Ecotoxicology, Environmental Risk Assessment and Potential Impact on Human Health¹

This chapter examines potential risks posed by active pharmaceutical ingredients (APIs) present in the aquatic environment to humans and aquatic life. We begin by describing the mechanisms by which pharmaceuticals enter the vertebrate body, produce effects and leave the body. Then we describe theoretical and practical issues limiting the certainty which can be expected from risk estimates. This is followed by a description of particular considerations applicable to evaluation of human risks, along with a summary of methods and conclusions from some important studies examining those risks. A similar discussion of theoretical issues and selected data relevant for estimating risks to aquatic life is then presented. We finish by discussing potential contributions of antibiotics present in the environment to the development and spread of antibiotic resistance. We conclude that there are too few data to definitively address every concern, particularly risks to aquatic life and contributions to development of antibiotic resistance. On the other hand, available data suggest risks to humans are very low for all active pharmaceutical ingredients (APIs) and risks to aquatic life are very low for most APIs. Although aquatic risks cannot be as confidently ruled out for a few APIs, potential risks are probably limited to particularly contaminated regions in close vicinity to concentrated pollution sources, such as wastewater treatment plant outfalls.