ERAVMIS Environmental Risk Assessment of Veterinary Medicines in Slurry

Country: EU Projects
Start Date:           Duration: 39 months         Project Type: RTD
Contract Number: EVK1-CT-1999-00003
Organisation Type:  EC Project
Soil-->Soil Overview
Water and sanitation-->Water and sanitation Overview
Project objectives:
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.
Project Summary:
Veterinary medicines are used widely across Europe and are released to land directly or indirectly through the application of sludge. The medicines may persist 
and have the potential to runoff to surface waters or leach to ground waters where they can impact human and environmental health. Unlike other classes of substances
the environmental fate of veterinary medicines is poorly understood and risk assessment procedures are poorly developed. Laboratory, semi-field field
and modelling studies are therefore proposed to improve current risk assessment procedures. Laboratory studies will assess the sorption, degradability
and toxicity of a wide range of veterinary medicines. Real data on concentrations of veterinary medicines in the environment will be generated. The results
of the studies will be used to validate existing models or develop new models for assessing the environmental risk of veterinary medicines contained in sludge.
Achieved Objectives:
Animal husbandry, slurry handling and environmental conditions throughout Europe were considered in order to define realistic worst case scenarios, in 
conjunction with environmental distribution models. Given the variability in manure management a straightforward approach for the manure model was selected.
Realistic worst case conditions were proposed in a simple scenario assuming single treatment per place, standard European nitrogen production values, application of the a manure application rate of170 kg N/ha/year in one time, with a manure production volume
of one month containing the full residue, no dissipation during storage, and incorporation into 5 cm soil. Risk reduction measures related to manure management
and manure treatment could not be assessed using the proposed methodology. Furthermore guidance is given on recommended methods for the risk assessment of veterinary medicinal products applied in slurry, for regulatory purposes. The document gives considerations to fate and effect testing
strategies in particular with respect to the hallmarks of veterinary medicinal antibiotics. It puts forward what modelling approaches are available and
what considerations to scenario definitions should be given. Risk characterisation is addressed as the focal point for exposure and effect assessment. Attention
is paid to risk mitigation measures and conditions under which these would be applicable.
Product Descriptions:
The overall objective of the project was to develop approaches for assessing the environmental impact of veterinary medicines (VMs) released to the environment 
through the spreading of manure, slurry and sludge. A guideline was published on the recommended methods for the risk assessment of veterinary medicinal products applied in slurry, for regulatory purposes.
A second guideline was published on the Environmental Risk Assessment for veterinary medicinal products applying exposure assessment scenarios. A number of papers have been published. The references are: BOXALL, A.B.A., BLACKWELL, P.A., CAVALLO, R., KAY, P., TOLLS, J. (2002) The sorption and transport of a sulphonamide antibiotic in soil systems. Toxicology
Letters 131: 19-28. (reprint: BOXALL, A.B.A., FOGG, L.A., BLACKWELL, P.A., KAY, P., PEMBERTON, E.J., CROXFORD, A. (2003) Prioritisation of veterinary medicines in the UK environment.
Toxicology Letters 142: 207 - 213(reprint: BOXALL, A.B.A., FOGG, L.A., KAY, P., BLACKWELL, P.A., PEMBERTON, E.J., CROXFORD, A. (2003) Veterinary medicines in the environment. Critical Reviews
in Environmental Contamination and Toxicology 180: 1 - 92. BOXALL, A.B.A., KAY, P., BLACKWELL, P.A. FOGG, L.A. (in press) Fate of veterinary medicines applied to soils. In: Kummerer K. (Ed) Pharmaceuticals in the
environment: 2nd Edt. Springer, Heidelburg, Germany BOXALL, A.B.A., KOLPIN, D.J., TOLLS, J., HALLING-SORENSEN, B. (2003) What are the environmental risks of veterinary medicines? Environmental Science
and Technology.37(15): 286A - 294A Abstract BRETON, R., BOXALL, A.B.A. (2003) Pharmaceuticals in the environment: regulatory drivers and research needs. QSAR Comb. Sci 22: 399 - 409. (
HALLING-SØRENSEN, B., LYKKEBERG A, INGERSLEV F., BLACKWELL P., TJØRNELUND J.(2003) Characterisation of the abiotic degradation pathway of oxytetracycline
in soil interstitial water using LC-MS-MS. Chemosphere 50:1331-1342. (reprint: HALLING-SORENSEN, B., SENGELOV, G., INGERSLEV, F., JENSEN, L.B. (2003) Reduced antimicrobial potencies of oxytetracycline, tylosin, sulfadiazin,
streptomycin,ciprofloxacin and olaquindox due to environmental processes. Archives of Environmental Contamination and Toxicology, 44: 7-16. (reprint: HALLING-SØRENSEN, B., SENGELØV G., TJØRNELUND J. (2002) Toxicity of Tetracyclines and Tetracycline degradation products to environmental relevant bacteria including selected Tetracycline resistant bacteria. Arch.
Environ. Contam.Toxicol 42:263-271. (reprint: JENSEN LB. (2003) Bacterial antibiotic resistance levels in farmland as a result of treatment with pig slurry accepted FEMS microbiology. Environ. Int.
28: 587-95.(reprint: KAY, P., BLACKWELL, P.A., BOXALL, A.B.A., (in press) Fate and transport of veterinary antibiotics in drained clay soils. Environmental Toxicology and
Chemistry MONTFORTS MHMM, DE KNECHT JA (2002) European medicines and feed additives regulation are not in compliance with environmental legislation and policy.
Toxicology Letters 131 (1-2): 125-136 (reprint: PRO J, ORTIZ JA, BOLEAS S, FERNANDEZ C, CARBONELL G, TARAZONA JV (2003) Effect assessment of antimicrobial pharmaceuticals on the aquatic plant Lemna minor.
Bulletin of Environmental Contamination and Toxicology 70 (2): 290-295 (reprint: TOLLS J (2001) Sorption of veterinary pharmaceuticals in soils: A review.Environmental Science and Technology 35 (17): 3397-3406 (reprint: SCHMITT H, VAN BEELEN P, TOLLS J, VAN LEEUWEN C (2004) Pollution-induced community tolerance of soil microorganisms caused by the antibiotic sulfachloropyridazine. Environmental Science & Technology 38 (4): 1148-1153 (reprint:
Additional Information:

Project Resources:

Environmental risk assessment for veterinary medicinal products: Part 4: Exposure Assessment Scenarios

A guide to risk assessment of veterinary medicinal products used in animal husbandry
Funding Programme(s): 
EC Framework Programme 5
Link to Organisations:
Submitted by: EUGRIS Team Dr Stefan Gödeke  Who does what?  06/12/2004 10:58:00
Updated by: EUGRIS Team Professor Paul Bardos  Who does what?  03/10/2006 11:33:00