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5B a - RA/ Ranking and Chemical Specific (TUP/204) Risk assessment of veterinary medicines: a report and analysis of potential versus actual environmental exposure. Tait, Alex1, Long, Carol1, Croxford, Andy2, Pemberton, Emma2, 1 Veterinary Medicines Directorate (VMD), Addlestone, Surrey, United Kingdom2 Environment Agency, Wallingford, Oxfordshire, United Kingdom ABSTRACT- Environmental risk assessment of veterinary medicines has been required in the European Union since 1993. The potential routes by which a product may enter the environment are considered and the predicted concentration in each relevant environmental compartment estimated. Decisions on environmental safety are made on the basis of a comparison between concentration of residue in the environment and results of effects tests. Following the introduction of the EU Pharmacovigilance Guidelines in 1998 the reporting of any environmental problems caused by veterinary medicines was included under the wider scope of post-marketing surveillance. In the UK the VMD operates this system and co-operates with a number of other agencies including the Environment Agency. The Environment Agency monitor for veterinary medicines (primarily sheep dip chemicals) in environmental waters in England and Wales. In addition, they investigate all reported environmental pollution incidents including those involving or suspected to involve veterinary medicines. In the presentation the potential routes by which a veterinary medicine may enter the environment and the environmental compartments placed at risk from the drug will be described. This potential for environmental exposure will be compared with pollution incident and routine monitoring data recorded by the Environment Agency. An analysis of the data in terms of active ingredient identified, type of incident and changes over time will be provided. The information on environmental exposure will be discussed in relation to the assessment procedure for veterinary medicines and the future collection, analysis and ranking of environmental incidents data. Key words: assessment, veterinary, monitoring, exposure |
