The OIE’s Codes and Manuals David Wilson Director International Trade OIE The OIE’s Codes and Manuals Comments (with copyright) / Commentaires (soumis au Copyright) : OIE SPS Workshop Bangkok 2005

Topics for discussion Codes Manuals updating OIE standards AI and BSE as examples Manuals updating OIE standards new standards adopted in 2005

OIE’s international standards

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

Purpose of the Codes ? the Codes are not textbooks on terrestrial or aquatic animal diseases, nor on zoonoses they are reference manuals for international standards for safe trade in terrestrial and aquatic animals and their products equivalent standards for the protection of human health are described in the Codex Alimentarius these should be read in conjunction with relevant requirements in the Codes

Codes recommends 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

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

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

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

Approach in the Terrestrial Code in 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

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

Avian influenza as an example

Code - AI status NAI status of a country, zone or compartment can be determined … outcome of a risk assessment, identifying all potential factors for NAI occurrence and their historic perspective when NAI is notifiable in the whole country, an on-going NAI awareness programme is in place, and all notified suspect occurrences of NAI are subjected to … investigations; appropriate surveillance is in place to demonstrate the presence of infection …

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 regardless of the NAI status of the country of origin, Veterinary Administrations should require, for live birds other than poultry, an IVC attesting that the birds: showed no clinical sign of NAI on the day of shipment; were kept in isolation approved by the Veterinary Services since they were hatched or for the 21 days prior to shipment and showed no clinical sign of NAI during the isolation period; were subjected to a diagnostic test 7 to 14 days prior to shipment to demonstrate freedom from NAI.

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

BSE status of a cattle pop the outcome of a risk assessment identifying all potential factors for BSE occurrence and their historic perspective: release assessment - likelihood that a TSE agent has been introduced into the cattle pop surveillance and other epidemiological investigations exposure assessment if the release assessment identifies a risk factor

BSE status of a cattle pop on-going awareness programme for vets, farmers compulsory notification and investigation of all cattle showing clinical signs consistent with BSE

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

Aquatic Code recommends health measures to be used by competent authorities to establish health regulations for the safe importation of aquatic animals and their products while avoiding unjustified trade restrictions principles as per Terrestrial 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 importance of disease surveillance and timely notification interactive publications

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

Terrestrial Manual provides general information for veterinary officials on each disease, with tests and vaccines introduction to the subjects should be regarded as background information rather than standards provides detailed techniques for laboratory technicians standards

Introductory Chapters – Terrestrial Manual sampling methods good laboratory practices, quality control and quality assurance principles of validation of diagnostic assays tests for sterility and freedom from contamination of biological materials human safety in the veterinary laboratory principles of veterinary vaccine production

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

Disease Chapters – Terrestrial Manual Part A - overview of the tests and vaccines available Part B - details of diagnostic test techniques intended for laboratory workers Part C - requirements for vaccines or diagnostic biologicals, where appropriate

Introductory Chapters – Aquatic Manual sampling methods quality management in veterinary diagnostic laboratories principles of validation of diagnostic assays for aquatic animal diseases

Disease Chapters – Aquatic Manual for listed diseases, clinical signs in fish are not pathognomonic and infections may be subclinical only dependable approach for diagnosis lies in the specific identification of the pathogen diagnostic methods are all direct due to the insufficient development of serological methodologies, detection of antibodies to fish pathogens has not been accepted for assessing the health status of fish populations for trade for mollusc and crustacean diseases diagnostic methods must be direct because these animals do not produce antibodies

Using the Codes and Manuals

Using the Codes and Manuals use the Codes to establish health requirements for trade use the OIE Scientific and Technical Review and other sources to obtain background information 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

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

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 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

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

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 bovine and small ruminant semen 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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