4 The OIE World Organisation for Animal Health an intergovernmental organisationoperating expenses are paid by member country contributionsfounded in 1924 – predates the UN167 Member Countriesheadquarters in ParisFive regional representations (Tokyo, Buenos Aires, Beyrouth, Bamako, Sofia)
5 The OIE’s objectivesensure transparency in global animal health situationcollect, analyse and disseminate scientific veterinary information on control methods of animal diseasescontribute expertise and encourage coordinated approach to disease outbreaksimprove veterinary serviceswithin its WTO mandate, safeguard world trade through animal health standardsanimal welfare and animal production food safety
6 Regional Representations INTERNATIONAL COMMITTEEAdministrative CommissionDirector GeneralSpecialist Commissions Terrestrial Code, Aquatic Code, Biological Standards, ScientificRegional CommissionsAfrica, Americas, Europe, Asia- Far East and Oceania, Middle EastCentral BureauCollaborating CentresReference LaboratoriesAd hoc GroupsWorking GroupsAdministrativeand FinancialDepartmentAnimal HealthInformationDepartmentInternational TradeDepartmentScientific andTechnicalDepartmentRegional ActivitiesDepartmentPublicationsDepartmentRegional Representations
8 Working with relevant experts OIE does not work only with vets.For BSE and other zoonoses, key is close cooperation with other experts, eg from WHO
9 OIE Reference Laboratories 157 Reference Laboratories in 30 countries cover 80 diseases and topicscentres of expertise and standardisation to other laboratories and to OIEstore and distribute reagentsdevelop / validate new diagnostic testscoordinate scientific / technical studiesprovide scientific and technical trainingprepare and distribute proficiency tests
10 Taiwan’s experts Reference laboratory for White spot disease Dr Grace Lo Department & Institute of Zoology, National Taiwan UniversityAd hoc Group on new chapters for crustacean diseases for the Aquatic Code and ManualDr Grace LoAd hoc Group on humane killing of animals for disease controle purposesDr De-shien JongNational Taiwan University
11 International trade context Let me explain WTO relations
12 OIE’s WTO mandateWTO SPS Agreement recognises OIE as a reference organisation for international standards (3 sisters)for food safety - the Codex Alimentarius Commissionfor animal health and zoonoses - the OIEfor plant health - the International Plant Protection Convention (IPPC)You have already heard this from previous sections of this seminar.The SPS Agreement which was adopted as a part of WTO agreement gave OIE new task.To avoid trade conflicts between countries over sanitary regulations, the SPS was born and the OIE came to be in charge of setting international standards for animal health and zoonoses.
13 Why standards necessary international public goodenhance safety of international tradefewer disease outbreaksencourage harmonisation of national legislation and control measuresfewer unjustified restrictions on tradepromote fairer tradebenefits to developing countries especiallyAlthough the OIE’s standards had been existing since 1968, the objective was purely to prevent disease spreading and give guideance to Member Country to that end.
15 OIE Codesrecommend health measures to be used by veterinary authorities or other competent authoritiesto establish health regulations for the safe importation of animals and animal productswhile avoiding unjustified trade restrictionsnow expanding into animal welfare and food safetyLater of this afternoon, I will explain the procedures to revise or develop the codes.I would like to move the principles and approaches of the Codes.OIE Codes are recommendations of health measures, and they are recommended for vetetinary authorities or other competent authorities.
16 Principles in the Codes WTO obligations complied withscientific basis for recommendationsassessment of risk factorsevaluation of veterinary serviceszoning and compartmentalisationepidemiological surveillancecredible health certificationimporting country assumed to be free of disease or with a control programme
17 Approach in the Code generic (horizontal) chapters general definitions obligations and ethics in international tradeimport risk analysis methodologymonitoring and surveillance systemsquality and evaluation of veterinary servicesimport/export procedures
18 Approach in the Code specific chapters on OIE listed diseases, eg FMDBSEAIwithin each chapter, articles ondescription of pathogen / diseasedetermining status of a country or zone‘safe’ commodities irrespective of status (if possible)recommendations for ‘unsafe’ commodities
19 Approach in the Code Appendices collection and processing of semen collection and processing of embryos/ovainactivation of pathogens and vectorstransport of animalsdiseases surveillance systemsModel veterinary certificates forlive animalsproducts of animal origin
20 Zoning, regionalisation and compartmentalisation
21 History of ZRC standard Appeared as Chapter on “Zoning and Regionalisation” when Section of “Import Risk Analysis” was introduced in 1993Current standard since 2000MCs’ need for clear understanding of concepts of zone and compartmentWTO’s request to present concrete steps to apply zoning and compartmentalisationExtended revision prepared by TAHSC for adoption in May 2005
22 Why need zone/compartment? Proposed new text clarifies the need“Given the difficulty of establishing and maintaining a disease free status for an entire country, especially for diseases the entry of which is difficult to control through measures at national boundaries, there may be benefits to Member Countries in establishing and maintaining a subpop with a different animal health status within national boundaries….”
23 OIE definitions in Ch.1.1.1 Zone/Region Compartment a clearly defined part of a country containing an animal subpopulation with a distinct health status with respect to a specific disease…Compartmentone or more establishments (premises in which animals are kept) under a common biosecurity management system containing an animal subpopulation with a distinct health status …
24 zoning/compartmentalisation in Ch. 1.3.5 ‘zoning’ and ‘regionalisation’ have the same meaningproposed new text uses ‘zoning’zoning applies to an animal sub-population defined on a geographical basiscompartmentalisation applies to an animal sub-population defined by management systems related to biosecurity
25 zoning/compartmentalisation in Ch. 1.3.5 Proposed new text clarifies the purposeszoning and compartmentalisation are procedures implemented by a country to define sub-populations of different animal health status within its territory for the purpose of disease control or international trade
26 application of the concepts the extent of a zone is established on the basis of natural, artificial or legal boundariesthe requirements for a compartment are established on the basis of management practices relating to biosecurityby the Veterinary Administration
27 types of zones INFECTED ZONE FREE ZONE FREE ZONE major BUFFER road riverrailwayFREE ZONE
29 application of the concepts there are Code recommendations for zones and compartments for diseases for which the concepts are appropriatethe recommendations depend onepidemiology of the diseaseenvironmental factorsappropriate and applicable biosecurity measuresnecessary surveillance
30 epidemiology how does the disease spread ? by live animals / humans ?by meat / eggs / semen ?by farm or veterinary equipment ?by wind ?by biting insects ?what species does it affect ?clinical signs ?
31 environmental factors temperature / humiditynatural barriersocean / major rivermountain rangeartificial barriersstate / county boundaryroad / rail system
32 biosecurity measures management regulations re biosecurity dedicated equipmentstaff showering in-and-outanimals housed vs free rangeimposed movement controls
33 surveillance necessary surveillance for presence / absence of pathogen prevalence of diseaseseasonal factors eg biting insectsstrains of virus eg FMDintermediate hosts eg tick-borne diseases
34 application of the concepts a Veterinary Administration must document the measures taken toidentify the animal sub-populationrecognise its distinct health statusmaintain its distinct health statusdossier will be as detailed as situation requires
35 animal sub-population dairy cattle herds in 4 adjacent countiesbison and buffalo in Albertawild pig population in a forest in Germanypoultry flocks managed by Tysons Inc as a unitwild waterfowl in a water catchment area during the breeding seasonbeef cattle over 3 years of age in the UK
36 health status infected free with vaccination free without vaccination seasonally freeunknown
37 application of the concepts if an exporting country wants to define a zone or compartment within its territory for an OIE-listed disease, it needs to implement the recommendations stipulated in the Code for setting up and maintaining such a zone or compartmentor equivalent measures
38 application of the concepts an importing country should recognise the existence of this zone or compartment, subject to the application of the appropriate recommendations in the Codewith regard to the importation, or transit through its territory, of commodities from that zone or compartment
39 uses in disease control / eradication campaign in trade zone progressive zoning/compartmentalisation allows stepwise approachallows concentration of resources where greatest chance of successin trade zoneto gain / maintain market access for certain commoditieswhere whole country freedom not possible / practicable
40 Summary of proposed modification Clarifies the uses/benefitsSuggests sequence of steps to be taken in defining a zone/compartmentImportance of accurate animal health informationNegotiation between exporting country and importing country indispensable
42 History of OIE AI standard Appeared as Fowl Plague in the first edition 1968simple Chapter- using mostly NCD standardCurrent standard since 1997significant outbreaks since late 1990sMCs’ demand to update, WHO’s request to address AI’s potential as a zoonosesAHG meetings since 2002 to draft new Chapter2004 GS placed new text as “under study” as MCs concerned at trade implications of notifying LPNAIFurther consideration by AHG and TAHSC towards adoption in May 2005
43 New proposed AI Chapter Incubation period: 21 daysNAI is defined as an infection of poultry caused either by any influenza A virus of the H5 or H7 subtypes or by any AI virus with an IVPI greater than 1.2 or as an alternative causing at least 75% mortality in 4 to 8 week old chickens when injected intravenously.NAI can be divided into HPNAI and LPNAI
44 HPNAI and LPNAIHPNAI viruses have an IVPI in 6 weeks old chickens greater than 1.2 or as an alternative, cause at least 75% mortality in 4 to 8 weeks old chickens infected intravenously. H5 and H7 not qualifying under these conditions should be sequenced to determine the presence of multiple basic amino acids at the cleavage site of the haemagglutinin moleculeLPNAI are all influenza A viruses of H5 and H7 subtype that are not HPNAI.
45 Definition of « Poultry » Poultry is defined as ‘all birds reared or kept in captivity for the production of meat or eggs for consumption, for the production of other commercial products, for restocking supplies of game or for breeding these categories of birds
46 Definition of « infection » HPNAI or LPNAI virus has been isolated and identified as suchviral antigen or viral RNA specific to HPNAI or LPNAI has been identifiedantibodies to H5 or H7 subtype of NAI virus that are not a consequence of vaccination have been detected in poultry
47 Definition of «NAI free establishment» Poultry show no evidence of NAI infection based on proposed surveillance appendixrandom testing of birds to show absence of NAIV infection using OIE approved testsfrequency of testing based on risk of infection and at a maximum interval of 21 daysIntroduced to enable safe trade of commodities that may transmit LPNAI, from country, zone or compartment not known free from LPNAIhatching eggs, poultry semen, day-old poultry
48 Determination of the NAI status of a country/zone/compartment outcome of a risk assessment identifying all potential factors for NAI occurrence and their historic perspectiveNAI is a notifiable disease in the whole countryappropriate surveillance is in place for demonstration of infection in the absence of clinical signs (see proposed OIE guidelines)
49 NAI free country, zone or compartment NAI infection has not been present for the past 12 monthsIn case of recovery of status, if a stamping out policy for HPNAI is applied the recovery period shall be 3 months after the killing of the last infected poultry followed by disinfection+ proof of surveillance during the 3 monthsIn case of LPNAI, slaughter for human consumption (conditions apply) is also allowed followed by disinfection and surveillance during the 3 months
50 HPNAI free country or zone or compartment HPNAI infection has not been present for the past 12 months. LPNAI status may be unknown, but any NAI detected must be proved NOT to be HPNAI.Recovery of status regained 3 months after stamping out followed by disinfection and surveillance during the 3 months.
51 Recommendations depending on commodity groups Live Poultry (other than day-old)should come from NAI free country, zone or compartment (CZC)Day-old poultry, hatching eggs, semenshould come from NAI free CZC / NAI free establishment in HPNAI free CZCEggs for human consumption, fresh meatshould come from NAI free CZC / establishment with no evidence of NAI in the past 21 days in HPNAI free CZCOthers (egg products, meat products, feathers etc.)If not coming from above mentioned commodity with higher status, should be processed to ensure the destruction of NAI virus
52 Live poultry (other than day-old) from NAI free status international veterinary certificate attesting that the poultry:showed no clinical signs of NAI on the day of shipmentkept in an NAI free country, zone or compartment for at least 21 days (surveillance carried out in establishment within the past 21 days)
53 Live birds other than poultry regardless of NAI status international veterinary certificate attesting that the birds:showed no clinical signs of NAI on the day of shipmentisolated since hatching or past 21 days with no indicative clinical sign during that periodtested negative for infection with NAI virus for poultry 7 to 14 days prior to shipment
54 Day-old poultry from NAI free status Kept in free country/zone/compartment since hatchDerived from parent flocks kept in NAI free country/zone/compartment for 21 days prior to and at time of egg collection
55 Day-old poultry from HPNAI free status HPNAI free country/zone/compartmentParent flocks in NAI free establishments for 21 days prior to and at time of egg collection
56 Eggs for human consumption From NAI free statuscountry/zone/compartment are free from NAIFrom HPNAI free status,country/zone/compartment (CZC) are free from HPNAIfrom establishments with no evidence of NAI in the past 21 days
57 Fresh meat From CZC with NAI free status kept in CZC free from NAI since hatched/for the past 21 daysslaughtered in an approved abattoir and subjected to ante- and post-mortem inspections for NAI with favourable resultsFrom CZC with HPNAI free statuskept in establishments with no evidence of NAI in the past 21 days
58 Meat products of poultry Regardless of health statusDerived from fresh meat that satisfies requirements for fresh meat (NAI free or HPNAI free CZC),ORprocessed to ensure destruction of virus and necessary precautions have been taken to avoid contact of the commodity with any source of NAI virus
60 History of OIE BSE standard Disease first reported in 1986 in UKOIE first work in 1988 via meeting of world renowned scientistsadded to disease list / required notification in 1990Discussed by MCs in General Sessions and Standard for BSE adopted in 1992Standard updated as often as necessary due to rapidly developing scientific information
61 Current BSE Chapter 5-category system Free Provisionally free Minimal riskModerate riskHigh riskBased on risk assessment, surveillance, number of cases (imported/indigenous), feed ban,etceven for High risk category, fresh meat can be traded under certain conditionsabsolute ban only for MBM
62 Current safe commodities When authorising import or transit of the following commodities, Veterinary Administrations should not require any BSE related conditions, regardless of the BSE status of the exporting country:milk and milk products;semen and in vivo derived cattle embryos;hides and skins (excl. from head) ;gelatin and collagen prepared exclusively from hides and skins (excl. from head);protein-free tallow (max of insoluble impurities of 0.15% in weight) and derivatives;dicalcium phosphate (with no trace of protein and fat);
63 Proposals for addition of list due to luck of evidence of transmissiondeboned skeletal muscle meat (excluding mechanically separated meat)blood and blood by-productsDue to luck of evidence of transmission
64 For other CommoditiesWhen authorising import or transit of other commodities listed in this chapter, Veterinary Administrations should require the conditions prescribed in this Chapter relevant to the BSE risk status of the cattle population of the exporting country and zone....
65 New approachCurrent 5-category system causes problems due to complexity of chapter - MCs wanted simpler approachad hoc group discussed simplification while retaining chapter’s scientific basesimplified 3-category system is proposed for adoption in May 2005
66 Factors for assessing the BSE risk Factors relating to the introduction of TSE agent into a cattle populationpresence/absence of animal TSE agentsmeat-and-bone meal from the indigenous ruminantimported meat-and-bone mealimported live animalsimported animal feed and feed ingredientsimported products of ruminant origin for humanimported products of ruminant origin for cattleSurveillance / epidemiological investigations should be taken into account
67 Factors for assessing the BSE risk Factors relating to the exposure of the BSE agent to cattle…:recycling and amplification of the BSE agent through consumption by cattle of MBMuse of ruminant carcasses etc, rendering process and method of animal feed manufacturefeeding or not of ruminants with MBM from ruminants, incl. measures to prevent cross-contaminationlevel of surveillance for BSE and the results
68 Proposed 3-category system 1. Negligible BSE risk without commodity-specific risk mitigation measures2. Negligible BSE risk with commodity-specific risk mitigation measures3. Undetermined BSE risk
69 3 category approach Risk based, not prevalence based based on assessment of risk factors and whether appropriate measures have been taken to address themfinding one case does not necessarily change trade measuresallow MCs to concentrate on commodity-specific risk mitigating measurestakes into account of efforts on farmer awareness and effectiveness of feed ban
70 1. Negligible risk without measures 1) risk assessment conducted and appropriate generic measures taken for the relevant period of time2) Type B surveillance is in placeEither3) No BSE case / any BSE case are importeda) criteria are compiled with at least for 7 years andb) meat-and-bone meal or greaves from ruminants not been fed to ruminants for at least 8 yearsOR4) Last indigenous case was more than 7 years agosame as 3) plus all cases and progeny are destroyed.
71 2. Negligible risk with measures 1) risk assessment conducted and appropriate generic measures taken for the relevant time2) Type A surveillance is in placeEither3) No BSE case / any BSE case are importeda) criteria are compiled with, but not for 7 years orb) meat-and-bone meal or greaves from ruminants not been fed to ruminants, but not for 8 yearsOR4) Indigenous case has been reportedsame as 3) plus all cases and progeny are destroyed.
72 3. Undetermined BSE riskcannot be demonstrated that it meets the requirements of another category.
73 Current SRMsFrom cattle of any age originating from a country with a moderate or a high BSE risk, the following commodities should not be traded for the preparation of food, feed, fertilisers, cosmetics, pharmaceuticals… :tonsils and intestine, and protein products derived thereof.
74 Current SRMs2) From cattle originating from a country with a moderate or a high BSE risk, that were at the time of slaughter over 12 months of age, the following commodities should not be traded for the preparation of food, feed, fertilisers, cosmetics, pharmaceuticals…:brains, eyes, spinal cord, skull and vertebral column and protein products derived thereof.
75 Current SRMs3) From cattle, originating from a country with a minimal BSE risk, that were at the time of slaughter over 30 months of age, the following commodities should not be traded for the preparation of food, feed, fertilisers, cosmetics, pharmaceuticals….:brains, eyes and spinal cord, skull, vertebral column and derived protein products.
76 Proposal for SRMsFrom cattle of any age originating from a country defined in the 2nd or 3rd category, the following commodities should not be traded for the preparation of food, feed, fertilisers, cosmetics, pharmaceuticals…:tonsils and distal ileum, and protein products derived thereof.
77 Proposals for SRMs (Cont.) From cattle over 30 months of age originating from a country defined in the 2nd and 3rd category, the following commodities should not be traded for the preparation of food, feed, fertilisers, cosmetics, pharmaceuticals…. :brains, eyes, spinal cord, skull, vertebral column and derived protein products.
79 History of BSE surveillance Appendix for BSE surveillance / monitoring system adopted in 1998Appendix updated in 2001,2002 and 2003 due to rapidly developing scientific informationrecommended minimum number of annual investigations (table1) unchangedconcept of gradient of importance of samples from different subpopulationsNew text based on accumulated EU experience and statistical examination is proposed for adoption
80 Current surveillance appendix Goals for surveillanceto determine whether BSE is present or notif present, to monitor the epizootic for aiding control measuresSubpopulations for surveillanceIn the order of decreasing likelihood1 cattle displaying signs consistent with BSE2 cattle displaying signs not necessarily indicative of BSE3 cattle subject to normal slaughter
81 Proposed surveillance “goals” Depending on BSE risk category, surveillance may have one or more goals:detecting BSE to a pre-determined design prevalencemonitoring the evolution of BSEmonitoring the effectiveness of a feed ban and/or other risk mitigation measuressupporting a claimed BSE statusgaining or regaining a higher BSE status
82 Proposed surveillance “role” BSE status cannot be determined only on the basis of a surveillance programme but should be determined in accordance with all the factors listed in Article
83 Proposed surveillance subpopulations Clarifies recommended sampling sub-popsover 30 months displaying clinical signs consistent with BSEover 30 months non-ambulatory / sent for emergency slaughterover 30 months found dead on farm, during transport or at an abattoirover 36 months at routine slaughterFirst sub-pop should be focused on, but at least 3 sub-pops should be sampled.
84 Proposed surveillance scheme Selects the “points target”,depends on adult cattle populationdepends on design prevalence chosen (maximum possible prevalence)1 / 1,000,000 or 1 / 100,000, either with 95% confidence
85 Proposed surveillance scheme Different “Point Value” allocated depending on the sampled subpopulationUrging greater sampling from riskier sub-popsSurveillance points remain valid for 7 years until reaching the target point
86 Proposed gradient point values (extract from Table 2) Routine slaughterFallen stockCasualty slaughterClinical suspectAge > 2 years and < 4 years (young adult)0.10.20.4260Age > 4 years and < 7 years (middle adult)0.91.6750Age > 7 years and < 9 years (older adult)0.7450
87 Proposed surveillance scheme Two types of surveillance, depending on the result of risk assessmentIf all risk factors negligible, less surveillance burdenDetails of “maintenance surveillance” need further investigationScientists believe that not all cattle need to be examined to give useful results
89 Perspective on vCJDIn the past, many models predicted likely pathways of vCJD epidemicHowever, now it appears to be minor compared to other public health concernsArticle published by the Royal Society makes a “best estimate" of 70 future deaths on top of 150 to date
90 Current activities of Terrestrial Animal Health Standard Commission
91 OIE international standards OIE develops and publishes health standards for trade in animals and animal products and biological standardsthrough elected Specialist Commissions of 4-6 members eachadopted by OIE Member Countries during General Session each May by consensusno other pathwayOIE standards help in controlling animal diseases and zoonoses world wide
92 OIE Specialist Commissions Terrestrial Animal Health Standards CommissionBiological Standards CommissionScientific Commission for Animal DiseasesAquatic Animal Health Standards Commissionusing working groups and ad hoc groups for specialist tasks eg animal welfare, BSE, epidemiology, avian influenza, TB
93 Updating OIE standards issue / problem identified by Delegate, OIE Commission, industry, scientist, individualnew scientific information eg from research or disease outbreaknew disease - emergingnew approaches eg vaccinationaddressed by appropriate Commission as new or revised standardusing appropriate expert advice on disease or procedure
94 Updating OIE standards proposal circulated for comment by Member Countries, experts, organisationsCommission may revise proposal on basis of comments receiveddiscussed by Delegates at General Sessionmay be discussed only and returned for further workmay be adopted as OIE international standardopportunity for all to be involved in standards development
95 Updating OIE standards COMMITTEE, COMMISSIONS, DELEGATESPROBLEMSpecialistCommissionsUpdating OIE standardsReviewAdvice of experts or other Specialist CommissionsDraft text12CommentsDELEGATESCOMMITTEEOIE INTERNATIONAL STANDARDAdoption
96 Proposals for adoption in May 2005 Revised textsGeneral definitions (Ch )Zoning and compartmentalisation (Ch )General Guidelines for Animal Health Surveillance (App )Criteria for listing diseases (Chapter )Foot and mouth disease (Ch ) and its Surveillance Appendix (App )Bluetongue (Ch )Bovine tuberculosis (Ch )
97 Proposals for adoption in May 2005 Revised texts (cont.)TSE agents inactivation procedure (App )Classical Swine Fever (Ch )Avian Influenza (Ch )Categorisation of diseases by IETS (App )Bovine and small ruminants semen (Ch )Rift Valley fever (CH )Antimicrobial resistance (section 3.9.)
98 Proposals for adoption in May 2005 New textBSE (Ch )BSE Surveillance Appendix (App )Classical swine fever Surveillance AppendixAvian Influenza Surveillance Appendix4 guidelines for Animal Welfare
99 Mid-term tasksWork not for adoption in May, but needing feedback from MCs includes;Carcass disposalAnimal production food safetyWorks towards developing/revising codes are;Animal identification and traceabilityParatuberculosisChapters on dourine and surraSmall hive beetle of honey beesRinderpest / Peste des petits ruminantsAfrican horse sickness
101 Dispute settlementif requested by parties, OIE may act as ‘mediator’ to help resolve differences on a particular technical issuetechnical-based process, rather than legalvoluntaryoutcomes not binding, unless agreed at startOIE experts discuss issues and make recommendationscan be alternative to WTO process or precursor to it
102 World organisation for animal health Thank you for your attentionWorld organisation for animal health12 rue de Prony75017 Paris, FranceTel: 33 (0)Fax: 33 (0)