Module I Flashcards
- Describe and present which national and EU laws and guidance which regulate the scientific use of animals and in particular the activities of those carrying out scientific procedures involving them, as well as other forms of relevant animal welfare legislation, and discuss how to find the relevant legislation
The Danish legislation is based on the EU directive. According to The Animal Welfare Act, no one is allowed to cause pain, suffering, distress or lasting harm in any species of animals. The Animal Experimentation Act overrules the Animal Welfare Act by stating that if the purpose is research, teaching, or the production of blood products, then pain, suffering, distress or lasting harm can be allowed if licensed in each specific case. Note that the European directive aims to protect vertebrates (including mammal fetuses in their last third of development or cephalopods) used for scientific purposes.
Animal experiments must be:
● Licensed,
● Beneficial,
● The use of animals must be necessary, and
● Should not cause strong pain, intensive fear, intensive suffering
Experiments performed under the Animal Experimentation Act need to be performed by qualified staff in proper settings on destination bred animals. The Animal Experimentation Order is a larger and more detailed document that details how to set up animal experimentation, how to take care of the animals, how to set up the facilities, etc. This includes animals which must be bred by licensed breeders, care and accommodation of animals, legal methods for killing animals, and severity classification of animal experiments.
How to find relevant legislation:
Webpages such as:
The EU directive
The animal welfare act
The animal experimentation act
The animal experimentation order
Dyreforsøgstilsynet.
- Describe the authorisation that is needed before acting as user, breeder or supplier of laboratory animals and especially the authorisation required for projects and where applicable individuals. Describe who will grant you a license in Denmark, how this authority is organized, and which other functions this authority has
The competent authority that each member must have in Denmark is Dyreforsøgstilsynet, ‘The Animal Experimentation Inspectorate’ under the Ministry of Food and Environment. They are in charge of processing applications for animal experiments and carrying out the inspections of all animal testing facilities in denmark. It is organized by a board that is led by an 11 member committee called the Animal Experimentations Board that issues all of the licenses after evaluation of the application.
The board members are appointed by the minister of food and environment after proposals from different organizations and then four members are proposed by the animal protection societies. Members are all suggested by different organizations, so some of them are suggested by animal welfare organizations, some of them are suggested by the ethical council, some of the members are suggested by the industry and by the grant giving committees and the Board of Health.
Main roles of the inspectorate: processing applications, carrying out inspections of all animal testing facilities in Denmark, advising on housing and use of experimental animals, as well as animal experimentation legislation.
- Describe the roles and responsibilities of the local animal welfare bodies and the national committee for the protection of animals used for scientific purposes
Each establishment must have a committee called the Animal Welfare Body for the protection of animals used for scientific purposes. An Animal Welfare Body should facilitate a climate of care (a commitment to improving animal welfare, scientific quality, care of the staff, and transparency for the stakeholders).
The committee will be responsible for:
● Advising the staff on animal welfare,
● The 3R’s,
● Technical and scientific developments,
● Rehoming,
● Establishing/reviewing internal operational processes, and
● Following the development and outcome of projects.
National committees for the protection of animals used for specific purposes advise the competent authorities and the animal welfare bodies on matters dealing with the acquisition, breeding and accommodation and care & use of the animals to ensure best practice.
- Describe who is responsible for compliance in relation how the experiment is performed, and how the animals are housed in the facility. Describe what is expected from the scientist in relation to being aware of local organisation of animal work
The license holder is responsible for compliance of animal experiments which require permission, an institution or company can apply for a license to carry out animal experiments instead of an individual researcher but then it is a requirement that the legal person (the establishment) must appoint a named person (a researcher) who will be responsible for carrying out the experiments i.e. a person who may be presumed to be able to ensure that the experiments are carried out in a responsible manner.
When animals are used for scientific purposes, the named responsible researcher shall:
● Have thorough knowledge of animal experimentation legislation
● Ensure that as far as possible methods which do not involve live animals are used
● Seek veterinary advice
● Ensure that animals are housed and kept in a way that takes the greatest possible account of the needs of the species.
● Ensure that the animals are handled, socialized and trained with the greatest possible consideration of the needs of the species.
● Ensure that the animals used for experiments which do not require a license are cared for, handled and housed in accordance with the legislation on animals experimentation.
● Ensure that all planned animal procedures which require permission are covered by a license to carry out animal experiments.
● Ensure that persons working with animals are competent and have detailed knowledge of the terms of any applicable experimentation license.
● Ensure that the least harmful methods are used, whenever experiments are performed.
● Ensure that in the case of complications, immediate steps are taken to give relief, or if that is not possible then the animals are humanely killed without delay.
● Ensure sufficient supervision of animals
● Ensure that records are kept of animal experiments.
● Contact the animal experiments inspectorate if there are questions on the above.
Animals must be housed in suitable rooms. Enclosures and equipment must be constructed and used in a way which can be expected to support the 3 R’s and most likely lead to satisfactory results. Your license to do the experiment will be valid only for those facilities that you specify for the competent authority (e.g. the Animal Experimentation Inspectorate). In Denmark, there are stricter rules than the EU directive for the housing of rats; the cage must be tall enough for the rat to stand on their hind legs.
- Describe minimum and maximum threshold of pain, suffering, distress or lasting harm, i.e. when a procedure becomes regulated as an animal experiment, and when it cannot be allowed no matter the purpose
An animal experiment is defined by a lower threshold (the injection criterion), an upper threshold (strong pain, intensive fear, intensive suffering), and a purpose (research, teaching, production of blood products). Recall: According to the Animal Welfare Act, no one is allowed to cause pain, suffering, distress or lasting harm in any species of animals. However, the Animal Experimentation Act overrules the Animal Welfare Act if the purpose is for research, teaching, or the production of blood products, but this needs to be licensed.
The injection criterion states that a procedure must be licensed if it causes pain, suffering, distress or lasting harm equivalent to, or higher than, that caused by the introduction of a needle in accordance with good veterinary practice. This also goes even if no injections are involved, for example if you feed the animal a diet deficient of essential nutrients to induce specific deficiency symptoms.
- What is meant by destinational breeding in relation animal experimentation legislation, and give examples of some species covered and some species not covered
In the EU directive and the Animal Experimentation Order, it states that you need a license to breed and deliver animals for research. Destination breeding means that animals are bred for a specific purpose (e.g. research) and the animals should only be used for this purpose. It covers mice, rats, rabbits, dogs, cats, all non-human primates, frogs, zebrafish. Dogs, cats, and primates need to be marked and followed by individual protocol so they can be traced from birth to death. Species not covered include farm animals (pigs, cattle, sheep, goats), so they can legally be purchased from ordinary farmers.
Use of wild animals is not allowed unless their use is supported by scientific arguments but then a license from the nature agency is required to catch wild animals from nature. If you want a limited number and it is for teaching and dissemination, then you don’t need a license if the animal is not on a protection list from the agency.
- 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, and describe the legislative controls over the killing of animals bred or used for scientific procedures
If the animal experiences strong pain, intensive suffering, or intensive fear, the animal must be humanely killed eventually after discontinuation of anaesthesia or other alleviating treatment. Animals should be humanely killed when they reach the humane endpoint or the experiment endpoint.
From the EU directive, the killing of animals shall be completed by one of the following methods:
● confirmation of permanent cessation of the circulation;
● destruction of the brain;
● dislocation of the neck;
● exsanguination; or
● confirmation of the onset of rigor mortis.
The method is dependent on the species of animal and the experiments that are being performed.
- 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 minimise the harm, maximise benefits and 3) promote good animal welfare practices
The Harm:Benefit analysis is an evaluation of the project that considers both the impact on the individual animal and the benefits of the study. In other words: What problem do the researchers expect to solve; what are the objective and hypothesis of the study and how much suffering, pain and distress will the animal be subjected to? This harm:benefit analysis must be carried out by the competent authority before granting the license for the study.
Replacement - use methods that avoid or replace the use of animals
Refinement - use methods which minimize suffering and improve animal welfare
Reduction - use methods that minimize the number of animals used per experiment.
You must choose an approach that either is most likely to involve the use of fewer animals (REDUCE), cause the least pain, suffering, distress or lasting harm or which are most likely to provide satisfactory results (REFINE) or eventually both. To the extent possible, species that are least prone to experiencing pain, suffering, distress or lasting harm must be used (REFINE). Sometimes cells, computers, or other non-animal methods may be equally good for the purpose (REPLACE).
- Describe the severity classification system, and give examples of each category. Describe cumulative severity and the effect this may have on the severity classification
To classify the severity of the animal experiment, you must consider:
● The Type of manipulation and handling you do with the animals
● The Nature of the pain, suffering, distress, or lasting harm
○ Including its intensity, duration, frequency, and multiplicity
● And also how high is the cumulative suffering, i.e. when you add up the effect of different procedures or multiple use of the same procedure
It’s also important to consider some issues related to the animal, e.g.:
● Which species and genotype do you use
● How mature and old is it, age and which sex do you use
● Do you prevent the animal from expressing natural behavior
● Has the animal been trained for the procedure
● And If reused, what was the severity of previous procedures
Non-Recovery: Procedures which are performed entirely under general anaesthesia from which the animal shall not recover consciousness shall be classified as ‘non-recovery’.
Mild Experiments (e.g. Administration of anaesthesia): Procedures on animals as a result of which the animals are likely to experience short-term mild pain, suffering or distress, as well as procedures with no significant impairment of the well-being or general condition of the animals shall be classified as ‘mild’.
Moderate Experiments (e.g. surgery under general anaesthesia): Procedures on animals as a result of which the animals are likely to experience short-term moderate pain, suffering or distress, or long -lasting mild pain, suffering or distress as well as procedures that are likely to cause moderate impairment of the well-being or general condition of the animals shall be classified as ‘moderate’.
Severe Experiments (e.g. severe restriction of movement over a long period): Procedures on animals as a result of which the animals are likely to experience severe pain, suffering or distress, or long-lasting moderate pain, suffering or distress as well as procedures, that are likely to cause severe impairment of the well - being or general condition of the animals shall be classified as ‘severe’.
● In this example, the period has to be defined by the competent authority and it is also mentioned in the directive that short term restriction is only categorized as mild.
- Describe the regulations regarding re-use of animals
According to The Animal Experimentation Order, you can only re-use animals if the severity has been only mild or moderate in the first experiment and this will be the same in the new experiments; or eventually the new experiment will be non-recovery. However, the health and well-being should be fully restored and the veterinarian must advise that the re-use is acceptable (after a veterinary examination.)
● Note: The Inspectorate may allow reuse of animals used only once with severe pain, distress or equivalent suffering.
- Describe the four functions in relation to educational demands for staff involved in animal experimentation, as well as the role of the manager (EU article 24) and the designated vet
(A) To carry out the practical parts of the procedures of an experiment. You must either be a professional laboratory animal technician, or have another relevant technical or academic education plus a shorter course in laboratory animal science. These are minimum demands, and you should always remember the wording of the animal experimentation act that you need to have the necessary professional training, which means that you should be competent for each individual procedure, and that you cannot do for instance surgery without having surgical training.
(B) To set up the experiment and to hold the licenses. To be a project designer, you must have a relevant academic degree, for instance being a medical doctor, a veterinarian, a biochemist, a pharmacist, a biologist or similar, and you must have completed a larger course in laboratory animal science.
(C) Taking care of the animals in the facilities. You can only employ Laboratory animal caretakers, Agricultural animal assistants (Animal Farmers) or Veterinary Nurses, that means staff which have 4 years technical education with both theory and practice within taking care of animals. The vets should also have laboratory animal science knowledge on function ABD level, have expert laboratory animal competences, and they should be familiar with the local environment.
(D) Killing the animals. The use of inappropriate methods for killing an animal can cause significant pain, distress and suffering to the animal. The level of competence of the person carrying out this operation is equally important. Animals should therefore be killed only by a competent person using a method that is appropriate to the species.
Role of the Manager. EU Article 24: there must be one or several persons responsible for welfare, access to species specific information, and for staff training. Known as an “Animal Welfare Officer” who is responsible for the design and operation of stables and test rooms, for the competencies of the staff, and for the care of the animals and the welfare of the animals.
Role of Designated Vet. EU Article 25:
● There must be a designated veterinarian with expertise in laboratory animal medicine to give veterinary advice. If the scientist is a veterinarian that’s fine otherwise another named vet must be available.
● If it is more appropriate, another suitable expert can be appointed, e.g. in fish or insect facilities. The directive states that they are there to give advice, and that inspections are performed by the competent authority, who probably themselves have hired some vets for this task.
