11.

Genetically altered animals 11.1. For the purposes of statistical reporting, ‘genetically altered animals’ refer to either of the following: (a) genetically modified (such as transgenic, knock-out and other forms of genetic alteration) and induced mutant animals (irrespective of the type of mutation); (b) animals with spontaneous deleterious mutations maintained for research for that specific genotype. 11.2. Genetically altered animals shall be reported in any of the following cases: (a) when used for the creation of a new line; (b) when used for the maintenance of an established line with an intended and exhibited harmful phenotype (see section B.10.7); (c) when used in procedures other than maintenance of a line. 11.3. All animals carrying the genetic alteration shall be reported during the creation of a new line. In addition, those used for superovulation, vasectomy, embryo implantation shall be reported (these may or may not be genetically altered themselves). 11.4. Genetically normal animals (wild type offspring) produced as a result of creation of a new genetically altered line shall not be reported in annual statistics, unless the animal has been genotyped (genetic characterisation/tissue sampling) using an invasive method which was not carried out for the purposes of identification/marking of the animal. Genetically normal animals (wild type offspring) not reported in annual statistics are covered in the five-year implementation report as described in Annex II. 11.5. In the category ‘Purposes’ as set out in Part A of this Annex, the animals used for the creation of a new genetically altered line shall be reported in the respective category for which the line is being created (generally expected to be ‘basic research’ or ‘translational and applied research’). 11.6. A new strain or line of genetically altered animals is considered to be ‘established’ where transmission of the genetic alteration is stable, which will be a minimum of two generations, and a welfare assessment has been completed. 11.7. The welfare assessment will determine if the newly created line is expected to have an intended harmful phenotype and, if this is the case, the animals from this point onwards shall be reported under category ‘Maintenance of colonies of established genetically altered animals, not used in other procedures’ – or, if appropriate, in the other procedures they are being used for. Such animals include, amongst others, those that require a specific bio-secure environment (for example, special housing arrangements to protect animals that are particularly sensitive to infection as a consequence of the gene alteration) or additional care beyond that required for conventional animals to maintain their health and well-being. 11.8. If the welfare assessment concludes that the line is not expected to have a harmful phenotype, its breeding falls outside the scope of a procedure and no longer needs to be reported. Such animals include, amongst others, inducible and cre-lox lines, which require an active intervention for the harmful phenotype to be expressed. 11.9. ‘Maintenance of colonies of established genetically altered animals, not used in other procedures’ 11.9.1. This category contains the animals required for the maintenance of colonies of genetically altered animals of established lines with an intended harmful phenotype and which have exhibited pain, suffering, distress or lasting harm as a consequence of the harmful genotype. The intended purpose for which the line is being maintained is not recorded. 11.9.2. This category also includes genetically altered animals during maintenance of an established line, irrespective of whether the line is of intended non-harmful or harmful phenotype, that have been subject to invasive genotyping (genetic characterisation/tissue sampling). See section B.10.7. 11.10. All genetically altered animals which are used in other procedures (not for the creation or maintenance of a genetically altered line) shall be reported under their respective purposes (the same way as any non-genetically altered animal). These animals may or may not exhibit a harmful phenotype. 11.11. Genetically altered animals, expressing a harmful phenotype, and killed for their organs and tissues, shall be reported under the respective primary purposes for which the organs/tissues were used.