EtO Warehouse Off-Gassing Claims

The Unregulated Warehouse Problem

After medical devices are sterilized with ethylene oxide, they continue to release residual EtO gas for days or weeks as the chemical desorbs from packaging and product materials. This process — known as off-gassing or aeration — was historically considered a minor issue because sterilization facilities maintained aeration rooms with some ventilation controls. But the explosive growth of medical device logistics has created a new and largely unregulated exposure pathway: EtO off-gassing from massive distribution warehouses.

Becton Dickinson (BD) operates a 1.3-million-square-foot distribution warehouse in Four Oaks, North Carolina, approximately 30 miles south of Raleigh. According to EPA Toxics Release Inventory data, this single warehouse emits approximately 5,694 pounds of ethylene oxide per year — not from sterilization operations, but purely from off-gassing of sterilized products stored on warehouse shelves. The facility sits approximately 1,100 feet from the nearest residential homes, with no emission controls, no continuous air monitoring, and no fenceline detection systems.

The problem extends beyond Four Oaks. Medline Industries operates a distribution warehouse in Lincolnton, North Carolina that stores EtO-sterilized products. Other manufacturers maintain similar warehouses across the Southeast and Midwest. In each case, the warehouse is classified as a distribution or logistics operation — not a sterilization facility — and therefore falls outside the scope of EPA's 2024 NESHAP rule for ethylene oxide commercial sterilizers.

The scale of the issue is significant. The U.S. medical device sterilization industry processes billions of devices annually, and the vast majority pass through distribution warehouses before reaching hospitals and clinics. Each sterilized device carries residual EtO that slowly releases into warehouse air and, through ventilation systems and building leaks, into surrounding communities. The cumulative emissions from hundreds of warehouses nationwide may rival those of the sterilization facilities themselves.

North Carolina Investigations

In June 2025, WRAL News published a major investigative report documenting EtO off-gassing from the BD Four Oaks warehouse, revealing that nearby residents had not been informed about the chemical emissions from the facility. The investigation found that Johnston County officials had approved warehouse construction permits without requiring environmental impact assessments for EtO off-gassing, because the facility was classified as a distribution warehouse rather than a chemical operation.

Fast Company and Grist subsequently published national investigations documenting the broader pattern of unregulated EtO warehouse emissions, identifying similar facilities in Georgia, Indiana, and Illinois. These reports revealed that major medical device manufacturers had internal knowledge that their warehouses emitted significant quantities of EtO but had not disclosed this to surrounding communities or installed emission controls.

Medline Industries' warehouse in Lincolnton, North Carolina became a second focal point after community members reported chemical odors and requested air quality testing. North Carolina Department of Environmental Quality (DEQ) conducted limited monitoring but acknowledged that the state lacked regulatory authority over warehouse EtO emissions because no state-level standard existed for this emission source.

The North Carolina investigations galvanized community organizing in Johnston County and Lincoln County. Residents formed advocacy groups, demanded fenceline air monitoring, and began documenting health complaints including headaches, respiratory issues, and — most critically — cancer diagnoses among long-term residents near the warehouse facilities. These community efforts have laid the groundwork for legal action.

The Regulatory Gap

The EPA's 2024 NESHAP rule for ethylene oxide commercial sterilizers was a landmark regulation requiring sterilization facilities to reduce EtO emissions by more than 90%. However, the rule explicitly applies only to facilities that perform sterilization operations — it does not cover warehouses, distribution centers, or other facilities where sterilized products are stored and off-gas.

This regulatory gap exists because the Clean Air Act's NESHAP authority is organized by source category. The EPA established a source category for "ethylene oxide commercial sterilizers" but has not created a separate source category for EtO warehouse emissions. Without a defined source category, the EPA cannot promulgate emission standards for warehouses under Section 112 of the Clean Air Act.

The EPA proposed addressing warehouse emissions in its 2024 rulemaking but ultimately deferred the issue, stating that additional data collection was needed to characterize the magnitude of warehouse off-gassing nationwide. Industry groups including AdvaMed (the medical device trade association) lobbied aggressively against including warehouses in the rule, arguing that the cost of retrofitting thousands of warehouses with emission controls would be prohibitive.

At the state level, no state has enacted specific regulations for EtO warehouse emissions. North Carolina, Georgia, Illinois, and other states with significant warehouse operations have acknowledged the issue but have not filled the federal regulatory gap. This leaves warehouse neighbors without the regulatory protections that community members near sterilization facilities now enjoy under the 2024 NESHAP rule.

The absence of federal tracking is particularly problematic. While sterilization facilities report their EtO usage and emissions through the Toxics Release Inventory (TRI), warehouses have no comparable reporting obligation. This means the EPA and state agencies lack basic data on how many warehouses emit EtO, how much they emit, and which communities are affected. The regulatory gap is not merely a gap in standards — it is a gap in knowledge.

Legal Theory for Warehouse Claims

Despite the regulatory gap, warehouse EtO exposure claims have strong legal foundations under state common law. Plaintiffs' attorneys are developing claims based on four primary theories, each of which can proceed independently of federal regulation.

First, negligence. Warehouse operators have a duty of care to surrounding communities to prevent foreseeable harm. The cancer risk from EtO exposure has been well-established since the EPA's 2016 IRIS assessment, and medical device manufacturers have internal data showing their warehouses emit significant EtO quantities. The failure to install readily available emission controls — activated carbon scrubbers, catalytic oxidizers, or enhanced ventilation with treatment — constitutes a breach of the duty of care when the foreseeable result is cancer in nearby residents.

Second, strict liability for abnormally dangerous activity. Storing large quantities of carcinogenic gas in proximity to residential communities may constitute an abnormally dangerous activity under the Restatement (Second) of Torts § 520. The key factors — high degree of risk, inability of reasonable care to eliminate the risk, inappropriateness of the activity to the location, and extent to which the activity's value is outweighed by its danger — weigh in favor of strict liability for residential-adjacent EtO warehouses.

Third, nuisance. Both public and private nuisance claims are viable against warehouse operators whose EtO emissions unreasonably interfere with the use and enjoyment of neighboring properties. Chronic exposure to a known carcinogen constitutes a substantial and unreasonable interference even at concentrations below acute health thresholds.

Fourth, class action potential. Because warehouse EtO exposure affects entire neighborhoods uniformly, class action or mass tort treatment is appropriate. Common questions of fact — whether the warehouse emits EtO, whether EtO causes cancer, whether the operator knew of the risk — predominate over individual issues. Attorneys in North Carolina and Georgia are actively evaluating class certification for warehouse communities.