3 R’s and their authors
Russell and Burch, 1959:
- Replacement
- Reduction
- Refinement
Three types of licenses:
- art 9 - people who design experiments
- art 12 - people who perform experiments
- art 14 - animal welfare officers
Housing/environmental features to be kept constant during an experiment:
- cage size
- cage mates
- odors
- bedding
- temperature
- light
- sound
- pathogens
- ventilation
Directive EU/2010/63
- adopted Sep 2010
- based on the principle of the 3 R’s
- minimum standards for housing and care
Wider scope of directive EU/2010/63
- includes foetuses of mammalian species in their last trimester of development
- includes cephalopods
The Netherlands: Experiments on Animals Act (EAA)
- still not in force
- section 1a: animal has intrinsic value
- forbidden to perform animal experiments without a license
- Includes the killing of animals solely for the use of their organs or tissues for purpose (NEAA)
Definition of a procedure EU/2010/63 animal experiment (scope)
- any use, invasive or non-invasive of an animal
= Chordates (non-human Vertebrates + cyclostomata) and Cephalopods including independently feeding larval forms and foetal forms (mammals last 1/3th of development)+ possibly other invertebrates - for experimental or other scientific purposes or educational purposes,
- which may cause a level of pain, suffering, fear or lasting harm
≥ the introduction of a needle according good veterinary practice (GVP) - includes breeding resulting in the birth or hatching of an animal or the creation and maintenance of a genetically modified animal line in any such condition
- excludes the killing of animals solely for the use of their organs or tissues
- NEAA Includes the killing of animals solely for the use of their organs or tissues for purpose
NEAA - aims that are allowed
- basic research;
- translational or applied research with aims:
- the avoidance, prevention, diagnosis or treatment of disease, ill-health or other abnormality or their effects in human beings, animals or plants;
- physiological conditions in humans, animals or plants; or
- welfare of animals and the improvement of the production conditions for animals reared for agricultural purposes;
- development, manufacture or testing of the quality, effectiveness and safety of drugs, foodstuffs and feed-stuffs and other substances or products;
- protection of the natural environment in the interests of the health or welfare of human beings or animals;
- research aimed at preservation of the species;
- higher education, or training for the acquisition, maintenance or improvement of vocational skills;
- forensic inquiries.
Structure (types of demands) of the Experiments on Animals Act
1 - Demands concerning infrastructure /procedures
2- Demands concerning relevant personnel
3- Demands concerning animal experiments
- Research plan
- Ethical review (AEC)
4- Statistics
5- Internal and external inspection
EAA demands concerning infrastructure/procedures
Housing
Size, bedding, nesting materials, T, RH, light,……….
Daily care, feed, water, treatment of illness,…..
Administration
Registration of animals and experiments, research plan, work protocol, welfare journal
EU 2010-63: evaluation afterwards (success, discomfort, alternatives; NL CoP )
At least severe discomfort or use of non-human primates
EAA demands concerning relevant personnel
• Experimental animal care and treatment (sect.12/ 13c&13f) Performer of project (10a1)& euthanasia
Experimental animal caretaker: professional education level 3
Biotechnician or biotechnologist: professional education level 4
Biological and Medical Lab. Research 4 years (sect 12 EAA certificate)
Veterinary surgeon.
• Researcher (sect 9) Performer of project (10a1?)
Education ……….? :
MSc with >500 hours Biological Science + Dutch laboratory animal science course comparable to FELASA level C
• Animal welfare officer (sect. 14) Internal Inspector?13f/14
Designated Veterinarian+ Animal welfare officer : Veterinary surgeon, medical doctor, biologist
Education & training 52 weeks MSc
Advising member of
• Animal welfare body (including designated personnel with focus on animal care & research) Sect 14a-c:
EAA demands concerning performance: Research plan
• Responsibility of the researcher (sect.9)
• Scientifically reviewed
• Submit to the AWB on behalf of the licence holder /user
• User=> CCAE=>Animal Experiment Committee (=AEC)
• Describe (e.g.)
Competence personnel: certified and skilled/ experience (sect. 9 and 12/ 13c &13f)
Number and source of animals (sect. 10 and 11 )
Housing and care (sect. 12/13f)
Anaesthesia, analgesia and euthanasia (sect. 13-13c)
Risk of discomfort (refinement sect. 10; humane endpoints sect. 13-13c)
Perhaps the best way to approach the problem of reduction:
- attempt to reduce the variance between experimental animals
