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Enhancing safe inter-
      regional livestock trade
                  Dubai, UAE
            13 – 16 June 2011



The OIE judgement of
         equivalence

                         Gideon Brückner
President: OIE Scientific Commission for Animal
                                      Diseases




                                                  1
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)
Factors favouring international
  spread of animal diseases




                                  4
Pathogen spread

•   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
What are the considerations in
international trade negotiations from an
animal health equivalence perspective?




                                           6
Key negotiating factor for the
 international trade in animals
 and animal products


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




                                                     7
International standard-setting
                      organisations




                    animal health and
food safety                                       plant health
                        zoonoses
  CODEX                                             IPPC
                           OIE




    Codex = Codex Alimentarius Commission (FAO/WHO)
    OIE =   World Organisation for Animal Health
    IPPC = International Plant Protection Convention (FAO)



                                                                 8
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
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)

                                             12
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
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


                                                          18
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   The OIE Code provides for the export of
      •   pH monitoring                    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/
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
                                                                             21
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

                                                                              22
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..

                                                                                   23
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

                                                                           24
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
                                                          25
Prerequisite considerations

• Categorisation of sanitary measures (contd)



  Specific technical                Infrastructure           Programme design
                                      Legislative base
    requirements                    Administrative systems    /implementation
     Use of secure facilities                 …               Documentation of systems
           Treatment                                                 Performance
         Specific tests                                            Decision criteria
   Procedures (e.g. pre-export                                      Lab. capability
          inspection)                                          Provision for certification
                                                                         Audit
                                                                     Enforcement


                            Categories not mutually exclusive
                                                                                             26
Principles for judgment of equivalence
• 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                                                              27
Steps in judgement of equivalence

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

                                                                          28
Conclusion - Equivalence

• 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)
                                                                      29
So what is equivalence all about?




  I take the high road and you take the low
                    road
World organisation for animal health
Organisation mondiale de la santé animale
Organizacion Mundial de Sanidad Animal



                                         12 rue de Prony
                                       75017 Paris, France
                     Tel: + 33 (0)1 44 15 18 88 – Fax: + 33 (0)1 42 67 09 87
                                        Email: oie@oie.int
                                   http://www.oie.int

                                                                               31

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The OIE judgement of equivalence

  • 1. Enhancing safe inter- regional livestock trade Dubai, UAE 13 – 16 June 2011 The OIE judgement of equivalence Gideon Brückner President: OIE Scientific Commission for Animal Diseases 1
  • 2. EQUIVALENCE - I take the high road and you take the low road
  • 3. 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)
  • 4. Factors favouring international spread of animal diseases 4
  • 5. Pathogen spread • 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
  • 6. What are the considerations in international trade negotiations from an animal health equivalence perspective? 6
  • 7. Key negotiating factor for the international trade in animals and animal products 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 7
  • 8. International standard-setting organisations animal health and food safety plant health zoonoses CODEX IPPC OIE Codex = Codex Alimentarius Commission (FAO/WHO) OIE = World Organisation for Animal Health IPPC = International Plant Protection Convention (FAO) 8
  • 9. WTO SPS Agreement (1995) • Legal framework for international trade • Recognises OIE as a reference organisation for international standards on animal and aquatic health
  • 10. 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
  • 11. 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
  • 12. 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) 12
  • 13. 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
  • 14. 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
  • 15. 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
  • 16. Import risk analysis An import risk analysis has 4 components • hazard identification • risk assessment • risk management • risk communication
  • 17. 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
  • 18. 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 18
  • 19. 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 The OIE Code provides for the export of • pH monitoring animal and animal products from infected countries provided the risk mitigation measures for the inactivation of virus are applied
  • 21. 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 21
  • 22. 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 22
  • 23. 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.. 23
  • 24. 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 24
  • 25. 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 25
  • 26. Prerequisite considerations • Categorisation of sanitary measures (contd) Specific technical Infrastructure Programme design Legislative base requirements Administrative systems /implementation Use of secure facilities … Documentation of systems Treatment Performance Specific tests Decision criteria Procedures (e.g. pre-export Lab. capability inspection) Provision for certification Audit Enforcement Categories not mutually exclusive 26
  • 27. Principles for judgment of equivalence • 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 27
  • 28. Steps in judgement of equivalence 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 28
  • 29. Conclusion - Equivalence • 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) 29
  • 30. So what is equivalence all about? I take the high road and you take the low road
  • 31. World organisation for animal health Organisation mondiale de la santé animale Organizacion Mundial de Sanidad Animal 12 rue de Prony 75017 Paris, France Tel: + 33 (0)1 44 15 18 88 – Fax: + 33 (0)1 42 67 09 87 Email: oie@oie.int http://www.oie.int 31