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Due to their genetic alteration, genetically altered mice
can experience pain, distress or harm. The BfR developed
a catalogue of criteria to determine severity classification.
Criteria for assessment of severity
of genetically altered laboratory animals
One of the new provisions of the Animal Welfare Act re-
vised in 2013 stipulates that even the breeding of ge-
netically altered animals is regarded as an animal experi-
ment which requires authorisation. The premise is that,
due to their genetic alteration, the animals are likely to
experience pain, distress or harm.
To determine the stress levels of animals and establish
suitable countermeasures, scientists and approval au-
thorities require the appropriate criteria and specifica-
tions. To this end, in collaboration with scientists and rep-
resentatives of the authorities, the national committee for
the protection of animals used for scientific purposes,
whose duties are performed by the BfR, developed a first
catalogue of criteria for severity classification of geneti-
cally altered mouse lines in 2013 (see BfR Annual Report
2013). This catalogue of criteria is already used nation-
wide.
In order to pay due consideration to the scientific pro-
gress, it is necessary to continuously further develop the
catalogue of criteria. To do so, a workshop was held at
the BfR in October 2014 at which experts shared and
discussed their experience with the application of the
criteria for severity classification. The updated document
now takes into account possible indications of embryonal
mortality in the evaluation of a new-born litter of geneti-
cally altered mice. This was done because the provisions
of the Animal Welfare Act now include the foetuses of
mammals in the last third of their normal development
before birth. The assessment of severity of the dams is
also taken into account in this way.
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In order to take new information on the severity experienced
by laboratory animals into account, it is necessary to con-
tinuously develop the criteria catalogue, which was compiled
in 2013 and is applied throughout Germany.
For future workshops, the plan is to develop special cata-
logues of criteria on the assessment of severity of geneti-
cally altered fish and other animal species.
Alternatives to Animal Experiments
