Abstract
In September 2015, the Dutch Minister of Agriculture requested the NCad (Netherlands National Committee for the protection of animals used for scientific purposes) to advise on methods of killing for laboratory animals that are considered to be at least as humane as the methods set out in European Directive 2010/63/EU. The Dutch Minister of Agriculture also asked for the Netherlands Food and Consumer Product Safety Authority (NVWA) to be given guidance in assessing such alternative methods of killing by providing elements that must comprise a scientific justification.
The Directive provides two possibilities for deviating from the prescribed methods of killing:
The purpose of the procedure cannot be achieved by the use of a method of killing set out in the Directive. The Central Authority for Scientific Procedures on Animals (CCD) can, on the basis of a scientific justification submitted by the applicant, decide to grant a project licence for a project in which a different method of killing is proposed than those set out in the Directive. The acceptance of such ‘divergent’ methods of killing is limited to the specific research project for which the licence is granted. The other method of killing is considered to be at least as humane as the appropriate methods set out in the Directive. On behalf of the Minister, the NVWA can, on the basis of a scientific justification submitted by the applicant, grant the establishment licensee an exemption or dispensation for a structural (i.e. outside-the-project) use of the alternative method of killing.
The present advice of the NCad focuses on the second option. At the same time, it may also offer guidance for the CCD, as, if a researcher opts for a divergent method of killing for scientific reasons, the CCD will review whether that method is also acceptable from an animal welfare perspective.
For the purpose of assessing whether an alternative method of killing is at least as humane with regard to the individual animal as the current legally permitted methods, the NCad advises using the following elements:
– rapidity of loss of consciousness – degree of pain, suffering and distress associated with (the entire experience relating to) the killing
If it is intended to be used for groups of animals, the method of killing should be assessed on the basis of the individual animal within that group with the highest expected degree of pain, suffering and distress.
The NCad recommends performing the assessment of the alternative method of killing in the following way.
The applicant for an exemption or dispensation submits to the NVWA, on the basis of a Synthesis of Evidence evaluation, data (also from the literature) demonstrating that with regard to the two elements stated above, the method is at least as humane as the current prescribed methods. This analysis should be based on relevant (or as relevant as possible) measurable parameters for and clinical observations (such as regarding behaviour) of the animals to which the application relates. Experts can compare those data with the available data for the prescribed methods of killing. If there are no data in the literature or a Synthesis of Evidence evaluation provides insufficient clarification for an assessment of the request for an exemption or dispensation, exploratory animal studies should be carried out in consultation with the NVWA (and after a project licence has been granted by the CCD), to add the missing data on the parameters relevant to welfare. The study (including ‘negative’ results) is required to be published in an open access, peer-reviewed scientific journal, in accordance with the ARRIVE Guidelines. If the NVWA assesses favourably the data in the literature and a possible exploratory study, the NVWA can grant a dispensation for a defined period. The dispensation is granted subject to the condition that the applicant must first arrange for a scaled-up practical test to be conducted to ascertain the functionality of the alternative method of killing under the conditions that apply in practice (validate). As soon as the alternative method has been demonstrated to be at least as humane as the appropriate methods set out in the Directive, the NVWA should issue a generally applicable exemption for it.
Active sharing of data on methods of killing and alternative methods makes it possible for knowledge to be used effectively and the animal procedures to be Refined. The NCad recommends making centrally available the conditions for dispensation applied by the NVWA and data on the exemptions granted for alternative methods of killing, preferably in the data warehouse for laboratory animal use and 3R developments recommended previously by the NCad. The Naturally, privacy protection and market positions should duly be taken into account. The Minister is also advised to promote knowledge sharing between the NVWA and CCD.
The NCad further recommends that the Animal Welfare Bodies (IvDs) should not only act in their legal role of sharing knowledge within the body concerned on humane methods of killing, refinement of these methods and related topics, but that they are also stimulated to share this knowledge between them. Licensees should, in turn, be aware of their obligation to have professionally competent employees.
The NCad has found that the rationale for the methods of killing set out in the annex (or text) of the European Directive is not clear. Therefore the NCad advises the Minister to propose that the evaluation of the Directive planned by the European Commission should also focus on the degree of scientific substantiation of the methods of killing currently prescribed in it. An evaluation of the degree to which the package of permitted methods of killing is adequate for the ways in which laboratory animals are currently used in practice should likewise be part of the evaluation of the Directive.