ENVIRONMENTAL ASSESSMENT OF THERAPEUTIC DRUGS USED IN AQUACULTURE

Potential risks to the environment from the use of veterinary pharmaceuticals, including for use in aquaculture, are required to be evaluated in a number of jurisdictions including the European Union, the United States, Japan and Australia. Harmonized guidance (VICH, 2000; VICH, 2004) as well as more recent guidance from the European Medicines Agency (EMEA, 2008) provides a process for conducting these environmental assessments which essentially involves comparing the Predicted Environmental Concentration (PEC) to the Predicted No-Effect Concentration (PNEC) for key receptors. However, available guidance is much more developed for drugs used on terrestrial animals than for aquatic animals. In particular, guidance is lacking on approaches for derivation of the PEC for aquaculture drugs. In this presentation, case studies are used to illustrate approaches for a variety of aquaculture systems. The assumptions and calculations used in these case studies to derive the initial PECs and refined PECs, for Tier A (acute) and Tier B (chronic) exposures, are discussed. In most instances, a typical case as well as a worst-case scenario was used. The PECs are compared to the PNECs to determine the risk quotients. Our analysis showed that the environmental risks of aquaculture drugs can be evaluated in a quantitative manner, leading to regulatory approval.