The OIE International Standards Dr Tomoko Ishibashi OIE Scientific and Technical Department The OIE International Standards Codes and Manuals Beijing, China, 26 – 27 February 2008

Topics for discussion Link between OIE Standards and SPS Agreement Brief outlay of OIE Codes and Manuals Updating OIE Standards Using the Codes & Manuals

OIE’s objectives ensure transparency in global animal health situation collect, analyse and disseminate scientific veterinary information provide expertise and encourage international solidarity in animal disease control within its WTO/SPS mandate, safeguard world trade by publishing animal health standards improve national Veterinary Services animal welfare and animal production food safety Do not misunderstand! OIE first Code was published in 1967. International Standards are not because of SPS. But Implication has changed.

WTO SPS Agreement Sanitary and Phytosanitary Agreement came into force in 1995 SPS Agreement Art 2 :Basic right “Members have the right to take sanitary and phytosanitary measures necessary for the protection of human, animal or plant life or health, provided that such measures are not inconsistent with the provisions of this Agreement” Already explained by Prof Zessin on Monday

International harmonization Encourage the use of international standards Presumption of conformity Right to be more strict, but the SPS Agreement requires scientific justification or based on a risk assessment. scientific evidence processes and production methods inspection, sampling and testing methods pest or disease prevalence ecological and environmental conditions quarantine and other treatment

International Standard Setting Organisations OIE’s WTO mandate WTO SPS Agreement recognises OIE as a reference organisation for international standards (3 sisters) on animal health and zoonosis International Standard Setting Organisations

Relevance of OIE standards to SPS trade concerns Food safety Animal health and 27% zoonoses 40% Other concerns Plant health 4% 29%

OIE International Standards Trade standards (Codes) Biological standards (Manuals) Terrestrial Animal Health Code – mammals, birds and bees Aquatic Animal Health Code – fish, molluscs and crustaceans Manual of Diagnostic Tests and Vaccines for Terrestrial Animals Comments (with copyright) / Commentaires (soumis au Copyright) : Manual of Diagnostic Tests for Aquatic Animals

What are 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 now expanding into animal welfare and food safety (Terrestrial Code)

Principles in the Codes Scientific basis for recommendations WTO obligations complied with Credible health certification Importing country assumed to be free of disease or with a control programme

Contents of the Terrestrial Code Part 1 - General provisions Section 1.1 - General Definitions and Notification of Epidemiological Information Section 1.2 - Obligations and Ethics in International Trade Section 1.3 - Risk Analysis Section 1.4 - Import/Export Procedures Section 1.5 - Risk Analysis for Biologicals for Veterinary Use

Contents of the Terrestrial Code Part 2 – Disease specific Chapters, e.g. FMD BSE avian influenza, etc. within each chapter, articles on description of pathogen / disease determining status of a country, zone or compartment ‘safe’ commodities irrespective of status (if possible) recommendations for ‘unsafe’ commodities Total 84 in 2007 Code (Bovine, sheep and goat, swine, equine bees etc.)

Contents of the Terrestrial Code Part 3 – Issue Specific Appendices Section 3.1 - Diagnostics tests for international trade Section 3.2 - Collection / processing of semen Section 3.3 - Collection / processing of embryos & ova Section 3.4 - Biosecurity in establishments Section 3.5 - Identification and traceability of live animals Section 3.6 - Inactivation of pathogens and vectors Section 3.7 - Animal welfare Section 3.8 - Disease surveillance systems Section 3.9 - Antimicrobial resistance

Contents of the Terrestrial Code Part 4 - Model international veterinary certificates Section 4.1 - Live animals Section 4.2 - Products of animal origin

OIE Code: BSE as an example -Disease specific Chapter and Surveillance guidelines-

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 Simplified chapter adopted in May 2005

Article 1: “safe commodities” When authorising import of the following commodities, Veterinary Authorities 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; gelatin and collagen prepared from hides and skins; protein-free tallow and derivatives; dicalcium phosphate; deboned skeletal muscle meat blood and blood by-products

For other Commodities Articles 6 to 17 When authorising import of other commodities listed in this chapter, Veterinary Authorities should require the conditions prescribed in this Chapter relevant to the BSE risk status of the cattle population of the exporting country and zone....

Criteria for BSE risk status Article 2 Outcome of a risk assessment Release assessment Exposure assessment On-going awareness programme Compulsory notification and investigation Examination carried out in accordance with the Manual

BSE risk status Article 3: Negligible BSE risk Article 4: Controlled BSE risk Article 5: Undetermined BSE risk Based on these criteria and surveillance outcomes

History of BSE surveillance Appendix for BSE surveillance / monitoring system adopted in 1998 Updated due to rapidly developing scientific information Full revision based on accumulated EU experience and statistical examination adopted in May 2005

OIE Manuals

OIE Biological Standards OIE harmonises diagnostic testing and procedures for the production of vaccines through the use of Standard methods – OIE Manuals Reference Laboratories/Collaborating Centres International Reference Sera Quality assurance guidelines OIE supports laboratories in Members  reliable results

Biological Standards in the Manuals Describe internationally agreed laboratory methods: for disease diagnosis, for production and control of biological products, e.g. vaccines (Terrestrial Manual) To avoid differences in interpretation of results, tests should be performed according to the Manuals The OIE Manual is a set of recommendation to be used by laboratories for disease diagnostic and for production of biologicals.

Disease chapters - Terrestrial Manual General information and recommended techniques for laboratory technicians, including diagnostic tests and vaccines Diagnostic tests ‘prescribed’ – those required by the Terrestrial Code for international trade – printed in blue not every listed disease has a ‘prescribed’ test ‘alternative’ – suitable for import/export after bilateral agreement

BSE Chapter of the Manual Adopted in 1992 together with the Terrestrial Code chapter on BSE Heavy revision adopted in 2007 (for 2008 edition) Introduction (current knowledge of BSE) Diagnostic Techniques Sample preparation Histological examination Detection of disease-specific PrP (Immunohistochemical methods, Western blot, Rapid tests) No prescribed test/No alternative test for BSE yet No vaccines/diagnostic biologicals

Developing/Updating OIE Standards Codes & Manuals

4 OIE Specialist Commissions Terrestrial Animal Health Standards Commission “Code Commission” Scientific Commission for Animal Diseases “Scientific Commission” Aquatic Animal Health Standards Commission "Aquatic Animals Commission “ Comments (with copyright) / Commentaires (soumis au Copyright) : Insérer quelques informations sur chacune des commissions Biological Standards Commission "Laboratories Commission

Updating OIE standards issue identified by Delegate, Commission, industry, scientist, etc. new scientific information eg from research or disease outbreak new disease - emerging new approaches eg vaccination addressed by appropriate Commission using working groups and ad hoc groups for specialist tasks eg animal welfare, BSE, epidemiology, avian influenza, TB

Developing / updating of international standards COMMITTEE, COMMISSIONS, DELEGATES PROBLEM Developing / updating of international standards Specialist Commissions Review Advice of experts or other Specialist Commissions Committee: Delegates of 172 Members Draft text 1 2 Comments DELEGATES COMMITTEE OIE INTERNATIONAL STANDARD Adoption

Trend in OIE standards setting increasingly, expert advice is outside government and OIE utilises all sources individual / expert group from industry / academia / government other OIE Commission or Reference Lab transitional period for transparency NGOs with OIE agreement are consulted with as per Member Countries, e.g. IDF Commission reports on OIE Web site http://www.oie.int/tahsc/eng/en_reports.htm

Using the OIE Standards

What information is available from the Code, Manuals and OIE? Criteria for disease freedom Guidelines for risk analysis Conditions for trade Risk mitigation to render products safe Surveillance for disease Procedures for carcass disposal Standards for diagnostic tests Foot & mouth disease Standards for vaccine production Model export certificates Guidelines for humane killing of animals Standards for zoning & compartementalisation OIE Scientific and Technical Review

Where in Code & Manual do I find information for FMD? Conditions for trade & risk mitigation measures Ch 2.2.10 (Articles 9 to 31) and App 3.6.2 of Code Surveillance for FMD and criteria for zoning and disease freedom Ch 2.2.10 (Articles 1 to 8) and App 3.8.7 of Code Standards for diagnostic tests and vaccine production Ch 2.1.1 of Manual Guidelines for killing of animals for disease control purposes App 3.7.6 of Code Guidelines for carcass disposal App 3.6.6 of Code Inactivation of FMD virus in products App 3.6.2 of Code Model health certificates for export App 4.2.1, 4.2.2 of Code Pathogeneses of FMD Not in the Codes or Manuals – in textbooks

A simplified pathway to use the OIE Codes & Manuals Code Disease Chapter – the 1st Article and description of disease in Manual Code Chapter – Articles 2 – 3, Appendix for surveillance for that disease, requirements for diagnostic tests in manual The last set of Articles in Code Chapter on disease, specific guidelines for surveillance (if exist) or general guidelines for surveillance in Code Appendix To know how a disease/infection is defined? To know what are the criteria, procedures and steps for disease freedom? To know what the requirements are to trade a specific commodity and sanitary guarantees are required for a specific disease?

A simplified pathway to use the OIE Codes & Manuals Manual for Diagnostic tests and Vaccines If vaccination is acceptable for the trade in live animals or products, what are the acceptable vaccine standards? To know what diagnostic tests must be conducted for acceptable certification?

How to use the Codes and Manuals Use the Codes to establish the sanitary requirements for trade Use the OIE Scientific and Technical Review to obtain background information on experiences in the practical application of standards Use the OIE Manuals to ensure the application of correct diagnostic tests and vaccines Use textbooks on diseases to understand the scientific justification for OIE standards, guidelines and recommendations

World organisation for animal health Thank you for your attention World organisation for animal health 12 rue de Prony 75017 Paris, France Tel: 33 (0)1 44 15 18 88 Fax: 33 (0)1 42 67 09 87 Email: oie@oie.int http://www.oie.int