EtO has come under heightened regulatory and public scrutiny as it relates to potential human health impacts following the US Environmental Protection Agency (US EPA) 2016 reassessment of its inhalation cancer risk for EtO, which lowered the acceptable exposure threshold. This reassessment has resulted in multiple enforcement actions, community health investigations, litigation, and regulatory rulemaking at both the federal and state levels.
To navigate the complexity surrounding EtO, medical device manufacturers and commercial sterilization operators have turned to Gradient to address complicated EtO emission, exposure, and transport issues, as well as potential health effects from exposure to EtO. Gradient’s team of toxicologists, epidemiologists, air transport scientists, risk assessors, and medical device specialists have deep experience with EtO, providing health risk characterization, air dispersion modeling, regulatory compliance, and product safety support.
Gradient Expertise:
Site- or Chemical-specific Evaluation
Medical Device and Products
Project Examples:
Health Effects and Exposure Evaluation. Gradient evaluated the potential for health effects from EtO exposure in ambient air for individuals living near a sterilization facility. We assessed the epidemiology, toxicology, and mechanistic literature on EtO and various cancer and noncancer health effects. In addition, our work involved a critical review of the derivation of estimates of EtO cancer potency by regulatory agencies.
Emissions and Historical Exposure Reconstruction. Gradient provided technical support for a medical device sterilization facility with past EtO emissions. We reviewed risk factors for breast cancer, leukemia, and lymphoma with respect to health claims. In addition, we analyzed data from the National Air Toxics Assessment (NATA) to reconstruct historical air concentrations of EtO, benzene, and other chemicals during the relevant period of facility ownership.
Medical Device Evaluation and Testing. Gradient toxicologists provided scientific consulting services to evaluate EtO residuals on medical device components. Gradient’s support included a technical review of the medical device and its components, the quality and level testing required for the medical device, the development of an appropriate tolerable intake for patients, and communication regarding potential risks associated with EtO exposure.
California Proposition 65 Exposure and Product Safety. Gradient conducted a California Proposition 65 exposure analysis of EtO residues (a byproduct of sterilization) on a consumer-use medical device. We developed a model to track residue decay over time based on EtO desorption from polymers. Our analysis included off-gassing, indoor inhalation exposure, and typical use patterns to meet Proposition 65 compliance and labeling laws.
Medical Device Evaluation and Testing. Gradient conducted an independent review of a medical device manufacturer’s cleaning and evaluation plan regarding EtO. Our client relied on our technical support to establish compliance relative to international standards.
In the News:
US EPA Proposes Roll Back of Ethylene Oxide Emissions Standards
