1. 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

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

3. 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 International Standards are not because of SPS.
But Implication has changed.

4. 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

5. 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

6. 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

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

8. 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

9. 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)

10. 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

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

12. 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.)

13. Contents of the Terrestrial Code
Part 3 – Issue Specific Appendices
Section Diagnostics tests for international trade
Section Collection / processing of semen
Section Collection / processing of embryos & ova Section Biosecurity in establishments
Section Identification and traceability of live animals
Section Inactivation of pathogens and vectors
Section Animal welfare
Section Disease surveillance systems
Section Antimicrobial resistance

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

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

16. 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

17. 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

18. 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....

19. 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

20. 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

21. 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

22. OIE Manuals

23. 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

24. 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.

25. 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

26. 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

27. Developing/Updating OIE Standards
Codes & Manuals

28. 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

29. 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

30. 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

31. 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

32. Using the OIE Standards

33. 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

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

35. 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?

36. 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?

37. 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

38. 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)
Fax: 33 (0)