Pharmaceuticals in the aquatic environment––a comparison of risk assessment strategies

• Published in: Chemosphere (Oxford) 2004-09, Vol.56 (11), p.1143-1155
• Main Authors: Bound, J.P., Voulvoulis, N.
• Format: Article
• Language: English
• Subjects: Animal, plant and microbial ecology; Applied ecology; Applied sciences; Biological and medical sciences; Biological and physicochemical phenomena; Brackish; Drug-Related Side Effects and Adverse Reactions; Drugs; Earth sciences; Earth, ocean, space; Ecotoxicology, biological effects of pollution; EMEA; Engineering and environment geology. Geothermics; Europe; Exact sciences and technology; FDA; Forecasting; Fresh water environment; Freshwater; Fundamental and applied biological sciences. Psychology; Guidelines; Guidelines as Topic; Marine; Models, Theoretical; Natural water pollution; Pollution; Pollution, environment geology; Risk Assessment; United States; United States Food and Drug Administration; Waste Disposal, Fluid; Wastewater; Water Pollutants, Chemical - poisoning; Water treatment and pollution
• ISSN: 0045-6535; 1879-1298
• DOI: 10.1016/j.chemosphere.2004.05.010

The growing concern over the release of pharmaceutically active compounds and personal care products into the environment has prompted the introduction of risk assessment guidelines in both the European Union by the European Medicines Evaluation Agency (EMEA) and in the United States by the Food and Drug Administration (FDA), details of which are presented herein. Both employ a similar tiered system that compares the predicted environmental concentrations (PEC) with the worst-case no effect concentrations estimated from standard toxicity assays. These approaches are compared and contrasted. Results demonstrate room for improvement in areas such as the use of threshold values to trigger investigations, chronic and mechanism specific toxicity screening and mixture toxicity for which possible solutions are proposed.