Post on 11-May-2015
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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?
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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