Ziel des Forschungsvorhabens ist es, die Aussagekraft von unter REACH abgeschätzten Umweltkonzentrationen (PEC) systematisch mit gemessenen Konzentrationen aus dem Umweltmonitoring (MEC) in Süßwasseroberflächengewässern zu vergleichen und daraus Schlussfolgerungen für die Bewertung von Einzelstoffen und Stoffmischungen abzuleiten. Der Fokus liegt dabei auf REACH Stoffen. Ein zentraler Ausgangspunkt ist die Auswahl geeigneter Stoffe und repräsentativer Fallstudien (Use Cases), die die realen Umweltbedingungen möglichst gut widerspiegeln. Dabei stehen insbesondere Stoffe im Fokus die dem regulatorischen Silo REACH zugeordnet werden. Für die Substanzen sollen sowohl belastbare Abschätzungen aus REACH-Registrierungen als auch Messdaten aus Oberflächengewässern vorliegen. Die ausgewählten Fallstudien sollen typische Expositionssituationen sowie relevante Ko-Expositionen mehrerer REACH Stoffe abbilden. Durch Analyse kuratierter Daten in der NORMAN Datenbank wurden ca. 60 Substanzen, mit Bezug zu REACH, festgestellt, die regelmäßig im Oberflächengewässer erfasst wurden. Schaut man standortspezifisch, kommen von diesen 60 Substanzen regelmäßig etwa 20 Substanzen, die REACH relevant sind, gemeinsam vor.
The VICH GL 6 guideline outlines a tiered assessment scheme that is mandatory for all active substances (AS) used in veterinary medicines before they enter the market. As the first step, the predicted environmental concentration of the AS in question is compared to a so-called “action limit” of 100 μg/kg for soil. If this action limit is exceeded, an extended environmental risk assessment is required. This limit is currently based on data that were recorded between 1973 and 1997 in the USA. Since then, new active ingredients with higher efficacy (and, therefore, potential environmental impacts at lower concentrations) have been developed and put on the market. This consequently elevates the probability of environmental and organismic impact, which in turn affects biodiversity and, ultimately, the natural functioning of ecosystems. A critical evaluation of the action limit is therefore necessary. Does it still serve its purpose as a precautionary decision criterion on whether an experimental Phase II risk assessment must be conducted? To assess the protectiveness of the soil action limit of 100 µg/kg, we evaluated 82 tests (34 plant and 48 earthworm tests) for 18 parasiticides, 28 antibiotic and 5 other AS, using data from European Medicines Agencies Public Assessment Reports, supplemented by internal data of the German Environment Agency. We included parasiticides in the data evaluation, although the action limit does not apply here, as their environmental hazard is determined by their toxicity to insects. Tests between model predictions reveal no difference between models with and without parasiticides (with parasiticides n = 51, without parasiticides n = 33). For each AS, we included the lowest available NOEC/EC10 and fitted a sigmoidal non-linear least squares model in the range of [0,1]. 18±5 % of the NOECs/EC10 values are below 100 µg/kg soil. This reduces to 17±6 % if only non- parasiticides are included in the data analysis. A total of 11 substances are below or equal to the action limit, 7 antibiotics and 4 parasiticides. In order to ensure that the action limit covers approximately 95 % of AS currently on the market, a reduction from 100 to 5 µg/kg would be necessary. The analysis shows that the current action limit is insufficient to protect organisms and ecosystems. In future revisions of the guideline, it will be necessary to adapt the action limit to current scientific standards.
The VICH GL 6 guideline outlines a tiered assessment scheme that is mandatory for all active substances (AS) used in veterinary medicines before they enter the market. As the first step, the predicted environmental concentration of the AS in question is compared to a so-called “action limit” of 100 μg/kg for soil. If this action limit is exceeded, an extended environmental risk assessment is required. This limit is currently based on data that were recorded between 1973 and 1997 in the USA. Since then, new active ingredients with higher efficacy (and, therefore, potential environmental impacts at lower concentrations) have been developed and put on the market. This consequently elevates the probability of environmental and organismic impact, which in turn affects biodiversity and, ultimately, the natural functioning of ecosystems. A critical evaluation of the action limit is therefore necessary. Does it still serve its purpose as a precautionary decision criterion on whether an experimental Phase II risk assessment must be conducted? To assess the protectiveness of the soil action limit of 100 µg/kg, we evaluated 82 tests (34 plant and 48 earthworm tests) for 18 parasiticides, 28 antibiotic and 5 other AS, using data from European Medicines Agencies Public Assessment Reports, supplemented by internal data of the German Environment Agency. We included parasiticides in the data evaluation, although the action limit does not apply here, as their environmental hazard is determined by their toxicity to insects. Tests between model predictions reveal no difference between models with and without parasiticides (with parasiticides n = 51, without parasiticides n = 33). For each AS, we included the lowest available NOEC/EC10 and fitted a sigmoidal non-linear least squares model in the range of [0,1]. 18±5 % of the NOECs/EC10 values are below 100 µg/kg soil. This reduces to 17±6 % if only non- parasiticides are included in the data analysis. A total of 11 substances are below or equal to the action limit, 7 antibiotics and 4 parasiticides. In order to ensure that the action limit covers approximately 95 % of AS currently on the market, a reduction from 100 to 5 µg/kg would be necessary. The analysis shows that the current action limit is insufficient to protect organisms and ecosystems. In future revisions of the guideline, it will be necessary to adapt the action limit to current scientific standards.
Quartäre Alkylammuniumverbindungen (QAAC) sind kationische organische Verbindungen mit amphiphilen Eigenschaften, die in vielfältigen Anwendungen u.a. der Landwirtschaft als Desinfektionsmittel und Tensid zum Einsatz kommen. Obwohl es wenige Daten zu Konzentrationen im Boden gibt, deuten Befunde aus anderen Umweltkompartimenten wie Abwasser, Sedimente und Klärschlamm die ubiquitäre Verbreitung der QAACs und eine Anreicherung an partikulärer Substanz an. Eine vorhergesagte Umweltkonzentration entspräche in Böden 3.5 mg kg-1. In Böden sind bereits mehrfach QAAC Resistenzen nachgewiesen worden und hier könnten sie an einer Co-Selektion für Antibiotikaresistenzgene mitverantwortlich zu sein, was Risiken für Mensch und Umwelt bergen könnte. Im vorangehenden einjährigen Projekte der Nachwuchsakademie Agrarökosystemforschung postulierten wir, dass QAACs in landwirtschaftlichen Böden vor allem in den Zwischenschichten von Tonmineralen zurückgehalten werden. Hier würden sie sich dem biologischen Abbau teilweise entziehen und ihre akute Toxizität wäre gegenüber der freien wässrigen Phase gemindert. Mithilfe eines Versuches zur Wirkung von Tonmineralen auf die Minimalen Hemmkonzatrationen (MHK) von QAAC auf verschiede Bakterienarten konnte bestätigt werden, dass die Smektite die MHK nach oben verschieben, d.h. dass die akute Toxizität gepuffert wird. Sorptionsisothermen bestätigten, dass Smektite die freien Konzentrationen herabsenkten. Transmissionselektronenmikroskopische Aufnahmen zeigten eine Aufweitung der Zwischenschichten dieser Tonminerale bei Zugabe von QAAC.QAACs führten zur Flockung der eingesetzten Tonminerale und es deutete sich auch ein Einfluss auf die Stabilität von Bodenaggregaten an. Im System Boden beeinflussen Aggregate mit ihrer internen Oberfläche, ihrer Größe und ihrer Mikrostuktur die Zugänglichkeit, die Retention und Sequestration von Schadstoffen.Deshalb ist es unser Anliegen, im Rahmen des Projektes den Einfluss der Mikroaggregat(MA)-bildung das Umweltverhalten und die Toxizität von auf QAAC, und umgekehrt, die Beeinflussung der QAAC von Mikroaggregierung von Bodenpartikeln durch QAAC zu klären.
Human pharmaceuticals are extensively studied and assessed before marketing approval. Since 2006, this also includes an assessment of environmental risks. In the European Union, this is based on the guideline on the environmental risk assessment of medicinal products for human use (EMEA/CHMP/SWP/4447/00 corr 2), which is currently under revision. For Germany, the German Environment Agency (UBA) is tasked with the evaluation of environmental risks of human pharmaceuticals. Applicants seeking approval of medicinal products need to submit fate and effect data, in case predicted environmental concentrations (PECs) exceed 10 ng/L in surface waters, or the substance is of specific concern through its mode of action or physico-chemical characteristics. Over the last decade, this regulatory work resulted in an internal agency database containing effect data on approximately 300 active pharmaceutical ingredients (APIs). A considerable part of this data is currently not publicly available due to property rights held by the respective applicants. The database was evaluated to draw conclusions on how the current assessment approach may be improved. The evaluation of aquatic effect data shows considerable variation in ecotoxic effect concentrations, but supports the current use of 10 ng/L as PEC action limit. For endocrine-active substances and antibiotics, a clear sensitivity profile was observed, which allows a more targeted assessment in the future. The conclusions drawn from terrestrial effect data are less clear, as the database itself is biased because information is only available for substances with high sorption. Further adaptations of the terrestrial assessment strategy, including action triggers, appear necessary. Fate data show a high persistence of many APIs: approximately 43% of all APIs are classified as very persistent; 12% of these show DT50 values in a range where abiotic or biotic degradation is not expected. Overall, the evaluation has shown that improvements of the current guideline are possible. © The Author(s) 2021
Based on the increased utilization of nanosilver (silver nanomaterials=AgNM) as antibacterial agent, there is the strong need to assess the potential environmental implication associated with its new application areas. In this study an exemplary environmental risk assessment (ERA) of AgNM applied in textiles was performed. Environmental exposure scenarios (via municipal sewage treatment plant (STP)) with wastewater supply from domestic homes) were developed for three different types of textiles equipped with AgNM. Based on these scenarios predicted environmental concentrations (PECs) were deduced for STPs and for the environmental compartments surface water, sediment as well as soil. These PECs were related to PNECs (predicted no effect concentrations). PNECs were deduced from results of ecotoxicity tests of a selected AgNM (NM-300K). Data on ecotoxicology were derived from various tests with activated sludge, cyanobacteria, algae, daphnids, fish, duckweed, macrophytes, chironomids, earthworms, terrestrial plants as well as soil microorganisms. Emission data for the AgNM NM-300K from textiles were derived from washing experiments. The performed ERA was based on the specifications defined in the ECHA Guidances on information requirements and chemical safety assessment. Based on the chosen scenarios and preconditions, no environmental risk of the AgNM NM-300K released from textiles was detected. Under conservative assumptions a risk quotient for surface water close to 1 indicated that the aquatic compartment may be affected by an increased emission of AgNM to the environment due to the high sensitivity of aquatic organisms to silver. Based on the successful retention of AgNM in the sewage sludge and the still ongoing continual application of sewage sludge on farmland it is recommended to introduce a threshold for total silver content in sewage sludge into the respective regulations. Regarding potential risk mitigation measures, it is emphasized to preferably directly introduce AgNM into the textile fiber since this will strongly minimize the release of AgNM during washing. If this is not possible due to technical limitations or other reasons, the introduction of a threshold level controlling the release of AgNM from textiles is suggested. It has to be noted that this study is a case study which is only valid for the investigated NM-300K and its potential application in textiles.Quelle: http://www.sciencedirect.com
The project is designed to improve hazard and risk assessment of chemical contaminants in soil at the ecosystem level using terrestrial model ecosystems (TMEs). TMEs consist of encased intact (non-homogenized) soil-cores that are extracted from field sites with the minimum of disturbance to the natural vegetation, soil microflora and fauna, and the layering of the soil inside the cores. The size of a soil-core will be between 17 and 20 cm in diameter and between 30 and 60 cm in depth. Parameters such as biological diversity and activity, cycling of essential elements, biodegradation of organic matter, biodegradation and accumulation of xenobiotic substances will be investigated to integrate structural and functional aspects of the soil environment. A key feature of the TME assemblage is that it allows determination of the potential fate and ecological effects of test substances in a replicated system of soil-cores. Four different soil types, representative of defined 'Euro-soils', will be used as terrestrial ecosystems in a ring-test performed by four participating European laboratories. Initially, the selected sites will be surveyed for species composition, and checked for homogeneity prior to soil-core extraction. After preparing the TME equipment and establishing the methods for measuring the various end-points a pre-test with a selected test substance will be performed. The test substance will be chosen after consultation and agreement with national and international competent authorities (eg Joint Research Centre, European Chemicals Bureau; Federal Environmental Agency of Germany) who are responsible for environmental risk assessments of existing and new chemicals. Based on the experience gained in the pre-test the TME main-test will be conducted in the following year in combination with a field study to validate the results from the TME test.Three treatment levels will be used, one of which is close to the predicted environmental concentration, one of which is 5 to 10 times higher and the control. After application of the test substance the test period will be at least 12 weeks and can be extended to one year. In order to minimize inter-laboratory variation, strict harmonization of equipment and experimental procedure will be rigorously applied and individual laboratories will handle certain designated tasks for all participants. The TME project firstly will provide improved effect data which help to evaluate single-species test results; secondly, experimentally gained fate data will allow significantly improved fate assessments; thirdly, the data gained on ecosystem functioning, which has been neglected so far in the environmental risk assessment of chemicals, may reveal indirect as well as synergistic or compensatory effects of a test substance at ecosystem level. The innovative step of the project will be to field-validate and ring-test the TME which is necessary before it can be integrated within ecologically relevant risk assessment
Seven-day composite effluent samples from a German monitoring campaign including 33 conventional wastewater treatment plants (WWTP) were analyzed for linear alkylbenzene sulfonates (LAS) and alkyl ethoxysulfates (AES) and were screened by wide-scope suspect screening for 1564 surfactants and their transformation products (TPs) by UHPLC-ESI-QTOF-MS. Corresponding seven-day composite influent samples of selected WWTPs showed high influent concentrations as well as very high removal rates for LAS and AES. However, average total LAS and AES effluent concentrations were still 14.4 ng/L and 0.57 ng/L, respectively. The LAS-byproducts di-alkyl tetralin sulfonates (DATSs), the TPs sulfophenyl alkyl carboxylic acids (SPACs) and sulfo-tetralin alkyl carboxylic acids (STACs) reached maximum effluent concentrations of 19 ng/L, 17 ng/L and 5.3 ng/L, respectively. In many cases the sum of the concentration of all LAS-related byproducts and TPs surpassed the concentration of the precursors. High concentrations of up to 7.4 ng/L were found for 41 polyethylenoglycol homologs. Quantified surfactants and their TPs and by-products together accounted for concentrations up to 82 ng/L in WWTP effluents. To determine the risk of individual surfactants and their mixtures, single homologs were grouped by a "weighted carbon number approach" to derive normalized Predicted No-Effect Concentrations (PNEC), based on experimental ecotoxicity data from existing risk assessments, complemented by suitable Quantitative Structure-Activity Relationships (QSAR) predictions. Predicted Environmental Concentrations (PEC) were derived by dividing effluent concentrations of surfactants by local dilution factors. Risks for all analyzed surfactants were below the commonly accepted PEC/PNEC ratio of 1 for single compounds, while contributions to mixture toxicity effects from background levels of LAS and DATS cannot be excluded. Maximum LAS concentrations exceeded half of its PNEC, which may trigger country-wide screening to investigate potential environmental risks. © 2019 Elsevier B.V. All rights reserved.
Das Institut für Umweltbiotechnologie bietet den Mitgliedern des COMET K2 Kompetenzzentrums die Durchführung von Biotests und die Methodenentwicklung auch für die Bestimmung der biologischen Abbaubarkeit an. Die während der letzten 14 Jahre aufgebaute Erfahrung kann für die Charakterisierung und zur Beschreibung des Umweltverhaltens von Schmierstoffen genutzt werden. Damit wird eine Risikoabschätzung dieser Produkte und der enthaltenen Substanzen möglich, welches auf Abbau- und Toxizitätsdaten beruht und damit die Anwendung, die unbeabsichtigte Freisetzung und allenfalls die Abfallbehandlung (H14 Kriterium der Europäischen Abfallliste 2000/532/EC) einschließt. Die Ökotoxizität eines Produkts wird mittels eines Sets an Biotests gemessen, in welchem repräsentative Testorganismen enthalten sind. Die dabei erfassten trophischen Ebenen sind: Bakterien (Vibrio fischeri), Algen (Pseudokirchneriella subcapitata, Chlorella sp.), Pilze (werden noch ausgewählt), Wasserflöhe (Daphnia magna), höhere Pflanzen (Lepidium sativum, Lemna minor), Regenwürmer (Eisenia sp. or Dendrobena sp.) und ein noch zu bestimmender Mutagenitätstest. Alle diese Biotests sind standardisiert und im praktischen Einsatz für Feststoffe, für eluierbare Anteile und für wasserlösliche oder wässrige Proben erprobt. Die typischen Messungen umfassen die akute und chronische Toxizität und erfasste Parameter sind im Einzelnen: Stoffwechselaktivität, Wachstum, Gewichtszunahme, Beweglichkeit, Überleben, Reproduktion und Mutagenität. Dosis-Wirkungs-Beziehungen werden für die Darstellung quantitativer Ergebnisse benötigt, um letztlich Endpunkte, wie EC- oder LC-Werte zu berechnen.
Im Zulassungsverfahren für Pflanzenschutzmittel (PSM) und im EU-Wirkstoffprogramm ist das Umweltbundesamt zuständig für die Belange des Naturhaushalts. Die Bewertung der Auswirkungen von PSM bzw. den darin enthaltenen Wirkstoffen auf dieses Schutzgut erfolgt nach Maßgabe der Datenanforderungen und Kriterien der Richtlinie 91/414/EWG. Für den Prüfbereich Boden weisen methodologische Fortentwicklungen der relevanten Prüfrichtlinien (u.a. Guidance Document 'Persistence in Soil' und 'Terrestrial Ecotoxicology') darauf hin, dass die Notwendigkeit einer grundlegend neuen Strategie bei der Ableitung von voraussichtlichen Umweltkonzentrationen (Predicted Environmental Concentration, PEC) in Böden besteht. Wurde im EU-Wirkstoffprogramm bisher angenommen, alle Wirkstoffe würden sich nach einer Applikation gleichmäßig in der obersten 5cm tiefen Bodenschicht verteilen, so soll zukünftig der spezifische Lebensraum der Bodenfauna bei der Ableitung von 'ökologisch relevanten' PECs berücksichtigt werden. Die Ausgangshypothese, dass Verhalten und Lebensformtyp standorttypischer Bodentiere Art und Dauer der Exposition ('Expositionsmodus') gegenüber PSM-Wirkstoffen entscheidend bestimmen, konnte bisher wissenschaftlich nicht untermauert werden. Zur Erarbeitung einer nationalen Position für die Risikobewertung von Bodenorganismen unter der zukünftigen EU-Pflanzenschutzmittelverordnung muss jedoch geklärt werden, ob der erwartete Zusammenhang zwischen der räumlichen Verteilung von 'Expositionsmodi', von PSM im Boden und dem Auftreten von ökotoxikologischen Wirkungen systematisch zu beobachten ist. Im Rahmen des F&E-Vorhabens sollen hierzu kontrollierte Freilanduntersuchungen mit folgenden Fragestellungen durchgeführt werden: - Sind räumliche Verteilungen von ökotoxikologischen Wirkungen für spezifische Bodentiergruppen zu beobachten? - Korreliert die räumliche Verteilung von Wirkstoffkonzentrationen im Boden mit der der beobachteten Effekte? - Kann weiterhin die mittlere usw.
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