Classification and reporting of severity experienced by animals used in scientific procedures: FELASA/ECLAM/ESLAV Working Group report

Abstract

Directive 2010/63/EU introduced requirements for the classification of the severity of procedures to be applied during the project authorisation process to use animals in scientific procedures and also to report actual severity experienced by each animal used in such procedures. These requirements offer opportunities during the design, conduct and reporting of procedures to consider the adverse effects of procedures and how these can be reduced to minimize the welfare consequences for the animals. Better recording and reporting of adverse effects should also help in highlighting priorities for refinement of future similar procedures and benchmarking good practice. Reporting of actual severity should help inform the public of the relative severity of different areas of scientific research and, over time, may show trends regarding refinement. Consistency of assignment of severity categories across Member States is a key requirement, particularly if re-use is considered, or the safeguard clause is to be invoked. The examples of severity classification given in Annex VIII are limited in number, and have little descriptive power to aid assignment. Additionally, the examples given often relate to the procedure and do not attempt to assess the outcome, such as adverse effects that may occur. The aim of this report is to deliver guidance on the assignment of severity, both prospectively and at the end of a procedure. A number of animal models, in current use, have been used to illustrate the severity assessment process from inception of the project, through monitoring during the course of the procedure to the final assessment of actual severity at the end of the procedure (Appendix 1).

Retrospective Assessment of Animals Experimentation Projects in Romania – A Critical Analysis of Non-Technical Summaries

“…Severe projects / procedures should be accepted only exceptionally, if the benefits are significant and refinement techniques are not available. As in the rest of the EU countries, the severity assessment is a problem, and it has been established that severity degree will be described and given for each procedure (Smith et al, 2018).…”

One score to rule them all: severity assessment in laboratory mice

“…We have developed a tool that enables evidence-based severity assessment. With the algorithm presented, an arbitrary number of outcome variables can be used to compute a composite score for welfare assessment and severity grading 17–19 . To our knowledge, this is the first attempt in preclinical science to combine phenotypical data using matrices of standardized differences to weigh variable contributions as a means for obtaining a measure for relative severity grades.…”

Control of Zootechnology Leads to Improved Cuttlefish (Sepia officinalis, L.) Reproduction Performance up to Pre-industrial Levels

“…This result indicates that bottom areas are clearly vital for the proper growth of this species in captivity and that the present density of 24 cuttlefish breeders per tank is suitable. On the other hand, considering a retrospective severity analysis (Smith D. et al, 2018), the nonnatural mortality observed during the growth stage raises issues related to the welfare of cuttlefish in this kind of studies. Thus, despite Directive 2010/63/EU provide exemption for studies carried out for veterinary and zootechnical purposes, we believe that the cephalopod community should consider prospective severity assessment analysis to be carried out in all instances (Smith D. et al, 2018;Cooke et al, 2019) and the application of the PREPARE guidelines (Smith A.J.…”