The OIE Standards and International trade Tomoko Ishibashi International Trade Dept OIE Paris, 17 May 2005

Regional Representations INTERNATIONAL COMMITTEE Administrative Commission Director General Specialist Commissions Terrestrial Code, Aquatic Code, Biological Standards, Scientific Regional Commissions Africa, Americas, Europe, Asia- Far East and Oceania, Middle East Central Bureau Collaborating Centres Reference Laboratories Ad hoc Groups Working Groups Administrative and Financial Department Animal Health Information Department International Trade Department Scientific and Technical Department Regional Activities Department Publications Department Regional Representations

OIE Specialist Commissions Terrestrial Animal Health Standards Commission Biological Standards Commission Scientific Commission for Animal Diseases Aquatic Animal Health Standards Commission using working groups and ad hoc groups for specialist tasks eg BSE, AI etc

WTO SPS Agreement Sanitary and Phytosanitary Agreement Key provisions came into force in 1995 Key provisions Scientific justification for measures Harmonisation (use international standards) Risk assessment Equivalence

OIE’s 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) 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.

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 Although 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.

OIE international standards OIE develops and publishes health standards for trade in animals and animal products biological standards covering diagnostic techniques and vaccine production through Specialist Commissions adopted by OIE Member Countries during General Session each May by consensus no other pathway

OIE International Standards Health standards Terrestrial Animal Health Code Aquatic Animal Health Code Biological standards Manual of Diagnostic Tests and Vaccines for Terrestrial Animals Manual of Diagnostic Tests for Aquatic Animals

Updating OIE standards issue / problem identified by Delegate, OIE Commission, industry, scientist, individual new scientific information eg from research or disease outbreak new disease - emerging new approaches eg vaccination addressed by appropriate Commission as new or revised standard using appropriate expert advice on disease or procedure

Updating OIE standards proposal circulated for comment by Member Countries, experts, organisations Commission may revise proposal on basis of comments received discussed by Delegates at General Session may be discussed only and returned for further work may be adopted as OIE international standard opportunity for all to be involved in standards development

Updating OIE standards COMMITTEE, COMMISSIONS, DELEGATES PROBLEM Specialist Commissions Updating OIE standards Review Advice of experts or other Specialist Commissions Draft text 1 2 Comments DELEGATES COMMITTEE OIE INTERNATIONAL STANDARD Adoption

Health measures in the Codes recommend actions 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 take into account the nature of the commodity and the animal health status of the exporting country

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

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

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

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

What is ‘zone’ or ‘compartment’? 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 …

types of zones INFECTED ZONE FREE ZONE FREE ZONE major BUFFER road river railway FREE ZONE

Compartment Equipment BREEDING FLOCK FEED SUPPLY Feed Equipment Birds Feed Feed Equipment GROWING FLOCK Equipment Birds Birds Equipment Birds SLAUGHTER HOUSE GROWING FLOCK Equipment

Current activities of Terrestrial Animal Health Standards Commission

Proposals for adoption in May 2005 Revised texts General definitions (Ch.1.1.1.) Zoning and compartmentalisation (Ch.1.3.5.) General Guidelines for Animal Health Surveillance (App. 3.8.1.) Criteria for listing diseases (Chapter 2.1.1.) Foot and mouth disease (Ch. 2.2.10.) and its Surveillance Appendix (App. 3.8.7.) Bluetongue (Ch.2.2.13.) Bovine tuberculosis (Ch. 2.3.3.)

Proposals for adoption in May 2005 Revised texts (cont.) TSE agents inactivation procedure (App. 3.6.3.) Classical Swine Fever (Ch. 2.6.7.) Avian Influenza (Ch. 2.7.12.) Categorisation of diseases by IETS (App. 3.3.5) Bovine and small ruminants semen (Ch. 3.3.1) Rift Valley fever (CH.2.2.14.) Antimicrobial resistance (section 3.9.)

Proposals for adoption in May 2005 New text BSE (Ch.2.3.13.) BSE Surveillance Appendix (App.3.8.4.) Classical swine fever Surveillance Appendix Avian Influenza Surveillance Appendix 4 guidelines for Animal Welfare

Updating OIE Standards - using AI as an example

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, WHO’s request to address AI’s 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

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

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.

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

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

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)

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

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.

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

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)

Eggs for human consumption From CZC with NAI free status country/zone/compartment are free from NAI From CZC with HPNAI free status, country/zone/compartment (CZC) are free from HPNAI from establishments with no evidence of NAI in the past 21 days

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

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