Introducing Innovative Diagnostics and HACCP in the Ornamental Fish Industry: sense or non-sense?

Introducing Innovative Diagnostics and HACCP

in the Ornamental Fish Industry:

sense or non-sense?

Prof. Kris A. Willems, PhD and Bart Lievens, PhD, Ir.

Scientia Terrae Research Institute (STRI), Belgium De Nayer Institute, K.U.Leuven Association, Belgium

Interzoo, OFI Fish Health Seminar

Quality

Driving Force in the Market

„ _{Diversity of systems}

„ ISO 9000, EFQM, TQM

„ GAP, GMP, GLP, GEP

„ Process control & improvement

„ Systematic approach

„ Appropriate resources & best available

technologies

„ Traceability

„ Total approach

„ Continuous improvement

„ Throughout organisation and/or food

supply chain

„ All aspects of supplier-customer

relationship

Product oriented

Process oriented

Total approach

Quality

Satisfy the customer’s needs at the best

Quality Systems

Process Control - Core of all Quality Systems

assignment resources requirements corrective actions instructions product (production) process measurements people registrations control limits specifications

Food Safety

Focus on Human Health and/or Spoilage

Chemicals Micro-organisms Fysical agents

Effect Intoxication Infection Intoxication

Wounds

Not acceptable Discolouring of ham Fungi on bread Hair in burger

Ornamental Fish Industry (OFI)

Focus on Disease Prevention

Ù

Biosecurity

„ Prevention of the entry of new or unwanted organisms, especially infectious agents

„ Biosecurity includes all measures in place to protect ornamental aquatic organisms (fish, invetabrate or plant) from contracting, carrying or spreading disease

„ Prevention „ Detection

Food Safety

Definition of HACCP

H

azard

A

nalysis

C

ritical

C

ontrol

P

oints:

“A

systematic approach

to the

identification

and

assessment

of the microbiological

hazards

and

risks

associated with the

manufacture

,

distribution

and

use

of a particular foodstuff and the

definition of means

for their control”

Food Safety

Primary Characteristic of Food Quality

„ Prevent disease

„ Legal requirement ‘post-farm’ „ Core HACCP concept

„ Diversity of systems

„ HACCP

„ BRC, IFS „ ISO 22000

„ General Food Law (EU)

Quality

HACCP – Essential Elements

Hazard Analysis & Process Control

„ Identify hazards and assess severity „ Determine Critical Control Points

(CCP’s)

„ Specify control criteria, i.e. limits and tolerances

„ Monitor Critical Control Points

„ Identify and take corrective action(s) „ Verify the system is working

„ Keep records

Quality

HACCP

Characteristics

„

Systematic approach

to identify those factors that directly

affect food safety / biosecurity

„

Preventive

instead of retrospective approach

„ Replaces traditional inspection and testing regimes

„

More

cost-effective

control system

„ Concentration resources, e.g. technical and financial, into critical

areas

„

No cure all

General Food Law

EU Hygiene Directive

„

General rules

for the production of all foodstuffs

„

Specific rules

for meat, fish, dairy, eggs, snails and frogs,

animal fats, gelatine and callogen

„

Implementation a HACCP is a

legal requirement

, except

for the primary sector

„

Primary sector =>

Good Agricultural Practices

(GAP)

Product liability

confirmed, now including

Terminology

From Hazard to Risk (1)

„

Hazard

„ Food safety - Biological, chemical or fysical agent that potentially

can affect the safety of a foodstuff

„ Biosecurity – Biological agent that potentially can affect fish

health, human health and/or ecosystems

„

Hazard Analysis

„ Process of collecting and evaluating information on hazards and

conditions leading to their presence to decide which are

significant for food safety and therefore should be addressed in the HACCP plan

Terminology

From Hazard to Risk (2)

„

Risk

„ Probability x Consequences = Risk

„

Risk Analysis

„ A process consisting of three components:

„ Risk assessment „ Risk management „ Risk communication

„ Advocated by many governments and intergovernmental

organisations

Terminology

From Hazard to Risk (3)

Risk Management

- Risk evaluation - Option assessment - Option implementation - Monitoring & review

Risk Assessment - Hazard Identification - Hazard characterisation - Exposure assessment - Risk characterisation Risk Communication Interactive exchange of information and opinions

Terminology

From Hazard to Risk (3)

„ Risk Assessment

„ A scientifically based process consisting of the following steps: 1. hazard

identification; 2. hazard characterisation; 3. exposure assessment; 4. risk characterisation

„ Risk Management

„ The process… of weighing policy alternatives, ……… considering risk

assessment and other factors relevant for the health of consumers and for the promotion of fair trade practices……

„ Risk Communication

„ The interactive exchange of information and opinions throughout the risk

analysis process concerning risk… among risk assessors, risk managers, consumers, industry, the academic community and other interested parties….

Risk Analysis

The Broader Context

Generic Hazard Management GHPs / GMPs / GAPs Specific Hazard Management HACCP Standards Policy Country level Operational level Risk Analysis - high level

- policy based guidance - specific standards, criteria

Food Safety Management - local

- specific management at supply chain level

Good Practices & HACCP

Foundation of Food Safety / Biosecurity

„

Good Practices

„ Foundation of all (food) safety systems

„ General guidance on sanitary practices and level of care of (food

manufacturing) facilities

„

HACCP

„ Applies to a specific product, manufactured on a specific location

and/or production line

„ Specificity and stringency of hazard control essential to its

success

Good Practices & HACCP

Require Technical and Scientific Data

„ Epidemiological data on (microbial) pathogens

„ Incidence of foodborne illness „ Surveillance programmes

„ Raw material, intermediate and final product data

„ pH, a_w, presence of preservatives, packaging materials and conditions,

product structure, processing conditions, shelf life, etc… „ Processing data

„ Number sequence of processing data, range of process parameters, efficacy

of cleaning and disinfecion „ Microbiological data

Good Practices & HACCP

Critical Success Factors

„

Technical and scientific skills of (food) business operator

Regulatory guidance regarding key operations, (i.e.

desinfection, pasteurisation, etc….

„

Regulatory guidance on ‘safety’ benchmarks,

Risk Analysis / Risk Assessment

Microbial Risk Assessment (MRA)

„ _Purpose

„ Systematic assessemnt (model/estimate) of the level of risk prevailing in a

country as associated to pathogenic micro-organisms (in foods)

„ Inventorisation of ‘typical’ risk contributing and risk mitigating factors „ Elaboration of possible risk mitigation strategies

„ Scope

„ All foods consumed in a specific country, whether produced or imported

„ Outcome

„ Estimated number of cases of (a certain) illness per year per (e.g.) 100.000

persons in a given population caused by a certain micro-organism or group of micro-organisms in a particular food product or food type

„ Chance of illness due to consumption of a specific food product (per serving

Risk Analysis / Risk Assessment

Microbial Risk Assessment (MRA)

„

Role of (Food) Business Operators

„ Do not need to conduct risk assessments

„ Need to ensure proper implementation of (food) safety

management systems, incl. HACCP

„ MRA studies can strenghten (food) safety sysyems

„

Relevance to (Food) Business Operators

„ Improvement of GHP & HACCP systems by

„ Learning about differences in levels of hazard control between (typical) operations

„ Appreciating different intervention strategies or management options „ Seeing examples of how to meet government requirementq (incl. (food)

Quality Systems

Process Control - Core of all Quality Systems

assignment resources requirements corrective actions instructions product (production) process measurements people registrations control limits specifications

Biosecurity

Fish Disease Management

„ Main fish pathogens: bacteria, fungi, viruses, and protozoa

„ Disease management

„ _{Accurate diagnosis}

„ _{Choice of appropriate process control and}

management strategies

Biosecurity

Main Limitations of Fish Disease Management

„ _{Lack of rapid and accurate detection and}

identification of fish pathogens

Biosecurity / Microbiological Methods

Traditional Methods

„ Wide diversity of assays „ Time consuming

„ Labour intensive

Biosecurity

Main Limitations of Fish Disease Management

„ Lack of rapid and accurate detection and identification of fish pathogens

„ Standard versus alternative methods „ Multiplexing and quantification

Biosecurity

Main Limitations of Fish Disease Management

„ Lack of rapid and accurate detection and identification of fish pathogens

„ Standard versus alternative methods „ Multiplexing and quantification

„ Most fishes can be infected by a multitude

of pathogens

„ Similar symptoms may be caused by

different pathogens

„ _{Disease symptoms often result from}

infection by multiple pathogens

Biosecurity

Main Limitations of Fish Disease Management

„ Lack of rapid and accurate detection and identification of fish pathogens

„ Standard versus alternative methods „ Multiplexing and quantification

„ Infectious threshold „ Action threshold

Biosecurity / Microbiological Methods

Alternative (

Molecular) Methods

„ Serological and nucleic acid-(DNA/RNA) based techniques

„ Generally faster, more specific, more sensitive and more accurate than

conventional methods

„ Equally suitable for the detection of culturable as well as non-culturable micro-organisms

„ No experienced taxonomists required „ However: detection limited to a single

Biosecurity / Microbiological Methods

Molecular Methods: DNA arrays

„ Hybridization of labeled target amplicons to specific DNA fragments bound to a solid support (macroarrays vs microarrays)

„ Combines PCR amplification with the unlimited screening capability of DNA arrays: high degrees of sensitivity, specificity, and

throughput capacity

„ Reduces costs and increases speed of diagnosis

Biosecurity / Microbiological Methods

DNA arrays: different approaches of detection

Discrimination of phylogenetically less related organisms (e.g. viruses) Discrimination of phylogenetically related

organisms (e.g. bacteria and fungi)

„ _{‘Universal Primer’ based}

multiplex detection

„ _{‘Random Primed’ based}

Biosecurity / Microbiological Methods

DNA arrays: results read as a checklist

„ Microorganisms present in the sample are literally ‘highlighted’ „ Compared to reference oligonucleotides the intensity of the

hybridization signal is an indicator for the amount of biomass present (semi-quantification)

Biosecurity / Microbiological Methods

Biosecurity / Microbiological Methods

DNA arrays: an example

Aeromonas sp. A. salmonicida Flavobacterium sp. F. branchiophilum Mycobacterium sp. M. marinum Universal ‘All bacteria’ ‘All oomycetes’ S. cerevisiae Calibration control

„ Detection of multiple pathogens

Biosecurity / Microbiological Methods

DNA array OFI -

Target Organisms

„ Bacteria: Aeromonas hydrophila, A. salmonicida, Edwardsiella ictaluri, Flavobacterium branchiophilum, F. columnare, F. psychrophilum,

Mycobacterium chelonae, M. fortuitum, M. marinum, Piscirickettsia salmonis, Pseudomonas anguilliseptica, Renibacterium salmoninarum, Streptococcus

iniae, Tenacibaculum maritimum, Vagococcus salmoninarum, Vibrio alginoyticus, V. anguillarum, V. parahaemolyticus, V. vulnificus, Yersinia ruckeri

„ DNA viruses: Koi Herpes Virus (KHV), Carp Pox Virus (CPV), Channel Catfish Virus (CCV)

„ _{RNA viruses:} Spring Viraemia of Carp Virus (SVCV), Viral Haemorrhagic Septicemia Virus (VHSV), Infectious Hematopoietic Necrosis Virus (IHNV),

Biosecurity / Microbiological Methods

DNA array OFI -

Applications

„ _{Analysis of different kind of samples including tissue, water, fish} nutrition, and water plants

„ Routine diagnosis of fish diseases

„ Ecological and epidemiological studies

„ Sectoral surveillance in support of HACCP & GMP

„ Allows taking well-informed decisions in terms of biosecurity and a safe ornamental fish trade

Biosecurity / Microbiological Methods

Validation of Alternative Methods

„ Essential steps required to evaluate new technologies rarely taken „ Microval => Harmonised EU validation procedure

„ Validation: „ Specificity „ _Sensitivity „ Reproducibility „ Accuracy of results „ Ring tests

„ Scientific support

„ Scientific advisors

• Dr. B. Austin, Heriott-Watt University, UK

• Dr. I. Pavlik, Veterinary & Pharmaceutical University Brno, Czech Republic • Dr. P. Silley, University of Bradford, UK

• Dr. F. Lieffrig, Centre d’Economie Rurale, Belgium

• Dr. B. Thomma, Wageningen University, the Netherlands • Dr. P. Sorgeloos, Ghent University, Belgium

„ Other

• Dr. M. Snow and Dr. A. McBeath, Fisheries Research Services, Marine Laboratory, UK • Dr. T. Nishizawa, Hokkaido University, Japan

• Dr. N. Gagne, Fisheries and Oceans Canada, USA

• Dr. K. Garver, Fisheries and Oceans Canada, Pacific Biological Station, USA • Dr. M. Sakai and Dr. T. Kono, University of Miyazaki, Japan

• Dr. T. Iida, Fisheries Research Agency, Japan

• Dr. G. Kurath and Dr. M. Purcell, Western Fisheries Research Center, USA • Dr. M. Kotler, Department of Pathology, Israël

„ Financial support

„ Vlaams Instituut voor de bevordering van het

Wetenschappelijk-Technologisch Onderzoek Vlaanderen, Belgium

„ Industrial sponsors

• Wholesalers: Bassleer Biofish nv., Aquaria Antwerp bvba., De Jong Marinelife bv. • Fish nutrition: INVE Technologies nv.,

• Fish breeder and fish hatchery: Joosen-Luyckx Aqua Bio nv.

• Veterinary Surgeons: Dr. S. Verbinnen, Dr. T. Barbé, Dr. M. Lammens, Dr. L. Lambrechts, Dr. S. Teerlinck

• Ponds and Aquarium Specialist Shop: Aqua Hobby nv. • Diagnostic company: BioART nv.

• Testing Laboratory: MicroBioMetrix bvba.

• International Trade Association: Ornamental Fish International

Introducing Innovative Diagnostics and HACCP

in the Ornamental Fish Industry:

sense or non-sense?

It makes a lot of sense!

Thank you