Decree No. 207 / 2004 Coll.
Decree on the protection, breeding and use of experimental animals
Valid
Order
Effective from 01.05.2004
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207
DECLARATION
of 14 April 2004
on the protection, breeding and use of experimental animals
The Ministry of Agriculture provides, pursuant to Article 29 of Act No. 246 / 1992 Coll., for the protection of animals against abuse, as amended by Act No. 77 / 2004 Coll., ("the Act ') for the implementation of § 17 (4), § 17a (3), § 17b, 17c, § 17d (1), § 17e, § 18b (5) and § 18f of the Act and in accordance with European Community law: 1)
CONDITIONS FOR THE CONDUCT AND USE OF POTENTIAL ANIMALS
Conditions for breeding, supplying and user facilities
(1) This decree implements the relevant provisions of the European Community1) and regulates the requirements and conditions for the protection of experimental animals against abuse, conditions for breeding, use and transport of experimental animals.
(2) For the purposes of this decree:
(a) an open system of breeding, whereby the entry and exit of animals, persons and material are free of barrier, subject to health and veterinary measures;
(b) a barrier farming system 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 isolation system for keeping a system in which the animal compartment is permanently and completely separated by a barrier to 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) The usual types of laboratory animals are listed in Annex 1, Table 1, to this Decree.
Requirements for premises for animals
(1) In premises within buildings which are permanently intended for animal husbandry, persons carrying out breeding, supplying 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) construction or other technological adaptations and equipment as required by the farming system and the conditions of the experiment project;
(c) for the breeding of laboratory rodents and similar animal species of breeding vessels or cages of the size referred to in Annex 2 to this Regulation;
(d) the spatial layout of boxes or stands for selected species of experimental animals in accordance with Annex 2 to this Decree;
(e) in barrier and insulator farming equipment, an appropriate separate replacement source of electricity;
(f) the operational separation of animal compartments, including access corridors, from technologies and operations, in particular from the water treatment plant, the machinery plant, replacement energy sources, expeditions, administration,
(g) disassembly of separate premises for carrying out simple diagnostic tests, administration of substances to animals and sampling in user facilities;
(h) separate premises for animals requiring emergency care, in particular for animals injured, sick or suspected of being sick or sick;
(i) separate premises for receiving new animals (quarantine room).
(2) The external designated areas (enclosures), permanently intended for animal husbandry, provide needs and equipment according to animal species for their protection and well-being, such as, in particular, suitable shelter or other protection against adverse climatic effects.
(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.
Storage and auxiliary facilities
(1) The storage and auxiliary premises shall be considered as separate premises in breeding, supply and user facilities intended for the storage of feed, (2) bedding and other material, or serve as a washroom of equipment, connecting corridors, machinery spaces, barrier access 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, cages and containers, breeding, supply and user facilities shall be equipped with premises for cleaning, disinfection and storage.
Animal care
(1) In order to optimise the health status, well-being and hygiene of animals in breeding (hereinafter referred to as "animal care"), persons operating breeding, supplying and user facilities shall, in accordance with the technological procedure:
(a) increased care of pregnant females, young and young females;
(b) the treatment and handling of animals in accordance with Annex 2, Table 2;
(c) ways of breeding laboratory animals in order to ensure their production that meets health, morphological, microbiological and genetic parameters;
(d) fitting of premises by suitable aids
1. to provide first aid;
2. to carry out the experiment and, where appropriate, to kill the animal,
3. to play or other activities enabling natural manifestations, especially in primates, dogs and cats,
(e) the marking of animals and the keeping of zootechnical records.
(2) Chemical, physical and microbial contamination should be avoided in the selection, manufacture and preparation of feed. All hoppers, rigs and other tools used for feeding are regularly cleaned and sterilised if necessary. The distribution of feed shall be carried out in such a way as to meet the physiological needs of the animals and to give each animal access to the feed.
(3) It is necessary to ensure that all animals are still provided with water not endangering their health. Water is permitted to be administered as part of wet feed during transport. The power system is analysed, cleaned and sterilised at regular intervals. Automatic feeders are regularly tested, maintained and rinsed to prevent accidents and spread of infections.
Zoohypgienic conditions for animals within buildings
(1) The premises for the normal types of laboratory animals must be equipped with an adequate ventilation system corresponding to the requirements of the animals present. The ventilation system shall provide sufficient fresh air supply of appropriate quality and the removal of odours, harmful gases, dust and pathogens of all kinds. At the same time, the system shall ensure the removal of excess heat and moisture. The air in the rooms must be replaced regularly, the minimum replacement is 15 air exchanges per hour, in cases where a small number of animals are occupied the air changes may be reduced, but there may not be less than 8 air exchanges per hour. The ventilation system shall be designed in such a way that the noise does not exceed 60 dB and that the flow does not exceed 0,3 m per second at 160 cm above the floor.
(2) The premises for carrying out work on infectious and toxic material must be closed and separate from other premises.
(3) The temperature in the animal compartments must be regulated in such a way as to ensure the care of animals according to the physiological needs of each species in accordance with the values set out in Annex 2, Table 1, to this Regulation or under the conditions laid down by the experiment project. Temperature and relative humidity values shall be recorded continuously at least once per hour and subsequently checked.
(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 outside the recommended values for more than 48 hours is considered to be causing stress effects.
(5) Pressure and vacuum values in barrier and insulator systems must be checked and recorded at least every 24 hours. In barrier systems, the constant pressure shall be at least 40 Pa; in working under pressure the pressure shall be at least 20 Pa.
(6) When breeding albino animals, the intensity of lighting does not exceed 200 lux at cage level with animals. 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 sources of sound in such a way as not to adversely affect the animals. In rodents, sounds exceeding 20 kHz are excluded.
(8) Only dry, clean material without toxic and irritating substances and micro-organisms capable of causing disease must be used for the litter. The quality and frequency of the 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, 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.
Preventive animal health care
The frequency of checks on the health status of laboratory animals in breeding and user establishments is determined for selected species in Annex 1, Table 2, to this Decree.
Conditions for protection in the movement and transport of animals
(1) The transfer may take place provided that it is ensured that:
(a) the security and storage of transport packages with animals so that they do not overturn during the movement or transport, are in a vertical position, bottom-down, and are secured in such a way that they do not flow or appear to be effluent, water supply, bedding or other objects and animals are not exposed to excessive shocks and adverse climatic changes, the care of animals according to the physiological needs of each species must be ensured during transport in accordance with the values set out in Annex 2, Table 1 and Annex 12 to this Regulation;
(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.
(2) Before transporting the animals, the consignor must also ensure
(a) that, at the same time as animals, goods which may adversely affect their well-being may be damaged or cause undue stress effects;
(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) Consignments of animals must be taken over and unpacked without undue delay.
(2) When accepting the consignment, the consignee shall check the condition of the consignment, the health status and the accompanying documentation of the animals, which are the delivery note and the consignor's report indicating the number and type of animals dispatched, the sex, weight, origin and the means of identification; for laboratory animals listed in Annex 1, Table 2, the results of the last laboratory examination of the health status, and
(a) take over the consignment;
(b) return the consignment for reasons other than health; or
(c) where injury or suspicion of disease or disease of animals transported is detected, it shall immediately summon a veterinarian who shall provide the animals with professional care and order measures in accordance with the special legislation (3) or decide within the meaning of Articles 4 (1) (d) and 5 (2) (b) of the Act on their possible killing.
(3) After inspection, the animals must be placed in clean cages or clean boxes, as well as fed and watered. Animals sick or in poor physical condition must be subjected to observations and kept separate from others.
(4) After the animals have been moved to breeding and user establishments, their breeding shall be separated on an operational basis by defining the location, space, time and extent of the clinical and laboratory examination provided for in accordance with specific legislation, (4) unless this is contrary to the experiment project.
Catch and quarantine of animals
(1) Wild animals may only be caught using gentle methods, through experienced personnel and in accordance with the law. If a narcotic agent or other medicinal product is used during the capture, it must be administered by a veterinarian or another competent person.
(2) If the health status of the animals taken into the establishment is not satisfactory, they must remain in quarantine for the time required. During the quarantine period, animals may be used for experiments if it is verified that they have become accustomed to a new environment and do not pose any particular threat to other animals or humans.
Conditions of use of 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 experimental project and, unless specific legislation does not exclude it (1).
(2) The period of treatment for selected species is set out in Annex 2, Table 2, to this Decree. for other animal species, that period shall be at least five days, except for fish where the period of recovery is at least three days.
(3) Experiments on wild animal species caught in nature may be conducted only if the purpose of the experiment is not proven by another animal.
Experimental project
(1) The test project contains the following data, which is marked by numbering:
1. identification of the person operating the user installation;
2. the number of the accreditation decision and its duration;
3. the name, surname, title and number of the certificate of qualification referred to in Article 17 (1) of the Law of the Head of the Experiment and his representative, if established,
4. the name, surname, title and number of the certificate of qualification referred to in Article 17 (1) of the Act of the person responsible for the care of animals in the user establishment;
5. the name, surname, title and number of the qualification certificate provided for in Article 17 (1) of the Law of the person who directs the activities of the expert committee;
6. name of the task of the study and, where appropriate, the designation of the grant;
7. the characteristics of the study's objectives, indicating the specific expected benefit, including the characteristics of the applied substances, or the inclusion of substances in the indicative groups, except for the output control of batches of substances;
8. The purpose of the experiment under Paragraph 15 (1) of the Act,
9. Methodological procedures for animals,
10. Declaration by the appellant on the demonstration of the necessity of the experiment or of the provision of legislation imposing the conduct of the experiment, including a justification why the animal experiment cannot be replaced by alternative methods,
11. justification for the choice of species, breed, strain and category of animals the use of which is planned, indicating their quality parameters;
12. the origin of the experimental animals, indicating the recording data of the breeding and supply establishment and the holding registration number, according to specific legislation, 5)
13. Justification for the number of animals planned to be used over a specified period of time,
14. method of marking animals in the experiment,
15. Method of numbness, administration of painkillers or pain relief measures,
16. location of animals during the experiment or in wild animals instead of the experiment;
17. Timetable for the individual stages of the animal experiment, including the date of its termination,
18. Level of operational equipment and method of post-operative care;
19. Method of loading animals after completion of the experiment,
20. Method of monitoring compliance with the animal protection rules,
21. Indication of the health risk to other animals and workers,
22. animal health conditions of the experiment laid down under specific legislation, 6)
23. Justification for repeated animal intervention, if any,
24. indication of the level of good laboratory practice conditions, if required by special legislation, 7)
25. Date and signature of the trial manager, representative of the trial manager and statutory authority, stamp of the user installation.
(2) The person operating a user facility that presents experimental projects on wild animal species shall extend the data in the trial project to the opinion of the nature conservation authority. 8)
(3) A person operating a user facility who submits a project of single-use sampling experiments from livestock and pet animals for obtaining biological material for the production of serum, vaccines, diagnostics and drugs shall extend it by a written contract with the owner of the animal from which a certificate for the breeding establishment is not 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 model form for the experimental project is set out in Annex 6 to this Decree.
(6) The design of the experiment project shall be processed in two copies to be sent to the competent national authority. 9) Following approval of the experiment project, the competent State authority shall send one copy to the expert committee.
Authorisation of use of animals for experimental project
The competent State authority (9) may authorise the use of animals in an experimental project 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 (h) of the Act.
Application for accreditation to a person operating a user facility
(1) The model of the application for accreditation to the person operating the user installation is set out in Annex 7 to this Decree.
(2) The application referred to in paragraph 1 shall include a declaration by the applicant that he is able to submit to the assessors:
(a) general data
1. the original or certified copy of the document of legal personality,
2. the power of attorney of the person empowered to represent in administrative proceedings,
3. the approval decision or the original or a certified copy of the binding opinion of the competent authority of the veterinary administration in the territorial, building and housekeeping proceedings, if required by specific legislation, (10) and written observations on the activity of the user installation;
4. operating rules,
5. technological processes;
6. documentation of the nature of the objects of the user device, including address, exact location, name or other indication of individual premises where animal experiments are carried out;
7. organisational chart,
(b) special particulars
1. proof of the provision of the person responsible for the care of the animals and the certificate of professional competence referred to in Article 17 (1) of the Act;
2. proof of the provisions and composition of the members of the Panel of Experts and the certificate of their competence pursuant to Article 17 (1) or Article 26 of the Act;
3. a list of functional posts, which can only be held under this Order with a certificate of professional competence pursuant to Sections 17 and 18 (6) (c) of the Act, supported by a list of employees, stating whether the certificate has been granted to them,
4. documentation on animal husbandry and use;
5. registration of the number of animals in the last three years if the activity is not started by the user device.
(3) A person operating a user facility requesting accreditation for experiments on wild animals shall extend the accreditation data to the opinion of the nature conservation authority. 8)
(4) Where an applicant requests accreditation for a further period, the application referred to in paragraph 1 shall include a declaration from the applicant that he is able to submit to the assessors also:
(a) records of the number of animals used, reared, bought or delivered, showing their origin;
(b) records of the number of dead animals;
(c) records of animal health checks, including results of laboratory control tests, and results of feed and drinking water tests;
(d) records of the supervisory authorities;
(e) all experimental projects, including documents not approved by the expert committee of the user establishment, by the competent State authority or by the Ministry of Agriculture (hereinafter referred to as the Ministry);
(f) documentation of the animals used in relation to the relevant experimental projects which have taken place since prior accreditation, but for a maximum period of five years;
(g) the supporting documents provided for the registration of animals to the competent State authority in accordance with the mandatory instructions of the Ministry;
(h) changes in accreditation data;
(i) where appropriate, additional data based on the requirements of the Ministry.
(5) When assessing a user installation on the spot, the assessors shall mark the individual sheets of the documents referred to in paragraph 2 (a) (4) to (7) (b) with the stamp of the Ministry and shall draw up a written opinion of the assessors of the user installation, the specimen of which is set out in Annex 10 to this Regulation.
Application for certification of a person operating a breeding and supply establishment
(1) The model of the application for certification to the person carrying out the breeding and supplying establishment is set out in Annex 8 to this Decree.
(2) The application referred to in paragraph 1 shall include a declaration by the applicant that he is able to submit to the assessors:
(a) general data
1. the original or certified copy of the document of legal personality,
2. the power of attorney of the person empowered to represent in administrative proceedings,
3. the approval decision or the original or a certified copy of the binding opinion of the competent authority of the veterinary administration in the territorial, building and approval proceedings, if required by specific legislation, 10) and a written statement on the activity of the breeding or supply establishment;
4. operating rules,
5. technological processes;
6. documentation of the nature of the objects of the breeding or supply establishment, including address, exact location, name or other indication of the individual premises where the animals are kept;
7. organisational chart,
(b) special particulars
1. a list of functional posts, which can only be held under this Order with a certificate of professional competence in accordance with Sections 17 and 18 (6) (c) of the Act, supported by a list of appointed staff with a statement of whether this certificate has been granted to them;
2. documentation on animal husbandry.
(3) Where an applicant requests further certification, the application referred to in paragraph 1 shall include a declaration by the applicant that he is able to submit to the assessors also:
(a) records of the number of animals reared, bought or delivered, showing their origin;
(b) records of the number of dead animals;
(c) records of animal health checks, including results of laboratory control tests, and results of feed and drinking water tests;
(d) records of the supervisory authorities;
(e) amendments to the particulars relating to the certificate;
(f) where appropriate, additional data based on the requirements of the Ministry.
(4) When assessing a breeding or supply establishment on the spot, the assessors shall indicate the individual sheets of the documents referred to in paragraph 2 (a) (4) to (7) (b) with the stamp laid down and shall draw up a written opinion of the assessors of the breeding and supply establishment, the specimen of which is set out in Annex 11 to this Regulation.
MARKING OF ANIMALS, THE METHOD OF EVIDENCE AND CONTROL
Labelling of animals
(1) The animals in the experiments are identified in a way that causes them least pain, does not restrict them in their natural functions and ensures their permanent identification in a manner that corresponds to the species, age category of animals and to the conditions of the experiment project, or in a manner that is laid down by specific legislation. 5)
(2) In the case of laboratory rodents, an operational record shall be kept indicating the cages and breeding vessels where the species, strain, sex, date of birth and identification of the breeding or testing group are indicated.
Records kept by user equipment
(1) The account of the user device is included
(a) summary reports submitted to the competent national authority, including the tables set out in Annex 3;
(b) protocols containing data on the conduct of the experiment, including compliance with the working procedures and methods established by the project of experiments, in particular the completion of the experiment, the reason and method of killing the animal, including details of who and when the killing took place;
(c) the experiments referred to in Article 11 (3)
1. the number of the contract with the owner of the animal and the date of its conclusion;
2. identification details of the owner of the animal entering into the contract;
3. identification marks and markings of the animal,
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Regulation Information
| Citation | Decree No. 207 / 2004 Coll., on the protection, breeding and use of experimental animals |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 26.04.2004 |
|---|---|
| Effective from | 01.05.2004 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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