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Veröffentlichung Advanced materials(Umweltbundesamt, 2023) Schwirn, Kathrin; Völker, Doris; Ahrens, Birgit; Berkner, Silvia; Blum, Christopher; Niederle, Werner; Süring, Kathrin; Tietjen, Lars; Vogel, Julia; Weißhaupt, PetraAdvanced materials promise technical solutions to support sustainable transformation. They play an important role for a variety of environmental topics worked on at UBA, such as energy transition, circular economy and chemical safety. Various sectors can benefit from the use of advanced materials, but they can also face challenges. The UBA position paper describes the area of tension between the promising use and possible challenges for environmental and health protection and other sustainability dimensions, illustrates this with various examples and derives corner stones for a safe and sustainable life cycle of advanced materials. Quelle: www.umweltbundesamt.deVeröffentlichung Antibiotic resistance and the environment̶there and back again(2014) Berkner, Silvia; Konradi, Sabine; Schönfeld, JensVeröffentlichung Antimikrobielle Resistenzen in der Umwelt(2017) Konradi, Sabine; Berkner, Silvia; Schönfeld, Jens; Westphal-Settele, KathiVeröffentlichung Biodegradability and transformation of human pharmaceutical active ingredients in environmentally relevant test systems(2013) Berkner, Silvia; Thierbach, ClaudiaHuman pharmaceutical active ingredients that are orally or parenterally administered may be metabolised in the body and after excretion may be further transformed in the receiving environmental compartments. The optimal outcome from an environmental point of view-complete mineralisation-is rarely observed. Small molecule pharmaceuticals are commonly not readily biodegradable according to Organisation for Economic Cooperation and Development (OECD) 301 tests. However, primary transformation is often observed. To gain information on the transformation of active ingredients in the environment, long-term studies like transformation in aquatic water/sediment systems according to OECD guideline 308 are required for the environmental risk assessment for human active pharmaceutical ingredients. Studies received until mid 2010 as part of the dossiers for marketing authorisation applications were evaluated concerning transformation products. The evaluation revealed that in 70 % of the studies, at least one transformation product (TP) is formed above 10 % of the originally applied dose, but in only 26 % of the studies are all TP identified. The evaluation also revealed that some TP of pharmaceutical active ingredients show a considerably longer DT50 compared to the parent compound. An example is the TP (val)sartan acid that is formed from an antihypertensive compound.
Quelle: http://link.springer.comVeröffentlichung Comparing pharmaceutical persistence across terrestrial and aquatic environments: do studies according to OECD 307 and OECD 308 lead to similar outcomes?(2023) Berkner, Silvia; Brandt, UteInformation on transformation and persistence of chemical substances in the environment is important for hazard and risk assessment within a regulatory context or as a decision criterion in a safe and sustainable by design framework. Half-lives for human and veterinary medicinal products available from marketing authorization applications were compared between soil (OECD 307) and aquatic water/sediment systems (OECD 308). The comparison shows, that there is no obvious correlation between the total system half-lives in the two different compartments and that surpassing persistence criteria is compartment-specific in 45% of the cases. © The Author(s) 2023Veröffentlichung Development of a test method for transformation of veterinary pharmaceuticals and biocides in anaerobic liquid manure(2020) Junker, Thomas; Atorf, Cornelia; Berkner, Silvia; Konradi, SabineBackground Spreading of manure on agricultural soils represents an important pathway by which veterinary medicinal and biocidal products enter the environment. To assess their environmental impact in the context of authorization processes, experimental testing of transformation of these compounds in manure is considered in regulatory guidance documents. However, there is no standardized experimental test method available so far. To fill this gap, an experimental test method was developed to examine transformation in liquid cattle and pig manure. Results To account for manure specifics and for a possible influence of manure parameters on transformation rates, a comprehensive data acquisition and statistical analysis were performed. To address the variability of liquid manure of different type and origin, 30 manures were sampled and characterized. Thereof, three cattle and three pig manures were selected to perform anaerobic transformation studies with two radiolabeled veterinary medicinal active substances (14C-salicylic acid and 14C-paracetamol) and a confidential radiolabeled "14C-biocide B" serving as test compounds. Spatial and seasonal variability of manure parameters was quantified, and a sampling technique to obtain homogenous manure samples was developed. Transformation studies with six replicates per sampling point were conducted to examine the influence of test setup, of manure storage conditions, and of parameter variations between manure of the same species and of different species on half-lives, formation of extractable and non-extractable residues and mineralization rates. Finally, a test design was established that yields reproducible results for transformation studies in liquid cattle and pig manure under anaerobic conditions. Conclusions Results give a reliable basis for an experimental test method to perform anaerobic transformation studies in liquid cattle and pig manure. The developed test method comprises detailed guidance on selection of sampling date and site, collection from manure tank, storage duration and temperature in the laboratory, duration of manure acclimation period, and the incubation system design. It proved to give reproducible results in a validation ring test performed in a follow-up project and is planned to be submitted as draft test guideline for approval by the OECD. © The Author(s) 2020.Veröffentlichung Development of a test protocol to study the transformation of veterinary pharmaceuticals and biocides in liquid manure(2015) Hennecke, Dieter; Atorf, Cornelia; Bickert, Claudia; Fraunhofer-Institut für Molekularbiologie und Angewandte Oekologie; Deutschland. Umweltbundesamt; Berkner, Silvia; Konradi, Sabine; Lehmann, ReneIt was the aim of the project to develop a method to determine the transformation of substances in liquid manure. In a first step, the heterogeneity of manure of different type and origin was tested. Furthermore, a procedure was tested which is capable to take samples homogeneously from a manure storage tank. Obviously, representative sampling is possible in case mixing devices which are routinely applied by the farmers are used prior to sampling. In order to get an overview on the variability of liquid manure of different type and origin (pig-/cattle manure; manure sampled in summer and winter, from different regions and livestock breeding) 30 manures were sampled and characterized. Furthermore, temperature (including a temperature profile) in manure tanks was reported in order to select a realistic test temperature. Six manures were selected to perform transformation studies of two veterinary medicinal products (Salicylic acid, Paracetamol) and a biocide. The experimental methodology which was developed in the project was used in a first inter-laboratory comparison (ring test) with 5 laboratories. Experiences of the participants were presented and discussed on a workshop and based on the results the developed test protocol was adapted.Veröffentlichung Environmental risk assessment of veterinary medicines(2013) Deutschland. Umweltbundesamt; Kühnen, Ute; Ebert, Ina; Berkner, Silvia; Simon, Markus; Herrchen, Monika; Förster, Bernard; Graf, Nadin; Römbke, JörgEnvironmental effects of veterinary medicines are assessed according to the guidelines of the European Medicines Agency (EMA) and the VICH GL 38 (ECOTOXICITY PHASE II). According to the guideline a terrestrial plant test in phase II is required because residues of pharmaceuticals release with dung and manure from treated animals on agriculture land. The terrestrial plant test is conducted using thestandardisedtest protocol OECD 208 (Seedling Emergence and Seedling Growth Test).
The current regulations take into account only the parent compound and not transformation products and NER (Non Extractable Residues). That might result in incorrect estimation of risk in case of substances applied on agricultural soils with manure. For these substances the German Federal Environmental Agency (UBA) has thus initiated a research project to develop a special terrestrial plant test with a more realistic exposure scenario. In order to evaluate the potential phytotoxicity of transformation products and NER the test substance is applied in manure and stored over a defined period prior to testing. After storing this mixture is tested in a standard terrestrial plant test according to OECD 208. The approach is currently developed with different plant species, different manures and storing periods by two research partners:Fraunhofer IME Schmallenberg and ECT Oekotoxikologie GmbH Flörsheim. The poster presents the regulatory background of this special plant testing approach and first results of the research project.
Quelle: ©Ute KühnenVeröffentlichung 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.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 biocides(2016) Junker, Thomas; Römbke, Jörg; Hennecke, Dieter; ECT Oekotoxikologie GmbH (Flörsheim am Main); Fraunhofer-Institut für Molekularbiologie und Angewandte Oekologie; Deutschland. Umweltbundesamt; Berkner, Silvia; Konradi, SabineThe spread of veterinary medicinal products (VMP) and biocides onto agriculturally used areas repre-sents 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 ma-nure“ (EMA/CVMP/ERA/430327/2009) (EMA, 2011) stipulates experimental studies on transfor-mation of VMPs and biocides in manure. Though, the documents only contain basic regulatory re-quirements, 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 interna-tionally 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” (Hennecke et al., 2015). The experimental method was examined and revised by an intra-laboratory comparisons 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 veteri-nary 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 pre-ceding project (Hennecke et al., 2015) 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.Veröffentlichung Nanomaterialien in der Umwelt - Aktueller Stand der Wissenschaft und Regulierungen zur Chemikaliensicherheit(2020) Schwirn, Kathrin; Bär, Susanne; Völker, Doris; Beer, Inga; Egerer, Sina; Berkner, Silvia; Scholz, Cornelia; Setzer, Sascha; Tietjen, Lars; Wurbs, JohannaNanomaterialien können im Vergleich zu konventionellen Chemikalien und Materialien veränderte oder neue Eigenschaften aufweisen. Bis heute gibt es aber - bis auf wenige Ausnahmen - keine Anpassungen von Stoffgesetzgebungen an Nanomaterialien. Dadurch können potenzielle spezifische Umweltrisiken nicht zureichend abgebildet und bewertet und geeignete Maßnahmen zur Minimierung der Risiken nicht getroffen werden. Schwerpunkt der vorliegenden Veröffentlichung ist daher die Darstellung der notwendigen Weiterentwicklung der Chemikalienregulierung für Nanomaterialien mit Bezug auf die Umwelt aus Sicht desUBA.Quelle: https://www.umweltbundesamt.deVeröffentlichung Nanomaterials in the environment - Current state of knowledge and regulations on chemical safety(2020) Schwirn, Kathrin; Bär, Susanne; Völker, Doris; Beer, Inga; Egerer, Sina; Berkner, Silvia; Scholz, Cornelia; Setzer, Sascha; Tietjen, Lars; Wurbs, JohannaNanomaterials can have different or new properties in comparison with conventional chemicals and materials. Until now, with few exceptions, there are no specific provisions for nanomaterials within the substance legislations. As a result, specific environmental risks cannot be described and assessed adequately and appropriate measures to minimize the risks cannot be taken. Therefore, the main aim of this paper is to outline the necessary further development of chemicals regulations for nanomaterials with regard to the environment from UBA´s perspective.Quelle: https://www.umweltbundesamt.deVeröffentlichung Nanopharmaceuticals - tiny challenges for the environmental risk assessment of pharmaceuticals(2015) Berkner, Silvia; Schwirn, Kathrin; Völker, DorisMany new developments and innovations in health care are based on nanotechnology. The field of nanopharmaceuticals is diverse and not as new as one might think; indeed, nanopharmaceuticals have been marketed for many years, and the future is likely to bring more nanosized compounds to the market. Therefore, it is time to examine whether the environmental risk assessment for human pharmaceuticals is prepared to assess the exposure, fate, and effects of nanopharmaceuticals in an adequate way. Challenges include the different definitions for nanomaterials and nanopharmaceuticals, different regulatory frameworks, the diversity of nanopharmaceuticals, the scope of current regulatory guidelines, and the applicability of test protocols. Based on the current environmental risk assessment for human medicinal products in the European Union, necessary adaptations for the assessment procedures and underlying study protocols are discussed and emerging solutions identified. Environ Toxicol Chem 2015;9999:1-8. © 2015 The Authors. Environmental Toxicology & Chemistry published by Wiley Periodicals, Inc. on behalf of SETAC.Veröffentlichung Neuartige Materialien(Umweltbundesamt, 2023) Schwirn, Kathrin; Völker, Doris; Ahrens, Birgit; Berkner, Silvia; Blum, Christopher; Niederle, Werner; Süring, Kathrin; Tietjen, Lars; Vogel, Julia; Weißhaupt, PetraNeuartige Materialen versprechen technische Lösungen zur Unterstützung der nachhaltigen Transformation. Sie spielen eine wichtige Rolle für eine Vielzahl der am ⥠UBA⥠bearbeiteten Umweltthemen wie beispielsweise die Energiewende, Kreislaufwirtschaft und Chemikaliensicherheit. Dabei können die verschiedenen Bereiche durch den Einsatz neuartiger Materialien profitieren, aber auch vor Herausforderungen gestellt werden. Das UBA-Positionspapier beschreibt das Spannungsfeld zwischen dem vielversprechenden Einsatz und möglichen Herausforderungen für den Umwelt- und Gesundheitsschutz und anderen Nachhaltigkeitsdimensionen, verdeutlicht dies an verschiedenen Beispielen und leitet Eckpunkte für ein sicheren und nachhaltigen Lebenszyklus von neuartigen Materialien ab. Quelle: www.umweltbundesamt.deVeröffentlichung P-Ident2 - Persistence Assessment in Surface Waters - addressing uncertainties in OECD 309 and OECD 308 studies(Umweltbundesamt, 2023) Seller, Carolin; Kitching, Elizabeth; Fenner, Kathrin Barbara; Eidgenössische Anstalt für Wasserversorgung, Abwasserreinigung und Gewässerschutz; Deutschland. Umweltbundesamt; Berkner, Silvia; Wöltjen, JaninaIm Projekt P-Ident 2 geht es darum, das Transformationsverhalten/die Persistenz von Chemikalien in Oberflächengewässern besser zu verstehen und Unsicherheiten zu adressieren. Ziele des Projektes sind es existierende Labortestmethoden (OECD 308 und 309) und Auswertemethoden weiterzuentwickeln. Des Weiteren soll das Transformationsverhalten/die Persistenz von Chemikalien in einem realen Oberflächengewässer (Rhein) mittels Modellierung von Feldmessdaten quantifiziert werden. Die Ergebnisse aus den Labortests, aus vorliegenden Daten aus Zulassungsverfahren sowie aus der Modellierung für den Rhein erlauben einen Vergleich des Transformationsverhaltens zwischen Labor und einem realen Oberflächengewässer. Quelle: ForschungsberichtVeröffentlichung Results of extended plant tests using more realistic exposure scenarios for improving environmental risk assessment of veterinary pharmaceuticals(2016) Richter, Elisabeth; Berkner, Silvia; Ebert, Ina; Förster, Bernhard; Graf, Nadine; Herrchen, Monika; Kühnen, Ute; Römbke, Jörg; Simon, MarkusVeröffentlichung Suitability of laboratory simulation tests for the identification of persistence in surface waters(Umweltbundesamt, 2017) Fenner, Kathrin Barbara; Honti, Mark; Stamm, Christian; Eidgenössische Anstalt für Wasserversorgung, Abwasserreinigung und Gewässerschutz; University of Technology and Economics; Deutschland. Umweltbundesamt; Berkner, Silvia; Gildemeister, Daniela; Rauert, Caren; Wöltjen, JaninaSimulationsstudien spielen bei der Bewertung der Biotransformation von Chemikalien für regulatorische Zwecke eine wichtige Rolle. Für die Biotransformation in Oberflächengewässern sind zwei OECD-Prüfrichtlinien relevant: OECD 308 und OECD 309, welche Transformation an der Wasser-Sediment-Grenzfläche beziehungsweise im Wasserkörper bewerten. Hauptkritikpunkte an diesen Richtlinien beziehen sich auf die Repräsentativität der Testbedingungen für den Abbau in realen Oberflächengewässern, sowie auf den Mangel an fehlenden Anleitungen und Instrumenten, um Abbau-Halbwertszeiten aus den Testresultaten abzuleiten. Dieses Forschungsprojekt adressiert beide Punkte. In Arbeitspaket I wurden inverse Modellierungsansätze angewendet, um Abbau-Halbwertszeiten für das Gesamtsystem und die einzelnen Kompartimente (DegT50,ts, DegT50,w und DegT50,sed) sowie ihre jeweiligen Unsicherheiten abzuleiten. Alle aus OECD 308 und 309-Daten abgeleiteten Persistenzindikatoren wiesen erhebliche Unsicherheiten auf. Diese liegen in der Regel bei einem Faktor von zwei für DegT50,ts und ein bis zwei Größenordnungen für DegT50,w und DegT50,sed. Dieser Befund steht in Widerspruch mit der derzeitigen Verwendung von starren Persistenzkriterien. DegT50,w-Werte lagen immer höher als DegT50,sed-Werte für die gleiche Verbindung. Entsprechend führten auch OECD 309-Ergebnisse wesentlich häufiger zu einer Persistenz-Klassifizierung für die gleiche Substanz wie OECD 308-Ergebnisse. Die gemeinsame Kalibrierung von verschiedenen Testsystemen mittels der Bioverfügbarkeits- und Biomasse-normalisierten k/bio reduzierte die Unsicherheit der DegT50,w und DegT50,sed. Die Reduktion der Unsicherheit war jedoch aufgrund des begrenzten Ausmaßes der beobachteten Biotransformation in OECD 309-Systemen gering. Es wurde vorgeschlagen, dass eine modifizierte Version des OECD 309 mit mehr Schwebstoffen die Genauigkeit der Schätzung von DegT50,w und DegT50,sed verbessern würde. Arbeitspaket II adressierte die Repräsentativität der Laborbasierten OECD 308 und 309-Simulationstests, um das Schicksal von Chemikalien in tatsächlichen Oberflächengewässern zu prognostizieren. Neben einer Literaturrecherche zu den wichtigsten Einflussfaktoren auf die Biotransformation von Chemikalien in Oberflächengewässern wurde eine Fallstudie über Substanzabbau im Rhein durchgeführt. Dazu wurden Daten aus der Rheinüberwachung mit Modell-vorhersagen zum Verbleib von chemischen Substanzen im Rhein verglichen. Basierend darauf wurde die Angemessenheit von Halbwertszeiten, die aus OECD 308-Daten hergeleitet worden sind, zur Beschreibung des Verbleibs von Chemikalien in einem großen Fluss wie dem Rhein bewertet. Diese Fallstudie ergab, dass die Anwendung von Kompartimentsspezifischen Halbwertzeiten nicht im Widerspruch zu beobachteten Konzentrationen steht. Die Anwendung von DegT50,ts jedoch überschätzte den Abbau deutlich. Insgesamt wird basierend auf den Ergebnissen des Projekts die Durchführung von zwei Simulationsstudien empfohlen, um Biotransformation in Wasser-Sediment-Systemen zu beurteilen. Dabei sollte es sich um eine OECD 308- und eine 309-Studie mit der maximal erlaubten Menge an Schwebstoffen handeln. Dadurch würde es möglich werden, Kompartiments-spezifische Halbwertszeit-Indikatoren mit reduzierter Unsicherheit abzuleiten, sowie die tatsächlichen Dimensionen des realen Oberflächengewässers in der Expositionsmodellierungen zu berücksichtigen. Quelle: ForschungsberichtVeröffentlichung Too advanced for assessment? Advanced materials, nanomedicine and the environment(2022) Berkner, Silvia; Schwirn, Kathrin; Völker, DorisAdvanced materials, and nanomaterials, are promising for healthcare applications and are in particular in the spotlight of medical innovation since rapidly developed nano-formulated vaccines provide relief in the SARS-CoV-2 pandemic. Further increased rapid growth is to be expected as more and more products are in development and reach the market, beneficial for human health. However, the human body is not a dead end and these products are likely to enter the environment, whereas their fate and effects in the environment are unknown. This part of the life-cycle of advanced medicinal products tends to be overlooked, if the perspective is human-centered and excludes the connectedness of human activity with, and consequences for our environment. Gaps are reviewed that exist in awareness, perspective taking, inclusion of environmental concerns into research and product development and also in available methodologies and regulatory guidance. To bridge these gaps, possible ways forward start to emerge, that could help to find a more integrative way of assessing human and environmental safety for advanced material medicinal products and nanomedicines. © The Author(s) 2022.Veröffentlichung Transformation von Bioziden und Veterinärpharmaka in Gülle(2016) Berkner, Silvia; Konradi, Sabine