UNMIK INSTITUCIONET E PËRKOHSHME TË VETQEVERISJES PRIVREMENE INSTITUCIJE SAMOUPRAVLJANJA PROVISIONAL INSTITUTIONS OF SELF-GOVERNMENT QEVERIA E KOSOVËS/ MINISTRIA E BUJQËSISË, PYLLTARISË DHE ZHVILLIMIT RURAL VLADA KOSOVA/ MINISTARSTVO POLJOPRIVREDE, SUMARSTVA I RURALNOG RAZVOJA GOVERNMENT OF KOSOVA/MINISTRY OF AGRICULTURE, FORESTRY AND RURAL DEVELOPMENT Pursuant to Article1.3 point (d) UNMIK Regulation No.2001/19 of September 13th 2001 on executive department of Provisional Institutions of Self-Government in Kosovo and Veterinary Law No.2004/21 of July 30th, 2004 Article 38,39,40,41,and 42. The Minister of the Ministry of Agriculture, Forestry and Rural Development, Issues the following: ADMINISTRATIVE INSTRUCTION MA-NO. 21/2007 Concerning the function, competencies, and responsibilities of the Kosovo Veterinary and Food Laboratory Article 1 Objective Under this Administrative Instruction is redressed function, competencies and responsibilities of the Kosovo Veterinary and Food Laboratory in the field of the Veterinary and food of animal origin, monitoring and diagnostification of animal disease, animal feed, residues with objective to protect animal and public health, food safety and its organizational structure. Article 2 (1) Kosovo Veterinary and Food Laboratory - KVFL is an organizational unit of the Kosovo Veterinary and Food Agency, within the Ministry of Agriculture, Forestry and Rural Development - MAFRD. (2) The Veterinary and Food Laboratory is managed by the director of the laboratory and for his duties reports to the Chief Executive of Kosovo Veterinary and Food Agency. Article 3 KVFL is an authorized and competent body, respectively by the MAFRD to carry out tests of the food of animal origin, monitoring and animal disease diagnostification, animal feed, and residues of the Veterinary drugs. Article 4 KVFL is consisted by these sectors: 1. Animal disease diagnostification sector; 2. Sector of the food of animal origin and animal feed; 3. Sector of Avian influenza; 4. Sector of disinfection, pest and rat control; 5. Sector of Quality control management.
Article 5 Sector of animal disease diagnostification is consisted by: 1. Unit of animal disease of the List A First Program; 2. Unit of the animal disease of the List B Second Program; 3. Unit of the bee and fish disease. Article 6 (1) According to the Governmental Program, Sector of animal disease diagnostification carries out the se tasks 1. Follows up and studies notification, movement, fighting and eradication status of the contagious disease, vermin us and other disease, 2. Assesses epistemological situation of the country, and details the diagnose of the contagious disease from the List A and B, as well as zoon tic ones based on OIE, 3. Dependently from the test reports suggests the following measures, prophylactic vaccination, diagnostic and research test of the animal disease, disinfection, pest and rat control with scope to prevent spreading of the animal disease, 4. Investigates, advances an implements research methods, prevention and prophylaxes of the contagious, parasitological disease and other rdisease, 5. Investigates zootechnic conditions in the premises for animal keeping and breeding as well as animal feed, 6. Researches progresses preparations and their application in diagnostification, prophylaxis and therapy, 7. Follows up, analyses and evaluates Environmental impact on animal s health status, 8. Cooperates with institutions and authorities within the country (KAI, KIPH, ands others), laboratories in the region and with accredited laboratories and standards of progressing of the laboratory testing methods, 9. Follows up innovations in carrying out laboratory tests conform ISO- 17025/2005 and EU referent laboratories 10. in a close cooperation with sector of quality control management validities and evaluates methods of laboratory testing. (2) For all activities from Paragraph 1 of this Article reports to the Director of KVFL. Article 7 (1) Sector of animal disease diagnostification is consisted by these functional laboratories: 1. Laboratory of Pathos-Histology; 2. Laboratory of Bacteriology, Parasitology and Mycology; 3. Laboratory of Serology; 4. Laboratory of Virus logy; 5. Diagnostification Laboratory of bee and fish disease. (2) Laboratory of Pathos Histopathology carries out: 1. Receiving of the samples; 2. Necroscopy of all animals, small animals and poultry; 3. Preparation of the samples for investigation, findings, and diagnosatification; 4. Prepears, proceeds samples for delivery abroad, with follow up documentation,with scope to confirm interlaboratory testing and other settings abroad; 5. Prep ears Patho-histopatology preparations; 6. Drafting and implementation of standard testing procedures of Operations sampling; 7. tissues for investigation virus logical bacteriological; 8. parasitological, and mycological findings; 9. Presentation, commenting, interpretation and reporting of the results. 2
(3) Laboratory of bacteriology, Parasitological, and Mycology caries out : 1. Diagnostification of the bacteriological, Parasitological and Mycological disease; 2. Receiving of the samples; 3. Preparation of the samples for settings including coloring of the preparations, planting in the feeding fields; 4. Incubation of the defined temperatures; 5. Reading f the results; 6. Sample re-incubation; 7. Drafting and implementation of the standard procedures of operation for testing; 8. Presentation, commenting, interpretation, and reporting of the results. (4) Laboratory of serology carries out: 1. Disease diagnostification taking in to account serological methods; 2. Receiving of the samples and their preparation for testing; 3. Testing of the samples with control samples (Test Kits); 4. HA/IH,NA/IN,AGID,CFR,IF,ELEKTROFOREZA, ELISA,VIDAS, RT-T-PCR, MINI-API etc; 5. Reading of the results; 6. re-testing according to written procedures; 7. drafting and implementation of the Standard Operation Procedures of the testings; 8. Presentation, commenting, interpretation and reporting of the results. (5) Virology Laboratory carries out: 1. Diagnostification of the viral disease; 2. Receiving of the samples and their preparation for testing; 3. ELISA, RT-T-PCR, HA, NA, AGID, CFR, IF ELEKTROPHORESIS, etc; 4. Dark room Inoculation of SPF Virus; 5. Sample testing with control samples (Test Kits); 6. HA/IH,NA/IN,AGID,CFR,IF,ELEKTROFOREZA, ELISA,VIDAS, RT-T-PCR, MINI-API etc; 7. Reading of the results; 8. re-testing according to written procedures; 9. drafting and implementation of Standard Operation Procedures of the testing; 10. Presentation, comments, interpretation and reporting of the results. (6) Laboratory of the bee and fish disease carries out: 1. Receiving of the samples and their preparation for testing; 2. Disease monitoring from the List A and B of OIE; 3. Complete monitoring of the health of fish holdings and bees; 4. ri-testing according to the written procedures; 5. drafting and implementation of Standard I operation Procedures of the testing; 6. Presentation, comments, interpretation and reporting of the results vet. (7) In the laboratory of the bee and fish disease are carried out testing of: 1. Spring Vermeil of the carp; 2. Viral hemorrhagic Septicemia; 3. Pancreas necrotic infection; 4. Salmon infective anemia; 5. Syndrome ulcer epizootic carp; 6. Adveral bakterial desease (Renibacterium salmoninarum) (8) Bee disease: 3
1. Bee acarose 2. American bee pest; 3. European bee Pest; 4. Nozemoza; 5. Varozis; 6. Parasitical disease of the bee hives. (9) Laboratories from the Paragraph 1 of this Article keep the obligation to record and maintain official documentation related to their work. Article 8 Sector of the food of animal origin animal feed is consisted by these units: 1. Microbiological Food unit of animal origin and animal feed; 2. Unit of the food chemistry and veterinary residues in food of animal origin and animal feed; 3. Testing unit of the Meat, milk and their products. Article 9 In compliance with Governmental Program in the food sector of animal origin and animal feed are carried out quantitative and qualitative analyses to implement: 1. Parameters which should fulfill food, based in legislation in force regarding to food issues, 2. Verification of the microbiological parameters according to the standards (ISO 7218),; 3. Verification of the contamination and contaminants; 4. Verification of the permitted chemical and toxically parameters; 5. Data verification in the product s labella; 6. Analyses for standardization of the products; 7. All analyses of the products of animal origin and animal feed (business operators, and all other person wishing to carry out self control; 8. Analyses of the premises, storage areas, storing and sale of the products of animal origin; 9. Analyses to determine of standards and certification of the products for export; 10. in compliance with legislation in force carries out analyses of the residues in food of animal origin, 11. performs analyses of the milk and milk products for technological processing; 12. Inter-laboratory analyses for vilification of the methods and their accreditation in the laboratories in the region and abroad; 13. Inter laboratory analyses for auditing and accrediting of the laboratory methods. Article 10 Sector of food of animal origin and animal feed is consisted by these functional laboratories: I. Laboratory of Microbiology and Phraseology: 1. Performs microbiological and parasitological analyses of the food from dairy plants 2. Performs microbiological and Parasitological analyses of the food from slaughterhouses 3. Performs microbiological and parasitological analyses in the meat processing plants and their milk products 4. analyses of the workers in the processing line 5. Analyses are carried out in the foreseen parameters by,,hygiene Package based with ISO 7218 6. Performs BSE analyses in slaughtered animals,those over 30 months,based in National Plan of BSE. 4
II. Laboratory of Chemistry and Veterinary residues 1. Performs analyses of national plan of residue monitoring,based in legislation in force and based for veterinary drugs based in EU directive of the food in three groups; A,B 1, B2; 2. control of the medicine for use in the veterinary; 3. analyses of the semen from certified companies for supply,storage and distribution (in the health and qualitative for artificial insemination and embryos in case of embryo transfer; 4. Inspection of animal feed and premises GMO-genetically modified organisms hormones, radiated food - with radioactivity etc, Article 11 Sector of avian influenza is consisted by : 1. Serology unit; 2. Unit of molecular Biology; 3. Unit of virology. Article 12 Sector of poultry disease: 1. Performs diagnostification of the poultry disease; 2. Follows up, analyses and studies status of notification, movement, fighting and eradication of the contagious, parasite disease and other poultry disease; 3. Studies epistemological situation in the country and determines disease diagnosis of the poultry disease; 4. Make proposals for prophylactic vaccination, and diagnostic and research tests of the poultry disease; 5. Proposes disinfection, pest and rat control with objective to stop spreading of the contagious poultry disease; 6. Investigates, advances and applies research methods, prophylaxis of contagious disease and there poultry disease; 7. investigates zoo technical status in the premises for poultry and poultry feed, 8. Investigates, advances, prep ears preparations and their application for diagnostification, prophylaxis and poultry disease; 9. Follows up, analyses an evaluates environmental impact in the poultry health status; 10. proposes samples and analyses for active monitor in of the poultry disease; 11. Cooperates with laboratories in the region and accredited laboratories in regard to advance methods of laboratory testing; 12. Continuously follows up innovations on performing laboratory tests conform standards ISO- 17025 and BE; 13. Permanently performs vilification and evaluation of the laboratory testing methods. Article 13 Sector of disinfection, pest and rat control performs: 1. Disinfection,pest and rat control in all premises in regard to food chain storage,plants,market places,means of transport, and transit sites; 2. Sampling from the surfaces,plant equipments and there working tools to define the leve of microorganisms presence be lore and after disinfection; 3. Performs tests to define the permitted maximum limits of Disinfection. 5
Article 14 Sector of quality control management (1) This sector is responsible for quality control management, draftin standard operation procedures in Compliance with ISO-17025 standards and in cooperation with there KVFL sectors receives,,records of the testing samples as well as information of the business operator which has required or has brought three sample. (2) The deadline on performing test sis defined dependently from the tests, researches and standard procedures. Article 15 The issue of the work description, number of the performers, and the leve of the multipliers of the KVFL employees shall be set by AI for organization of KVFL Article 16 For the serviles of the testing which performs KVFL, by a specific decision may define the level of the payment serviles, dependently from type of the service and may cage them dependently from increase of their costs. Article 17 The main contents of this Administrative Instruction are its Annex I and II. Article 18 Coming in to the force This Administrative Instruction comes in to the force in the day of signature. Prishtine 2007 Ministry of Agriculture, Forestry and Rural Development, Deputy Minister Mr. Tomë Hajdaraj 6
Annex I List of the disease and diagnostification methods in KVFL based in OIE diagnostification methods No r Disease name Prescribed tests Alternativ e tests 2.1.1. Foot and mouth disease ELISA*, VN CF 2.1.2. Vesicular stomatitis CF, ELISA, VN - 2.1.3. Swine vesicular disease VN ELISA 2.1.4. Rinderpest ELISA VN 2.1.5. Peste des petits ruminants VN ELISA 2.1.6. Contagious bovine pleuropneumonia CF, ELISA - 2.1.7. Lumpy skin disease - VN 2.1.8. Rift Valley fever VN HI, ELISA 2.1.9. Bluetongue Agent id., AGID, ELISA, PCR VN 2.1.10. Sheep pox and goat pox - VN 2.1.11. African horse sickness CF, ELISA VN 2.1.12. African swine fever ELISA IFA 2.1.13. Classical swine fever (hog cholera) NPLA, FAVN, ELISA - 2.1.14. Highly pathogenic avian influenza - AGID, HI 2.1.15. Newcastle disease - HI 2.2.1. Anthrax - - 2.2.2. Aujeszky's disease ELISA, VN - 2.2.3. Echinococcosis/Hydatidosis - - 2.2.4. Leptospirosis - MAT 2.2.5. Rabies VN ELISA 2.2.6. Paratuberculosis (Johne's disease) - DTH, ELISA 2.2.7. Heartwater - ELISA, IFA 2.2.8. Chapter No. Disease name Prescribed tests Alternative tests 2.2.9. Trichinellosis Agent id. ELISA 7
2.2.10. Q fever - CF 2.2.11. Leishmaniosis - Agent id. 2.3.1. Bovine brucellosis BBAT, CF, ELISA, FPA - 2.3.2. Bovine genital campylobacteriosis Agent id. - 2.3.3. Bovine tuberculosis Tuberculin test - 2.3.4. Enzootic bovine leukosis AGID, ELISA PCR 2.3.5. Infectious bovine rhinotracheitis/ infectious pustular vulvovaginitis VN, ELISA, Agent id. (semen only) - 2.3.6. Trichomonosis Agent id. Mucus agg. 2.3.7. Bovine anaplasmosis - CF, Agg. card 2.3.8. Bovine babesiosis - ELISA, IFA 2.3.9. Bovine cysticercosis - Agent id. 2.3.10. Dermatophilosis - - 2.3.11. Theileriosis Agent id., IFA - 2.3.12. Haemorrhagic septicaemia - Agent id. 2.3.13. Bovine spongiform encephalopathy - - 2.3.14. Malignant catarrhal fever - VN, IFA, PCR 2.3.15. Trypanosomosis (Tsetse-transmitted) - IFA 2.4.1. Ovine epididymitis (Brucella ovis) CF ELISA 2.4.2. Caprine and ovine brucellosis (excluding Brucella ovis infection) BBAT, CF Brucellin test, FPA 2.4.3. Contagious agalactia - - 2.4.4/5. Caprine arthritis/encephalitis & Maedivisna AGID, ELISA - 2.4.6. Contagious caprine pleuropneumonia CF - 2.4.7. Enzootic abortion of ewes (ovine chlamydiosis) - CF 2.4.8. Scrapie - - 2.4.9. Ovine pulmonary adenomatosis (adenocarcinoma) - - 2.4.10. Nairobi sheep disease - - 2.4.11. Salmonellosis (S. abortusovis) - Agent id. 2.5.1. Contagious equine metritis Agent id. - 2.5.2. Dourine CF IFA, ELISA 8
2.5.3. Equine encephalomyelitis (Eastern and Western) - HI, CF, PRN 2.5.4. Equine infectious anaemia AGID ELISA 2.5.5. Equine influenza - HI 2.5.6. Equine piroplasmosis ELISA, IFA CF 2.5.7. Equine rhinopneumonitis - VN 2.5.8. Glanders Mallein test, CF - 2.5.10. Equine viral arteritis VN, Agent id. (semen only) - 2.5.11. Horse mange - Agent id. 2.5.12. Venezuelan equine encephalomyelitis - HI, CF, PRN 2.5.13. Epizootic lymphangitis - - 2.5.14. Japanese encephalitis - - 2.5.15. Surra (Trypansoma evansi) - - 2.6.1. Atrophic rhinitis of swine - - 2.6.2. Porcine brucellosis ELISA BBAT, FPA 2.6.3. Enterovirus encephalomyelitis (previously Teschen/Talfan diseases) - VN 2.6.4. Transmissible gastroenteritis - VN, ELISA 2.6.5. Porcine reproductive and respiratory syndrome - ELISA, IFA, IPMA 2.6.6. Porcine cysticercosis - Agent id. 2.7.1. Infectious bursal disease (Gumboro disease) - AGID, ELISA 2.7.2. Marek's disease - AGID 2.7.3. Avian mycoplasmosis (Mycoplasma gallisepticum) - Agg., HI 2.7.4. Avian chlamydiosis - - 2.7.5. Fowl typhoid and Pullorum disease - Agg., Agent id. 2.7.6. Avian infectious bronchitis - VN, HI, ELISA 2.7.7. Avian infectious laryngotracheitis - AGID, VN, ELISA 2.7.8. Avian tuberculosis - Tuberculin test, Agent id., 2.7.9. Duck virus hepatitis - - 2.7.10. Duck virus enteritis - - 9
2.7.11. Fowl cholera (avian pasteurellosis) - - 2.7.12. Fowl pox - - 2.8.1. Myxomatosis - AGID, CF, IFA 2.8.2. Tularemia - Agent id. 2.8.3. Rabbit haemorrhagic disease - HI 2.9.1. Acariosis of bees - - 2.9.2. American foulbrood - - 2.9.3. European foulbrood - - 2.9.4. Nosemosis of bees - - 2.9.5. Varroosis - - 2.9.6. Tropilaelaps infestation of honey bees (Tropilaelaps clareae, T. koenigerum) - - 2.10.1. Cysticercosis - Agent id. 2.10.2. Bunyaviral diseases of animals (excluding Rift Valley fever) - - 2.10.3. Salmonellosis - Agent id. 2.10.4. Mange - Agent id. 2.10.5. Border disease Agent id. - 2.10.6. Bovine viral diarrhoea Agent id. - 2.10.7. West Nile encephalitis - - 2.10.8. Campylobacter jejuni and C. coli - - 2.10.9. Cryptosporidiosis - - 2.10.10. Hendra and Nipah virus diseases - - 2.10.11. Swine influenza - - 2.10.12. Toxoplasmosis - - 2.10.13. Verocytotoxigenic Escherichia coli - - 2.10.14. Listeria monocytogenes - - 10
Agent id. Agent identification HI Haemagglutination inhibition Agg. Agglutination test IFA Indirect fluorescent antibody AGID Agar gel immunodiffusion IPMA BBAT Buffered Brucella antigen test MAT CF Complement fixation NPLA Immunoperoxidase monolayer assay Microscopic agglutination test Neutralising peroxidaselinked assay DTH Delayed-type hypersensitivity PCR Polymerase chain reaction ELISA Enzyme-linked immunosorbent assay PRN Plaque reduction neutralisation FAVN Fluorescent antibody virus neutralisation VN Virus neutralisation FPA Fluorescence polarisation assay - No test designated yet 11
Annex II SAMPLE SUBMITTION FORM KOSOVO VETERINARY AND FOOD LABORATORY Lab Date of relieve Owner s name Municipality Village Animal specie Age Number of animal s Breed Farmer s information Last changes in the enlivenment Number of the dead /sick animals Vaccines used Clinical signs Injures /Necroscopy Suspected disease Type of the sample /Animal identification,etc Blood Tissue Milk Feaces Others Veterinarian Address Signature Date 12