Seminar on the Dialogue and Common activities DG SANCO - DG ENLARGEMENT - TAIEX Seminar on the Dialogue and Common activities between OIE Member Countries of the European Union and other Member Countries of the OIE Regional Commission for Europe Serbia, Belgrade, 4-5 May 2006

The Codes and Manuals of the OIE Dr Gideon Brückner Head of the Scientific and Technical Department and Dr Francesco Berlingieri Deputy Head of the International Trade Departmant The Codes and Manuals of the OIE Comments (with copyright) / Commentaires (soumis au Copyright) :

Topics for discussion Codes and Manuals AI and BSE as examples Updating OIE standards New standards adopted in 2005

The international standards of the OIE

OIE international standards OIE develops and publishes health standards for trade in animals and animal products biological standards for diagnostic tests and vaccines adopted by OIE Member Countries during General Session each May by consensus no other pathway for adoption

OIE international standards to maximise harmonisation of the health aspects of international trade, Veterinary Administrations should base their health measures on OIE standards

The OIE Codes and Manuals Terrestrial Animal Health Code Aquatic Animal Health Code Manual of Diagnostic Tests and Vaccines for Terrestrial Animals Manual of Diagnostic Tests for Aquatic Animals

OIE Specialist Commissions Terrestrial Animal Health Standards Commission Terrestrial Animal Health Code Aquatic Animal Health Standards Commission Aquatic Animal Health Code Manual of Diagnostic Tests for Aquatic Animals Biological Standards Commissions Manual of Diagnostic Tests and Vaccines for Terrestrial Animals

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 (Terrestrial Code)

Principles in the Codes WTO obligations complied with scientific basis for recommendations assessment of risk factors evaluation of veterinary services / competent authorities zoning and compartmentalisation epidemiological surveillance credible health certification importing country assumed to be free of disease or with a control programme

The linkage between OIE Codes and Manuals and the SPS Agreement International standard setting organizations Article 3 talks about harmonization of measures. It recognizes that while each country can take its own measures, they are encouraged to take the standards from international organizations into consideration. This is more likely to result in harmonized approaches. These three are the only three standard-setting organizations recognized by the SPS, OIE for the purpose of animal health and zoonoses (diseases transmitted from animals to man); the Codex Alimentarius for purposes of public health and food safety; and the IPPC for plant health. Codes and Manuals must be used in context with Codex and SPS Agreement

Linkage of Codes, Manuals & SPS Agreement with national legislation and sanitary measures

What information is available from Codes and Manuals ? Criteria for disease freedom Guidelines for risk analysis Conditions for trade Risk mitigation to render products safe Surveillance for disease Guidelines 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

Summary: relationship between OIE Codes & SPS Agreement ALOP determined by the importing country Appropriate level of protection (ALOP) OIE Codes and Manuals Risk Analysis SPS Agreement OIE Code used as international standard for negotiations Exporting country’s legislation must facilitate ALOP & withstand risk analysis SPS Agreement determines “rules of the game” Trade negotiations – How?? Risk analysis done by importing country to match ALOP

Terrestrial Animal Health Code

Approach in the Terrestrial Code generic (horizontal) chapters general definitions obligations and ethics in international trade disease notification import risk analysis methodology evaluation of veterinary services import/export procedures

Approach in the Terrestrial Code specific chapters on diseases for live animals genetic material products of animal origin (meat, milk, hides / skins) covering diseases of mammals birds bees

Aim of OIE Codes and Manuals Terrestrial Animal Health Code: To assure the sanitary safety of the international trade in terrestrial animals (mammals, birds and bees). Aquatic Animal Health Code: To assure the sanitary safety of international trade in aquatic animals (fish, molluscs and crustaceans) and their products. Diagnostic Manuals: To provide standards for diagnostic tests and vaccines for the diseases listed in the OIE Terrestrial Animal Health Code and the Aquatic Animal Health Code

What is the purpose of the Codes? The Codes are not intended to be textbooks on animal or aquatic diseases The Codes are not textbooks on zoonosis The primary object is to set recommendations. standards and guidelines to PROTECT ANIMAL HEALTH and guard against zoonotic diseases in the trade of terrestrial and aquatic animals and their products The Codes are thus a reference manual for the international standards, guidelines and recommendations for the trade in terrestrial and aquatic animals and their products as specified in the SPS Agreement The standards for the trade in animal products to protect HUMAN HEALTH is described in the Codex Alimentarius but should be read in conjunction with the relevant requirements in the Codes

Approach in the Codes for the description of diseases Definitions: tend to overlook – also international standard and reference Ethics on certification – value judgment for both importing and exporting countries Appendices – give more detailed description – surveillance, disinfection, collection of samples, inactivation of pathogens, risk mitigation Model health certificates – based on contents of applicable chapters and minimum requirements Diseases: Science-based approach Incubation period – determining quarantine period and other risk mitigation procedures Criteria for recognizing a country, zone or establishment free from disease/infection – with or without vaccination (FMD) Movement and risk mitigation recommendations between countries/zones/establishments of different status Importing and exporting risk mitigation procedures for animals and animal products

Key principle for the international trade in animals and animal products The acceptance of the sanitary guarantees of the exporting country and how closely it satisfies the desired level of protection for human and animal health of the importing country

The Codes give guidelines and recommendations for ANIMAL HEALTH PROTECTION for both importing and exporting countries The outcome of trade negotiations, is of equal importance to both the importing and exporting country IMPORTING COUNTRY: To ensure that the imported commodity do not endanger the required level of protection for human and animal health EXPORTING COUNTRY: To focus on the shortcomings indicated by the IRA or negotiations and the ability to render the sanitary guarantees required by the importing country

What information will I need to negotiate trade and will I find it in the Codes and Manuals of the OIE? What sanitary guarantees could the importing country require? What risk mitigating measures would I be required to put in place? What tests need to be conducted to verify disease-free claims? What are the requirements to accept a disease free zone? When and why is an import risk assessment necessary? What will be an acceptable certification? What products will be acceptable for export? What products will not be acceptable for export and why not? How do I know that the standard of veterinary service delivery is acceptable? What are the alternatives if a country cannot declare a disease-free zone? If the disease is present in my country can I still export products irrespective of the disease status?

Approach in the Terrestrial Code appendices collection and processing of semen collection and processing of embryos/ova disease surveillance - general and disease specific inactivation of pathogens and vectors animal welfare antimicrobial resistance model veterinary certificates for live animals products of animal origin

Using the Codes and Manuals

Summary: Critical aspects in using the Codes and Manuals do not use the Codes as a textbook on diseases use it as an international standard to evaluate measures to protect animal and aquatic health in the trade of animals and animal products ensure that the application of the standards of the Codes for national health measures are in accordance with obligations under the SPS Agreement

Critical aspects in using the Codes and Manuals use the Guidelines for the Evaluation of Veterinary Services as an essential baseline for risk assessment use the Codes to establish baseline arguments to establish equivalence for trade negotiations use the Codes to establish cost-effective risk mitigation measures for trade use the Codes and Manuals to challenge scientific unjustifiable sanitary measures of importing countries

OIE Manuals

OIE biological standards OIE harmonises diagnostic testing and vaccination procedures through use of standard methods – OIE Manuals Reference Laboratories / Collaborating Centres International Reference Sera quality assurance guidelines supports laboratories in Member Countries  reliable results coordinated by BSC and AAHSC

OIE Manuals describe internationally agreed laboratory methods for disease diagnosis to enable the requirements for health certification in connection with trade to be met Terrestrial Manual also covers the production and control of biological products eg vaccines tests in the Manuals should be performed according to the methods described in order to avoid differences in interpretation of results

Disease Chapters – Terrestrial Manual diagnostic tests for OIE listed diseases and other diseases of importance to trade diagnostic tests ‘prescribed’ – those required by the Code for international trade – printed in blue not every listed disease has a ‘prescribed’ test ‘alternative’ – suitable for import/export after bilateral agreement not same level of confidence can provide valuable information for the diagnosis of disease nationally or regionally or for evaluating the risks of any proposed trade in animals or animal products

Avian influenza as an example

Code - AI status NAI free establishment NAI free country, zone or compartment HPNAI free country, zone or compartment

Code measures for AI when importing live poultry from an NAI free country or zone/compartment, Veterinary Administrations should require an international veterinary certificate attesting that the poultry: showed no clinical sign of NAI on day of shipment; were kept in an NAI free country, zone or compartment since hatched or for past 21 days; either have not been vaccinated against NAI, or have been vaccinated (and the details provided) required surveillance within past 21 days

Code measures for AI when importing from a country, zone or compartment free from HPNAI infection, … should require for fresh meat of poultry, an IVC attesting that the consignment comes from birds: which have been kept in an establishment since they were hatched or for the past 21 days in which there has been no evidence of NAI in the past 21 days; which have been slaughtered in an approved abattoir and have been subjected to AM and PM inspections for NAI with favourable results

Code measures for AI when importing from a country or zone/compartment regardless of its NAI status, … should require for meat products of poultry, an IVC attesting that: the commodity is derived from fresh meat, meat products and/or viscera which meet the requirements of Articles [dealing with those commodities]; or the commodity has been processed to ensure the destruction of the NAI virus, and the necessary precautions were taken after processing …

BSE as an example

Code - BSE status negligible BSE risk controlled BSE risk undetermined BSE risk

Code measures for BSE When importing from a country, zone or compartment posing a controlled BSE risk, … should require for cattle an IVC attesting that: cattle are identified by a permanent identification system enabling them to be traced back to the dam and herd of origin, and are not BSE exposed cattle in the case of a country, zone or compartment with an indigenous case, cattle selected for export were born after the date from which the feed ban had been effectively enforced

Code measures for BSE When importing from a … posing a controlled BSE risk … should require for fresh meat and meat products from cattle (other than those listed as safe) an IVC attesting that: AM and PM inspections on all cattle from which the fresh meat and meat products originate special stunning requirements were carried out the fresh meat and meat products do not contain "prohibited tissues"

Aquatic Animal Health Code

Approach in the Aquatic Code generic (horizontal) chapters obligations and ethics in international trade disease notification import risk analysis methodology import/export procedures disinfection specific chapters for diseases of finfish molluscs Crustaceans model certificates

Evolution of OIE standards harmonisation between Terrestrial and Aquatic Codes and with Codex and IPPC standards to extent possible regular updating of chapters based on latest scientific information re-emphasis from disease status to risk-based measures for commodities

Updating OIE standards

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 working groups and ad hoc groups for specialist tasks eg animal welfare, BSE, epidemiology, avian influenza, TB

Updating OIE standards 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 as per Member Countries eg IDF experts may participate in meetings Commission reports on OIE Web site

Updating OIE standards Commission proposal circulated for comment to 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 to Commission for further work may be adopted as OIE international standard opportunity for all to be involved in standards development

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

New standards adopted in 2005

Revised terrestrial texts zoning and compartmentalisation criteria for listing diseases general guidelines for animal health surveillance FMD and its surveillance appendix bluetongue bovine tuberculosis classical swine fever avian influenza Rift Valley fever antimicrobial resistance

New terrestrial texts BSE (3 category approach) BSE surveillance (new approach) classical swine fever surveillance avian influenza surveillance 4 animal welfare standards

New and revised aquatic texts notification criteria and epidemiological information infection with Marteilia refringens white spot disease epizootic haematopoietic necrosis general recommendations on disinfection

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