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The OIE judgement of

equivalence

Gideon BrücknerPresident: OIE Scientific Commission for Animal

Diseases

Enhancing safe inter-

regional livestock trade

Dubai, UAE

13 – 16 June 2011

EQUIVALENCE - I take the high road and you take the low road

Some determinants of the international meat trade1

• Difference in the resource base of countries

• Preference for meat types and cuts

• Extent of barriers to trade

• Industry structure

• Fluctuations in domestic demands and preferences

• Future growth determined by:– Further liberalization of protectionist

barriers

– Eradication of animal diseases

– Increased sensitivity on food safety

– Economic development

– Population growth

1 J. Dyke & K. Nelson (USDA, 2007)

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Factors favouring international

spread of animal diseases

• Pathogens are transported

around the world faster than the

average incubation time of most

animal diseases

• There is no place in the world

from which we are remote and

no one from whom we are

disconnected

Pathogen spread

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What are the considerations in

international trade negotiations from an

animal health equivalence perspective?

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The acceptance of the sanitary guarantees of the

exporting country and how closely it satisfies the

desired or appropriate level of protection for

human and animal health and zoonosis of the

importing country

Key negotiating factor for the

international trade in animals

and animal products

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International standard-setting

organisations

food safetyCODEX

plant healthIPPC

animal health and

zoonoses

OIE

Codex = Codex Alimentarius Commission (FAO/WHO)

OIE = World Organisation for Animal Health

IPPC = International Plant Protection Convention (FAO)

WTO SPS Agreement (1995)

• Legal framework for

international trade

• Recognises OIE as a

reference

organisation for

international

standards on animal

and aquatic health

Terrestrial Animal Health Code of the OIE

• To facilitate trade in animals and products while avoiding unjustified trade barriers

• To support countries in the control of animal diseases and prevention of zoonoses

Using the Codes and Manuals

use the OIE Scientific and Technical Review and other sources to obtain background information

use the Codes to establish health requirements for trade

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

Code is not a textbook on animal diseases

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How to use the OIE Code for an IRA on Rift

Valley Fever (Chapter 8.11)

Consider the disease description

in Code (infective period, species,

epidemiology)

Consider safe commodities (hides

and skins, wool & fibre)

Consider requirements for free

zones, country

Consider risk mitigations for trade

(free country, infected country,

different commodities)

Consider the requirements of the

OIE Manual for vaccines,

diagnostic tests

Consider the horizontal chapters

(Vet services, IRA, certification)

Obligations of importing countries

• Consider sanitary status

exporting country

• Choose an appropriate level

of protection (ALOP)

• Consider the sanitary

guarantees offered by the

exporting country

• Conduct an import risk

analysis when indicated

Obligations of

exporting

countries

• Provide sanitary

information as requested

by the importing country

• Inspection, certification

by official veterinarian of

importing country

• Transparency in

providing sanitary

information

Acknowledgement of the principle of

equivalence

• Acceptance by importing country that

sanitary measures applied in exporting

country are appropriate (but may differ)

• SPS Agreement (article 4) and OIE

Code (chapter 5.3) encourage the

recognition of equivalence

Import risk analysis

An import risk analysis has 4

components

• hazard identification

• risk assessment

• risk management

• risk communication

Risk mitigation provisions in the OIE Terrrestrial

Animal Health Code for the import of animals and

animal products

Approach in OIE Code animal disease chapters:

• Consist of 3 sections within each chapter

• Description of disease – case definition

• Criteria for being recognised as free – country,

zone, compartment

• Risk mitigation measures for trade - animals and their

products – for import from both free and infected countries

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Risk mitigation measures for trade - animals and

their products – for import from both free and infected

countries

• Risk mitigation measures based on risk

assessment

• Code in itself do provide for the mimimum

import requirements based on risk

• If higher sanitary standards or ALOP required

– then do additional import risk assesment

Facilitation for trade in beef from FMD infected countries

• Pre-abattoir risk mitigation –surveillance, quality of veterinary service delivery

• Pre-slaughter risk mitigation at abattoir – ante-mortem inspection, verification of records

• Post-slaughter risk mitigation

• Detailed inspection

• Removal of visible lymph nodes, risk material

• Manual deboning

• Chilling for 24 hours at pH <6

• pH monitoringThe OIE Code provides for the export of animal and animal products from infected countries provided the risk mitigation measures for the inactivation of virus are applied

http://www.oie.int/en/international-standard-setting/terrestrial-code/access-online/

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EQUIVALENCE

(Art 5.3.2 Terr. Code)

Context:

•Different animal health and production systems among countries

•Provision of equivalent animal and human health protection

Concerns for trade:

•Manage risk appropriately

- different options possible to achieve same level of protection

Principles and step-wise process developed to facilitate judgement

of equivalence

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EQUIVALENCE

Benefits of applying equivalence:

• minimise costs by tailoring animal health measures

• maximise animal health outcome for a given level of resource input

• facilitate trade by achieving the required health protection through less

trade restrictive sanitary measures

• decrease reliance on costly commodity testing and isolation procedures

OIE Code chapters recommend alternative measures for many

diseases/pathogenic agents

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General considerations

Risk management in the importing country (post import) will rely in part on

judgements about:

- animal health and production systems

- effectiveness of sanitary procedures in the exporting country

• Possible differences :

- infrastructure - approaches to pests/diseases present

- policies/operating procedures - border security

- laboratory systems - internal movement controls..

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Prerequisite considerations

Application of risk assessment

=> examination of :

- the effect of a measure on a particular step

- relative effect of alternative measure(s) on same/related step

=> need to define :

- purpose of the measure

- LOP achieved by the measure

- contribution of the measure to achieve the ALOP

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Prerequisite considerations

• Categorisation of sanitary measures

=> sanitary measures can be applied :

- alone or in combination

- consecutively or concurrently

=> include :

- test requirements

- processing requirements

- inspection or certification procedures

- quarantine confinements

-sampling procedures

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InfrastructureLegislative base

Administrative systems

…

Programme design

/implementationDocumentation of systems

Performance

Decision criteria

Lab. capability

Provision for certification

Audit

Enforcement

Specific technical

requirementsUse of secure facilities

Treatment

Specific tests

Procedures (e.g. pre-export

inspection)

Prerequisite considerations

• Categorisation of sanitary measures (contd)

Categories not mutually exclusive

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• Importing country (IC) should:

- set its ALOP

- describe reason for each sanitary measure

- enter into consultation with export. country if so requested

- limit data collection to that necessary

- evaluate submission: timely, objectively, consistently, transparently

- consider request for technical assistance if developing country

• Exporting country (EC) should:

- demonstrate equivalence of proposed alternative sanitary measure

- submission to import country should help to facilitate judgement of

equivalence

- enable evaluation of procedures/systems by importing country

…Using OIE Standards

Principles for judgment of equivalence

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Recommendations:

EC request IC reason for sanitary measure in terms of ALOP + identify

alternative measures to propose

IC answers

EC demonstrates equivalence and answer any technical concern from IC

IC judge, taking into account impact of biological variability and

uncertainty, expected effect of alternative. measure(s) on relevant hazards

IC notifies the EC of its judgement and reasons within reasonable period

of time : recognition/further information/rejection

Steps in judgement of equivalence

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• Integral to SPS Agreement

• Guidelines on procedures / technical

measures provided in OIE Codes/Manuals

• Use of risk assessment

• Possible use of OIE dispute mediation process to resolve

differences of opinion

• Measures accepted as part of a system of infrastructure, policies

and procedures

• Using different ways (roads) to arrive at the same goal

(destination)

Conclusion - Equivalence

I take the high road and you take the lowroad

So what is equivalence all about?

31

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Email: oie@oie.int

http://www.oie.int

World organisation for animal health

Organisation mondiale de la santé animale

Organizacion Mundial de Sanidad Animal