John Wiley & Sons, Ltd.

New test strategy for dung beetles during the authorization process of parasiticides

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According 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 SETAC advisory group DOTTS (Dung Organism Toxicity Test Standardization) test systems for phase II Tier A standardized tests on the mortality of dung fly and dung beetle larvae were developed and published by 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. But so far no advice is given for such studies in the existing guidelines. Therefore, four workshops took place between 2007 and 2009 with international dung fauna experts (Aveiro‐Group) in order to find an appropriate test strategy for dung fauna organisms beyond Tier A mortality testing. For the first time two different Tier B extended laboratory test approaches for dung beetles and test strategies for scenarios beyond Tier B are described here 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) is 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 SETAC

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