1. OIE Regional Representative for Asia and the Pacific
International Standards for Control of TADs including FMD and HPAI from an OIE Perspective International Conference on Animal Health Development from Thai-Japan Technical Cooperation to International Cooperation Bangkok, Thailand, January 2007
T. Fujita
OIE Regional Representative for Asia and the Pacific
Tokyo, Japan

2. Contents OIE International trade of animals and animal products
Transboundary Animal Diseases
International Standards for Animal Health
FMD and HPAI in International Standards
Summary

3. What’s OIE?? World Organisation for Animal Health
an intergovernmental organisation
founded in 1924
by 28 countries
predates the UN
167 Member Countries
headquarters in Paris
5 Regional Representatives

4. Objectives and Functions of OIE
1. To ensure transparency in the global animal disease situation
*OIE Early Warning Systems (for listed diseases)
2. To collect, analyse and disseminate scientific veterinary information
*Information for preparedness, control and eradication of diseases
*Improve data quality at the field level (depending on Surveillance systems set up by National Veterinary Services)
3. To contribute expertise and encourage international solidarity in the control of animal diseases.
*Network of OIE Collaborating Centres and OIE Reference
Laboratories
*Provide technical support to Member Countries in animal disease
control and eradication operations.

5. Within its mandate under the WTO SPS Agreement, to safeguard world trade by publishing health standards for international trade in animals and animal products.
*OIE’s normative documents relating to rules that Member Countries can use
to protect themselves from the introduction of diseases and pathogens, without
setting up unjustified sanitary barriers.
- OIE Code
-OIE Manual
*OIE standards being recognized by WTO as reference international sanitary
rules
To improve the legal framework and resources of National Veterinary Services.
*Strengthening Veterinary Services and laboratories including infrastractures,
resources and capabilities.
* Veterinary Services as a Global Public Good and as a public investment priority.
* Evaluation of Veterinary Services to support further functions

6. 6. To provide a better guarantee of the safety of food of animal origin and to promote animal welfare through a science-based approach
(1) Food Safety
*OIE’s standard-setting activities focusing on eliminating potential
hazards (before the slaughter of animals or the primary processing
of their products that could be a source of risk for consumers)
　*greater synergy (OIE + Codex Alimentarius Commission)
(2) Animal Welfare
*OIE’s key role as the sole international reference organization for
animal health, and because of the close relationship between
animal health and animal welfare (Animal welfare Guidelines;
adopted in 2005)

7. International trade and Risks
Development of International trade
-Globalization: international travel and trade
　　-Risks always present by globalization and import of animals and their
products
-Affect communications, international trade and economies
Zero risk option; usually an unattainable goal in agricultural biosecurity
and food safety
Risk Analysis: technically no option to reduce it to the “zero-level„ but
possibility reducing risks to an insignificant level
International Standards: to harmonize sanitary measures for international trades by basing on international standards

8. Factors for Emerging/Transboundary Diseases
Globalization; Rapid increase of travelling & international trade (including unrestricted trade of animals; domestic and wild) borderless era
Expansion of human population, particularly into areas not previously inhabited
Environmental changes; Vectors – Arbovirus infection
Changes of farming systems; BSE, Nipah Virus Infection, etc.
Microbiological adaptation; Avian Influenza, etc

9. Socio-Economic Impacts of Transboundary/Emerging Diseases
Strong negative impacts on animal productivity and animal resources (deaths), and economic losses (esp. significant economic impacts to smallholders)
Threats to human health (in case of zoonoses)
Loss of trading opportunities in animals and animal products (because of animal health status)
Increased uncertainty about the stability of production management
Socio-economic confusion

10. International Standards and Scientific justifications
The SPS Agreement: encouraging WTO members to base
their sanitary measures on international standards,
guidelines and recommendations, where they exist OIE
If a country decides it needs a higher level of protection
than the Standard gives A health measure must be based on a risk analysis (scientific justifications).

11. Measures to be established under SPS Agreement
Sanitary Measures to be established by the member countries
based on “International Standards, Guidelines or
Recommendations”.
Animal health measures for protection of animal life and
health
Obligations of the member countries to pay attention to
those normative documents of Standards

12. OIE and WTO Agreement on SPS Measures
OIE identified by WTO as the International Standard Setting Organization for animal health and zoonosis
The OIE standards for the global harmonization of sanitary measures in trade
Conditions for international acceptance: transparency-consistency with the OIE standards (or scientific justification and risk analysis)
In case of dispute: settlement in accordance with WTO procedures or mediation by the OIE

13. International Standards of Animal Health
International Standards on disease prevention and control, diagnosis and surveillance for assessment of animal health status
　 -for good governance on animal health and worldwide
reference
-Importance of keeping quality of and supports to the
development of National Veterinary Services and to the legal
framework, policies and strategies of animal health
In the form of Standards, Guidelines and
Recommendations, by WTO-SPS Agreement
OIE’s International Standards, etc.
-OIE Code
-OIE Manual
-OIE Guidelines and Recommendations

14. OIE’s international standards

15. Roles of Standards on Disease Control and International Trade
WTO-SPS Agreement: to provide the legal framework for the application of OIE Standards, guidelines and recommendations for the international trade in animals and animal products.
Standard Setting Organizations;
OIE Animal Health and Zoonoses
Codex Alimentarius Food Safety Standards
IPPC Plant Health
OIE’s trade mediation procedure and participation in an advisory capacity during the discussion on trade disruption.
Harmonization as a Key word for the Agreement:
to encourage MCs to harmonize their sanitary measures, based on International Standards, etc.

16. Codes giving Guidelines and Recommendations for Animal Health Protection
The outcome of trade negotiations, is of equal importance to both the importing and exporting country.
IMPORTING COUNTRY: To ensure that the imported commodities 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

17. Concept of OIE Code
OIE Terrestrial Animal Health Code: in the form of Standards, guidelines and recommendations:
Aim: to assure the sanitary safety of international trade in animals and animal products
Achievement of the Code: through health measures by the veterinary authorities of importing and exporting countries, to avoid the transfer of agents pathogenic for animals and humans, while avoiding unjustifed sanitary barriers
Development of Standards: by OIE Terrestrial Animal Health Standards Commission
Adoption of the Code: by the OIE International Committee

18. Concept of OIE Code Value:
6. Scientific basis for recommendations
Value:
(a) the result of consensus among veterinary authorities of the OIE
Member Countries and
(b) a reference within the WTO Agreement on application of SPS
measures as an international standard for animal health and
zoonoses
Use: a reference for use by Veterinary Authorities, import/export
services, epidemiologist and all those involved in international
trade
9. Import risk analysis
-Assessment of risk factors
-Evaluation of Veterinary Services
-Zoning Concept
-Epidemiological surveillance
10. Health certification

19. Import Risk Analysis
National Sovereignty; to authorize the introduction of goods into its territory
Responsibility of governments; to carry out an assessment of the health risks (No supra-national authority to take over this task) in providing an importing
country with measures of assessing the risk associated with the 　importation of animals and their products
Adoption of the appropriate solution; No single method and need to consider necessary components to implement a risk analysis procedure (including geographical origin, type of commodity, probability containing a harmful pathogen etc.)
The analysis to be transparent;
– the exporting countries to be provided with clear reasons for the
imposition of import conditions or refusal to import
– essential for distinction between facts and the analyst’s value
judgements

20. Evaluation of Veterinary Services of the exporting country
The quality of Veterinary Services depends on a set of factors including fundamental principles of an ethical, organizational and technical nature
Credibility of certificates depending on the capacity for action of Veterinary Services
Evaluation only on a bilateral basis between the exporting countries and the importing countries for trade matters
Careful attention to the quality of the information

21. Concept of FMD Chapter (OIE Code)
Definition of FMD situation; FMD cases and infection
Criteria of FMD conditions;
*FMD free – non vaccination
*FMD free – with vaccination
*FMD infected
FMD free country or zone (Zoning concept)
OIE Official Recognition of the FMD Status of Member Countries
Veterinary Administrations’ Requirements for imports from various countries/zones with different FMD status
Issuance of an International Veterinary Certificate attesting various animal health conditions, by Veterinary Administrations of the exporting country

22. Criteria of FMD Status Conditions under OIE Code
FMD Free - Non Vac.
FMD Free – With Vac.
FMD infected
Country/zone
Country or Zone
①Record of disease reporting
②Send OIE declaration; No outbreak, No evidence of FMDV infection, No vaccination, for all during 12 months
③Surveillance in operation and regulatory measures for prevention and control in place
④No import of vaccinated animals since cessation of vaccination
① Record of disease reporting
②Send OIE declaration; No outbreak 2 years, No evidence of FMDV circulation 12 months
④Routine vaccination for prevention with vaccines complying with Manual (for Zones, vaccination with vaccines complying with Manual)
Country or Zone not fulfilling the requirements to qualify freedom

23. OIE Official Recognition of FMD status
OIE official FMD freedom
The International Committee in every May recognizes the publication of FMD free status of Member Countries.
Recovery of free status (waiting periods to gain the status)
No vaccination practiced status
Vaccination practiced status
3 months
6 months
12 months
18 months
After last case (without vaccination practice), stamping-out policy and sero-surveillance
After slaughter of all vaccinated animals, where applied stamping-out policy, emergency vaccination and sero-surveillance
After last case or last vaccination, where stamping-out policy, emergency vaccination NOT followed by slaughtering.
No stamping-out policy
After last case where stamping-out policy, emergency vaccination and sero-surveillance applied
After last case where stamping-out policy NOT applied, but emergency vaccination and sero-surveillance applied.

24. Concept of Country/Zoning
Definition of Zone; a clearly defined part of a country containing an animal sub-population with a distinct health status, with respect to a specific disease for which required surveillance, control and biosecurity measures have been applied for the purpose of international trade.
Concept;
Difficulty to establish/maintain a disease free status for an entire country (esp. national boundaries)
Sub-population with a different animal health status; separated by natural or artificial geographical barriers
Benefits to MCs
Trading partners; (a) recognize such the sub-population, (b) establish parameters and (c) gain agreement on the sanitary measures before disease outbreaks (☺An importing country; to be satisfied with animal health status in an exporting country)
Responsibility of Veterinary Services;
Clearly define the sub-population and explain animal health status for the zone, to an importing county

25. zones INFECTED ZONE FREE ZONE FREE ZONE major BUFFER road ZONE BUFFER
railway
river
FREE ZONE

26. Infected countries/zones
Requirements by importing Veterinary Administrations (Example;　Animals)
International veterinary certificates are required for presentation.
Free countries/zones
With vaccination;
Infected countries/zones
No vaccination
With vaccination
FMD susceptible
animals
Domestic ruminants and
pigs
Domestic ruminants and pigs
1. No clinical sign of
FMD on shipment
2. Kept in an FMD free
country/zone since
birth or >3 months
3. Not vaccinated (with
negative results for
anitibodies, case to
free countries/zones)
1. No clinical sign of FMD
country/zone since birth
or >3 months
3. Not vaccinated and with
antibody (case to free
countries/zones)
1. No clinical sign of FMD on shipment
2. Kept in establishment of origin since birth
or 30 days when stamping- out policy in
place, or otherwise for 3 months, and no
FMD case in 10 km radius of establishment
of origin for the above periods
3. Isolated in establishment 30 days, all animals
subject to tests (probang and serology)
with negative results and No FMD 10 km
radius of establishment for 30 days, or kept
in quarantine station for 30 days, the above
diagnostic tests with negative results, and
no FMD occurred 10 km for 30 days.

27. Requirements by importing Veterinary Administrations (Example; Fresh Meat)
International veterinary certificates are required for presentation.
Free countries/zones
Infected countries/zones
No Vaccination
With Vaccination
Fresh meat of FMD
susceptible animals
Fresh meat of cattle and
buffalo (excluding feet, head and
viscera)
Fresh meat of cattle and buffalo
(excluding feet, head and viscera)
(1) Kept in free
Country/zone since
birth or imported from
FMD free Country/zone,
etc.
(2) Animals having not
been vaccinated.
(3) Slaughtered in approved
abattoir and ante-mortem
& post-mortem inspection
Country/zone where
vaccination is practiced
since birth or imported
under such specified
Conditions as those for
animals from infected
countries/zones .
(2) Slaughtered in approved
& post-mortem inspection
Official control programme in place (including
compulsory systematic vaccination of cattle) for
animals in exporting country for >3 months prior
to slaughter.
(1)remained for >3 months prior to slaughter,
Regularly vaccinated in a part of the country where
official controls are in Operation, >twice
vaccination with last vaccination, etc.
(2) Deboned carcass: Major lymphatic
nodes removed, maturation at>2C,
>24hours following slaughter, Ph value<6.0

28. Experience in FMD Control
Experience learned from FMD cases in Europe
(1) Outbreaks in Great Britain, Ireland, France and the Netherlands in 2001
(2) Importance of movement control of animals and animal products
(3) Negative effect to economic losses & environment (Tourism, etc.)
(4) Stamping-out or control by vaccination; animal welfare,
(5) Internationally recognized rapid diagnostic methods
(6) Strengthening Veterinary Services for early detection
(7) Others
Experience learned from SEAFMD in Southeast Asia; Refer to the presentation by OIE SEAFMD RCU, Bangkok

29. HPAI Chapters in OIE Code
Definition of Notifiable Avian Influenza (NAI)
1. Infection of H5 or H7 subtypes,　or
2. Infection by any AI virus with an Intravenous Pathogenicity Index (IVPI)
>1.2 or as an alternative; at least 75% mortality
Two types of NAI;
*High Pathogenic NAI; HPNAI with IVPI >1.2 or >75% mortality
*Low Pathogenic NAI ; all influenza A viruses of H5 and H7 subtypes that are not HPNAI
Code deals with (a) occurrence of clinical signs caused by NAI virus +
(b) presence of infection with NAI virus in the absence of clinical signs, for
international trade

30. NAI status in OIE Code
NAI status determination of a country, a zone or a compartment :
based on the following criteria:
*Outcome of a Risk assessment identifying potential factors for NAI
occurrence and their historical perspective
*Notifiable in the whole country, On-going NAI awareness in place, All
suspected cases subjected to field and laboratory investigations
*Appropriate surveillance in place to demonstrate the presence of infection
in the absence of clinical signs in poutry
Concept of country/zone and *compartment:
*compartment: One or more establishments under a common biosecurity
management system containing an animal sub-population with a distinct health
status with respect to a specific disease(s) for which required surveillance, control
and biosecurity measures have been applied for the purpose of international trade.

31. Import conditions for International trade (Examples)
(Fresh meat)
International Veterinary Certificate
From NAI free country, zone or compartment; (A)
-Birds kept since they were hatched or for > the past 21 days and
-Birds slaughtered in an approved abattoir and subjected to ante-mortem and post-mortem inspections for NAI with favorable results
From HPNAI free country, zone or compartment; (B)
-Birds which have been kept in HPNAI free country/zone/compartment since they were hatched or for >21 days, and
(Meat products of poultry)
Regardless of the NAI status (of country, zone or compartment);
-Commodity derived from fresh meat which meet the requirements of (A) or (B), or
-Commodity processed to ensure the destruction of NAI virus (under study);
-Necessary precautions taken to avoid contact of the commodity with any source of NAI virus

32. OIE Manual
Manual of Diagnostic Tests and Vaccines for Terrestrial Animals
Purpose: To contribute to the international harmonization of methods for the surveillance and control of the most important animal diseases
Description of internationally agreed laboratory diagnostic tests and the production and control of biological products (principally vaccines) for veterinary use
Writing and reviewing: by experts of international standing and approving by the Member Countries
Linkage with the OIE Code: Diagnostic tests and Protocols referred to in the Code
Two different Parts:
(1) General: Introductory Chapters; Sampling methods, Good laboratory practices, Principles of veterinary vaccine production, etc.
(2) Each disease Chapter; Details of diagnostic tests, requirements for vaccines or diagnostic biologicals

33. Diagnostic tests and vaccine production of FMD (OIE Manual)
Diagnosis: by virus isolation or by the demonstration of FMD viral antigen or nucleic acid
Practically used for identification of the agent:
*ELISA (replacing CF)
*RT-PCR (nucleic acid recognition test)
Requirements for vaccines and diagnostic biologicals
*Inactivated virus vaccines (multivalent) available commercially
*Free from residual live virus (using in-vitro and/or in-vivo tests)
*Challenge tests: to establish PD50 (50% protective dose) value
*Vaccine production facilities in compliance with OIE requirements
*Diagnostic and reference reagents: available from the OIE Reference Laboratories for FMD (ex. Institute for Animal Health Pirbright Laboratory)

34. Diagnostic tests and vaccine production of AI (OIE Manual)
Isolation of the virus (embryonated eggs)
RT-PCR, AGID, HI test, ELISA
Requirements for vaccines and diagnostic biologicals:
-Historically, in most countries, vaccines to prevent HPNAI
banned or discouraged by government agencies.
-Inactivated oil-emulsion vaccines employed in some countries.
-Recombinat fowl poxvirus vaccine also used in some countries.
------
Capacity building of Veterinary Services by OIE under OIE/Japan Special Trust Fund (Diagnosis and Surveillance in participating countries and DLD’s cooperation for the Project)

35. Regional Mechanism for Control of TADs
GF-TADs: FAO/OIE Global Framework for progressive control of Transboundary Animal Diseases
Forum for Regional alliance and Partnerships, Capacity building and Support to the National project formulation
Targeted Diseases; in Southeast Asia—FMD, AI, CSF and in South Asia---- FMD, AI, PPR
OIE Tokyo – Permanent Secretariat for Regional GF-TADs Steering Committee

36. Summary Globalization and International trade
Transboudary/Emerging Diseases involving Risks and need of Risk Analysis
WTO-SPS Agreement
International Standards for Animal Health based on scientifically proven facts (OIE Code, Manual, etc.)
Provision of scientific information about diseases for preparedness and control more effectively
Transparent and timely notification of disease occurrences and preparedness
Veterinary Services as international public good; Capacity building of and Quality of Veterinary Services; Strengthen relevant infrastructures and sustainable (human and financial) resources, for Early detection and Rapid Response and strict implementation of legislation
Evaluation of Veterinary Services
A more global/regional approach to implement Strategies

37. Thank you for your attention!!