facility in Cobb County, Georgia, caused cancer and other health complications in nearby residents.

The agreement represents a key development in the expanding litigation landscape surrounding ethylene oxide exposure across Georgia.

The lead plaintiff in the settled case was diagnosed with leukemia at age 20 after living for 13 years in proximity to the Sterigenics facility.

His lawsuit, filed in 2020, claimed that long-term inhalation of airborne ethylene oxide—a chemical classified as a known carcinogen—was the most likely cause of his illness.

Ethylene oxide is widely used in the sterilization of medical equipment due to its effectiveness at disrupting DNA, but those same properties have been linked to increased cancer risk, particularly leukemia and lymphoma, according to the CDC and National Institutes of Health.

The case was one of the earliest legal actions in Georgia focused on emissions from Sterigenics, and its progression has helped prompt broader legal and regulatory attention to similar facilities.

The plaintiff is now in remission and has recently earned his degree from the University of Utah.

Under the terms of the proposed settlement, the agreement is contingent on full participation from all plaintiffs involved in the case.

Sterigenics and Sotera have not admitted liability or fault but stated the settlement is intended to resolve the claims efficiently and avoid further litigation.

This resolution does not address all pending lawsuits, as the companies continue to face additional personal injury and property damage claims.

Further hearings, including those set for October 2024, will examine scientific evidence concerning general causation and the risks posed by EtO exposure.

The $35 million agreement may influence the direction of other EtO-related cases in Georgia and potentially nationwide, as plaintiffs and regulators alike continue to scrutinize emissions from sterilization facilities and their impact on public health.

The U.S. Environmental Protection Agency (EPA) has finalized a sweeping regulatory update aimed at curbing emissions of hazardous air pollutants from the Synthetic Organic Chemical Manufacturing Industry (SOCMI) as well as polymer and resin production facilities.

This final rule specifically targets reductions in emissions of ethylene oxide (EtO) and chloroprene, both of which are classified as known human carcinogens.

Key Provisions of the Rule:

• Emission Reductions: The EPA anticipates that the rule will result in a reduction of approximately 54 tons of ethylene oxide and 14 tons of chloroprene emissions each year, cutting emissions from regulated sources by about 80 percent.
• Health Impact: The EPA projects that these reductions will lead to a 96 percent decrease in cancer risks associated with toxic air exposure for communities located near the impacted industrial sites.
• Broader Environmental Gains: In addition to lowering toxic emissions, the rule is expected to reduce the release of volatile organic compounds (VOCs)—which contribute to smog formation—by more than 23,000 tons annually.
• Monitoring and Transparency: A major component of the rule includes mandatory fenceline air monitoring for chemicals such as EtO and chloroprene, with results made publicly available to enhance community awareness and environmental oversight.

This regulatory action reflects the EPA’s ongoing commitment to addressing the health risks posed by toxic air pollutants and to increasing transparency for populations living in proximity to chemical manufacturing operations.

The U.S. Environmental Protection Agency (EPA) is finalizing a long-awaited overhaul of its safety regulations for ethylene oxide (EtO), a toxic chemical widely used in the sterilization of medical devices and long linked to increased cancer risks.

The final rule—set to be issued by the March 1 deadline imposed by federal court—marks the EPA’s most significant update in over a decade concerning EtO emissions and occupational exposure standards.

Public Health Risks Prompt Regulatory Action

The new regulations follow years of growing concern fueled by a 2016 EPA risk assessment that identified EtO as substantially more carcinogenic than previously recognized.

EtO is already designated a human carcinogen by both the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH), with established links to breast cancer, non-Hodgkin lymphoma, leukemia, and other serious conditions.

Particularly vulnerable populations include children and residents living near sterilization facilities—many of whom were unknowingly exposed to harmful concentrations of the gas for years.

Protests and litigation have emerged in communities from Laredo, Texas to Covington, Georgia, and the Chicago suburbs, where residents have demanded accountability and stronger protections after revelations of long-term exposure.

Recent legal outcomes include a $35 million settlement in Georgia involving Sterigenics and its parent company Sotera Health, and a $363 million jury verdict in Illinois awarded to a breast cancer survivor who lived near a sterilization facility.

Key Components of the New Rule

The EPA’s finalized rule is expected to include:

• More stringent emission limits for commercial sterilizers
• An 18-month timeline for facilities to achieve compliance
• Enhanced safety requirements for employees working directly with EtO

Despite these updates, environmental advocates have expressed concern that the rule does not go far enough.

Critics point to the lack of mandatory air monitoring around facilities and the absence of emissions controls for off-site warehouses where sterilized products may continue to release EtO.

Industry Response and FDA Warnings

While public health and environmental groups largely support the rule, industry representatives have voiced alarm over potential consequences.

The Advanced Medical Technology Association (AdvaMed) has warned that the new compliance standards could cost companies more than $500 million and disrupt sterilization operations critical to the medical supply chain.

The Food and Drug Administration (FDA) has also raised concerns, cautioning that overly burdensome regulations might limit the availability of essential medical devices.

Although alternative sterilization methods such as steam, radiation, and vaporized hydrogen peroxide exist, they are not universally suitable for complex or heat-sensitive products, making EtO a vital component of current sterilization protocols.

As the EPA implements this regulatory shift, the challenge will be balancing urgent public health needs with the operational realities of a medical system still heavily reliant on EtO.

Sterigenics and its parent company, Sotera Health, have agreed to pay $408 million to resolve claims from 879 individuals who allege they developed cancer and other illnesses due to ethylene oxide (EtO) emissions from the company’s former Willowbrook, Illinois facility.

The settlement resolves nearly all of the 882 pending lawsuits connected to the facility, which became the focus of litigation following a 2018 EPA report detecting dangerously high EtO levels in the surrounding community.

In 2019, Illinois officials ordered the permanent closure of the plant.

Since then, Willowbrook has been referred to as part of a broader network of “cancer alley” communities, where residents report elevated health risks tied to long-term EtO exposure.

EtO is used to sterilize approximately half of all medical devices in the United States, but it is also recognized as a human carcinogen with links to leukemia, lymphoma, breast cancer, and other diseases.

Children are considered especially vulnerable to its effects due to EtO’s ability to damage DNA.

The decision to settle follows a high-profile 2022 jury verdict that awarded $220 million to plaintiff Susan Kamuda, a breast cancer survivor who lived near the facility.

Additional penalties imposed on Sotera and Griffith Foods brought the total judgment in that case to $363 million.

That verdict likely played a significant role in prompting Sterigenics to settle the remaining claims rather than risk further multimillion-dollar trial outcomes.

Although the company continues to deny any wrongdoing and asserts that its operations were safe, it acknowledged the financial risks associated with prolonged litigation.

Based on the settlement total, the estimated average pre-tax payout per plaintiff is approximately $545,000.

Three plaintiffs have opted out of the agreement and will proceed with discovery and litigation.

This settlement does not conclude all of Sterigenics’ legal battles, as the company still faces EtO-related lawsuits in Georgia and New Mexico.

Meanwhile, the EPA has enacted new rules to sharply reduce EtO emissions, signaling that regulatory scrutiny and legal exposure for sterilization firms are likely to intensify.

The U.S. Environmental Protection Agency has initiated a national effort to educate the public about the health dangers of ethylene oxide (EtO), a gas commonly used to sterilize medical equipment.

The campaign features updated health risk assessments, online webinars, and in-person meetings for residents living near approximately 100 commercial sterilization sites.

Out of those, 23 facilities have been flagged as presenting heightened lifetime cancer risks due to prolonged exposure to EtO.

EPA Administrator Michael Regan stated that the agency is prioritizing transparency and increased community engagement, particularly in the most affected areas.

EtO exposure has been associated with several serious health conditions, including breast cancer and leukemia.

Although short-term exposure levels do not currently exceed federal safety thresholds, the EPA is most concerned about the risks of long-term, cumulative exposure, particularly for children and facility workers.

In response, the agency is gathering emissions data, reviewing Clean Air Act standards, and planning to introduce more rigorous pollution control measures for sterilization operations.

The EPA is also working closely with the Food and Drug Administration to ensure that tighter regulations do not disrupt the supply of critical medical devices.

In a major development aimed at enhancing transparency and environmental justice, the U.S. Environmental Protection Agency (EPA) announced an expansion of its Toxics Release Inventory (TRI) reporting requirements to include 29 commercial sterilization facilities previously exempt from such oversight.

These facilities utilize large quantities of ethylene oxide (EtO), a chemical classified as a known human carcinogen with documented links to breast cancer, leukemia, and other serious health conditions.

Under the new rule, facilities will also be required to report data related to ethylene glycol, a chemically related compound.

Prompted by years of concern from community advocates about undisclosed EtO emissions—especially in residential areas, near schools, and within historically underserved communities—the EPA is invoking its discretionary authority under the Emergency Planning and Community Right-to-Know Act (EPCRA) to require reporting from these high-use facilities.

The mandate applies to activities beginning January 2022, with data reporting starting in 2023.

The selected 29 facilities represent some of the highest EtO users in the contract sterilization industry and are expected to exceed the TRI threshold of 10,000 pounds annually.

Two additional facilities initially considered for inclusion were ultimately excluded—one has ceased sterilization operations, and the other uses EtO in minimal amounts that fall below reporting requirements.

This move marks a substantial step forward in the EPA’s efforts to provide communities with critical information on chemical exposures and to hold industrial emitters accountable.