Australia's OIE Standards Experience: Assessment & Compliance for Disease-Free Aquatic Animals

1. Applying the OIE standards-Australia’s experience

2. Our Role & Responsibility • Protect • Australia’s favourable disease status • Facilitate trade • In healthy aquatic animals & their products • Using • OIE standards

3. Types of Experience • ASSESSMENT based on: DISEASE FREEDOM • Country • Zone • Zone / Compartment • Integrated Compartment • Partially Integrated/Single Compartment The differences are never clearly defined

4. AssessmentA 2-way process EXAMPLE: We assess Country X for ZONE freedom from shrimp disease. Country Y assesses us for supply of disease-free oyster spat.

5. Assessment using the OIE standards • Based on: • PVS Tool -AquaticCode - SPS Agreement & Australian Quarantine Legislation • Desk assessment • In-country visit • About 9 months to get this far • An ongoing relationship, compliance, auditing, resourcing, management & sustainability

6. PVS Tool OIE code CHAPTER I HUMAN, PHYSICAL AND FINANCIAL RESOURCES Section I-1 Professional and technical staffing of the Veterinary Services Section I-2 Competencies of veterinarians and veterinary para-professionals Section I-3 Continuing education Section I-4 Technical independence Section I-5 Stability of structures and sustainability of policies Section I-6 Coordination capability of the Veterinary Services Section I-7 Physical resources Section I-8 Operational funding Section I-9 Emergency funding Section I-10 Capital investment Section I-11 Management of resources and operations CHAPTER II TECHNICAL AUTHORITY AND CAPABILITY Section II-1 Veterinary laboratory diagnosis Section II-2 Laboratory quality assurance Section II-3 Risk analysis Section II-4 Quarantine and border security Section II-5 Epidemiological surveillance Section II-6 Early detection and emergency response Section II-7 Disease prevention, control and eradication Section II-8 Food safety Section II-9 Veterinary medicines and biologicals Section II-10 Residue testing Section II-11 Emerging issues Section II-12 Technical innovation Section II-13 Identification and traceability Section II-14 Animal welfare CHAPTER III INTERACTION WITH STAKEHOLDERS Section III-1 Communications Section III-2 Consultation with stakeholders Section III-3 Official representation Section III-4 Accreditation/authorisation/delegation Section III-5 Veterinary Statutory Body Section III-6 Participation of producers and other stakeholders in joint programmes CHAPTER IV ACCESS TO MARKETS Section IV-1 Preparation of legislation and regulations Section IV-2 Implementation of legislation and regulations and stakeholder compliance Section IV-3 International harmonisation Section IV-4 International certification Section IV-5 Equivalence and other types of sanitary agreements Section IV-6 Transparency Section IV-7 Zoning Section IV-8 Compartmentalisation The PAPERWORK Up to 500 pages of tables

7. 5 staff – 4 with PhD’s in aquatic animal health Priority List Budget • RESOURCES

8. AUSTRALIA’S EXPERIENCE USING THE OIE STANDARDS • POSITIVE FOCUS ON ISSUES & IMPROVEMENTS

9. The first hurdle - contact • WHY is the • submission for trade • access being made? • QUALITY = COMMITMENT • The RELATIONSHIP • Principled negotiation in good faith

10. First Contact: What have we learnt? • Negotiations must be principled, transparent & held in good faith • Clear channels of communication • Roles & Responsibilities agreed • Introduction to the system • Expectations • Priorities agreed

11. First Contact: What have we learnt? • The PVS Tool should recommend that countries develop a framework for the consistent & systematic evaluation of their trading partners’ animal health controls. This fosters confidence in the continuity & timeliness of the process.

12. Aquatic animals Fisheries Authorities Primary Industry Authorities Health Certification Authorities MOU’s EM-OH-YOUZ Memorandum of Understanding • Legislation & • Multiple Authorities

13. Legislation & Control:What have we learnt? • Legislative arrangements for government control of aquatic animal industries & health are often complicated & may restrict market access until legal arrangements between the controlling authorities are secured.

14. 1 - 2 years: high quality – good health controls – good relations 5 years: No legislation – build controls from scratch – poor quality • TIME is a major limiting factor

15. TIME is a major limiting factor • What have we learnt? • Negotiations - transparent & in good faith • Good communications • Consistent system • Leadership

16. QUALITY MANAGEMENT SYSTEMS • No QMS is a major limiting factor • Seamless systems integration • Complete biosecurity management • Traceability • Reassurance for trading partners • Basis for reporting • Sustainability • Continual feedback & improvement

17. Connectors & QMS FUNCTION Manage DISEASE-FREE ZONE Animal Health Controls Import Export QUALITY MANAGER’S NETWORK Internal Audit Training R & D Surveillance Certification Emergency OIE reporting Laboratories Processor

18. Connectors & QMS REPORTING Animal Health Controls Import Export CONNECTOR OIE FOCAL POINT Internal Audit Training R & D Surveillance Certification Emergency Legal & Policy Laboratories Processor

19. QMS: What have we learnt? • QMS is CRITICAL • Function - Traceability - Improvement • More consideration given to the importance of QMS in the PVS Tool critical competencies • ‘One Health’ concept to integrate animal health controls – e.g. EQuIP

20. When things go wrong • Don’t panic… it’s not the end of the world, • it’s a new beginning. • Review your assessment. • Review compliance. • Observe emergency response & reporting. • Review emergency preparedness. • Review improvements. • Does your system allow for continued trade? • Start again using the Aquatic Code guidelines.

21. What have we learnt when things go wrong? • =Opportunity… • …not Disaster • Having systems in place provides a foundation to rebuild

22. What have we learnt when things go wrong? • Compartmentalise • where possible COMPARTMENTS ZONE

23. What have we learnt when things go wrong? • The Aquatic Code • Re-declaration of disease freedom e.g. WSSV = 2 years? • Could be quicker for semi-closed - closed systems - processing compartments

24. CHAIN of CUSTODY: a CCP 3rd party & 3rd country processing Origin Approved Country A Country B Processor Critical Control Point for substitution or contamination SAME Processor Country B Origin Not Approved Country X Destination Approved fish Country C

25. Chain of Custody: What have we learnt? • Evaluation of the chain-of-custody (Product integrity) of aquatic animals & their products should be more thoroughly considered in the PVS Tool critical competencies

26. BENEFITS of involvement • Building stronger relationships • Improve animal health controls • Better ways to manage risk • Consistent & successful way to facilitate trade without compromising biosecurity

27. Special thanks to … OIE Aquatic Animal Health Standards Commission & member nations Dr Yuko Hood Dr Ramesh Perera Our aquatic team Dr Geoff Grossel Mark Kelly Dr Kally Gross Maps by