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The Provisions On Reference Laboratory Status And Accreditation Procedures, Roles And Responsibilities, As Well As Facilities And Equipment Requirements For Food, Animal Feed And Animal Health

Original Language Title: Noteikumi par references laboratorijas statusa piešķiršanas un akreditācijas kārtību, funkcijām un pienākumiem, kā arī iekārtām un aprīkojumam noteiktajām prasībām pārtikas, dzīvnieku barības un dzīvnieku veselības jomā

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Cabinet of Ministers Regulations No. 864 in Riga august 4 2009 (pr. No 51 39 §) rules for designating a reference laboratory and accreditation procedures, roles and responsibilities, as well as facilities and equipment requirements for food, animal feed and veterinary field Issued in accordance with article 11.1 of law veterinary, food surveillance law, article 21 of the sixth and animal feed law article 21, paragraph 1 (I). General questions 1. determines the procedure for attributing the status of reference laboratories reference laboratories, accreditation procedures, functions, and responsibilities, as well as the requirements of the reference laboratory facilities and equipment for the food, animal feed and veterinary field.
2. food and veterinary service (hereinafter service) when assessing this provision reference areas listed in the annex, shall submit to the Ministry of Agriculture information on the laboratory, which is nominated for the reference laboratory in one of the reference areas.
3. Reference Laboratory functions monitor and control the service. The Ministry of agriculture shall monitor the use made of the financial reference areas.
4. the status of the reference laboratory referred to in the annex to these provisions the reference in the performance of the field lab, which granted: 4.1 comply with the European Parliament and of the Council of 29 April 2004, Regulation (EC) No 882/2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (hereinafter referred to as the European Parliament and Council Regulation (EC) No 882/2004) 33. the requirements set out in article and provides reference laboratory in that article, given the performance of the tasks;
4.2. is accredited in accordance with European Parliament and Council Regulation No 882/2004 article 12 paragraphs 2 and 3;
4.3. the requirements laid down by the European Commission 4 March 2005 Regulation (EC) No 378/2005 on detailed rules for the application of the European Parliament and Council Regulation (EC) no 1831/2003 as regards the Community reference laboratory duties and responsibilities in connection with applications for authorisation of food additives.
5. the reference laboratory for rabies vaccination serological determination of effectiveness followed European Union legislation, which determines the list of laboratories authorised to check the effectiveness of certain domestic carnivores vaccination against rabies. These include the laboratories of the Member States of the European Union reference laboratory in the list established on the basis of the results of the qualification, which has announced the European Community reference laboratory for rabies vaccination serological determination of efficiency.
6. Metrology and accreditation Department of the national agency of Latvia's National Accreditation Bureau-is the national accreditation body according to the laws and regulations on assessment of conformity assessment bodies, accreditation and monitoring shall be carried out at the bottom of this rule 4.2 of this accreditation.
7. Reference Laboratory performs the function of the national diagnostic centre of the service, and it is held by the following reference: 7.1 animal infectious disease diagnostics: 7.1.1. classical swine fever;
7.1.2. avian influenza;
7.1.3. Newcastle disease;
7.1.4. foot-and-mouth disease;
7.1.5. the infectious diseases of fish;
7.1.6. crustaceans infectious diseases;
7.1.7. rabies;
7.1.8. brucellosis;
7.1.9. bovine tuberculosis;
7.1.10. fever or Bluetongue the blue tongue disease;
7.1.11. swine vesicular disease;
7.1.12. African swine fever;
7.1.13. African horse sickness;
7.2. the food, materials and articles in contact with food, animal feed, residues, including pesticides residues, disease agents and antimikr in the biāl resistance: 7.2.1. milk and milk products control;
7.2.2. salmonella (all isolated agent) control;
7.2.3. Listeria monocytogenes control;
7.2.4. the staphylococci coagulase-positive (including s. aureus) control;
7.2.5. E. coli (including e. coli in verotoksigēn);
7.2.6. Campylobacter (all isolated agent) control;
7.2.7. parasites (in particular Trichinella, Echinococcus, Anisak);
7.2.8. resistance to antimicrobial agents;
7.2.9. detection of animal proteins in animal feed;
7.2.10. veterinary medicines and residues of pollutants in food of animal origin: 7.2.10.1. the resorcilikskāb lactones including zeranol control, steroid, antitiroīd, of stilbenes, stilbene derivatives, their salts and esters, the sedative features and control of mycotoxins;
7.2.10.2. antibacterial substances, including the sulfonamide, kvinolon, Carbadox and olaquindox dyes, control;
7.2.10.3. beta-agonists, antihelmintisk, antikokcidiāl features, including steroids and nitroimidazole, anti-inflammatory products control;
7.2.10.4. carbamate and pyrethroid kont role;
7.2.10.5. chloramphenicol, nitrofurans Dapsone and control;
7.2.11. transmissible spongiform encephalopathies;
7.2.12. additives used in animal nutrition;
7.2.13. control of materials intended to come into contact with food;
7.2.14. determination of pesticide residues: cereals and feedingstuffs 7.2.14.1.;
7.2.14.2. in food of animal origin and products with high fat content;
7.2.14.3. fruit and vegetables, including products with high water and high acid content;
7.2.14.4. one method of determining residues;
7.2.15. determination of heavy metals in feed and food;
7.2.16. determination of mycotoxins;
7.2.17. polycyclic aromatic hydrocarbons;
7.2.18. levels of dioxins and dioxin-like PCBs determination of feed and food;
7.2.19. bakterovirusāl pollution of bivalve molluscs;
7.3. standards and methods of diagnosis and monitoring: 7.3.1. enzootic bovine leukosis Diagnostics (immune diffusion method, the imūnfermentatīv method of analysis);
7.3.2. the effectiveness of rabies vaccination serological detection;
7.3.3. Aujeszky's disease diagnostics (imūnfermentatīv check of the method of analysis, in particular for the production and the national reference Sera according to the European standardization community reference Sera).
8. Service contracts: 8.1 with reference laboratories within the territory of a given function defined in the reference area;
8.2. with the other European Union Member State laboratory or the European Free Trade Association Member States laboratory on a separate reference area the specific functions, if this area is not included in the national reference and Latvia is not nominated for the reference laboratory that performs the following functions and reference laboratories.
9. Service contracts reference laboratory functions with other laboratories in the Member States of the European Union or the European Free Trade Association Member States laboratories, the laboratory in question complies with the provisions in paragraph 4.
10. Insert the Service Department homepage on the internet information on reference laboratory name, ad res and the assigned reference area and ensuring the accessibility of information to the public, the Member States of the European Union and the competent authorities.
11. the Ministry of agriculture in accordance with European Parliament and Council Regulation No 882/2004 article 33 paragraph 4, the reference to the procedure defined in the right ratorij name, address and reference areas assigned to it shall be notified to the European Commission.
12. the reference laboratory for each year up to January 7, submit to the Department a report (in paper form) on the use of the previous financial year to 31 March – report on the previous year's activities. The report indicates the following: 12.1 the reference function, results;
12.2. the budget allocation and utilization, as well as off-budget income and expenditure;
12.3. the number and composition of staff;
12.4. details of organised inter-laboratory comparative testing.
13. Service: 13.1. each year, prepare and submit to 31 March in the State Ministry of agriculture reference program for next year;
13.2. the calculation not the overwhelming financing from the State budget to the national reference program as well sets the reference function delegated to another Member State of the European Union or the European Free Trade Association Member State reference laboratory and the function required for the implementation of the funding;
13.3. in the official laboratory (laboratory for services is a contract on the individual responsibilities of the national monitoring and control of the infectious animal disease control) list that controlled infections animal disease and whose activities are coordinated by the reference laboratory.
II. Animal infectious diseases (with the exception of epizootic diseases in aquaculture animals and exotic infectious diseases) proposing the establishment of a reference laboratory for general functions, duties, and requirements of the facilities and equipment 14. Reference Laboratory for carrying out of laboratory investigation of infectious animal disease agents, have the following functions: 14.1 develop, optimize and validate laboratory methods of investigation;
14.2. to coordinate the activities of official laboratories assigned reference area, as well as to define and coordinate laboratory diagnostic methods;

14.3. to train the staff involved in laboratory work or provide retraining to the harmonisation of diagnostic techniques;
14.4. at the request of a service to perform scientific and technical expertise;
14.5. to create and sustain the strains of the agent and the bank, the sinātāj of antigen bank trainee, diagnostic reagents the kit item, specific immunoglobulins and serum bank;
14.6. to control analytical reagents and diagnostic tests;
14.7. to evaluate disinfectants and analytical reagent efficiency;
14.8. to participate in the monitoring network of the epizootiological creation laboratory Diagnostics;
14.9. to carry out laboratory investigations in the field and in the reference in case of dispute, to approve or reject a State authorized or accredited laboratory results obtained in the reference area;
14.10. If the suspected State supervision of existing infectious diseases (with the exception of epizootic diseases in aquaculture animals and exotic infectious diseases), to inform the staff that the disease has been confirmed in the laboratory studies;
14.11. to coordinate the State method of the infectious animal disease investigation laboratory, aligning them with the relevant European Community reference laboratory;
14.12. to organize periodic comparative tests of diagnostic procedures at national laboratories notified;
14.13. to cooperate with the Community reference laboratory and participate in the comparative tests organized.
15. paragraph 14 of these regulations, the reference laboratory is required to make: 9.4. confidentiality of laboratory tests, objectivity and independence;
15.2. quick and rapid action in an emergency, to receive and investigate samples in a given period;
15.3. quality and operational business tasks.
III. Animal infectious diseases (with the exception of epizootic diseases in aquaculture animals and exotic infectious diseases) proposing the establishment of a reference laboratory for special functions and responsibilities 16. This provision 14. reference laboratory referred to in paragraph 1 shall be responsible for: 16.1. tuberculosis diagnostic test and monitoring, as well as reagent controls these tests and reagents and ensure their compliance with the standards;
16.2. brucellosis diagnostic test and monitoring, as well as reagent: 16.2.1. make and evaluate the studies that show the country the test method used, and confirms the results of the test;
16.2.2. the standard secondary reference national standard for calibration against primary international reference serum;
16.2.3. controls the entire country used Antigen and imūnfermentatīv methods of analysis Kit lot quality tests;
16.2.4. cooperate with other Member States of the European Union reference laboratories for brucellosis laboratory investigations agent;
16.3. enzootic bovine leukosis diagnostic test and monitoring, as well as reagent: 16.3.1. standard working Antigen of the laboratory calibration against the official European Community reference serum, supplied by the Technical University of Denmark national Veterinary Institute;
16.3.2. not less frequently than once a year, serving as the standard control antigens in order to expedite examination thereof and compare with the official European Community reference serum.
17. The reference laboratory, which is responsible for monitoring the effectiveness of rabies vaccination, carried out serological tests to monitor the effectiveness of rabies vaccines.
IV. Office of epizootic diseases in aquaculture animals and exotic infectious disease agent identification reference laboratories for general functions, duties, and requirements of the facilities and equipment 18. Reference Laboratory carrying out laboratory investigations on epizootic diseases (foot-and-mouth disease, classical swine fever, African swine fever, African horse sickness, avian influenza, Newcastle disease, rinderpest, small ruminants, Rift Valley fever, blue tongue disease, deer epizootic haemorrhagic disease , swine vesicular disease, sheep and goat pox, vesicular stomatitis, lumpy skin dermatitis) or of aquaculture animals, exotic infectious diseases (epizootic haematopoietic necrosis, ulcers syndrome, epizootic bonamiosis, perkinsoz, mikrocitoz, Horn syndrome, yellow head disease) agent discovery is equipped with facilities and equipment to perform the abrupt and extensive outbreak of the disease diagnostic super-power duals.
19. paragraph 18 of these rules reference laboratories referred to in the staff is trained in infectious disease virus identification reference assigned to the area.
20. The provisions referred to in paragraph 18, the reference laboratory: 20.1. cooperate with the European Community reference laboratory and other Member States of the European Union reference laboratories, developing improved diagnostic methods and exchange of information and materials related to the infectious animal disease Diagnostics;
20.2. the European Community reference laboratory in the external quality assurance programs and tasks, which are being tested in a reference laboratory staff skills and knowledge in the exercise of its tasks;
20.3. to immediately provide the European Commission with the requested information, as well as inform the laboratory equipment and laboratory methods used in compliance with the International Office of Epizootics approved standards "diagnostic test and vaccine Guide for wild and aquatic animals";
20.4. the European Community reference laboratory and service data in its possession for epizootic diseases in aquaculture animals or exotic infectious diseases.
21. paragraph 18 of these rules reference laboratory referred to in the assessed country authorized laboratories diagnostic methods to be used for specific detection of the disease, as well as its. The reference laboratory shall be responsible for the use of reagents and testing of vaccines, and has the following rights: 21.1. supply diagnostic reagents to other country authorised laboratories (upon request);
21.2. the control over the quality of diagnostic reagents;
21.3. periodically organise interlaboratory comparative tests;
21.4. store the material containing the virus of the disease, if the diagnosis is confirmed;
21.5. examine and give a final opinion on other State authorized laboratories the results obtained.
V. Office of epizootic diseases in aquaculture animals and exotic infectious disease agent identification reference laboratories for specific functions and responsibilities 22. Reference Laboratory carrying out laboratory investigations of African swine fever agent, ensure that the laboratory tests the presence of African swine fever virus detection and the identification of the genetic type in accordance with the African swine fever diagnostic manual.
23. The reference laboratory, which carried out an investigation of the laboratory for classical swine fever agent, ensure that the laboratory tests the presence of classical swine fever and the identification of the genetic type of virus isolated for identification in accordance with the classical swine fever diagnostic manual.
24. the reference laboratory in handling live foot-and-mouth disease virus carried out laboratory investigations and foot-and-mouth disease agent Discovery runs security under the conditions laid down in the European Union legislation on minimum conditions in laboratories working with the foot-and-mouth disease virus in the laboratory and in living organisms.
25. Antigenic and genomic characteristics determined all the viruses that caused the secondary foot-and-mouth disease outbreaks. If the reference laboratory is not equipped with suitable facilities, antigenic and genomic characteristics determined by the European Community reference laboratory. To the European Community reference laboratory shall transmit the disease samples and more detailed characteristics of authorisations requested (including advice on the relationship between the field of antigens of the strains and vaccine strain) European Community antigen and vaccine bank. This procedure also applies to the type of virus antigens and the determination of the characteristics of the genome, what reference laboratory receives from third countries.
26. Reference laboratory that performs laboratory investigation of foot-and-mouth disease agent: 26.1. also gives the vesicular virus diseases laboratory investigation services;
26.2. maintain all foot-and-mouth disease virus serotype inaktivēto for reference and Antisera against these viruses, as well as all other reagents necessary for rapid diagnosis. Negative diagnosis is prepared for approval by the appropriate cell cultures;
26.3. cooperate with other national laboratories authorized by serological test and other tests that do not involve working with the live foot-and-mouth disease virus.
27. Official laboratories involved in this provision, paragraph 26:27.1. the tests do not produce foot-and-mouth disease virus from the samples obtained to confirm or rule out a suspected animal infected with the virus from vesicular;
27.2. does not implement biosecurity measures, but laboratory order determines procedures for possible foot-and-mouth disease virus spreading, to ensure effective limitation and elimination of the infection;

27.3. samples obtained inconclusive results on the presence of infectious agents, reported to the reference laboratory for the final result.
28. the reference laboratory for carrying out of laboratory investigation of avian influenza agent: 28.1. laboratory investigations of avian influenza the presence of agents and the determination of the genetic type of virus shall be carried out in accordance with the diagnostic manual for avian influenza;
28.2. the European Community reference laboratory isolates of avian influenza virus full characterisation: 28.2.1. from all primary outbreaks of avian influenza;
28.2.2. from secondary outbreaks of avian influenza, taking into account their number;
28.2.3. from poultry, other captive birds or mammals, if it is a serious threat to human or animal health;
28.3. cooperate with the State Agency "Infektoloģij Center", to exchange information on the laboratory diagnostic methods used, as well as the isolation of avian influenza virus type.
29. the reference laboratory for carrying out of laboratory investigation of Newcastle disease agent discovery supports the Newcastle disease virus full antigenic and biological.
30. Reference Laboratory carrying out laboratory investigations of rinderpest, small ruminants, Rift Valley fever, deer epizootic haemorrhagic disease, swine vesicular disease, sheep and goat pox, vesicular stomatitis, lumpy skin dermatitis agent discovery is equipped with equipment that allows at any time, the type, sub-type and variant of the relevant virus.
VI. final question 31. Be declared unenforceable in the Cabinet of Ministers of 4 December 2007 Regulation No 834 "the provisions on reference laboratory status and accreditation procedures, roles and responsibilities, as well as reference laboratory facilities and equipment requirements" (Latvian journal, 2007, no. 198). 
Informative reference to European Union directives, the regulations include provisions resulting from: 1) of the Council of 26 June 1964 directives 64/432/EEC on animal health problems affecting intra-Community trade in bovine animals and swine;
2) Council on 29 April 1992 by Directive 92/35/EEC laying down control rules and measures to combat African horse sickness;
3) Council of 14 July 1992 Directive 92/66/EEC introducing Community measures for the control of Newcastle disease;
4) 1992 of the Council of 17 December Directive 92/119/EEC introducing general Community measures for the control of certain animal diseases and specific measures relating to swine vesicular disease;
5) Council of 20 November 2000 Directive 2000/75/EC laying down specific provisions for the Bluetongue control and eradication;
6) Council of 23 October 2001 directive 2001/89/EC on Community measures for the control of classical swine fever;
7) Council of 27 June 2002 Directive 2002/60/EC laying down specific provisions for the control of African swine fever and amending Directive 92/119/EEC as regards Teschen disease and African swine fever;
8) Council of 29 September 2003 of Directive 2003/85/EC on Community measures for the control of foot-and-mouth disease repealing Directive 85/511/EEC and decisions 89/531/EEC and 91/665/EEC and amending Directive 92/46/EEC;
9) Council of 20 December 2005 Directive 2005/94/EC on Community measures for the control of avian influenza and repealing Directive 92/40/EEC;
10) Council of 24 October 2006 of Directive 2006/88/EC for aquaculture animals and products thereof animal health requirements, as well as on the prevention and control of certain diseases in aquatic animals;
11) Council on 15 July 2008, Directive 2008/73/EC simplifying information and publication procedures in the veterinary and zootechnical fields and amending Directives 64/432/EEC, 77/504/EEC, 88/407/EEC, 88/661/EEC, 89/361/EEC, 89/556/EEC, 90/426/EEC, 90/427/EEC, 90/428/EEC, 90/429/EEC, 90/539/EEC, 91/68/EEC , 91/496/EEC, 92/35/EEC, 92/65/EEC, 92/66/EEC, 92/119/EEC, 94/28/EC, 2000/75/EC, decision 2000/258/EC and directives 2001/89/EC, 2002/60/EC and 2005/94/EC.
Prime Minister, Minister of Finance Minister of Agriculture e. Repše j. Dūklav Editorial Note: regulations shall enter into force with 12 august 2009.
 
 
Annex to the Cabinet of Ministers of 4 august 2009. terms of reference of the field no 864 i. infectious animal disease diagnostic reference areas No.  PO box
Infectious animal disease name infectious animal disease agent 1.
Classical swine fever in the mother tongue, Pestivir Flavivirida 2.
Bird flu-Orthomyxovirida family, Influenzavir A 3.
Newcastle disease Is a family of 4, Rubulavir.
Foot-and-mouth disease in Picornavirida family, Aphthovir 5.
African horse sickness in the family, Reovirida Orbivir 6.
Rinderpest Is a native of Morbillivir, 7.
Small ruminants plague Is a family of 8, Morbillivir.
Swine vesicular disease in the family, Enterovir Picornavirida 9.
Bluetongue fever-Reovirida family, Orbivir 10.
African swine fever Iridovir, Poxvir-11.
Sheep and goat pox the Poxvirida family, Capripoxvir 12.
Vesicular stomatitis-Rhabdovirida family, Vesiculovir to 13.
Rift Valley fever in the mother tongue, Bunyavirida Phlebovir 14.
Lumpy skin dermatitis Poxvirida in family, Capripoxvir 15.
Deer epizootic haemorrhagic disease of Reovirida family, Orbivir to 16.
All the isolated causative agents brucellosis 17.
Tuberculosis, Mycobacterium bovis, Mycobacterium Avium 18.
Viral haemorrhagic septicaemia in Rhabdovirida family, Novirhabdovir 19.
Infectious haematopoietic necrosis of the Rhabdovirida family, Novirhabdovir 20.
Salmon anaemia in the mother tongue, Orthomyxovirida Isavir 21.
Haplosporidioz-Haplosporidi of Haplosporidi of Nelson, costal 22.
Perkinsoz-Perkins, Perkins of Marinus olsen 23.
Mikrocitoz Mikrocytos mackini of 24.
Abalon White syndrome of Xenohaliot by californiens by 25 Candidate.
Marteiliosis in Marteill, Marteilia refringens sidney 26.
Bonamioz of Bonamia ostreae, Mikrocytos exitios, Bonamia roughley 27.
Epizootic haematopoietic necrosis of the Iridovirida family, Ranavir 28.
The epizootic ulcerative syndrome Aphanomyc-invadan 29.
Horn syndrome of Dicistrovirida family, Cripavir 30.
Yellow head disease of Okavir in the Ronavirida family, 31.
Mikoplazmoz Mycoplasma gallisepticum, a Mycoplasma meleagridis 32.
Rabies Rhabdovirida family, the Lyssavir, Ephemerovir, Vesiculovir-33.
Koi Herpes virus disease of the Herpesvirida family, herpesvir-3 34.
White spot disease of Nimavirida family, Whispovir reference areas II. food, animal feed, residues, including pesticides, control and disease resistance in antimicrobial agents in determining No.  PO box
The reference name of the field 1.
Milk and milk products control 2.
The monitoring of marine biotoxins.
Shellfish contamination monitoring bakterovirusāl 4.
Determination of antimicrobial agent resistance 5.
Detection of animal proteins in animal feed 6.
Veterinary medicines and residues of pollutants in food of animal origin: 6.1.
the resorcilikskāb lactones including zeranol control, steroid, antitiroīd, of stilbenes, stilbene derivatives, their salts and esters, the sedative features and control of mycotoxins in 6.2.
antibacterial substances, including the sulfonamide, kvinolon, Carbadox and olaquindox colouring control 6.3.
beta-agonist, antihelmintisk, antikokcidiāl features, including steroids and nitroimidazole, anti-inflammatory products control 6.4.
carbamate and pyrethroid controls 6.5.
chloramphenicol and nitrofurans, Dapsone control 7.
Animal nutrition additives used in the determination of 8.
Control of materials intended to come into contact with food 9.
Determination of pesticide residues: 9.1.
cereals and feedingstuffs 9.2.
in food of animal origin and products with high fat content of 9.3.
fruit and vegetables, including products with high water and high acid content of 9.4.
one method of determining residues of 10.
Determination of heavy metals in feed and food 11.
12. determination of mycotoxins
Determination of polycyclic aromatic hydrocarbons by 13.
Levels of dioxins and dioxin-like PCBs in feed and food establishment 14.
Salmonella (all the isolated causative agents) control 15.
Listeriosis (Listeria monocytogenes) control 16.
Coagulase-positive staphylococci (including s. aureus) control 17.
Intestinal wand (e. coli, including verotoksigēn in e. coli) control 18.
Kampilobaktērij (Campylobacter isolated all agents) control 19.
Parasites (in particular Trichinella, Echinococcus, Anisak) 20 determination.
Transmissible spongiform encephalopathies, the discovery III. Infectious animal disease diagnostic standards and methods, reference areas no PO box
The reference name of the field 1.
Enzootic bovine leukosis Diagnostics (immune diffusion method, the imūnfermentatīv method of analysis) 2.
Rabies vaccination serological determination of the effectiveness (of the Rhabdovirida family, Lyssavir, Ephemerovir, Vesiculovir) 3.
Aujeszky's disease (imūnfermentatīv check of the method of analysis, in particular for the production and the national reference Sera according to the European standardization community reference Sera) Minister of Agriculture j. Dūklav in