List of topics, the National Committee is currently working on or that have been recently completed:
- Severity assessment of genetically altered laboratory fish
Since the amendment of the Animal Welfare Act (TierSchG; Federal Gazette I p. 1308 dated 4 July 2013), the breeding of genetically altered animals has been defined as an animal experiment requiring approval if it is to be expected that the progeny may experience pain, suffering or harm due to the genetic alteration (§ 7 Para. 2 in conjunction with § 7a Para. 5 TierSchG)). In accordance with § 14 No. 1 of the Regulation on the protection of animals used for experiments or other scientific purposes (TierSchVersV), these regulations are also applicable to the larvae of vertebrates as soon as they feed independently. The consequence is that a severity assessment now has to be completed in genetically altered fish species. A BfR workshop on this topic took place in June 2015 with experts and representatives of the competent authorities.
Objective of the workshop: To define criteria and to compile forms for the severity assessment of genetically altered fish contributing to a nationwide harmonisation.
Result: The severity assessment forms including general information can be downloaded on the subpage “Recommendations of the National Committee”. A summary of the results was published 2016 by Bert et al. in EMBO J 35(11):1151-4 (link to the publication).
- "Reasonable cause" to kill surplus animals when breeding genetically altered laboratory animals
According to the new legislation, the breeding of genetically altered animals is subject to approval if animals are born that may experience pain, suffering or harm as a result of the genetic alternation (§ 7 Para. 2 in conjunction with § 7a Para. 5 TierSchG). In the course of this legal amendment and the resulting obligation to specify how many animals are needed for breeding, the high number of surplus animals has become apparent. The Animal Welfare Act stipulates that there must be a reasonable cause for the killing of these surplus animals. The legislator has not, however, defined what is considered to be "reasonable cause".
Objective: To draft a legal opinion explaining under which circumstances it can be justified to kill surplus animals.
Result: A summary of the legal opinion was published 2015 by Chmielewska et al. in NuR 37: 677 (link to the publication).
- Qualifications for performing anaesthesia and analgesia in laboratory animals
Following the enactment of the regulations on the welfare of animals used for experiments or for other scientific purposes (Tierschutz-Versuchstierverordnung - TierSchVersV), scientists have faced with some uncertainties regarding the authorisation to anaesthetise animals used in experiments, especially in regard to technicians. An issue to clarify is whether technicians are allowed to acquire the necessary skills to anaesthetise laboratory animals after they have completed their training (and not as a part of their professional degree, as stated in the regulation). Some occupational groups who have to date been permitted to perform this task at least under supervision would now no longer be permitted to perform anaesthesia, and this has resulted in legal uncertainty.
Objective: preparation of a legal opinion
Outcome: a summary of the legal opinion was published in 2017 by Chmielewska et al. in NuR 39: 538.
Link to publication (in German): https://link.springer.com/content/pdf/10.1007%2Fs10357-017-3212-2.pdf
- Legal classification of the breeding of animals with a modified immune system as well as of genotyping methods
According to Article 7 Para. 2 No. 2 of the amended German Animal Welfare Act (Tierschutzgesetz - TierSchG), the breeding of animals can also constitute an "animal experiment" if the offspring can experience pain, suffering or harm. This raises the question of the legal classification of the breeding of immune-deficient animals. There is still disagreement in practice as to whether the above falls within the scope of an "animal experiment" as defined by the German Animal Welfare Act.
There are also uncertainties with regard to the legal situation based on the German Animal Welfare Act in the case of the interventions on animals (in particular so-called tail-tip biopsy) for the purpose of genotyping.
Objective: preparation of a legal opinion to clarify the aforementioned issues.
Outcome: a summary of the legal opinion was published in 2017 by Chmielewska et al. in NuR 39: 385.
Link to publication (in German): https://link.springer.com/content/pdf/10.1007%2Fs10357-017-3190-4.pdf
- Use of pharmacological active substances/medicines in laboratory animals
This text version is a translation of the original German text which is the only legally binding version.