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Understanding andapplying risk analysisin aquacultureA manual for decision-makers

Understanding andapplying risk analysisin aquacultureA manual for decision-makers

519/1

FAOFISHERIES ANDAQUACULTURE

TECHNICALPAPER

ISSN2070-7010


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Cover photographs:

Left column, top to bottom: ish armers administering antibiotic treatment to a suspected viral

inection o ish (courtesy o M.B. Reantaso).Middle column, top: Suminoe oyster (Crassostrea ariakensis) (courtesy o E. Hallerman); bottom:

mortalities o common carp in Indonesia due to koi herpes virus (courtesy o A. Sunarto).

Right column: women sorting post-larvae shrimp at an Indian shrimp nursery (courtesy o M.J. Phillips).


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FOOD AND AGRICULTURE ORGANIZATION OF THE UNITED NATIONS

Rome, 2009

Understanding andapplying risk analysis

in aquacultureA manual or decision-makers

FAOFISHERIES ANDAQUACULTURE

TECHNICALPAPER

519/1

byJames Richard ArthurFAO ConsultantBarriere, British Columbia, Canada

Melba G. Bondad-ReantasoFishery Resources Ocer (Aquaculture)Aquaculture Management and Conservation ServiceFAO Fisheries and Aquaculture DepartmentRome, Italy

Marnie L. CampbellAssociate ProessorAustralian Maritime College

University o TasmaniaLaunceston, Tasmania, Australia

Chad L. HewittProessorAustralian Maritime CollegeUniversity o TasmaniaLaunceston, Tasmania, Australia

Michael J. PhillipsSenior ScientistWorldFish CenterPenang, Malaysia

Rohana P. SubasingheSenior Fishery Resources Ocer (Aquaculture)Aquaculture Management and Conservation ServiceFAO Fisheries and Aquaculture DepartmentRome, Italy


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The designations employed and the presentation o material in this inormationproduct do not imply the expression o any opinion whatsoever on the parto the Food and Agriculture Organization o the United Nations (FAO) concerning thelegal or development status o any country, territory, city or area or o its authorities,or concerning the delimitation o its rontiers or boundaries. The mention o speciiccompanies or products o manuacturers, whether or not these have been patented, doesnot imply that these have been endorsed or recommended by FAO in preerence toothers o a similar nature that are not mentioned.

The views expressed in this inormation product are those o the authors anddo not necessarily relect the views o FAO.

ISBN 978-92-5-106414-6

All rights reserved. FAO encourages reproduction and dissemination o material inthis inormation product. Non-commercial uses will be authorized ree o charge.Reproduction or resale or other commercial purposes, including educational purposes,may incur ees. Applications or permission to reproduce or disseminate FAO copyrightmaterials and all other queries on rights and licences, should be addressed by e-mail to

[email protected] or to the Chie, Publishing Policy and Support Branch, Oice oKnowledge Exchange, Research and Extension, FAO, Viale delle Terme di Caracalla,00153 Rome, Italy.

FAO 2009


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Preparation of this document

The need for a manual for decision-makers on understanding and applying risk analysisin aquaculture was discussed and guidance on its approach and contents formulatedby the participants at the FAO/NACA Expert Workshop on Understanding andApplying Risk Analysis in Aquaculture, held from 8 to 11 June 2007 in Rayong,Thailand. The experts attending the Rayong workshop recognized that the aquaculturesector, which is characterized by a high diversity in operating systems, environmentsand species cultured, faced a wide range of biological, physical, chemical, economic

and social risks to its successful and sustainable development. As a consequence,this document was prepared to provide policy-makers and senior managers whomust deal with the rapid development of their national aquaculture sectors with aconcise overview of risk analysis methodology as applied in seven key risk categories(pathogen, food safety and human health, genetic, environmental, ecological [pestsand invasives], financial and social risks) and advice on the application of risk analysisat the national and farm levels can lead to a more sustainable aquaculture industry.

This document will also be of relevance to aquaculture operators, industryorganizations, non-governmental organizations (NGOs) and other groupsinterested in understanding risk analysis and its influences on national aquaculture

policy, industry regulation and the management of aquatic resources.This manual was developed under the technical supervision of Dr Melba B. Reantaso,

Fishery Resources Officer, Aquaculture Management and Conservation Service,Fisheries and Aquaculture Management Division, FAO Fisheries and AquacultureDepartment. The manual draws heavily on the proceedings of the Rayong workshop(FAO Fisheries and Aquaculture Technical Paper No. 519) and particularly onthe review papers of M.G. Bondad-Reantaso and J.R. Arthur (pathogen risks),M.L. Campbell and C.L. Hewitt (environmental pest risks), I. Karunasagar (foodsafety and public health risks), E. Hallerman (genetic risks), M.J. Phillips andR.P. Subasinghe (environmental risks), K.M.Y. Leung and D. Dudgeon (ecologicalrisks), L.E. Kam and P. Leung (financial risks) and P.B. Bueno (social risks).

Preparation and publication of this document were made possible with financialassistance through the Programme Cooperation Agreement of Norway underB.1 and D.1 objectives, through the FishCode Programme of the FAO Fisheriesand Aquaculture Department, the Nutrition and Consumer Protection Divisionand the Plant Production and Protection Division of the FAO Agriculture andConsumer Protection Department.


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Abstract

Aquaculture is a rapidly expanding sector o the global economy with an averagegrowth rate o 8.8 percent per annum since 1970. This consistent increase inproduction is a result o expansion o markets, globalization o market access andan increasing market demand or seaood products during a period in which mostcapture isheries are stagnating or in decline. Aquaculture is expected to continue toincrease its contribution to the worlds production o aquatic ood and will urtherstrengthen its role in ood security and ood saety, while also oering opportunities

to alleviate poverty, increase employment and community development and reduceoverexploitation o natural aquatic resources, thus creating social and generationalequity, particularly in developing countries.

This rapid development o the industry under various national and regional jurisdictions has resulted in a diversity o regulatory rameworks. Thus, FAOMembers have requested guidance on the application o risk analysis with respectto aquaculture production. The purpose o this manual is to provide an overview othe risk analysis process as applied to aquaculture production and to demonstratethe variety o ways in which risk can maniest in aquaculture operations andmanagement. The intention o this manual is to promote wider understanding and

acceptance o the applications and beneits o risk analysis in aquaculture productionand management.

This manual is directed towards decisions-makers and senior aquaculture managersin FAO Members States. It includes an introduction to the methodology used toassess the risks posed by aquaculture operations to the environment, socio-politicaland economic well-being and cultural values, as well as the risks to aquaculture romoutside inluences, including potential environmental, socio-political, economic andcultural impacts. The manual contains six sections. Section 1 provides a background tothe aquaculture sector and an introduction to the concepts o risk analysis. Section 2presents the operating environment or risk analysis or the aquaculture sectorby briely reviewing the relevant international rameworks applicable to each riskcategory. Section 3 discusses a general risk analysis process or aquaculture. Section4 provides brie overviews o the risk analysis process as applied in each o the sevenrisk categories. Section 5 briely summarizes actions that need to be taken by FAOMembers to promote the wider use o risk analysis or aquaculture development.Finally, Section 6 discusses uture challenges to aquaculture and the role risk analysismight play in addressing them.

Arthur, J.R.; Bondad-Reantaso, M.G.; Campbell, M.L.; Hewitt, C.L.; Phillips, M.J.;

Subasinghe, R.P.Understanding and applying risk analysis in aquaculture: a manual or decision-makers.

FAO Fisheries and Aquaculture Technical Paper. No. 519/1. Rome, FAO. 2009. 113p.


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v

Contents

Preparation o this document iiiAbstract ivAcknowledgements viiiAbbreviations and acronyms ixGlossary xi

1. INTRODUCTION 11.1 Background 1

1.2 Purpose 21.3 Target audience 21.4 Scope 21.5 Structure o the manual 31.6 Concepts o risk Analysis 31.7 General ramework o risk analysis 7

2. OPERATING ENVIRONMENT 112.1 Overview o regulatory rameworks 112.2 Overview o the key risk categories 18

3. A RISK ANALYSIS PROCESS FOR AQUACULTURE 273.1 Determining the scope o the risk analysis 273.2 Hazard identifcation 293.3 Risk assessment 323.4 Risk management 353.5 Risk communication 38

4. BRIEF OVERVIEW OF THE RISK ANALYSIS PROCESS BY RISK CATEGORY 414.1 Overview o the pathogen risk analysis process 414.2 Overview o the ood saety and public health risk analysis process 47

4.3 Overview o the ecological (pests and invasives) risk analysisprocess 53

4.4 Overview o the genetic risk analysis process 684.5 Overview o the environmental risk analysis process 754.6 Overview o the fnancial risk analysis process 824.7 Overview o the social risk analysis process 90

5. IMPLEMENTATION OF RISK ANALYSIS IN AQUACULTURE 97

5.1 National policy level 97

6. FUTURE CHALLENGES 103

REFERENCES 107


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Acknowledgements

The authors would like to acknowledge all participants at the FAO/NACAExpert Workshop on Understanding and Applying Risk Analysis in Aquaculture,held rom 8 to 11 June 2007 in Rayong, Thailand. The authors also thankP. Appleord, J. Clay, T. Huntington, I. Karunasagar, Z. Mehmedbasic, P. Secretan,P. Sonsangjinda, M.R. Umesh and C. Wo Wing, who, as members o the workinggroup on Development o the Contents o the Manual on Understanding andApplying Risk Analysis in Aquaculture, developed the initial outline or this

manual. The contributors o the review papers contained in the FAO Fisheriesand Aquaculture Technical Paper No. 519, rom which this manual was based, arealso grateully acknowledged. They were P.B. Bueno, D. Dudgeon, E. Hallerman,L.E. Kam, I. Karunasagar, K.M.Y. Leung and P. Leung. In addition, thanks arealso due to T. Farmer and F. Schatto (FAO Fisheries and Aquaculture Inormationand Statistics Service) and J.L. Castilla (layout design) or various types oassistance during the inal production and publication o this document. J. Jia(FAO Aquaculture Management and Conservation Service), I. Kollavik-Jensen(Programme Coordination Unit o FAO Fisheries and Aquaculture Department),M. Robson and P. Kenmore (FAO Plant Production and Protection Division) are

especially thanked or encouragement and or acilitating unding support to theproject on Risk Analysis in Aquaculture Production.


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Abbreviations and acronyms

ALARA as low as reasonably achieved (approach)ALOP appropriate level o protectionALOR acceptable level o riskANP analytic network processAPEC Asia-Pacic Economic CooperationASEAN Association o Southeast Asian NationsBMPs best management practices

CAC Codex Alimentarius CommissionCBD Convention on Biological DiversityCCRF Code o Conduct or Responsible FisheriesCSR corporate social responsibilityEIA environmental impact assessmentEIFAC European Inland Fisheries Advisory Commission (o the FAO)ERA ecological risk assessment; environmental risk assessmentEU European UnionFAO Food and Agriculture Organization o the United NationsFSO ood saety objective

GAP good aquaculture practicesGESAMP IMO/FAO/UNESCO-LOC/WMO/IAEA/UN/UNEP

Joint Group o Experts on the Scientic Aspects o MarineEnvironmental Protection

GISD Global Invasive Species DatabaseGMO genetically modied organismHABs harmul algal bloomsHACCP Hazard Analysis And Critical Control Point AnalysisICES International Council or the Exploration o the SeaICPM Interim Commission on Phytosanitary Measures (o the IPPC)IPPC International Plant Protection ConventionIRA import risk analysisIRR internal rate o returnISO International Standards OrganisationISPM International Standards or Phytosanitary MeasuresISR International Sanitary RegulationsIUCN World Conservation UnionLIFDCs low-income ood-decit countriesMCMD multicriteria decision-making

MPEDA Marine Products Export Development Authority ( India)MOTAD minimization o total absolute deviationsNACA Network o Aquaculture Centres in Asia and the Pacic


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NaCSA National Centre or Sustainable Aquaculture (India)NEMESIS National Exotic Marine and Estuarine Species Inormation

System

NIMPIS National Introduced Marine Pest Inormation SystemNGO Non-governmental organizationNPPOs National Plant Protection OrganizationsOIE World Organisation or Animal HealthORP organism risk potentialPAHO Pan American Health OrganizationPRP pathway risk potentialROI return on investmentPRA pathogen risk analysis

RPPOs Regional Plant Protection Organizations (o the IPPC)SEAFDEC South East Asian Fisheries Development CenterSOPs standard operating proceduresSPS Sanitary and Phytosanitary (Agreement) (o the WTO)SRM social risk managementTAADs transboundary aquatic animal diseasesTBT Agreement on Technical Barriers to Trade (TBT Agreement)UN United NationsUNICLOS United Nations Convention on the Law o the SeaUSEPA United States Environmental Protection Agency

WGITMO Working Group on Introductions and Transers o MarineOrganisms (o ICES)

WHO World Health OrganizationWSD whitespot syndrome diseaseWSSV whitespot syndrome virusWTO World Trade Organization


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Appropriate level oprotection (ALOP)

The level o protection deemed appropriate by acountry establishing a sanitary or phytosanitarymeasure to protect identied or assessed values

Acceptable level o risk(ALOR)

The level o risk a country establishing a sanitaryor phytosanitary measure is willing to assume toprotect identied or assessed values

Biosecurity A strategic and integrated approach thatencompasses both policy and regulatory rameworksaimed at analyzing and managing the risks o thesectors dealing with ood saety, animal lie andhealth, plant lie and health and the environment

Consequence The evaluated impact an event may have on assessedvalues (environmental, economic, socio-political,cultural)

Consequence assessment The process o evaluating the impact o an event.

Cultural value Those aspects o the aquatic environment thatrepresent an iconic or spiritual value, includingthose that create a sense o local, regional or nationalidentity

Delphi process A semi-quantitative method rom the social sciencesthat is used to capture stakeholder and/or expertopinions and belies

Economic value Components within an ecosystem that provide acurrent or potential economic gain or loss

Environmental value Everything rom the biological to physicalcharacteristics o an ecosystem being assessed,excluding extractive (economic) use and aestheticvalue

Exposure assessment The process o describing the mechanism orpathway(s) necessary or an adverse event to occurand estimating the likelihood o that event occurring

Food saety Theprocess o ensuring that products or humanconsumptionmeet or exceed standards o quality toensure that human consumption will not result in

morbidity or mortality

Glossary


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Food security The protection and management o biologicalresources or sae and sustainable humanconsumption

Genetically modifedorganism (GMO)

An organism in which the genetic material has beenaltered by human intervention, generally throughuse o recombinant DNA technologies

Hazard An organism, action or event that can produceadverse consequences relative to the assessmentendpoint

Hazard identifcation The process o identiying events, actions or objectsthat can potentially cause adverse consequences tovalues

Impact The alteration or change in value caused by a hazardIntroduction The intentional or accidental transport and release

by humans o any species into an environmentoutside its present range

Invasive species An organism that causes negative impact toeconomic, environmental, socio-political or culturalvalues due to prolic growth and unmanagedpopulation

Likelihood Probability o an event occurring, ranging rom rare

events to likely or requent eventsNon-indigenous species An organism that has been transerred to a location

in which it did not evolve or in which it was notpresent in its historic range

Pathogen An inectious agent capable o causing disease

Pest An organism that causes harm toeconomic,environmental, socio-political or cultural values

Precautionaryapproach

An approach to risk management that takes intoaccount the precautionary principle

Precautionary principle The axiom that a lack o ull scientic certaintyshall not be used as a reason or postponing cost-eective measures to prevent environmentaldegradation (CBD, 1992)

Quarantine The isolation o a region, area or group o organismsto contain the spread or prevent the entry osomething considered dangerous or likely to causeharm (e.g. a pest or pathogen)

Release assessment The process o describing the pathway by which ahazard is released into the operating environmento the risk analysis and estimating the likelihood othis occurring


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Risk The potential occurrence o unwanted, adverseconsequences associated with some action over aspecied time period

Risk analysis A detailed examination including risk assessment,risk evaluation, and risk management alternatives,perormed to understand the nature o unwanted,negative consequences to human lie, health,property, or the environment in order to minimizethe risk

Risk assessment The process o assessing the likelihood andconsequence o an event

Risk communication The act or process o exchanging inormation

concerning riskRisk management The pragmatic decision-making process concerned

with what to do about risk

Risk mitigation Actions or controls that, when put in place, willalter, reduce or prevent either the likelihood or theconsequence o an event, thus acting to reduce therisk o an event

Socio-political value The value placed on a location in relation to humanuse or pleasure, aesthetic or generational values.This value may also include human health andpolitics. Examples include tourism, amily outings,learning and aesthetics

Transer The intentional or accidental transport and release oany species within its present range


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1

1. Introduction

1.1 BACKGROUND

As the global population expands to exceed six billion people, ecological securityhas become a ocal point or many national and international bodies (Homer-Dixon,2001; Degeest and Pirages, 2003; Pirages and Cousins, 2005). Indeed, signiicantpressures have come to bear on the inrastructure, ood security, ood saety andnatural resources o many nations (McMicheal, 2001). It is estimated that nearly

75 percent o the human population will live within 150 km o a coastline by 2025(Cohen, 1995; Hinrichsen, 1995), placing signiicant pressure on ocean and coastalresources.

In order or the current level and rate o economic growth to continue, relianceon aquatic resources to supply ood products, speciically protein, will increase(GESAMP, 2008). The current intensive development o aquaculture in manycountries is bridging the gap between stagnating yields rom many capture isheriesand an increasing demand or ish and ishery products, such that aquaculturenow contributes almost 50 percent o the global oodish supply (FAO, 2007a).As the worlds supply o aquatic ood will need to increase by at least 40 million

tonnes by 2030 to sustain the current per capita consumption level, it is expectedthat aquacultures contribution to the worlds production o aquatic ood willcontinue to increase. Thus, aquaculture will continue to strengthen its role incontributing to ood security and ood saety, while also oering opportunities toalleviate poverty, increase employment and community development, and reduceoverexploitation o natural aquatic resources, thus creating social and generationalequity, particularly in developing countries.

Aquaculture encompasses a very wide range o arming practices with regardto species (seaweeds, molluscs, crustaceans, ish and other aquatic species groups),environments (reshwater, brackishwater and marine) and systems (extensive,semi-intensive and intensive), oten with very distinct resource use patterns.This complexity oers a wide range o options or diversiication o avenues orenhanced ood production and income generation in many rural and peri-urbanareas. The majority o the global aquaculture output by weight is produced indeveloping countries, with a high proportion originating in low-income ood-deicitcountries (LIFDCs).

The aquaculture industry represents a solution to many o the ood securityissues acing the growing human population. However, it is also oten in directconlict with other users o aquatic habitats and the adjacent coastal and riparian

areas, including economic, environmental and social interests. The aquaculturesector is largely private, with increasing business demands or proitability. Asa consequence, the application o risk analysis to aid in identiying the various


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Understanding and applying risk analysis in aquaculture A manual for decision-makers2

business, economic, environmental and social risks has become necessary in themanagement o this growth sector. These include both risks to the environmentand society rom aquaculture and to aquaculture rom the environmental, social

and economic settings in which it operates.

1.2 PURPOSE

The purpose o this manual is to provide an overview o the risk analysis processas applied to aquaculture production and to demonstrate the variety o waysin which risk can maniest in aquaculture operations and management. Theintention o this document is to promote wider understanding and acceptanceo the applications and beneits o risk analysis in aquaculture production andmanagement. Thereore this manual is a high-level guiding document with

resources to allow urther enquiry.It is not a recipe book to be ollowed or instant success. Risk analysis andthe resulting guidelines, requently oered as industry best practice or standardoperating procedures (SOPs), are typically developed in an explicit context andrequire an understanding o the risk undamentals in order to be adapted toa new situation. To accomplish this, it is necessary that risk analysis capacityand capability in relation to aquaculture operations is developed in Food andAgriculture Organization o the United Nations (FAO) Member States andrelated to speciically identiied outcomes.

1.3 TARGET AUDIENCEThis manual is targeted towards senior managers and policy-makers o FAOMember States to aid in an understanding o the application o risk analysis inthis growing sector o the world economy. Thereore the primary ocus is onrisk issues outside the domain o business, except at a macro-economic level.Policy-level risks, however, may incorporate broad elements relevant to businessdecisions across an industry base (e.g. prawn armers, the salmonid industry).

It is likely that some inormation presented in this manual will be relevant toaquaculture operators, industry organizations, non-governmental organizations(NGOs) and other groups interested in the inluences on national policy relatingto the aquaculture industry and the management o aquatic resources.

1.4 SCOPE

This manual provides an overview o the considerations or risk analysis in decisionmaking or all orms o aquaculture and includes the impacts o aquacultureoperations on environmental, socio-political, economic and cultural values as wellas the impacts to aquaculture rom outside inluences, including environmental,socio-political, economic and cultural inluences. For example, hazards (andrisks) will low to production risks rom market risks, oten incorporating the

externalities o environmental and economic actors.Seven risk categories have been identiied in previous expert discussions,

speciically at the FAO/Network o Aquaculture Centres in Asia-Paciic (NACA)


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Introduction 3

Workshop on Understanding and Applying Risk Analysis in Aquaculture, heldin Rayong, Thailand rom 811 June 2007, as having relevance. These categorieswere:

PathogenrisksFoodsafetyandpublichealthrisksEcological(pestsandinvasives)risksGeneticrisksEnvironmentalrisksFinancialrisksSocialrisksIn most o the above risk categories the development o methodologies and

risk-based policies is well advanced. The irst two categories (pathogen risks,

ood saety and public health risks) are mature as a consequence o risk analysisstandards developed under international agreements in application to internationaltrade and ood saety. Pathogen risk analysis is covered under theAquatic Animal

Health Code o the World Organisation or Animal Health (OIE, 2009) (seeSection 2), with attempts to establish consistency across aquatic animal productionsystems regardless o operating environment. Food saety and public healthrisk analyses have also been developed in the international community underthe Codex Alimentarius (see Section 2). Financial risk and social risk analyseshave occurred in a variety o sectors, the most relevant o which is the insuranceindustry (Secretan, 2008). In contrast, ecological, genetic and environmental risk

analyses have proceeded along disparate lines, with various sectors developingdiscrete methodologies and contrasting terminologies. In many instances, therehave been limited applications to aquaculture production.

1.5 STRUCTURE OF THE MANUAL

The manual contains six sections. Section 1 provides a background to theaquaculture sector and an introduction to the concepts o risk analysis; Section2 presents the operating environment or risk analysis or the aquaculture sectorby briely reviewing the relevant international rameworks applicable to eachrisk category; Section 3 discusses a general risk analysis process or aquaculture;Section 4 provides brie overviews o the risk analysis process as applied in eacho the seven risk categories; Section 5 briely summarizes actions that need tobe taken by FAO Member States to promote the wider use o risk analysis oraquaculture development; and Section 6 discusses uture challenges to aquacultureand the role risk analysis might play in addressing them.

1.6 CONCEPTS OF RISK ANALYSIS

We live in a complex world, with various and requently conlicting prioritiesrequiring our attention. In most instances, our ability to make decisions is balanced

between these conlicting priorities, and we rarely have all o the inormationnecessary to develop the ideal solution. Instead we must make decisions in the aceo uncertainty to ascertain the best outcome. Take, or example, the decision to


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immunize our children against disease. Immunization provides signiicant humanhealth beneits to individuals and the general population; however, there is theslight potential or immunization to cause signiicant harm to any individual.

We cannot know with certainty whether any one child will experience a negativereaction. In this instance, public health oicials have analysed the overallbeneits o immunization relative to the risks to the individual and thus supportimmunization programmes. This assessment is a risk analysis.

In general terms, risk is the potential occurrence o unwanted, adverseconsequences associated with some action over a speciied time period (e.g. Arthuret al., 2004a). Risk is the possibility that a negative impact will result rom anaction or decision and the magnitude o that impact.

1.6.1 The risk analysis processRisk analysis is requently used by decision-makers and management todirect actions that potentially have large consequences but also have a largeuncertainty. Risk analysis1 is a structured process or determining what eventscan occur (identiying hazards), analyzing the probability that the event willoccur (determining likelihood), assessing the potential impact once it occurs(determining consequence), identiying the potential management options andcommunicating the elements and magnitude o identiied risks.

In simple terms, risk analysis is used to determine the likelihood that anundesired event will occur and the consequences o such an event. This is generally

developed in a repeatable and iterative process (MacDiarmid, 1997; Rodgers, 2004;OIE, 2009) where we seek answers to the ollowing questions:Whatcanoccur?(Hazard identiication)Howlikelyisittooccur?(Risk assessment: likelihood assessment through

release assessment and exposure assessment)What would be the consequences of it occurring? (Risk assessment:

consequence assessment and risk estimation; risk management: riskevaluation); and

What can be done to reduce either the likelihood or the consequencesof it occurring? (Risk management: option evaluation, Implementation,Monitoring and review).

The entire process includes risk communication, the communication o the riskto others in order to generate a change in management, regulation or operation.

It should be noted that a risk analysis must be scoped as the irst step.Risk analysis cannot determine the scope o the assessment, the endpoint othe assessment or (in most cases) the acceptable level o risk (ALOR) used todetermine management action. These decisions must be made beore the analysis,

1 It should be noted that risk analysis as used by FAO represents the overarching term that includesthe activities o hazard identiication, risk assessment, risk management and risk communication

(e.g. Arthur et al., 2004; GESAMP, 2008; OIE, 2009). In contrast, others (including the WorldHealth Organization, WHO) use the term Risk Assessment to represent the overarching termthat encompasses hazard identiication, risk analysis and risk evaluation (e.g. Aven, 2003; Nash,Burbridge and Volkman, 2005, 2008).


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Introduction 5

as they inluence the operating environment o the risk analysis. The scope o theassessment can limit or restrict the evaluation o impacts. For example, the scopeo the assessment may be restricted to economic actors alone, rather than include

environmental, social, political or cultural actors. Similarly, the endpoint (literally,where the assessment stops) must be identiied, as it will determine the extent oanalysis o hazards and impacts that must occur. Lastly, the acceptable level orisk (more oten reerred to in the opposite: the appropriate level o protection ALOP) is the level o risk (or protection) deemed acceptable by the authorityundertaking the risk analysis and is based upon socio-political perceptions orisk and thereore comprises value judgments within which the risk analysis willproceed. Frequently, neither ALOR nor ALOP are explicitly stated as policy, butthey can oten be determined rom existing standards and practices in protecting

human, animal and plant health, ecosystem well-being, and environmental andeconomic values rom external hazards (Wilson, 2001).

1.6.2 Why do we undertake risk analysis?

The purpose o risk analysis is to provide a structured means by which risks to orrom a sector can be assessed and communicated in order to guarantee a uniormand transparent process o decision making or regulatory control. It is highlydesirable or decision-making to be consistent, repeatable, objective and to providea clear methodology that makes the inormation eeding into the decision-makingprocess and its use transparent to others (including stakeholders). The ormality o

the risk analysis process provides a consistent guide to decision-makers that alsoestablishes a level o surety to stakeholders that the process will meet the desiredequitable outcomes.

Oten, risk analysis processes are either mandated or suggested underinternational agreements to meet speciic ends. For example, risk analysisprocedures have been agreed under the World Trade Organization (WTO) as ameans to guarantee that all trading partners are ollowing similar procedures (e.g.WTOsAgreement on Sanitary and Phytosanitary Measures the SPS Agreement).Similarly, a ormalized risk analysis can provide equity between competingproponents o a development project or aid regulators in determining the likelyoutcomes o a proposed activity. Risk outcomes can be codiied into standardso best practice or guidelines by regulatory or industry bodies or congruence.Ultimately, the use o risk analysis is to identiy decision options, including riskmanagement options that may eliminate or ameliorate the adverse eects o adecision. Risk management provides a tool that has been successully employedin numerous industries where the cost o management (e.g. actions ranging romcomplete prevention to doing nothing) needs to be weighed against the likelihoodo an undesired event occurring.

1.6.3 When do we use risk analysis?Risk analysis is suited to any circumstance where a decision must be made in theace o incomplete inormation and where the potential or adverse eects exists.


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I all were certain, the need or risk analysis would not exist. In some instances,risk analysis may be mandated as a statutory or regulatory requirement as part ointernational or regional agreements.

Risk analysis need not be an overly complicated process. It can be undertakenas a ully quantitative assessment o probabilities or alternately, can be based onqualitative (categorical) assessments o perceptions (as in socio-political impactanalysis). Risk analysis as a process should be considered as a highly lexibletool that can be readily adapted to various situations. As Arthur et al. (2004a)have stated, Countries or industries must determine the best methods that aremost eective and cost eicient or their particular circumstances, taking intoconsideration that the process needs to be science-based, systematic, iterative,consistent and transparent with timely and repeatable outcomes.

1.6.4 The Precautionary Principle

In general, risk analysis should operate under the approach o precaution (e.g. Peel,2005); however, the use o precautionary approaches in dealing with risk has beenthe ocus o much debate (see FAO, 1996; GESAMP, 2008). The precautionaryprinciple (and its application through the use o precautionary approaches) asagreed in the Convention on Biological Diversity Conerence o Parties (UNEP/CBD/COP/6/20) provides that uncertainty associated with the lack o knowledgeshould not be used to preclude making a decision. It should be noted that inthis context, the WTO SPS and CBD positions on precaution are opposed (see

Campbell et al., 2009). The precautionary principle is widely adopted by the FAOin regards to managing uncertainty in isheries (and aquaculture) management.The Code of Conduct for Responsible Fisheries (FAO, 1995) encourages States to

apply the precautionary approach widely to conservation,management and exploitation o living aquatic resources in order toprotect them and preserve the aquatic environment. The absence oadequate scientiic inormation should not be used as a reason orpostponing or ailing to take conservation and management measures.

1.6.5 Dealing with uncertainty

Risk analysis provides a systematic and scientiically deensible method oestimating probabilities in the ace o uncertainty. Uncertainties come in a varietyo types: uncertainty o method, uncertainty o measurement (associated withhuman error) and uncertainty o knowledge.

Uncertainty o method is typically managed through the iterative process orisk analysis coupled with open and transparent risk communication and eedbackrom stakeholders. In this ashion, the uncertainty associated with methodologyis improved through time as procedural errors are detected or alternate methodsare developed.

Uncertainty o measurement is most requently associated with the quality o therisk analyst, however methods to provide consistency between analysts are increasinglybeing developed (as part o the process) to reduce human-associated error.


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Introduction 7

Uncertainty o knowledge remains the greatest and most diicult issue tomanage. Typically this is associated with poor or incomplete biological (e.g. howan organism will react to speciic stimulus; what impact will an organism have

on another organism), economic or socio-political knowledge (e.g. variations inperceptions o impact between cultural groups; regional valuations o aesthetics)where best estimates or judgment must be used. For biological knowledge,the level o uncertainty will vary according to the organism or system beingassessed. We will have greater knowledge or a well-known organism or systemand thereore less uncertainty about the biological unctions or reactions. Social,political and cultural knowledge will vary according to the degree to which priorstudy has been undertaken. For smaller population groups o homogeneous socio-economic or cultural backgrounds, the level o uncertainty is likely to be much

reduced, whereas larger population groups or those with signiicant variation insocio-economic or cultural backgrounds are likely to be less similar and thereorehave greater uncertainty in response outcomes.

In all instances, uncertainty must be quantiied or estimated in order to providethe risk analyst the ability to account or uncertainty in the decision-makingprocess. In addition, documenting uncertainty aids in identiying how the riskanalysis might be improved through additional inormation-gathering research.

1.6.6 Application o risk analysis to aquaculture development

Risk analysis has wide applicability to aquaculture (see Arthur et al., 2004a,b;

Nash, Burbridge and Volkman, 2005, 2008; GESAMP, 2008) in assessing risks tosociety (human health) or to the environment due to hazards created through theestablishment or operation o aquaculture enterprises (e.g. GESAMP, 2001a, 2008;Nash, Burbridge and Volkman, 2005, 2008). These assessments remain importantin the national and local planning process and will continue to provide signiicantinput to policy development. In turn, the aquaculture industry will beneit byreducing its external impact on environmental, economic, social, political andcultural values.

Risk analysis, however, has been less commonly used to achieve successul andsustainable aquaculture production by assessing the risks to aquaculture that areposed by the biological, physical, social and economic environment in which ittakes place (GESAMP 2001b, 2008; Arthur, 2008). Issues important to aquacultureproponents such as site selection (e.g. biological risks o pathogen outbreaks,predator impacts, biological introductions) and operational risks (includinginancial and social impacts) can be managed through a risk analysis approach.

1.7 GENERAL FRAMEWORK OF RISK ANALYSIS

A risk management ramework operates by establishing the context (hazardidentiication); identiying the risk by determining the likelihood o the hazard

occurring (generally through release and exposure assessments) and the magnitudeo its eect or consequence (i.e. impacts); assessing the risks (analysing andevaluating the risks through the interaction o likelihood and consequence); and


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managing or treating the risk(s) (i.e. management, mitigation, communication). Ameasure o risk is derived by multiplying likelihood by consequence. This processis summarized in Figure 1.

Beore undertaking a risk analysis, the scope o the risk assessment, includingits endpoint, must be determined. The scope o the assessment provides a clearindication o the values that are assessed or impact and includes economic,environmental, social, political, and cultural values. Endpoint selection determineswhat type o null hypothesis is tested during the risk analysis. Endpoints tend tobe either: a) quarantine related beore a barrier control has been breached; orb) impact driven where the eect/impact/harm o an activity is assessed as thebasis o decision making. I a quarantine stance is taken, then consequences aterthe release are typically classiied as signiicant and the likelihood determines

risk. I the assessment is impact driven, then both the likelihood and consequencemust be determined to derive risk. An impact approach is typically ollowed whendetermining i an activity and its broader eect can or should be prevented ormanaged.

To aid management in prioritizing action in relation to hazards, the real andperceived impacts the hazard will have are examined against the core values(environmental, economic, social and political, and cultural values) in the regionthat will be directly aected and other regions that may be potentially aected (e.g.Campbell, 2005). The use o core values places management actions into a contexto being able to objectively assess hazards across environmental, economic, social

Identify

hazards

Determine

likelihood

Determine

consequence

Calculate risk =

likelihood x

consequence

Risk ranking =

direct advice /

prioritize actions

Assess uncertainty

Riskcommunication

FIGURE 1

Simpliied risk analysis process

Source: rom Campbell, 2006a.


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Introduction 9

and political, and cultural issues. The use o core values also ensures that our biasescan be accounted or and that the implications o a risk can be assessed across morethan just economic concerns. The core values are:

Environmental values Everything rom the biological to the physicalcharacteristics o an ecosystem being assessed, excluding extractive (economic)use and aesthetic value. Examples include loral and aunal biodiversity;habitat; rare, endangered and protected species and marine protected areas.

Economicvalues Components within an ecosystem that provide a current orpotential economic gain or loss. Examples include the inrastructure associatedwith ports, marinas and shipping channels; moorings and allocated isheriesareas, including stocks o exploitable living and non-living resources.

Socialandpoliticalvalues The values placed on a location in relation to

human use or pleasure, aesthetic and generational values and also includinghuman health and politics. Examples include tourism, amily outings andlearning.

Culturalvalues Those aspects o the environment or location that representan iconic or spiritual value or provide aesthetically pleasing outcomes ora region, including those that create a sense o local, regional or nationalidentity.

Each core value consists o a variety o dierent subcomponents that will dierboth spatially and temporally. A risk assessment can occur at the level o the corevalue or at the level o the core-value subcomponents. A risk assessment o the

impact a hazard may have on the our core values can be determined through asix-step process, as outlined in Figure 1.


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11

2. Operating environment

2.1 OVERVIEW OF REGULATORY FRAMEWORKS

This section provides an overview o relevant international and regional agreementsthat should be considered during risk analysis. It is not intended to be an exhaustivelist, and the range o agreements, legislation and policy rameworks should beexplored prior to the risk analysis process. The relationship between the sevenrisk categories identiied in Section 1.4 and the relevant regulatory agreements is

identiied in Table 1.TABLE 1

Relationship between the seven risk categories and relevant rameworks

FrameworkPathogens

Foodsafetyandpublic

health

Ecological(pestsand

invasivespecies)

Genetic

Environmental

Financial

Social

FAO/WHO Codex Alimentarius X

Convention on Biodiversity (CBD) X X X X X

International Plant ProtectionConvention (IPPC) X X X X

World Health Organization (WHO) X X X

OIEAquatic Animal Health Code X X

WTOAgreement on Sanitary andPhytosanitary Measures X X X X X

FAO Code of Conduct for ResponsibleFisheries (CCRF) X X X X X

ICES Code of Practice on theIntroductions and Transfers of Marine

Organisms X X X X X

2.1.1 International and regional agreements

Codex AlimentariusThe Codex Alimentarius Commission (CAC) was created in 1963 by FAO andthe World Health Organization (WHO) to develop ood standards, guidelines andrelated texts such as codes o practice under the Joint FAO/WHO Food StandardsProgramme (www.codexalimentarius.net/web/index_en.jsp). The main purposeso this programme are to protect the health o consumers, ensure air trade

practices in the ood trade and promote coordination o all ood standards workundertaken by international governmental and non-governmental organizations(NGOs).


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The signiicance o the ood code or consumer health protection wasunderscored in 1985 by the UN Resolution 39/248, whereby guidelines wereadopted or use in the elaboration and reinorcement o consumer protection

policies. The guidelines advise that Governments should take into account theneed o all consumers or ood security and should support and, as ar as possible,adopt standards rom the Codex Alimentarius o FAO and WHO.

The Codex Alimentarius has relevance to the international ood trade. Withrespect to the ever-increasing global market, in particular, the advantages ohaving universally uniorm ood standards or the protection o consumersare sel-evident. It is not surprising, thereore, that the Agreement on the

Application of Sanitary and Phytosanitary Measures (the SPS Agreement) and theAgreement on Technical Barriers to Trade (TBT Agreement) both encourage the

international harmonization o ood standards. A product o the Uruguay Roundo multinational trade negotiations, the SPS Agreement cites Codex standards,guidelines and recommendations as the preerred international measures oracilitating international trade in ood. As such, Codex standards have become thebenchmarks against which national ood measures and regulations are evaluatedwithin the legal parameters o the Uruguay Round Agreements.

The Codex Alimentarius has 180 members and has produced over 300 FoodStandards that are implemented worldwide.

Convention on Biological Diversity (CBD)

The Convention on Biological Diversity was created in 1992 at Rio de Janeiro todevelop consensus on protection o biological diversity at a global scale (CBD,1992). The CBD, with 191 Parties to the Convention, is not a standards-settinginstrument but is rather a acilitating body through which a balance betweeneconomic growth (including international trade) and the protection o biologicalvalues can be sought. The CBD Conerence o Parties recommends non-bindingactions to Parties, including Decision VII/5 on marine biological diversity, thatrecommends Parties and other governments use native species and subspeciesin marine aquaculture (paragraph 45(g)), and expresses support or regionaland international collaboration to address transboundary impacts o marineaquaculture on biodiversity, such as the spread o disease and invasive alien species(paragraph 51).

The CBD and its supplement, the Cartegena Protocol (CBD, 2000), haverelevance to the increasing allocation o riparian and ocean resources to aquacultureand the increasing ocus on the use o non-native species or aquaculturedevelopment. The Cartegena Protocol is explicitly designed to protect theenvironment and human health rom the eects o modern biotechnology.

International Plant Protection Convention (IPPC)

The International Plant Protection Convention is an international treaty tosecure action to prevent the introduction and spread o pests o plants and plantproducts and to promote appropriate measures or their control (www.ippc.int/


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13Operatingenvironment

IPP/En/deault.jsp). The IPPC was placed within the Agriculture Directorateo the Director-General o the FAO since its initial adoption by the Conerenceo FAO at its Sixth Session in 1951. It is governed by the Interim Commission

on Phytosanitary Measures (ICPM), which adopts International Standards orPhytosanitary Measures (ISPMs). The Secretariat o the IPPC was established in1992 by FAO in recognition o the increasing role o the IPPC in internationalstandard setting. It coordinates the activities o the IPPC and is hosted by FAO.As part o the organization, there are Regional Plant Protection Organizations(RPPOs) intergovernmental organizations unctioning on a regional basis ascoordinating bodies or National Plant Protection Organizations (NPPOs). TheSecretariat is responsible or coordinating the IPPC work programme, whichinvolves three main activities:

developingInternationalStandardsforPhytosanitaryMeasures(ISPM);providing information required by the IPPC and facilitating informationexchange between contracting parties; and

providing technical assistance,especiallyforcapacitybuilding, tofacilitatethe implementation o the IPPC.

As o May 2009, there are 170 governments that are currently Parties tothe Convention. The authority that the IPPC holds is that aorded to it bythe SPS agreement in Article 3 paragraph 1, which relates to the requirementthat members base their SPS measures on international standards, guidelines orrecommendations, where they exist.

World Health Organization (WHO)Established on 7 April 1948, the World Health Organization is the UNsspecialized agency or human health (www.who.int/en/). WHOs objective, as setout in its constitution, is the attainment by all peoples o the highest possible levelo health, health being deined as a state o complete physical, mental and socialwell-being and not merely the absence o disease or inirmity.

The WHO has 193 Member States. All countries that are Members o the UNmay become members o WHO by accepting its constitution. Other countriesmay be admitted as members when their application has been approved by asimple majority vote o the World Health Assembly. Territories that are notresponsible or the conduct o their international relations may be admitted asAssociate Members upon application made on their behal by the Member orother authority responsible or their international relations. Members o WHOare grouped according to regional distribution.

The authority that WHO has is through the authority o the UN. WHOis governed through the World Health Assembly, which is composed orepresentatives rom WHOs Member States. The main tasks o the World HealthAssembly are to approve the WHO programme and the budget or the ollowing

biennium and to decide major policy questionsThe purpose o the International Health Regulations is to ensure the maximum

security against the international spread o diseases with minimum intererence


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with world traic. Its origins date back to the mid-nineteenth century whencholera epidemics overran Europe between 1830 and 1847. These epidemics werecatalysts or intensive inectious disease diplomacy and multilateral cooperation

in public health, starting with the irst International Sanitary Conerence in Parisin 1851.

Between 1851 and the end o the century, eight conventions on the spread oinectious diseases across national boundaries were negotiated. The beginningo the twentieth century saw multilateral institutions established to enorcethese conventions, including the precursor o the present Pan American HealthOrganization (PAHO).

In 1948, the WHO constitution came into orce and in 1951, WHO MemberStates adopted the International Sanitary Regulations, which were renamed the

International Health Regulations in 1969. The regulations were modiied in 1973and 1981. The International Health Regulations were originally intended to helpmonitor and control six serious inectious diseases: cholera, plague, yellow ever,smallpox, relapsing ever and typhus. Today, only cholera, plague and yellow everare notiiable diseases.

The WHO continues to monitor and disseminate inormation on harmul algalblooms (HABs) that cause signiicant human morbidity or mortality associatedwith seaood poisonings.

World Organisation for Animal Health (OIE)

The World Organisation or Animal Health is an intergovernmental organizationthat was created on 25 January 1924 as the Oice international des pizooties(OIE) and is based in Paris (www.oie.int/eng/en_index.htm). In April 2009, theOIE had 172 Member Countries and Territories. Its objectives are to ensuretransparency in the global animal disease and zoonosis situation by eachmember country undertaking to report the animal diseases that it detects onits territory. The OIE then disseminates the inormation to other countries,which can take the necessary preventive actions. This inormation also includesdiseases transmissible to humans and the intentional introduction o pathogens.Inormation is sent out immediately or periodically depending on the seriousnesso the disease.

The OIE collects and analyses the latest scientiic inormation on animaldisease control. This inormation is then made available to the member countriesto help them to improve the methods used to control and eradicate these diseases.The OIE also provides technical support to member countries requestingassistance with animal disease control and eradication operations, includingdiseases transmissible to humans. The OIE notably oers expertise to the poorestcountries to help them control animal diseases that cause livestock losses, presenta risk to public health and threaten other Member Countries.

The OIE develops guidelines relating to animal health that member countriescan use in establishing rules to protect themselves rom the introduction odiseases and pathogens without setting up unjustiied sanitary barriers. The OIE


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risk analysis ramework allows or the assessment o all potential diseases that maybe associated with a particular commodity. The release and exposure assessmentsinclude the risk o transer to both indigenous and domestic animals and humans,

and the consequence assessment also includes consequences o exotic diseases thatmay enter on that pathway, to indigenous wildlie (alongside consequences to theeconomy and human health). The OIE risk analysis ramework can also be usedor assessment o risks rom new pests and diseases. With regard to aquatic animaldiseases, the main normative works produced by the OIE are the Aquatic Animal

Health Code (OIE, 2009) andthe Manual of Diagnostic Tests for Aquatic Animals(OIE, 2006). OIE standards are recognized by the World Trade Organization(WTO) as reerence international sanitary rules.

World Trade Organization (WTO) SPS AgreementThe Agreement on the Application of Sanitary and Phytosanitary Measures (theSPS Agreement) entered into orce with the establishment o the World TradeOrganization on 1 January 1995. It concerns the application o ood saety andanimal and plant health regulations, and it sets out the basic rules or ood saetyand animal and plant health standards. For the purposes o the SPS Agreement,sanitary and phytosanitary measures are deined as any measures applied: toprotecthumanoranimallifefromrisksarisingfromadditives,contaminants,

toxins or disease-causing organisms in their ood; toprotecthumanlifefromplant-oranimal-carrieddiseases;

to protect animal or plant life from pests, diseases, or disease-causingorganisms; and

topreventorlimitotherdamagetoacountryfromtheentry,establishmentor spread o pests.

Measures or environmental protection (other than as deined above) are aspeciic aspect o the SPS Agreement. Any environmental protection or beneitsare as a result o measures taken to meet the objectives o the above, so are notidentiied as solely or environmental protection.

The process or development o international standards, guidelines andrecommendations is through expert advice by leading scientists in the ieldand governmental experts on health protection and is subject to internationalscrutiny and review. Most o the WTOs member governments participate in thedevelopment o these standards by other international bodies; the WTO itsel isnot a standard-setting body.

Member countries are encouraged to use international standards, guidelinesand recommendations where they exist. International standards are oten higherthan the national requirements o many countries, including developed countries,but the SPS Agreement explicitly permits governments to choose not to use theinternational standards. However, when members use measures that result in

higher standards than those speciied in international agreements, these must bebased on appropriate assessment o risks so that the approach taken is consistentand not arbitrary. They should be applied only to the extent necessary to protect


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human, animal or plant lie or health and should be implemented impartially to allcountries and regions where identical or similar conditions prevail. The agreementstill allows countries to use dierent standards and dierent methods o inspecting

products. I the national requirement results in a greater restriction o trade, acountry may be asked to provide scientiic justiication, demonstrating that therelevant international standard would not result in the level o health protectionthe country considered appropriate.

As o 23 July 2008, there are 153 member governments belonging to the WTO.By accepting the WTO Agreement, governments have agreed to be bound bythe rules in all o the multilateral trade agreements attached to it, including theSPS Agreement. In the case o a trade dispute, the WTOs dispute settlementprocedures encourage the governments involved to ind a mutually acceptable

bilateral solution through ormal consultations. I the governments cannot resolvetheir dispute, they can choose to ollow any o several means o dispute settlement,including good oices, conciliation, mediation and arbitration. Alternatively, agovernment can request that an impartial panel o trade experts be established tohear all sides o the dispute and to make recommendations.

2.1.2 Voluntary rameworks

Numerous voluntary rameworks exist that have inluence over aquacultureproduction. Here we outline two that have explicit relevance to aquaculture.

FAO Code of Conduct for Responsible Fisheries (CCRF)The FAOs Code of Conduct for Responsible Fisheries (CCRF) (FAO, 1995) is abest-practice guide to the management and maintenance o capture isheries andaquaculture enterprises and has been promoted by FAO and other internationalinstruments, resulting in numerous ollow-up initiatives towards improving thesustainability o capture isheries and aquaculture practices. Article 9 o the Codedeals with Aquaculture Development, with Articles 9.2 and 9.3 explicitly identiyingthe introduction o alien species as requiring additional evaluation to minimize orprevent impacts to native ecosystems, including transboundary contexts.

O particular relevance to assessing and managing risks in aquaculturedevelopment, to support implementation o the CCRF, the FAO has developedthe FAO Technical Guidelines for Responsible Fisheries, a series o guidelinesproviding more detailed guidance to member countries on the application o theCCRF. Technical Guidelines No. 2 Precautionary approach to capture fisheries andspecies introductions (FAO, 1996) concerns the application o the precautionaryprinciple with respect to capture isheries and species introductions (includingintroductions or aquaculture development), highlighting the need or riskevaluation and the use o precaution. Technical Guidelines No. 5 Aquaculturedevelopment (FAO, 1997) is explicit to aquaculture development and discusses

each CCRF Article in Section 9 in urther detail. O these articles:Article 9.1.2 identifies the potential genetic impacts of released species

through introgression and competition with native stocks.


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Article9.2.3explicitlydiscussestheneedforconsultationwithneighbouringstates when considering the introduction o alien species into a transboundaryaquatic system. This discussion includes the need to identiy or establish a

regional body or consideration o applications and the sharing o inormationrelevant to the introduction.

Article9.3(andallsub-articles)identifiestheneedtominimizetheadverseeects o alien species to genetic resources and ecosystem integrity andencourages the use o native species whenever possible, the application ostandard quarantine procedures and the establishment (or adoption) o codeso practice or approvals and management o introduced species.

Additionally, to urther support Technical Guidelines No. 5 on Aquaculturedevelopment, Supplement 2 o the series (FAO, 2007c) deals with Health

management for the responsiblemovementof live aquaticanimals, stresses theneed or countries to use risk analysis procedures as the basis or preventing theintroduction and spread o transboundary aquatic animal diseases (TAADs) andthe application o a precautionary approach in cases where insuicient knowledgeexists.

The ICES Code of PracticeAs a ishery-oriented intergovernmental organization, the International Councilor the Exploration o the Sea (ICES) was conronted early on with issues relatedto the introduction o non-indigenous species, in particular the potential or the

spread o diseases and parasites via the international movement o live ish andshellish or stocking, ranching, aquaculture development and resh-ish markets.During the late 1960s and early 1970s, the need to assess the risks associated withdeliberate introductions and transers o species was primarily o concern. Whilegreat successes have been achieved by these activities, leading to the creation o newand important ishery and aquaculture resources, three challenges have suracedover the past several decades relative to the global translocation (introduction ortranser) o species to new regions. These include:Thepotentialecologicalandenvironmentalimpactsoftranslocatedspecies,

especially those that may escape the conines o aquaculture acilities andbecome established in the natural environment, with possible negativeimpacts on native species.

Thepotentialgeneticimpactofintroducedandtransferredspeciesrelativetothe mixing o armed and wild stocks, as well as to the release o geneticallymodiied organisms (GMOs).

The inadvertent coincident movement of harmful organisms associatedwith the movement o the target species, resulting in the spread o pests andpathogens to new geographic areas where they may negatively impact thedevelopment and growth o new ishery resources (including aquaculture)

and native isheries.ICES, through its Working Group on Introductions and Transers o Marine

Organisms (WGITMO) and its cooperation with other ICES Working Groups


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and with FAO, has addressed these three levels o concern since 1973 throughpublication o a series o successive Codes. These Codes represent a riskmanagement ramework or operational implementation to provide surety to

neighbouring coastal states that intentional introductions ollow acceptableguidelines. The most recent version o the ICES Code of Practice on theIntroductions and Transfers of Marine Organisms (ICES, 2005) provides guidanceor assessing the ecological, genetic and pathogen risks posed by a proposedintroduction or transer o an aquatic animal and provides decision-makers with aormal mechanism or deciding i a proposed translocation should proceed.

2.2 OVERVIEW OF THE KEY RISK CATEGORIES

For the purposes o this manual, the potential areas o risk, and thereore application

o risk analysis, have been summarized in seven risk categories. Within these broadcategories, it is impossible to outline all possible types o hazards that may beencountered during aquaculture development or even, given the wide range orisk analysis models that have been recommended and/or legislated or the sevenrisk categories, to recommend a single risk analysis model to be ollowed. Insteadwe provide a starting point or understanding the approaches and methodologiesthat are applied in the analysis o risk in the various categories. Below we outlinethe seven risk categories and provide or each, a short description and linkage tothe relevant guidance and the international agreements that inorm risk analyseswithin these categories. A brie summary o the risk analysis process as applied in

each o the seven risk categories is presented in Section 4.

2.2.1 Pathogen risks

The movement o live aquatic biota (animals and plants), their products and thewater they are in has the potential to transer pathogens rom one country orregion to another where the pathogens may not currently exist. Risks associatedwith the uncontrolled movements o aquaculture species, gear and eeds are wellknown (e.g. Sindermann, 1986, 1991; Arthur et al., 2004a; Bondad-Reantasoet al., 2005; OIE, 2006, 2009). Pathogen risks have largely been managed romthe perspective o international importation, but several countries and regionaleconomic communities have internal quarantine borders (e.g. Australia, Canada,the United States o America and the European Union (EU); Bondad-Reantasoand Arthur, 2008). Pathogen risk analysis (PRA) (oten termed import risk analysis(IRA) when applied to international movements) is a structured process used inmany countries to analyse the disease risks associated with the international ordomestic transport o live animals and their products. The endpoint o the riskanalysis is the outbreak o a serious disease in managed or wild stocks o thereceiving country or region. PRA represents only one aspect o a larger nationalbiosecurity strategy (also typically known as a national aquatic animal health

strategy) (Arthur et al., 2004a).In order to protect human, animal and plant health, the member countries

have signed the Agreement on Sanitary and Phytosanitary Measures (the SPS


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Agreement) (WTO, 1994). Under this agreement, member countries are requiredto use the risk analysis process as a means to justiy restrictions on internationaltrade in live animals or animal products based on their risk to human, animal or

plant health. For aquatic animals this includes the application o sanitary measuresbeyond those outlined in the OIE Aquatic Animal Health Code (WTO, 1994;Rodgers, 2004; Arthur et al., 2004a). Section 1.4 o the Aquatic Animal HealthCode (OIE, 2009) provides a ramework and general guidelines or the IRAprocess, but leaves signiicant leeway or member countries to adapt the detailso the process to their individual needs and situations. More recent advice on themethods or application o risk analysis to pathogen risks can be ound in Arthuret al. (2004a), ICES (2005), Bondad-Reantaso and Arthur (2008) and Copp et al.(2008).

The OIE Code provides or both qualitative and quantitative assessments orisk. Under speciic agreement, the OIE maintains a list o reportable diseasesthat present a suite o internationally agreed levels o unacceptable impact. Theseinclude pathogens o aquatic organisms aecting ish, crustaceans, molluscs andamphibians (Table 2).

TABLE 2

List o aquatic animal diseases notiiable to the OIE (rom OIE, 2009)

Aected taxon OIE-listed Disease

Fish Epizootic haematopoietic necrosis

Inectious haematopoietic necrosis

Spring viraemia o carp

Viral haemorrhagic septicaemia

Inectious salmon anaemia

Epizootic ulcerative syndrome

Gyrodactylosis (Gyrodactylus salaris)

Red sea bream iridoviral disease

Koi herpesvirus disease

Crustacea Taura syndrome

White spot disease

Yellowhead disease

Tetrahedral baculovirosis (Baculovirus penaei)Spherical baculovirosis (Penaeus monodon-type baculovirus)

Inectious hypodermal and haematopoietic necrosis

Crayish plague (Aphanomyces astaci)

Inectious myonecrosis

White tail disease

Mollusc Inection with Bonamia ostreae

Inection with Bonamia exitiosa

Inection with Marteilia refringens

Inection with Perkinsus marinus

Inection with Perkinsus olseni

Inection withXenohaliotis californiensis

Abalone viral mortality

Amphibia Inection with Batrachochytrium dendrobatidis

Inection with ranavirus


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Pathogen risks associated with aquaculture include the importation o liveorganisms as ood, eed products, ry, ingerlings, spat, and broodstock, as wellas uncooked products. Commodities include live invertebrates (e.g. molluscs,

arthropods) and vertebrates (e.g. inish, amphibians) in various lie-cycle stagesand their products (e.g. gametes, non-viable chilled aquatic animals (whole, or invarious orms) or human ood, eed products, etc.) that can potentially transerpathogens into cultured and wild stocks in the receiving country.

2.2.2 Food saety and public health risks

Outbreaks o ood-borne illness continue to be a major problem worldwide,with a signiicant number o deaths relating to contaminated ood and drinkingwater (Karunasagar, 2008). In order to protect public health and acilitate sae

international trade in ood products, the member countries o the World TradeOrganization (WTO) have signed the Agreement on Sanitary and PhytosanitaryMeasures (the SPS Agreement; WTO, 1994). Under this agreement, membercountries are encouraged to apply internationally negotiated standards; however,member countries have a right to adopt higher standards than internationallyagreed, but only i they are based upon strict risk analysis guidelines (produced bythe Codex Alimentarius Commission, CAC) and are not deemed to be arbitraryor used as an excuse to protect domestic markets.

The CAC guidelines provide or both qualitative and quantitative assessmentso risk and include both chemical and biological hazards capable o causing

adverse human health eects. The detailed knowledge o the majority o hazardsin this risk category allows or signiicant sophistication in the risk analysisprocess. Hazard characterization may include dosage and temporal exposureeects, inluences o target physiological condition (e.g. at content, age, gender,race) and population characteristics.

It should be noted that ood saety and public health risk analyses are highlypro-active, anticipating the inormation needs. As a consequence, dose-responseassessments are conducted rom outbreak assessments, volunteer studies and/oranimal studies.

Food saety and public health risk analyses within the aquaculture productionsector include assessments to allow international trade (e.g. development oimport health standards, generally via Import Risk Assessments), industry-wide closures due to pathogen outbreaks and detection o tainted products onimportation or in the marketplace. These assessments are largely restricted to thepresence o a hazard (i.e. a viral, microbial or chemical agent), the dosage necessaryto cause human morbidity (generally as a percentage o population), and the oodhandling and ood preparation opportunities to reduce or eliminate the harm. Asa consequence, risk management options are outlined that ollow a structuredapproach to meet appropriate levels o protection (ALOP).

Other public health risks associated with aquaculture production includeworker saety, public saety and externalities on the community (e.g. impacts ondrinking water). Worker saety is generally managed under public saety legislation


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covering occupational health and saety (variously called occupational saety andhealth, occupational saety, health and environment) and is not discussed urtherhere.

Public saety may be aected through the unintentional access o untrainedpersonnel to the arm site or through interactions between the aquaculture acilityand competing stakeholder uses (e.g. swimmers, recreational and commercialishers, boaters, coastal navigation). The evaluation and management o these risksis generally the authority o coastal planning agencies (GESAMP, 2001a). Thepotential or aquaculture to release waste eluents into coastal waterways andthereby increase the likelihood o harmul algal blooms (HAB) has been discussedby Yin, Harrison and Black (2008).

2.2.3 Ecological (pests and invasives) risksEcological risks both to and romaquaculture are here restricted to the human-mediated introduction o non-native species to regions where they did not evolveor did not historically exist. Such introductions have had signiicant impacts toenvironmental, economic, social and political, and cultural values on a globalscale (Campbell and Hewitt, 2008; Leung and Dudgeon, 2008). Non-native (alsotermed exotic or introduced) species are now considered to be one o the top ivethreats to native biodiversity in the worlds oceans (Carlton, 2001; Hewitt, 2003a).Non-native species may cause harm through both direct and indirect avenues suchas predation on and competition with native species, habitat alteration, and toxic

eects on humans and native animals and plants (Hewitt, 2003b).The increasing use o non-native species or aquaculture development is o

signiicant concern, as subsequent escapes o these species and their associatedpathogens pose a serious threat to native biodiversity, economic value andecosystem unction, particularly in regions rich in endemic species (Cooket al., 2008). Aquaculture-associated introductions have contributed as much as20 percent o the total introduced auna and lora to many regions, both throughmovement o the intentional target species and through inadvertent movemento hitch-hikers (pests and pathogens) that live on, in or with the target species(Hewitt et al., 2004; Weigle et al., 2005; Casal, 2006). The contribution o non-native species to the growth o the global aquaculture industry and the economicbeneits that they have brought to many developed and developing countries,however, cannot be underestimated (see FAO, 2007a).

Currently no international instrument explicitly addresses the use o non-nativespecies or establishing new aquaculture industries or capture isheries. Hewitt,Campbell and Gollasch (2006) review the international agreements and codesassociated with the use o non-native species in aquaculture. The United NationsConvention on the Law o the Seas (UNCLOS, 1982) created the legal basis orsubsequent marine legal regimes. UNCLOS explicitly places a general requirement

or Parties to take measures to prevent, reduce and control pollution o the marineenvironment and includes all activities involving the development o economicresources, as does the Convention on Biological Diversity (see Section 2).


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Several codes have been developed as voluntary guidelines on these issues,such as the ICES Code of Practice for the Introductions and Transfers of MarineOrganisms (ICES, 2005) and FAOs Code of Conduct for Responsible Fisheries

(CCRF), whoseArticle 9 addresses AquacultureDevelopment (FAO, 1995) (seeSection 2.1.2 or details).

Ecological risks to aquaculture rom non-native species and invasive nativespecies also remain signiicant. Species introduced via other transport vectorssuch as international shipping, intentional movements or isheries stockingor other aquaculture activities (e.g. Ruiz et al., 1997; Carlton, 2001) canhave signiicant impacts on aquaculture operations. These impacts can includepredation; competition; the ouling o nets resulting in reduced water low, oxygendepletion and scariication o gills; algal blooms and associated biotoxins; and loss

or reduction o ood stocks (e.g. Hewitt, 2003b).Ecological risk analyses can be either qualitative or quantitative and cancontribute to import health standards or organism impact assessments ater thespecies has been introduced (Campbell, 2005, 2006a,b, 2008). The processes andmethodologies used or these risk analyses ollow similar steps to those in otherrisk categories.

2.2.4 Genetic risks

The development and application o molecular and genetic techniques will play animportant role in the uture development o aquaculture (Hallerman, 2008), with

contributions to improved quality o genetic stocks (Dunham, 2004; Gjedrem,2005) and the concomitant increase in production levels and eiciencies (ADB,2005). Cross (2000) described the genetic improvement o aquaculture speciesas an economic imperative and without it, the industry would ind it impossibleto compete. For example, coho salmon (Oncorhynchus kisutch) with introducedgrowth hormone genes rom chinook salmon (O. tshawytscha) demonstratedmuch aster growth compared to the control group (Devlin et al., 1994). Thisincreased attention to and use o genetic methods or the improvement o stockshas led to direct genetic harm to natural populations, including loss o localadaptation and introgression o new genetic material (e.g. Mooney and Cleland,2001; Arnaud-Haond et al., 2004).

The potential or aquaculture to aect the genetic integrity o naturalpopulations is recognized in a number o international agreements, guidelines andcodes o conduct; however, these vary widely in their approaches (Hallerman,2008). The CBD (1992) addresses the use o genetically modiied organisms(GMOs) or research and commercial activity and provides implementationpolicies (CBD, 2000). However policies or aquatic GMOs are still underdevelopment. The release o genetically distinct stocks rom aquaculture acilitiesinto native populations is considered as an introduction o non-native species

under the CBD, FAOs CCRF and the ICES Code o Practice.The use o risk analysis in relation to genetic risks rom aquaculture has notably

been used in assessing triploid oyster impacts (Dew, Berkson and Hallerman, 2003;


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NRC, 2004) and transgenic ishes (OAB, 1990; Hallerman and Kapuscinski, 1995);however, it has had limited application elsewhere (Hallerman, 2008). Recently,GESAMP (2008) developed a risk analysis methodology or environmental risks

that incorporated the impacts o genetic introgression o armed stocks on wildpopulations (Davies, Greathead and Black, 2008).

2.2.5 Environmental risks

The development o aquaculture poses several potential threats to the naturalenvironment, including (but not limited to) increased organic and inorganicloading, residual heavy metals, residual therapeutants, physical interactions withmarine lie o gear and escapes, use o wild juveniles or grow-out, use o wildstocks or ish eed and degradation or replacement o habitat (Nash, Burbridge

and Volkman, 2005, 2008; GESAMP, 2008).It has been noted that the eects o environmental risks can be subtle andcumulative, leading to diiculties in prediction and management (Phillips andSubasinghe, 2008). Indeed, environmental impacts rom aquaculture are highlydiverse, leading to no single international or regional agreement that providesinsights to appropriate management. As previously mentioned under Ecologicalrisks (Section 2.2.4), UNCLOS and the Convention on Biological Diversity(CBD) (see Section 2) create obligations on Parties to prevent the pollution othe marine environment. Many environmental impacts occur at some distancerom the source (aquaculture arm) and may result in transboundary eects.

Similarly, impacts to locations o high value may be covered under a number ointernational agreements such as the World Heritage Convention (UNESCO,1972), the Ramsar Convention (Convention on Wetlands, 1971) or other site-speciic agreements. In addition, the FAOs CCRF provides guidance on the needto manage the environmental impacts o ishing and aquaculture activities.

The use o risk analysis to aid in management o environmental risks to androm aquaculture is limited. Nash, Burbridge and Volkman(2005, 2008) provideguidelines or ecological risk assessment2 o marine ish aquaculture. They identiythe standard risk process and provide ten environmental impacts (hazards) ashaving greatest importance. Environmental risk assessment (ERA) is noted to relyon inormation with signiicant uncertainty and oten deals with eects that arenot clearly quantiiable. As a result, the ERA process is typically qualitative orsemi-quantitative in orm. This is particularly the case when impacts are assessedbased on environmental, social and cultural values.

The Joint Group o Experts on Scientiic Aspects o the Marine EnvironmentalProtection (GESAMP) Working Group 31 has recently completed the reporton Assessmentandcommunicationofenvironmentalrisksincoastalaquaculture (GESAMP, 2008). This document provides advice on the potential environmentalimpacts o coastal aquaculture and identiies mechanisms to maintain consistency

in assessment and communication o risks rom coastal aquaculture. The report

2 It should be noted that the terms environmental risk assessment and ecological risk assessment arerequently used interchangeably.


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provides a clear and concise methodology with examples across a number oenvironmental eects, including impacts on primary producers and changes introphic resources and in habitat.

2.2.6 Financial risks

Financial risk in aquaculture reers primarily to investment risk associated withindividual arms or acilities (Kam and Leung, 2008). While these risks are likelyto be o primary concern to individual armers, shareholders, enterprises orinancial institutions providing inance or insurance (Secretan, 2008), the impactso inancial loss across a large sector o an economy can create macro-economicmarket luctuations that must be considered at the national policy level or even atthe international level, as seen by the increase in global salmon prices ollowing the

recent severe disease outbreaks in Chilean salmon arming. Agriculture (includingaquaculture) activities have been deemed inherently risky ventures by some(Goodwin and Mishra, 2000).

Kam and Leung (2008) suggest that inancial risk is largely broken intoproduction threats and market threats. Production threats result in inancial lossdue to reduced yield. These impacts can be realized based on adverse environmentalconditions, equipment ailure, poor quality stock, disease or pest inestation, andothers. Many o these external actors can be ameliorated by knowledgeable sta;hence, employee management (social risks) may lead to signiicant productionailures.

In contrast, market threats include price luctuations and the impacts o theregulatory environment (Jorion, 2007). Competition, either domestically orinternationally, will add to the volatility o market prices and hence to proitmargins. In contrast, the regulatory environment may create additional costburdens at the national level that are equally shared across the industry, but createsigniicant inancial risks on the international market.

Analyses o inancial risk are typically quantitative in their approach becauseinancial risk generally implies monetary loss (Jorion, 2007). Analyses can beapplied at the level o an individual enterprise (arm) or across a sector at thenational or regional level. No speciic international or regional agreements existthat provide guidance on inancial risk analysis, and as Kam and Leung (2008)state, ew examples o inancial risk analysis exist that would be comparable toanalyses conducted or other risk categories.

2.2.7 Social risks

Much like inancial risks, social risks are widely associated with the corporatesphere and have had limited application in national policy planning or theaquaculture industry (Bueno, 2008). Social risk analysis is widely used as part oproject planning; however, there has been recent application to address poverty

alleviation and social welare in developing economies (Holzmann, 2001; ADB,2003). Social risks incorporate business practices that adversely impact humanwelare and development, working conditions and industrial relations. As Bueno


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(2008) states, Social risks in aquaculture are challenges by society to the practiceso the sector, industry, company or arm over the perceived or real impacts o thesepractices on issues related to human welare.

Many social risks can be ound in other risk categories; however, the explicitimpact o aquaculture business practice on local human welare requires specialattention to developing this area at a national policy level. The development orexpansion o an aquaculture sector can have signiicant impacts on native accessrights, artisanal isheries, traditional values or earning potentials. In some instancesthe use o oshore (e.g. non-domestic) labour may reduce the social beneit tolocal communities rom establishing the aquaculture industry in the irst place.

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understanding and applying risk analysis

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