Applying the OIE standards - Australia’s experience

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Applying the OIE standards-Australias
experience
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Our Role Responsibility

• Protect
• Australias favourable disease status
• Facilitate trade
• In healthy aquatic animals their products
• Using
• OIE standards

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Types of Experience

• ASSESSMENT based on DISEASE FREEDOM
• Country
• Zone
• Zone / Compartment
• Integrated Compartment
• Partially Integrated/Single Compartment

The differences are never clearly defined
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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.
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Assessment using the OIE standards

• Based on
• PVS Tool - Aquatic Code - 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

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The PAPERWORK
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/author
isation/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
Up to 500 pages of tables
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• RESOURCES

5 staff 4 with PhDs in aquatic animal
health Priority List Budget
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AUSTRALIAS EXPERIENCE USING THE OIE STANDARDS

• POSITIVE

FOCUS ON ISSUES IMPROVEMENTS
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The first hurdle - contact

• WHY is the
• submission for trade
• access being made?
• QUALITY COMMITMENT
• The RELATIONSHIP
• Principled negotiation in good faith

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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

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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.

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• Legislation
• Multiple Authorities

Aquatic animals Fisheries Authorities Primary
Industry Authorities Health Certification
Authorities MOUs EM-OH-YOUZ Memorandum of
Understanding
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Legislation ControlWhat 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.

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• TIME is a major limiting factor

1 - 2 years high quality good health
controls good relations 5 years No
legislation build controls from scratch poor
quality
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• TIME is a major limiting factor
• What have we learnt?

• Negotiations - transparent in good faith
• Good communications
• Consistent system
• Leadership

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• 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

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Connectors QMS
FUNCTION Manage DISEASE-FREE ZONE
Import Export
Animal Health Controls
QUALITY MANAGERS NETWORK
Internal Audit
Training
Surveillance
R D
Certification
Emergency
OIE reporting
Laboratories
Processor
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Connectors QMS
REPORTING
Import Export
Animal Health Controls
CONNECTOR OIE FOCAL POINT
Internal Audit
Training
Surveillance
R D
Certification
Emergency
Legal Policy
Laboratories
Processor
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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

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When things go wrong

• Dont panic its not the end of the world,
  
• its 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.

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What have we learnt when things go wrong?

• Opportunity
• not Disaster
• Having systems in place provides a foundation to
  rebuild

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What have we learnt when things go wrong?

• Compartmentalise
• where possible

COMPARTMENTS
ZONE
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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

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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
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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

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BENEFITS of involvement

• Building stronger relationships
• Improve animal health controls
• Better ways to manage risk
• Consistent successful way to facilitate trade
  without compromising biosecurity

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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