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World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi...

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World Organisation for Animal Health Slide 2 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop Taipei March 2005 Slide 3 3 Role and structure of the OIE Slide 4 4 The OIE World Organisation for Animal Health an intergovernmental organisation operating expenses are paid by member country contributions founded in 1924 predates the UN 167 Member Countries headquarters in Paris Five regional representations (Tokyo, Buenos Aires, Beyrouth, Bamako, Sofia) Slide 5 5 The OIEs objectives ensure transparency in global animal health situation collect, analyse and disseminate scientific veterinary information on control methods of animal diseases contribute expertise and encourage coordinated approach to disease outbreaks improve veterinary services within its WTO mandate, safeguard world trade through animal health standards animal welfare and animal production food safety Slide 6 INTERNATIONAL COMMITTEE Administrative Commission Specialist Commissions Terrestrial Code, Aquatic Code, Biological Standards, Scientific Regional Commissions Africa, Americas, Europe, Asia- Far East and Oceania, Middle East Central Bureau Director General Regional Activities Department Administrative and Financial Department Animal Health Information Department Publications Department Scientific and Technical Department Collaborating Centres Reference Laboratories Ad hoc Groups Working Groups Regional Representations International Trade Department Slide 7 7 OIE expertise Slide 8 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 Slide 9 9 OIE Reference Laboratories 157 Reference Laboratories in 30 countries cover 80 diseases and topics centres of expertise and standardisation to other laboratories and to OIE store and distribute reagents develop / validate new diagnostic tests coordinate scientific / technical studies provide scientific and technical training prepare and distribute proficiency tests Slide 10 10 Taiwans experts Reference laboratory for White spot disease Dr Grace Lo Department & Institute of Zoology, National Taiwan University Ad hoc Group on new chapters for crustacean diseases for the Aquatic Code and Manual Dr Grace Lo Ad hoc Group on humane killing of animals for disease controle purposes Dr De-shien Jong National Taiwan University Slide 11 11 International trade context Slide 12 12 OIEs WTO mandate WTO SPS Agreement recognises OIE as a reference organisation for international standards (3 sisters) for food safety - the Codex Alimentarius Commission for animal health and zoonoses - the OIE for plant health - the International Plant Protection Convention (IPPC) Slide 13 13 Why standards necessary international public good enhance safety of international trade fewer disease outbreaks encourage harmonisation of national legislation and control measures fewer unjustified restrictions on trade promote fairer trade benefits to developing countries especially Slide 14 14 OIE trade standards Slide 15 15 OIE Codes recommend health measures to be used by veterinary authorities or other competent authorities to establish health regulations for the safe importation of animals and animal products while avoiding unjustified trade restrictions now expanding into animal welfare and food safety Slide 16 16 Principles in the Codes WTO obligations complied with scientific basis for recommendations assessment of risk factors evaluation of veterinary services zoning and compartmentalisation epidemiological surveillance credible health certification importing country assumed to be free of disease or with a control programme Slide 17 17 Approach in the Code generic (horizontal) chapters general definitions obligations and ethics in international trade import risk analysis methodology monitoring and surveillance systems quality and evaluation of veterinary services import/export procedures Slide 18 18 Approach in the Code specific chapters on OIE listed diseases, eg FMD BSE AI within each chapter, articles on description of pathogen / disease determining status of a country or zone safe commodities irrespective of status (if possible) recommendations for unsafe commodities Slide 19 19 Approach in the Code Appendices collection and processing of semen collection and processing of embryos/ova inactivation of pathogens and vectors transport of animals diseases surveillance systems Model veterinary certificates for live animals products of animal origin Slide 20 20 Zoning, regionalisation and compartmentalisation Slide 21 21 History of ZRC standard Appeared as Chapter on Zoning and Regionalisation when Section of Import Risk Analysis was introduced in 1993 Current standard since 2000 MCs need for clear understanding of concepts of zone and compartment WTOs request to present concrete steps to apply zoning and compartmentalisation Extended revision prepared by TAHSC for adoption in May 2005 Slide 22 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. Slide 23 23 OIE definitions in Ch.1.1.1 Zone/Region a clearly defined part of a country containing an animal subpopulation with a distinct health status with respect to a specific disease Compartment one or more establishments (premises in which animals are kept) under a common biosecurity management system containing an animal subpopulation with a distinct health status Slide 24 24 zoning/compartmentalisation in Ch. 1.3.5 zoning and regionalisation have the same meaning proposed new text uses zoning zoning applies to an animal sub-population defined on a geographical basis compartmentalisation applies to an animal sub-population defined by management systems related to biosecurity Slide 25 25 zoning/compartmentalisation in Ch. 1.3.5 Proposed new text clarifies the purposes zoning 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 Slide 26 26 application of the concepts the extent of a zone is established on the basis of natural, artificial or legal boundaries the requirements for a compartment are established on the basis of management practices relating to biosecurity by the Veterinary Administration Slide 27 27 FREE ZONE BUFFER ZONE railway major road river types of zones BUFFER ZONE INFECTED ZONE Slide 28 28 BREEDING FLOCK FEED SUPPLY GROWING FLOCK SLAUGHTER HOUSE GROWING FLOCK Equipment Birds Equipment Birds Equipment Feed Equipment Compartment Equipment Birds Feed Equipment Birds Slide 29 29 application of the concepts there are Code recommendations for zones and compartments for diseases for which the concepts are appropriate the recommendations depend on epidemiology of the disease environmental factors appropriate and applicable biosecurity measures necessary surveillance Slide 30 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 ? Slide 31 31 environmental factors temperature / humidity natural barriers ocean / major river mountain range artificial barriers state / county boundary road / rail system Slide 32 32 biosecurity measures management regulations re biosecurity dedicated equipment staff showering in-and-out animals housed vs free range imposed movement controls Slide 33 33 surveillance necessary surveillance for presence / absence of pathogen prevalence of disease seasonal factors eg biting insects strains of virus eg FMD intermediate hosts eg tick-borne diseases Slide 34 34 application of the concepts a Veterinary Administration must document the measures taken to identify the animal sub-population recognise its distinct health status maintain its distinct health status dossier will be as detailed as situation requires Slide 35 35 animal sub-population dairy cattle herds in 4 adjacent counties bison and buffalo in Alberta wild pig population in a forest in Germany poultry flocks managed by Tysons Inc as a unit wild waterfowl in a water catchment area during the breeding season beef cattle over 3 years of age in the UK Slide 36 36 health status infected free with vaccination free without vaccination seasonally free unknown Slide 37 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 compartment or equivalent measures Slide 38 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 Code with regard to the importation, or transit through its territory, of commodities from that zone or compartment Slide 39 39 uses in disease control / eradication campaign progressive zoning/compartmentalisation allows stepwise approach allows concentration of resources where greatest chance of success in trade zone to gain / maintain market access for certain commodities where whole country freedom not possible / practicable Slide 40 40 Summary of proposed modification Clarifies the uses/benefits Suggests sequence of steps to be taken in defining a zone/compartment Importance of accurate animal health information Negotiation between exporting country and importing country indispensable Slide 41 41 OIE AI Chapter Slide 42 42 History of OIE AI standard Appeared as Fowl Plague in the first edition 1968 simple Chapter- using mostly NCD standard Current standard since 1997 significant outbreaks since late 1990s MCs demand to update, WHOs request to address AIs potential as a zoonoses AHG meetings since 2002 to draft new Chapter 2004 GS placed new text as under study as MCs concerned at trade implications of notifying LPNAI Further consideration by AHG and TAHSC towards adoption in May 2005 Slide 43 43 New proposed AI Chapter Incubation period: 21 days NAI 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 Slide 44 44 HPNAI and LPNAI HPNAI 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 molecule LPNAI are all influenza A viruses of H5 and H7 subtype that are not HPNAI. Slide 45 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 Slide 46 46 Definition of infection HPNAI or LPNAI virus has been isolated and identified as such viral antigen or viral RNA specific to HPNAI or LPNAI has been identified antibodies to H5 or H7 subtype of NAI virus that are not a consequence of vaccination have been detected in poultry Slide 47 47 Definition of NAI free establishment Poultry show no evidence of NAI infection based on proposed surveillance appendix random testing of birds to show absence of NAIV infection using OIE approved tests frequency of testing based on risk of infection and at a maximum interval of 21 days Introduced to enable safe trade of commodities that may transmit LPNAI, from country, zone or compartment not known free from LPNAI hatching eggs, poultry semen, day-old poultry Slide 48 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 perspective NAI is a notifiable disease in the whole country appropriate surveillance is in place for demonstration of infection in the absence of clinical signs (see proposed OIE guidelines) Slide 49 49 NAI free country, zone or compartment NAI infection has not been present for the past 12 months In 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 months In case of LPNAI, slaughter for human consumption (conditions apply) is also allowed followed by disinfection and surveillance during the 3 months Slide 50 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. Slide 51 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, semen should come from NAI free CZC / NAI free establishment in HPNAI free CZC Eggs for human consumption, fresh meat should come from NAI free CZC / establishment with no evidence of NAI in the past 21 days in HPNAI free CZC Others (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 Slide 52 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 shipment kept in an NAI free country, zone or compartment for at least 21 days (surveillance carried out in establishment within the past 21 days) Slide 53 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 shipment isolated since hatching or past 21 days with no indicative clinical sign during that period tested negative for infection with NAI virus for poultry 7 to 14 days prior to shipment Slide 54 54 Day-old poultry from NAI free status Kept in free country/zone/compartment since hatch Derived from parent flocks kept in NAI free country/zone/compartment for 21 days prior to and at time of egg collection Slide 55 55 Day-old poultry from HPNAI free status HPNAI free country/zone/compartment Parent flocks in NAI free establishments for 21 days prior to and at time of egg collection Slide 56 56 Eggs for human consumption From NAI free status country/zone/compartment are free from NAI From HPNAI free status, country/zone/compartment (CZC) are free from HPNAI from establishments with no evidence of NAI in the past 21 days Slide 57 57 Fresh meat From CZC with NAI free status kept in CZC free from NAI since hatched/for the past 21 days slaughtered in an approved abattoir and subjected to ante- and post-mortem inspections for NAI with favourable results From CZC with HPNAI free status kept in establishments with no evidence of NAI in the past 21 days slaughtered in an approved abattoir and subjected to ante- and post-mortem inspections for NAI with favourable results Slide 58 58 Meat products of poultry Regardless of health status Derived from fresh meat that satisfies requirements for fresh meat (NAI free or HPNAI free CZC), OR processed to ensure destruction of virus and necessary precautions have been taken to avoid contact of the commodity with any source of NAI virus Slide 59 59 OIE BSE Chapter Slide 60 60 History of OIE BSE standard Disease first reported in 1986 in UK OIE first work in 1988 via meeting of world renowned scientists added to disease list / required notification in 1990 Discussed by MCs in General Sessions and Standard for BSE adopted in 1992 Standard updated as often as necessary due to rapidly developing scientific information Slide 61 61 Current BSE Chapter 5-category system Free Provisionally free Minimal risk Moderate risk High risk Based on risk assessment, surveillance, number of cases (imported/indigenous), feed ban,etc even for High risk category, fresh meat can be traded under certain conditions absolute ban only for MBM Slide 62 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) ; Slide 63 63 Proposals for addition of list due to luck of evidence of transmission deboned skeletal muscle meat (excluding mechanically separated meat) blood and blood by-products Due to luck of evidence of transmission Slide 64 64 For other Commodities When 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.... Slide 65 65 New approach Current 5-category system causes problems due to complexity of chapter - MCs wanted simpler approach ad hoc group discussed simplification while retaining chapters scientific base simplified 3-category system is proposed for adoption in May 2005 Slide 66 66 Factors for assessing the BSE risk Factors relating to the introduction of TSE agent into a cattle population presence/absence of animal TSE agents meat-and-bone meal from the indigenous ruminant imported meat-and-bone meal imported live animals imported animal feed and feed ingredients imported products of ruminant origin for human imported products of ruminant origin for cattle Surveillance / epidemiological investigations should be taken into account Slide 67 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 MBM use of ruminant carcasses etc, rendering process and method of animal feed manufacture feeding or not of ruminants with MBM from ruminants, incl. measures to prevent cross- contamination level of surveillance for BSE and the results Slide 68 68 Proposed 3-category system 1. Negligible BSE risk without commodity- specific risk mitigation measures 2. Negligible BSE risk with commodity- specific risk mitigation measures 3. Undetermined BSE risk Slide 69 69 3 category approach Risk based, not prevalence based based on assessment of risk factors and whether appropriate measures have been taken to address them finding one case does not necessarily change trade measures allow MCs to concentrate on commodity-specific risk mitigating measures takes into account of efforts on farmer awareness and effectiveness of feed ban Slide 70 70 1. Negligible risk without measures 1) risk assessment conducted and appropriate generic measures taken for the relevant period of time 2) Type B surveillance is in place Either 3) No BSE case / any BSE case are imported a) criteria are compiled with at least for 7 years and b) meat-and-bone meal or greaves from ruminants not been fed to ruminants for at least 8 years OR 4) Last indigenous case was more than 7 years ago same as 3) plus all cases and progeny are destroyed. Slide 71 71 2. Negligible risk with measures 1) risk assessment conducted and appropriate generic measures taken for the relevant time 2) Type A surveillance is in place Either 3) No BSE case / any BSE case are imported a) criteria are compiled with, but not for 7 years or b) meat-and-bone meal or greaves from ruminants not been fed to ruminants, but not for 8 years OR 4) Indigenous case has been reported same as 3) plus all cases and progeny are destroyed. Slide 72 72 3. Undetermined BSE risk cannot be demonstrated that it meets the requirements of another category. Slide 73 73 Current SRMs 1)From 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. Slide 74 74 Current SRMs 2) 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. Slide 75 75 Current SRMs 3) 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. Slide 76 76 Proposal for SRMs 1)From cattle of any age originating from a country defined in the 2 nd or 3 rd 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. Slide 77 77 Proposals for SRMs (Cont.) 2)From cattle over 30 months of age originating from a country defined in the 2 nd and 3 rd 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. Slide 78 78 BSE surveillance Slide 79 79 History of BSE surveillance Appendix for BSE surveillance / monitoring system adopted in 1998 Appendix updated in 2001,2002 and 2003 due to rapidly developing scientific information recommended minimum number of annual investigations (table1) unchanged concept of gradient of importance of samples from different subpopulations New text based on accumulated EU experience and statistical examination is proposed for adoption Slide 80 80 Current surveillance appendix Goals for surveillance to determine whether BSE is present or not if present, to monitor the epizootic for aiding control measures Subpopulations for surveillance In the order of decreasing likelihood 1 cattle displaying signs consistent with BSE 2 cattle displaying signs not necessarily indicative of BSE 3 cattle subject to normal slaughter Slide 81 81 Proposed surveillance goals Depending on BSE risk category, surveillance may have one or more goals: detecting BSE to a pre-determined design prevalence monitoring the evolution of BSE monitoring the effectiveness of a feed ban and/or other risk mitigation measures supporting a claimed BSE status gaining or regaining a higher BSE status Slide 82 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 2.3.13.2. Slide 83 83 Proposed surveillance subpopulations Clarifies recommended sampling sub-pops over 30 months displaying clinical signs consistent with BSE over 30 months non-ambulatory / sent for emergency slaughter over 30 months found dead on farm, during transport or at an abattoir over 36 months at routine slaughter First sub-pop should be focused on, but at least 3 sub-pops should be sampled. Slide 84 84 Proposed surveillance scheme Selects the points target, depends on adult cattle population depends on design prevalence chosen (maximum possible prevalence) 1 / 1,000,000 or 1 / 100,000, either with 95% confidence Slide 85 85 Proposed surveillance scheme Different Point Value allocated depending on the sampled subpopulation Urging greater sampling from riskier sub-pops Surveillance points remain valid for 7 years until reaching the target point Slide 86 86 Proposed gradient point values (extract from Table 2) Routine slaughter Fallen stock Casualty slaughter Clinical suspect Age > 2 years and < 4 years (young adult) 0.10.20.4260 Age > 4 years and < 7 years (middle adult) 0.20.91.6750 Age > 7 years and < 9 years (older adult) 0.10.40.7450 Slide 87 87 Proposed surveillance scheme Two types of surveillance, depending on the result of risk assessment If all risk factors negligible, less surveillance burden Details of maintenance surveillance need further investigation Scientists believe that not all cattle need to be examined to give useful results Slide 88 88 Perspective on vCJD Slide 89

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