The OIE judgement of equivalence

Similar documents
OIE Standards (Terrestrial and Aquatic Codes and Manuals) and the Role of the Specialist Commissions

Global capacity for sustainable surveillance of emerging zoonoses

ANIMAL HEALTH STANDARDS AND INTERNATIONAL TRADE

OIE SUB-REGIONAL TRAINING SEMINAR ON VETERINARY LEGISLATION FOR OIE FOCAL POINTS

GLOSSARY. Annex Text deleted.

OIE Terrestrial and Aquatic Animal Health Code Workshop for OIE National Focal Points on Wildlife (2nd Cycle) Colombo, Sri Lanka, April 2012

The OIE s Codes, Manuals and associated standards

OIE International standards related to control, inspection and approval procedures

The OIE Terrestrial and Aquatic Animal Health Codes

Harmonizing International Standards. The SPS Agreement and the Three Sisters

The OIE: General working principles, operating modalities and standard setting process AU-IBAR Abidjan, Cote d Ivoire April 2013

OIE Aquatic Animal Health Code and Manual of Diagnostic Tests for Aquatic Animals

OIE Standards for Animal feed and food safety: terrestrial and aquatic animals

OIE Terrestrial & Aquatic Animal Health Code

Building Competence and Confidence. The OIE PVS Pathway

Office International des Épizooties World Organisation for Animal Health created in 1924 in Paris

OIE Standards for: Animal identification and traceability Antimicrobials

OIE Aquatic Animal Health Code

Collection of quantitative data on the use of antimicrobial agents including the establishment of an OIE database

Dr. Karin Schwabenbauer, President. EP Animal Welfare Intergroup, Strasbourg 5th July 2012

and suitability aspects of food control. CAC and the OIE have Food safety is an issue of increasing concern world wide and

Overview of OIE Standards: A step-by-step user s guide for safe trade and disease prevention and control

World Organisation for Animal Health (OIE) Sub-Regional Representation for Southern Africa

in food safety Jean-Luc ANGOT CVO France

OIE Aquatic Animal Health Code

The PVS Tool. Part 4. Introduction to the concept of Fundamental Components and Critical Competencies

OIE Strategy for Veterinary Products and Terms of Reference for the OIE National Focal Points

OIE Tool for the Evaluation of Performance of Veterinary Services (OIE PVS Tool)

GOOD GOVERNANCE OF VETERINARY SERVICES AND THE OIE PVS PATHWAY

Recommendations of the 3 rd OIE Global Conference on Animal Welfare

INTERNATIONAL AND NATIONAL COORDINATION IN STANDARD SETTING

International Harmonisation in the Field of Pharmacovigilance from an OIE perspective

OIE PVS Pathway including Veterinary Education

Dr Karim Ben Jebara Head of Department, Copyright Animal ( OIE 2013) Health Information Department, OIE

Support for OIE Member Countries OIE PVS / Gap Analysis, Reference Laboratories and twinning programmes

OIE global strategy for rabies control, including regional vaccine banks

OIE Activities for the Containment of Antimicrobial Resistance. Dr Elisabeth Erlacher-Vindel, Deputy Head of the Scientific and Technical Department

Terrestrial and Aquatic Manuals and mechanism of standard adoption

RABIES SURVEILLANCE. Ronello Abila Sub-Regional Representative for South-East Asia

Recognition of Export Controls and Certification Systems for Animals and Animal Products. Guidance for Competent Authorities of Exporting Countries

Responsibilities of OIE National Focal Points for Animal Production Food Safety

Terrestrial and Aquatic Manuals and mechanism of standard adoption

OIE capacity-building activities

of Conferences of OIE Regional Commissions organised since 1 June 2008

Third Global Conference on Animal Welfare Kuala Lumpur, Malaysia. Bernard Vallat Director General

21st Conference of the OIE Regional Commission for Europe. Avila (Spain), 28 September 1 October 2004

Dr Bernard Vallat OIE Director General

OIE Digital Action Plan

The Integration of WTO Agreements into National Legislation: Case of the SPS Agreement

OIE international standards on Rabies: Movement of dogs,, vaccination and vaccines

The OIE-PVS: a tool for good Governance of Veterinary Services

Science Based Standards In A Changing World Canberra, Australia November 12 14, 2014

THE INTERNATIONAL STANDARDS OF THE OIE

Role and responsibilities of the veterinarian in the aquatic sector The OIE perspective

OIE Standards and guidelines on biosecurity and compartmentalisation

Ways to escape. EPP Congress 30 May 1 June, 2012, Vilnius,Lithuania

OIE Reference Centres : General Overview

Part A: Sanitary and international standards considerations. Dr Gideon Brückner. January Page 1 of 43

Collection of quantitative data on the use of antimicrobial agents including the establishment of an OIE database

OIE standards : procedures, model certificates

Overview of the OIE PVS Pathway

Investing in Human Resources in Veterinary Services

Sanitary and Phytosanitary (SPS) issues in exports from the EU to Russia What will Russia s accession to the WTO change?

OIE Standards for Animal Welfare

OIE Role in International Trade

OIE List of Antimicrobial Agents of Veterinary Importance and OIE Standards and Activities

OIE stray dog control standards and perspective. Dr. Stanislav Ralchev

Animal Welfare: the role of the OIE

International approach for veterinary medicinal products: OIE and Codex alimentarius

14th Conference of the OIE Regional Commission for Africa. Arusha (Tanzania), January 2001

( ) Page: 1/8 COMMUNICATION FROM THE WORLD ORGANISATION FOR ANIMAL HEALTH (OIE)

OIE International Standards The OIE Standard Setting Process

Stuart Slorach Chair, OIE Working Group on Animal Production Food Safety. Cooperation between the OIE and Codex: OIE perspective

Surveillance. Mariano Ramos Chargé de Mission OIE Programmes Department

Peste des Petits Ruminants

FACILITATING SAFE TRADE: HOW TO USE THE TERRESTRIAL CODE TO SET HEALTH MEASURES FOR TRADE IN TERRESTRIAL ANIMALS AND PRODUCTS

OIE International Standards. Scientific and Technical Department

Mandate of OIE Reference Centres Capacity Building Support and Networking

OIE Standards on biosecurity and compartmentalisation

Introduction to Biorisk and the OIE Standard

OIE Standards on Veterinary Legislation: Chapter 3.4 of the OIE Terrestrial Animal Health Code

Progress of Rabies Control from OIE perspective

Stray Dog Population Control

Promoting One Health : the international perspective OIE

OIE initiative establishing a global database on consumption of antimicrobials for animals: state of play

The general Information of the OIE (Organization, Roles, Mandate, Functions and 5 th Strategic Plan)

OIE activities related to wildlife and biodiversity

Rights and responsibilities of Permanent Delegates and role of National Focal Points

The impact of Good Veterinary Services Governance (GVSG) on the control over Veterinary Medicinal Products (VMP s)

The OIE Laboratory Twinning Program. Approach. M. Kathleen Glynn, DVM, MPVM and Keith Hamilton, BVSc MSc Scientific and Technical Department

Benefit of a Strengthened Enabling Environnement for FMD Control

Dr Stuart A. Slorach

INTRODUCTION TO THE OIE & OIE INT L STANDARDS

Aquatic animal disease control what lessons can we learn to meet the ongoing challenge?

The OIE Standards on the quality of Veterinary Services and The OIE PVS Pathway

EU Programmes for Animal Welfare in the European region

OIE international standards on Rabies:

Contents & results of 3 years of VMP FP training Susanne Münstermann OIE Scientific and Technical Department

OIE Tool for the Evaluation of Performance of Veterinary Services (OIE PVS Tool)

The structure, objectives and Strategic Plan of the OIE OIE Focal Points Seminar on Animal Welfare Teramo / Italy March 5-7, 2013

Transcription:

Enhancing safe interregional 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 trade 1 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 food safety CODEX animal health and zoonoses OIE plant health IPPC 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 ph monitoring The 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/

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