Current Topics of the National Committee for Animal Welfare

The National Committee has released several recommendations to the following current topics:

• Tägliche Inaugenscheinnahme von Versuchstieren
• Rechtliche Einstufung des Embryotransfers
• Weitergabe der Stellungnahme von Tierschutzbeauftragten an die Kommission nach § 15 Tierschutzgesetz
• Tierschutzgerechte Tötung von Föten bzw. Embryonen und tragender Muttertiere
• Darlegung der Berücksichtigung von Umweltbelangen im Tierversuchsantrag
• Nichttechnische Projektzusammenfassung (NTP) für Tierversuchsvorhaben im vereinfachten Genehmigungsverfahren

In addition, the National Committee for Animal Welfare is currently working on following topics:

•  “Surplus” Animals and the „Reasonable Cause“

Scientific establishments and competent authorities are still occupied by the issue of the “surplus” animals. According to § 1 S. 2 TierSchG it is not allowed to expose animals to any pain, suffering or lasting harm without a reasonable cause. This includes also the killing of laboratory animals. If a reasonable cause for the killing of animals is missing, criminal penalties could be the consequences according to § 17 Nr. 1 TierSchG.

In the course of generating genetically altered animal lines, regularly animals derive, which cannot be used for experiments due to an unwanted genotype and are, thus, being killed as surplus.

In 2022, the National Committee has again addressed this topic and released following publications dealing with the “reasonable cause” for killing surplus laboratory animals:

• EURL ECVAM Recommendation on Non-Animal-Derived Antibodies

In 2020, the EU Reference Laboratory for alternatives to animal testing EURL ECVAM has released a recommendation on non-animal-derived antibodies. A distinctive statement of this recommendation is that animals should no longer be used for the development and production of antibodies for research as well as for regulatory, diagnostic and therapeutic applications. In addition, EU countries should no longer authorize animal experiments for these purposes where robust, legitimate scientific justification is lacking.

This general statement was highly criticised by the scientific community and pharmaceutical industry. They argued that the use of animal-derived antibodies is still necessary as the new techniques using phagedisplay for the development and production of antibodies cannot replace animal experiments for all applications and that an absolute ban of animal-derived antibodies could seriously hamper biomedical research.

On meetings of the European National Committees it became clear that the EURL ECVAM is not only in Germany seen critically but also in other EU Member States.

Thus, the German National Committee decided to take part at a European working group under the lead of the Dutch National Committee, which wants to address the topic of animal-derived antibodies from a more differentiated perspective. The working group consists of several national and international experts on the field of the production and use of antibodies. The goal of the working group is to elaborate a common paper on the use of (non-)animal-derived antibodies, which is aiming to get a broad support by the European National Committees. The group will continue its work, which started in 2022, in 2023.

Over the last years the National Committee has addressed following issues:

• Feeding Genetically Modified Laboratory Animals to Other Animals

When breeding genetically modified laboratory rodents, many animals are born that cannot be used in the experiments, e.g. due to the wrong genotype or sex. According to the Animal Welfare Act, these animals may only be killed with an appropriate reason. A possible useful purpose could be feeding the previously killed rodents (especially mice) to other animals, e.g. birds of prey and snakes in zoo facilities. This requires that all measures have been taken to reduce the number of so-called surplus animals (see also Chmielewska et al. in NuR 37: 677 via the following link: https://link.springer.com/article/10.1007/s10357-015-2903-9 The feeding of laboratory animals to other animals is subject to various legal areas.

Goal: The legal assessment of the facts at hand should explain the relevant legal areas and the associated legal problems.

Result: An opinion is available here in German and also under the recommendations of the National Committee

• 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 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 for the Protection of Animals used for Experiments or other Scientific Purposes (TierSchVersV), this regulation is also applicable to larvae of vertebrates as soon as they feed independently. In consequence now a severity assessment has to be carried out for all genetically altered fish lines. 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). The results of this work were included in the revised EU Working Document on genetically altered animals, which can be downloaded here.

• "Reasonable Cause" to Kill Surplus Animals when Breeding Genetically Altered Laboratory Animals

According to the amendment of the Animal Welfare Act the breeding of genetically altered animals is categorized as an animal experiment if there is a possible expectation that 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). The legal amendment with the new obligation to specify how many animals are needed for breeding showed the evidence of a high number of surplus animals. The Animal Welfare Act stipulates that there must be a “reasonable cause” for the killing of these surplus animals. The legal term "reasonable cause" is not defined by the German Animal Welfare Act.

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 in German 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 Regulation for the Protection of Animals used for Experiments or for other Scientific Purposes (Tierschutz-Versuchstierverordnung - TierSchVersV), scientists have been faced with some uncertainties regarding the authorisation to perform anesthesia of animals used in experiments. One of the issues that need clarification is whether laboratory technicians may acquire the necessary skills to anaesthetise laboratory animals after they have completed their professional training. Some professional groups who had under the old legislation the permission to perform this task under supervision would now no longer be permitted to perform anesthesia, and this has resulted in legal uncertainties.

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 § 7 Para. 2 No. 2 of the German Animal Welfare Act (Tierschutzgesetz - TierSchG), the breeding of animals can be classified as  an animal experiment if the offspring may 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 regarding the legal situation in the case of interventions for the purpose of genotyping (in particular the so-called tail snipping).

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

• Legal Aspects of the Use of Tamoxifen in Experimental Animals

The use of pharmacologically active substances in laboratory animals is subject to several areas of law, in particular laboratory animal law and pharmaceutical law. Various legal questions are raised, especially when using tamoxifen for conditional gene switching, including the extent to which the provisions of drug law are applicable.

Goal: The legal classification is intended to show the problems that arise in laboratory animal law in this context and to propose practical solutions.

Result: A summary of the legal opinion in German was published in 2019 by Chmielewska et al. in NuR 41: 26.

Link to publication: https://link.springer.com/content/pdf/10.1007/s10357-018-3457-4.pdf

• Workshop on Demonstrating Ethical Justification in Animal Experiment Applications

In October 2019, the National Committee for the Protection of Laboratory Animals held a first internal workshop at the BfR with representatives of science, law and ethics as well as the licensing authorities for animal experiments in order to reflect on the presentation of ethical justification regarding the applications of animal experiments. The requirement to specify both the content and the procedure for assessing ethical justification was expressed in inquiries to the National Committee. Discussion during the workshop included the current status and the problems for practical implementation of the provisions of the Animal Welfare Act, as well as starting points for improvement.

In Germany, the applicant has to explain scientifically that the expected pain, suffering and harm to the animals are ethically justified considering the purpose of the experiment in order to get an approval for an animal experiment. This approach is corresponding with the harm-benefit analysis required in Directive 2010/63/EU. However, the German legal provisions do not contain any conclusive instructions for this explanation and it is not clear, how the applicant should present the content. The working paper on project assessment and retrospective assessment (Brussels, September 18/19, 2013 by the EU Commission (https://ec.europa.eu/environment/chemicals/lab_animals/pdf/guidance/  project_evaluation/de.pdf)) offers recommendations, which have not yet lead to a sufficient implementation in practice. So far, there are no scientific criteria regarding the evaluation of the ethical justification or the harm-benefit analysis in project applications. This may lead to possible divergences regarding the requirements of the German law and the project applications in Germany, therefore also within the European Union.

On October 11 2019, the National Committee convened a one-day, internal workshop on the subject of “Assessment and presentation of ethical acceptability in animal experiment applications” to discuss the content and procedure of the ethical acceptability test.

The workshop showed that all those involved perceive the current situation to be unsatisfactory and that procedural improvements are necessary. The participants agreed that further development should focus on establishing a procedure that is as uniform as possible for both applicants and competent authorities. It should contain clear definitions and structures without additional bureaucracy. An argumentative assessment of the ethical acceptability of the applications, guided by a set of criteria, is essential in order to meet scientific standards in ethics. A possible solution would be to develop a guideline for demonstrating ethical justification as part of a cooperation project lead by BfR and to test and further develop it in a pilot project with the participation of various stakeholders.