このSection V Experiments on animalsはZEBETのDr. Barbara Grune からお送りいただいたAnimal Welfare Act 1998の英訳の一部です．
Experiments on animals
(1) For the purpose of this Act "Experiments on animals" means any operation or treatment for experimental purposes
(2) Experiments may only be carried out on animals if they are indispensable for one of the following purposes:
- on animals which may cause these animals pain, suffering or harm or
- on the animal genotype which may cause the genetically modified animals, or their carrier animals pain, suffering or harm.
The decision whether experiments on animals are indispensable shall be based in particular on the scientific findings available at the time and on checks whether the same purpose can be achieved by other methods or procedures.
- the prevention, diagnosis or treatment of diseases, suffering, bodily defects or other abnormalities or the detection or exertion of influence of physiological conditions or functions in human beings or animals;
- the detection of environmental hazards;
- the testing of substances or products to ensure that they are safe in terms of human or animal health or that they are effective against animal pests;
- basic research.
(3) Experiments may be carried out on vertebrates only if the pain, suffering or harm they can be expected to inflict on the laboratory animals is ethically justifiable in view of the purpose of the experiment. Experiments causing lasting or repeated severe pain or suffering to vertebrates may be carried out only if the results are expected to be of outstanding importance for the fundamental needs of human beings or animals, including the solution of scientific problems.
(4) Experiments on animals to develop or test weapons, ammunition and related equipment shall be prohibited.
(5) In principle, experiments on animals to develop tobacco products, detergents and cosmetics shall be prohibited. The Federal Ministry shall be empowered, with the consent of the Bundesrat by ordinance to stipulate exemptions in the case of cosmetics in agreement with the Federal Ministry of Health, wherever necessary to
- avoid specific health hazards and wherever there is no other way of obtaining the new findings required or
- implement legal instruments of the European Community.
(1) Any person wishing to conduct experiments on vertebrates must obtain authorization of the planned experiment from the competent authority.
(2) The application for authorization of the planned experiment must be submitted to the competent authority in writing. The application must:
In addition, the application must contain the data mentioned in (1) to (5) of Article 8a, paragraph 2
- set out scientific evidence substantiating that the conditions laid down in (1) of paragraph 3 have been met;
- demonstrate that the conditions laid own in (2) to (4) of paragraph 3 have been met;
- set out that the conditions laid down in (5) of paragraph 3 have been met.
(3) Authorization shall be granted only if and when:
(4) The notice of authorization shall state the head of the experiment and his deputy. The authorization holder shall inform the competent authority immediately of any change of head of the experiment or deputy; the authorization shall remain valid unless revoked within one month.
- scientific evidence is produced that:
- the conditions laid down in Articles 7, paragraphs 2 and 3 have been met;
- not enough is known about the test result aimed at despite exhausting all accessible sources of information or a repeat or duplicate experiment is essential to confirm a result which is sufficiently known;
- the head of the experiment and his deputy possess the requisite expertise, particularly with respect to the supervision of animal experiments and there are no facts casting doubt on their reliability;
- the requisite installations, equipment and other technical resources are available together with the personnel and organization for conducting experiments on animals, including the activities of the animal welfare ofiicer;
- it can be ensured that the animals' accommodation, care, supervision and medical attention satisfying the requirements laid down in Article 2;
- Articles 9, paragraphs 1 and 2 and 9a can be expected to be observed.
(5) The authorization shall apply for a limited period. In the case referred to in paragraph 5a, first sentence, the expected duration of the planned experiment mentioned in the application shall apply.
(5a) The authorization shall be deemed to be granted if the authority has not made a written decision on the application within a period of three months, in the case of experiments on anaesthetized animals to be killed during anaesthetization within a period of two months. The competent authority may extend the period of two months if required up to three months after hearing the applicant. In calculating the period, the times shall not be considered during which the applicant did not meet the requirements under paragraph 2 despite written request of the competent authority. The authorization under the first sentence may subsequently be made subject to requirements if this is required to meet the conditions of paragaraph 3 .
(6) If the authorization is granted to a university or other such establishment, the persons conducting the experiments on animals must be employed at the establishment or authorized to use the establishment by the director in charge.
(7) No authorization shall be required for planned experiments
In addition, the authorization does not require any changes in authorized planned experiments if
- expressly required:
- by an act, an ordinance or the Pharmacopoeia or directly applicable legal instrument issued by an institution ofthe European Communities;
- by general administrative provisions issued by the Federal Government or by a Federal Ministry, with the consent of the Bundesrat, in line with Articles 7, paragraphs 2 and 3 or
- by order of a judge or an authority, based on a law, ordinance or directly applicable legal instrument issued by an institution ofthe European Communities or in individual cases as a prerequisite for the issue of administrative acts;
- taking the form of vaccinations, withdrawal of blood samples or any other diagnostic measures in line with proven methods and
- serving to detect, in particular, diseases, suffering, bodily defects or other abnormalities in human beings or animals or
- serving to test serums, blood preparations, vaccines, antigens or test allergens within the framework of authorization procedures or batch tests.
- the purpose of the planned experiment remains the same;
- the laboratory animals do not sustain any more pain, suffering or harm;
- there is no major increase in the number of laboratory animals and
- these changes had been notified to the competent authority beforehand; Article 8a, ' paragraphs 2 and 5 shall apply mutatis mutandis.
(1) Any person intending to conduct experiments on vertebrates for which no authorization is required or on cephalopods or decapods shall notify the planned experiment to the competent authority at least two weeks before the experiment begins. This time limit need not be observed in emergencies where the experiment must be carried out immediately. In this case notification shall be sent immediately afterwards. The time limit referred to in the first sentence may be extended by the competent authority, if required, to up to four weeks.
(2) The notification shall indicate:
(3) If several experiments of the same type are planned, notification of the first shall suffice, provided the notification indicates the expected number of planned experiments. At the end of each year the competent authority shall be informed of the number of experiments conducted and, in the case of vertebrates, of the type and total number of animals used.
- the purpose of the planned experiment;
- the species and, in the case of vertebrates, also the number of animals to be used for the planned experiment;
- the type of animal experiments planned and the procedures to be used, inciuding anaesthetization;
- the place, beginning and likely duration of the planned experiment;
- the name, address and expertise of the head of the experiment in charge, of his deputy and of the person performing the experiment as well as of the eligible persons for after-treatment;
- in the case of planned experiments pursuant to Article 8. paragraph 7 (1) the legal basis for exemption from authorization.
(4) Should the details listed in paragraph 2 change in the course of the experiment, the competent authority must be notified of the changes immediately unless the changes make no difference to the supervision of the experiment.
(5) The competent authority shall prohibit experiments on animals if the facts justify the assumption that the observance of Articles 7, paragraphs 2 or 3, 8b, paragraphs 1 , 2, 4, 5 or 6 or 9, paragraphs 1 or 2 cannot be ensured and this defect cannot be remedied within the time limit set by the competent authority.
(6) The Federal Ministry shall be empowered by ordinance. with the consent of the Bundesrat, to extend the notification requirement under paragraph 1 to experiments on other invertebrates, if this is required for the welfare of animals of a corresponding sensory development stage as vertebrates.
(1) Heads of institutions, where experiments are conducted on vertebrates, shall appoint one or more animal welfare officers and notify each appointment to the competent authority. The notification shall also indicate the position and powers of the animal welfare officer under paragraph 6, third sentence of this Article.
(2) Only persons who have completed university studies of veterinary medicine, medicine or biology (specializing in zoology) may be appointed as animal welfare oificers. They must possess the expertise and reliability needed to discharge their tasks. In individual cases the competent authority may grant exemptions from the first sentence.
(3) The animal welfare officer shall be obliged:
(4) If the animal welfare officer conducts an experiment himself, another animal welfare officer must supervise the planned experiment.
- to ensure that the provisions, conditions and requirements shall be observed in the interest of animal welfare;
- to advise the institution and the staff involved in animal experiments and the keeping of laboratory animals;
- to give his opinion on each application for authorization to conduct an experiment on animals;
- to work towards the development and introduction of procedures and means for avoiding or reducing experiments on animals inside the institutions.
(5) The institution must support the animal welfare officer in the performance of his tasks and inform him of every planned experiment so that he can carry out his duties without restriction.
(6) The animal welfare officer shall not be bound by any instructions when fulfilling his tasks. He may not be discriminated against because of the performance of his tasks. His position and powers shall be laid down by statute, by internal instructions or in a similar form. In the process steps shall be taken to ensure that the animal welfare officer can voice his proposals or reservations directly before the decision-making body in the institution. If several animal welfare officers are appointed, the scope of duties of each shall be clearly defined.
(1) Only persons with the requisite expertise may conduct experiments on animals. Furthermore, only persons who have completed university studies of veterinary medicine or medicine or natural sciences or persons, who demonstrably possess the requisite expertise due to vocational qualifications, may conduct experiments on vertebrates, with the exception of the experiments covered by Article 8, paragraph 7 (2). Animal experiments involving surgical operations on vertebrates may be performed only by persons who have completed university studies in:
(2) Experiments on animals shall be limited to the absolute minimum. In performing them account shall be taken of scientific knowledge. The following conditions shall apply, in particular:
- veterinary medicine or medicine or
- biology (specializing in zoology), provided these persons are employed at universities or other scientific establishments. The competent authority may grant exemptions from the provisions in the second and third sentences, if proof of the requisite expertise can be furnished in another way.
(3) The head of the experiment or his deputy shall be responsible for the observance of the provisions laid down in paragraphs 1 and 2. The same shall apply to fulfilment of any requirements attached to the authorization in line with Article 8.
- Experiments may be carried out on animals with more highly developed sensory systems, and in particular on warm-blooded animals, only when experiments on animals with less developed sensory systems will not suffice for the purpose. Experiments may be carried out on animals taken from the wild only if experiments on other animals will not suffice for the purpose.
- No more animals than necessary to achieve the purpose of the experiment may be used.
- Pain, suffering or harm may be inflicted on the animals only in so far as unavoidable to attain the purpose of the experiment. They may not be inflicted, in particular, to save work, time or costs.
- Subject to the provisions of the fourth sentence of this paragraph, experiments may be conducted on vertebrates only under anaesthetic. The anaesthetic may be administered only by, or under the supervision of, a person meeting the conditions laid down in sentences 1 and 2 of paragraph 1. If the vertebrate is likely to suffer considerable pain when the anaesthetic wears off, the animal must be treated with pain-killing drugs in good time, unless this is incompatible with the purposes of the experiment. Vertebrates which have not been anaesthetized may:
Vertebrates, which have not been anaesthetized, may only be subjected once to an operation or treatment entailing severe pain unless there is no other way of attaining the purpose of the experiment. Vertebrates, which have not been anaesthetized, may not be given any drug to stop or restrict them from showing their pain.
- not be subjected to operations causing serious injuries;
- only be subjected to an operation if the resultant pain is less serious than the impairment of the laboratory animal's well-being caused by the anaesthetic or if the purpose of the experiment excludes anaesthetization.
- Vertebrates subjected to serious operations or used for an experiment entailing severe or lasting pain or suffering or serious harm may not be used for any further experiments unless their general state of health and well-being have been fully restored and the further experiment
- entails no suffering or harm and only minor pain or
- is performed under anaesthetic and the animal is killed under this anaesthetic.
- Animals used in experiments to determine the lethal dose or lethal concentration of a substance shall be put down painlessly as soon as it becomes clear that they are dying under the action of the substance.
- Vertebrates, except horses, cattle, pigs, sheep, goats, chicken, pigeons, turkey, ducks, geese and fish, may be used in experiments on animals only if they have been bred for such a purpose. If compatible with animal welfare, the competent authority may grant exemptions from this provision if no animals of the species in question specifically bred for experimental purposes are available for the experiment or if the purpose of the experiment demands the use of animals of other origin.
- At the end of the experiment every surviving monkey, lemur, soliped or cloven-hoofed animal, dog, hamster, cat, rabbit and guinea pig used shall be presented to a veterinarian for examination without delay. If the veterinarian concludes that the animal cannot survive without pain or suffering, the animal shall be put down painlessly without delay. Animals other than those specified in the first sentence shall also be put down painlessly without delay if deemed necessary by the person performing the experiment. Animals to be kept alive at the end of the experiment must receive the care appropriate to their state of health, be placed under the supervision of a veterinarian or another qualified person and be given any medical care that might be necessary.
(1) Records shall be kept of all experiments on animals. The records must state the purpose of each experiment, in particular the reasons for allowing experiments on animals with more highly developed sensory systems in line with Article 9, paragraph 2 (1), the number and designation of the animals used and the nature and procedure of the experiments. Whenever vertebrates are used, details of their origin, including the name and address of the previous owner, shall also be given. Where cats and dogs are concerned, details of their sex, breed, coat type and pattern and any identifying markings must also be given. The records must be signed by the persons performing the experiments and the head of the experiment. Records drawn up automatically need not be signed. The records shall be kept for three years after the end of the experiment and shall be submitted to the competent authority for inspection on request.
Operations and treatment for purposes of
education, training and further training
(1) Operations or treatment causing animals pain, suffering or harm may be carried out for purposes of education, training and further training only:
They may be performed only when there is no other way of attaining the same purpose, for example, by showing films. Reasons shall be given to the competent authority on request why the purpose of the operations or treatment cannot be attained in any other way.
- at a university, another scientific establishment or a hospital or
- as part of a vocational or further training course for medical or scientific ancillary professions.
(2) Articles 8a, 8b, 9, paragraphs 1 and 2 and 9a shall apply mutatis mutandis to operations or treatment for educational or traininga purposes. Article 8a, paragraph1, first sentence, shall apply mutatis mutandis provided that notification shall be given of the operations or treatment before they are included in the curriculum or before the curriculum is changed. Article 9, paragraph 1 shall apply mutatis mutandis provided that the operations and treatments are only performed by, or under the supervision or in the presence of the persons named therein or under the supervision of a qualified person authorized by the person responsible for the respective course.
(3 ) The head of the education, training and further training courses or his deputy shall be responsible for ensuring compliance with paragraphs 1 and 2.