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Decision trees for managing genetically burdened laboratory animal lines under Directive 2010/63/EU
Myhailo Reshetnykov1, Jan Baumgart1,2
1Translational Animal Research Center (TARC), University Medical Center of the Johannes Gutenberg-University Mainz, Germany.
Laboratory Animals
|July 31, 2026
Summary
Navigating ethical and regulatory challenges for genetically burdened laboratory animal lines is crucial. Decision trees offer a structured framework for consistent documentation and authorization of procedures involving these animals, applicable across jurisdictions.
Area of Science:
- Laboratory Animal Science
- Bioethics
- Regulatory Affairs
Background:
- Genetically modified (GM) animals with harmful phenotypes (genetically burdened lines) present unique ethical and regulatory challenges in research settings.
- European Union Directive 2010/63/EU mandates project authorization and severity assessment for GM animals with harmful phenotypes and related breeding.
- Practical questions arise regarding the definition of a regulated 'procedure,' documentation of killing, tissue collection, and animal reuse.
Purpose of the Study:
- To provide a structured and reproducible framework for consistent decision-making concerning genetically burdened laboratory animal lines.
- To address practical questions regarding authorization, documentation, and severity assessment for these animals.
- To offer a jurisdiction-neutral decision logic adaptable to various regulatory systems.
Main Methods:
- Development of decision trees to guide researchers and animal facilities.
- Illustration of decision trees using the German implementation of Directive 2010/63/EU (German Animal Welfare Act and Ordinance).
- Analysis of EU terminology for 'continued use' versus 'reuse' of animals.
Main Results:
- Decision trees provide a clear framework for determining when breeding constitutes a regulated procedure.
- Guidance is offered on appropriate documentation for killing, tissue collection, and reuse of genetically burdened animals.
- The decision logic is designed for adaptability to different national and international regulatory contexts.
Conclusions:
- The proposed decision trees enhance consistency and reproducibility in managing genetically burdened animal lines.
- This framework supports compliance with ethical standards and regulatory requirements, such as Directive 2010/63/EU.
- The adaptable decision logic facilitates consistent application across diverse regulatory landscapes for laboratory animal welfare.
