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

Abstract

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 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.

Soil biodiversity data: Actual and potential use in European and national legislation

“…These are performed where a risk has been identified in lower-tier laboratory studies (usually focusing on earthworms (ISO (International Organization for Standardization), 1999), but sometimes and also for their post-registration monitoring (Hilbeck et al, 2008), including developing potential schema for soil monitoring activities (Ruf et al, 2013;Toschki et al, 2015). Monitoring of dung organism communities, especially dung flies and dung beetles, was recently proposed as part of the registration of veterinary pharmaceuticals (Adler et al, 2013). As far as is known today no actual monitoring of soil organism communities have been required by authorities in the context of GMO authorization or veterinary pharmaceuticals.…”

Nontarget effects of ivermectin residues on earthworms and springtails dwelling beneath dung of treated cattle in four countries

“…We recommend including soil organisms in field studies assessing side effects of veterinary pharmaceuticals only when effects were observed in lower‐tier, laboratory studies with soil organisms, in particular earthworms or springtails (for these organisms standard Organisation for Economic Co‐Operation and Development tests are available; e.g., Römbke et al ). Guidance concerning such work should include recommendations provided by Jochmann et al (see also Adler et al ). A detailed guidance document should be prepared according to the rules of the Organisation for Economic Co‐Operation and Development.…”

Effects of ivermectin application on the diversity and function of dung and soil fauna: Regulatory and scientific background information

“…If test results show that the veterinary medicinal product poses a significant level of risk to these organisms based on expected environmental concentrations of residues in dung and soil, International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products guidelines mandate the conduct of tier IIB tests. No guidance documents yet exist for tier IIB tests , which potentially could include additional requirements such as additional single‐species laboratory bioassays on dung organisms susceptible to residues, laboratory multiple species tests, and/or field tests to assess the fate and effect of veterinary medicinal product residues under natural conditions (the latter called tier C).…”

“…Seasonal variation in the abundance and biodiversity (= number of species) of dung beetles in southern France juxtaposed with possible treatment periods of farm animals (translated from Lumaret ; see also Adler et al ).…”