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Training Seminar: “The OIE PVS Tool” 16 – 20 April 2012 Beijing, China Dr. Patrick Bastiaensen Dr. Tomoko Ishibashi Dr. Emilio A. León Dr. Herbert Schneider.

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Presentation on theme: "Training Seminar: “The OIE PVS Tool” 16 – 20 April 2012 Beijing, China Dr. Patrick Bastiaensen Dr. Tomoko Ishibashi Dr. Emilio A. León Dr. Herbert Schneider."— Presentation transcript:

1 Training Seminar: “The OIE PVS Tool” 16 – 20 April 2012 Beijing, China Dr. Patrick Bastiaensen Dr. Tomoko Ishibashi Dr. Emilio A. León Dr. Herbert Schneider The PVS Critical Competencies Fundamental Component II: Technical Authority and Capability 1

2 CC II-1: Veterinary Laboratory Diagnosis Terrestrial (aquatic) manual : Chapter Collection and shipment of diagnostic specimens Chapter Biosafety and biosecurity in the veterinary microbiology laboratory and animal facilities Chapter 1.1.4/5. Principles of validation of diagnostic assays for infectious diseases Chapter Laboratory methodologies for bacterial antimicrobial suscep- tibility testing Chapter Biotechnology in the diagnosis of infectious diseases and vaccine development 2/Item11

3 CC II-1: Veterinary Laboratory Diagnosis 3 words: “veterinary”, “laboratory” and “diagnosis” “Veterinary” Animal diseases : at least the list of notifiable diseases (exotic…) Animal diseases : zoonoses (brucellosis, tuberculosis, echinococcosis, Residues ? (pesticides, heavy metals), antimicrobials Food micro-biology ? trichinellosis, ………., Aquatic diseases ? marine capture, aquaculture, wild inland Rabies titres ? import and export of dogs Pharmacovigilance ? 3/Item11

4 CC II-1: Veterinary Laboratory Diagnosis LevelLaboratory typeComments, examples Field levelField personnelClinical diagnosis, Bang ring tests, microscopy, tuberculosis tests, rapid tests (Influenza type A) Provincial levelProvincial laboratory National/State levelNational/State reference laboratory Private laboratory Public health laboratoryResidues, zoonosis, food,… Regional levelRegional reference laboratoryASEAN, … International levelInternational reference laboratoryOIE, FAO “Laboratory” 4/Item11

5 “Laboratory” Funding, management and administration, infrastructure, organisation (clean/dirty), disinfection and …. systems (  BSL), waste management, equipment, personnel (quantitative and qualitative), personnel (safety  BSL), Standard Operating Procedures (SOPs), maintenance and calibration, reagents and antigens (expiry dates…), IT support and reporting (qualitative and quantitative), time spans for delivery, regional reference services, linkages with public health or other (private) services. Access to power, clean and distilled water, ice, dry ice, liquid nitrogen Requirements for laboratory animals : maintenance, justification, welfare Bio-Safety Level (BSL), ventilation, biosafety cabinets, surroundings,… Regional dimension : reference services, proficiency testing exercises Chain of command over provincial laboratories Vaccine production ? CC II-1: Veterinary Laboratory Diagnosis 5/Item11

6 “Diagnosis” Necropsy : poultry, small animals, large animals, aquatic animals,… Parasitology : coprology (quantitative, qualitative), protozoology, ELISA,… Microbiology (bacteriology and mycology) : quantitative, qualitative / Mycoplasma spp. culturing, Virology : virus isolation, virus inoculation, serology Serology : parasitology, microbiology and virology Selection of tests for domestic use or for trade (OIE recommended) ! CC II-1: Veterinary Laboratory Diagnosis 6/Item11

7 Bigger is not better ! …tailored to the needs of the country CC II-1: Veterinary Laboratory Diagnosis 7/Item11

8 II-1 Veterinary laboratory diagnosis The authority and capability of the VS to identify and record pathogenic agents, including those relevant for public health, that can adversely affect animals and animal products. Levels of advancement 1. Disease diagnosis is almost always conducted by clinical means only, with laboratory diagnostic capability being generally unavailable. 2. For major zoonoses and diseases of national economic importance, the VS have access to and use a laboratory to obtain a correct diagnosis. 3. For other zoonoses and diseases present in the country, the VS have access to and use a laboratory to obtain a correct diagnosis. 4. For diseases of zoonotic or economic importance not present in the country, but known to exist in the region and/ or that could enter the country, the VS have access to and use a laboratory to obtain a correct diagnosis. 5. In the case of new and emerging diseases in the region or world, the VS have access to and use a network of national or international reference laboratories (e.g. an OIE Reference Laboratory) to obtain a correct diagnosis. 8/Item11

9 CC II-2: Laboratory quality assurance Terrestrial (aquatic) manual : Chapter Quality management in veterinary testing laboratories 9/Item11

10 CC II-2: Laboratory quality assurance Terrestrial (aquatic) manual : Chapter Quality management in veterinary testing laboratories Quality Standards and Guide- lines for Veterinary Laboratories 10/Item11

11 CC II-2: Laboratory quality assurance Valid laboratory results are essential for diagnosis, surveillance, and trade. Such results are achieved by the use of good management practices, valid test and calibration methods, proper technique, quality control, and quality assurance, all working together within a quality management system. 11/Item11

12 CC II-2: Laboratory quality assurance covers… ISO : laboratory accreditation OIE accredits diagnostic capacity for a particular OIE-listed disease, not for entire laboratories (Reference Laboratories). …Accreditation …Organisation and management …Management systems and internal audits …Documents control and record keeping …Control of non-conformity …Complaints and appeal 12/Item11

13 CC II-2: Laboratory quality assurance Key issues to assess during PVS evaluations QA Manager appointed? Handling of specimens? traceability, suitability, conditioning Validated SOP’s? Participation in inter-laboratory testing / proficiency testing exercices ? Statistical techniques to ensure the quality of test results? Replicability of the tests and correlation of test results? Use of international standard reagents? Proof of calibration of (measuring) equipment 13/Item11

14 II-2 Laboratory quality assurance The quality of laboratories (that conduct diagnostic testing or analysis for chemical residues, antimicrobial residues, toxins, or tests for, biological efficacy, etc.) as measured by the use of formal QA systems and participation in relevant proficiency testing programmes. Levels of advancement 1. No laboratories used by the public sector VS are using formal QA systems. 2. Some laboratories used by the public sector VS are using formal QA systems. 3. All laboratories used by the public sector VS are using formal QA systems. 4. All the laboratories used by the public sector VS and most or all private laboratories are using formal QA systems. 5. All the laboratories used by the public sector VS and most or all private laboratories are using formal QA programmes that meet OIE, ISO 17025, or equivalent QA standard guidelines. 14/Item11

15 CC II-3: Risk Analysis Glossary of terms Risk means the likelihood of the occurrence and the likely magnitude of the biological and economic consequences of an adverse event or effect to animal or human health. Risk Analysis means the process composed of hazard identification, risk assessment, risk management and risk communication. 15/Item11

16 CC II-3: Risk Analysis Hazard identification Risk assessment Risk management Risk communication Terrestrial Code references - Chapter 2.1: Import risk analysis 16/Item11

17 Terrestrial Code references - Chapter 2.1: Import risk analysis Article 2.1.2: Hazard identification Is the process of identifying the pathogenic agents which could potentially be introduced in the commodity considered for importation. The pathogenic agent has be able to affect the species to be imported and susceptible to be carried in the product. It has to be present in the exporting country / zone / compartment. CC II-3: Risk Analysis 17/Item11

18 Terrestrial Code references - Chapter 2.1: Import risk analysis Article 2.1.3: Risk assessment Is the evaluation of the likelihood and the biological and economic consequences of entry, establishment and spread of a hazard within the territory of an importing country. Assessment may be performed either by qualitative or quantitative method. It should be based in the best available information. It has to be well documented. Transparency is essential in order to ensure understanding by all interested parties. CC II-3: Risk Analysis 18/Item11

19 Terrestrial Code references - Chapter 2.1: Import risk analysis Article 2.1.6: Risk management components Is the process of identifying, selecting and implementing measures that can be applied to reduce the level of risk (minimize negative effects). Article 2.1.7: Principle of risk communication Is the interactive transmission and exchange of information and opinions throughout the risk analysis process concerning risk, risk-related factors and risk perceptions among risk assessors, risk managers, risk communicators, the general public and other interested parties. CC II-3: Risk Analysis 19/Item11

20 II-3 Risk analysis The authority and capability of the VS to base its risk management decisions on a scientific assessment of the risks. Levels of advancement 1. Risk management decisions are not usually supported by scientific risk assessment. 2. The VS compile and maintain data but do not have the capability to systematically assess risks. Some risk management decisions are based on scientific risk assessment. 3. The VS can systematically compile and maintain relevant data and carry out risk assessment. Scientific principles and evidence, including risk assessment, generally provide the basis for risk management decisions. 4. The VS systematically conduct risk assessments in compliance with relevant OIE standards, and base their risk management decisions on the outcomes of these risk assessments. 5. The VS are consistent in basing sanitary decisions on risk analysis, and in communicating their procedures and outcomes internationally, meeting all their OIE obligations (including WTO SPS Agreement obligations where applicable). 20/Item11

21 CC II-4: Quarantine and border security Glossary of terms Border post means any airport, or any port, railway station or road check-point open to international trade of commodities, where import veterinary inspections can be performed. Quarantine station means an establishment under the control of the Veterinary Authority where animals are maintained in isolation with no direct or indirect contact with other animals, to ensure that there is no transmission of specified pathogen(s) outside the establishment while the animals are undergoing observation for a specified length of time and, if appropriate, testing and treatment Illegal activities (PVS Tool) include attempts to gain entry for animal or animal products other than through legal entry points and/or using certification and/or other procedure not meeting the country’s requirements. 21/Item11

22 CC II-4: Quarantine and border security Terrestrial Code references Chapter 5.4. “Animal health measures applicable before and at departure” Chapter 5.5. “Animal health measures applicable during transit from the place of departure in the exporting country to the place of arrival in the importing country” Chapter 5.6. “Border posts and quarantine stations in the importing country” Chapter 5.7. “Animal health measures applicable on arrival” Chapter 5.9. “Quarantine measures applicable to non-human primates” 22/Item11

23 CC II-4: Quarantine and border security Terrestrial Code references - Chapter 5.6: Border posts and quarantine stations Article Border posts and quarantine stations should be provided with an adequate organisation and sufficient equipment for application of measures recommended in the Terrestrial Code. Article When justified by the amount of international trade and by the epidemiological situation, should be provided with means for: a)making clinical examinations and obtaining specimens b)detecting and isolating animals affected by or suspected of being affected by an epizootic disease; c)carrying out disinfection and possibly disinfestation of vehicles The presence of disease or infection in imported animals in a quarantine station does not affect the animal health status of the country or zone. 23/Item11

24 Terrestrial Code references - Chapter 5.7: Animal health measures applicable on arrival Article An importing country should only accept animals which have been subjected to a health examination by an Official Veterinarian of the exporting country and which are accompanied by an international veterinary certificate provided by the exporting country. An importing country may prohibit the introduction of animals if these are found, on examination at the border post by an Official Veterinarian, to be affected by, suspected of being affected by or infected with a disease capable of being transmitted to the animals in its territory. If the diagnosis of an epizootic disease is confirmed, or if the certificate cannot be corrected, the importing country may take the following measures: a)return the animals to the exporting country; b)slaughter and destroy. CC II-4: Quarantine and border security 24/Item11

25 II-4 Quarantine and border security The authority and capability of the VS to prevent the entry and spread of diseases and other hazards of animals and animal products. Levels of advancement 1. The VS cannot apply any type of quarantine or border security procedures for animals or animal products with their neighbouring countries or trading partners. 2. The VS can establish and apply quarantine and border security procedures; however, these are generally based neither on international standards nor on a risk analysis. 3. The VS can establish and apply quarantine and border security procedures based on international standards, but the procedures do not systematically address illegal activities relating to the import of animals and animal products. 4. The VS can establish and apply quarantine and border security procedures which systematically address legal pathways and illegal activities. 5. The VS work with their neighbouring countries and trading partners to establish, apply and audit quarantine and border security procedures which systematically address all risks identified. 25/Item11

26 CC II-5: Epidemiological Surveillance Glossary of terms Surveillance means the systematic ongoing collection, collation, and analysis of information related to animal health and the timely dissemination of information to those who need to know so that action can be taken Terrestrial Code references - Chapter 1.4: Animal Health Surveillance 26/Item11

27 This CC is divided into two sub-CC’s, being: A. Passive epidemiological surveillance ; and B. Active epidemiological surveillance CC II-5: Epidemiological Surveillance 27/Item11

28 II-5 Epidemiological surveillance The authority and capability of the VS to determine, verify and report on the sanitary status of the animal populations under their mandate. A. Passive epidemiological surveillance Levels of advancement 1. The VS have no passive surveillance programme. 2. The VS conduct passive surveillance for some relevant diseases and have the capacity to produce national reports on some diseases. 3. The VS conduct passive surveillance in compliance with OIE standards for some relevant diseases at the national level through appropriate networks in the field, whereby samples from suspect cases are collected and sent for laboratory diagnosis with evidence of correct results obtained. The VS have a basic national disease reporting system. (…) 28/Item11

29 II-5 Epidemiological surveillance The authority and capability of the VS to determine, verify and report on the sanitary status of the animal populations under their mandate. A. Passive epidemiological surveillance Levels of advancement (…) 4. The VS conduct passive surveillance and report at the national level in compliance with OIE standards for most relevant diseases. Appropriate field networks are established for the collection of samples and submission for laboratory diagnosis of suspect cases with evidence of correct results obtained. Stakeholders are aware of and comply with their obligation to report the suspicion and occurrence of notifiable diseases to the VS. 5. The VS regularly report to stakeholders and the international community (where applicable) on the findings of passive surveillance programmes. 29/Item11

30 II-5 Epidemiological surveillance The authority and capability of the VS to determine, verify and report on the sanitary status of the animal populations under their mandate. B. Active epidemiological surveillance Levels of advancement 1. The VS have no active surveillance programme. 2. The VS conduct active surveillance for some relevant diseases (of economic and zoonotic importance) but apply it only in a part of susceptible populations and/or do not update it regularly. 3. The VS conduct active surveillance in compliance with scientific principles and OIE standards for some relevant diseases and apply it to all susceptible populations but do not update it regularly. 4. The VS conduct active surveillance in compliance with scientific principles and OIE standards for some relevant diseases, apply it to all susceptible populations, update it regularly and report the results systematically. 5. The VS conduct active surveillance for most or all relevant diseases and apply it to all susceptible populations. The surveillance programmes are evaluated and meet the country ’ s OIE obligations. 30/Item11

31 CC II-6 : Early detection and emergency response Glossary of terms Early detection system means a system for timely detection and identification of an incursion of disease/infection in a territory. It should be under the control of the VS and should include the following characteristics: a.representative coverage of target animal populations by field services; b.ability to undertake effective disease investigation and reporting; c.access to laboratories capable of diagnosing and differentiating relevant diseases; d.a training programme for veterinarians, veterinary para-professionals, livestock owners/keepers and others involved in handling animals for detecting and reporting unusual animal health incidents; e.the legal obligation of private veterinarians to report to the Veterinary Authority; f.a national chain command. 31/Item11

32 II-6 Early detection and emergency response The authority and capability of the VS to detect and respond rapidly to a sanitary emergency (such as a significant disease outbreak or food safety emergency). Levels of advancement 1. The VS have no field network or established procedure to determine whether a sanitary emergency exists or the authority to declare such an emergency and respond appropriately. 2. The VS have a field network and an established procedure to determine whether or not a sanitary emergency exists, but lack the necessary legal and financial support to respond appropriately. 3. The VS have the legal framework and financial support to respond rapidly to sanitary emergencies, but the response is not coordinated through a chain of command. (…) 32/Item11

33 II-6 Early detection and emergency response The authority and capability of the VS to detect and respond rapidly to a sanitary emergency (such as a significant disease outbreak or food safety emergency). Levels of advancement (…) 4. The VS have an established procedure to make timely decisions on whether or not a sanitary emergency exists. The VS have the legal framework and financial support to respond rapidly to sanitary emergencies through a chain of command. They have national contingency plans for some exotic diseases. 5. The VS have national contingency plans for all diseases of concern through coordinated actions with all stakeholders through a chain of command. 33/Item11

34 CC II.7: Disease prevention, control and eradication Background* * * Thrusfield M. (2005), Chapter 22 The control and eradication of diseases. Veterinary Epidemiology, 3rd Ed. Blackwell Science Ltd. Oxford. Pag.384 Prevention implementation of methods ensuring that specified diseases do not enter a country, zone or compartment Control reduction of the frequency of a specified disease in a country, zone or compartment Eradication elimination of a specified pathogenic agent from a country, zone or compartment 34/Item11

35 lI-7 Disease prevention, control and eradication The authority and capability of the VS to actively perform actions to prevent, control or eradicate OIE listed diseases and/or to demonstrate that the country or a zone are free of relevant diseases. Levels of advancement 1. The VS have no authority or capability to prevent, control or eradicate animal diseases. 2. The VS implement prevention, control and eradication programmes for some diseases and/or in some areas with little or no scientific evaluation of their efficacy and efficiency. 3. The VS implement prevention, control and eradication programmes for some diseases and/or in some areas with scientific evaluation of their efficacy and efficiency. 4. The VS implement prevention, control and eradication programmes for all relevant diseases but with scientific evaluation of their efficacy and efficiency of some programmes. 5. The VS implement prevention, control and eradication programmes for all relevant diseases with scientific evaluation of their efficacy and efficiency consistent with relevant OIE international standards. 35/Item11

36 CC II-8: Food safety Glossary of terms Animal for slaughter means an animal intended for slaughter within a short time, under the control of the relevant Veterinary Authority. Fresh meat means meat that has not been subjected to any treatment irreversibly modifying its organoleptic and physicochemical characteristics. This includes frozen meat, chilled meat, minced meat and mechanically recovered meat. Meat means all edible parts of an animal. 36/Item11

37 Slaughter means any procedure which causes the death of an animal by bleeding Slaughterhouse/abattoir means premises, including facilities for moving or lairaging animals, used for the slaughter of animals to produce animal products and approved by the Veterinary Services or other Competent Authority. Zoonosis means any disease or infection which is naturally transmissible from animals to humans. CC II-8: Food safety Glossary of terms 37/Item11

38 CC II-8: Food safety Terrestrial Code Reference Chapter 6.1: The role of the Veterinary Services in Food Safety Chapter 6.2: Control of biological hazards of animal heath and public health importance through ante- and post- mortem meat inspection 38/Item11

39 This CC is divided into two sub-CC’s, being: A. Ante and post mortem inspection at abattoirs and associated premises (e.g. meat boning/cutting establishments and rendering plants); and B. Inspection of collection, processing and distribution of products of animal origin CC II-8: Food safety 39/Item11

40 II-8 Food safety A. Ante and post mortem inspection at abattoirs and associated premises (e.g. meat boning/cutting establishments and rendering plants). The authority and capability of the VS to implement and manage the inspection of animals destined for slaughter at abattoirs and associated premises, including for assuring meat hygiene and for the collection of information relevant to livestock diseases and zoonoses. This competency also covers coordination with other authorities where there is shared responsibility for the functions. Levels of advancement 1. Ante- and post mortem inspection and collection of disease information (and coordination, as required) are generally not undertaken in conformity with international standards. 2. Ante- and post mortem inspection and collection of disease information (and coordination, as required) are undertaken in conformity with international standards only at export premises. 3. Ante- and post mortem inspection and collection of disease information (and coordination, as required) are undertaken in conformity with international standards for export premises and for major abattoirs producing meat for distribution throughout the national market. (…) 40/Item11

41 II-8 Food safety A. Ante and post mortem inspection at abattoirs and associated premises (e.g. meat boning/cutting establishments and rendering plants). The authority and capability of the VS to implement and manage the inspection of animals destined for slaughter at abattoirs and associated premises, including for assuring meat hygiene and for the collection of information relevant to livestock diseases and zoonoses. This competency also covers coordination with other authorities where there is shared responsibility for the functions. Levels of advancement (…) 4. Ante- and post mortem inspection and collection of disease information (and coordination, as required) are undertaken in conformity with international standards for export premises and for all abattoirs producing meat for distribution in the national and local markets. 5. Ante- and post mortem inspection and collection of disease information (and coordination, as required) are undertaken in conformity with international standards at all premises (including family and on farm slaughtering) and are subject to periodic audit of effectiveness. 41/Item11

42 II-8 Food safety B. Inspection of collection, processing and distribution of products of animal origin The authority and capability of the VS to implement, manage and coordinate food safety measures on collection, processing and distribution of products of animals, including programmes for the prevention of specific food-borne zoonoses and general food safety programmes. This competency also covers coordination with other authorities where there is shared responsibility for the functions. Levels of advancement 1. Implementation, management and coordination (as appropriate) are generally not undertaken in conformity with international standards. 2. Implementation, management and coordination (as appropriate) are generally undertaken in conformity with international standards only for export purposes. 3. Implementation, management and coordination (as appropriate) are generally undertaken in conformity with international standards only for export purposes and for products that are distributed throughout the national market. 4. Implementation, management and coordination (as appropriate) are generally undertaken in conformity with international standards for export purposes and for products that are distributed throughout the national and local markets. 5. Implementation, management and coordination (as appropriate) are undertaken in full conformity with international standards for products at all levels of distribution (including on farm processing and farm gate sale). 42/Item11

43 CC II-9: Veterinary medicines and biologicals Glossary of terms Antimicrobial agent means a naturally occurring, semi-synthetic or synthetic substance that exhibits antimicrobial activity (kill or inhibit the growth of micro-organisms) at concentrations attainable in vivo. Anthelmintics and substances classed as disinfectants or antiseptics are excluded from this definition. Terrestrial Code references Chapter 6.6 – 6.10 Antimicrobial resistance 43/Item11

44 The VS has the authority and capability to regulate veterinary medicines and biologicals through authorisation (of eg. import, export, manufacture) registration (eg. by an appropriately qualified body) importation ( e. g. through licensing, approved sources) control over production efficacy testing and labelling distribution (e.g by wholesalers, retail pharmacists, veterinarians) sale (e.g. on prescription only, over-the-counter) use (withdrawal times, restricted use in species, prevention of antimicrobial resistance) CC II-9: Veterinary medicines and biologicals 44/Item11

45 II-9 Veterinary medicines and biologicals The authority and capability of the VS to regulate veterinary medicines and veterinary biologicals, i.e the authorisation, registration, import, production, labelling, distribution, sale and use of these products. Levels of advancement 1. The VS cannot regulate veterinary medicines and veterinary biologicals. 2. The VS have some capability to exercise administrative control over veterinary medicines and veterinary biologicals. 3. The VS exercise effective administrative control and implement quality standards for most aspects of the regulation of veterinary medicines and veterinary biologicals. 4. The VS exercise comprehensive and effective regulatory control of veterinary medicines and veterinary biologicals. 5. In addition to complete regulatory control, the VS systematically monitor for adverse reactions (pharmacovigilance) and take appropriate corrective steps. The control systems are subjected to periodic audit of effectiveness. 45/Item11

46 CC II-10: Residue testing Terrestrial Code references Chapter 6.6 – 6.10 Antimicrobial resistance 46/Item11

47 II-10 Residue testing The capability of the VS to undertake residue testing programmes for veterinary medicines (e.g. antimicrobials and hormones), chemicals, pesticides, radionuclides, metals, etc. Levels of advancement 1. No residue testing programme for animal products exists in the country. 2. Some residue testing programme is performed but only for selected animal products for export. 3. A comprehensive residue testing programme is performed for all animal products for export and some for domestic use. 4. A comprehensive residue testing programme is performed for all animal products for export and/or internal consumption. 5. The residue testing programme is subject to routine quality assurance and regular evaluation. 47/Item11

48 CC II-11: Emerging issue Glossary of terms Emerging disease means a new infection resulting from the evolution or change of an existing pathogenic agent, a known infection spreading to a new geographic area or population, or a previously unrecognized pathogenic agent or disease diagnosed for the first time and which has a significant impact on animal or public health. 48/Item11

49 Emerging disease means a new infection resulting from the evolution or change of an existing pathogenic agent, a known infection spreading to a new geographic area or population, or a previously unrecognized pathogenic agent or disease diagnosed for the first time and which has a significant impact on animal or public health. Example : H 5 N 1, ebola, etc. CC II-11: Emerging issue Glossary of terms 49/Item11

50 Emerging disease means a new infection resulting from the evolution or change of an existing pathogenic agent, a known infection spreading to a new geographic area or population, or a previously unrecognized pathogenic agent or disease diagnosed for the first time and which has a significant impact on animal or public health. Example : Bluetongue, Rift valley fever, etc. CC II-11: Emerging issue Glossary of terms 50/Item11

51 CC II-11: Emerging issue Glossary of terms Emerging disease means a new infection resulting from the evolution or change of an existing pathogenic agent, a known infection spreading to a new geographic area or population, or a previously unrecognized pathogenic agent or disease diagnosed for the first time and which has a significant impact on animal or public health. Example : Schmallenberg virus 51/Item11

52 Emerging issues (under the VS’s mandate) May relate to the sanitary status of the country, public health, the environment, or trade in animals and animal products. Example : global warming, climate change, vector distribution Example : increase of animal-borne tuberculosis and toxoplasmosis casualties in countries that are severaly affected by HIV-AIDS. Example : trade of commodities, compartmentalisation, venison Example : bio-terrorism applications of animal diseases Example : multi-drug resistance in pathogens CC II-11: Emerging issue 52/Item11

53 Monitoring of emerging diseases and issues requires: Electronic and paper-based access to scientific information Participation in scientific conferences and seminars Contingency planning, including simulation exercises Communication and information planning (risk communication) Regional integration (neighbouring countries) CC II-11: Emerging issue 53/Item11

54 II-11 Emerging issues The authority and capability of the VS to identify in advance, and take appropriate action in response to likely emerging issues under their mandate relating to the sanitary status of the country, public health, the environment, or trade in animals and animal products. Levels of advancement 1. The VS do not have procedures to identify in advance likely emerging issues. 2. The VS monitor and review developments at national and international levels relating to emerging issues. 3. The VS assess the risks, costs and / or opportunities of the identified emerging issues, including preparation of appropriate national preparedness plans. The VS have some collaboration with other agencies (e.g. human health, wildlife and environment) and with stakeholders on emerging issues. (…) 54/Item11

55 II-11 Emerging issues The authority and capability of the VS to identify in advance, and take appropriate action in response to likely emerging issues under their mandate relating to the sanitary status of the country, public health, the environment, or trade in animals and animal products. Levels of advancement (…) 4. The VS implement, in coordination with stakeholders, prevention or control actions due to an adverse emerging issue, or beneficial actions from a positive emerging issue. The VS have well-developed formal collaboration with other agencies (e.g. human health, wildlife and environment) and with stakeholders on emerging issues. 5. The VS coordinate actions with neighbouring countries and trading partners to respond to emerging issues, including audits of each other ’ s ability to detect and address emerging issues in their early stages. 55/Item11

56 CC II-12: Technical innovation Background Technical innovation Keeping up-to-date with the latest scientific advances and to comply with the standards of the OIE (and Codex Alimentarius Commission where applicable). 56/Item11

57 Technical innovation Keeping up-to-date with the latest scientific advances and to comply with the standards of the OIE (and Codex Alimentarius Commission where applicable). Example : PCR technology in laboratories Example : penside-test technology in the field Example : digital pen technology and SMS – based reporting Example : digital identification systems for cattle, dogs, birds CC II-12: Technical innovation Background 57/Item11

58 Technical innovation Keeping up-to-date with the latest scientific advances and to comply with the standards of the OIE (and Codex Alimentarius Commission where applicable). Example : fit-for-purpose tests, accredited by the OIE Example : GPS and geographical information systems (GIS) Example : new listed diseases, e.g. BTB of farmed deer Example : new welfare standards for stray dog control. CC II-12: Technical innovation Background 58/Item11

59 II-12 Technical innovation The capability of the VS to keep up-to-date with the latest scientific advances and to comply with the standards of the OIE (and Codex Alimentarius Commission where applicable). Levels of advancement 1. The VS have only informal access to technical innovations, through personal contacts and external sources. 2. The VS maintain a database of technical innovations and international standards, through subscriptions to scientific journals and electronic media. 3. The VS have a specific programme to actively identify relevant technical innovations and international standards. 4. The VS incorporate technical innovations and international standards into selected policies and procedures, in collaboration with stakeholders. 5. The VS systematically implement relevant technical innovations and international standards. 59/Item11

60 CC II-13: Identification and traceability Glossary of terms Animal identification means the combination of the identification and registration of an animal individually, with a unique identifier, or collectively by its epidemiological unit or group, with a unique group identifier. Animal identification system means the inclusion and linking of components such as identification of establishments/owners, the person(s) responsible for the animal(s), movements and other records with animal identification. Animal traceability means the ability to follow an animal or group of animals during all stages of its life. 60/Item11

61 Terrestrial Code references - Chapter 4.1: General principles on identification and tracebility of live animals Article Animal identification and animal traceability are tools for addressing animal health (including zoonoses) and food safety issues. These tools may significantly improve the effectiveness of activities such as: the management of disease outbreaks and food safety incidents, vaccination programmes, (…) surveillance, (...) animal movement controls, inspection, certification (...). The objective(s) of animal identification and animal traceability for a particular country, zone or compartment and the approach used should be clearly defined following an assessment of the risks CC II-13: Identification and traceability 61/Item11

62 Terrestrial Code references - Chapter 4.2: Design and implementation of identification systems to achieve animal traceability Article 4.2.1: Introduction and objectives These recommendations are based on the general principles presented in Article Whatever animal identification system the country adopts, it should comply with relevant OIE standards, including Chapters to for animals and animal products intended for export Article 4.2.3: Key elements of the animal identification system CC II-13: Identification and traceability 62/Item11

63 This CC is divided into two sub-CC’s, being: A.Animal identification and movement control and B.Identification and traceability of products of animal origin CC II-13: Identification and traceability 63/Item11

64 II-13. Identification and traceability A. Animal identification and movement control The authority and capability of the VS, normally in coordination with stakeholders, to identify animals under their mandate and trace their history, location and distribution for the purpose of animal disease control, food safety, or trade or any other legal requirements under the VS/OIE mandate. Levels of advancement 1. The VS do not have the authority or the capability to identify animals or control their movements. 2. The VS can identify some animals and control some movements, using traditional methods and/or actions designed and implemented to deal with a specific problem (e.g. to prevent robbery). 3. The VS implement procedures for animal identification and movement control for specific animal subpopulations as required for disease control, in accordance with relevant international standards. 4. The VS implement all relevant animal identification and movement control procedures, in accordance with relevant international standards. 5. The VS carry out periodic audits of the effectiveness of their identification and movement control systems. 64/Item11

65 II-13. Identification and traceability B. Identification and traceability of products of animal origin The authority and capability of the VS, normally in coordination with stakeholders, to identify and trace products of animal origin for the purpose of food safety, animal health or trade. Levels of advancement 1. The VS do not have the authority or the capability to identify or trace products of animal origin. 2. The VS can identify and trace some products of animal origin to deal with a specific problem (e.g. products originating from farms affected by a disease outbreak). 3. The VS have implemented procedures to identify and trace some products of animal origin for food safety, animal health and trade purposes, in accordance with relevant international standards. 4. The VS have implemented national programmes enabling them the identification and tracing of all products of animal origin, in accordance with relevant international standards. 5. The VS periodically audit the effectiveness of their identification and traceability procedures. 65/Item11

66 CC II-14: Animal welfare Glossary of terms Animal welfare means how an animal is coping with the conditions in which it lives. An animal is in a good state of welfare if (as indicated by scientific evidence) it is healthy, comfortable, well nourished, safe, able to express innate behaviour, and if it is not suffering from unpleasant states such as pain, fear, and distress. Good animal welfare requires disease prevention and veterinary treatment, appropriate shelter, management, nutrition, humane handling and humane slaughter / killing. 66/Item11

67 CC II-14: Animal welfare Terrestrial Code references - Section 7: Animal Welfare Chapter 7.1 Introduction to the recommendations for animal welfare Chapter 7.2 Transport of animals by sea Chapter 7.3 Transport of animals by land Chapter 7.4 Transport of animals by air Chapter 7.5 Slaughter of animals Chapter 7.6 Killing of animals for disease control purposes [Note: At this time this competency covers only chapters 7.1. to 7.6. inclusive.] 67/Item11

68 CC II-14: Animal welfare Terrestrial Code references – Chapter 7.1: General principles of animal welfare Article 7.1.2: Guiding principles for animal welfare There is a critical relationship between animal health and animal welfare “Five freedoms” provide valuable guidance in animal welfare: freedom from hunger, thirst and malnutrition freedom from fear and distress freedom from physical and thermal discomfort freedom from pain, injury and disease freedom to express normal pattern of behaviour Scientific assessment of animal welfare involves diverse elements which need to be considered together using value-based assumptions Improvements in farm animal welfare can often improve productivity and food safety, and hence lead to economic benefits. Equivalent outcomes based on performance criteria, rather than identical systems based on design criteria 68/Item11

69 Terrestrial Code references – Chapter 7.3: Transport of animals by land apply for domesticated animals (cattle, sheep, pigs, poultry and equines). Article 7.3.3: Responsibilities The welfare of the animals during their journey is the joint responsibility of all people involved (e.g. owners, business agents, animal handlers, drivers, Competent Authorities etc.) Article 7.3.4: Competence All people responsible for animals during journeys, should be competent according to their responsibilities. Competence may be gained through formal training and/or practical experience. Article 7.3.5: Planning the journey Plans should be made in relation to preparation of animals for journey, vehicle and container design and maintenance, space allowance, rest, water and feed, control of disease, emergency response procedures, etc. CC II-14: Animal welfare 69/Item11

70 CC II-14: Animal welfare Terrestrial Code references – Chapter 7.3: Transport of animals by land Article 7.3.6: Documentation Article 7.3.7: Pre-journey period Point 2. Selection of compatible groups Point 3. Fitness to travel Article 7.3.8: Loading Point 1. Competent supervision Point 2. Facilities Point 3. Goads and other aids (in case of their use) Article 7.3.9: Travel Point 4. Sick, injured or dead animals Point 5. Water and feed Point 6. Rest period and conditions 70/Item11

71 CC II-14: Animal welfare Terrestrial Code references – Chapter 7.3: Transport of animals by land Article : Unloading and post-journey handling Point 4. Cleaning and disinfection Article : Actions in the event of refusals to allow the completion of the journey The welfare of the animals should be the first consideration When the animals have been refused import, the Competent Authority of the importing country should make available suitable isolation facilities to allow the unloading of animals from a vehicle. Article : Species-Specific Issues Various 71/Item11

72 CC II-14: Animal welfare Terrestrial Code references – Chapter 7.6: Killing of animals for disease control purposes Article 7.6.1: General principles Point 1. All personnel involved in the humane killing of animals should have the relevant skills and competencies Cleaning and disinfection; Point 4. The handling and movement of animals should be minimised; Point 5. Animal restraint should be sufficient to facilitate effective killing; when restraint is required, killing should follow with minimal delay; Point 6. Methods used should result in immediate death or immediate loss of consciousness lasting until death; Point 8. There should be continuous monitoring of the procedures by the Competent Authorities; Point 10. These general principles should also apply when animals need to be killed for other purposes such as after natural disasters. 72/Item11

73 SpeciesAge range ProceduresRestraint necessary Animal welfare concerns Article CattleallFree bulletnoNon-lethal wounding7.6.6 ・・・ CC II-14: Animal welfare Terrestrial Code references – Chapter 7.6: Killing of animals for disease control purposes Article 7.6.5: Table summarising killing methods described in Article – /Item11

74 II-14 Animal welfare The authority and capability of the VS to implement the animal welfare standards of the OIE as published in the Terrestrial Code. Levels of advancement 1 OIE standards are generally not implemented. 2. Some of OIE standards are implemented, e.g. primarily for the export sector. 3. All of OIE standards are implemented but this is primarily for the export sector. 4. All of OIE standards are implemented, for the export and the domestic sector. 5. OIE standards are implemented and implementation is periodically subject to independent external evaluation. 74/Item11

75 Organisation Mondiale de la Santé Animale World Organisation for Animal Health Organización Mundial de Sanidad Animal 75/Item11


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