Basic

Question 1

3 R’s and their authors

Answer 1

Russell and Burch, 1959:

• Replacement
• Reduction
• Refinement

Question 2

Three types of licenses:

Answer 2

• art 9 - people who design experiments
• art 12 - people who perform experiments
• art 14 - animal welfare officers

Question 3

Housing/environmental features to be kept constant during an experiment:

Answer 3

• cage size
• cage mates
• odors
• bedding
• temperature
• light
• sound
• pathogens
• ventilation

Question 4

Directive EU/2010/63

Answer 4

• adopted Sep 2010
• based on the principle of the 3 R’s
• minimum standards for housing and care

Question 5

Wider scope of directive EU/2010/63

Answer 5

• includes foetuses of mammalian species in their last trimester of development
• includes cephalopods

Question 6

The Netherlands: Experiments on Animals Act (EAA)

Answer 6

• 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)

Question 7

Definition of a procedure EU/2010/63 animal experiment (scope)

Answer 7

• 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

Question 8

NEAA - aims that are allowed

Answer 8

• 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.

Question 9

Structure (types of demands) of the Experiments on Animals Act

Answer 9

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

Question 10

EAA demands concerning infrastructure/procedures

Answer 10

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

Question 11

EAA demands concerning relevant personnel

Answer 11

• 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:

Question 12

EAA demands concerning performance: Research plan

Answer 12

• 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)

Question 13

Perhaps the best way to approach the problem of reduction:

Answer 13

• attempt to reduce the variance between experimental animals