Considerations for a European animal welfare standard to evaluate adverse phenotypes in teleost fish

Fish, in particular genetically modified zebrafish, are important model organisms for biomedical research and research into human diseases. The European Directive 2010/63/EU on the protection of animals used for scientific purposes entails that genetically altered vertebrates need to be assessed for pain, suffering, distress, or lasting harm (collectively referred to here as “adverse phenotypes”). If such phenotypes are present, maintenance of genetically altered animals is now subject to project authorization. As genetically altered fish are commonly imported into the EU and exchanged between laboratories, fish lines should be classified consistently. To this end, the German Federal Institute for Risk Assessment (BfR) organized a workshop in June 2015 to define criteria for assessing genetically induced adverse phenotypes in fish. Here, we describe the Workshop's considerations that guided the design of dedicated evaluation sheets. We believe that broad use of these evaluation sheets and the explanatory notes associated with them can contribute substantially to harmonizing how teleost fish phenotypes are assessed across Europe. In our view, this would protect both animal welfare and ensure progress in biomedical research. Across Europe, welfare of laboratory animals is a growing public concern (Ormandy & Schuppli, 2014). Yet, a majority of European citizens is willing to accept animal experimentation to promote biomedical progress (http://ec.europa.eu/public\_opinion/archives/ebs/ebs\_340_en.pdf). The spirit of the European Directive 2010/63/EU on the protection of animals used for scientific purposes, which has been implemented by all EU member states only last year, reflects these attitudes: Recital 10 of the Directive states that the final goal is to phase out all animal testing, but it also acknowledges that animal experiments are still needed to advance research and to safeguard human, animal, and environmental health (http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32010L0063&from=EN). To that end, all member states agreed on a high standard of animal welfare in …