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Veröffentlichung New Test Strategy for Dung Beetles During the Authorization Process of Parasiticides(2013) Adler, Nicole; Bachmann, Jean; Römbke, JörgAccording to European legislation, an environmental risk assessment (ERA) of veterinary medicinal products (VMPs) for dung fauna is required in the authorization process, if the substance acts as a parasiticide for the treatment of pasture animals. In the past, however, the demonstration of the environmental safety of those VMPs for dung fauna was strongly hampered by the fact that no standardized tests were available. Therefore, starting with recommendations from the Society of Environmental Toxicology and Chemistry (SETAC) advisory group, dung organism toxicity test standardization (DOTTS) test systems for phase II Tier A standardized tests on the mortality of dung fly and dung beetle larvae were developed and published by the Organisation for Economic Co-operation and Development (OECD) in 2008 and 2010. If a risk is identified for dung organisms in phase II Tier A of the ERA process, further tests are required for Tier B. So far, however, no advice is given for such studies in the existing guidelines. Therefore, 4 workshops took place between 2007 and 2009 with international dung fauna experts (Aveiro-Group) to find an appropriate test strategy for dung fauna organisms beyond Tier A mortality testing. For the first time, 2 different Tier B extended laboratory test approaches for dung beetles and test strategies for scenarios beyond Tier B are described in more detail. In case the risk assessment is still not clear, further options for Tier C (i.e., field studies) or Tier D (modeling) are briefly presented. Finally, the role of uncertainty and variability of test results is discussed, including recommendations for assessment factors for the different tiers to be used when assessing the risk of VMPs on dung organisms. The approach, especially the test strategy, will help industry, consultants, and assessors appropriately assess the environmental risk assessments during the authorization procedure of parasiticides. Integr Environ Assess Manag 2013;9:524-530. © 2013 SETACVeröffentlichung Environmental fate and effects assessment of human pharmaceuticals: lessons learnt from regulatory data(2021) Gildemeister, Daniela; Hein, Arne; Schröder, Patrick; Bachmann, Jean; Schwarz, SimonHuman 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