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World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

Apr 01, 2015

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Page 1: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

World Organisation for Animal Health

Page 2: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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The OIE and international trade

Tomoko IshibashiInternational Trade Department

OIE

WTO/SPS National Workshop Taipei March 2005

Page 3: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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Role and structure of the OIE

Page 4: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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The OIE

World Organisation for Animal Health an intergovernmental organisation

operating expenses are paid by member country contributions

founded in 1924 – predates the UN 167 Member Countries headquarters in Paris Five regional representations (Tokyo,

Buenos Aires, Beyrouth, Bamako, Sofia)

Page 5: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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The OIE’s objectives• ensure transparency in global animal health

situation

• collect, analyse and disseminate scientific veterinary information on control methods of animal diseases

• contribute expertise and encourage coordinated approach to disease outbreaks

• improve veterinary services

• within its WTO mandate, safeguard world trade through animal health standards

• animal welfare and animal production food safety

Page 6: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

INTERNATIONAL COMMITTEEAdministrative Commission

Specialist Commissions Terrestrial Code, Aquatic Code,

Biological Standards,Scientific

Specialist Commissions Terrestrial Code, Aquatic Code,

Biological Standards,Scientific

Regional CommissionsAfrica, Americas, Europe, Asia- Far

East and Oceania, Middle East

Regional CommissionsAfrica, Americas, Europe, Asia- Far

East and Oceania, Middle East

Central BureauCentral Bureau

Director General

Regional ActivitiesDepartment

Regional ActivitiesDepartment

Administrativeand FinancialDepartment

Administrativeand FinancialDepartment

Animal HealthInformationDepartment

Animal HealthInformationDepartment

PublicationsDepartment

PublicationsDepartment

Scientific andTechnical

Department

Scientific andTechnical

Department

CollaboratingCentres

ReferenceLaboratories

CollaboratingCentres

ReferenceLaboratories

Ad hoc Groups

Working Groups

Ad hoc Groups

Working Groups

Regional RepresentationsRegional Representations

International TradeDepartment

International TradeDepartment

Page 7: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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OIE expertise

Page 8: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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Working with relevant experts

OIE does not work only with vets.

For BSE and other zoonoses, key is close cooperation with other experts, eg from WHO

Page 9: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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OIE Reference Laboratories

157 Reference Laboratories in 30 countries cover 80 diseases and topics

centres of expertise and standardisation to other laboratories and to OIE store and distribute reagents develop / validate new diagnostic tests coordinate scientific / technical studies provide scientific and technical training prepare and distribute proficiency tests

Page 10: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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Taiwan’s experts

Reference laboratory for White spot disease Dr Grace Lo

Department & Institute of Zoology, National Taiwan University

Ad hoc Group on new chapters for crustacean diseases for the Aquatic Code and Manual Dr Grace Lo

Ad hoc Group on humane killing of animals for disease controle purposes Dr De-shien Jong National Taiwan University

Page 11: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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International trade context

Page 12: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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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)

Page 13: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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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

Page 14: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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OIE trade standards

Page 15: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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OIE 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

Page 16: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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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

Page 17: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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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

Page 18: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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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

Page 19: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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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

Page 20: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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Zoning, regionalisation and compartmentalisation

Page 21: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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History of ZRC standard

Appeared as Chapter on “Zoning and Regionalisation” when Section of “Import Risk Analysis” was introduced in 1993

Current standard since 2000 MCs’ need for clear understanding of concepts

of zone and compartment WTO’s request to present concrete steps to

apply zoning and compartmentalisation Extended revision prepared by TAHSC for

adoption in May 2005

Page 22: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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Why need zone/compartment?

Proposed new text clarifies the need “Given the difficulty of establishing and maintaining a disease free status for an entire country, especially for diseases the entry of which is difficult to control through measures at national boundaries, there may be benefits to Member Countries in establishing and maintaining a subpop with a different animal health status within national boundaries….”

Page 23: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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OIE definitions in Ch.1.1.1

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 …

Page 24: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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zoning/compartmentalisation in Ch. 1.3.5

‘zoning’ and ‘regionalisation’ have the same meaning proposed new text uses ‘zoning’

zoning applies to an animal sub-population defined on a geographical basis

compartmentalisation applies to an animal sub-population defined by management systems related to biosecurity

Page 25: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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zoning/compartmentalisation in Ch. 1.3.5

Proposed new text clarifies the purposes zoning and compartmentalisation are

procedures implemented by a country to define sub-populations of different animal health status within its territory for the purpose of disease control or international trade

Page 26: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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application of the concepts

the extent of a zone is established on the basis of natural, artificial or legal boundaries

the requirements for a compartment are established on the basis of management practices relating to biosecurity

by the Veterinary Administration

Page 27: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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FREE ZONE

FREE ZONE

BUFFERZONE

railway

major road

river

types of zones

BUFFER

ZONE

INFECTED ZONE

Page 28: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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BREEDINGFLOCK

BREEDINGFLOCK

FEEDSUPPLY

GROWINGFLOCK

SLAUGHTERHOUSE

GROWINGFLOCK

Equipment

Birds

Equipm

ent

Birds

Equipment

Equ

ipm

ent

Fee

dEquipment

Compartment

Equipment

Birds

Feed

Feed

Equipment

Birds

Page 29: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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application of the concepts

there are Code recommendations for zones and compartments for diseases for which the concepts are appropriate

the recommendations depend on epidemiology of the disease environmental factors appropriate and applicable biosecurity

measures necessary surveillance

Page 30: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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epidemiology

how does the disease spread ? by live animals / humans ? by meat / eggs / semen ? by farm or veterinary equipment ? by wind ? by biting insects ?

what species does it affect ? clinical signs ?

Page 31: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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environmental factors

temperature / humidity natural barriers

ocean / major river mountain range

artificial barriers state / county boundary road / rail system

Page 32: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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biosecurity measures

management regulations re biosecurity dedicated equipment staff showering in-and-out animals housed vs free range imposed movement controls

Page 33: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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surveillance

necessary surveillance for presence / absence of pathogen prevalence of disease seasonal factors eg biting insects strains of virus eg FMD intermediate hosts eg tick-borne diseases

Page 34: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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application of the concepts

a Veterinary Administration must document the measures taken to identify the animal sub-population recognise its distinct health status maintain its distinct health status

dossier will be as detailed as situation requires

Page 35: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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animal sub-population

dairy cattle herds in 4 adjacent counties bison and buffalo in Alberta wild pig population in a forest in Germany poultry flocks managed by Tysons Inc

as a unit wild waterfowl in a water catchment area

during the breeding season beef cattle over 3 years of age in the UK

Page 36: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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health status

infected free with vaccination free without vaccination seasonally free unknown

Page 37: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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application of the concepts

if an exporting country wants to define a zone or compartment within its territory for an OIE-listed disease, it needs to implement the recommendations stipulated in the Code for setting up and maintaining such a zone or compartment or equivalent measures

Page 38: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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application of the concepts

an importing country should recognise the existence of this zone or compartment, subject to the application of the appropriate recommendations in the Code with regard to the importation, or transit

through its territory, of commodities from that zone or compartment

Page 39: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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uses

in disease control / eradication campaign progressive zoning/compartmentalisation

allows stepwise approach allows concentration of resources where

greatest chance of success in trade zone

to gain / maintain market access for certain commodities

where whole country freedom not possible / practicable

Page 40: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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Summary of proposed modification

Clarifies the uses/benefits

Suggests sequence of steps to be taken in defining a zone/compartment Importance of accurate animal health

information Negotiation between exporting country and

importing country indispensable

Page 41: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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OIE AI Chapter

Page 42: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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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

Page 43: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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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

Page 44: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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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.

Page 45: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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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

Page 46: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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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

Page 47: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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Definition of «NAI free establishment»

Poultry show no evidence of NAI infection based on proposed surveillance appendix random testing of birds to show absence of

NAIV infection using OIE approved tests frequency of testing based on risk of infection

and at a maximum interval of 21 days Introduced to enable safe trade of

commodities that may transmit LPNAI, from country, zone or compartment not known free from LPNAI hatching eggs, poultry semen, day-old poultry

Page 48: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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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)

Page 49: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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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

Page 50: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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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.

Page 51: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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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

Page 52: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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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)

Page 53: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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Live birds other than poultry regardless of NAI status

international veterinary certificate attesting that the birds: showed no clinical signs of NAI on the day of

shipment

isolated since hatching or past 21 days with no indicative clinical sign during that period

tested negative for infection with NAI virus for poultry 7 to 14 days prior to shipment

Page 54: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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Day-old poultry from NAI free status

Kept in free country/zone/compartment since hatch

Derived from parent flocks kept in NAI free country/zone/compartment for 21 days prior to and at time of egg collection

Page 55: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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Day-old poultry from HPNAI free status

HPNAI free country/zone/compartment

Parent flocks in NAI free establishments for 21 days prior to and at time of egg collection

Page 56: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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Eggs for human consumption

From NAI free status country/zone/compartment are free from NAI

From HPNAI free status, country/zone/compartment (CZC) are free

from HPNAI from establishments with no evidence of NAI

in the past 21 days

Page 57: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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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 slaughtered in an approved abattoir and subjected

to ante- and post-mortem inspections for NAI with favourable results

Page 58: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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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

Page 59: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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OIE BSE Chapter

Page 60: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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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

Page 61: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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Current BSE Chapter 5-category system

Free Provisionally free Minimal risk Moderate risk High risk

Based on risk assessment, surveillance, number of cases (imported/indigenous), feed ban,etc

even for High risk category, fresh meat can be traded under certain conditions

absolute ban only for MBM

Page 62: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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Current safe commodities When authorising import or transit of the

following commodities, Veterinary Administrations 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 (excl. from head) ; gelatin and collagen prepared exclusively from

hides and skins (excl. from head); protein-free tallow (max of insoluble impurities of 0.15% in weight)

and derivatives; dicalcium phosphate (with no trace of protein and fat);

Page 63: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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Proposals for addition of list

due to luck of evidence of transmission

deboned skeletal muscle meat (excluding mechanically separated meat)

blood and blood by-products

Due to luck of evidence of transmission

Page 64: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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For other Commodities

When authorising import or transit of other commodities listed in this chapter, Veterinary Administrations should require the conditions prescribed in this Chapter relevant to the BSE risk status of the cattle population of the exporting country and zone....

Page 65: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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New approach

Current 5-category system causes problems due to complexity of chapter - MCs wanted simpler approach

ad hoc group discussed simplification while retaining chapter’s scientific base

simplified 3-category system is proposed for adoption in May 2005

Page 66: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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Factors for assessing the BSE risk

Factors relating to the introduction of TSE agent into a cattle population

presence/absence of animal TSE agents meat-and-bone meal from the indigenous ruminant imported meat-and-bone meal imported live animals imported animal feed and feed ingredients imported products of ruminant origin for human imported products of ruminant origin for cattle

Surveillance / epidemiological investigations should be taken into account

Page 67: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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Factors for assessing the BSE risk

Factors relating to the exposure of the BSE agent to cattle…: recycling and amplification of the BSE agent

through consumption by cattle of MBM use of ruminant carcasses etc, rendering

process and method of animal feed manufacture

feeding or not of ruminants with MBM from ruminants, incl. measures to prevent cross-contamination

level of surveillance for BSE and the results

Page 68: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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Proposed 3-category system

1. Negligible BSE risk without commodity-specific risk mitigation measures

2. Negligible BSE risk with commodity-specific risk mitigation measures

3. Undetermined BSE risk

Page 69: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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3 category approach

Risk based, not prevalence based based on assessment of risk factors and

whether appropriate measures have been taken to address them

finding one case does not necessarily change trade measures

allow MCs to concentrate on commodity-specific risk mitigating measures

takes into account of efforts on farmer awareness and effectiveness of feed ban

Page 70: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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1. Negligible risk without measures

1) risk assessment conducted and appropriate generic measures taken for the relevant period of time

2) Type B surveillance is in place

Either3) No BSE case / any BSE case are imported

a) criteria are compiled with at least for 7 years andb) meat-and-bone meal or greaves from ruminants

not been fed to ruminants for at least 8 yearsOR4) Last indigenous case was more than 7 years ago

same as 3) plus all cases and progeny are destroyed.

Page 71: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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2. Negligible risk with measures

1) risk assessment conducted and appropriate generic measures taken for the relevant time

2) Type A surveillance is in place

Either3) No BSE case / any BSE case are imported

a) criteria are compiled with, but not for 7 years or b) meat-and-bone meal or greaves from ruminants not been fed to ruminants, but not for 8 years

OR4) Indigenous case has been reported

same as 3) plus all cases and progeny are destroyed.

Page 72: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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3. Undetermined BSE risk

cannot be demonstrated that it meets the requirements of another category.

Page 73: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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Current SRMs

1) From cattle of any age originating from a country with a moderate or a high BSE risk, the following commodities should not be traded for the preparation of food, feed, fertilisers, cosmetics, pharmaceuticals… :

tonsils and intestine, and protein products derived thereof.

Page 74: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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Current SRMs

2) From cattle originating from a country with a moderate or a high BSE risk, that were at the time of slaughter over 12 months of age, the following commodities should not be traded for the preparation of food, feed, fertilisers, cosmetics, pharmaceuticals…:

brains, eyes, spinal cord, skull and vertebral column and protein products derived thereof.

Page 75: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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Current SRMs

3) From cattle, originating from a country with a minimal BSE risk, that were at the time of slaughter over 30 months of age, the following commodities should not be traded for the preparation of food, feed, fertilisers, cosmetics, pharmaceuticals….:

brains, eyes and spinal cord, skull, vertebral column and derived protein products.

Page 76: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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Proposal for SRMs

1) From cattle of any age originating from a country defined in the 2nd or 3rd category, the following commodities should not be traded for the preparation of food, feed, fertilisers, cosmetics, pharmaceuticals…:

tonsils and distal ileum, and protein products derived thereof.

Page 77: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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Proposals for SRMs

(Cont.)2) From cattle over 30 months of age

originating from a country defined in the 2nd and 3rd category, the following commodities should not be traded for the preparation of food, feed, fertilisers, cosmetics, pharmaceuticals…. :

brains, eyes, spinal cord, skull, vertebral column and derived protein products.

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BSE surveillance

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History of BSE surveillance

Appendix for BSE surveillance / monitoring system adopted in 1998

Appendix updated in 2001,2002 and 2003 due to rapidly developing scientific information recommended minimum number of annual

investigations (table1) unchanged concept of gradient of importance of samples

from different subpopulations New text based on accumulated EU experience

and statistical examination is proposed for adoption

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Current surveillance appendix

Goals for surveillance to determine whether BSE is present or not if present, to monitor the epizootic for aiding

control measures Subpopulations for surveillance

In the order of decreasing likelihood1 cattle displaying signs consistent with BSE2 cattle displaying signs not necessarily

indicative of BSE3 cattle subject to normal slaughter

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Proposed surveillance “goals”

Depending on BSE risk category, surveillance may have one or more goals: detecting BSE to a pre-determined design

prevalence monitoring the evolution of BSE monitoring the effectiveness of a feed ban and/or

other risk mitigation measures supporting a claimed BSE status gaining or regaining a higher BSE status

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Proposed surveillance “role”

BSE status cannot be determined only on the basis of a surveillance programme but should be determined in accordance with all the factors listed in Article 2.3.13.2.

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Proposed surveillance subpopulations

Clarifies recommended sampling sub-pops over 30 months displaying clinical signs

consistent with BSE over 30 months non-ambulatory / sent for

emergency slaughter over 30 months found dead on farm, during

transport or at an abattoir over 36 months at routine slaughter

First sub-pop should be focused on, but at least 3 sub-pops should be sampled.

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Proposed surveillance scheme

Selects the “points target”, depends on adult cattle population depends on design prevalence

chosen (maximum possible prevalence) 1 / 1,000,000 or 1 / 100,000, either with 95%

confidence

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Proposed surveillance scheme

Different “Point Value” allocated depending on the sampled subpopulation Urging greater sampling from riskier sub-pops

Surveillance points remain valid for 7 years until reaching the target point

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Proposed gradient point values(extract from Table 2)

Routine slaughter

Fallen stock

Casualty slaughter

Clinical suspect

Age > 2 years and < 4 years (young adult)

0.1 0.2 0.4 260

Age > 4 years and < 7 years (middle adult)

0.2 0.9 1.6 750

Age > 7 years and < 9 years (older adult)

0.1 0.4 0.7 450

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Proposed surveillance scheme

Two types of surveillance, depending on the result of risk assessment If all risk factors negligible, less surveillance

burden Details of “maintenance surveillance” need

further investigation Scientists believe that not all cattle need to

be examined to give useful results

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Perspective on vCJD

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Perspective on vCJD

In the past, many models predicted likely pathways of vCJD epidemic

However, now it appears to be minor compared to other public health concerns

Article published by the Royal Society makes a “best estimate" of 70 future deaths on top of 150 to date

Page 90: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

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Current activities of Terrestrial Animal Health Standard Commission

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OIE international standards

OIE develops and publishes health standards for trade in animals and animal products and biological standards

through elected Specialist Commissions of 4-6 members each

adopted by OIE Member Countries during General Session each May by consensus no other pathway

OIE standards help in controlling animal diseases and zoonoses world wide

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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 animal welfare, BSE, epidemiology, avian influenza, TB

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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

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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

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UpdatingUpdatingOIE OIE

standardsstandards

PROBLEMPROBLEM

SpecialistCommissions

ReviewReview

Advice of experts or other Advice of experts or other Specialist CommissionsSpecialist Commissions

Draft textDraft text

COMMITTEE

DELEGATESDELEGATES

AdoptionAdoption

COMMITTEE,COMMITTEE,COMMISSIONS,COMMISSIONS,

DELEGATESDELEGATES

12

OIE INTERNATIONALOIE INTERNATIONALSTANDARDSTANDARD

Comments

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Proposals for adoption in May 2005

Revised texts General definitions (Ch.1.1.1.) Zoning and compartmentalisation (Ch.1.3.5.) General Guidelines for Animal Health

Surveillance (App. 3.8.1.) Criteria for listing diseases (Chapter 2.1.1.) Foot and mouth disease (Ch. 2.2.10.) and its

Surveillance Appendix (App. 3.8.7.) Bluetongue (Ch.2.2.13.) Bovine tuberculosis (Ch. 2.3.3.)

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Proposals for adoption in May 2005

Revised texts (cont.) TSE agents inactivation procedure (App.

3.6.3.) Classical Swine Fever (Ch. 2.6.7.) Avian Influenza (Ch. 2.7.12.) Categorisation of diseases by IETS (App.

3.3.5) Bovine and small ruminants semen (Ch.

3.3.1) Rift Valley fever (CH.2.2.14.) Antimicrobial resistance (section 3.9.)

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Proposals for adoption in May 2005

New text BSE (Ch.2.3.13.) BSE Surveillance Appendix (App.3.8.4.) Classical swine fever Surveillance Appendix Avian Influenza Surveillance Appendix 4 guidelines for Animal Welfare

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Mid-term tasks Work not for adoption in May, but needing

feedback from MCs includes; Carcass disposal Animal production food safety

Works towards developing/revising codes are; Animal identification and traceability Paratuberculosis Chapters on dourine and surra Small hive beetle of honey bees Rinderpest / Peste des petits ruminants African horse sickness

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OIE dispute settlement process

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Dispute settlement

if requested by parties, OIE may act as ‘mediator’ to help resolve differences on a particular technical issue technical-based process, rather than legal voluntary outcomes not binding, unless agreed at start

OIE experts discuss issues and make recommendations

can be alternative to WTO process or precursor to it

Page 102: World Organisation for Animal Health. 2 The OIE and international trade Tomoko Ishibashi International Trade Department OIE WTO/SPS National Workshop.

World organisation for animal healthWorld organisation for animal health

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Tel: 33 (0)1 44 15 18 88 Fax: 33 (0)1 42 67 09 87

Email: [email protected]://www.oie.int

Thank you for your attention