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

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.