Legislation

Question 1

Where can you find the present legislation?

Answer 1

Denmark: retsinformation.dk
EU: EUR-lex.dk

Question 2

EU directive of the protection of animals used for experimental and other scientific purposes

Caring for animals aiming for better science

Answer 2

The law every EU member state must follow, the members will implement the EU law through national legislation.
- appendixes: detailed descriptions of the law

it is allowed the member states to have stricter rules if all ready agreed in 1986.

An additional guide for implementing the EU directive in the member states was published in 2013: Caring for animals aiming for better science: PROJECT EVALUATION AND RETROSPECTIVE ASSESSMENT
written by an expert working group established by the EU commission

Question 3

Danish legislation regulating the scientific use of animals

Answer 3

The animal experimentation act (Dyreforsøgsloven)
- The Danish implementation of the EU directive
- In general describing the responsibilities and the main points in the Directive

The animal experimentation order (Dyreforsøgsbekendtgørelsen)
- a detailed description of what to do when breeding/using/working with experimental animals

Question 4

Demands for an animal experimentation

Answer 4

An animal experiment is performed if the needle criteria is met

Must be:
- licensed
- beneficial
- animals must be necessary
- (max limit) not cause: strong pain/intensive fear and intensive suffering
performed by: qualified staff, in proper settings on destination bred animals (breeders with license)

Question 5

The Danish legislation - the 3 specific protecting the animals

Answer 5

The animal welfare act - protect all animals

The animal experimentation act - covering animals used in science/teaching/for blood products
- a general legislation - the Minister for Food, Agriculture and Fisheries is responsible for delegating the making of more detailed rules

The animal experimentation order - a detail description of facility requirements, how to take care of the animals, what educations for care takes ect. Annexes as in the EU-directive - 1: which animals must be bred by breeders, 2: care and accommodation of animals, 3: killing animals, 4: severity classification

Question 6

The competent authority in Denmark:
- inspections
- accreditation of facilities

Answer 6

The animal experiment inspectorate (Dyreforsøgstilsynet)

Is placed under the Ministry of Food and Environment

Question 7

The competent authority in Denmark issuing the licenses (animal experiments and facilities)?

Answer 7

Council for animal experimentation (the animal experimentation board (Rådet for dyreforsøg))

11 members - 1 judge and 10 laymen/experts

Question 8

The National Committee for Animal Experimentation and Alternatives

Answer 8

According to the EU-directive a member stat must have this committee

7 experts in the 3Rs - administered by the Ministry of Food and Environment

The overall authority for all Animal Welfare bodies in Denmark

Advises the council for animal experimentation and AWB in the implementation of the 3Rs

and advises the AWBs in how to enhance a culture of care for the animals (an the employees)

Question 9

How to be a breeder of laboratory animals

Answer 9

Grant a license to breed animals - the application is evaluated and approved by the Animal experimental council.
The buildings must be inspected an approved by the animal experimentation inspectorate.

A person must be responsible for the animal welfare at site. this could be the designated veterinarian (responsible for the housing).

A person must be responsible for the education and training of the staff

establish an animal welfare body if conducting experiments at site - the license holder must be a member. a minimum of to members.

Question 10

How to get a license for conducting animal experiments

Answer 10

License holder must:
- Have a FELASA ABD course
- Get the application approved by the animal experiment council
- include the 3Rs in the application
- seek advice by the animal welfare officer and the animal welfare body at the site were the experiment are to be conducted
- ensure clear humane endpoints
- ensure that the most refined methods are used

Question 11

The education of the care takers

Answer 11

The animal care takes must have an education as mentioned in the animal experimentation order:
- animal caretaker
- Agriculturist education
- veterinary nurse
All with documented knowledge about the species.

Question 12

Describe the roles and responsibilities of the local animal welfare bodies and the national committee for the protection of animals used for scientific purposes

Answer 12

The animal welfare body must at least include the person responsible for the care of the animals at site (often the designated veterinarian) and the license holder.

1. Advise in matters related to animal welfare
2. Advise on the 3Rs refinement, reduction, replacement
3. Inform of technical and scientific developments of 3R
4. Review internal SOPs covering monitoring, reporting and follow up in relation to animal welfare
5. Follow the projects - development and outcome
6. Advise on the reuse of animals - rehomed

Must keep a journal regarding the tasks - keep them in at least 3 years

Question 13

who is the designated veterinarian?

Answer 13

A veterinarian with expertise in laboratory animal medicine (or a suitably qualified expert)

Advises in wellbeing and treatment of the animals.

Breeders, suppliers and facilities where experiments are conducted (the license holder) must have a designated veterinarian.

Question 14

Describe who is responsible for compliance in relation how the experiment is performed, and how the animals are housed in the facility.

Answer 14

The license holder is responsible for how the experiment is performed. The license holder can seek advise from the designated veterinarian (scientist) in the welfare and housing of the animals including the treatment of the animals.

the license holder is responsible for instruction of the care takers

Question 15

What is expected from the scientist in relation to being aware of local organization of animal work

Answer 15

With the scientist being the license holder:
you must know:
- Who the designated veterinarian is and how to contact
- Who is member of the animal welfare body
- who to contact if anything unexpected happens

Question 16

minimum and maximum threshold of pain regarding the definition of an animal experiment

Answer 16

minimum: the pain, suffering, distress or lasting harm is equivalent or higher than the being punched by a needle (needle criteria)

maximum: i DK you will not be allowed to conduct studies resulting in: strong pain, intense fear or intense suffering (defined by the animal experiment council)

OBS diet induced phenotypes are also considered an experiment (NASH and DIO animals)

Question 17

When can an animal experiment not be allowed no matter the purpose?

Answer 17

If the animal in the experiment suffers intense fear, intense suffering or strong pain.
no matter the benefits (only DK)

Question 18

Destinational breeding is? Give examples (species)

Answer 18

Animals bred specifically for experiments at a licensed breeder.
- mice, rats
- rabbits
- cats and dogs

NOT farm animals (pigs, cows, horses, hens)

Question 19

Indicate the circumstances in which animals under the scope of the Directive should be humanely killed or removed from the study to receive veterinary treatment

Answer 19

Humane endpoints is an important part of the license; at what point must the animal leave the experiment (for treatment or euthanasia)? at what point does it suffer too much?

the animal is to be removed even though the experimental end-point haven´t been reached yet and no results are achieved.

Question 20

Describe the legislative controls over the killing of animals bred or used for scientific procedures

Answer 20

The animals must be killed by a competent person.

Minimum pain, suffering and distress

Methods to be used for the different species are listed in Annex IV (EU directive) and annex 3 in the animal experimentation order

The death of the animal must be confirmed:
- Conformation of permanent stop of circulation
- Destruction of brain
- Dislocation of neck
- Rigor mortis

Question 21

Describe how the animal experimentation act is based on an ethical framework which requires 1) weighing the harms and benefits of projects (the harm/benefit assessment)
2) applying the Three Rs to minimize the harm, maximize benefits and
3) promote good animal welfare practices

Answer 21

1) From a utilitarian ethical point of view the animals can be used for experiments as long as the benefits is larger than the cost. This is evaluated by the animal experiment council in the application for a license to conduct animal experiments.
2) The 3Rs are implemented in the legislation (EU) which gives the animals rights
3) Multiple persons at an animal facility performing experiments are dedicated to increase and monitor the welfare of the animals.
- specific demands to the education of all personel handling the animals - they must all have species specific knowledge

Question 22

Describe the severity classification system and give examples of each category.
NON-Recovery

Answer 22

The classification is determined by the degree of pain, suffering, distress or lasting harm expected to be experienced by the individual animal in the experiment.

Non-recovery: procedure performed under general anaesthesia from which it shall not recover consciousness – Rederivation (female mous will be killed after the pups are removed)

Question 23

Describe cumulative severity and the effect this may have on the severity classification

Answer 23

example: a mild procedure is done over and over – how is the animal affected? It is assumed that the repetition of mild procedures will affect the animal in a moderate way, why the experiment will be classified as moderate instead of mild.

Often the severity of the animal experiment must be sharpened.

Question 24

Give examples of each category in the severity classification system.
MILD

Answer 24

short-term mild pain, suffering or distress = no significant impairment of the well-being or general condition of the animal
- blood samples <10% of circulating blood volume
- injections: IM, SC, IP, Oral dosage, IV - appropriate volumes.
- Breeding a genetically altered animal with an mild adversed phenotype

Question 25

Give examples of each category in the severity classification system. MODERATE

Answer 25

• Short-term moderate pain, suffering or distress
• Long-lasting mild pain, suffering or distress, or
• Moderate impairment of the well-being or general condition
• Blood samples >10% of circulating volume in an awake animal within a few days without volume replacement
• Models with spontaneous tumors expected to cause moderate pain or distress
• Breeding a genetically altered animal with an expected moderate adversed phenotype
• Adult rats: withdrawal of food for 48 hours

Question 26

Give examples of each category in the severity classification system. SEVERE

Answer 26

Severe pain, suffering or distress or long-lasting moderate pain, suffering or distress
Servere impairment of the well-being or general condition of the animal

• Toxicity testing with death as an end-point
• Tumors allowed to ulcerate
• Breeding animals like Huntington models or muscular dystrophy models
• forced swim or exercise test with exhaustion as the end-point

Question 27

Describe the regulations regarding re-use of animals

Answer 27

EU directive, Article 16 – Reuse of an animal
The animal can only be reused if the following conditions are met:
- The actual severity of the previous procedure was mild or moderate
- The health and well-being of the animal has restored completely
- The further procedure is classified as mild, moderate or non-recovery
- Advice from the veterinarian at site, taken into account the lifetime experience of the animal

Question 28

Describe the four functions in relation to educational demands for staff involved in animal experimentation

Answer 28

Care taker: Must have an education as animal caretaker, veterinary nurse of similar
License holder: FELASA ABD course

Any person involved in the experiment, must be educated, trained an supervised in:
- Carrying out the procedure
- Designing procedures and projects - must have species specific knowledge
- Taking care of animals
- Killing animals

Question 29

Manager role at the facility (Welfare officer)

Answer 29

Responsible for overseeing the welfare and care of the animals

Ensure that the staff is informed of the species housed

Responsible for ensuring that the staff is proper educated and trained

Mandatory member of the animal welfare body

Question 30

Role of the designated veterinarian

Answer 30

Each breeder, supplier and user must have a designated veterinarian with expertise in laboratory animal medicine or an other expert. The person is responsible for advising in relation to the well-being and treatment of the animals.