Genetic alterations can unpredictably compromise the wellbeing of animals. Thus, more or less harmful phenotypes might appear in the animals used in research projects even when they are not subjected to experimental treatments. The severity classification of suffering has become an important issue since the implementation of Directive 2010/63/EU on the protection of animals used for scientific purposes. Accordingly, the breeding and maintenance of genetically altered (GA) animals which are likely to develop a harmful phenotype has to be authorized. However, a determination of the degree of severity is rather challenging due to the large variety of phenotypes. Here, the Working Group of Berlin Animal Welfare Officers (WG Berlin AWO) provides field-tested guidelines on severity assessment and classification of GA rodents. With a focus on basic welfare assessment and severity classification we provide a list of symptoms that have been classified as non-harmful, mild, moderate or severe burdens. Corresponding monitoring and refinement strategies as well as specific housing requirements have been compiled and are strongly recommended to improve hitherto applied breeding procedures and conditions. The document serves as a guide to determine the degree of severity for an observed phenotype. The aim is to support scientists, animal care takers, animal welfare bodies and competent authorities with this task, and thereby make an important contribution to a European harmonization of severity assessments for the continually increasing number of GA rodents.

The use of animals in research requires careful ethical consideration of whether the burden on the animals is justified. As one important part of the project evaluation, a harm–benefit analysis (HBA) must be carried out in order to approve projects in line with the EU Directive 2010/63/EU. This implies that harms and benefits must be assessed prospectively beforehand in order to weigh them. Although there are different methods of weighing, it is clear that an assessment of prospective harms and benefits is a precondition for any weighing procedure. In this context, projects that use genetically altered (GA) lines raise new issues. A unique challenge when using GA lines is the significant lack of knowledge in this context, making it difficult and sometimes impossible to estimate harm prospectively with sufficient certainty, since it is not predictable what sort of harm—if at all—the animals are going to experience. Therefore, this contribution aims to deal with the challenges of harm assessment in GA animals and their implications for welfare assessment and the HBA. A practical guideline is presented herein to serve as guidance for relevant harm factors and address the main challenges, particularly when dealing with uncertainties in the process of HBA.

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