PARENT SESSION
WP7 Human and Veterinary drugs in the environment
3:00 PM to 6:30 PM, Wednesday, 09 May 2001
Session Chair: D. Calamari
Room 7

(409) Environmental risk assessment of veterinary medicines: an evaluation of the registration procedure.

De Knecht, Joop¹, Van Vlaardingen, Peter¹, Janssen, Peter¹, Linders, Jan ¹, Montforts, Mark¹, ¹

ABSTRACT- Since several years the veterinary medicinal industry is obliged to submit an assessment of ecotoxicity in order to register their products for the European market. In the current guideline of the European Agency for the Evaluation of Medicinal Products the risk assessment is divided in two phases. In the first phase the potential exposure of the environment to the product, its ingredients or relevant metabolites is assessed. Based on trigger values for the concentration in manure, soil and groundwater it is decided whether a phase II assessment is necessary. In phase II a further investigation of the environmental fate and effects of the ingredients of the product is performed. Besides our reservation with respect to the use of these trigger values (instead of risk quotients) we foresee difficulties in obtaining adequate input data for calculation of the concentrations in soil and groundwater. The following gaps are observed : (1) Protocols for studying pharmacokinetics in the target animal and biodegradation in manure are not available, resulting in ambiguous test results. (2) Information on (differences in) metabolism and excretion in different animal species and in different groups of animal species (sex, growth stadium) is often not available, hampering the possibility for extrapolation. This also applies to differences in the pharmacokinetics of products with the same active ingredient(s) but another route of application and for biodegradation in different manure types. (3) Insufficient knowledge on the formation and relevance of metabolites in the target animal and in manure. Assuming no metabolism or no biodegradation does not necessarily imply a worst case scenario. (4) Experimental data on organic matter partitioning (Koc) of many pharmaceuticals is not supplied hampering calculation of realistic groundwater concentrations. Besides our own vision we present an inventory of the visions of the evaluating authorities of other European member states as evolved at an international workshop held in January 2001.

Key words: veterinary medicines, risk assessment, registration