Decree of the Ministry of Agriculture No. 311 / 1997 Coll.
Decree of the Ministry of Agriculture on the production and use of experimental animals
Valid
Order
Effective from 01.01.1998
Text versions:
01.01.1998
22.12.1997
Zobrazeno prvních 200 z celkem 548 ustanovení tohoto předpisu.
Zobrazit celý předpis →
Pro stažení celého znění použijte tlačítko Stáhnout výše.
311
DECLARATION
Ministry of Agriculture
of 4 December 1997
on the breeding and use of experimental animals
The Ministry of Agriculture provides pursuant to Section 29 of the Act of the Czech National Council No. 246 / 1992 Coll., for the protection of animals against abuse, as amended by Act No. 162 / 1993 Coll., (hereinafter referred to as "the Act"):
BLISTER CONDITIONS FOR ANIMAL CONSUMPTION AND USE
CONDITIONS FOR MOVABLE, ADDITIONAL AND USEFUL EQUIPMENT
Objects and premises of breeding, supply and user facilities
(1) Breeding, supplier and user facilities shall, by law, carry out the activities of breeders in premises or premises or in a designated territory. User devices shall carry out this activity according to an approved project which determines the intentions, methodology or standard operating procedure for the conduct and termination of experiments (hereinafter referred to as "trial project ').
(2) Objects shall be considered as buildings or areas defined as enclosures, optionaries and tanks, equipped for the breeding and use of experimental animals (hereinafter referred to as "animals') with farming systems:
(a) open, where the entry and exit of animals, persons and material are free from barrier, subject to health and veterinary measures;
(b) a barrier where the animal compartment is separated from the external environment and the entry and exit of animals, persons and material are only possible in such a way as to protect against the penetration of undesirable effects from the external environment;
(c) an insulator where the animal compartment is permanently and completely separated from the external environment and persons handling the animal; the barrier ensures the isolation of the area in which the animal is kept, has specific technological inputs for all material needed for animal husbandry and experiments.
(3) In order to ensure the conditions of rearing and use of animals specified in the operating rules developed by breeding, supplier and user establishments and which are a set of personnel, material and technical measures to ensure the operation with the establishment of a method of control of such measures in the premises, they
(a) the use of materials for animals of animal health, non-irritating and not disturbing their well-being;
(b) exclusion of unauthorised persons;
(c) equipment for effective disinfection at entry into animal compartments; in barrier systems, entry only through the release and movement of all material only according to the established standard operating procedure or procedure under which a set of follow-up operations related to the rearing of animals, in particular the operation, and the use of technological equipment (hereinafter referred to as "the technological process') is ensured,
(d) continuous inspection of technical equipment, including automatic identification of defects, with the possibility of day-to-day control of animal health and their environment in barrier and insulator farms;
(e) disinfecting, disinfecting, exerting and, in attempts with radioactivity, deactivation as well as cleaning and cleaning of premises, technological equipment, tools, tools, tools and personal protective equipment of persons according to the technological procedure, in order to avoid irritating stimuli for animals;
(f) the security of the premises against the release of kept animals and the intrusion of other animals;
(g) rearing only such animals for which a certificate has been granted for breeding and supply establishments or an accreditation has been granted for the use of such establishments, if specific rules allow, 1)
(h) in barrier and insulator farming equipment, an appropriate separate replacement source of electricity;
(i) separate premises and laying down the technological procedure for storage and the necessary technological treatment of feed, bedding and aids;
(j) the fitting-out of premises and the establishment of a technological procedure for the disposal and disposal of used biological materials, aids and waste;
(k) spatial and, where appropriate, acoustic and optical separation of individuals or species of animals who for any reason hate each other;
(l) operational separation of animal compartments, including access corridors, from technologies and operations, in particular from water treatment plant, air-conditioning plant, replacement energy source, expedition, administration,
(m) the exclusion of separate spaces for carrying out simple diagnostic tests, administration of substances to animals and sampling in user establishments using animals kept only for experimental purposes over several generations, defined and standardised in terms of genetic, health and environmental external factors (hereinafter referred to as "laboratory animals"); the normal species are listed in Annex 1, Table 1,
(n) separate premises in breeding establishments, in the range of at least 5% of the capacity of breeding areas for animals requiring emergency care, in particular animals injured or sick or suspected of being infected.
Requirements for premises for animals
(1) In premises within buildings which are permanently intended for animal husbandry, breeding, supply and user facilities shall ensure:
(a) ensuring that the zoohypgienic and hygienic conditions of operation are ensured by technological equipment, including tools and aids appropriate to the species and number of animals kept, ensuring the care of the animals and enabling immediate emergency assistance to the animals;
(b) that persons who are affected by obvious signs of diseases communicable to animals and persons entering them use occupational clothing, footwear and other protective equipment should not have access to such premises;
(c) exclusion of irritants such as smoke, odours and toxic gases, as well as ornamental objects in animals handling;
(d) construction or other technological adaptations and equipment as required by the farming system and the conditions of the experiment project;
(e) for the production of laboratory rodents and similar animal species of breeding vessels or cages of the size referred to in Annex 2, including graphs;
(f) the spatial layout of boxes or stands for selected species of experimental animals in accordance with Annex 2.
(2) The external designated areas (enclosures), permanently intended for the rearing of animals, provide the needs and equipment according to the species of animals for their protection, such as, in particular, suitable shelter or other protection against adverse climatic effects.
Storage and auxiliary facilities
(1) The storage and auxiliary premises shall be considered as separate premises in premises of breeding, supply and user facilities intended primarily for the storage of feed, (2) bedding and other material, or serve as a washing room for equipment, connecting corridors, machinery spaces, barrier release for persons and chambers for sterilisation and loading of material at the inputs and outputs of barrier and insulator systems.
(2) The cleaning and storage facilities for animal products should be adapted so that clean products are stored separately from the used ones and avoid contamination.
(3) In case of repeated use of transport packaging, breeding, supply and user facilities shall be equipped with separate spaces for cleaning, disinfection and storage of transport cages, containers and packaging, including the washroom.
Animal care
(1) In order to optimise the health, well-being and hygiene of animals in breeding (hereinafter referred to as "animal care"), breeding, supply and user facilities are provided according to the technological process
(a) at least once every 24 hours, regular checks on the welfare and health of animals, the function of technical equipment and the state of the environment in which the animals are kept, including the timely removal of defects;
(b) increased care of pregnant females, females with pups and pups,
(c) the treatment and handling of animals;
(d) ways of breeding laboratory animals in order to ensure their production that meets health, morphological, microbiological and genetic parameters;
(e) equipping premises with aids and tools for handling animals of the animal species and the technology used which do not cause pain, injury or other damage to animals;
f) equipment of premises with suitable aids according to approved project experiments
1. to prevent the release of animals;
2. to provide first aid;
3. to carry out the experiment and, where appropriate, to kill the animal,
4. to play or other activities, especially in primates, dogs and cats,
(g) the marking of animals and the keeping of zootechnical records.
(2) Animals are treated and treated only by persons authorised to do so and who have acquired professional competence.
Zoohypgienic conditions for animals within buildings
(1) Ventilation is carried out in such a way as to avoid draught and ensure continuous air exchange
(a) in open systems at least 10 times per hour;
(b) in barrier systems with fully occupied animal compartments at least 15 times per hour with a constant pressure of at least 40 Pa;
(c) at a reduced concentration of animals by 40% in barrier and insulator systems at least 8 times per hour.
(2) The premises for carrying out work on infectious and toxic material are closed and separate from other premises and are kept under pressure at least 20 Pa, unless otherwise specified in the approved experiment project.
(3) The temperature in the animal compartments is regulated in such a way as to ensure the care of animals according to their physiological needs in accordance with the values set out in Annex 2, Table 1, or under the conditions laid down by the experiment project.
(4) In laboratory animals, the necessary relative humidity is ensured within the range of values for the species and age category according to the established technological procedure. The relative humidity in these areas below 30% and above 70% for more than 48 hours is considered to be disproportionate to the generation of stress effects.
(5) Overpressure and underpressure values should be checked and recorded at least once every 24 hours, temperature and relative humidity values recorded and checked continuously at least once per hour. such records shall be kept by breeding, supplying and user establishments for at least one calendar year.
(6) When keeping albino animals, the intensity of the lighting shall not exceed 200 lux, measured 1 m above the floor level. The lowest intensity of lighting in areas with other laboratory animals is 200 lux. In spaces without natural lighting, the rhythm of day and night is ensured by artificial lighting.
(7) The animal compartments shall be isolated from disruptive sound sources so that their levels do not exceed 60 dB and frequencies above 20,000 Hz.
(8) Only dry dust-free material without toxic and irritating substances and micro-organisms capable of causing disease is used for bedding. For laboratory animals, the quality and frequency of bedding replacement shall be determined by a technological procedure.
(9) Signalling systems, in particular for the control of the operation of technological equipment, air conditioning, water supply and maintenance of its quality in fish tanks, as well as for the notification of the occurrence of fire or intrusion of unauthorised persons, are installed in such a way that their operation does not disturb the welfare of animals and in places where persons are present to ensure the removal of the defects caused.
Nutrition and power
(1) Animals are given a healthy, full feed (2), (3) and water corresponding to the farming, species and use of animals. Free access to food and supply is governed by the biorytm of animals; they must be used gradually to change feed.
(2) The microbiological purity and chemical composition of the supply water source are checked by laboratory testing at least twice a year. In cases where the quality of the drinking water must meet the specific requirements resulting from the requirements of the animal species, from the farming system or from the experimental project, the breeding, supplier and user facilities shall ensure its examination in accordance with the requirements of the technological process or experiment project; the results of the examination shall be kept archived for at least three years.
(3) Maintenance and cleaning of feed, feeder, feeder and, where appropriate, supply systems and equipment used for feeding and supply are governed by a technological process.
Preventive animal health care
(1) Breeding and user establishments shall ensure the permanent veterinary care of animals, (3) in particular regular preventive checks on their health status and breeding areas, which they keep records of and retain for at least three years.
(2) The frequency of checks on the health status of laboratory animals in breeding establishments is determined for selected species in Annex 1, Table 2.
Conditions for protection in the movement and transport of animals
(1) Laboratory animals may be moved into breeding, supply and user facilities only from breeding, supply and user facilities authorised by the Central Commission for Animal Protection ("the Central Commission"). Transfers from abroad may not be carried out without the designation of these animals in the manner laid down by law and without the indication in the accompanying documentation.
(2) After the animals have been moved to breeding and user establishments, their breeding shall be separated on an operational basis by defining the place, space, time and extent of the clinical and laboratory examination (hereinafter referred to as "quarantine ') provided for in the specific regulation.4)
(3) Only animals in good condition, clinically healthy from disease-free sites in accordance with special law and regulations (5), taking into account the needs of the species concerned, the system of breeding, their place of origin or the way in which they are obtained, may be moved in breeding, supply and user establishments and transported between breeding, supply and user establishments, under conditions
(a) the security and storage of transport packages with animals so that they do not overturn during movement or transport, are in a vertical position, bottom-down and secured in such a way that they do not flow or fall out of faeces, water supply, bedding or other objects and the animals are not exposed to excessive shocks and adverse climatic changes;
(b) identification of transport packages with symbols indicating the presence and position of the animals transported standing;
(c) allow for inspection of animals with the possibility of providing the necessary care, with the exception of animals from isolator and barrier farms transported in opaque air filter packaging.
(4) Before transporting the animals, the consignor shall also ensure:
(a) that goods which are liable to harm them or cause undue effects of stress effects are not transported simultaneously with the animals;
(b) separation of aggressive individuals and pregnant females; pregnant females to be born during the period of transport or expected to give birth within 48 hours before the start of transport are excluded from transport;
(c) that animals are fed and watered at least once every 12 hours; in rabbits, guinea pigs, rats, mice and other rodents, feed with high water content may be replaced for a maximum period of 24 hours,
(d) timely and proper information to the consignee on the details of the shipment and the estimated time of arrival of the consignment.
Recruitment and location of animals
(1) When receiving the consignment, the consignee shall check the condition of the consignment, the health status and the accompanying documentation of the animals made up by the delivery note and the consignor's report indicating the number and type of animals dispatched, their health status, sex, weight, origin and means of identification; in the case of laboratory animals listed in Annex 1, Table 2, the results of the last and previous laboratory examination of the health status, and shall decide:
(a) taking over the consignment and providing care to the animals supplied;
(b) the return of the consignment for reasons other than health reasons which are only possible if the conditions for the transfer and transport referred to in Section 8 are met;
(c) where injury or suspicion of an animal disease or disease is detected, a veterinary surgeon who shall provide the animals with professional care and order measures under the Specific Act (3) or decide within the meaning of Sections 4 (d) and 5 (2) (b) of the Act on their possible killing.
(2) When animals are taken over and placed from a barrier or insulator system, the technological procedure of these systems shall be followed.
(3) Animals from the insulator system shall be placed either in the same system or in the barrier system under the conditions of the technological procedure.
(4) Animals from the barrier system are placed in the same system.
(5) The conditions referred to in paragraphs 2 to 4 shall not apply if the animals are intended for experiments which do not last more than 30 days after the animals have left that system and if the animals are for breeding.
CONDITIONS USED BY ANIMALS
Protection of animals in conducting experiments
(1) The action on live animals, its observation or handling for the purpose of the experiment and the activity directly related thereto (hereinafter referred to as "use of the animal") shall be carried out only to the extent and under the conditions laid down in the approved experiment project and, unless this is excluded by special provisions (1).
(2) The use of the animal shall not be considered to be a veterinary preventive and therapeutic action and related diagnostic, slaughter or marking of animals and keeping them in rescue holdings in accordance with the law and specific rules. 6)
(3) If this is not contrary to the purpose of the experiment, the animals are adapted to a new environment before starting it. The recovery period for selected species is given in Annex 2, Table 2, for other species of animals is at least five days, except for fish where the recovery period is at least three days.
(4) Animals with clinically evident symptoms of the disease may not be used for the experiment unless it is part of an approved trial project.
(5) Insensitivity or other pain-reducing methods shall be guided by the benefit of the animal, taking into account its species and the purpose of the experiment.
(6) Devices that only cause muscle paralysis are not considered as suitable for numbness.
(7) Experiments on wild animal species caught in nature may be conducted only if the purpose of the experiment is not proven by another animal. In endangered species, which are provided for in specific regulations, (1) experiments may be carried out only if there are attempts to preserve the species.
Start and end of experiment
(1) The start of the experiment shall be considered as the time when the animal is ready for use for the first time under the conditions laid down in the experiment project.
(2) The experiment ends with the achievement of its objective, but at the latest at the time set by the experiment.
(3) After completion of the experiment, the animal is treated by a project of experiments.
(4) The farm animal may be returned to the original breeding conditions after the completion of the experiment, provided that its condition is consistent with its health, its further usability and the disease situation in accordance with a special law. 7)
(5) The wild animal caught for the purpose of the experiment should be returned to the site of the original occurrence after completion of the experiment, provided that this is provided for by the experiment project and that the animal's health, environmental conditions and conditions laid down by law and special legislation.1), 3), 8)
(6) An animal which, by its kind, corresponds to pet animals may be passed on to the pet when the experiment has been completed, provided that this is provided for by the experiment and that the health status of the animal so permits, the environmental conditions and conditions laid down by law and specific laws, 3), 8).
(7) In the event of a disease with clinical signs of disease or mortality, and in the case of a laboratory certificate of disease communicable from animals to other animals or to humans, the experiment shall be terminated if the monitoring of those manifestations is not provided for by the experiment project.
(8) The disposal of a dead animal is not permitted before rigidity occurs.
Experimental project
(1) The test project contains the following data, which is marked by numbering:
1. identification of the user installation (name, registered office, identification number),
2. the number of the accreditation decision;
3. the name of the person responsible for the experiment ("the trial leader"),
4. the name of the person responsible for the care of animals in the user facility;
5. the title of the task of the study (hereinafter referred to as "the study") and, where appropriate, the designation of the grant;
6. the characteristics of the study's objectives, indicating the specific expected benefit;
7. a brief description of the experiment in relation to the use of animals,
8. Methodological procedures for animals,
9. a statement by the appellant of proof of the necessity of the experiment or of the provision of legislation imposing the conduct of the experiment, including a justification for why the animal experiment cannot be replaced by alternative methods;
10. justification for choice of species, breed, strain and category of planned animals, indicating their quality parameters;
11. the origin of the test animals;
12. Justification for the number of animals planned,
13. method of marking animals in the experiment,
14. Method of numbness, possibly administration of painkillers and pain relief measures, if considered in the experiment,
15. location of animals during the experiment or in wild animals instead of the experiment;
16. Timetable for the individual stages of the animal experiment, including the time of its termination,
17. Level of operational equipment and method of post-operative care in the case of animal operations where they are part of an experiment;
18. Method of loading animals after completion of the experiment,
19. Method of monitoring compliance with animal protection rules,
20. Indication of the health risk to other animals and workers,
21. Animal health conditions of the experiment, if required by special regulations, 9)
22. justification for repeated animal intervention,
23. Indication of the level of good laboratory practice conditions if required by a special regulation. 10)
(2) The user installation which presents experimental projects on wild animal species expands the data in the trial project for the opinion of the nature protection.1)
(3) A user facility which presents a project of attempts to collect from livestock and pet animals for the production of biological material for the production of serum, vaccines, diagnostics and drugs shall extend it by a written contract between the user and the owner of the animal from which no certificate for the breeding establishment is required. The collection of biological material under these conditions may be carried out on the same animal not more than twice a year.
(4) The experimental project referred to in paragraph 3 shall always determine the type and quantity of the material to be collected, the time of its collection, its methodology and the method of care of the animal after collection, as well as the way in which the owner of the animal has been introduced and checked.
(5) The expert committee of the user installation shall submit a proposal for an experiment project leading the experiment, which shall, in case of approval of the trial project, conduct a test protocol and confirm the actions set out in the experiment project.
(6) An indication of an experiment relating to the protection of state, economic or commercial secrets, discoveries or copyrights which deal with specific laws, 11) is not a reason for not being able to supervise the protection of animals.
Authorisation of use of animals for experimental project
(1) Where the competent authority pursuant to Article 23 (1) (a) of the Act authorises the use of animals for the experimental project submitted, it shall indicate in its authorisation its number with a period of validity. The permit becomes an integral part of the experiment project.
(2) The competent authority may also authorise the use of animals in a project of experiments which does not comply with the conditions of rearing and using animals laid down in this Decree, provided that monitoring of such changed conditions is the objective of an experiment which complies with the purpose of the experiment under § 15 (1) (a) to (f) of the Act.
(3) The non-notification of a change in the data of an experiment project concerning a change in the head of the experiment, a change in the type of animals used, an intervention in animals, handling of animals and a change in the place of the experiment to the competent national authority is considered to be the conduct of an experiment without authorisation.
Conditions for accreditation
(1) The accreditation procedure provided for in Article 21 (3) (e) of the Act is initiated by the submission of an application for accreditation (hereinafter referred to as the "application") to the Central Commission by a user facility pursuant to Article 19 (1) (b) of the Act. The request shall be made on a form issued by the Central Commission.
(2) The application contains:
(a) identification of the user device
1. name or name of applicant,
2. a seat with an exact address,
3. identification number,
4. bank number,
(b) the name of the statutory representative, in the absence of a natural person;
(c) the name of the person responsible for representing the user installation in the accreditation procedure;
(d) the main focus of the user installation;
(e) the species and numbers of animals kept and the maximum possible number of animals;
(f) the subject matter and scope of the activities for which accreditation has already been issued with the registration number of this Decision;
(g) consent to the implementation of the accreditation procedure and assessment of the user installation, including the provision of the necessary documentation to the assessor;
(h) the stamp and signature of the applicant and the date of processing of the application;
(i) any other information provided in the single form.
Award of accreditation
(1) The Central Commission shall grant accreditation if the user installation fulfils the conditions laid down. The Central Commission shall decide on the basis of opinions in the written report of the assessors or its own investigation.
(2) Accreditation is granted for a fixed period of time, but for a maximum of three years at the first granting of accreditation, for each subsequent granting of accreditation for a maximum of five years.
(3) The accreditation decision shall include the identification data of the user installation and shall specify:
(a) the type of activity;
(b) animal species and their maximum number;
(c) the person responsible for the care of animals,
(d) the date of approval and the period of validity.
(4) The Central Commission will send the accreditation decision to the applicant, the competent national authority and the competent authority for the protection of animals.
Accreditation data
(1) The user facility shall provide evidence to the assessor during the accreditation procedure
(a) general data
1. the original or certified copy of the document of legal personality,
Sign in for notes, favorites and notifications
Regulation Information
| Citation | Decree of the Ministry of Agriculture No. 311 / 1997 Coll., on the breeding and use of experimental animals |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 22.12.1997 |
|---|---|
| Effective from | 01.01.1998 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
Comments 0