OIE Standards and guidelines on biosecurity and compartmentalisation
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1 OIE Standards and guidelines on biosecurity and compartmentalisation Nordic-Baltic seminar on Biosecurity; experiences, training, motivation and economic aspects Rimbo, Sweden, 6-8 May 2014 Dr. Nadège Leboucq OIE Representative based in Brussels 1
2 The OIE in a nutshell An intergovernmental organisation founded in Creation of the Office International des Epizooties (OIE) Headquarters in Paris (France) Creation of the United Nations 5 Regional Representations World Organisation for Animal Health (OIE) 6 Sub-Regional Representations 2
3 The OIE in a nutshell 178 Member Countries in 2013 Europe Asia, the Far East and Oceania Americas Africa Middle- East (one Member = one vote) 3
4 The OIE in a nutshell Core mandate and missions Transparency of world animal disease situation (including zoonoses) Collect and publish veterinary scientific information, notably animal disease prevention and control methods Sanitary safety of international trade in animals and their products under the mandate given by the WTO 4
5 The OIE in a nutshell Standard setting OIE is the WTO reference organisation for international trade and surveillance and control of animal diseases and zoonoses SPS Agreement Animal Health OIE Food Safety CODEX Plant Health IPPC International standard setting organisations 5
6 The OIE international Standards Official reference for WTO under the SPS Agreement Transparent standard setting process Adopted by consensus of OIE Members Volume 1 horizontal chapters Volume 2 Disease specific chapters (available online at 6
7 The OIE international Standards 1 OIE Delegate and National Focal Points Committee, Commissions, Delegates ISSUE / PROBLEM Specialist Commissions Review OIE standard setting process Once adopted, OIE standards are applicable in all OIE member countries Comments Advice of experts or other Specialist Commissions Delegates Draft text World Assembly 4 OIE INTERNATIONAL STANDARD Adoption 7
8 The OIE international Standards Historically, the emphasis of OIE standards have been on the determination of country or zone freedom (and how to regain such freedom when lost) to facilitate trade However, For some countries with disease freedom status, the situation may be difficult to maintain (risk from neighboring countries; movement of wildlife) safe trade can not just be limited to animals and products originating from countries or zones declared free of relevant diseases no risk if proper mitigating conditions are met => Compartmentalisation concept = an alternative way to manage animal disease without necessarily impeding/disrupting trade 8
9 The OIE international Standards on Compartmentalisation Volume 1 of the TAHC Glossary Chapter 4.3 on zoning and compartmentalisation Chapter 4.4 on application of compartmentalisation Chapter OIE procedures relevant to the Agreement on the Application of SPS Measures of WTO Volume 2 of the TAHC 14 diseases with specific provisions for compartment 9
10 The OIE Guidelines on Compartmentalisation Checklist on the practical implementation of Compartmentalisation Checklist on the Practical Application of Compartmentalisation for Avian Influenza and Newcastle Disease 10
11 The OIE Guidelines And standards on Biosecurity - trans-cutting principle across The TAHC and AAHC - Chapter 6.4. on Biosecurity procedures in poultry production - Guidelines: biosecurity for HPAI: 6.PDF 11
12 Definition of Compartment Glossary - Compartment: means an animal subpopulation contained in one or more establishments under a common biosecurity management system with a distinct health status with respect to a specific disease or specific diseases for which required surveillance, control and biosecurity measures have been applied for the purpose of international trade. (Free compartment) 12
13 Definition of Compartment Zoning and compartmentalisation are procedures implemented by a Member Country with a view to defining subpopulations of distinct health status within its territory - Zoning applies to an animal subpopulation defined primarily on a geographical basis (using natural, artificial or legal boundaries) - Compartmentalisation applies to an animal subpopulation defined primarily by management and husbandry practices related to biosecurity Zoning and Compartmentalisation are procedures for the purpose of disease control and/or international trade. 13
14 Zones free zone Infected zone river free zone 14
15 Feed Equipment Compartment BREEDERS Equipment Feed FEED SUPPLY FATTENING SLAUGHTER HOUSE Birds Equipment FATTENING 15
16 Definition of the Compartment (con t) A compartment must be established with respect to one or more diseases be clearly defined (location of components and functional units and their the interrelationships) must take into account epidemiological factors, production systems, infrastructures and biosecurity practices, as well as surveillance 16
17 Application of compartmentalisation Influenced by technical issues: epidemiology of the disease(s) of concern health status of animals in adjacent areas structure and distribution of the animal population country and infrastructure factors environmental factors biosecurity measures which may be applicable the public/private relationship 17
18 Application of compartmentalisation Compartment management should provide evidence / address: Separation from potential sources of infection: Physical and spatial factors that affect biosecurity Infrastructural factors Biosecurity Plan Traceability system Documentation Surveillance of the agent(s) Diagnostic capability Emergency response and notification Supervision and control of a compartment 18
19 Application of compartmentalisation Biosecurity Plan* The effective implementation of the biosecurity plan should ensure that the compartment is epidemiologically closed throughout its routine operating procedures potential pathways for introduction and spread critical control points for each pathway mitigating measures for each critical control point detailed standard operating procedures (SOPs) comprehensive Contingency Plan reporting procedures to the Veterinary Authorities program for educating and training personnel surveillance program in place 19
20 Application of compartmentalisation Biosecurity Plan : Evidence of the efficacy of the Biosecurity Plan should be structured in line with HACCP, and its risks assessed and documented regularly Application of HACCP at the farm implies: the inventory and analysis of all hazards and potential pathogen risks for the compartment the identification of the most appropriate biosecurity measures applied at the most effective and controlled points within the premise or its surroundings. Well documented protocols Assessing risks Determine essential biosecurity measures Implementing biosecurity measures Monitoring risks and measures Always assess change Adjusting program 20
21 Application of compartmentalisation Traceability system animal identification in line with OIE chapters 4.1 and 4.2; individual identification is desirable, if not feasible, sufficient information on assurances is provided all animal movements in and out of the compartment should be recorded and when needed, certified by the Veterinary Authority records must be kept within the compartment on internal animal movements 21
22 Application of compartmentalisation Documentation should provide clear evidence that the biosecurity, surveillance, traceability and management practices are effectively applied should include (records) all animal movements, feed sources, production records, illness and deaths, laboratory tests, visitors logbook, medications, etc documentation on historical status of the compartment for the disease it was defined, and compliance with freedom requirements should be submitted to the Veterinary Authority when seeking recognition 22
23 Application of compartmentalisation Surveillance of the agent(s) surveillance system in place must comply with Ch. 1.4 Sensitivity of the internal and external surveillance must be adjusted according to changes in risk levels internal surveillance: must provide a baseline of the status, as well as procedures for early detection, and records of suspect investigations external surveillance: to be able to identify changes in the surrounding level of exposure. Should be targeted at epidemiological units in close proximity to the compartment the surveillance and monitoring programme in place should allow verify the status of such a subpopulation with respect to such disease(s). 23
24 Application of compartmentalisation Diagnostic capability provide a list of officially designated laboratories according to Chapter for sample testing provide type of tests to be conducted, capacity of laboratories, quality control procedures laboratories should have systematic procedures for rapid reporting results to the Veterinary Authorities where appropriate, results should be confirmed by an OIE reference laboratory 24
25 Application of compartmentalisation Emergency response early detection, diagnosis and notification are essential In event of suspicion of disease occurrence for which compartment was defined, Management must immediately notify Veterinary Authorities, and free status should be suspended, and if confirmed, revoked and importing countries notified as per Article management should notify the Veterinary Authorities the occurrence of any listed disease or breach in biosecurity, in which case status could be suspended Veterinary Authority should describe procedures and measures applied for each circumstance 25
26 Application of compartmentalisation Supervision and Control The Veterinary Authority as the final authority and should provide procedures for auditing and for granting, suspending and revoking the status of a compartment The authority, organisation and infrastructure of the Veterinary Services (include. Laboratories) should be in line with Chapter 3.1 and clearly documented (confidence in the integrity of the compartment) Appropriate implementation of compartmentalisation can only be achieved with good governance of Veterinary Services, including close cooperation between public and private sector. 26
27 Good governance of Veterinary Services "Treatment" Capacity Building, Specific Activities, Projects and Programs Veterinary Legislation "Diagnosis" PVS Evaluation "Prescription" PVS Gap Analysis including Veterinary Services Strategic Priorities Public / Private Partnerships Veterinary Education PVS Pathway Follow-Up Missions Laboratories The OIE collaborates with governments, donors and other stakeholders 27
28 Good governance of Veterinary Services OIE International Standards on the Quality of Veterinary Services Current edition (2013): TAHC (Veterinary Services) : Chapter 3.1 (VS) Chapter 3.2 (evaluation of VS) AAHC (AAHS): Chapter 3.1 (quality of AAHS) 28 28
29 Good governance of Veterinary Services A tool for the Good Governance of Veterinary Services Chapter 3.1. Veterinary Services Chapter 3.2. Evaluation of Veterinary Services 29 29
30 Good governance of Veterinary Services Objective: the evaluation should demonstrate that the Veterinary Services have the capability for effective control of the sanitary and zoosanitary status of animals and animal products. Key elements to be covered : Adequacy of resources Management capability Legislative and administrative infrastructures Independence in the exercise of official functions History of performance, including disease reporting. 30
31 Good governance of Veterinary Services 4 fundamental components Human, Physical, Financial Resources Technical Capability and Authority Interaction with Interested Parties Market Access 47 Critical competencies A definition CC I.1 CC II.1 CC III.1 CC IV.1 5 Levels of advancement (1 5) CC I.2 CC II.2 CC III.2 Compartmentali sation Indicators References to the Code CC I.11 CC II.13 CC III.6 CC IV.8 31
32 Good governance of Veterinary Services IV.8 Compartmentalisation The authority and capability of the VS to establish and maintain disease free compartments as necessary and in accordance with the criteria established by the OIE (and by the WTO SPS Agreement where applicable). Levels of advancement 1. The VS cannot establish disease free compartments 2. As necessary, the VS can identify animal sub-populations with a distinct health status suitable for compartmentalisation. 3. The VS ensure that biosecurity measures to be implemented enable it to establish and maintain disease free compartments for selected animals and animal products, as necessary. 4. The VS collaborate with producers and other interested parties to define responsibilities and execute actions that enable it to establish and maintain disease free compartments for selected animals and animal products, as necessary. 5. The VS can demonstrate the scientific basis for any disease free Compartments and can gain recognition by other countries that they meet the criteria established by the OIE (and by the WTO SPS Agreement where applicable). 32
33 Application of compartmentalisation Relationship between the public and private sectors: - Veterinary Authority is delegating the daily responsibility to apply biosecurity measures and conducting surveillance activities to the industries (should implement the biosecurity plan, compile documentation for audits, immediately notify authorities on risk changes, breaches in biosecurity or disease suspicions) - The Veterinary Authority retains the responsibility for controlling the activities within the compartments and for animal and products certification from the compartment The compartment is maintained through a partnership between the relevant enterprise/industry and the Veterinary Services 33
34 Having a compartment recognised for international trade Purposes (chapter 5.3) Sequence of steps to be taken in establishing a compartment (recommendations) Exporting country The Veterinary Authorities of the - Identifies a compartment importing and - Examines exporting the biosecurity countries plan and confirms should its enter effectiveness into a through audits Resolution formal agreement process - Describes (using recognizing the compartment for instance the according the compartment. to OIE informal requirement - Provides procedure all necessary for dispute mediation) documentation to the Importing country Importing country - determines whether it accepts such a subpopulation as a compartment - notifies the exporting country of its determination and the underlying reasons - recognizes the compartment - requests additional info - rejects No OIE recognition procedure for compartments (contrary to country or zones recognition of official status or national endorsement of control programmes Chapter 1.6 of the TAHC) 34
35 Application of compartmentalisation Few application of compartmentalisation - Lack of awareness of the concept (both in the public and private sectors) - Lack of infrastructure or economical structure - Lack of commercial incentives (exportation opportunities) - Lack of cooperation between the public and the private sectors - Legislation problems - Private sector capacities - Public sector capacities 35
36 Application of compartmentalisation 36
37 Application of compartmentalisation 37
38 Application of compartmentalisation 38
39 The High Health High Performance concept A certain number of sport horses are under close veterinary supervision, governed by FEI 1 and IFHA 2 rules They present a low health risk They are identified and traceable Their welfare is essential to their capacity to perform They enter countries on a temporary basis for competition purpose only, not for breeding 1 FEI = Federation Equestre Internationale 2 IFHA = International Federation of Horse racing 39
40 The High Health High Performance concept They can be defined as a SUB-POPULATION of the global equine population Proposed name HHP horse (High health, high performance horse) 40
41 Application of compartmentalisation The High Health High Performance concept Sub-population High health, high performance (HHP) sub-population Sport horses Other horses 41
42 Application of compartmentalisation The High Health High Performance concept Conceptually compartmentalisation could be applied to HHP horse movements (bubble to bubble movement), if: ID, traceability, management, biosecurity in place If public-private partnership in place 42
43 Proposal for the Facilitation of International Competition Horse Movements based on OIE Standards and approaches All available at: 43
44 BECOMING AN HHP HORSE Home (at stable) 1. BSC established National Federation Veterinarian 2. Issuing passport & chip Private Veterinarian 3. Vaccination Private Veterinarian 4. Tests Private Veterinarian 5. Second BSC National Federation Veterinarian 6. Health Certificate Government Veterinary Services Day of shipment Activation of the HHP card in the database 44
45 Travel Travel Shipment BSC Control during transport Country of destination Clean disinfected vehicles Person responsible for ensuring BS requirements Individual holdings, cleaned and disinfected Only horses from same health status travel together Vector control Venue Veterinary FEI inspection postarrival Layout of the venue Minimun stabling distance 10 metres Cleaning and sanitisation Separation of horses during the event Control of vehicles within the venue Record keeping Pet animals forbidden 45
46 Travel End of the competiton Government Veterinary Inspection BS Control during transport Country of residence Home options Permanent HHP horse Temporary HHP horse 46
47 OPTIONS Inactivation of the HHP card Permanent HHP horse (meet HHP requirements constantly) Normal horse e.g for: - Breeding - Training - Grazing 3 months to reactivate membership Health safeguards Vaccination requirements BS conditions 47
48 The draft chapter prepared for the Code Commission s review aims to establish the concept and principles for temporary movement of high health status horses based on the existing standards for identification, compartmentalisation and certification. 48
49 Thank you for your attention! 82 nd OIE General Session Paris, May th Conference of the OIE regional Commission for Europe Bern, September
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