T.C.
GIDA, TARIM ve HAYVANCILIK BAKANLIĞI
Gıda ve Kontrol Genel Müdürlüğü
Regulation On The Procedures And Principles For The Protection Of Animals Used For Experimental Or Other Scientific Purposes, Breeding Establishments For Experimental Animals And The Establishment, Operation And Inspection Of Laboratories Performing The Experiments
Referance Law 3285, 6343, 441
Official Journal 16.05.2004-25464
CHAPTER ONE
Objective, Scope, Legal Basis and Definitions
Objective
Article 1 – The objective of this regulation is to ensure that breeding establishments for animals used for experimental or other scientific purposes are established and operated under appropriate technical, health and hygienic conditions, and that these establishments are maintained and used so as to provide the welfare and safety of the animals concerned.
Scope
Article 2 – This Regulation comprises the rules, technical and hygienic requirements which shall be complied with during the breeding, usage, sale and transportation of animals used for experimental or other scientific practices carried out by real persons, legal entities, public bodies and institutions, as well as the processes which apply in conformity with the provisions of this Regulation.
Legal Basis
Article 3 – This Regulation has been prepared on the basis of Law No. 3285 on Animal Health and Police, the Decree having the force of Law No. 441 on the Establishment and Functions of the Ministry of Agriculture and Rural Affairs, Law No. 6343 on the Practice of the Profession of Veterinary Medicine, Organization of Societies for Veterinary Medicine and Liabilities of the Organizations
Definitions
Article 4 – For the purpose of this Regulation the following definitions shall apply;
Ministry: The Ministry of Agriculture and Rural Affairs
General Directorate: General Directorate of Protection and Control
Institute Directorate: the Veterinary Control and Research Institutes to which the veterinarian services in the province where the facility is located are bound to, the Central Veterinary Control and Research Institute Directorate, the Poultry Diseases and Vaccine Production Institute Directorate and the Foot and Mouth Disease Institute
Provincial Directorate: the Provincial Directorates of the Ministry of Agriculture and Rural Affairs
District Directorate: the District Directorates of the Ministry of Agriculture and Rural Affairs
Responsible Facility Manager: the veterinarian who, together with the owner of the establishment is jointly responsible for the management and operation of the facility
Expert: the veterinarians, doctors or biologists who are to work at the facility, and who have specialized in their own field or have pursued an academic career
Veterinarian: Veterinarians working at the facility and the establishment
Doctor: Doctors working at the establishment
Biologist: the biologist working at the facility and the establishment
Technical Personnel: Chemists and biologists employed in the technical service staff at the facility and the establishment
Technician: Veterinary health technicians working at the facilities
Laboratory Technician: the laboratory technicians working at the facilities and the establishment
Animal: means any live non-human vertebrate, including free-living larval and/or reproducing larval forms, but excluding fetal or embryonic forms
Race: races of animals especially bred for use in approved, registered experiments
Experiment: the use of an animal for experimental or other scientific purposes which may cause it pain, suffering, distress or lasting harm, including any course of action liable to result in the birth of an animal in such a condition, but excluding the least painful methods ('humane' methods) of killing or marking an animal that are accepted in modern medical practice
Establishment: bodies where animals are used for experimental and scientific purposes
Laboratory: units within the establishments where interventions for experimental and scientific purposes are performed on experimental animals
Facility: the breeding facilities for animals to be used for experimental or other scientific purposes
Permission for establishment: the letter of authority granted by the Ministry for the establishment of the facilities and laboratories provided that the place, project and plans have been approved by the Ministry
Working Permit: the letter of authority granted by the Ministry so that establishments constructed according to the appropriate place, project and plans, and which have been previously granted permission for establishment from the Ministry, can start their operations.
CHAPTER TWO
Issues Related to Experimental Animals
Experimental and Other Scientific Activities where Animals May Be Used
Article 5 – The activities where animals may be used for experimental and other scientific purposes are presented below:
a. To prevent diseases and health-related abnormalities in humans, animals or plants
b. For the research of the production, safety, effectiveness, quality and side effects of drugs, substances, products or clinical applications used on humans, animals or plants
c. For the diagnosis or treatment of diseases or health-related abnormalities in humans, animals or plants
d. For the research of physiological occurrences in humans, animals or plants
e. For activities regarding environmental protection and environmental pollution
f. For training and education
g. For scientific researches
h. For forensic (medicine) researches
The General Care and Housing Conditions of Experimental Animals
Article 6 – Animals used or intended to be used for experimental or other scientific purposes shall be provided with a living environment and space for freedom of movement, food, water, environmental conditions and care that can adequately meet their physiological needs and maintain their health and well-being. Locations where animals are bred, cultivated or used should be checked on a daily basis. The well-being and health condition of animals should be observed closely and with adequate frequency so that pain, suffering and other avoidable harmful situations may be eliminated. All conditions determined as potentially harmful for the animal should be ameliorated in the shortest possible time.
Issues Related to the Application of Processes on Experimental Animals
Article 7 – In the application of processes on experimental animals;
a. Provided that another scientifically satisfactory, reasonable and practical method, which does not necessitate the use of an animal, is available, animals should not be used for the attainment of any of the purposes specified in article 5 of this Regulation.
b. When the use of an animal is unavoidable, the choice of species and genus shall be carefully considered; in the choice between the methods to be applied, those which require the minimum number of animals, cause the least pain, suffering or lasting harm, and which are most likely to provide satisfactory scientific results shall be selected. Information on the research to be conducted may be requested from the researchers, if this is deemed necessary by the Ministry.
c. For cases other than those defined in sub-paragraphs 1) and 2) of this paragraph herein, general or local anaesthesia or other pain-relieving treatment shall be applied to the animal during all processes involving pain or suffering.
1. If the process to be applied causes less pain than the application of anaesthesia/analgesia
2. If the application of anaesthesia/analgesia impairs the conditions of the research being carried out; a description for the necessity of the processes performed should be prepared for both of the cases stated above.
d. Unless otherwise required by the research, the conditions for the animals used, specified in Article 6 of this Regulation shall be provided.
e. When the process applied has been completed, a decision shall be made on whether the animal used is to be kept alive or killed by a humane method. The animal shall not be kept alive if it is likely to remain in lasting pain or distress, even though it has been restored to normal health in all other respects. The decision on whether the animal is to be kept alive or not shall be made by a veterinarian.
At the end of the process applied;
1. If the animal is to be kept alive; it shall receive the care appropriate to its state of health and be placed under the supervision of a veterinarian or other competent person, and it shall be provided with the conditions specified in Article 6 of this Regulation.
2. If an animal is not to be kept alive or cannot benefit from the conditions stated in Article 6 of this Regulation, it shall be killed by a humane method as soon as possible.
3. Regardless of whether anaesthesia/analgesia has been applied or not, an animal which has been subject to severe pain during or after the process applied and which has not yet been restored to its normal health condition cannot be re-used for a new process. However, if the new process is to be performed under general anaesthesia and until the animal dies, or if it involves only minor interventions then it may be carried out.
4. Unless a scientific obligation exists, no animal can be used in more than one major surgical intervention.
The Sale of Experimental Animals and their usage in Scientific Researches
Article 8 – The market price for experimental animals is determined by the Ministry. The breeding and supplying establishments of experimental animals are responsible for;
a. Supporting at least two researches involving the use of experimental animals, and notifying the Ministry of the studies they have supported the previous year, as of January,
b. Supporting at least one study involving alternative approaches to experimental animals, and notifying the Ministry of the studies they have supported the previous year, as of January,
c. Conducting at least one activity involving the reasons for using animals in experiments and bearing an informative characteristic in view of the public opinion, and notifying the Ministry of the relevant activity from the previous year, as of January.
CHAPTER THREE
Issues related to the Permission for Establishment, Work Permit and Personnel of
Breeding or Supplying Establishments for Experimental Animals
Permission for Establishment
Article 9 – Those willing to take place in the breeding, selling and transportation of animals used or intended to be used for experimental or other scientific practices, and all real persons, legal entities and public bodies and institutions currently using these animals for experimental and scientific purposes must apply to the Ministry by submitting a petition, and must complete the information and documents stated below:
a. Declaration filled out by the owner of the establishment in conformity with Annex 1 of this Regulation,
b. Three layout plans of 1/500 or 1/1000 scale, identifying the location and containing information on the settlement and environment of the facility, prepared with the approval of a relevant development institution,
c. Three detailed projects, prepared in accordance with technical rules and containing all the parts of the facility.
These documents, which are to be submitted by the owner of the facility to the Ministry, are first examined at the Ministry. The plans and projects of the facility are then sent to the relevant Institute Directorate for approval of their conformity. The facility is examined on-site by a commission consisting of two expert veterinarians from the Institute Directorate assigned by the Ministry, one veterinarian from the Animal Health Head Section of the Provincial Directorate, and if the facility is to be established in a district a veterinarian from the District Directorate. The report for choice of location in Annex 2 of this Regulation is filled out.
Permission for establishment is granted to facilities that are found suitable by the Ministry. The permission for establishment is valid for a period of one year. Additional time is granted by the Ministry, if appropriate, to real persons, legal entities and public bodies and institutions that are unable to complete their facilities within the said time. A written notification is submitted to the relevant Governorship on the issuance of permission for establishment or the prolongation of time. The Ministry replies to the applications latest within one month.
Work Permit
Article 10 – Real persons, legal entities and public bodies and institutions that have acquired permission for establishment and completed their facilities according to the approved projects and plans must apply to the Ministry with a petition containing the following information and documents:
a. A contract made at the notary based upon the work permits, acquired by the veterinarian who is the responsible facility manager and the veterinarians who are to work in the laboratory, and the doctors from the relevant chambers of profession,
b. The technical characteristics and capacities of the apparatus to be used in the laboratory as well as a list of materials such as the chemicals and biological substances that are to be used,
c. A document showing the number of experts and their fields of specialization,
d. If the business to be established is a company, the Commercial Registry Journal showing the foundation of the said company,
e. A document received from the fire brigade department showing that the measures necessary for the prevention of fire and explosions have been taken,
Subsequent to the examination of the said documents; the facility is examined on-site by a commission consisting of the competent authority or authorities from the Ministry, two expert veterinarians from the Institute Directorate assigned by the Ministry, one veterinarian from the Animal Health Head Section of the Provincial Directorate, and if the facility is to be established in a district a veterinarian from the District Directorate. The report for inauguration in Annex 3 of this Regulation is issued.
A work permit is granted by the Ministry to a facility found to be technically and hygienically suitable. The work permit is addressed to the facility on behalf of the real persons, legal entities and public bodies and institutions. These are then submitted by written notification to the Governorship.
Establishments breeding or supplying animals for use in experiments are obligated to fulfill the requirements stated in Article 6 of this Regulation. Facilities that have acquired a work permit by specifying in their declaration the species of animals to be bred must get further permission from the Ministry if they are to breed different species than those declared.
Technical and Hygienic Requirements
Article 11 – The technical and hygienic requirements regarding breeding establishments and laboratories within the scope of this Regulation are determined with a guideline issued by the Ministry.
Issues Related to Personnel
Article 12 – The personnel who should be present within the research unit and their duties are as follows:
a. Responsible facility manager: Employment of a responsible manager in establishments breeding or supplying animals for use in experiments, is obligatory. Issues concerning the duties, responsibilities and assignment of responsible facility managers are given below:
1. The responsible facility manager; under joint responsibility with the employer, must ensure that the establishment performs its operations in conformity with the provisions of this Regulation, that correct measures are taken to prevent any harm caused by wastes and residuals to the public health and the environment by means of health control and training of the staff.
2. Keep or make someone keep records in protocols and counterfoil report books of species and genus, date of arrival, birth, death, selling, transportation, treatments applied, the name and address of the person applying for the purchase or use of the animals, and their outcomes regarding the animals are brought to, bred, sold, used, die at or are transported to the breeding establishment for experimental animals.
3. Maintain the audit book and submit to concerned parties, upon request, the information and documents specified by the Ministry.
4. In order to enable the responsible manager to perform his/her duties, the owner of the establishment must provide all kinds of equipment and facilities.
5. Responsible facility managers cannot engage in other work during the working hours.
6. They are responsible for preparing the plans and programs for the general cleaning, maintenance and operation of the facility.
b. Veterinarian: is responsible for the acceptance, care, feeding, breeding, observing the health condition, treatment of diseases, recordkeeping of the animals in the research unit as well as for ensuring that the researches performed are in compliance with veterinary medical practice,
c. Technician: the veterinary health technician must assist the veterinarian in the fulfillment of the tasks which are under the responsibility of the veterinarian,
d. To have present in the research units where genetically engineered animals (such as transgenic or knockout animals) are found a veterinarian, doctor or biologist who has received education on genetics (specialization, doctorate or post graduate education),
e. To have present in the research units where animals requiring special care due to their microbiological characteristics (such as athymic, without flora, pathogenic microorganisms) are found a veterinarian, doctor or biologist who has received education on microbiology (specialization, doctorate or post graduate education),
f. Security personnel,
g. Cleaning personnel,
h. Technical personnel,
i. At least one personnel, other than the security personnel, should remain on duty on a 24/7 basis in facilities where experimental animals are kept. The personnel who is to remain on duty must have the adequate knowledge and skills required for emergencies.
CHAPTER FOUR
Issues Related to the Establishments
User Establishments of Experimental Animals
Article 13 – User establishments where animals are used for experimental or other scientific purposes are obligated to fulfill the requirements stated in Article 6 of this Regulation.
User establishments must ensure that they conform to the following:
a. The minimum number of animals shall be used with the object of obtaining scientifically satisfactory results.
b. Arrangements shall be made to have installations and equipment suitable to the characteristics of the animals being used and causing the minimum degree of pain, suffering, or lasting harm.
c. The persons who are responsible for the care of the animals and the functioning of the equipment shall be identified.
d. A personnel, who has sufficient knowledge and experience in view of the subject of interest is to be present or work is to be conducted within the knowledge context of such a person.
e. Necessary arrangements shall be made, as appropriate, in order for the veterinarian services to be performed.
f. It is obligatory for these establishments to employ at least one veterinarian, on the basis of the number of animals to be used. The veterinarian shall be responsible for the checking the health condition and well-being of the animals. The department of experimental animals within the establishment shall also be under the responsibility of the veterinarian.
g. The animals used are to be purchased from breeding or supplying facilities for experimental animals.
h. Endangered / protected species shall not be used in experimental researches. A species of which a certain genus is under protection shall not be fully included within this context.
i. Permission from the Ministry should be acquired in advance for processes that shall be applied to the animals outside the establishment.
j. These establishments must provide information regarding the processes they carry out on the experimental animals, upon request from the Ministry.
The Use of Animals for Training and Education
Article 14 – Establishment using the animals for training and educational purposes must notify the Ministry of the animals they are using or intend to use and of their purposes. Bodies and establishments shall allow for the performance of scientific experiments by means of a Council of Ethics to be formed within their own structure.
a. The veterinarian, who is responsible for ensuring that the animals are used in conformity with the provisions of this Regulation, shall arrange and check the processes performed on the animals.
b. Animals shall be used for training and educational purposes if this is absolutely necessary.
c. Personnel responsible for training and education shall have sufficient knowledge and experience.
Obtaining Information from the Establishments
Article 15 – The establishments must provide the Ministry with the information requested, within the required frequency and time.
Regarding processes related to experimental animals performed at any site, no public announcement may be made and no information may be given out, without the permission of the person/persons or establishment responsible for the said processes. In case it is deemed necessary;
A public announcement may be made by a person/establishment to be assigned from or by the Ministry. Information obtained from the establishments are published and submitted for use by the Ministry.
Breeding or supplying establishments for experimental animals are responsible for arranging the following documents and sending them to the Ministry as of January each year.
a. A list of the apparatus/equipment used in the facility/laboratory,
b. A list of all personnel employed at the facility/laboratory,
c. The species, genus (strains) and numbers or animals bred during the previous year,
d. The species, genus (strains), place of arrival, for whom they were supplied and numbers of animals supplied during the previous year,
e. The species, genus (strains) and numbers of animals bred and sold during the previous year,
f. A list of supported studies from the previous year (on experimental animals and alternative approaches to experimental animals), the names and full addresses of the person or establishments being supported, the results of the study, the means of support (financing, equipment, technical personnel, working material etc.) and the dimension of the support given,
g. The form, place, target audience and two copies of the materials presented during publicly informative activities from the previous year, regarding the necessities of the use of experimental animals (seminars, video films, speech text, newspaper advertisement etc.).
User establishments shall arrange the information concerning the species and numbers of animals used as well as the purposes they were used for in the form of a notice, and they shall be responsible for sending the information of the previous year to the Ministry as of January each year.
The Ministry may request new additional documents and alter the frequency of request and the contents of the said documents.
CHAPTER FIVE
Penal Provisions, Closing, Modifications and Supplements
Penal Provisions
Article 16 – Work permits or permissions for operations are annulled according to Law No. 3285 on Animal Health and Surveillance, and work permits are annulled in accordance with the Regulation on Animal Health and Surveillance published in the Official Journal No. 20109 and dated 15/3/1989 in cases where; establishments fail to meet or achieve the requirements and responsibilities stated in this Regulation, disagreements determined as a result of inspections are not settled even though warnings have been made, a new responsible facility manager has not been appointed within one month of the departure of the present responsible manager, modifications are made at the facilities without the permission of the Ministry although a work permit in view of the Projects has previously been acquired from the Ministry in accordance with the provisions of this Regulation, and where the practices being carried out are found to be inappropriate by the Ministry.
Closing Modifications and Supplements
Article 17 – No modifications and supplements (partial or complete renewal of the facility, increasing or decreasing the breeding capacity of the facility, constructing new units within the facility with the object of breeding new species or strains) may be made in facilities that have a work permit, without getting permission from the Ministry. In case the Ministry allows for such modifications to be made information and documents specified in this Regulation may be requested once more. The work permit granted; applies to the real person, legal entity or public body and institution, address and field of activity written on it. In case of a change in any one of these factors the work permit loses its validity. In cases where the facilities are closed down by their owners, the ownership or title changes, an application is submitted to the Governorship and a petition is sent to the Ministry from at least one month in advance. Information and documents on the modifications as well as the original copy of the work permit are enclosed with the petition. A work permit is issued for the facility according to the new owner and title, if deemed appropriate by the Ministry.
In case the work permit is misplaced or destroyed so as to make it illegible, the relevant newspaper advertisement or the original copy of the work permit is attached to a petition and submitted to the Governorship. A work permit is re-issued with the old date and number, and including the necessary explanation, if deemed appropriate by the Ministry. In cases where the operation of the facility is ceased by its owner or the facility is closed down by its owner, this situation should be made known via a written notification to the Governorship.
CHAPTER SIX
Miscellaneous Provisions
Provisional Article 1 – The following apply for facilities actively operating:
a. Facilities that have been established before the publication of this Regulation, but that have not acquired a work permit must submit an application to the Ministry within 6 months as of the publication of this Regulation, arrange their facilities in accordance with the provisions of this Regulation and acquire a new work permit.
b. Action will be taken against those who fail to make an application within the specified time period, according to Law No. 3285 on Animal Health and Surveillance and the Regulation on Animal Health and Surveillance published in the Official Journal No. 20109 and dated 15/3/1989. Facilities shall be closed down until they have fulfilled their liabilities.
CHAPTER SEVEN
Final Provisions
Enforcement
Article 18 – This Regulation will enter into force on the date of its publication.
Execution
Article 19 – The provisions of this Regulation are executed by the Ministry of Agriculture and Rural Affairs.
ANNEX-1
DECLARATION
| 1- | Information related to the facility | ; |
| a. Name and surname of the owner | : | |
| b. Commercial name | : | |
| c. Full address | : | |
| d. Telephone number | : | |
| e. Fax number | : | |
| f. Island, section and parcel number | : | |
| 2- | Field of activity | |
| a. Supplying | : | |
| (which animals are to be supplied?) | ||
| b. Breeding | : | |
| (which animals are to be bred?) | ||
| 3- | Descriptive report on the field of activity of the facility. | |
| 4- | The starting date considered for the construction of the facility. | |
| Name and Surname of the Owner of the Facility Signature |
||
ANNEX-2
REPORT ON THE CHOICE OF LOCATION
| 1- | Information related to the facility | |
| a. Name and surname of the owner | : | |
| b. Commercial name | : | |
| c. Full address | : | |
| d. Telephone number | : | |
| e. Fax number | : | |
| f. Island, section and parcel number | : | |
| g. Field of activity | : | |
| 2- | The location of the facility and for what purpose its environment is being used? | |
| 3- | Whether the location is suitable for a facility involved in the breeding of experimental animals or not? | |
| The location where the breeding facility for experimental animals is to be constructed is / is not suitable (reasons). | ||
| Competent Authority of the Institute Directorate Expert Veterinarian |
Competent Authority of the Institute Directorate Expert Veterinarian |
Competent Authority of the Provincial Directorate Veterinarian |
Competent Authority of the District Directorate Veterinarian |
ANNEX-3
INAUGURATION REPORT
| 1- | The facility’s | ||
| a. Name and surname of the owner | : | ||
| b. Commercial name | : | ||
| c. Full address | : | ||
| d. Telephone number | : | ||
| e. Fax number | : | ||
| f. Island, section and parcel number | : | ||
| g. Field of activity | : | ||
| 2- | Has the facility been built in accordance with the plans and projects submitted during the permission of establishment stage? | ||
| a) Yes | b) No | ||
| 3- | Does it have a certificate of operation in accordance with the Statute on Worker Health and Work Safety? | ||
| a) Yes | b) No | ||
| 4- | Has a document, showing that the necessary measures have been taken to prevent fires and explosions been acquired from the fire brigade department? | ||
| a) Yes | b) No | ||
| 5- | Does the responsible, doctor, laboratory expert, veterinarian and technical personnel have a contract approved by the notary? | ||
| a) Yes | b) No | ||
| 6- | Are the technical properties and capacities of the installations and equipment to be used in the facility’s units suitable? | ||
| a) Yes | b) No | ||
| 7- | Is the number of laboratory experts, doctors, veterinarians, laboratory technical personnel and laboratory technicians employed in the facility’s units sufficient? | ||
| a) Yes | b) No | ||
| 8- | Findings and observations resulting from the on-site examination: | ||
| The issuance of an inauguration report for diagnosis and analysis/breeding laboratory is approved / not approved (reasons). | |||
| Competent Authority of the Ministry Veterinarian | Competent Authority of the Institute Directorate Expert Veterinarian | Competent Authority of the Institute Directorate Expert Veterinarian | Competent Authority of the Provincial Directorate Veterinarian | Competent Authority of the District Directorate Veterinarian |