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Environmental risk assessment of veterinary medicines in sludge

Objective

Problems to be solved
Veterinary medicines are widely used across Europe and are released to land either directly or indirectly through the application of sludge. The medicines may persist and have the potential to runoff to surface water or leach to groundwater where they could impact human and environmental health. Under EU Directive 81/852/EEC, an environmental risk assessment is required on certain veterinary medicines. However, unlike other classes of chemical (e.g. pesticides, nutrients and industrial chemicals) the environmental impact of veterinary medicines is poorly understood. Consequently current risk assessment procedures are simple and have been developed to predict 'worst case' concentrations. Moreover, the approaches have not been validated. There is therefore a need to generate data on the behaviour of a range of veterinary medicines in the environment in order to develop an improved understanding of those factors and processes that affect their fate and to refine and validate current risk assessment approaches. This study, which will combine laboratory, semi-field, field and modelling studies, will investigate sorption, degradability, ultimate fate and ecotoxicity of a range of veterinary medicines. On the basis of the studies rules, models and experimental approaches will be recommended for the assessment of veterinary medicines that will be used in the EU in the future. A range of scenarios will be developed to assess the risk of veterinary medicines across Europe and finally, a tiered approach will be developed for use by industry and regulators involved in assessing the environmental risk of veterinary medicines.
Scientific objectives and approach
The overall objective of the project is to develop approaches for assessing the environmental impact of veterinary medicines released through the spreading of manure, slurry and sludge.
The specific aims of the study are:
1) to identify those factors and processes controlling the degradability of veterinary medicines in the environment;
2) identify those factors and processes controlling the sorption of veterinary medicines in manure, sludge, soil and water;
3) assess the effects of veterinary medicines on microbial functioning in soils;
4) assess the effects of veterinary medicines on soil organisms
5) assess the environmental distribution of a range of veterinary medicines at the semi-field and field scales; and
6) use information from 1-5 to develop exposure assessment models, scenarios and risk assessment approaches for use by regulators and industry across Europe. These objectives will be achieved using a combination of laboratory, semi-field, field and modelling studies.
Expected impacts
On the basis of the project results, a guidance document will be produced for use by industry and regulators involved in the risk assessment of veterinary medicines. It is envisaged that this document will be used in the future to perform more accurate assessments of the environmental risk of groundwater and surface water contamination by new and existing veterinary medicines and to identify appropriate management options for veterinary medicines in sludges. The results of the study will also be made available to the Veterinary International Co-operation on Harmonisation (VICH, which comprises representatives from industry and regulators from Europe, America and Japan) so that it is likely that the results of the study may also influence risk assessment approaches applied internationally.

Funding Scheme

CSC - Cost-sharing contracts

Coordinator

CRANFIELD UNIVERSITY
Address
Shardlow Hall
DE72 2GN Derby
United Kingdom

Participants (4)

INSTITUTO NACIONAL DE INVESTIGACION Y TECNOLOGIA AGRARIA Y ALIMENTARIA
Spain
Address
Carretera De La Coruça Km7
28040 Madrid
NATIONAL INSTITUTE OF PUBLIC HEALTH AND ENVIRONMENT
Netherlands
Address
Antonie Van Leeuwenhoeklaan 9
3720 BA Bilthoven
THE UNIVERSITY OF PHARMACEUTICAL SCIENCES
Denmark
Address
2,Universitetsparken 2
2100 Koepenhagen
UTRECHT UNIVERSITY
Netherlands
Address
50,Yalelaan 2
3584 CL Utrecht