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Veröffentlichung Harmonization of environmental exposure assessment for veterinary pharmaceuticals and biocides(2016) Düring, Rolf-Alexander; Wohde, Manuel; Junker, Thomas; ECT Oekotoxikologie GmbH (Flörsheim am Main); Fraunhofer-Institut für Molekularbiologie und Angewandte Oekologie; Deutschland. Umweltbundesamt; Berkner, Silvia; Konradi, SabineThe spread of veterinary medicinal products (VMPs) and biocides onto agriculturally used areas represents a very important path of entry into the environment for these product groups. Within this literature study public available transformation studies with liquid manure are summarized. Transformation studies were evaluated considering the transformation fate of tested substances, the origin and characteristics of used manure, the experimental setup, the measured parameters and the main outcome of the studies. Test duration throughout the studies ranges from 2 to 374 days and study temperature ranges from 5 °C to 55 °C. As main topics within the 34 found transformation studies the high dependency of transformation on temperature, redox potential, dry matter content and many other parameters is reported. It was further critically analyzed which basic information and parameters were neglected. Unfortunately only six publications give information on the redox potential of the manure. Further, the characterization of the matrix in many cases is inadequate due to missing parameters such as dry matter content, pH, and TOC.Additionally, public available monitoring data of VMPs in manure were collected and evaluated regarding the origin and characteristics of the manure, the minimum and maximum found concentrations, and percentage of identified compounds. Within the 27 found publications, 1568 manure samples were analyzed and 39 different active substances for VMPs and 11 metabolites and transformation products of VMPs could be found in manure. Mainly, the samples were analyzed for sulfonamides, tetracyclines and fluorquinolones. In no case a non-target approach was used. Single active substances were found in some studies with more than 100 analyzed samples in more than 50 % of the analyzed manure samples. This is the case for sulfadimidine, chlortetracycline, oxytetracycline, and tetracycline. It can be concluded that for both transformation studies and monitoring studies a standardized guidance would be beneficial for their applicability in regulatory contexts and also enhance the scientific outcome of these studies.Veröffentlichung Harmonization of environmental exposure assessment for veterinary pharmaceuticals and bio-cides(2016) Herrchen, Monika; Hennecke, Dieter; Junker, Thomas; Fraunhofer-Institut für Molekularbiologie und Angewandte Oekologie; ECT Oekotoxikologie GmbH (Flörsheim am Main); Deutschland. Umweltbundesamt; Berkner, Silvia; Konradi, SabineThe spread of veterinary medicinal products (VMP) and biocides onto agriculturally used areas represents a very important path of entry into the environment for these product groups. For this reason, current guidance (e.g. „Guideline on determining the fate of veterinary medicinal products in manure“ (EMA/CVMP/ERA/430327/2009) (EMA, 2011) stipulates experimental studies on transformation of VMPs and biocides in manure. However, the documents only contain basic regulatory requirements, whereas an experimental test guideline is still missing, both on EU and OECD level. To allow for a consistent assessment of studies within the registration process, a harmonized internationally accepted and validated test method is needed.A draft test guideline was developed within a previous R&D-Project “Development of test guidance for transformation of veterinary pharmaceuticals and biocides in liquid manure” (FKZ 3710 67 422) (Hennecke et al., 2015). The experimental method was examined and revised by an intra-laboratory comparison as well as an international inter-laboratory comparison (pre-validation ring test).In the present project, an international ring test has been performed and evaluated testing a veterinary medicinal product (florfenicol) in pig manure and a biocide (imidacloprid) in cattle manure. Moreover, two international workshops were organized; one at the beginning in connection with proceeding project (FKZ 3710 67 422) and one at the end of the project to discuss and evaluate the ring test. Based on the experimental results of the ring test as well as discussions and conclusions of both workshops, a revised draft test guideline was prepared.