Environmental exposure scenario for reagents used in in-vitro diagnostics

Area of Science:

• Environmental Science
• Chemical Risk Assessment
• Public Health

Background:

• In-vitro diagnostic (IVD) assays utilize various substances.
• Discharging IVD effluent into drains can release these substances into the environment via sewage treatment plants.
• National and local regulations govern liquid waste discharge, necessitating site-specific risk assessments.

Purpose of the Study:

• To develop a screening tool for assessing the environmental risks of chemical substances from IVD assays.
• To facilitate regulatory compliance checks for discharging IVD effluent into sewer systems.
• To evaluate potential risks to surface water from such discharges.

Main Methods:

• Development of a screening tool generating exposure scenarios for IVD assay chemicals.
• Tool based on typical usage conditions in Switzerland and Germany, adaptable to other regions.
• Incorporation of measured liquid waste data and diagnostic equipment operational parameters as default inputs.
• Comparison of predicted environmental concentrations (PEC) with regulatory limits and predicted no-effect concentrations (PNEC) for risk estimation.

Main Results:

• The screening tool aids in determining regulatory permissibility of effluent discharge.
• It helps identify potential risks to surface water quality.
• Demonstrated utility through assessments for fictitious hospitals in Switzerland and Germany.
• Identified substances requiring further, advanced risk assessment.

Conclusions:

• The developed screening tool effectively assesses environmental risks associated with IVD assay effluent.
• It supports regulatory compliance and protects surface water quality.
• The tool highlights the need for advanced assessments for specific concerning substances.