1. The OIE Standards and International trade
Tomoko Ishibashi
International Trade Dept
OIE
Paris, 17 May 2005

2. Regional Representations
INTERNATIONAL COMMITTEE
Administrative Commission
Director General
Specialist Commissions Terrestrial Code, Aquatic Code, Biological Standards, Scientific
Regional Commissions
Africa, Americas, Europe, Asia- Far East and Oceania, Middle East
Central Bureau
Collaborating Centres
Reference Laboratories
Ad hoc Groups
Working Groups
Administrative
and Financial
Department
Animal Health
Information
Department
International Trade
Department
Scientific and
Technical
Department
Regional Activities
Department
Publications
Department
Regional Representations

3. OIE Specialist Commissions
Terrestrial Animal Health Standards Commission
Biological Standards Commission
Scientific Commission for Animal Diseases
Aquatic Animal Health Standards Commission
using working groups and ad hoc groups for specialist tasks eg BSE, AI etc

4. WTO SPS Agreement Sanitary and Phytosanitary Agreement Key provisions
came into force in 1995
Key provisions
Scientific justification for measures
Harmonisation (use international standards)
Risk assessment
Equivalence

5. OIE’s WTO mandate
WTO SPS Agreement recognises OIE as a reference organisation for international standards (3 sisters)
for food safety - the Codex Alimentarius Commission
for animal health and zoonoses - the OIE
for plant health - the International Plant Protection Convention (IPPC)
You have already heard this from previous sections of this seminar.
The SPS Agreement which was adopted as a part of WTO agreement gave OIE new task.
To avoid trade conflicts between countries over sanitary regulations, the SPS was born and the OIE came to be in charge of setting international standards for animal health and zoonoses.

6. Why standards necessary
international public good
enhance safety of international trade
fewer disease outbreaks
encourage harmonisation of national legislation and control measures
fewer unjustified restrictions on trade
promote fairer trade
benefits to developing countries especially
Although the OIE’s standards had been existing since 1968, the objective was purely to prevent disease spreading and give guideance to Member Country to that end.

7. OIE international standards
OIE develops and publishes
health standards for trade in animals and animal products
biological standards covering diagnostic techniques and vaccine production
through Specialist Commissions
adopted by OIE Member Countries during General Session each May by consensus
no other pathway

8. OIE International Standards
Health standards
Terrestrial Animal Health Code
Aquatic Animal Health Code
Biological standards
Manual of Diagnostic Tests and Vaccines for Terrestrial Animals
Manual of Diagnostic Tests for Aquatic Animals

9. 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 appropriate expert advice on disease or procedure

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

11. 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

12. Health measures 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
take into account the nature of the commodity and the animal health status of the exporting country

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

14. Approach in the Code generic (horizontal) chapters general definitions
obligations and ethics in international trade
import risk analysis methodology
monitoring and surveillance systems
quality and evaluation of veterinary services
import/export procedures

15. Approach in the Code specific chapters on OIE listed diseases, eg
FMD
BSE AI
within each chapter, articles on
description of pathogen / disease
determining status of a country or zone
‘safe’ commodities irrespective of status (if possible)
recommendations for ‘unsafe’ commodities

16. Approach in the Code Appendices collection and processing of semen
collection and processing of embryos/ova
inactivation of pathogens and vectors
transport of animals
diseases surveillance systems
Model veterinary certificates for
live animals
products of animal origin

17. What is ‘zone’ or ‘compartment’?
Zone/Region
a clearly defined part of a country containing an animal subpopulation with a distinct health status with respect to a specific disease…
Compartment
one or more establishments (premises in which animals are kept) under a common biosecurity management system containing an animal subpopulation with a distinct health status …

18. types of zones INFECTED ZONE FREE ZONE FREE ZONE major BUFFER road
river
railway
FREE ZONE

19. Compartment Equipment BREEDING FLOCK FEED SUPPLY Feed Equipment
Birds
Feed
Feed
Equipment
GROWING
FLOCK
Equipment
Birds
Birds
Equipment
Birds
SLAUGHTER
HOUSE
GROWING
FLOCK
Equipment

20. Current activities of Terrestrial Animal Health Standards Commission

21. Proposals for adoption in May 2005
Revised texts
General definitions (Ch )
Zoning and compartmentalisation (Ch )
General Guidelines for Animal Health Surveillance (App )
Criteria for listing diseases (Chapter )
Foot and mouth disease (Ch ) and its Surveillance Appendix (App )
Bluetongue (Ch )
Bovine tuberculosis (Ch )

22. Proposals for adoption in May 2005
Revised texts (cont.)
TSE agents inactivation procedure (App )
Classical Swine Fever (Ch )
Avian Influenza (Ch )
Categorisation of diseases by IETS (App )
Bovine and small ruminants semen (Ch )
Rift Valley fever (CH )
Antimicrobial resistance (section 3.9.)

23. Proposals for adoption in May 2005
New text
BSE (Ch )
BSE Surveillance Appendix (App )
Classical swine fever Surveillance Appendix
Avian Influenza Surveillance Appendix
4 guidelines for Animal Welfare

24. Updating OIE Standards - using AI as an example

25. History of OIE AI standard
Appeared as Fowl Plague in the first edition 1968
simple Chapter- using mostly NCD standard
Current standard since 1997
significant outbreaks since late 1990s
MCs’ demand to update, WHO’s request to address AI’s potential as a zoonoses
AHG meetings since 2002 to draft new Chapter
2004 GS placed new text as “under study” as MCs concerned at trade implications of notifying LPNAI
Further consideration by AHG and TAHSC towards adoption in May 2005

26. New proposed AI Chapter
Incubation period: 21 days
NAI is defined as an infection of poultry caused either by any influenza A virus of the H5 or H7 subtypes or by any AI virus with an IVPI greater than 1.2 or as an alternative causing at least 75% mortality in 4 to 8 week old chickens when injected intravenously.
NAI can be divided into HPNAI and LPNAI

27. HPNAI and LPNAI
HPNAI viruses have an IVPI in 6 weeks old chickens greater than 1.2 or as an alternative, cause at least 75% mortality in 4 to 8 weeks old chickens infected intravenously. H5 and H7 not qualifying under these conditions should be sequenced to determine the presence of multiple basic amino acids at the cleavage site of the haemagglutinin molecule
LPNAI are all influenza A viruses of H5 and H7 subtype that are not HPNAI.

28. Definition of « Poultry »
Poultry is defined as ‘all birds reared or kept in captivity for the production of meat or eggs for consumption, for the production of other commercial products, for restocking supplies of game or for breeding these categories of birds

29. Definition of « infection »
HPNAI or LPNAI virus has been isolated and identified as such
viral antigen or viral RNA specific to HPNAI or LPNAI has been identified
antibodies to H5 or H7 subtype of NAI virus that are not a consequence of vaccination have been detected in poultry

30. Determination of the NAI status of a country/zone/compartment
outcome of a risk assessment identifying all potential factors for NAI occurrence and their historic perspective
NAI is a notifiable disease in the whole country
appropriate surveillance is in place for demonstration of infection in the absence of clinical signs (see proposed OIE guidelines)

31. NAI free country, zone or compartment
NAI infection has not been present for the past 12 months
In case of recovery of status, if a stamping out policy for HPNAI is applied the recovery period shall be 3 months after the killing of the last infected poultry followed by disinfection+ proof of surveillance during the 3 months
In case of LPNAI, slaughter for human consumption (conditions apply) is also allowed followed by disinfection and surveillance during the 3 months

32. HPNAI free country or zone or compartment
HPNAI infection has not been present for the past 12 months. LPNAI status may be unknown, but any NAI detected must be proved NOT to be HPNAI.
Recovery of status regained 3 months after stamping out followed by disinfection and surveillance during the 3 months.

33. Recommendations depending on commodity groups
Live Poultry (other than day-old)
should come from NAI free country, zone or compartment (CZC)
Day-old poultry, hatching eggs, semen
should come from NAI free CZC / NAI free establishment in HPNAI free CZC
Eggs for human consumption, fresh meat
should come from NAI free CZC / establishment with no evidence of NAI in the past 21 days in HPNAI free CZC
Others (egg products, meat products, feathers etc.)
If not coming from above mentioned commodity with higher status, should be processed to ensure the destruction of NAI virus

34. Live poultry (other than day-old) from NAI free status
international veterinary certificate attesting that the poultry:
showed no clinical signs of NAI on the day of shipment
kept in an NAI free country, zone or compartment for at least 21 days (surveillance carried out in establishment within the past 21 days)

35. Eggs for human consumption
From CZC with NAI free status
country/zone/compartment are free from NAI
From CZC with HPNAI free status,
country/zone/compartment (CZC) are free from HPNAI
from establishments with no evidence of NAI in the past 21 days

36. Fresh meat From CZC with NAI free status
kept in CZC free from NAI since hatched/for the past 21 days
slaughtered in an approved abattoir and subjected to ante- and post-mortem inspections for NAI with favourable results
From CZC with HPNAI free status
kept in establishments with no evidence of NAI in the past 21 days

37. Meat products of poultry
Regardless of health status
Derived from fresh meat that satisfies requirements for fresh meat (NAI free or HPNAI free CZC), OR
processed to ensure destruction of virus and necessary precautions have been taken to avoid contact of the commodity with any source of NAI virus