Depar tment of Pr imar y Industr ies, Par ks, Water and Environment
Impor t RiskAnalysis
Edition 1
A FRAMEWORK OF CONTEXT, CONCEPTS , METHODS AND ADMINISTRATIVE PROCEDURES
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Foreword
The work that informs pest and disease regulation must address diverse and complex matters. Deciding which hazards to investigate, distinguishing between knowledge gaps that are more or less important, identifying risk mitigation options likely to give best returns, and managing the analysis process, are just a few elements that make import risk analysis a challenging exercise. Over the last decade, publications have become available that set out technical and administrative elements of import risk analysis for regulatory purposes. These aim to bring consistency to the work of Government biosecurity analysts and decision‐makers, and demonstrate a jurisdiction’s ability to meet international environmental and trade obligations, and goals for domestic social, environmental and economic wellbeing. Equally, such publications communicate to stakeholders how Governments manage import risk. This applies in particular to administering the distribution of costs and benefits arising from biosecurity action (or inaction) in ways that serve public interests, and ensuring decisions are scientifically and technically defensible but sensitive to other legitimate considerations and values expressed by the community. The Import Risk Analysis framework herein borrows from a number of existing publications, and has similar objectives. It is distinguished by being set in the uniquely Tasmanian context and reflects Government’s commitment to preserving one of the most important and fragile State assets ‐ good biosecurity status. As an island, Tasmania is readily identifiable as a biosecurity unit. But clearly it does not function entirely on its own in this regard. At the time of writing, the Australian, State and Territory Governments are crafting responses to the review of national biosecurity completed in late 2008. One Biosecurity: A Working Partnership recommends changes to legislative, institutional and administrative arrangements for Australian biosecurity. Depending on how these are translated in the current inter‐governmental work, many can be expected to have fundamental implications for biosecurity, including for import risk analysis. This framework could be deferred until national reforms become clear. However, Tasmania confronts a range of factors that are changing, and probably increasing biosecurity risk across the globe. The expansion of trade and travel, and climate change are familiar, but there are others such as increased transfer of animal and plant breeding material, new animal and human diseases resulting from more or different interactions between wild animal populations, livestock and people, and an apparently thriving hobbyist trade in novel biota. These things are with us now. As such, there is no compelling reason to put off developing guidance for our own risk practitioners, even if this needs to be modified in the future. And it would be wrong in any case to represent this framework as a final word because the practice of import risk analysis needs to evolve with a shifting set of challenges, a situation that will continue to confront us.
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The quality of Tasmanian Government import risk analysis work is high, reflecting the commitment, skills and knowledge of its officers. However, by exploring the challenges posed by import risk analysis, the framework provides some prompts that may lead to yet more effective approaches to predicting, preventing and communicating pest threats associated with import activity. A scan of what lies ahead for import risk analysis suggests potential for development in many areas. Improved recognition and control of pathways for environmental pests, more meaningful import risk economics, techniques for meta‐analysis, greater use perhaps, of Bayesian statistics, more attention to risk perception, and to modes of stakeholder participation, all seem likely. In particular, increasing application of adaptive management principles, including targeted monitoring of risk mitigation measures to provide effective feedback, is becoming evident. I look forward to these developments, and on behalf of the Tasmanian Biosecurity Committee, commend to you Tasmania’s first edition of Import Risk Analysis: a framework of context, concepts, methods and administrative procedures. Michele Moseley Deputy Secretary, Corporate Services and Primary Industries Department of Primary Industries, Parks, Water and Environment Email: [email protected] Internet: http://www.dpipwe.tas.gov.au Chair, Tasmanian Biosecurity Committee July 2010
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Contents
Foreword .................................................................................................................................... 2 Acronyms and abbreviations ...................................................................................................... 7 Tables and Figures ...................................................................................................................... 8 Chapter One Introduction......................................................................................................... 9 1.1 Purpose and scope ............................................................................................. 9 1.2 Relation to existing risk analysis methods ....................................................... 13 1.3 Perspectives and principles .............................................................................. 15
Chapter Two Pests, diseases and Tasmania ........................................................................... 25 2.1 Tasmania’s pest status ..................................................................................... 26 2.2 Threats to Tasmania’s pest status ................................................................... 31 2.3 Tasmania’s biosecurity risk profile ................................................................... 36
Chapter Three International policy and legal environment ..................................................... 45 3.1 International policy and law relevant to biosecurity ........................................ 45 3.2 Regional and bilateral arrangements relevant to biosecurity .......................... 66
Chapter Four National policy and legal setting ...................................................................... 68 4.1 Australia’s biosecurity system ......................................................................... 68 4.2 Australian biosecurity policy ............................................................................ 72 4.3 Federal, State and Territory powers for regulation of trade and movement
into Australia ..................................................................................................... 79 4.4 Federal, State and Territory powers for regulation of interstate trade and
movement ......................................................................................................... 87 4.5 National Import Risk Analysis Administration ................................................. 89
Chapter Five Tasmanian policy and legal setting ..................................................................... 92 5.1 Tasmania’s biosecurity system ........................................................................ 92 5.2 Tasmanian import policy and law .................................................................. 101
Chapter Six Concepts for import risk analysis ...................................................................... 104 6.1 The relevance of risk perception ................................................................... 104 6.2 Influences on risk perception ......................................................................... 107 6.3 Risk perception and ability to estimate risk ................................................... 112 6.4 Moderating undesirable effects of risk perception ....................................... 114 6.5 Uncertainty analysis, treatment and portrayal ............................................. 116 6.6 Eliciting expert opinion .................................................................................. 130
Chapter Seven Import risk analysis method ......................................................................... 134 7.1 Risk analysis model ........................................................................................ 134 7.2 Establish the context ...................................................................................... 137 7.3 Define the problem ........................................................................................ 141 7.4 Collect information and specify assumptions ................................................ 154 7.5 Establish the risk model ................................................................................. 160 7.6 Assess the risks ............................................................................................... 174 7.7 Identify management options ....................................................................... 196 7.8 Test sensitivity and finalise the analysis ........................................................ 209 7.9 Decide ............................................................................................................ 212 7.10 Monitor and update ....................................................................................... 213
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Chapter Eight Import risk analysis administration ............................................................... 216 8.1 Concepts for import risk governance ............................................................. 216 8.2 Regulatory authority and import risk analysis structures .............................. 219 8.3 Administrative processes ................................................................................ 224
Glossary .................................................................................................................................. 229 References .............................................................................................................................. 234 Recommended reading .......................................................................................................... 243 Appendix 1 The World Trade Organisation Agreement on the Application of Sanitary
and Phytosanitary Measures (SPS Agreement) ............................................ 246 Appendix 2 Comparison of OIE and IPPC import risk ....................................................... 259 Appendix 3 Import Risk Analysis Templates .................................................................... 262 Appendix 4 Peer review questions ................................................................................... 267
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Acknowledgements
Thanks to the following people for providing advice and other assistance: Andrew Bishop, Mark Burgman, Mary‐Lou Conway, Tim Farrell, Hugh Griffiths, Paul Keese, Alastair Morton, Alice Morris, Stefan Petrow, Annie Philips, Darren Phillips, Grant Rootes, Alex Schaap, John Virtue, Chinatsu Yahata
© Department of Primary Industries, Parks, Water and Environment, Tasmania, 2010 All rights reserved. No part of this document may be reproduced in any form without written permission from the publisher. Compiled by Cindy Hanson ISBN ‐978‐0‐7246‐6523‐5 pdf
Comments? Feedback on the framework may be submitted to: [email protected] Biosecurity and Plant Health Branch Department of Primary Industries, Parks, Water & Environment
Disclaimer The information provided in this document is provided in good faith. The Crown, its officers, employees and agents do not accept liability however arising, including liability for negligence, for any loss resulting from the use of or reliance upon the information in this manual and/or reliance on its availability at any time.
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Acronyms and abbreviations ACERA Australian Centre of Excellence for Risk Analysis ALOP Appropriate Level of Protection AQIS Australian Quarantine and Inspection Service BA Biosecurity Australia BPID Biosecurity and Product Integrity Division (Tasmanian Government) BSG Biosecurity Services Group (Australian Government) BTG Biosecurity Technical Group (Tasmania) CBD Convention on Biodiversity (International) CITES Convention on the International Trade in Endangered Species of Wild Fauna and Flora CVO Chief Veterinary Officer (Tasmanian Government) DAFF Department of Agriculture, Fisheries and Forestry (Australian Government) DEWHA Department of the Environment, Water, Heritage and the Arts (Australian
Government) DPIPWE Department of Primary Industries, Parks, Water and Environment (Tasmanian
Government) DQMAWG Domestic Quarantine and Market Access Working Group (Australian) FAO Food and Agriculture Organisation of the United Nations GATT General Agreement on Tariffs and Trade IGAB Intergovernmental Agreement on Biosecurity (Australia) IPPC International Plant Protection Convention IRA Import Risk Analysis ISPM International Standard for Phytosanitary Measures MOU Memorandum of Understanding on Animal and Plant Quarantine Measures (Australia) NEBRA National Environmental Biosecurity Response Agreement (Australia) NRMMC Natural Resource Management Ministerial Council (Australia) OIE Organisation des Epizooties (International) PIMC Primary Industries Ministerial Council (Australia) PRA Pest Risk Analysis PWS Parks and Wildlife Service (Tasmanian Government) SPS Agreement on the Application of Sanitary and Phytosanitary Measures Agreement SPS measure Sanitary or phytosanitary measure TBC Tasmanian Biosecurity Committee TWWHA Tasmanian Wilderness World Heritage Area WTO World Trade Organisation
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Tables and Figures TABLE 1 SOME SIGNIFICANT EXOTIC PESTS ESTABLISHED IN TASMANIA ..................................................... 27 TABLE 2 SIGNIFICANT EXOTIC PESTS PRESENT ON THE AUSTRALIAN MAINLAND WHICH COULD ESTABLISHED IN
TASMANIA ........................................................................................................................ 28 TABLE 3 RISK RANKING MATRIX USED BY BIOSECURITY AUSTRALIA WHERE 'VERY LOW RISK' MEETS AUSTRALIA'S
APPROPRIATE LEVEL OF PROTECTION ..................................................................................... 73 TABLE 4 DECISION RULES USED BY BIOSECURITY AUSTRALIA FOR DETERMINING THE IMPACT SCORE BASED ON THE
MAGNITUDE OF CONSEQUENCES AT FOUR GEOGRAPHIC SCALES (BIOSECURITY AUSTRALIA 2009C) ..... 95 TABLE 5 TASMANIAN LEGISLATION FOR CONTROLLING IMPORTATION OF PESTS AND DISEASES ..................... 102 TABLE 6 RISK RANKING MATRIX ...................................................................................................... 175 TABLE 7 NOMENCLATURE FOR DESCRIPTIVE LIKELIHOODS .................................................................... 177 TABLE 8 RULES FOR COMBINING DESCRIPTIVE LIKELIHOODS .................................................................. 182 TABLE 9 MAGNITUDE OF LOCAL, DISTRICT, REGIONAL AND STATE CONSEQUENCES ................................... 192 TABLE 10 MAIN ECONOMIC COSTS AND BENEFITS RELEVANT TO QUARANTINE REGULATION (ADAPTED FROM
BINDER 2002 AND TANNER 2003) ..................................................................................... 205
FIGURE 1 WORLD TRADE ORGANISATION LEGAL SYSTEM ‐ BASIC STRUCTURE ........................................... 50 FIGURE 2 CROSS‐JURISDICTIONAL AND CROSS‐SECTORAL GOVERNANCE OF AUSTRALIAN BIOSECURITY POLICY .. 78 FIGURE 3 GOVERNANCE OF TASMANIA'S BIOSECURITY SYSTEM ............................................................. 100 FIGURE 4 IMPORTATION SCENARIO FOR AN HYPOTHETICAL PEST OF WARE POTATOES FROM THE AUSTRALIAN
MAINLAND ................................................................................................................... 165 FIGURE 5 DISTRIBUTION SCENARIO FOR AN HYPOTHETICAL PEST OF WARE POTATOES FROM THE AUSTRALIAN
MAINLAND ................................................................................................................... 166
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Chapter One
Introduction The approaches (to risk analysis) share a common belief in the epistemic nature of risk: there is a fact and it is the job of the risk analyst to estimate it. An opposing philosophy is that risks are subjective and context dependent...... Burgman 2005
1.1 Purpose and scope
1.1.1 Genesis and definition
This framework for import risk analysis has been prepared under the auspices of the
Tasmanian Biosecurity Committee (TBC). The committee oversees the Tasmanian Biosecurity
Strategy in which risk analysis and tools for conducting it are identified as essential to
Tasmania’s biosecurity system. The framework is offered as one such tool.
Its purpose is to provide guidance on practical ways of reliably and consistently estimating
risks of pests (including pests, pathogens, weeds and other invasive species) that may arrive
here in any kind of trade or travel. These risk estimates inform Government import policy
decisions that protect public interests by safeguarding animal and plant health, the natural
environment, and the Tasmanian community.
The framework is for risk analysts and decision‐makers in the Department of Primary
Industries, Parks, Water & Environment (DPIPWE), and other Tasmanian Government
agencies, engaged in preventing or minimising harm caused by pests associated with
movement of animals, plants, goods or conveyances into this state. Biosecurity operational
staff may also find the framework a useful reference, given their critical roles in import risk
management and monitoring, and risk communication.
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The framework is also available to anyone else within or outside the Tasmanian Government
interested in how Tasmania approaches import risk analysis and regulation.
It should be read with future improvement in mind. The fluid nature of biosecurity risk and
the continuing evolution of risk analysis and risk regulation theory and practice mean
updates will be required. Comments are welcome.
In addition, a review of national biosecurity has been completed (Beale et al. 2008), the
practical outcomes of which are taking shape. Changes in how import risk analysis and risk
regulation are undertaken and administered at the national level may occur which could
have implications for Tasmania. For example, one theme of the review report is the
importance of ‘risk‐return’, meaning investments should be made in alternatives that
maximise the cost‐effectiveness of biosecurity activity relative to risk. Import risk analysis is
one process that could potentially be used to assess and more explicitly demonstrate risk
return.
Regardless that national biosecurity reform is underway, the present approach to import risk
analysis in Tasmania is documented as a platform for ongoing internal discussion, with a
view to contributing to nation‐wide talks, and to support the Tasmanian Government’s
abiding commitment to State biosecurity.
So what is import risk analysis and why does Government do it?
Import risk analysis is defined here as an exercise undertaken in the public interest, in
determining effective and acceptable options for avoiding or reducing harm from pests
associated with importation or other movement into Tasmania.
It is based on the structured distillation of relevant scientific, economic and technical
evidence, and uncertainty attending that evidence. It involves communicating information in
a way that addresses the needs of decision‐makers and other parties affected by or
interested in import regulation. It encompasses import regulation decisions by the
Tasmanian Government that mitigate biosecurity risk and which are consistent with
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Tasmanian community expectations. It includes monitoring and updating decisions as new
information comes to hand, and as circumstances and risks change.
This definition is elaborated throughout the document but two aspects are highlighted
below as pertinent to framework scope.
1.1.2 Costs and benefits
The analytical approach in the framework is confined to questions of hazard (ie. sources of
harm under certain circumstances) potentially posed by pests associated with inbound trade
or travel.
Clearly, those activities bring benefits to the economy, social welfare and sometimes to the
natural environment, as well as imposing other non‐pest related costs. Examples of benefit
include access to cheaper or a more diverse range of goods, and tourism revenue.
Competition from cheaper or better quality imported goods that reduces the profitability of
Tasmanian businesses is a potential cost.
There are reasons stemming from international law, why the approach to estimating import
risk outlined in this framework is limited to characterising harm of pests, and does not
include means for weighing this against the broader scope of potential consumer or other
benefits and costs of trade. These reasons are explained later.
1.1.3 What kind of hazard?
There are several types of potential biological hazards associated with inbound trade and
travel. The framework covers many but not all of them.
Hazards within scope are living organisms that directly or indirectly diminish animal or plant
health or life, or the integrity of the natural environment, whether introduced deliberately
or by accident. Certain human health and safety hazards are included in the framework, but
only to the extent these result from pests or pathogens of animals that are also capable of
harming people, or are pests or pathogens of humans carried in or on imported plants or
plant products.
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Hazards not addressed in the framework are food‐borne biological contaminants (eg. toxin‐
producing bacteria, parasites) and genetically modified organisms. While there are elements
in common, import risk analysis for these hazards is addressed under separate policy.
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1.2 Relation to existing risk analysis methods
Human, animal, plant and environmental health protection responsibilities, including for
import risk regulation, are delegated to a number of Tasmanian Government agencies.
Import policy formulated by these agencies has always involved risk evaluation but the
processes for doing this are maturing, and becoming more systematic and formalised. The
framework is part of this evolution.
The Department of Primary Industries, Parks, Water & Environment (DPIPWE) is the lead
agency for most import risk regulation concerning animal, plant and environmental health. It
coordinates as required with other agencies or Tasmanian Government entities. For
example, liaison between the DPIPWE and the Department of Health and Human Services is
critical for zoonotic diseases. Likewise, Forestry Tasmania entomologists and pathologists
are consulted on matters of plantation and native forest health. The Inland Fisheries Service
provides expertise on freshwater pest fish risks, particularly those relevant to threatened
Tasmanian fish.
Within the DPIPWE, responsibilities for import risk analysis and decision‐making lie across
several Divisions. One result of this is that sector‐based methods for evaluating import risks
have developed.
The weed risk assessment which takes after the score‐based screening protocol used by
Australian biosecurity authorities is one example. The process used to evaluate applications
to import animals that are ‘controlled animals’ under Tasmanian law involves appraisal
against seven wide‐ranging assessment criteria. Pest fish risks for inland waters are assessed
according to establishment and environmental impact criteria. Marine pest risks not
addressed under national arrangements are assessed during consideration of development
applications that involve barges or other vessels visiting a proposed construction site. An
assessment method for deliberately introduced invertebrates is under development.
These and other import risk analysis methods are based on some form of risk‐ranking. Direct
empirical evidence may be collected or generated through experiments however the
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methods are essentially qualitative rather than quantitative, relying primarily on the advice
of people deemed to have relevant knowledge.
In risk ranking, estimates may be compared (ranked) against a chosen risk threshold
identified on an ordinal scale (eg. the weed risk assessment uses a ‘cut‐off’ score).
Alternatively, a risk acceptable/risk not acceptable judgement may be made at the
conclusion of a specific analysis, as for ‘controlled animal’, marine pest and freshwater pest
fish assessments.
This framework also prescribes a risk‐ranking approach, largely because it is implicit in the
way Tasmania’s Appropriate Level of Protection (ALOP) is set. Tasmania’s ALOP is described
in Chapter Five. Risk ranking is capable of supporting sound decision‐making while furnishing
a level of operational simplicity compared with quantitative methods for import risk analysis.
This simplicity is important from public agency capability, resource‐efficiency and
communication perspectives.
However, risk ranking is vulnerable to several faults. These include arbitrary complexity in
problem modelling, ambiguous language, inadequate communication of the acceptable risk
threshold against which estimates are judged, failure to analyse for sensitivity, failure to
validate over time (Burgman 2005), and incorrectly portraying results as unique and exact.
Ways of reducing the susceptibility of an analysis based on risk ranking to these faults are
explored in the framework.
The framework does not replace risk analysis methods currently used within the Tasmanian
Government. However, by highlighting issues common to risk ranking and providing a broad
analytical planning model, it may be useful as a reference and standard against which
existing approaches can be reviewed.
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1.3 Perspectives and principles
1.3.1 What is good biosecurity import risk analysis? The interface between trade, travel and biosecurity is a challenging place for the people who
work there. Competing interests collide, risks change rapidly, information can be lacking or
inconclusive, resources can be scarce, decisions must be made soon, and then made again.
This stew of pressures means judging how best to control inbound movement for biosecurity
purposes is demanding, even for a relatively small place like Tasmania.
Accordingly, the framework lays out diverse matters which need to be considered if risk
analysis work is to support import policy that yields net benefits for Tasmania’s
environment, economy and people.
The framework’s premise is that the capacity of Tasmanian biosecurity import policy to
deliver net benefit depends on the calibre of the risk analysis work that informs it. Three
propositions are made about what constitutes good quality import risk analysis. These
concern context, uncertainty and risk perception, and process administration, outlined
below and elaborated in the rest of the framework.
1.3.1.1 Context
The first proposition is that relevant context must be understood. Context creates the space
and boundaries for import risk analysis, giving it direction and purpose.
Context operates at many levels but two are recognised here. ‘Meta‐context’ comprises the
policy, legal, social, environmental and economic dimensions that apply to all Tasmanian
import risk analysis work. This large domain must be appreciated if analytical and regulatory
effort is to be directed towards the right problems and the right questions. The big picture
within which Tasmanian import risk analysis is conducted is described over Chapters Two to
Five.
Chapter Two considers the question – What does Tasmanian import policy seek to protect,
and why is this important? It outlines Tasmania’s pest status, threats to it and elements that
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influence how pest impacts are felt here. The latter is referred to as Tasmania’s biosecurity
risk profile. Biosecurity risk profile provides the locally unique environmental, social and
economic context to Tasmanian import risk analysis work.
This is not as straightforward as it might seem. Tasmania’s biosecurity risk profile
encompasses some difficult concepts. These include brand, the relations between pest
pressure, primary industries and the wellbeing of small communities, the role and value of
unspoiled natural areas in the social and economic life and welfare of a place, and the notion
of island identity.
Nevertheless, awareness of Tasmania’s biosecurity risk profile and that it is distinct from the
rest of Australia, is important. Without it, reliable prediction of consequences of pest
incursions, and identification of options for effective management, could be constrained.
Chapters Three and Four describe the broad policy and legal environments at international
and national levels respectively. They address the questions – What external rules or
arrangements must be observed in undertaking import risk analysis, what rights do these
confer and what constraints and obligations do they impose on how import risk analysis is
done in Tasmania?
A basic outline is provided in Chapter Three of the origin, structure and operation of the
global trading system governed by the World Trade Organisation, particularly as it relates to
the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement)
and the work of international animal and plant health standard‐setting organisations.
Implementation of the SPS Agreement has unleashed considerable debate. Some aspects of
this are highlighted for relevance to import risk analysis work.
Chapter Four outlines Australia’s biosecurity system and policy settings. The level of
biosecurity protection the Australian Government seeks to provide for in all its import risk
analysis work is described. Chapter Four also outlines how rights and responsibilities for
regulation of trade for quarantine purposes into Australia, and between the States and
Territories, are apportioned in Commonwealth law, and elaborated in various
intergovernmental agreements.
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Chapter Four also traces the shift across the Australian federation toward a remodelled
partnership approach to biosecurity, and describes the practical expression of this in the
administration of national import policy development processes. Chapter Four notes the
recent review of Australia’s quarantine and biosecurity arrangements, and considers how
responses to it may change current regulatory, institutional and administrative landscapes in
ways relevant to the conduct of import risk analysis.
Chapter Five provides an overview of Tasmania’s biosecurity system, and underpinning
policy and governance as these pertain to import policy formulation. Although the level of
biosecurity protection the Tasmanian Government applies to import risk analysis is the same
as that of the Australian Government, a risk estimate by Tasmanian practitioners may differ
from an estimate for the same problem made at the national level. Chapter Five explains
how this may come about and discusses implications, including in light of the recent national
review.
The concepts of risk‐based and cost‐efficient resource allocation and the notion of shared
responsibility for biosecurity are highlighted as issues of particular relevance to the design
and implementation of Tasmanian import policy.
Chapter Five also describes the gathering of animal, plant and environmental protection
expertise across Tasmanian Government agencies under a unified committee structure that
furnishes a coordinated, powerful approach to state biosecurity, including for import risk
analysis. Tasmanian legislation is identified that provides for import regulation for animal,
plant and environmental health protection purposes, along with the basic mechanisms used
to do this.
In this way, Chapters Two to Five set out the basis for acceptable and lawful conduct of
Tasmanian import risk analysis work, from international, national and state policy
perspectives. Knowledge of relevant international and national rules and agreements, and
local settings is essential if risk analyses are to contribute to sound import policy outcomes.
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The other type of context addressed in the framework relates to specific import risk
problems. Establishing problem‐specific context is the first step in the risk analysis planning
model presented in Chapter Seven. It is explained in that chapter.
1.3.1.2 Facts, uncertainty and risk perception
The second proposition for good import risk analysis is that it must take systematic account
of pertinent scientific, economic and technical facts, and that the same must be done for
knowledge gaps and uncertain information. Chapters Six and Seven address the problem –
How can reliable predictions and decisions about biosecurity risk be made when data do not
exist or are equivocal?
This proposition is necessary because information pertinent to import risk problems is
frequently sparse or open to more than one plausible interpretation. Predictions and
decisions must often be made in uncertain circumstances and the consequences of getting
them wrong may be serious.
Uncertainty caused by imperfect knowledge, natural variation or the way information is
communicated, is a feature of most import risk problems. Recognising different types of
uncertainty and treating these in an open, rigorous manner that engenders confidence in a
risk analysis on the part of those with an interest in it, is the common thread of Chapters Six
and Seven.
In describing how information is gathered, organised and evaluated, these Chapters echo
similar import risk analysis guidance documents produced by biosecurity authorities in
Australia and overseas, and by international zoosanitary and phytosanitary standard‐setting
bodies. These publications are also intended to foster greater technical consistency and
scientific rigour in import risk analysis.
From them, a convention in import risk analysis for biosecurity purposes is discernable to
which this framework is largely faithful. It accepts that risk analysis should comprise
consideration of context, hazard identification, risk assessment, and risk management option
identification, throughout which risk communication plays a critical role.
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Chapter Seven proposes a risk analysis planning model that incorporates each of these
components and positions them within an adaptive risk management cycle. In doing so, it
emphasises the need to be explicit about uncertainty and assumptions, and to consider
plausible alternate explanations. It also stresses the importance of monitoring the
effectiveness of regulatory decisions to ensure these remain responsive and appropriate to
the circumstances. Chapter Seven works through each of the model components highlighting
relevant issues, criteria and scientific, technical and economic considerations.
Although the current analytical paradigm is adopted in which the importance of evidence is
paramount, Chapters Six and Seven also question whether import risk analysis construed as
a purely technical and scientific exercise can deliver the best kind of public policy outcome.
Social science research shows that risk analysis and risk regulation is vulnerable to the
effects of values, preferences and beliefs about cause and effect held by all those who
participate in an analysis, including analysts. Cognitive influences bring subjective filters to
the analytical process, affecting how the risk problem is cast and evaluated, what
conclusions are drawn and therefore the type of decisions that are made. These influences
may undermine the reliability of an analysis. Chapter Six includes some basic guidance for
moderating undesirable effects of risk perception.
However, risk perception is not a disability per se. On the contrary, well‐practiced analysts
who have access to regular, constructive feedback on their predictions, use risk perception
to produce highly reliable work. In addition, other stakeholders are demonstrably capable of
bringing perspectives to risk regulation processes that enhance technical approaches.
Chapter Six lays out the concepts relevant to this while Chapter Seven gives guidance on
how logical, testable positions on risk which incorporate diverse forms of information, might
be practically achieved.
1.3.1.3 Administration
The final proposition for good import risk analysis is that as well as being concerned with
problem‐solving, it is also a democratic decision‐making process which must be supported
by administrative structures and procedures that set appropriate limits on regulator
conduct, and hold Government sufficiently to account for decisions.
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Chapter Eight addresses the question – How can import risk analysis be managed to ensure
its conduct is transparent, participatory, efficient, coherent and accountable?
Failure to adequately manage an import risk analysis process can lead to doubt about
priorities and objectives, confusion over who is supposed to be doing what, misjudgement of
how much public resource to invest, inappropriate exercising of authority, and neglect of
alternative, legitimate viewpoints. Any of these can result in poor biosecurity outcomes.
Equally, inadequate process administration, especially in managing public participation and
failing to communicate import risk decisions in a full and transparent manner, can erode
stakeholder trust, and discourage risk practitioners themselves.
Once damaged, confidence in the process and people administering it is hard to recover. The
role of trust in risk regulation is well recognised, and applies no less to biosecurity than it
does in any other area of public service. Trust damage brought on by poor process may be
amplified in Tasmania due to the relatively small pool of Government officials and local
stakeholders who need to come together repeatedly on different pest risk issues.
Chapter Eight lays out arrangements and procedures for managing import risk analysis work
to help ensure it is organised, supervised effectively, suitably communicated and conducted
in an open, inclusive manner from the perspective of stakeholders inside and outside
Government. It describes an adaptive governance approach that recognises good
communication as central to coordinating stakeholder efforts to address import risk
regulation problems fairly and effectively.
Chapter Eight also outlines how work is prioritised and planned according to Tasmanian
Government project management methods to ensure efficient and effective use of public
resources. Administrative roles are defined, and options for working group structures that
provide for an appropriate, practicable mix of expertise and levels of stakeholder
participation are described.
Chapter Eight details arrangements for oversight and deliberation commensurate with the
complexity of a particular import risk problem. Guidance about public consultation is
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provided, appeal mechanisms are described and procedures for meeting internal and
national decision notification requirements are set out.
1.3.2 Principles for Import Risk Analysis
Clearly, import risk analysis for biosecurity can be a challenging endeavour. How might
issues thrown up by context, analytical complexity, and process administration be navigated
with probity, confidence and competence?
While this is substantially a matter of practice, some guiding principles are provided below
which express the Tasmanian Government’s vision for good import risk analysis. Some
principles have been adapted from Gray et al. (1998), Slovic (2002), Murray (2003) and
Burgman (2005), and all are embedded in the remaining chapters.
The broader domain
Substantive knowledge of the risk area (eg. plant health, animal health, invasive species) is critical, but social, economic and political landscapes, administration, and risk analysis itself are also relevant. Risk regulation theory and practice are integral components of the broader domain.
The stakes
The range of public, private, social, environmental, monetary and non‐monetary interests should be identified. This influences the priority of an import risk problem, how it should be approached, and which risk management options provide for the fairest distribution of costs and benefits. Stakeholders include parties who create or mitigate risk, or who benefit from, or incur costs as a result of, risk management.
Transparency Stakeholders within and outside the Tasmanian Government should be informed through unambiguous communication of data sources, reasoning and analytical approach, uncertainty, assumptions, peer review outcomes, final results and decisions. This is to be achieved primarily by careful documentation. The test for transparency is that anyone with a basic understanding of the import problem should be able to follow how the analysis was accomplished, based on its documentation.
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Fairness Stakeholders should be provided with genuine opportunity to participate in import risk analysis, to an extent appropriate to the import risk problem. The expectation for consultation is that it should open up discussion about an import risk problem, not shut it down. It should provide sufficient opportunity for stakeholders to clarify their views but it cannot guarantee different views will be reconciled or that all interests will be protected. Stakeholders should also have access to appeal mechanisms. Effective consultation on technical and scientific matters during the import risk analysis means that appeals on those grounds will not be entertained. However, grievances about the way the import risk analysis process was administered, including in the provision of opportunities to provide comment, will be heard. Requirements of the Tasmanian State Service Act 2000 relating to provision of services, public officer accountability and ethics must be satisfied to a high standard in the conduct of all import risk analyses.
Efficiency The priority of import risk work should be established early and effort invested in proportion to that priority. The scope of an analysis, oversight and administration arrangements should reflect the importance of the risk management decision that needs to be made. Resource duplication and waste should be minimised by referring where possible to existing import policy, and by considering whether a risk analysis, including those undertaken in other jurisdictions, might also usefully inform subsequent work. Management options should be undertaken with risk‐based and cost‐efficient public resource allocation in mind.
Method consistency and flexibility
The import risk analysis method described in this framework should be followed, but not slavishly. While technical consistency is important and risk estimates should all refer to Tasmania’s Appropriate Level of Protection, methodological convention need not always be applied nor can it be applied without thought. Rather, the approach should be selected or designed that is appropriate to the problem and the available data.
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Although the framework recommends a risk ranking method, others are not ruled out. Experimentation and adaptation are encouraged. When divergence from the risk ranking method occurs, reasons should be documented for framework review and development.
Evidence and bias
Best endeavours should be made to access direct empirical scientific, technical or economic data, but use of other types of evidence such as extrapolated data, theory, grey literature and expert opinion will typically need to be considered. Information must be assessed for veracity, meaningfulness and given weight commensurate with its quality and relevance to the import risk problem. In particular, when information is ambiguous explore the alternate explanations. Potential for information to reflect subjective bias should be recognised and moderated.
Uncertainties, assumptions and precaution
The incompleteness of knowledge embodied in an analysis must be clearly described along with assumptions made to deal with it. Aim for no hidden or disguised uncertainties or assumptions.
Policy will incorporate prudent use of precaution commensurate with the level of uncertainty in the analysis. It will reflect that the importance of knowledge limits increases with severity and irreversibility of potential negative impacts.
Case‐by‐case and cumulative risk
Import risk analysis is undertaken on a case‐by‐case basis. This does not preclude consideration of potential cumulative effects, where two or more separate importation activities carry similar pest risks which together pose risks greater than a discrete importation activity.
Relevance and conciseness
Written work is critical to effective communication with stakeholders inside and outside Government, and throughout the import risk analysis process. The import risk analysis report should only include information relevant to the chain of logic that precedes a risk estimate and recommendations for risk management. The risk analysis report should be succinct and comprehendible. Jargon or technical terms should be avoided, or adequately explained in the text of the analysis, or a glossary.
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Standard of reasoning
Peer review tests whether an import risk analysis demonstrates appropriate use of evidence and logic, and hence embodies a satisfactory standard of reasoning. It also tests the analysis for undue influence by the subjective preferences of participants. Reviewers with diverse but relevant expertise may be required and should be given sufficient time to provide meaningful feedback.
Monitoring and updating
Risk analysis capability relies on accurate feedback. The ongoing effectiveness and appropriateness of risk management measures should be appraised using monitoring and review strategies which are commensurate with the importance of the import risk problem. Data capture, management and tools to interrogate the data are important elements.
Compliance and Tasmania’s rights
National and international obligations for import risk policy formulation must be met, particularly in regard to using scientific evidence and principles, and avoiding restriction of trade beyond an extent necessary to satisfy Tasmania’s Appropriate Level of Protection. Tasmania’s unique biosecurity risk profile must be accounted for, especially in consequence estimation.
Administration and due diligence
Import risk analysis work should be administered and documented consistent with Tasmanian Government project planning guidelines. In managing import risk analyses, explicit consideration should be given to the appropriate level and type of public participation.
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Chapter Two Pests, diseases and
Tasmania
Sir JOHN FORREST (WESTERN AUSTRALIA). -
All I can say is that we do not want anything from anyone; we are quite content as we are. Our object in being here is to try and frame a Constitution which all can accept.
Under the proposal I have, Western Australia, we will lose an immense amount. I expect we will lose something like £150,000 a year. That is a loss I do not know how I shall be able to dissipate. I want to get the Bill into such a shape that I can say something in its favour. I have explained how difficult that is for me at the present time.
Our protection to native industries will be gone. You will have our markets free, whereas now you are confronted with the duties. Besides that, you will be able to compete to a larger extent and this is an argument against our own people with our home productions, which, under ordinary circumstances, our own people have a right to. I am sure that to Victoria, South Australia, and New South Wales our markets are worth a great deal.
Sir EDWARD BRADDON (TASMANIA). -
What about your market for our fruit?
Sir JOHN FORREST. -
The market for your fruit? If you will get rid of the codlin moth, there is no reason why your fruit should not be sent to Western Australia now.
Adapted from the Federation Debates, Melbourne, 1898
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2.1 Tasmania’s pest status
2.1.1 Presence and absence
Codling moth, in Tasmania since at least 1857 (Australian National Insect Collection 2008), is
one of a number of pests, pathogens, weeds and other invasive species established in this
State. Table 1 lists some significant introduced pests in Tasmania that affect the health of
native flora and fauna, production plants, livestock, terrestrial, inland water and marine
environments, and potentially in some cases, people.
Considerable survey and monitoring efforts across a range of taxa means Tasmania’s exotic
pest burden is relatively well known. However, it is not completely known and some exotic
taxa are better described than others. Obtaining a more accurate picture is challenging
because of technical difficulties and the often hard cost benefit judgements that have to be
made about detection work. Incomplete knowledge of pest presence, absence and
distribution, and how much to invest in improving it, are problems not unique to Tasmania.
Despite this and despite the known complement of serious exotics, Tasmania’s pest status is
favourable, relatively speaking. Like Australia as a whole, Tasmania is free from many serious
pests that take significant tolls abroad. However, Tasmania is also so far unscathed by a
number of damaging pests present on the Australian mainland which could conceivably take
hold here. Table 2 lists some of these.
Conversely, there appear to be very few significant terrestrial introduced pests recorded in
Tasmania that are not also recorded somewhere on the Australian mainland (eg. bumble
bee, braula fly). However, Tasmania may have been the initial establishment point for
several aquatic pests which later spread to the mainland (Morton pers comm.). Japanese
kelp and Northern Pacific seastar, discovered in Tasmanian waters in the mid‐1980s, and
then in Port Phillip Bay, Victoria, by the mid‐1990s, may be other examples (Low 1999,
Morton pers comm.).
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Table 1 Some significant exotic pests established in Tasmania Affected sector Pest
Production plants Potato scab Streptomyces scabies Sirex wood wasp Sirex noctilio Wheat streak mosaic virus Potato Viruses A,S, X,Y
Native plants Phytophthora cinnamomi
Livestock Ovine Johne’s disease Mycobacterium paratuberculosis American Foulbrood Paenibacillus larvae European Foulbrood Melissococcus plutonius Marine aeromonad disease Aeromonas salmonicida Green blowfly Lucilia sericata
Wildlife Amphibian chytridiomycosis Batrachochytrium dendrobatidis Toxoplasmosis Toxoplasma gondii Pinniped tuberculosis Mycobacterium pinnipedii
Weeds Gorse Ulex spp. Serrated tussock Nassella trichotoma Boneseed Chrysanthemoides monilifera ssp. monilifera Paterson’s curse Echium plantagineum Ragwort Senecio jacobaea Sea spurge Euphorbia paralias Rice grass Spartina anglica
Terrestrial environments
European red fox Vulpes vulpes rabbit Oryctolagus cuniculus cat Felis catus starling Sturnus vulgaris goat Capra hircus ferret Mustela furo European wasp Vespula germanica Bumblebee Bombus terrestris
Marine environments
Northern Pacific seastar Asterias amurensi European fan worm Sabella spallanzanii European green crab Carcinus maenas European clam Varicorbula gibba Japanese kelp Undaria pinnatifida Toxic dinoflagellates eg. Gymnodinium catenatum
Inland waters Eastern gambusia Gambusia holbrooki European carp Cyprinus carpio Mainland yabbie Cherax destructor Redfin perch Perca fluviatilis Salmonids eg. Salmo spp. Oncorhynchus spp. Salvelinus spp.
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Table 2 Significant exotic pests present on the Australian mainland which could established in Tasmania
Potentially affected sector
Pest
Production plants Grape phylloxera Daktulosphaira vitifoliae Potato cyst nematode eg. Globodera rostochiensis Queensland fruit fly Bactrocera tryoni Mediterranean fruit fly Ceratitis capitata Silverleaf whitefly Bemisia tabaci Bacterial wilt of potato Ralstonia (Pseudomonas) solanacearum Bean leaf roll virus African black beetle Heteronychus arator
Native plants Five spined bark beetle Ips grandicollis
Livestock and wildlife Hydatidiasis Echinococcus granulosus Australian bat lyssavirus Leptospirosis Leptospira spp. Iridovirus of fish and amphibians Murray valley encephalitis Murray Valley encephalitis virus Ross River fever Ross River virus Q fever Coxiella burnetii
Weeds Spiny emex Emex australis Xanthium species Chilean needle grass Nassella neesiana Lippia Phyla canescens
Terrestrial environments Red eared slider turtles Trachemys scripta elegans European house borer Hylotrupes bajulus Tramp ants – eg. Solenopsis invicta, Wasmannia auropunctata
Marine environments
Caulerpa taxifolia
Inland waters Oriental weatherloach Misgurnus anguillicaudatus Tilapia spp. Gambusia spp. Redclaw crayfish Cherax quadricarinatus
2.1.2 Geography, history and Tasmania’s biosecurity culture
The explanation for why Tasmania is free from many exotic pests that afflict similar
Australian mainland environments mirrors that of Australia relative to the rest of the world –
geographic isolation and a strong biosecurity culture.
Tasmania’s island nature, small size and peripheral location afford some degree of
geographic protection from natural pest dispersal, although atmospheric and oceanic
currents are well known to assist species range expansion by dispersing propagules,
including over long distances. The 2004 currant lettuce aphid (Nasonovia ribisnigri) incursion
in Tasmania may have resulted from wind‐assisted dispersal from New Zealand. The coastal
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vegetation transformer, sea wheat‐grass (Thinopyrum junceiforme), is another possible
example. First recorded in Australia at Port Philip Bay in 1933, it produces rhizomes capable
of sea‐rafting (Hilton 2003), which may have facilitated its later appearance in Tasmania in
the mid‐1980s (Rudman 2002). While individually significant, these natural dispersal events
are less important overall than human‐mediated pest introduction (Mack 2003).
In that regard, being an island is also advantageous to biosecurity because it provides for
supervised control of incoming goods and people, far more so than is often practically
possible along land borders which may be traversed by road, rail and river networks that are
less defendable than air and sea routes.
Various exclusion zones and protected areas (eg. Tri‐State Fruit Fly Exclusion Zone, Rice Pest
and Disease Exclusion Zone) that operate on mainland Australia illustrate the difficulty of
implementing movement controls where natural geographic barriers do not exist.
Conversely, people and goods can only enter Tasmania through permitted entry points,
subject to quarantine inspection. While there are 32 of these (22 ports, 10 airports), eight
receive the bulk of incoming travellers and cargo.
History is also likely to have contributed to Tasmania’s biosecurity status and culture,
especially pest experiences soon after European colonisation. These are likely to have
inspired early reflection on the advantages of keeping pests out in the first place. For
example, Rootes (2008) describes repeated and ultimately failed attempts between 1871
and 1907 to administer law for mitigating impacts of rabbit and codling moth upon
Tasmania’s fledgling sheep and fruit industries respectively.
Both pests thrived amid those efforts and attained almost state‐wide distribution by the turn
of the 20th Century. Tensions between producers, local control boards, and the colonial
Government over resourcing, alleged corruption, and technical and administrative
competence appear to have played a large role. The contentious and difficult nature of pest
eradication in colonial Tasmania is also exemplified by Californian thistle, which continued to
spread despite legislated control efforts (Breen 2001).
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Not all early pest encounters were entirely discouraging. Kirkpatrick and Bridle (2007)
describe how effective enforcement of the Scab Act 1870 allowed Tasmania’s sheep districts
to be declared scab‐free by 1894, although the formation of an Anti‐Scab Act Association
(Breen 2001) suggests this was not an easy win.
Nonetheless, regulatory success, as much as the failures, would have illustrated to the early
colonial community and government alike, the cost burden and cooperative effort required
to eliminate serious pests and diseases.
These experiences are likely to have informed the introduction of one of Tasmania’s earliest
quarantine statutes, the Vegetation Diseases Act 1898, which provided for increased
inspection of plants and fruit coming into the colony (Rootes 2008).
Rising concern about pest and disease prevention across the country in this period was also
evident, especially since the opening of the Suez Canal in 1869 allowed faster transport to
Australia, via Eastern and Asian ports where serious human diseases were endemic. Calls for
a coordinated Australian quarantine scheme were made (Australian Bureau of Statistics
1988) which perhaps led to what Nairn et al. (1996) describe as uniform State quarantine
legislation (the 'Federal Quarantine Acts'). These preceded enactment of the Australian
Quarantine Act 1908.
From those times, successive Tasmanian governments have continued to legislate to make
the most of Bass Strait in preventing pest introductions in trade and travel. Current
Tasmanian legislation that provides for pest prevention through import control is described
in Chapter Five.
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2.2 Threats to Tasmania’s pest status
2.2.1 What are the threats to biosecurity?
Despite safeguards provided by an island geography and contemporary Tasmanian law, it is
generally accepted that faster, more frequent, higher volume, globalised trade and travel
pose a greater, and probably with the exception of European colonisation, an
unprecedented biosecurity challenge to Tasmania.
Hulme (2009) suggests the world is in a new ‘step phase’ or leap in the magnitude and
diversity of biological invasions, the Era of Globalisation. The technical and logistic speed of
commerce is generally outstripping ability to identify and control pathways that facilitate the
spread of pests.
Moreover, emergent threats and shifts in the nature of pest potential exacerbate biosecurity
risk, also making it more complex, immediate and difficult to predict.
Climate change is highlighted in Australia because of potential for warming and altered
rainfall patterns to open additional natural pathways and increase the likelihood that pests
will spread southwards or more readily establish at higher latitudes, once introduced by
travel or trade (Pittock 2006). This could in particular, alter the current range of animal
diseases in Tasmania. Cooler climate is thought to limit the establishment of several
arthropods and bats that transmit significant terrestrial animal diseases found on the
mainland, but not here (M. Conway and A. Philips pers. comm).
Other factors are also changing the face of pest risk. Globally, infectious diseases of humans
are spreading further and more rapidly than before. New diseases are emerging at a rate of
one per year (Rose 2008). Around 75% of new or re‐emerging diseases affecting humans
come from a wildlife reservoir. Human encroachment into natural habitats, changes to
agricultural practice, wildlife trade, bush‐meat and exotic food markets, ecotourism, petting
zoos and exotic pet ownership, are contributing factors (Chromel et al. 2007).
Thus, zoonoses are becoming an increasingly important component of biosecurity risk, and
information about wildlife and invasive animal pathways and health is likely to become more
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significant to risk analyses involving animal diseases. Philips and Driessen (2008) describe the
status of zoonotic diseases in the Tasmanian Wilderness World Heritage Area, identifying six
that are here already.
Global trade liberalisation is clearly relevant to biosecurity risk. The rapid spread of Western
flower thrips from North America has been attributed to world‐wide trade in cut flowers
that commenced in the 1980s. The insect was detected in Australia in 1993 and as well as
causing feeding damage, may have potential to spread significant viral diseases of
production and native plant species (Low 1999). Some commentators have dissected free
trade deals and found potential for biosecurity to be undermined because of administrative
arrangements that appear to bring trade imperatives into biosecurity decision‐making. An
example of this is provided in Chapter Four (Weiss et al. 2004).
New forms of business may also affect biosecurity. For instance, the rapid rise of e‐
commerce allows individuals to more easily purchase almost anything from almost
anywhere without involvement of an import and distribution business. This has risk
management and risk communication ramifications because the number of importers
comprising the regulated community increases enormously, along with demands on systems
for screening mail for seeds, invertebrates imported as pets or pet feed, but also food items,
home‐wares and packaging that may carry exotic pests. Between 1999 and 2002, use of the
internet by Australians for purchasing goods and services trebled (Harris 2004) and is likely
to be even more significant now.
Beale et al. (2008) identify increased global movement of genetic material (seeds, sperm,
ova, bacterial cultures, viral DNA, etc.) to boost agricultural productivity or for research
purposes, as another significant influence on biosecurity risk. Some may be directly related
to the need for breeders to remain economically competitive, but increased movement of
genetic stock is also a response to environmental pressures on farmed environments, such
as water stress and salinity.
Educational pursuits can go wrong. Caulerpa taxifolia, a marine alga used in a tropical fish
display at the Oceanographic Museum of Monaco, was first detected in the Mediterranean
Sea outside the museum’s window in the mid‐1980s and has spread rapidly over thousands
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of hectares of seafloor, as well as being transported to ports outside the Mediterranean
(Lockwood et al. 2007).
Other forms of deliberate introduction also heighten biosecurity risk. For example, 22 of the
approximately 34 exotic freshwater fish species established in Australia are thought to have
been introduced via the ornamental fish industry. Consistent with global trends, substantial
unregulated and unrecorded trade in pet fish between hobbyists within Australia is believed
to occur (Natural Resource Management Ministerial Council 2006). Collector trade in other
novel animals (including reptiles, invertebrates) and plants also appears to be strong. These
activities can result in other biosecurity risks. Use of live rock (live coral or sand potentially
containing a range of life forms) for aquarium filtration is considered to be increasing
(Natural Resource Management Ministerial Council 2006). Release of mail‐order butterflies
at weddings has become fashionable.
In some circles, the acclimatisation ethos lives on. Illegal introduction of trout to waters
within the Tasmanian Wilderness World Heritage Area still occurs and can seriously degrade
native inland aquatic systems (Parks and Wildlife Service 2004). While there is no direct
evidence, it is plausible that fox cubs were smuggled into Tasmania during the late 1990s
and are the source of the current incursion (Phillips 2008).
2.2.2 Are biosecurity threats increasing?
The factors and trends outlined above imply increasing threats to biosecurity. However, for
policy formulation and especially in terms of effective public resource allocation, it is
prudent to look in more detail at what first appear to be straightforward cause and effect
relations.
What evidence is there that threats are rising, and if they are, where are the most significant
increases occurring that would warrant greater investment of public funds?
Waage et al. (2004) considered these issues while endeavouring to improve the approach to
biosecurity in the United Kingdom. A cross‐taxon survey allowed a qualified conclusion that
the rates of establishment of harmful, non‐native terrestrial invertebrates, plant diseases,
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animal diseases and weeds had increased over several decades, and were not showing signs
of levelling out. However, the rate of introduction of harmful terrestrial vertebrates
appeared to be declining. These trends may reflect variations in exotic species pool sizes
between different taxa, as relevant to the UK.
They also examined risk sources and found that the importance of pest contaminants of
agricultural imports (plants, animals, their products), traditionally identified as a major
source of biosecurity risk, is now less than that of plants and animals introduced deliberately
as garden plants or pets, new food (bush‐meat, game fish) or for new food production
systems (crayfish or other aquaculture).
Waage et al. (2004) assert that while trade and import volume figures for commodities show
an increasing trend, there is nothing in particular to link this exclusively to increased
biosecurity risk. Lower volume speciality importers, and individual travellers, potentially
pose greater threats so far as UK biosecurity is concerned.
The study seems pertinent to biosecurity decision‐making everywhere. For Tasmania, the
evidence base for the proposition of increased biosecurity risk is general and could stand
refinement to better inform decisions about where to direct resources for the greatest
return. For example, some of the import, incursion and pest record databases held within
Tasmanian Government agencies could potentially be used to assess trends in biosecurity
pressure.
This can be pursued in two ways. One is to use individual risk analyses to progressively build
and update the nature and relative importance of factors that influence pest threats to
Tasmania. This is essentially an exercise in meta‐analysis, and one of the reasons why a
generally consistent approach to import risk analysis, which provides for easier comparisons,
is important.
The other involves literature and expert network scanning for pest trends and patterns.
Island studies are particularly relevant because it is well established that island ecosystems
are among the most invaded worldwide. The explanation is not entirely restricted to
biogeography and ecology. The generally higher import dependence of islands compared
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with continental jurisdictions (38% vs 26.8%) correlates with pest status. For instance, the
relationship between weed species richness and Gross Domestic Product, which reflects the
contribution of imports to an economy, is considerably stronger for island jurisdictions
(Hulme 2009).
Considering the results of Tasmanian import risk analyses and the global literature, should
facilitate improved deployment of public biosecurity resources. Beale et al. (2008)
considered issues around a ‘risk‐return’ approach for biosecurity, and have recommended
various means by which Australia as a whole might achieve it. Tasmania may have an
opportunity to contribute to and draw benefit from national efforts in this regard.
In the meantime, and consistent with a precautionary approach, it can be accepted that
Tasmania faces significant pest pressure from a range of sources. Consequently, its relatively
good biosecurity status can be regarded as vulnerable. Protecting it into the future will
depend on ensuring import control policy continues to be cognisant of all factors that define
the contemporary pest threat.
There is another side to Tasmanian biosecurity worth considering. Just as outward scanning
for threats enhances prospects of preventing pest ingress, so too is an inward glance
required to identify what import risk analysis actually seeks to protect‐ that is, the nature of
what is at risk.
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2.3 Tasmania’s biosecurity risk profile
2.3.1 Definition
The things in Tasmania that are at risk from pests are the same as everywhere else ‐ natural
environments, plant and animal industries, infrastructure and people.
However, closer examination of what this State stands to lose from further incursions of
significant pests reveals some particular attributes of Tasmania’s economy, environment and
its community that are distinct and highly relevant to import policy formulation.
These features define Tasmania’s biosecurity risk profile. Biosecurity risk profile influences
how the consequences of pest incursion and establishment play out here, and so forms the
local backdrop to every Tasmanian import risk analysis.
2.3.2 Primary industries
2.3.2.1 Competitive advantage from lower on‐farm costs
It is often observed that Australia is able to perform reasonably well as an exporter against
the subsidised agriculture of other developed countries because it is free of many of the
world’s worst primary production pests. This translates to lower yield penalties and control
costs (eg. Weiss et al. 2004).
Tasmania’s favourable biosecurity status enhances the competitiveness of its primary
industries (excluding mining) in the same way. Freedom from pests has a direct, positive
bearing on net profit due to farm‐level savings and efficiencies. The significance of this is
illustrated by considering costs that would be avoided if pests that are established here were
absent.
For example, Ireson et al. (2006) estimate the annual cost of weeds in Tasmanian pastures
and field crops is $58 million, comprising around $49 million in production losses and almost
$9 million in herbicide costs. This equates to some 8.5% of the $685 million farm‐gate value
of Tasmanian agricultural produce (Department of Primary Industries and Water 2005) and
represents a substantial ‘avoidable’ cost.
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Similarly, Sinden et al. (2004) conclude an annual economic impact from weeds to Australian
agriculture as a whole, of $39 billion based on production penalty and control cost criteria.
This is around 10% of the gross value of Australian agriculture (Australian Bureau of Statistics
2008) and thus proportionately comparable to loss suffered in Tasmania.
Hence, if weeds are an indication, Tasmania and Australia appear to face similar levels of risk
in terms of what new pests might mean for agricultural competitiveness, so far as that is
influenced by farm level control costs and forfeited production.
However, the similarities between what further serious pest incursions and establishments
might imply for Tasmania compared with mainland Australia seem to end there.
2.3.2.2 Comparative economic and social importance of primary industries
Tasmania’s biosecurity risk profile is also defined by the economic and social importance of
primary industries, with various data suggesting it is distinct in several ways from Australia as
a whole, and from other States and Territories.
Around 6.7% of Tasmania’s Gross State Product (GSP) is generated directly by the
agriculture, forestry and fisheries sector, making it the third largest industry contributor,
behind combined services (eg. health, community) and manufacturing. The direct
contribution of these primary industries to the State economy is significantly higher than the
Australian average of around 3%, and the highest of all States and Territories, with
Queensland and South Australia coming closest at 4% and 5% respectively (Davey and
Maynard 2007).
The direct value added measure on which the 6.7% GSP contribution is based does not fully
reflect the importance of primary industries to Tasmania because it excludes the value of
products after processing and packaging that occurs here as well. Agriculture and allied
enterprises beyond the farm‐gate (eg. food and beverage manufacture) make a more
significant contribution to Tasmania’s economy than in any other jurisdiction, providing 16%
of GSP compared with a national average of just over 12% (Davey and Maynard 2007).
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Further, and despite slow growth and some job shedding, agriculture, services to agriculture,
and in particular, manufacturing and service industries dependent on agriculture, support a
workforce of over 40 000 Tasmanians, which is around 20% of total state employment. This
is again higher than the national average of just over 17% employment in agriculture and
sectors closely associated with it.
By combining production value and employment, the importance of agriculture to an
economy can also be described using the Farm Dependent Economy (FDE) measure. FDE
comparisons show agriculture is 30% more important to Tasmania than it is to Australia
overall. Tasmanian FDE may be underestimated since some Tasmanian processing output
may be allocated to mainland states because company headquarters are located there
(Davey and Maynard 2007).
Another feature of Tasmanian primary industries is that these generate a proportionately
larger food surplus, with around 60% of production traded interstate and overseas,
compared with the 30% Australia as a whole exports overseas. Trade in locally grown food is
therefore twice as important to Tasmania compared with trade in food at the national level
(Department of Primary Industries and Water 2005).
These figures are explained in part by Tasmania’s status as a small island economy. Tasmania
displays characteristics that are well documented for other island jurisdictions whose
economic growth potential is defined by small spatial and population size, and relative
remoteness from major markets. In summary, small island economies generally have in
common:
• small domestic markets that limit local economic growth (less opportunity for
economies of scale, higher costs per capita for basic services, weak internal
competition);
• narrow range of domestic output and export markets (related to inability to access
economies of scale and giving rise to specialised output); and
• openness to trade (reliance on imported goods and services means export‐led
economic growth becomes proportionately more important than supplying the
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domestic market by import substitution) (Bureau of Infrastructure, Transport and
Regional Economics 2008).
While Tasmanians, like other island inhabitants, have become skilled in finding significant
international markets for the goods they produce (Stratford 2008), a small, less diverse,
export‐dependent economy nonetheless confers a comparatively higher level of exposure to
external perturbations, particularly when an important sector is involved. For Tasmania, a
decision by trading partners to swap to new food suppliers, including due to pest incursions
here is likely to result in more severe consequences.
Furthermore, these market impacts may not be confined to primary producers because of
the centrality of that sector to small Tasmanian communities which are particularly
vulnerable to the flow‐on effects of external shocks. Tasmania’s population is strongly
decentralised compared with most other States and Territories. For example, at June 2008
only Tasmania recorded more than 55% of its population living outside its capital city. Even if
Launceston is included, the proportion of people in Tasmanian rural areas is still greater than
all other jurisdictions, with the exception of the Northern Territory (Australian Bureau of
Statistics 2008). The relative importance of rural communities in Tasmania is also indicated
by population change data. For example, growth in remote areas across Australia over 2007‐
2008 was higher in Tasmania compared with other States and Territories except the
Northern Territory, and nearly twice the national average (Australian Bureau of Statistics
2008).
Quantifying the economic and social impact of pest pressure on rural communities, and
separating it from other stressors is difficult. However, a pest incursion can be the final straw
for small communities already precariously balanced on a population threshold beyond
which basic service provision becomes unviable (Cook et al. 2008).
These small and generally undiversified economies tend to be more vulnerable to
disturbances such as reduction in viable crop choice because the opportunities to transfer
displaced labour (and perhaps capital) to other productive uses are typically limited. This
often results in emigration of both labour and capital from those local economies.
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Community‐wide economic manifestations also occur. Since Tasmania is free of a number of
serious pests present on mainland Australia, incursions of any of those are new incursions
and will require new public and private resources for eradication, including training and
acquisition of skills and equipment. This generally means diverting resources from other
areas. For affected places on the mainland, another outbreak is just that, and is likely to be
able to be addressed in part within existing capacity with relatively less additional cost. Thus,
an incursion here of a significant pest that is present in other States or Territories, can be
expected to have more severe and immediate resource allocation and management
implications.
2.3.3 Natural heritage
Isolation over geological time has produced in Tasmania distinct and diverse terrains, unique
temperate ecologies, and some of the most distinctive flora and fauna on the planet. Island
biogeography and the vulnerability that attends being a small biodiversity ark are also
integral to Tasmania’s biosecurity risk profile.
For example, Tasmania’s long coastline relative to landmass, variety of marine and coastal
habitat and particular ocean current regime, have contributed to marine biomes that are
compositionally and structurally unique, as recognised in Tasmania’s system of Marine
Protected Areas (Department of Primary Industries, Water and the Environment 2000).
Terrestrial natural assets include Gondwanan relicts and assemblages, and species that have
become rare or extinct on the Australian mainland due to multiple depredations, including
introduced pests such as foxes. Nearly 40% of the State’s land area is managed primarily for
nature conservation and cultural heritage purposes (Parks and Wildlife Service 2004).
However and despite the creation of protected areas and conservation programs for
privately owned land, Tasmania’s small island nature and dispersed human settlement mean
native species populations are also relatively small in size and number, and hence generally
less able to withstand and recover from perturbations, including from invasive species, other
pests or diseases. An evaluation of the Tasmanian Wilderness World Heritage Area
(TWWHA) identified weeds, introduced animals and exotic plant diseases as amongst the
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most serious of pressures (Parks and Wildlife Service 2004). At least seven animal diseases
are present and pose moderate to extreme risk to wildlife in the TWWHA (Philips and
Driessen 2008). More than 130 introduced or cryptogenic marine pests are recorded in
Tasmanian coastal or estuarine waters (Tasmanian Planning Commission 2009). Around a
dozen in particular, seriously affect marine biodiversity and public amenity.
Being special and vulnerable explains in large part, the contribution of natural heritage to
Tasmania’s biosecurity risk profile. However, there is also another dimension found in the
rationale for protecting natural areas in parks and reserves. Protection status can be viewed
as the sum of values invested by the community in those areas, and hence highlights a
different aspect of what is diminished by pest incursions. The types of values embodied in
protected areas include conservation (or existence) values, legacy (or bequest) values and
the value of experience opportunities, whether in natural beauty, scientific endeavour,
extreme environment challenges, exercise, or solitude (Eslake 2008). Mostly, these defy
quantification and hence are not readily amenable to direct comparison with the similar
values elsewhere. What can be concluded however is that the allocation of substantial
proportions of Tasmania’s land and marine areas to maintenance of these values means that
our society places a very high premium upon them.
2.3.4 Brand Tasmania and Island Identity
Tasmania’s biosecurity risk profile also encompasses two concepts that synthesise and link
the natural, social and economic attributes that determine how pest impacts manifest in this
State. These are the Tasmanian brand and the notion of island identity.
2.3.4.1 The Tasmanian Brand
Brand Tasmania is a marketing device, concerned primarily with selling from a common,
cohesive platform, goods, services, experiences and the lifestyles uniquely available in this
State.
The intention of the brand is to enhance prosperity across multiple sectors and hence
improve the social, environmental and economic wellbeing of Tasmania. To achieve this, the
products, services and experiences must embody qualities that differentiate them, are
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recognisable and which are valued by prospective purchasers, whether from overseas,
mainland Australia, or Tasmania itself. Tasmania’s small island economy means a successful
brand is as necessary as it is possible.
It is evident, including from the market access experience of Tasmanian industries with a
strong export culture, and Tasmania’s nature‐based tourism performance, that good
biosecurity status lies at the heart of the developing brand. It is linked intimately with buyer,
visitor and resident perceptions that Tasmania is a region apart from the rest of Australia
with something different and better to offer, including because it has fewer serious pests.
For example, and notwithstanding that there is some way to go before Tasmania
consolidates its reputation as a distinct source of quality food and beverages (Department of
Economic Development and Tourism 2007), good biosecurity status is one feature that
allows Tasmanian produce to be represented in the market as deriving from a natural place,
unspoilt by ravages suffered elsewhere (Tasmanian Government 2008). There is anecdotal
evidence which suggests this narrative is compelling in certain markets and plays an
important role in setting Tasmanian produce apart from food of comparable quality
produced elsewhere.
Equally, a relatively good pest status contributes to the attractiveness of Tasmania’s unique
environments, and not just because these are free of some of the obvious pest impacts
suffered elsewhere. At least part of the value of experiences offered by the State’s protected
areas can be estimated from what people are willing to pay to access them (including
travelling to and staying in Tasmania), and how many people are willing to pay.
For example, around 720 000 non‐residents visited those eight of Tasmania’s parks for which
reliable figures are available, every year for the three years to 2008. Tourism Tasmania data
also suggest a large proportion of interstate and international tourists come here primarily
to frequent natural areas, meaning that some similarly significant share of the $2 billion per
annum spent by visitors to Tasmania can be attributed to the unique experiences these offer
(Eslake 2008).
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However, Eslake (2008) contends there are other interesting community‐wide benefits to be
had from natural areas. He asserts that natural assets may play a direct role in attracting to
Tasmania people with skills and aptitudes most likely to lift its economic performance. He
cites Canadian work showing the ‘creative classes’ are more likely to find a place desirable to
live if there are good opportunities for outdoor pursuits, especially challenging ones.
On this basis, Tasmania’s parks and reserves, because they are part of the lifestyle that
attracts certain people, are an integral part of Tasmania’s future economic prosperity. If this
is true, pest incursions, as with other forms of degradation that reduce that quality of
natural areas and therefore the experiences available from them, may also have direct
impacts on Tasmania’s economic and social well being.
But a market image for products, experiences or lifestyles, foundered on good biosecurity
status can be double‐edged. On one hand, it has potential to open up opportunities which
by definition are unavailable outside Tasmania. On the other, it means a significant pest
incursion in a single industry or in the natural environment could damage the whole
Tasmanian brand, and have wide‐ranging market consequences and flow‐on effects for
enterprises other than those directly affected.
This is because maintaining freedom from significant pests speaks directly to Tasmania’s
fundamental biosecurity intelligence, competence and commitment, and hence how
confidently and reliably any claims to uniqueness and superior product, service or
experience might be viewed and valued by prospective buyers, visitors, immigrants, or
residents.
2.3.4.2 Island Identity
While it is essentially market focussed, Brand Tasmania is equally a statement of pride and in
this way is linked to the notion of small island identity. However, small island identity is an
idea that extends beyond selling things or experiences, or lifestyle promotion. It is also about
sense of place and the particular values and behaviours this can foster. Small island identity
also has relevance for Tasmania’s biosecurity risk profile.
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Stratford (2008) describes islandness as a complex expression of identity that attaches to
places smaller than continents and surrounded entirely by water with which are associated
strong perceptions of island self and mainland other, and potent connections to community
and environment.
She asserts that islandness moves people to value the special qualities of islands and to
protect them from becoming like everywhere else. Tasmanians appear to cherish and draw
deep personal meaning from the island’s sharp and nearby land/sea boundary and the small
space within, in ways less available to people who live on mainland Australia (Stratford
2008).
Sense of place is a matter of psychology and emotion. However, it is as much a part of
Tasmania’s biosecurity risk profile and as tangible as rational aspects of environment and
economy because it is intimately connected to values invested by the state’s residents in
small‐community life, the natural environment and a thriving primary production sector.
In summary, Tasmania’s biosecurity risk profile is defined by the small island nature of its
society, economy, and its unique native biodiversity and the special identity and sense of
place these inspire in its citizens. These features are the very features that contribute to the
brand, and in this way the brand and island identity suggest one another. What imperils or
damages one, imperils or damages the other. These features produce particular
opportunities and assets, but also give rise to unique vulnerabilities, including in regard to
biosecurity. Pest incursions can be expected to have proportionately greater environmental,
economic and social ramifications for Tasmania than other more populous and diverse
mainland economies and landscapes.
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Chapter Three International policy
and legal environment
The present focus on the science/democracy dichotomy is dangerous because it is resulting in (pursuit of) the wrong lines of inquiry about the SPS Agreement, dispute settlement and the interface between trade regulation and social regulation Fisher 2006
3.1 International policy and law relevant to biosecurity
3.1.1 Animal and plant health standards
International trade may generate benefits but it can also bring significant disadvantage and
risk, including to human, animal, plant and environmental health. In the last 50 years,
acceleration of trade between countries has resulted in a substantial burden of recent
biological invasions (Hulme 2009) that has brought these risks to the fore in the minds of
national regulators and the general community.
While some specific intergovernmental plant protection initiatives were undertaken in the
nineteenth century (eg. International Convention on Phylloxera vastatrix, 1881 (Food and
Agriculture Organisation 2006)), the first major steps toward broad‐ranging consensus for
minimising health risks associated with global trade came with the formation between the
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1920s and 1960s of three entities by, or under which sanitary and phytosanitary standards
are set.
These are the Office International des Epizooties (OIE), the International Plant Protection
Convention (IPPC) and the Codex Alimentarius Commission (Codex). Codex is largely
concerned with human food safety and so is not described further here. The work of the OIE
and the IPPC Secretariat is most relevant to pest threats to animals and plants respectively.
Office International des Epizooties The Office International des Epizooties (OIE), now known
as the World Organisation for Animal Health, is an inter‐governmental organisation founded
in 1924 to improve coordination in addressing animal health issues, and human health issues
to the extent these are directly related to animal pests and diseases. Among other things,
OIE promotes the harmonisation of regulations for trade in animals and animal products by
publishing a series of animal health Codes, and maintaining lists of the most significant
transmissible diseases, including epizootic and zoonotic diseases, which may be spread
between one country and another in the course of trade in animals or animal products.
The Codes are intended to assist authorities in formulating scientifically sound import and
export zoosanitary measures to minimise the spread of the significant, listed diseases. The
Codes include sanitary measures for each disease, along with a list of commodities that may
transmit them.
The OIE Terrestrial Animal Health Code: mammals, birds and bees Edition 17 2009 sets out
procedures for animal and animal product import risk analysis that provide guidance on the
method for assessing biosecurity risks associated with movement between countries of
animals, animal products, genetic material, feedstuffs, biological products and pathological
material. Similarly, the OIE Aquatic Animal Health Code provides information on aquatic
animal health certification, risk analysis and movement issues.
Diseases for which OIE has generated zoosanitary advice, detail about the import risk
analysis method it recommends, the animal health Codes and various resources are at
http://www.oie.int.
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The International Plant Protection Convention The International Plant Protection
Convention (IPPC) is a legally binding treaty for plant health established in 1951, replacing an
earlier 1929 version, and administered by a Secretariat assigned out of the Food and
Agriculture Organisation (FAO) of the United Nations. The convention allows Member
countries, including Australia, to apply phytosanitary measures to protect their plant
resources from pests which may be introduced through international trade.
To achieve consistency in the design and application of those measures and ensure
satisfactory scientific rigour, the IPPC Secretariat issues guidelines known as International
Standards for Phytosanitary Measures (ISPMs). More than 30 ISPMs have been agreed, with
several others in preparation.
Of these, ISPM Nos. 2 (Guidelines for pest risk analysis 1995), 11 (Pest risk analysis for
quarantine pests, including analysis of environmental risk and living modified organisms
2004) and 21 (Pest risk analysis for regulated non‐quarantine pests 2004) describe the main
elements of the pest risk analysis (PRA) process endorsed by Members for evaluating risk
associated with plants, plant products and other articles, including conveyances and
packaging that may carry pests of plants.
The ISPMs, detail about the approach to risk analysis recommended by the IPPC Secretariat
and other resources are at http://www.ippc.int.
3.1.2 GATT 1947 and non‐tariff barriers to free trade
For years, OIE and IPPC health standards and other work were not explicitly coupled to any
specific international trade agreement. The need to consider this gathered momentum when
the 1947 General Agreement on Tariffs and Trade (GATT 1947) came into force.
The aim of GATT 1947 was to bring down barriers to trade in foreign goods by reining in
scope for tariffs, quotas and other regulations which impose competitive disadvantage on
those goods relative to goods produced domestically. Measures that protect particular
domestic industries can sometimes be welfare reducing to the community as a whole (eg.
Tanner 2003).
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Importantly, the system for trade liberalisation established in GATT 1947 also recognised
that measures that had the effect of restricting trade could be applied when necessary to
protect human, animal and plant health, although not in an arbitrary or discriminatory
manner, or for protectionist purposes. However, in providing for such restrictions, GATT
1947 was silent on the form measures should take or how they might be practically
implemented.
As tariff elimination proceeded, some countries found sufficient incentive to look to various
non‐tariff means of sheltering their domestic animal and plant industries from external
competition. Sanitary and phytosanitary measures imposed on foreign goods began to
feature prominently in discussions about the problem of unjustifiable, non‐tariff barriers to
international trade. By the 1990s, quarantine was being described as the new protectionism
(Cook 2001).
3.1.3 Uruguay, Marrakech and international animal and plant
health law
The matter of protectionist behaviours using sanitary and phytosanitary measures became a
special focus of the 1986‐1994 Uruguay Round of Multilateral Trade Negotiations.
There were two chief outcomes of the Uruguay talks relevant to plant and animal health.
The general sanitary and phytosanitary principles articulated in GATT 1947 were reaffirmed
in GATT 1994. Article XX exempts countries from violating the agreement if measures
adopted are necessary for health protection. This time however, the general principles were
elaborated in two sets of rules.
The Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement)
is the principal instrument in this regard and was created because negotiators agreed that
rules for SPS measures could not be conveniently incorporated into the existing Technical
Barriers to Trade Agreement (TBT Agreement) (Roberts 2001). The SPS and TBT Agreements
are part of a series of nearly 60 agreements drafted or revised during the Uruguay Round
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which forms the legal foundation of the international trading system that operates across
most countries today.
At the apex of this system sits the World Trade Organisation (WTO) with a current
membership of over 150 countries. The WTO was established under a separate agreement
made at Marrakech in 1995 to provide oversight for the Uruguay agreements, thence forth
known as WTO agreements (World Trade Organisation 2000).
The Marrakech Agreement sorts the business of the WTO according to four annexes. Annex
1 comprises agreements relating to trade in goods and services, including GATT 1994, and
the SPS and TBT Agreements. Annex 2 establishes procedures and structures for resolving
arguments over compliance with WTO rules, and for enforcing compliance. These matters
are the responsibility of the WTO Dispute Settlement Body which has powers to form expert
panels, convene an Appellate Body to hear appeals on decisions, and authorise retaliation
when a country is deemed to have violated a ruling. Annex 3 addresses trade policy review
mechanisms. Annex 4 comprises pluri‐lateral agreements that are binding only to Members
who have specifically endorsed them (World Trade Organisation 2000). Figure 1 depicts the
broad hierarchy of international trade law that transpired from negotiations at Uruguay and
Marrakech in the mid‐1990s.
The Uruguay Round and Marrakech negotiations changed the way WTO Member countries
approach pest regulation by obliging them to devise and implement policies and procedures
for observing the new rules. When in doubt, keep out was no longer an appropriate decision
making guide. WTO structures and rules continue to provide the primary point of reference
for trade‐related plant, animal and human health dialogue between countries. In addition,
some countries, including Australia, use WTO rules and principles to guide the
administration of domestic trade.
Accordingly, familiarity with those parts of the WTO legal system most relevant to pest
regulation is necessary and prudent. The SPS Agreement is foremost.
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Figure 1 World Trade Organisation Legal System ‐ Basic Structure
3.1.4 Agreement on the Application of Sanitary and Phytosanitary Measures
The Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement)
comprises 14 articles and three annexes intended to bring fairness, transparency and
predictability to international trade in goods and conveyances which may carry organisms
that threaten human, animal or plant health.
Fisher (2006) identifies two objectives of the SPS Agreement. One is to eliminate
discrimination and protectionism in trade using sanitary and phytosanitary measures (SPS
measures), by regulating the setting of those measures. The other is to provide a common
Marrakech Agreement Establishing the World Trade Organisation (1995)
Annex 1
Trade in Goods and Services Agreements
Annex 2
Dispute Settlement
Annex 3
Trade Policy Review Mechanism
Annex 4
Pluri‐lateral Agreements
Annex 1A
Including: General Agreement on Tariffs and Trade (GATT 1994) Agreement on the Application of Sanitary and Phytosanitary Measures (SPS
Agreement) Agreement on Technical Barriers to Trade (TBT Agreement)
Annex 1BGeneral Agreement on Trade in Services (GATS)
Annex 1CAgreement on Trade‐Related Aspects of Intellectual Property (TRIPS)
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set of rules to reduce regulatory heterogeneity which, since it may result in extra costs to
importers and consumers, can also be a barrier to free trade. The full text of the SPS
Agreement is at Appendix 1.
The SPS Agreement establishes the legal prerogative of countries to impose animal and plant
health, and food safety measures on foreign imports by:
• recognising the sovereign right of Members to adopt a level of health protection they
deem appropriate; and then
• obliging Members to ensure that SPS measures are set with direct reference to the
chosen protection target, and in a way that avoids unnecessary, arbitrary,
scientifically unjustifiable or disingenuous restrictions on international trade.
The scope of the SPS Agreement is specific. SPS measures can only by applied to protect
against certain risks to human, animal or plant health or life. These are:
• risks to human life from plant or animal‐carried diseases;
• risks to human or animal life arising from additives, contaminants, toxins or disease‐
causing organisms in food;
• risks to animal* or plant* life from pests, including weeds, diseases or disease‐
causing organisms; and
• other risks to a country from the entry, establishment or spread of pests (World
Trade Organisation 2000).
(*where animals include fish and wild fauna, and plants include forests and wild flora)
While the SPS Agreement limits the scope of measures and does not apply to risks that lie
outside one of the listed categories, these have been given broad ‘judicial’ interpretation by
WTO dispute resolution panels.
Rulings of the WTO panel affirm the SPS Agreement covers environmental risks such as
threats to biodiversity, risks that are indirect, and risks that may not necessarily come to
bear immediately in time (Gruszczynski 2008). The latter may have implications for the way
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measures intended to protect against adverse effects of climate change, and other factors
capable of elevating pest risk into the future, may be viewed under the SPS Agreement.
Furthermore, an organism subject to an SPS measure need not itself be the pest the
measure is designed to prevent. Animal or plant imports that could result in genetic
transfers that enhance the environmental tolerances of established ‘sleeper’ weeds, feral
animals, vector species, including those capable of transmitting human disease appear to fall
within the ambit of the SPS Agreement.
Aside from scope and its broad interpretation, the key feature of the SPS Agreement is that
it lays out central principles and an administrative framework for the design and application
of SPS measures (World Trade Organisation 2000). The principles are:
Harmonisation: Article 3 promotes harmonisation of SPS measures by recognising the
standards, guidelines and recommendations of the OIE and the IPPC Secretariat. In this way,
the work of these organisations is now explicitly linked to a formal trade agreement. SPS
measures based on OIE or IPPC standards are presumed in law to comply with the SPS
Agreement.
However, the OIE and IPPC guidelines form neither a floor nor a ceiling for the adoption of
measures (World Trade Organisation 2000) and Members may elect not to refer to them. In
countries for which compliance with those standards is beyond current capacity, a lower
national standard may be implemented. WTO, FAO and other international organisations run
programs for sanitary and phytosanitary capacity‐building to help improve this situation.
On the other hand, a higher level of protection than would be achieved if measures were
based solely on OIE or IPPC guidelines may be imposed providing it can be demonstrated
that the circumstances warrant it. The WTO Appellate Body has confirmed that stricter
measures may be applied if they can be scientifically justified, or if a Member’s chosen level
of acceptable risk demands a regime more stringent than recommended by the OIE or the
IPPC (World Trade Organisation 2009).
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Equivalence: Article 4 requires that SPS measures must be accepted if the exporting country
demonstrates those measures achieve the importing country’s Appropriate Level of
Protection (ALOP).
This acknowledges that a target level of protection may be achieved by alternative means.
When economically and technically feasible alternatives for meeting ALOP are available, the
least trade restrictive option must be chosen. Evaluating equivalence may not always be
straightforward and the concept is not always applied consistently. For instance, Japan and
the European Union apparently do not always accept irradiation for phytosanitary purposes
(Follet and Neven 2006).
Appropriate Level of Protection (ALOP): Article 5 allows each Member to determine the
level of protection it deems necessary to safeguard human, animal and plant life or health,
and does not limit what may be taken into account in doing so.
With the right to choose ALOP come various obligations, including that it must be applied
consistently and should minimise negative trade effects. The ALOP concept is central to
contemporary trade policy and yet there are several difficulties with it. These are discussed
shortly.
Risk assessment: Article 5 also requires that SPS measures imposed to maintain ALOP are
based on risk assessment.
Technical guidance developed by the IPPC or the OIE must be taken into account but
Members may undertake their own risk assessments if such guidance has not been
formulated or if stricter measures are shown to be justified.
One example of a gap in the coverage of OIE and IPPC guidance occurs due to the specific
mandates of both (Biosecurity New Zealand 2006). The OIE is limited to consideration of
animal health risks associated with imported animals and animal products while the IPPC
extends only to risks to plant life and health. With the exception of human food safety issues
(covered by Codex), the result is that Members must develop their own policy on animal and
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human pests or diseases carried on plants, plant products or inanimate objects. A mollusc
that travels on plants and is a secondary host to a human parasite is an example.
Article 5 also specifies what can be included in processes for estimating potential economic
consequences of trade. A dilemma occurs because SPS measures must be set against ALOP,
and ALOP is able to express the full range of national interest values, including trade benefits
and costs not associated with pests. However, in devising SPS measures, Members may only
consider production losses, control costs associated with the entry, establishment and
spread of a pest, and the relative cost‐effectiveness of alternative management options. The
difficulty created by this disjunction is examined later in relation to Australia’s ALOP.
Another significant aspect of Article 5 is that it permits the adoption of provisional SPS
measures when scientific information is insufficient. Efforts must be made to obtain the
outstanding information in a reasonable period. The use of precaution in imposing SPS
measures is discussed further below.
Regional conditions: Article 6 recognises that a country, part of a country or all or part of
several countries taken together, may form an identifiable region in terms of pest presence
or absence, which may be independent of political boundaries.
Pest‐free areas and areas of low pest prevalence must be acknowledged by ensuring SPS
measures take into account differences between the status of the importing and exporting
countries.
Regional conditions can become contested when distinct bio‐geographical, economic or
other settings occur within the same country or block of countries, but are inadequately
recognised in trade policy. This issue is significant in Australia and is examined later.
Transparency: Article 7 requires Members to achieve a high level of transparency in the
imposition of SPS measures. It specifies systematic notification and publication
arrangements and maintenance of a point for enquiries (World Trade Organisation 2000).
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Communication and consultation procedures for risk analysis are also critical to increasing
transparency in sanitary and phytosanitary measures. These are discussed later in the
framework.
3.1.5 The SPS Agreement experience
The SPS Agreement has generated tremendous interest among and controversy between,
regulators, scholars and the public. It has spawned a vast and sometimes impenetrable
literature.
The literature is equivocal about whether a balance between trade and health protection is
being achieved that enhances human and environmental wellbeing. Nonetheless, over the
life of the SPS Agreement several issues with special relevance to import risk policy
formulation have emerged.
3.1.5.1 Science, democracy and risk regulation
The strict and basic requirement for measures to be supported by scientific evidence is the
feature of the SPS Agreement that has attracted the most attention.
The requirement for scientific evidence is criticised on the basis that it blocks consideration
of non‐scientific matters of a social welfare, cultural, political or ethical nature that may be
equally relevant to import policy formulation. The concern is that exclusion of other
considerations potentially imperils democratic decision‐making (Epps 2008).
The rationale for using science as the benchmark for determining the legitimacy of a SPS
measure is predicated on it being a field of knowledge concerned with facts and which can
therefore confer value‐free objectivity, fairness and transparency upon regulatory decisions.
This view is challenged by social science work concerning what people who are not scientists
may also bring to the consideration of risk. It is observed that while technical experts might
use scientific information to characterise animal and plant health risks in credible ways, they
do not have any special ability to judge whether those risks are worth taking, and thus what
form SPS measures should take.
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This raises the question of whether there is a need for other information to be taken into
account in the formulation of SPS measures. People without scientific training or expertise
are capable of a rationality that can complement that of experts because it can be more
sensitive to relevant concerns that are typically left out of technical, science‐based risk
assessments. These include how ‘dreaded’ the risk is in terms of catastrophic potential or
inability to control it, how ‘unknown’ it is in the case of new risks, or those with delayed
consequences, and how many people are likely to be exposed (Slovic 2002).
Epps (2008), in referring to WTO case law, concludes that the SPS Agreement has sufficient
flexibility to allow countries to entertain in the adoption of measures, cultural, ethical,
political and social concerns expressed by their constituencies, provided scientific rationality
is observed.
She further contends that even if a measure reflects a view of the technical evidence that is
divergent from mainstream scientific opinion, and again provided it is within reasonable
scientific bounds, that measure should meet the requirements of WTO law. Indeed, the WTO
Appellate Body, in considering the relation between a risk assessment and an SPS measure,
has indicated responsible and representative governments may take into account opinion
that differs from the mainstream, if it is provided by qualified and respected persons (World
Trade Organisation 2009).
Peel (2004), examining WTO case law against the approach to risk assessment by American
and European courts, likewise identifies non‐scientific input as potentially playing a more
prominent and legitimate role in the formulation of SPS measures. However, she finds
narrow scientific views of risk continue to dominate WTO rulings, and that requirements for
scientific evidence to support SPS measures are becoming tighter.
Yet others assert that the focus on the science and democracy dichotomy is misconceived
and that the more productive line of thinking lies in the relation between international trade
regulation and national social risk regulation.
Setting SPS measures, like other forms of national risk regulation, is an administrative
exercise (Fisher 2006). In most jurisdictions it is an activity delegated by the primary law‐
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maker (eg. a parliament) to a non‐elected body (eg. an executive comprising government
officials). The legislature does not have the time, resources or capability to gather and
evaluate information about biosecurity risk, much less to deal with analytical problems, or
communicate with relevant stakeholders on individual import risk problems.
As such, SPS standard‐setting necessarily draws on science and democratic input in the
forms of expert advice and public participation respectively. The issue therefore is not about
whether one conflicts with the other, but how they are to be properly managed for
technically effective and socially acceptable regulatory outcomes (Fisher 2006).
The balance between science and other concerns reflecting the unique circumstances of
countries, and how SPS measures are administered by government officials will continue to
be a focus of debate. Tasmania’s approach to these issues in the conduct of import risk
analysis is set out across Chapters Seven and Eight.
3.1.5.2 Appropriate Level of Protection
Appropriate Level of Protection (ALOP) is an expression of the level of biosecurity risk that a
country is prepared to take in the course of trade. It is also described as the risk target, or
level of acceptable risk.
ALOP is a political decision and a statement of political intent. The SPS Agreement does not
circumscribe the determination of ALOP. The full range of national interest values and
considerations – social, economic, environmental, cultural, political ‐ may be applied in
setting an ALOP.
While the choice of ALOP is a right under the SPS Agreement, making that choice implicitly
obliges Members to articulate their base position about the level of risk they accept in trade.
This is intended to reduce potential for arbitrary, discriminatory or capricious measures, and
provide clarity about the market access challenge for prospective importers.
When imposing a SPS measure, Members must demonstrate a specific relationship between
the risk posed by a proposed import, the chosen risk target and that measure. That is, the
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import poses pest risk above the risk target and the measure reduces that risk to or below
the risk target, but in the least trade restrictive way.
The ALOP must also be applied consistently and transparently across different situations of
import risk. Since every trade‐restricting action taken is judged against it, there is a practical
need for Members to be clear about their ALOP and how they formulate measures in
relation to it. That said, ALOP is not a static concept. The WTO Appellate Body has observed
that Members need not aim for absolute or perfect consistency, since governments establish
ALOPs over time as different risks present (World Trade Organisation 2009).
A difficulty arises because the definition of ALOP in the SPS Agreement gives rights but little
guidance as to how it should be set, framed or implemented. The WTO Appellate Body has
however, recognised that the need for Members to determine their ALOPs is implicit rather
than explicit in the SPS Agreement. It has also observed that ALOP need not be expressed in
quantitative terms, and that when a Member has not determined its ALOP or not done so
with sufficient precision, SPS measures can be interpreted as reflecting the level of
protection the Member considers appropriate (World Trade Organisation 2009).
Notwithstanding comments from the WTO Appellate Body, ambiguity around ALOP persists
and makes it harder for regulators to evaluate and decide consistently, and communicate
that work to interested parties. Apart from the risk of adopting measures that are not
necessary or failing to adopt measures that are, another drawback of ALOP ambiguity is that
it elevates scope for challenges to import policy decisions, and heightens the difficulty of
defending against them (Binder 2002).
Different approaches and techniques have been suggested for formulating and expressing
ALOP with greater precision.
Bigsby (2001) suggests plotting a sufficiently large sample of pests or products about which
regulatory decisions have already been made as a function of probability (of entry,
establishment and spread) and magnitude of consequences. Current regulated pests and
organisms for which a decision not to regulate has been taken establish a curve indicating
acceptable risk against which new pest risk estimates can be compared.
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This approach relies on at least three assumptions: that a country’s acceptable risk remained
stable over time (Binder 2002); that previous decisions about acceptable risk were made
consistently (Bigsby 2001); and that the decisions that were made actually do reflect the
chosen level of acceptable risk.
Establishment of the ‘cut‐off score’ for the well‐regarded Australian weed risk assessment
method (also used by the Tasmanian Government) was accomplished using this approach.
Therefore, there may be some circumstances (eg. certain subsets of pests) in which it can be
reliably employed.
A Dutch study examined an integrated process for establishing ALOP and Food Safety
Objectives (FSOs) in regard to chemical and microbiological hazards (de Swart and Donker
2005). The system involves cross‐discipline risk assessments (scientific, social, economic
considerations) of a product or group of products which subsequently inform the setting of
ALOP.
ALOP is then used to derive quantitative FSOs (eg. Acceptable Daily Intakes (ADIs) for
chemicals or quantity present at consumption for bacteria). Apart from reversing the typical
order and relation between ALOP setting and risk assessment, this approach highlights
whether separate risk targets could be considered for different imported product groups,
plants or animals ‐ ie. whether several ALOPs can legitimately operate at once. The
Australian weed risk assessment cut‐off score of ‘7’ could be considered a sub‐category of
ALOP that operates alongside and in conjunction with the formally articulated ALOP of ‘very
low’.
And at this time, no country expresses its ALOP with any great precision. Beale et al. (2008)
found that while some Members are considering ways of better expressing ALOP, others
define it in terms of measures taken to manage risk. An SPS Committee representative
confirmed to Beale et al. that most Members use SPS measures as a proxy for ALOP.
The other significant issue for biosecurity decision‐making stems from the mismatch in
criteria used to set ALOP and criteria for the conduct of risk analysis used to develop SPS
options.
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Beale et al. (2008) considered the proposition that ALOP is an emergent property of a
sequence of import risk analyses and decisions based on them and concluded that the
different ALOP and risk analysis criteria confer inconsistency to this definition. The issue is
discussed in relation to Australia’s ALOP in the next Chapter.
Tasmania’s ALOP is described Chapter Five, while its application in risk analysis is addressed
in Chapter Seven.
3.1.5.3 Use of precaution
The SPS Agreement is described by the WTO as one of the most elaborated operational
balance of rights and obligations on the role and use of precaution and in managing risks in a
multilateral agreement (World Trade Organisation 2001).
While precaution is described as having broad relevance to the SPS Agreement, this is so
particularly in Article 5.7 which permits the adoption of provisional measures if there is
insufficient scientific evidence for a risk assessment to be completed. Provisional measures
can range from imposing tighter restrictions than might apply if more was known, to
prohibiting importation altogether. Interestingly, and though there is a logical relation
between the two, the WTO Appellate Panel has determined that the concepts of ‘insufficient
scientific evidence’ and ‘scientific uncertainty’ are not interchangeable in the interpretation
of Article 5.7 (World Trade Organisation 2009).
Precaution is also reflected in the preamble to the SPS Agreement and Article 3.3 which
recognise that Members may impose measures that are more demanding than those
specified in international standards if an ALOP requires it. In setting ALOP, Members
distinguish acceptable from unacceptable risk, and in doing so inevitably make judgments
about how much precaution they wish to exercise (World Trade Organisation 2001, 2009).
The WTO Panel and Appellate Body have affirmed a consistent view of the relation between
precaution and the SPS Agreement (Niu 2007). This is that precaution does not take
precedence over obligations to base measures on scientific evidence and risk assessment,
nor the requirement to apply ALOP consistently and transparently. However, the Appellate
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Body has explicitly recognised that responsible, representative governments apply prudence
and precaution where irreversible risks are concerned (World Trade Organisation 2009).
Nonetheless, there are also views that the relation between precaution and the SPS
Agreement is unclear and may lead to illegitimate import policy. Precaution in SPS measures
is part of a broader dialogue on risk management in circumstances of inconclusive science,
particularly as applies to human health or the environment, and particularly when
technological capacity appears to outstrip ability to reliably predict consequences.
Such situations have prompted many attempts to formulate a decision rule about when it is
appropriate to exercise restraint in the pursuit of progress and development – now known
as the precautionary principle. The most familiar version of the precautionary principle is
from the 1992 Rio Declaration on Environment and Development. It is:
Where there are threats of serious or irreversible damage, lack of full scientific certainty shall
not be used as a reason for postponing cost‐effective measures to prevent environmental
degradation.
The precautionary principle has been referred to as a statement of common sense that
allows competent authorities to err on the side of caution and to be more concerned with
Type II errors (false negatives) than Type I errors (false positives) (De Marchi 2003 after
Christoforou 2002).
The concern from a free trade perspective is that precaution may be invoked to deliberately
disguise import restrictions with protectionist motives, thus undermining the role of risk
analysis in the development of SPS measures. Sentiment in this vein features in the broader
risk regulation dialogue. A leading risk practitioner has stated that ‘the precautionary
principle is threatening to take the place of risk analysis as the basis for regulatory decision‐
making in a number of places’ (Sandin et al. 2002).
The question of what constitutes insufficient scientific information, a trigger for use of
precaution is central to this debate. Therefore, it is critical to understand the nature of
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scientific uncertainty that attends a particular risk problem if precaution is to be applied
legitimately in public policy formulation.
Another approach is for Members to state clearly the precaution‐related considerations they
apply to domestic biosecurity generally, in risk assessments, and in the formulation of SPS
measures, as New Zealand has done (Hellstrom undated), and undertakes to do in its import
risk analysis reports.
Tasmania’s approach to the use of precaution in import policy formulation is set out in
Chapters Six and Seven.
3.1.5.4 Relation of the SPS Agreement to environmental risk regulation
Since the SPS Agreement covers risks posed by pests to wild flora and fauna, and has been
explicitly interpreted to apply to threats to biodiversity, reservations have been expressed
about potential for the international environmental legal regime to be subordinated to WTO
rules.
There is a perception that the traditional approach taken to plant and animal health
protection and advanced in the SPS Agreement does not match the more recently evolved
approach for environmental protection, and cannot be expected to satisfy international
nature conservation and related goals.
One difference is, as the WTO Appellate Body has noted, that the precautionary principle is
regarded by some as a general principle of customary international environmental law,
whereas it remains unclear whether the principle is widely accepted by Members as a
principle of customary international law in general (World Trade Organisation 2009).
Another difference is that many schemes for environmental protection do not rely
exclusively upon scientific information and may also take into account social, cultural and
other factors, whereas the SPS Agreement is less explicitly permissive of non‐scientific
considerations. In addition, the traditional subjects of SPS measures, pests of primary
production, are arguably more known, and more amenable to empirical investigation than
threats to natural environments (Gruszczynski 2008).
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Moves have been made to more clearly align parts of the SPS framework with management
of risks posed by pests to natural systems, recognising the need for good environmental
protection outcomes.
For example, when guiding principles for the management of invasive alien species were
issued under the 1992 Convention on Biological Diversity (CBD), the IPPC revisited its role in
biodiversity protection. A number of ISPMs have been or are being modified to more
explicitly apply to risks posed to all plants, including plants not in cultivation.
The IPPC maintains environmental protection has always been part of its portfolio (Food and
Agriculture Organisation 2006). Nonetheless, the benefit of these revisions is that the CBD
guiding principles are strengthened by being brought within the domain of the IPPC. IPPC
standards have legal status under the SPS Agreement while the CBD is non‐binding (Baker et
al. 2005).
One change made to IPPC standards is clarification in ISPM No. 5 Glossary of Phytosanitary
Terms (Food and Agriculture Organisation 2006) that potential economic importance
includes environmental and social impacts, reflecting the IPPC view that these can be
measured in economic terms using monetary and non‐monetary values. Another example is
extension of ISPM No. 11 on risk analysis for quarantine pests to species that cause indirect
harm to plants through competition, or by injuring beneficial organisms such as pollinators,
seed dispersers, detritus feeders and root symbionts.
IPPC is also considering how best to take into account risks posed by plant pests that may
further endanger native plant species, affect keystone plants, change plant biological
diversity in ways that destabilise ecosystems, and impacts on biodiversity of control and
eradication programs (Food and Agriculture Organisation 2006).
In addition to the CBD, nature conservation and protection obligations are established in
other international or regional agreements for specific environments. Those to which
Australia is a party include the Convention on Wetlands of International Importance, the
United Nations Convention on the Law of the Sea, and the Convention for the Protection of
the Natural Resources and Environment of the South Pacific. Governments that sign such
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agreements inherently accept responsibility to ensure import policy is fit to deal with
biosecurity risks posed to natural environments (Nairn et al. 1996).
The importance of Tasmania’s natural environments was described in Chapter Two. The
approach to incorporating environmental considerations in Tasmanian import risk analyses is
outlined in Chapter Seven.
However, regardless of adjustments to international standards and protection commitments
implicit in environmental agreements, some commentators observe that international
quarantine policy development lags behind environmental policy by two or three decades.
This is largely because the SPS Agreement does not sufficiently or explicitly incorporate
evaluation of costs and benefits to consumers (Anderson et al. 2001). Matters around this
dilemma are also explored in Chapter 7.
3.1.5.5 The SPS Agreement and the TBT Agreement
The relationship between the SPS Agreement and the TBT Agreement is of interest because
both provide for human, animal and plant health protection. Whereas the SPS Agreement is
narrow in its objective of protecting human, animal or plant health or life, the scope of the
TBT Agreement is broad and includes measures that may be adopted to prevent deceptive
practices, safeguard national security, and protect human health and safety, animal and
plant health, and the environment (World Trade Organisation 2000).
TBT measures include technical regulations and product standards that include product
characteristics, production methods, labelling and packaging, and audit procedures for
checking whether the regulations and standards are being met.
The SPS Agreement is the more stringent, principally due to its requirements for scientific
risk assessment. The TBT Agreement on the other hand, allows factors not of a scientific
nature to be taken into account in the imposition of measures. Accordingly, there may
appear potential for imposing restrictions in a way that circumvents the demands of the SPS
Agreement, possibly leading to the type of trade barrier the WTO system is intended to
prevent.
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However, the SPS and TBT Agreements were drafted to be complementary, to minimise
potential for confusion about which applies to a particular type of measure. The key
determinant in this regard is the purpose of the measure and the type of risk it addresses
(World Trade Organisation 2000). Any measure that aims to protect human, animal or plant
health from one of the risks listed in the SPS Agreement falls within the ambit of that
agreement while others are likely to come under the TBT Agreement.
Despite this separation, two types of measure are ambiguous and not so readily assigned to
either agreement (Gruszczynski 2008). One group includes measures that appear to be
technical regulations within the meaning of the TBT Agreement but which are put in place to
protect SPS interests. The other concerns measures with multiple purposes that fall within
the scope of both agreements. It is not clear whether these types of measure have yet
caused significant disagreement. The SPS/TBT issue is not discussed further in the
framework.
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3.2 Regional and bilateral arrangements relevant to biosecurity
3.2.1 Regional and bilateral trade agreements
While the WTO‐SPS framework is the dominant influence on trade and health negotiations
between countries, regional and bilateral arrangements concerned with reducing trade
barriers may also contain import provisions relating to pests.
Australia has formal bilateral trade agreements with New Zealand, Singapore, the United
States of America, Thailand and Chile (Department of Finance and Trade www.dfat.gov.au).
A similar number are at various stages of negotiation. A regional free trade agreement
between ASEAN countries (Australia, New Zealand, Singapore, Thailand, Malaysia,
Indonesia, Vietnam, The Philippines, Brunei, Laos, Cambodia and Burma) will take effect in
January 2010.
Nairn et al. (1996) point out these arrangements provide valuable points of focus for
progressing specific quarantine issues, including technical market access issues, advancing
cooperative work programs of mutual interest....., and addressing developments in national,
regional and multilateral quarantine policies and programs and that Australia has much to
gain by being at the forefront in these ... fora in negotiations and discussions on quarantine
issues.
3.2.2 Biosecurity issues
Article XIII of the Marrakech Agreement stipulates that several WTO agreements, including
the SPS Agreement, need not apply between one Member and another if one does not
consent to it. Beale et al. (2008) also note that SPS‐related trade disagreements may be
dealt with bilaterally, outside WTO dispute resolution structures.
Regional or bilateral trade agreements generally contain provisions for pest and disease
regulation consistent with WTO‐SPS rules and might be presumed not to have a different
bearing on risks to domestic biosecurity.
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However, the nature of bilateral negotiations may generally lend some added potential for
unfavourable outcomes for parties unable to assume a dominant negotiating position. Weiss
et al. (2004) argue that this came to pass in the Australia‐USA Free Trade Agreement of 2004
(AUSAFTA), and identify quarantine as one of the Australian institutions that has been
endangered as a result.
The core of this assertion is the AUSAFTA committee structure for quarantine decision‐
making that permits trade official participation, and is independent of the WTO‐SPS
framework. The authors contend the motive behind this administrative mechanism on the
part of the USA is to ensure a more private and controllable alternative for resolving market
access issues to WTO dispute settlement.
The AUSAFTA administrative structure consists of two bodies, the Australia‐US Committee
on Sanitary and Phytosanitary Matters, and the Australia‐US Standing Technical Working
Group on Animal and Plant Health Measures. The Committee refers quarantine‐related
disagreements to the Technical Working Group for advice. Article 7.4 provides for trade
representatives to join scientists and others on the Committee.
Weiss et al. (2004) are concerned about potential for USA trade interests to prevail over
Australia’s biosecurity interests in a bilateral forum open to trade officials but effectively
closed to international scrutiny.
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Chapter Four National policy and
legal setting
Equally, the Panel found...there exists almost universal confusion about what the Appropriate Level of Protection actually is as distinct from what it is not – zero, that is, it is ‘not zero risk’ Beale et al. 2008
4.1 Australia’s biosecurity system
4.1.1 Scope, attributes and recent revision
Australia has wide‐ranging and relatively sophisticated biosecurity arrangements. Its
biosecurity system covers policy, legislative, administrative and operational matters for all
pests with potential to impact upon primary industries, natural ecosystems and social
amenity. It includes animal diseases that affect human health, food safety and security. The
system encompasses prevention, preparedness and incursion response, and ongoing
management of established pests. It covers pests relevant to terrestrial, freshwater, marine
and built environments.
The system reflects Australia’s international animal, plant and environmental health
obligations stemming from the SPS Agreement, the CBD and other environmental protection
agreements. It incorporates State, Territory and Australian Government relations in
administering national biosecurity, and biosecurity between jurisdictions. The system
depends on partnerships between Governments, industries and the community.
A joint Primary Industries Ministerial Council (PIMC) and Natural Resource Management
Ministerial Council (NRMMC) biosecurity initiative began under the Howard Government in
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2005. Its purpose was to identify and find ways of addressing significant gaps, particularly in
environmental and social amenity protection.
At the time of writing this framework, an Inter‐governmental Agreement on AusBIOSEC
(AusBIOSEC IGA) had been drafted. Its aim was to guide the implementation of
improvements proposed through the joint Ministerial Council work, and to enhance and
clarify cross‐jurisdictional collaboration and coordination on all biosecurity matters. The
AusBIOSEC IGA was intended to provide an overarching framework of principles and
guidelines for a partnership approach, especially for institutional arrangements, incursion
response cost‐sharing for pests not already covered by existing agreements, and for shoring‐
up system capability.
However, finalisation and signing of the IGA was deferred, pending outcomes of a formal,
independent review of Australia’s quarantine and biosecurity arrangements commissioned
by the Rudd Government in early 2008, and chaired by Mr Roger Beale, AO.
4.1.2 The Beale Review and import policy
In late 2008, the review panel released its report, One Biosecurity: A Working Partnership.
The panel found that Australia’s biosecurity system is generally sound, but that legislative,
institutional and operational reforms and associated investments are required to strengthen
capacity to deal with changing and increased pressures into the future. The Australian
Government signalled in‐principle support for each of the 84 recommendations and work on
interpreting and implementing these commenced shortly thereafter. Government advised
this work would take time and be subject to the usual budgetary processes.
Anticipated changes with particular relevance to import policy formulation include:
• New national biosecurity legislation to replace the federal Quarantine Act 1908 and in
particular make greater use of the Australian Government’s constitutional powers. It is
proposed that the new legislation will explicitly subordinate the authority of States and
Territories to impose SPS measures on imported goods from other countries, and
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domestically produced goods imported between States and Territories. In addition, the
new Act will prescribe a regime for national regulation of ballast water management.
The legislation is also likely to provide for the federal Minister of Agriculture, Fisheries
and Forestry to determine Australia’s ALOP, and issue guidelines for the conduct of
Import Risk Analysis, Import Policy Determinations, and import permit decisions. The
new legislation is anticipated to come before parliament in 2010;
• A National Biosecurity Agreement. While the review panel recommended a national
agreement to replace the 1995 Memorandum of Understanding on Animal and Plant
Quarantine Measures (MOU), and the proposed Inter‐governmental Agreement on
AusBIOSEC, a slightly different approach has been taken.
A new Intergovernmental Agreement on Biosecurity (IGAB) is proposed as a head
agreement under which the MOU and other existing national agreements such as the
Government and Plant Industry Cost‐sharing Deed in Respect of Emergency Plant Pest
Responses and the Government and Livestock Industry Cost‐sharing Deed in Respect of
Emergency Animal Disease Responses will continue to operate, although these may also
be reviewed.
In addition, those parts of the AusBIOSEC IGA dealing with incursion response have been
adopted into a new National Environmental Biosecurity Response Agreement (NEBRA)
focussed exclusively on cost share for pests that primarily affect natural environments
and social amenity.
The IGAB is also anticipated to be finalised for signing by Governments who wish to do
so in 2010. The likely content of the IGAB is outlined below.
• A new organisational structure intended to enhance and better integrate biosecurity
governance at the national level.
The new biosecurity administrative structure envisioned by the review (see Beale et al
2008), and designed in particular to reduce scope for political influence or the
perception of political influence, has not been wholly implemented at the time of
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writing. However interim changes have been made, including the consolidation of
policy, administrative and operational units responsible for pre‐border, border and post‐
border functions into a single Biosecurity Services Group (BSG) within the Department
of Agriculture, Fisheries and Forestry (DAFF) (Department of Agriculture, Fisheries and
Forestry 2009a).
An interim Inspector General of Biosecurity responsible for auditing and otherwise
ensuring system integrity has also been appointed (Department of Agriculture, Fisheries
and Forestry 2009a). A Biosecurity Advisory Council comprising eight members with
diverse biosecurity expertise was also announced in December 2009. Its function is to
provide strategic and policy advice on a broad range of biosecurity issues (Burke 2009).
The detail of the proposed changes continues to unfold and specific implications for
Australia’s biosecurity system are not yet confirmed. However, to the extent possible, the
rest of this Chapter makes reference to One Biosecurity recommendations, and subsequent
work in progress that are pertinent to features of import risk regulation in Australia as it
stands, and which may indicate where it is headed.
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4.2 Australian biosecurity policy
4.2.1 Australia’s Appropriate Level of Protection
Consistent with WTO rights and obligations, Australia’s import regulation is administered
against an Appropriate Level of Protection (ALOP). ALOP was forged between
Commonwealth, State and Territory Ministers after an Australian Senate committee inquiry
into the Canadian salmon affair, in which Canada won its WTO appeal against the Australian
Government’s Import Risk Analysis.
Australia’s ALOP is intended to provide for a high level of sanitary and phytosanitary
protection aimed at reducing risk to a very low level, but not to zero. This conservative
position recognises the impracticality of achieving zero risk in the face of international trade
and travel, and reflects community expectations about the importance of protecting
Australia’s environment, economy and people from new pests (Department of Agriculture,
Fisheries and Forestry 2007).
As well as the general statement above, Australia’s ALOP is elaborated in Biosecurity
Australia’s (BA) Draft Import Risk Analysis Guidelines of 2001, and in the method section of
each import risk analysis report generated by BA.
‘Very low’ risk is defined as resulting from any one of six different combinations of likelihood
that a pest will enter, establish and spread, and magnitude of consequences were it to do
so. The risk ranking matrix (Table 3) depicts this relationship. The matrix uses six categories
of likelihood and six categories of impact magnitude to produce six categories (ranks) of risk
from ‘negligible’ to ‘extreme’ distributed across the 36 matrix cells. ‘Very low’ risk is one
rank removed from ‘negligible’ risk.
The six risk categories create an iso‐risk framework (Bigsby 2001) in which particular
combinations of likelihood and consequence indicate equal levels of risk. For example, 16
different combinations of likelihood and consequence equate to negligible risk, 6 cells in the
matrix equate to very low risk, 5 equate to low risk, and so on. In this iso‐risk framework,
‘very low’ is the upper limit for acceptable risk. The band formed by the six ‘very low’ risk
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cells represents the highest risk Australia is prepared to tolerate in regard to imports
without imposing specific SPS measures.
Prob
ability of e
ntry, estab
lishm
ent an
d spread
High
likelihood
Negligible
risk
Very low
risk
Low risk Moderate
risk
High risk Extreme
risk
Moderate Negligible
risk
Very low
risk
Low risk Moderate
risk
High risk Extreme
risk
Low Negligible
risk
Negligible
risk
Very low
risk
Low risk Moderate
risk
High risk
Very low Negligible
risk
Negligible
risk
Negligible
risk
Very low
risk
Low risk Moderate
risk
Extremely
low
Negligible
risk
Negligible
risk
Negligible
risk
Negligible
risk
Very low
risk
Low risk
Negligible
likelihood
Negligible
risk
Negligible
risk
Negligible
risk
Negligible
risk
Negligible
risk
Very low
risk
Negligible
impact
Very low Low Moderate High Extreme
impact
Magnitude of consequences of entry, establishment and spread
Table 3 Risk ranking matrix used by Biosecurity Australia where 'very low risk' meets Australia's Appropriate Level of Protection
4.2.1.1 Towards better definition of ALOP?
ALOP is given practical expression in national import policy determinations but also in the
conduct of import risk analyses used to inform decisions about applications for import of
foreign goods.
If an analysis indicates the estimated risk posed by a pest is at or below any ‘very low’ cell in
the matrix, that risk is deemed acceptable without the need for Australian authorities to
impose specific SPS measures. This does not mean general quarantine measures may not be
applied, especially where high levels of uncertainty attend the risk scenario.
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If the estimated risk falls above ‘very low’ on the matrix, specific measures may be applied
to reduce risk to ‘very low’.
Australia’s efforts to formulate its ALOP and to link it to SPS standard‐setting are amongst
the most considered in the world. Beale et al. (2008) found no other country appears to
have devised a formulation of ALOP that renders its meaning any clearer.
In Australia, the two problems inherent to ALOP, lack of definitional precision and the fact
that SPS standard‐setting cannot incorporate the full range of national interest
considerations, had not received much attention prior to the most recent review. As Beale
et al. (2008) found, there is no coherent understanding among governments or the
community, about Australia’s ALOP or how it is applied to import regulation.
The review reaffirmed that ALOP is essentially a political decision, and recommended it
become explicitly so in the proposed biosecurity legislation wherein the relevant Australian
Government Minister will be given authority to determine ALOP. This seems likely to occur
and in the spirit of One Biosecurity, presents an opportunity for all Governments to
collaborate in revisiting the ALOP definition. The Intergovernmental Agreement on
Biosecurity is also expected to provide for consultation on ALOP expression.
4.2.1.2 A national ALOP and regional risk
The review also recognised that legislative guidance for officials regarding how to conduct
import risk analyses against ALOP is limited, and that this also contributes to confusion and
conflict over risk regulation decisions. It therefore recommended that the Minister should
be provided with authority to issue guidelines that establish principles and the method for
estimating biosecurity risk.
The review advanced suggestions on the content of the guidelines, and recognised the
desirability of accounting explicitly for regional difference in risk. Regional difference and
how it is recognised in SPS standard‐setting is contentious in Australia because it is a
federation of States and Territories that have each exercised constitutional rights for more
than 100 years.
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In addition, Tasmania has argued that evaluation of regional risk in national import risk
analyses must occur in a way that does not invariably see it overwhelmed and hidden by
consideration of risk at a national scale, which tends currently to be the case. That is,
regional risk should be assessed independently at a regional scale because it is prone to
being underestimated when incorporated into national scale risk estimation.
However, there are two caveats to this proposition. To qualify for separate assessment, a
region must have a risk profile in relation to the pest being assessed that differs from the
rest of the country (eg. pest is absent, likelihood of establishment is greater, or
consequences are more serious). The region must also be capable of being managed to
exclude the pest (ie. return on risk management is likely to be positive). That is, the region
must be practically defendable against the pest in question. For example, a region that is
separated from the rest of the country by a significant geographical barrier that the pest is
unlikely to breach through natural dispersal is more amenable to protection than a region
that directly adjoins other regions.
There are potential benefits all round from a shift to this mode of split assessments. For
regions that satisfy the two criteria, ALOP is more likely to be met because SPS measures
commensurate with the comparatively higher risks faced by those regions could be applied.
For areas outside those regions (ie. the majority of the country), less trade restrictive
measures could apply. Chapter Five explains this proposition in more detail, with reference
to the assessment method used by Biosecurity Australia.
Again, collaboration on regional risk evaluation between all Governments in regard to the
guidelines would be consistent with the Beale review’s findings and tenor.
4.2.1.3 ALOP and cost benefit analysis
On the matter of cost and benefit considerations in import risk regulation, the review
acknowledged the case for a full national interest test in the course of import risk analysis
which would provide for examination of consumer and other benefits and losses, in addition
to potential for damage caused by pests.
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However, it was unable to suggest how this might be achieved without risking contravention
of WTO rules. The review observed that including non‐pest related costs and benefits would
increase scope for countries to use SPS measures as non‐tariff trade barriers – the free‐trade
obstacle the SPS Agreement is designed to eliminate. This is discussed further in Chapter
Seven.
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4.2.2 National biosecurity policy formulation
While Australia is considered to have a biosecurity system amongst the most advanced in
the world, policy formulation has arguably not kept pace with the evolution of legal,
administrative or operational arrangements.
Beyond broad acknowledgement of the importance of preventing pest incursions,
integration across the whole biosecurity continuum, decision‐making based on science, and
the idea of shared responsibility, there is no cohesive statement about why biosecurity
occurs or the fundamental principles to which the Australian and State and Territory
Governments should refer in determining national investment and regulatory priorities.
In the absence of a basic but sufficiently comprehensive interpretation of the rationale for
biosecurity, a range of assumed and disparate or outmoded objectives may operate.
Choices about the allocation of what is a substantial proportion of public resource ($Aus544
million in 2007‐08) may not be the right ones. Overall, the situation undermines chances of a
strategic, adaptive, resource efficient and equitable approach that delivers outcomes
appropriate to the contemporary biosecurity threat, and the Australian community’s
aspirations and expectations for human, animal, plant and environmental health protection.
However, the Beale review provided impetus to address this and in early 2009, primary
industries Ministers instructed a Working Group of Chief Executive Officers to formulate an
Intergovernmental Agreement on Biosecurity (IGAB). Indications are that the draft IGAB,
scheduled for presentation to Governments in mid‐ 2010, will attempt to articulate a set of
overarching policy principles and desirable system features by which all national biosecurity
endeavour will be guided, and under which enhanced cooperation might be achieved.
The principles and features are expected to refer inter alia to risk assessment and regulation
that is technically justifiable, least trade restrictive and otherwise consistent with SPS
Agreement provisions, recognition and meaningful treatment of regional difference,
resource allocation for greatest return, equitable and efficient distribution of costs among
biosecurity risk creators and beneficiaries and arrangements for use of Commonwealth
powers to override State or Territory biosecurity measures. These are particularly relevant to
import risk analysis.
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However, detailed interpretation of the IGAB in underpinning work such as a more cogent
statement of ALOP and national import risk assessment guidelines, including how
differences in regional difference are to be treated, remains to be done. This will ultimately
determine whether any real and beneficial policy reform is achieved. If the Australian
Government adopts the collaborative approach implicit in One Biosecurity, this underpinning
work can be expected to fall primarily to groups within the current intergovernmental
structure for national biosecurity policy‐setting, depicted in Figure 2.
Figure 2 Cross‐jurisdictional and cross‐sectoral governance of Australian biosecurity policy
National Biosecurity Committee
Primary Industries Ministerial Council
Natural Resource Management Ministerial Council
Primary Industries Standing Committee
Natural Resource Management Standing Committee
Animal Health Committee Vertebrate Pest Committee
Aquatic Animal Health Committee Australian Weeds Committee
Plant Health Committee National Introduced Marine Pest Coordination Group
Environmental Biosecurity Committee
Ad hoc Ministerial or
Chief Executive Officer fora
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4.3 Federal, State and Territory powers for regulation of trade and movement into Australia
The current roles, rights and obligations of the Australian Government, and State and
Territory governments in regulation of trade into Australia and interstate trade are pertinent
to import risk regulation.
It should be noted however that if One Biosecurity recommendations relating to new
national biosecurity legislation are adopted, the regulatory landscape can be expected to
change, and parts of what follows will become redundant.
4.3.1 The Australian Constitution
The broad rights and obligations of the Australian, and State and Territory governments for
pest and disease regulation are established in the Australian Constitution Act 1900.
Among other things, the Constitution specifies the division of regulatory powers by listing in
Section 51 subjects for which the federal parliament may enact law, with anything not listed
being exclusively a matter for each State or Territory. However, States and Territories may
also pass legislation on any subject in Section 51 provided it is not inconsistent with any
existing federal law on the same subject.
Two subjects in Section 51 relate directly to pest regulation – quarantine, and trade and
commerce with other countries, and between the States and Territories. The external affairs
power and the corporations’ power are also relevant to biosecurity regulation (Beale et al.
2008).
The current federal legislation for quarantine and biosecurity‐related matters is the
Quarantine Act 1908 and the Environmental Protection and Biodiversity Conservation Act
1999. The Mutual Recognition Act 1992 deals with trade between States and Territories.
Each Act is augmented or underpinned by national inter‐governmental policy agreements.
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4.3.2 Quarantine Act 1908
The Commonwealth Quarantine Act 1908 provides for the prevention of pest introduction
into Australia.
The Act is notable for being one hundred years old and is described as having resulted from
the States' perception of the need for a comprehensive set of national laws governing the
control of infected persons, vessels, goods, animals and plants entering the country from
overseas (Nairn et al. 1996). Also, the threat of plague had reached Australia by 1900 and
might have been the impetus behind State Premiers agreeing in 1906 to hand over
administration of quarantine to the Federal Government (Australian Bureau of Statistics
1988).
The scope of the Quarantine Act 1908 is broad, covering measures for the inspection,
exclusion, detention, observation, segregation, isolation, protection, treatment and
regulation of vessels, installations, humans, animals, plants or other goods or things, and
having as their object the prevention or control of the introduction or spread of diseases or
pests that will or could cause damage to humans, animals, plants other aspects of the
environment or the economy.
The Act is supported by the Quarantine Regulations 2000 and three Quarantine
Proclamations which list items that are prohibited or permitted import to Australia.
Responsibility for administration of those parts of the Quarantine Act 1908 relevant to
animal and plant health currently lies with the recently formed Biosecurity Services Group
(BSG) in the Department of Agriculture, Fisheries and Forestry (DAFF). BSG, headed by the
Deputy Secretary of DAFF (also the Director of Animal and Plant Quarantine), manages all
the agency’s pre‐border, border and post‐border functions. BSG is responsible for national
biosecurity policy, and regulation development and implementation effected through:
• Biosecurity Australia (BA) – conducts import risk analyses (IRAs) and develops policy
advice for the Director of Animal and Plant Quarantine;
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• The Australian Quarantine and Inspection Service (AQIS) – delivers quarantine
services and develops technical and operational procedures for risk management,
including for implementation of import policy determinations made by the Director
of Animal and Plant Quarantine; and
• Other plant and animal health units within BSG which provide liaison for inter and
intra‐state quarantine in conjunction with State and Territory Governments, and
coordinate emergency pest preparedness and response (Department of Agriculture,
Fisheries and Forestry 2009a).
The Quarantine Act 1908 reflects a century’s worth of change to biosecurity risk. Legislative
reforms subsequent to Australia signing the SPS Agreement and which are relevant to risk
analysis and regulation include:
• definition of the ‘level of quarantine risk’ as a reference to the probability of a pest
being introduced, establishing or spreading in Australia and the probability of the
pest causing harm to humans, animals, plants, other aspects of the environment, or
economic activities, and the probable extent of that harm;
• requirements for the Director of Animal and Plant Quarantine to consider the level of
quarantine risk if a permit to import to Australia were granted; and if the permit was
granted, conditions that should be imposed to limit quarantine risk to an acceptably
low level;
• a requirement for the Director of Animal and Plant Quarantine to request and take
into account in certain situations, advice from the Federal Minister for the
Environment; and
• regulation of the import risk analysis (IRA) process by:
o Differentiating standard IRAs from expanded IRAs
o Identifying certain steps that must be included in each type of IRA
o Specifying statutory IRA completion and consultation periods
o Specifying publication requirements
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o Providing for IRAs to be terminated
o Providing for a partially completed risk analysis to be completed as an IRA
(Department of Agriculture, Fisheries and Forestry 2007).
4.3.3 Memorandum of Understanding on Quarantine
While administration of the Quarantine Act 1908 is a function of the Australian Government,
on occasion States and Territories impose SPS measures that may directly or indirectly affect
trade into Australia. As reflected in One Biosecurity, in numerous national level discussions,
and in WTO disputes involving Australia as the defendant, this is a contentious practice.
Sub‐national regulation of foreign imports is attempted when additional or more stringent
measures to those imposed by the Australian Government are considered necessary by the
government of the potentially affected State or Territory. This typically results from
divergent views about regional difference.
Measures applied by regional or local governments of a WTO Member that affect
international trade are also subject to the requirements of the SPS Agreement. If States or
Territories impose measures on trade into Australia that do not or may not conform to SPS
requirements, other Members may invoke WTO dispute settlement procedures against the
Australian Government. The GATT 1994 provisions for compensation or suspension of
concessions may also apply.
Consequently, in preparing for Australia to become a party to the Marrakech Agreement,
the Australian, and State and Territory governments acknowledged a need for clarification
and agreement about how States and Territories should approach regulation of foreign
goods for biosecurity purposes, to avoid undesirable attention in the WTO.
The intergovernmental Memorandum of Understanding on Animal and Plant Quarantine
Measures (MOU) was drafted that is intended to reduce the likelihood of non‐compliance
with the SPS Agreement by establishing requirements for State or Territory biosecurity
policy affecting trade into Australia. The MOU took effect 1 January 1995 when Australia
assumed its obligations under the Marrakech Agreement. It is non‐binding in a legal sense.
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The MOU affirms the legal competence of States and Territories to impose sanitary and
phytosanitary measures to the extent this is consistent with Australian Government
legislation. It also prohibits the adoption of measures that do not comply with SPS
Agreement provisions, and places conditions on how measures should be formulated.
These include a requirement for consultation with the Australian Government before State
or Territory measures are implemented that could restrict trade into Australia and may not
conform to the SPS Agreement. If the WTO finds against a measure imposed by an
Australian State or Territory, the MOU specifies that the jurisdiction must take prompt and
appropriate corrective action. The Australian, and State and Territory governments also
agreed to make relevant information freely available to each other to implement the MOU.
Seven years after the MOU was signed, all parties agreed to update it to reflect the
partnership approach that had begun to evolve in domestic biosecurity over the interim, and
that this could be done via an exchange of letters between Ministers (Department of
Agriculture, Fisheries and Forestry 2002). The 2002 letters explicitly recognised regional
difference as critical to the successful implementation of the MOU.
From the perspective of reducing risk to the Australian Government of an action in the WTO,
the MOU has not been entirely successful. The MOU did not prevent the Tasmanian
Government from imposing measures on prospective killed salmon imports from Canada
that it deemed necessary to provide sufficient protection against disease risks associated
with that material.
That this situation arose has less to do with whether State and Territory governments have
behaved according to the MOU, and more to do with how regional difference is handled
during national import risk analysis and decision‐making.
Predictably, the Beale review heard abundant testimony on this matter. The review’s
solution to the problem of regional difference as it applies to regulation of foreign imports is
two‐part. It recommends, as mentioned, that the Australian Government extend its
legislative reach and actively prohibit States and Territories from imposing SPS measures on
foreign imports in addition to any imposed at the national level.
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At the same time however, the Beale review recommends that the legislative reforms,
including consultation processes necessary to clarify how this will work, should also
specifically take into account regional difference, and other matters (eg. ALOP, import risk
analysis method) that cause differences of opinion between governments about biosecurity
risk regulation for foreign imports.
In this way, the review believed the Australian and State and Territory Governments could
move forward in a workable, efficient partnership that reduces the risk of contravening
international trade law, and caters in a genuine fashion to the legitimate and unique
biosecurity risk concerns of States and Territories.
However and as outlined earlier, while the legal reforms that enable the Australian
Government to extend its legislative powers are underway, the consultative, foundation
work on ALOP and guidelines for risk analysis, including the matter of regional difference, is
unlikely to be completed by then and will need to continue outside the legislation
development process.
4.3.4 Environment Protection and Biodiversity Conservation
Act 1999
The Commonwealth Environment Protection and Biodiversity Conservation Act 1999 (EPBC
Act) provides the regulatory and decision‐making framework within which Australia’s
nationally and internationally significant flora, fauna, ecological communities and heritage
places are managed.
The EPBC Act embodies principles of ecologically sustainable development, including the
precautionary principle, and has broad ranging objectives for protecting Australia’s
environmental and cultural assets and values. It is administered by the Department of the
Environment, Water, Heritage and the Arts (DEWHA) (Department of the Environment,
Water, Heritage and the Arts undated).
Among many other things, the EPBC Act is used alongside the Quarantine Act 1908 to
regulate the importation of live animals and plants into Australia which may pose threats to
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biodiversity. DAFF and DEWHA coordinate the assessment and approval process, and
approval under both Acts is required before importation can proceed.
Section 303 of the EPBC Act provides for a list of live plant and animal specimens (including
viable reproductive material) that are permitted import to Australia for commercial or non‐
commercial purposes. Species that are not on the list cannot be lawfully imported. The list is
divided into two parts. Part 1 lists species that do not require approval to import under the
EPBC Act. Part 1 is taken to include plants that are permitted entry to Australia in
accordance with the Quarantine Act 1908, and excludes animals and plants listed on the
Convention on the International Trade in Endangered Species of Wild Fauna and Flora
(CITES).
Part 2 lists species that require an import permit from the DEWHA subject to conditions and
restrictions. For example, some species are restricted to importation to highly secure
facilities. Others may be received for eligible non‐commercial purposes. Conditions on age,
sex, country of origin may be set and there may be requirements for micro‐chipping or DNA
identification.
Applications to amend the list may be made to DEWHA in the event a species does not
appear in either Part 1 or Part 2. DEWHA assesses the application in consultation with BA,
other government and non‐government stakeholders and advises the relevant Australian
Government Minister who makes a decision to amend the list or not.
Beale et al. (2008) note that in undertaking the development of new biosecurity legislation,
links with the EPBC Act as well as other relevant Commonwealth legislation, will need to be
considered.
4.3.5 Intergovernmental Agreement on the Environment
The EPBC Act was preceded by and resulted from the Intergovernmental Agreement on the
Environment (IGAE) which took effect in 1992. The IGAE was the result of a Heads of
Government agreement two years earlier that the Commonwealth, State, Territory and local
governments of Australia should forge a more cooperative national approach to
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environmental protection, based on better clarity about roles and responsibilities across the
three tiers of government leading to enhanced nature and biodiversity conservation
outcomes.
The IGAE commits all levels of government to ensuring policies and programs affecting the
environment are implemented consistent with a range of principles and considerations for
ecologically sustainable development. The IGAE also includes several schedules. Schedule 9
addresses nature conservation and requires acknowledgement of pest species as a
significant threat requiring a national approach.
Implementation of One Biosecurity recommendations may result in changes to the IGAE,
however these are difficult to pre‐empt.
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4.4 Federal, State and Territory powers for regulation of interstate trade and movement
4.4.1 Mutual Recognition Act 1992 Section 51 of the Constitution allows the Australian Government to regulate trade and
commerce between the States and Territories, and to this effect it has enacted the
Commonwealth Mutual Recognition Act 1992. This legislation forms part of the national
legal regime for biosecurity because it contains a rule that clarifies the status of pest
regulation in trade between one State or Territory and another.
The broad purpose of the Mutual Recognition Act 1992 is to provide for free movement of
goods and the operation of service providers in the domestic market.
In regard to goods, the legislation establishes the principle that goods produced in or
imported into one State or Territory that may be lawfully sold in that State or Territory may
also be lawfully sold in another State or Territory without additional requirement. This
reduces potential for regulatory barriers to interstate trade in goods of sufficient standard,
which might otherwise result in unnecessary disadvantage.
Schedule 2 of the Mutual Recognition Act 1992 lists some permanent exemptions from
compliance with the principle, including matters of State or Territory quarantine.
The exemption requires that goods traded between Australian jurisdictions must comply
with State or Territory quarantine laws if the importing jurisdiction is free or substantially
free of a pest that is likely to be introduced by trade in a particular good, and that pest
would have a long‐term and substantially detrimental effect on all or any part of that
jurisdiction.
The Beale review does not appear to have explicitly considered the Mutual Recognition Act
1992. However, it recommended that the Australian Government be provided with
authority to override State and Territory SPS measures for domestically produced product,
which appears likely under the new biosecurity legislation. In this event, the quarantine
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exemption under the Mutual Recognition Act 1992 will continue to operate, but only to the
extent there is no dispute about a regulation imposed by a State or Territory on domestically
produced goods, or if there is, the regulation is considered to be justified on scientific
grounds and not more trade restrictive than required.
The Intergovernmental Agreement on Biosecurity is likely to commit the Australian
Government to developing a consultative process for determining the steps preceding the
Commonwealth’s use of powers to override State or Territory biosecurity controls, including
for domestic trade. In addition, the National Biosecurity Committee is developing principles
specifically for domestic quarantine and cross‐border movement controls.
4.4.2 Marine Pest Inter‐governmental Agreement
While not primarily concerned with items in trade, the Intergovernmental Agreement on a
National System for the Prevention and Management of Marine Pest Incursions is also
instrumental in establishing the relative roles and responsibilities of the Australian, and
State and Territory Governments in managing significant pest and disease risks associated
with ballast water.
The marine pest IGA is intended to help fulfil Australia’s obligation to ensure nationally
consistent measures for vessels carrying internationally or domestically sourced ballast
water, as agreed under the International Maritime Organisation’s Convention for the Control
and Management of Ships’ Ballast Water and Sediments. Variable measures are permitted
under the convention when supported by appropriate scientific evidence, for example, of
the presence or absence of a pest or disease in a certain port.
Under the IGA, the Australian Government is responsible for managing ballast water risks
associated with international vessels, while State and Territory Governments manage
vessels carrying domestically sourced ballast water. This is not ideal for a range of practical
reasons. One Biosecurity recommends the Australian Government assume responsibility for
managing marine pest risks associated with vessels carrying ballast water, irrespective of
source. This appears likely and hence amendments to the IGA can be expected.
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4.5 National Import Risk Analysis Administration
The Australian Government’s administrative processes for determining SPS measures for
specific import issues are also relevant to national biosecurity policy setting because they
specify consultation arrangements consistent with the partnership approach for Australian
biosecurity.
4.5.1 Import Risk Analysis under the Quarantine Act 1908
The Import Risk Analysis Handbook 2007 (Department of Agriculture, Fisheries and Forestry
2007) describes the administrative process Biosecurity Australia applies to assessing
proposals to import plants, animals, plant and animal products and other goods against
Australia’s ALOP.
The process is regulated under the Quarantine Regulations 2007. Its principal output is an
import risk analysis report, one piece of advice the Director of Animal and Plant Quarantine
considers when deciding whether to grant an import permit.
BA consults over the course of an import risk analysis. The national process includes
opportunities for States, Territories and other interested parties to comment on import
proposals prior to a decision.
If an expanded analysis is undertaken, an Issues Paper is released for comment over 60 days.
Feedback is considered in the formulation of a draft report which is also open to public
comment for up to 60 days. The regulated process further provides for a single extension at
the discretion of the Chief Executive of BA, should she or he believe that stakeholders have
not had reasonable time to comment on the draft report.
In addition to those provided for in law, BA offers informal consultation opportunities. It
also notifies State and Territory authorities about analysis scheduling and places information
on its website.
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Comments on a draft report are considered in the development of a provisional final report.
In the case of expanded import risk analyses, review of the draft report is undertaken by an
independent Eminent Scientists Group, which also informs the final provisional version.
Once the final provisional report is published, the regulated process concludes. However, a
final avenue for input is available via non‐judicial appeal.
The appeal process is limited. Objection may be made only to the provisional final report
and only on the ground of significant deviation from the process for producing that report,
set out in the Handbook. Scientific merits of the analysis or of recommendations or
conclusions in a provisional final report are not open to further consideration.
Once the regulated import risk analysis process concludes, further discussion about risk
management arrangements may occur between AQIS, BA and the relevant authority of the
prospective exporting country. This situation arises because the operational detail of
conditions to which an import permit is subject typically requires elaboration.
In mid‐June 2009 BA released updates to the Handbook designed to reflect interim
arrangements put in place in response to the Beale review, such as the formation of the
Biosecurity Services Group. In addition, the appointment of an economist to the Eminent
Scientists Group was advised. The import risk analysis process was however, unchanged by
any of these developments (Department of Agriculture, Fisheries and Forestry 2009a).
4.5.2 Import Risk Analysis under the Environment Protection
and Biodiversity Conservation Act 1999
The Department of the Environment, Water, Heritage and the Arts also administers a
comprehensive process for receiving State, Territory and other stakeholder input during the
assessment of applications to amend the list of live species that are permitted for
importation into Australia.
The process is initiated when a completed application including Terms of Reference for an
environmental assessment is submitted to DEWHA. The Terms of Reference are the
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questions that will be addressed in the assessment report which addresses impacts of the
proposed import on the Australian environment. DEWHA reviews the information and if
applicable, notifies relevant stakeholders and publishes draft Terms of Reference on its
website for comment, for at least 10 business days.
After the applicant has revised the Terms of Reference in response to comments, if
necessary, and DEWHA has approved the Terms of Reference, the applicant prepares a draft
assessment report. DEWHA publishes the report for comment for at least 20 business days
and notifies stakeholders. The Commonwealth Minister formally invites comment from
other Australian, State and Territory government Ministers.
The applicant is required to address feedback collated by DEWHA in a revised assessment
report. DEWHA reviews the assessment, considers the risks and advises the Minister.
The Minister makes a decision about amending the live import list within 30 business days
and notifies the applicant. If approved, the relevant instrument is tabled in both Houses of
the Australian Parliament for 15 sitting days.
Applicants who are dissatisfied with the Minister’s decision are encouraged to discuss the
matter with DEWHA in the first instance. They may also request an investigation from the
Commonwealth Ombudsman, limited to administrative actions. Persons with legal standing
may also have recourse to appeal provisions under the Administrative Decisions (Judicial
Review) Act 1977 (Department of the Environment, Water, Heritage and the Arts website
http//www.environment.gov.au).
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Chapter Five Tasmanian policy and
legal setting
Where we differ from the rest of the country..........is that we carefully consider the consequences of pest introduction specifically for Tasmania and the sort of Tasmania we want to project to the rest of the world Tasmanian Government submission to the Beale Review 2008
5.1 Tasmania’s biosecurity system
5.1.1 Biosecurity policy and strategy
In 2007, the Minister for Primary Industries and Water, the Honourable David Llewellyn MP
launched the Tasmanian Government’s Policy on Biosecurity (Department of Primary
Industries and Water 2007a) and a plan for implementing it, the Tasmanian Biosecurity
Strategy (Department of Primary Industries and Water 2007b).
The policy and strategy resulted from Government’s appreciation that it was time to update
the approach to biosecurity, reinforced by 21 recommendations made by Mr Geoff Gorrie in
a 2004 review of Tasmania’s quarantine system (Gorrie 2004). While he concluded the
system was sound and effective, Gorrie identified scope for operational and administrative
improvements. Government was advised to position these improvements within an explicit
policy framework and adopt a more strategic approach to carrying them out.
Thus, the policy and strategy were developed, signalling a new phase for Tasmanian
biosecurity. They are designed to ensure the State’s biosecurity system is robust enough to
protect natural environments, primary industries and public health, safety and amenity from
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contemporary pest threats in ways cognisant of relevant international and national
agreements, and to a standard that meets community expectations.
The biosecurity policy articulates elements that form the foundation of Tasmania’s approach
to preventing new pests and reducing the impacts of those that are already here.
While each element applies across the biosecurity continuum, all have relevance to import
risk analysis and risk regulation, described below. The requirement for science‐based risk
analysis to inform decision‐making is not elaborated here since it is detailed in Chapter
Seven.
5.1.2 Tasmania’s Appropriate Level of Protection
5.1.2.1 Definition of Appropriate Level of Protection
Tasmania’s Appropriate Level of Protection (ALOP) is set at a high and conservative level,
expressed as the level of biosecurity risk it is prepared to accept. That is, Government
accepts a ‘very low’ but non‐zero level of biosecurity risk, reflecting a balance of practical
allowances for trade and travel that does not unduly comprise Tasmania’s relatively good
pest and disease status. Tasmania’s ALOP is set at the same level as Australia’s ALOP.
Like the Australian ALOP, Tasmania’s ALOP is qualitatively defined in terms of likelihood that
a pest will enter, establish and spread, and magnitude of consequences were that to occur.
When an import risk analysis is conducted, likelihood and consequence estimates are
combined with reference to the same 6 x 6 (iso) risk estimation matrix used by Biosecurity
Australia (Table 3), and decisions about whether SPS measures are warranted are made
according to the same basic rules.
While there are other modes of expressing and applying ALOP that Tasmania may have
looked to when developing its biosecurity policy, compatibility with national policy settings
was deemed preferable to facilitate practical and clearer dialogue on import risk with other
States, the Territories and the Australian Government.
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5.1.2.2 Appropriate Level of Protection at a regional scale
Despite expressing ALOP in similar terms and adopting similar methods for assessing import
risk against it, it is possible for Tasmanian import risk analyses to result in different, and
typically more conservative conclusions about risk compared with those made for Australia
as a whole. This may occur, for example, when Tasmanian practitioners review a specific
import risk analysis offered for comment by Biosecurity Australia, or when Tasmania
participates in endeavours to achieve national regulatory ‘harmony’ for a pest that is
present somewhere in Australia, and which has implications for domestic trade or other
movement, or for export of host product to other countries.
Differences in risk estimates for the same risk problem occur for several reasons. Many
stem from the biology and ecology of the pest in question, and the relation between these
and likelihood of entry, establishment and spread, potential direct consequences, and risk
mitigation efficacy. Divergent interpretation of available scientific and technical evidence
and attendant uncertainties is commonplace in import risk analysis, and may or may not be
resolvable through discussion and consultation.
However, there are less recognised reasons why Tasmanian practitioners may return
comparatively conservative risk estimates for this State compared with estimates for
Australia or other parts of it. As explained in Chapter Two, several environmental, social and
economic attributes give Tasmania a distinct biosecurity risk profile. These attributes
combine to render this State more vulnerable to impacts of pests relative to the rest of
Australia. Impacts are likely to be felt more keenly in Tasmania compared with more
populous, urbanised, economically diverse mainland jurisdictions that do not rely so heavily
on a Brand and island identity susceptible to damage from serious pests. Accordingly, and if
the State’s biosecurity risk profile is not sufficiently recognised in national work, Tasmanian
practitioners are likely to contend that consequences and hence risk have been
underestimated, and that resulting SPS measures do not achieve Tasmania’s ALOP.
Another situation in which estimates of risk for Tasmania may be higher than estimates
made at a national level derives from the method Biosecurity Australia uses for evaluating
consequences at various geographic scales when considering international import proposals.
The method involves estimating impact at local, district, regional and national levels using a
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set of decision rules that yield for each type of impact, a letter score (A‐G) reflecting the
potential magnitude of the impact (Table 4). The combination (according to a second set of
rules) of letter scores for all impacts at each scale determines an overall consequence rating
(negligible to extreme) that is used in the risk estimation matrix (Table 3).
The decision rules for geographic scale are structured such that impacts assessed as
significant for smaller areas are assigned decreasing importance at successively larger scales,
while potentially significant impacts over larger areas will be increasingly significant at scales
below. This is logical and provides a consistent and convenient way of considering the
spatial dimension of impact, which in turn helps understand and articulate the nature of
risk.
Table 4 Decision rules used by Biosecurity Australia for determining the impact score based on the magnitude of consequences at four geographic scales (Biosecurity Australia 2009c)
G Major significance Major significance Major significance Major significance
Impa
ct score
F Major significance Major significance Major significance Significant
E Major significance Major significance Significant Minor significance
D Major significance Significant Minor significance Indiscernible
C Significant Minor significance Indiscernible Indiscernible
B Minor significance Indiscernible Indiscernible Indiscernible
A Indiscernible Indiscernible Indiscernible Indiscernible
Local District Regional National
Despite its merits, a problem occurs if this scaling scheme is applied indiscriminately. While
the scheme usefully highlights differential impact at relevant scales, it also invariably results
in impact estimates for smaller areas being translated against, and subsumed into, the
estimate for the largest (ie. national) geographic scale. That is, impacts at all scales are
ultimately rated for significance from a national perspective. In most cases, this is
appropriate, not least because Biosecurity Australia is charged with informing national
import policy but also because it would be impractical to undertake and difficult to justify
individual pest risk assessments at multiple scales.
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However, there are circumstances in which serious impacts at sub‐national scales deserve
separate treatment. As outlined in Chapter Four, Tasmania’s contention is that a separate
pest risk assessment is warranted at a regional level if a national import risk analysis:
• identifies impacts for a region that are potentially ‘significant’ or of ‘major
significance’ (as per Table 4); and
• the region can be practically managed to exclude the pest.
To reiterate, the advantages of such an approach to regional risk evaluation are two‐way. A
separate regional assessment allows for the formulation of SPS measures commensurate
with risk posed to the region by avoiding the impact‐downplaying effect inherent in Table 4.
Also, removing a potentially significantly affected region from the national risk estimate
means that estimate may be moderated and that SPS measures that are less trade
restrictive may be considered for the rest of the country.
These are the same two benefits that result from the current BA practice of conducting
separate regional pest risk assessments in the event a pest is absent from a particular State
or Territory (typically) but present elsewhere in Australia. Therefore, the split assessment
approach outlined above would seem a reasonable extension and refinement of current
practice.
Thus, and although Tasmania’s ALOP is formulated and applied in ways that mirror the
national ALOP, this does not always lead to coinciding views on risk. While pest
presence/absence and biology/ecology are accepted as bases for different risk estimates
and hence different SPS measures within Australia, a broader appreciation of Tasmania’s
specific regional character and its relation to pest impact is required, along with some fine
tuning of current assessment methods. Clearly, Tasmania cannot effect either remedy on its
own however both could be pursued in the course of national biosecurity policy reform
concerning regional difference, as recognised in One Biosecurity.
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5.1.3 Risk‐based and cost‐effective resource allocation
The Tasmanian policy also stipulates that biosecurity is to be administered according to level
of risk posed and in a cost‐effective manner, to achieve the greatest reduction in high
priority risks in a way that maximises benefits.
The need to address a growing list of biosecurity risks creates an imperative for careful
prioritisation and distribution of limited public funds for risk regulation. This situation is not
unique to Tasmania and it means that not all risks will be mitigated all the time to
everyone’s satisfaction.
Resource allocation is relevant to import risk analysis because potential SPS measures for
pests and disease agents may have cost implications for Government that need to be
understood before decisions about those measures are finalised. This applies particularly to
quarantine barrier activity and post‐barrier surveillance. If relevant costs are not adequately
identified, it is possible that a plan for import risk mitigation will be compromised either
because it makes demands in excess of barrier capacity or because effective monitoring
cannot be resourced.
5.1.4 Shared responsibility
Directly in relation to the substantial cost of biosecurity, the policy also embodies the
Tasmanian Government’s belief that biosecurity cannot be regarded as a matter for
government alone.
Rather, the effectiveness of Tasmania’s biosecurity system depends on responsibility being
taken up by Government and those groups in the community that create biosecurity risk or
draw benefit from risk mitigation actions undertaken by Government. Groups include
importing and exporting industries, primary producers, home gardeners, animal enthusiasts,
outdoor recreationalists, the travelling public and consumers – in short, everyone.
The notion of shared responsibility is easily invoked because it speaks to principles of equity
and cooperation with which few people would argue. However, the practical application of
shared responsibility in biosecurity is difficult because it involves making concrete
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distinctions between, and decisions about, public versus private goods, and therefore who
ought to pay, why, under what circumstances and how much.
As mentioned, there is considerable scope and need for addressing these matters in national
biosecurity policy fora. In the meantime, the Tasmanian Government will endeavour to
encourage shared responsibility, and further develop internal mechanisms for incorporating
cost and benefit considerations into decisions about import requirements while upholding
SPS obligations. To start with, cost effectiveness of barrier and post‐barrier measures are
incorporated into import risk analysis consequence evaluation, as outlined in Chapter Seven.
5.1.5 Governance
The Tasmanian biosecurity policy recognises that whole‐of‐government cooperation is
critical to achieving strategic direction, consistency and cohesion in programs and measures
across the biosecurity continuum, including in import policy development. To this end,
Tasmania’s biosecurity system is administered according to a governance structure led by
the inter‐agency Tasmanian Biosecurity Committee (TBC).
The TBC is responsible for providing high level policy advice to Government, and oversees
implementation of the Tasmanian Biosecurity Strategy. It also reports up to the Secretary of
the Department of Primary Industries, Parks, Water and Environment (DPIPWE) who has
decision‐making powers under most State biosecurity‐related legislation, and represents
Tasmanian interests in relevant national biosecurity inter‐governmental fora.
The TBC is chaired by the Deputy Secretary (Biosecurity, Agricultural Policy, Corporate
Services and Communications), DPIPWE, and in addition to DPIPWE Divisional
representation, draws its membership from other Tasmanian Government agencies with
significant roles in State biosecurity. These are the Departments of Health and Human
Services; Police and Emergency Services; and Energy, Infrastructure and Resources.
The TBC receives and may request scientific or technical advice from the Tasmanian
Biosecurity Technical Group (BTG). BTG is chaired by the General Manager of DPIPWE’s
Biosecurity and Product Integrity Division (BPID), reflecting BPID’s primary role in policy
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formulation and the delivery of diagnostic, quarantine and incursion response programs and
services for animal and plant pests and diseases.
The BTG accesses the broader pool of scientific expertise held by other Tasmanian
Government agencies or entities with important policy interests in animal, plant or
environmental health protection. It also recognises the special relation between the
Australian Antarctic Division and Tasmania in matters of biosecurity. Thus, BTG is constituted
to include a wide range of professional officers able to bring rigour and experience to the
consideration of technical matters and formulation of advice for the TBC, including in regard
to import risk. The governance structure for Tasmania’s biosecurity system is shown in
Figure 3.
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Figure 3 Governance of Tasmania's biosecurity system
Tasmanian Biosecurity Committee
Department of Primary Industries, Parks, Water and Environment Department of Health and Human Services
Department of Police and Emergency Services Department of Energy, Infrastructure and Resources
Secretary Tasmanian Department of Primary
Industries, Parks Water and Environment
Biosecurity Technical Group
Biosecurity and Product Integrity Division, DPIPWE Policy, diagnostics, incursion response, quarantine and compliance programs and services
Resource Management and Conservation Division, DPIPWE Nature conservation on all land tenures including TWWHA
Water and Marine Resources Division, DPIPWE
Wild marine fisheries and farmed fish management, marine pests
Parks and Wildlife Service, DPIPWE Protection of reserved land, including from new pest incursions and spread of established pests
Inland Fisheries Service
Inland fisheries and ecosystem management including pest fish and other lake, stream or river pests
Forestry Tasmania Pest and disease management in plantation and managed native forests
Department of Health and Human Services
Liaison for zoonotic and other human health issues that intersect with animal or plant imports
Australian Antarctic Division Biosecurity for Antarctic and sub‐Antarctic territory
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5.2 Tasmanian import policy and law
Import risk analysis informs regulatory action (or inaction). Control of movement of goods
and conveyances into Tasmania for biosecurity purposes is provided for in several discrete
Acts listed in Table 4, rather than under a single piece of quarantine or biosecurity
legislation.
Within the suite of legislation that addresses import control, there is some overlap, a few
gaps and scope for improvement. These issues are being addressed progressively in the
course of legislative review activities specified in the Tasmanian Biosecurity Strategy.
The legislation most frequently used for animal and plant health protection in relation to
imports is the Animal Health Act 1995 and the Plant Quarantine Act 1997 respectively.
The Animal Health Act 1995 prohibits importation of all animals, restricted materials and
infected animal materials unless the Chief Veterinary Officer (CVO) has granted prior
approval. It prescribes a ‘permitted’ or ‘white’ list approach.
The CVO has issued a series of general authorities that set out import conditions for a range
of animals and animal products, and considers applications by individual importers for
special import authorities. If a general import authority does not exist or a special import
authority is denied, the animal or animal product is prohibited import.
Although the Plant Quarantine Act 1997 does not purport to prohibit all plants and plant
products, a declaration made under it restricts all plants and plant products grown or packed
outside Tasmania from being brought into the State without the approval of the Secretary,
DPIPWE, and otherwise than in accordance with any condition or restriction he or she has
placed upon them. Conditions and restrictions on the importation of plants, plant products
and other prescribed material are set out in the Plant Quarantine Manual Tasmania.
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Table 5 Tasmanian legislation for controlling importation of pests and diseases
Statute
Responsibility in Department of Primary Industries, Parks, Water and Environment
Import or inward movement provisions
Animal Health Act 1995
Biosecurity and Product Integrity Division
Prohibits or restricts of movement of animals, restricted materials and infected animal materials into Tasmania to protect animal resources from pests and diseases
Living Marine Resources Management Act 1995
Water and Marine Resources Division
Prohibits importation of live fish into Tasmania, and allows actions to prevent the introduction of any harmful pest or disease into State waters
Inland Fisheries Act 1995
Inland Fisheries Service Prohibits importation of freshwater fish to protect freshwater resources from pests and diseases
Plant Quarantine Act 1997
Biosecurity and Product Integrity Division
Prohibits or restricts movement of plants, plant products or prescribed matter into Tasmania to protect plant resources from pests and diseases
Nature Conservation Act 2002
Resource Management and Conservation Division
Prohibits movement of controlled or restricted animals into Tasmania to help conserve and protect native flora and fauna
National Parks and Reserves Management Act 2002
Parks and Wildlife Service Prohibits introduction of certain animals to reserved land in Tasmania and restricts access to certain classes of reserved land, including Macquarie Island Nature Reserve. Provides for statutory management plans for reserved land which may specify conditions, including in relation to access.
Other Tasmanian legislation also provides for plant import regulation (Eg. Weed Management Act 1999, Seeds Act 1985) However, in
practice the Plant Quarantine Act 1997 is used to support the objects of those Acts in regard to importation risks.
Although the Animal Health Act 1995 requires the CVO to consider several matters when
deciding whether to issue an authority, including the likely purpose of importation and
degree of risk of any disease associated with a proposed import becoming established or
further spread in Tasmania, the scientific, technical, economic or other criteria statutory or
delegated officers should take into account when determining import policy, or the process
for making the determination, is not specified in law.
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This circumstance, combined with the imperative of protecting Tasmania’s biosecurity status
consistent with national and international policy and legal environments, and Tasmanian
policy, provides the broad impetus for this framework. The three remaining chapters discuss
concepts and methods of import risk analysis, and how it is administered in Tasmania.
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Chapter Six
Concepts
for
import risk analysis
Many interesting and provocative things occur when people judge risks
from the essay, Trust, emotion, sex, politics and science, Slovic 2002
6.1 The relevance of risk perception
Social research over several decades reveals insights into the nature of risk perception, its
connection to risk management and how it might be used to improve scientific analysis and
decision‐making processes.
This research mostly takes the form of interview‐based studies of judgement about many
different areas of human health and environmental risk, and is not specific to import
situations involving pests. However, the outcomes apply equally to import risk problems
because the central concern – to manage risks in ways that provide adequate protection
from harm that are also acceptable to society – is the same.
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The following, unless otherwise indicated, is summarised from Stern and Fineberg (1996),
Slovic (2002), Burgman (2005). All should be consulted for a fuller treatment.
6.1.1 The nature of risk
A theoretical framework of risk perception has emerged from the social sciences over the
last 30 to 40 years. At its core is a new definition of the concept of risk.
The traditional view, rooted in engineering and perpetuated amongst other scientific
disciplines, is that risk is an entity that can be characterised and measured as a function of
the probability and consequences of injury, damage or loss, using data about relevant
physical and natural processes and factors (eg. for import risk analysis, biology, ecology,
pathology, pathways, treatment efficacy, etc.).
The traditional concept of risk represents it as something real, independent of the minds of
people (ie. objective), calculable from the probability of an event and its consequences. The
six by six matrix for import risk estimation used by the Australian Government and by
Tasmania embodies this view, as do similar matrices used in other situations where
judgements about risk are required (eg. occupational health and safety, gene technology).
The risk perception paradigm proposes a different conception of risk. It suggests that while
harm is real (eg. biodiversity is lost when weeds move in, profit is smaller when a flock or
crop becomes diseased), risk is not. Rather, risk is a mental construct developed by society
to help understand and make judgements about the extent to which it is prepared to
tolerate harm. This definition suggests that risk is not readily represented by a number, and
that solutions to risk problems are more likely to be diverse and changeable, and less likely
to be unique and static.
In calculating risk, general society uses a different, broader equation than that typically
reflected in scientific and technical analyses. The public takes into consideration factors in
addition to probability and consequences, such as uncertainty about harm, how dreaded it
is, its catastrophic potential, the extent to which it can be controlled, whether some groups
are more or less exposed, and how it might affect future generations.
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The cognitive processes used to make this broader computation of risk are influenced by
values and beliefs that vary according to social, cultural, gender and political factors and
affiliations at individual, community and societal levels.
These factors affect the perception of risk by scientists, technical experts and analysts, in
much the same way as everyone else. This is relevant because judgements need to be made
throughout a technical risk analysis by the people conducting it. Risk problem framing,
choice of data and measurement criteria, and how potential losses and gains are portrayed,
are each subject to judgement.
Accordingly, the theoretical framework for risk perception proposes that risk is inherently
subjective and value‐laden, irrespective of whether it is viewed through a scientific or non‐
scientific lens. This does not suggest facts, probabilities and harm do not exist. Rather, it
emphasises that care must be taken in acquiring and interpreting information used to inform
risk analyses.
If the risk perception paradigm is correct, the implications for risk management and
regulation are significant. Before turning to these, a selection of the cognitive factors that
influence risk perception is outlined below. Some of these are so well demonstrated they
have heuristic (ie. rule of thumb) status.
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6.2 Influences on risk perception
6.2.1 The thought of loss
In making judgements about whether or not a risk is worth taking, most people will be more
influenced by what they stand to lose than by the prospect of gain. The importance of loss
aversion is recognised as a fundamental driver of risk perception and judgement. It is linked
to motivational bias which describes a tendency to over or underestimate risk depending on
where personal losses and gains are perceived to lie.
People make calculations about loss based on the goods or other assets they already have,
or think they have, which can include future opportunities. Judgements about prospective
loss will be closely related to the specific circumstances of the people making them, and are
therefore subjective. Even small risks may present a prospect of unacceptable loss to some
people. In import risk analysis and regulation, a number of potential losses and losers can be
identified.
Economic loss potentially incurred by importers and consumers, when regulation of a
previously unregulated item is being considered, is an example. Regulation is likely to
increase import costs and hence may reduce competitiveness and profitability to importing
businesses, and may increase costs to consumers.
Conversely, a decision not to regulate, while perhaps relieving importer concerns, may not
be welcomed by local industry participants fearful of potential for pest outbreaks to reduce
their profitability, and present and future market access prospects.
Less obvious potential losses are those that fall to the public analyst or decision‐maker.
Practitioners might naturally be motivated to enhance and preserve their professional
reputations. Some may be inclined to adopt a stricter position on import requirements
because the personal consequences of doing so, and then having a serious pest outbreak,
are less adverse than the consequences of not taking a strict position, and also having an
outbreak.
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Conversely, public analysts who work closely with industry representatives with a stake in
less strict import requirements may come to value those relationships to the extent more
weight is given to industry judgements of risk than might otherwise occur. This is a form of
‘regulatory capture’, and it can work in favour of more or less conservative judgements
about risk.
Perception of potential loss in any situation of risk is also closely related to how the risk is
framed. Different evaluations and decisions will be made when risk information that is
otherwise logically equivalent, is presented in different ways.
6.2.2 Stigma
Stigma occurs when someone or something (a product, a technology, a place) has an
attribute or condition that departs from what is considered normal, desirable and good by
society, causing others to disparage or discriminate against the person or thing.
The negative impacts of stigma can be intensely personal, economic or social in nature, and
it can perhaps be considered an insidious and potent form of loss. Stigma has six features:
• Concealability – is the condition hidden or obvious and if so, can its visibility be
reduced?
• Course – how does the condition change over time, does it get better or worse?
• Disruptiveness – does the condition prevent normal interaction and communication?
• Aesthetic quality – to what extent does the condition make the person, product or
place repellent or distressing to others?
• Origin – how did the condition develop and who was responsible?
• Peril – does the condition pose danger and how serious and imminent is it?
Examples of stigma are not hard to find in biosecurity situations. In import risk analysis it is
particularly relevant to consideration of management options, but also to estimating indirect
economic and social impacts of pest incursions.
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For instance, a property placed under quarantine as a result of a disease outbreak may be
subject to stigma in all its dimensions. The disruption caused to the property owner and his
or her family is stressful and expensive, the quarantine signs, barriers, official vehicles and
people in plastic overalls are highly visible, the situation may get worse before it gets better
(eg. stock may be slaughtered), distressing sights, sounds and smells may occur (eg. piles of
carcasses), there will be speculation and rumour over who is to blame.
The media and other entities may amplify these impacts, pushing them out across time and
space. The business may take a longer time to recover, even after the disease is eradicated.
Market access for neighbouring businesses or the broader industry may also end until
evidence showing they are also free of the disease is gathered.
Stakeholders will bring to import risk analysis and decision‐making processes, visions of what
could happen to their businesses, industries and the people in them as a result of a pest
outbreak, and this can be expected to affect their views about risk. Cook et al. (2008)
describe stigma‐related social impacts of pest incursions. For instance, a survey of residents
after the outbreak of Newcastle disease at Mangrove Mountain in New South Wales
revealed significant damage to community cohesion.
6.2.3 Effect of affect
Affect refers to either a feeling state (elation, sadness, anger, sympathy) or a quality
associated with an external stimulus (goodness, badness, beauty, repulsiveness). It is about
liking or not liking a thing.
When a stimulus (visual, aural, touch, taste) occurs, affective reactions are the reactions
people have first, before they have time to process other information. Affective reactions
are intuitive, emotional responses. In that sense, affect is about not thinking, at least in an
analytical way.
The primary nature of affective reactions suggests affect is an important orienting
mechanism. Orientation describes the base position a person takes for coping with the
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complexity, danger and uncertainties of life, and therefore has implications for how risk is
perceived.
The influence of affect has been studied by considering risk‐benefit judgments. There
appears to be a consistent inverse relationship between perceived risk and perceived
benefit. Most people are inclined to view benefits of a particular activity as larger if they also
perceive the risks to be low, while they see lower benefit in activities they consider to be
high risk. This is despite a generally positive correlation between risk and benefit in the
environment (ie. the more risk you take, the greater the potential return).
Affect also plays a role in the judgement of risk because people automatically refer to their
own pool of ‘likes’ and ‘dislikes’, built from memory, experience and personal motivations. If
an activity is associated with something a person likes, he or she is inclined to see in the first
instance, higher benefit and lower risk. Conversely, if there is an association with something
the person doesn’t like, he or she will regard risk as higher and the benefits lower.
The significance of affect appears to increase if time pressures are introduced.
Affective processes operate alongside cognitive analytical ones and seem to be integral to
normal, rational thought. While affect can lead to poor judgement, skilled people are also
capable of making more accurate judgements in their area of expertise when they trust their
intuition, than when they conduct a detailed analysis (Kahneman 2003). Therefore, it is not
necessarily useful to take the view that affect always works to the detriment of reliable risk
analysis.
6.2.4 View of the world
Worldview describes the sum of social, political and cultural beliefs and attitudes that
underpin a person’s responses to what goes on around them. It is another orienting
mechanism.
Some ordered ways for characterising world views and examining their influence on risk
perception have been constructed. Five main categories of worldview are:
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• Fatalism (eg. I have very little control over risks. What happens in life is preordained
and I can’t change it);
• Hierarchy (eg. I prefer decisions about risk to be left to the experts. Command and
control should flow down the hierarchy while obedience should flow up);
• Individualism (eg. Government interference is too high. I should have the right to do
as I wish, unhindered by authority);
• Egalitarianism (eg. If people were treated more equally there would be fewer
problems. The distribution of power and wealth needs to be evened out); and
• Technological enthusiasm (eg. New technology is important for improving societal
well being. We should not be afraid of it).
Worldview can be a reliable predictor of how people will judge risk. In the nuclear power
debate for instance, people with egalitarian worldviews tend to judge the risks to be too
high and unacceptable. This group sorts neatly from fatalists, hierarchists and individualists,
who generally rate nuclear power risks as more acceptable.
6.2.5 White males
Women and men perceive risk in consistently different ways. The primary difference is that
men judge risks to be smaller and less significant than women. A phenomenon now called
the white male effect is identified. White males stand out because they repeatedly rate risks
lower than white females, and non‐white males and females.
Perception of low risk is not the result of similar views being held by all white males. Rather
around 30% of white men are responsible, judging risk to be extremely low. These
individuals drag down the average risk ratings of the whole cohort. The other 70% of white
men rate risks at levels similar to women and non‐white men.
Individuals in the special subset of men responsible for the white male effect are likely to be
better educated with higher household incomes, and disposed to more politically
conservative positions. They are also likely to have greater trust in authorities and
institutions, and are reluctant to view placement of decision‐making power on matters of
risk in the hands of citizens, as prudent.
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6.3 Risk perception and ability to estimate risk
In addition to leading to differences in the way people estimate risk, the heuristics described
above produce behaviours that hamper the ability of most people to judge risk well.
This does not always occur. If people have cause to make judgements frequently and have
access to quick, clear feedback about the accuracy of their predictions, risk estimates can be
quite reliable. Typically however, important and difficult decisions have to be made in the
absence of unambiguous feedback. Accordingly, inconsistent and less reliable risk analysis
and decision‐making may result. The biases which impede reliable risk judgement include:
6.3.1 Insensitivity to sample size
Inferences are frequently made from available observational, experimental or other data. In
doing this, conclusions may be drawn that would be warranted only by much larger data
sets, based on standard statistical sampling theory. In the area of environmental science, this
leads to:
• Underestimation of risk by proponents;
• Overestimation of risk by those faced with dealing with potential
consequences;
• Research based on underpowered samples;
• Undue confidence in early trends and patterns; and
• Undue confidence in failure to detect impacts.
Import risk analysis includes many sample size problems. These take the form of survey
information about pest presence/absence or host range, the results of experiments that
endeavour to measure the natural dispersal ability of a pest and the efficacy of a treatment
or combination of treatments in eradicating a pest from a product proposed for import.
6.3.2 Overconfidence and judgement bias
Many people also consistently overrate their own ability to estimate risk, regardless of level
of knowledge and training, and even in situations of high uncertainty and complexity such as
characterise import risk problems. Over‐confidence in risk estimation ability is associated
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with failure to recognise the assumptions that have been made, and accordingly can lead to
unreliable risk estimation.
Overconfidence correlates with a range of factors, sometimes in ways that seem irrational or
counterintuitive. For example, overconfidence can become greater when regular, systematic
feedback is not provided, and can increase as questions become more difficult (Speirs‐Bridge
et al. 2008). It is also strongly correlated with cognitive style (Burgman et al. 2006), and
linked to motivational bias.
Overconfidence is identified as one of the most significant obstacles to eliciting reliable
expert opinion about risk. This is addressed further below.
6.3.3 Anchoring
People may become unduly influenced by information they encounter first. This is called
anchoring and occurs when preliminary data about the risk problem is gathered. Certain
data may come to be used as a reference point for judgements about risk which are adjusted
as more information flows into the analysis. Even though the initial data may be speculative
or otherwise unreliable, adjustments for additional, better quality information tend to be
insufficient. Final risk estimates are nonetheless weighted towards the first data.
Anchoring can also occur when a person aligns his or her risk estimate with one made by
someone with greater authority. Being wrong alongside someone of perceived stature may
not be as terrible as being wrong on your own.
6.3.4 Availability
Events that are easier for people to recall or imagine are judged as more probable than
others. The availability of an event to a person’s memory or imagination is influenced by
how often they are exposed to it via literature, discussions within professional networks, and
the news media. Availability also contributes to overconfidence. The influence of availability
operates even when the event in question receives attention because it is rare and unusual.
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6.4 Moderating undesirable effects of risk perception
Thus, various social and psychological factors exert an influence on judgements about
whether a risk is worth taking. There are two general problems associated with risk
perception which may lead to pest import regulation that is less effective in managing risk.
Broad remedies are described but these are ameliorative rather than total solutions.
6.4.1 Risk regulation conflict
Many groups have a stake in pest import risk management in Tasmania, and have views on
how this should be done. Consequently, there is scope for disagreement about risk level and
the type of regulation State Government should undertake. This creates potential for
protracted, expensive delays, sub‐optimal compliance and ultimately, for poor biosecurity
outcomes.
Some of the tension about risk regulation may be attributed to the different risk estimation
formulae used by government practitioners and other technical experts compared with
society as a whole. Analysts and decision‐makers may be inclined (or required) to take
narrower views of risk relative to those used by the public.
However, since subjectivity and values play a role in judgement of risk by either group,
neither can be more right or wrong, assuming both have access to the same scientific and
technical facts. When stakeholders question conclusions about risk and how to manage it,
they may be using broader but no less legitimate reasoning that reflects for example, greater
sensitivity to uncertainty about potential consequences and the ability to control them and
to variable impacts across different groups of people.
It follows that if conclusions about risk are contentious, providing more science or extra
explanation will not always cause stakeholders to align their views with those put forward by
technical experts. Science may not be the real issue.
While there is no expectation that different views will always be reconciled or that an
analysis should be dominated by non‐technical perspectives on risk, it has been proposed
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that potential for conflict can be reduced by making greater allowances for public
participation in the risk analysis process and that forms of public participation should be
crafted which acknowledge the influence of risk perception on stakeholder positions.
The reasoning behind this is sound but the extent to which public participation is provided
for in Tasmanian import risk analysis will depend on the importance of the risk problem, the
decision that has to be made and the degree of public interest.
A pragmatic approach is required because accommodating high levels of public consultation
comes at a cost, and there will be cases when modest efforts will be adequate. Equally,
stakeholders may struggle to sustain effective participation in overly‐demanding
consultation processes. Broad guidance for determining investment in stakeholder
consultation and participation in an import risk analysis are provided in Chapter Eight.
6.4.2 Poor judgement of risk
That a person’s ability to reason may be vulnerable to cognitive biases (overconfidence,
sample size insensitivity, etc.) is well demonstrated (eg. Burgman 2005). Accordingly, there is
a chance that risk regulation will be less effective because of the personal mark left by the
people whose work informs it, and those making the decisions.
Potential adverse effects of risk perception can be moderated and more reliable, consistent
and informative import risk analyses performed if attention is paid to technical and scientific
uncertainty, and the assumptions made to deal with it. This involves identifying the nature of
the uncertainty, what can be done to reduce it, being explicit about assumptions, and
checking the validity of those assumptions as the analysis proceeds. This process should also
involve identifying alternative by plausible explanations for the information (eg.
experimental results) or lack of information that causes uncertainty.
Next, different types of uncertainty are described which are relevant to import risk analysis.
Chapter Seven gives guidance on assumptions that might be made to deal with these. Both
sections aim to assist achievement of the principle technical aim of import risk analysis ‐ no
disguised uncertainties or assumptions.
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6.5 Uncertainty analysis, treatment and portrayal
Uncertainty is ubiquitous in import risk regulation. It manifests in the likelihood of a pest
being on a pathway, being associated with a vector, establishing and spreading in a
particular area, and how serious the consequences of those processes might be. The identity
of the pest itself can be uncertain, as can other basic parameters such as whether it occurs in
a place or not.
Uncertainty arises in the efficacy of measures proposed to deal with risk that is deemed
unacceptable. It can permeate the import risk problem solving process itself in the choice of
risk scenario, the type of data included or excluded, the type of technique applied to
interpreting the data, risk communication and so on. There may be uncertainty about which
uncertainties actually matter in any given import risk situation.
Despite its central and dominating role in most import risk analyses, there is a tendency and
a temptation to underplay uncertainty as a technical challenge, and in the way the analysis
and the decision is presented. Highlighting unknowns and doubts seems at cross‐purposes
with fostering confidence in a technical analysis or associated decision, both within the
regulating agency and amongst stakeholders outside it.
The framework takes the position that stakeholder confidence, trust and hence good
biosecurity outcomes are more endangered if these issues are not made plain.
There is also an ethical imperative on the part of practitioners to identify the limits of their
work (Office of the Gene Technology Regulator 2009) so that everyone with an interest in it
can be clear about the nature and extent of the information used to inform a decision, even
if they do not agree with the decision.
Furthermore, tackling uncertainty in an upfront manner is likely to facilitate a more robust
analysis from a technical perspective. It clarifies the state of knowledge, and can highlight
prospects and priorities for improving it, such as areas most likely to benefit from additional
research. Uncertainty analysis can also help identify priorities for precautionary measures,
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reveal complexities of a problem that may have appeared simpler at first glance, and avoid
giving misleading impressions of more scientific certainty than actually exists.
This is not to deny that it is fundamentally difficult to analyse and represent uncertainty in
an understandable way. Simplistic analyses and representations are more prone to giving
the wrong impression about the nature and significance of what is known, not known or
unknowable. Highly detailed uncertainty analysis can be too hard to grasp or communicate
and hence is less usable to decision‐makers.
Nonetheless, if problems caused by uncertainty are to be moderated, it must be recognised
in the first instance. Several schemes have been developed for classifying uncertainty,
reflecting that understanding uncertainty is challenging. The main benefit of these schemes
is that uncertainty is less likely to be avoided or go unnoticed, and therefore untreated.
The schema below is adapted from Burgman (2005) after Regan et al. (2002), with updates
from Burgman (M. Burgman pers comm.) Both texts can be consulted for a more
comprehensive discussion.
At the broadest level, three categories of uncertainty are identified – epistemic, uncertainty
due to natural variation and linguistic uncertainty.
6.5.1 Epistemic uncertainty
Lack of knowledge (also called incertitude) is responsible for epistemic uncertainty. This
type of uncertainty occurs because ability to measure relevant parameters may be limited.
Data insufficiency and use of surrogate data also contribute. Epistemic uncertainty can also
result from ignorance of ignorance. Four types of epistemic uncertainty are identifiable:
6.5.1.1 Measurement error
This type of epistemic uncertainty occurs because the accuracy of measuring equipment, the
techniques and the skill of the people using them can vary, resulting in a measured quantity
that may differ from the true quantity in a random way. Scope for error can be large and this
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can reduce confidence in measured parameters relevant to an import risk analysis. Examples
include:
• Pest presence, absence or abundance in the place from which a proposed import
originates, or in the receiving environment. This can involve surveys based on
counting. Finding one individual or population may be enough to disqualify a place
from area freedom status. If pest abundance is above a particular level on the basis
of visual inspection, blood tests etc, a place may be disqualified from being
considered an area of low pest prevalence.
• Efficacy of pre‐import pest treatment. Pest kill rates under variable doses, duration,
temperature and pressure conditions may be measured in the course of trials on
different plants, animals or products derived from them.
• Pest presence or abundance in a sample of the proposed import. Sampling and
testing is frequently used to manage import risks in commodities that may be
infested, infected or contaminated with pests. The sample needs to be
representative however lot heterogeneity typically presents a challenge. The
accuracy of test results will depend on the competence of the sampler and the
diagnostician, the sensitivity of the chemical or molecular test and the proficiency of
the laboratory undertaking the test.
Incertitude caused by measurement error is typically addressed but rarely eliminated, by
taking multiple measurements, applying relevant statistical techniques and reporting bounds
such as confidence intervals.
Measured data are sometimes obtained directly during an import risk analysis, by for
example, survey work in Tasmania to establish the presence, absence or distribution of a
pest. However, in many cases measured information is gathered from other sources. This
can be checked against relevant standards. For example, OIE and IPPC provide basic
standards for the design of inspection or survey regimes for area freedom, low pest
prevalence, and for detecting certain pests in plants or animals proposed for import.
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Other guidance is available in the form of International Seed Testing Association rules, or
research specific to a measured parameter (eg. transmission or spread rates) may be
available. Potential for measurement error can also be gauged by referring to
manufacturer’s specifications for diagnostic tests, or examining test method protocols from
laboratories.
6.5.1.2 Systematic error
Repeated, non‐random bias in measurement gives rise to systematic error, a source of
epistemic uncertainty that often goes unnoticed.
Systematic errors can be unintentional, occurring as a result of incorrect equipment
calibration or data recording, or intentional in the form of data choices made by the risk
analyst (eg. to exclude or include information that should have been included or excluded).
Systematic error can also arise when conclusions are made on the basis of what an existing,
but incorrect theory suggests is reasonable.
An example is the taxonomy of a species, which is essentially theory about the evolutionary
relations of that organism to other organisms. If an organism is not recognised as a species,
it is unlikely to be collected and recorded as such and so may either be absent from or
invisible in reference collections.
Species collections are important to import risk analysis because they feed into species
distribution databases used to answer questions about pest or host presence, absence and
prevalence in an area of interest (eg. Australian Plant Pest Database, Virtual Herbarium and
National Introduced Marine Pest Information System, OIE Disease Distribution Maps).
Consequently, if a previously unrecognised organism is determined to be a distinct species,
judgements about its range may be systematically biased toward underestimation until such
time as more samples are collected or existing collections are re‐examined and updated.
Systematic errors leading to less reliable estimation of biosecurity risk can also result from
poorly maintained sampling equipment (eg. bulk grain vacuum samplers), incorrect theory
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about pest/host specificity, or continuing exclusion of certain areas from scheduled pest
survey based on outdated knowledge of host distribution.
Remedies for systematic error in import risk analysis include identifying and justifying why
particular information is excluded or included, ensuring relevant equipment works and that
staff are trained to use it, periodic checks on the appropriateness of survey coverage, and
considering the extent to which experimental results are replicated across discrete studies
(eg. by meta‐analysis).
6.5.1.3 Model uncertainty
A model is the device used to characterise a particular risk problem or scenario, for example,
a linear or network diagram, a logic tree or a computer simulation. A model is a simplified
representation of reality and provides a structured way of identifying and thinking about
critical parts of a risk scenario, and communicating that to other parties.
Models are an important source of epistemic uncertainty because choices are made about
what parameters and processes are most relevant to solving a question, and how to
represent them.
In import risk analysis, choice of model parameters can be influenced by how much is known
about the biology and ecology of the pest, which is sometimes very little. This could lead to
an analysis ignoring potentially significant consequences.
For example, the pest could have a host range larger than that accounted for in the model
which could result in underestimation of economic or environmental impact. The pest may
access a pathway that was not apparent when the model was built, resulting in an
underestimation of the probability of entry. It may be moved rapidly and efficiently between
susceptible host populations by a vector not identified in the model, causing spread to be
underestimated.
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Each of these is coupled to system complexity and so also related to uncertainty arising from
natural variation. Vector/pathway/species considerations in model building are outlined in
the next chapter.
Similar concerns arise when the model relies on surrogate evidence, for instance, treatment
efficacy data obtained from trials conducted on pests other than those addressed by the
model.
When human health risks are modelled, the uncertainty inherent in extrapolating data from
animal toxicology experiments to humans or data from one group of humans (eg. young, old,
immune‐compromised, pregnant, exposed workers, etc.) to another is taken into account by
applying uncertainty factors. These are numerical corrections used to derive acceptable
threshold or ‘guidance’ values for human exposure.
For example, a no‐observable‐adverse‐effect‐level for a particular toxicant is typically
divided by an uncertainty factor of 100 to produce the standard threshold level against
which a chemical is regulated (Department of Health and Ageing and enHealth Council
2002). The determination of uncertainty factors relevant to human toxicology is based on
apparently well established conventions in precaution, however whether a similar approach
for pest and disease data extrapolations is possible, does not seem to have been explored.
While oversimplified models can yield results that are less meaningful and hence less useful
for decision‐making, the reverse can also be true. Model uncertainty can arise when too
many parameters about which not enough is known, or which are second‐order to the
problem, are included. In these instances, the more parameters used, the more uncertain
the model becomes.
While decisions about model complexity will need to be made on a case‐by‐case basis, the
parsimony principle recommends that generally the simplest model involving the smallest
reasonable number of model parameters should be used, to avoid ‘over‐fitting’ and
introducing extra uncertainty (Baker and Stuckey 2008).
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Remedying model uncertainty involves validating predictions against observed outcomes,
and adjusting the model accordingly. The overarching planning model for import risk analysis
described in Chapter Seven includes a monitoring and update step that allows for validation.
Investment in comprehensive early detection systems may be essential for addressing model
uncertainty in regard to particularly significant pests.
6.5.1.4 Subjective judgement
When there is no or insufficient empirical data, estimates of risk parameters necessarily
involve subjective judgement. This can also introduce epistemic uncertainty to an analysis.
For example, a particular life stage of an insect pest may be demonstrated on a vegetable,
but an expert might consider that the likelihood of the pest leaving imported, infested
vegetables and transferring to a host in the receiving environment is negligible. Another
expert with equivalent knowledge might conclude that the probability of successful transfer
from the vegetable to a host is greater than negligible.
Because there is no empirical demonstration of the insect leaving the vegetable and
establishing on a host after importation, both opinions embody some level of uncertainty.
The previous section of this chapter outlined a range of cognitive factors that affect the
reliability of such estimates. A section further below provides some guidance on how
opinions might be extracted from experts in ways that moderate potential for subjective
bias, and which handle disparate views.
6.5.2 Natural variation
Natural variation is described as the range of values for a parameter or trait, and the
processes that lead to changes in parameters or traits. The first definition casts natural
variation as a measurement problem. The parameter has a range that can’t be reduced but
which may be statistically characterised (mean, standard deviation) (Virtue pers comm.).
Uncertainty about the parameter arises when it has not been measured, hasn’t been
measured often enough or can’t be reliably measured.
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The second definition emphasises system complexity and the difficulty of establishing causal
pathways. Uncertainty related to changes in biological or ecological systems and processes is
hard to judge because the causes depend on factors that operate independently and in non‐
linear ways, can be chaotic, and vary over time and space. This is sometimes also referred to
as entropic uncertainty. The influence of natural variation on potential for pest harm is
difficult to predict without knowledge of initial, ‘baseline’ conditions and the factors and
processes that affect them.
For instance, making accurate judgements about potential ecological impacts of a pest in the
receiving environment can be problematic, even if its impacts in other places have been
relatively well described. The biotic factors influencing establishment (eg. availability of
predators, competitors, mutualists) are likely to be different, as are the conditions that
affect short or long distance spread (eg. presence of vectors, geographical barriers,
population growth rate). The combined abiotic influence (climate, soil, water etc) may also
differ in ways that elevate or reduce impact. Therefore genetic, individual, population,
community, ecosystem and regional impacts can be difficult to predict with confidence.
While collecting additional data can help deal with uncertainty caused by natural variation,
there are situations in which the thing, quality or process being considered will be largely
indeterminable or unknowable, even if the research effort is large.
The key feature of indeterminacy is that it is not treatable by amassing more information. It
can only be addressed by incorporating precautionary measures into risk management.
6.5.3 Linguistic uncertainty
Linguistic uncertainty results when words are used differently or inexactly, causing doubt
about what is meant. It can result in confusion among people participating in a risk analysis
leading to delays, distraction from the important issues, misunderstanding, and
disagreement about an analysis or decision.
Five types of linguistic uncertainty are apparent and more than one can operate at the same
time. Linguistic uncertainty is a main form of descriptive uncertainty, which also includes use
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of diagrams, pictures, symbols in ways that are open to interpretation (Office of the Gene
Technology Regulator 2009). The comments below may apply to those forms of
communication as well.
6.5.3.1 Vagueness
Vagueness is common in import risk analysis. For example, even commonly used terms such
as ‘entry’, ‘establishment’ and ‘spread’ require careful use because a variety of overlapping
interpretations are possible.
Linguistic vagueness occurs because it is an efficient way of encompassing situations that
occur along a continuum for which all points cannot be practically described.
In some cases, sharp but ultimately arbitrary boundaries are introduced to reduce
vagueness. The use of tolerance levels for weed seeds or other contaminants in seed for
sowing is one (controversial) example of a sharp boundary sometimes imposed for
biosecurity purposes.
One problem with sharp boundaries is that although they are typically established to
support yes/no decisions, they are also inherently insensitive to borderline cases (values
either side of and close to a nominated significant value on a continuum). It is arguable, for
instance, that 2 weed seeds per kg of seed for sowing in a lot of several tonnes is less
concerning or more tolerable than 4 weed seeds. Therefore, if a sharp boundary is set, it is
prudent to ensure its basis and limits are made apparent.
It may be possible to work in qualifiers that allow for the boundary to be moved, depending
on the circumstances. The use of fuzzy sets which describe degrees of membership is
another way of increasing the sensitivity of decisions to borderline cases, as is the
delineation of descriptive categories which divide a continuum into meaningful subsets
(Carey and Burgman 2008).
The use of a Kent scale to relate a set of descriptive, ranked likelihoods (high, medium, low)
to percent probabilities (eg. High = 75‐100% probability, medium = 25 – 74% probability, low
= 0‐24% probability) is another example.
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6.5.3.2 Ambiguity
Uncertainty can also occur when a word has two or more meanings and there is no attempt
to clarify which one applies.
Import risk analysis parlance is frequently ambiguous. There is variable use of terms such as
‘endemic’, ‘exotic’, ‘naturalised’, ‘pathway’, ‘vector’. The word ‘risk’ may be used
interchangeably with ‘likelihood’.
Reference to IPPC or OIE or other standards that define terms relevant to import or pest risk
analysis can help reduce ambiguity. A glossary within the text of an import risk analysis
report, especially for more complex analyses, may also help. Dealing with ambiguity is
largely a matter of clarifying meanings.
6.5.3.3 Context dependence
This type of linguistic uncertainty arises when there is room for different interpretations
about the context in which the risk problem is being considered.
For import risk analysis, failure to adequately specify the item or commodity being assessed
(a whole plant, a fruit, seed) its condition (raw, washed, heat‐treated, fungicide coated), and
its intended use in the receiving environment (eg. widespread planting, processing,
consumption) can lead to confusion about what risks are being analysed.
Context‐related uncertainty is remedied by ensuring the scope of the analysis is accurately
and fully described, and not straying outside that scope in the course of that analysis.
Matters that lie outside the scope of the analysis should also be specified.
6.5.3.4 Under‐specificity
Under‐specificity occurs when a statement about risk does not reveal adequate detail about
the data that informs it, leaving people in doubt about its significance and reliability.
Failure to describe the current range in farm profit margins when estimating the magnitude
of potential economic losses consequent of a new pest incursion is an example. Without an
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appreciation of profit margin variation in the absence of the pest, it is difficult to judge the
reliability of conclusions about the significance of profit loss that might occur if the pest
were present.
Treatments for under‐specificity are to make the relevant data apparent and clarify the
nature of the hazard to which they relate (Carey and Burgman 2008).
6.5.4 Uncertainty and probability
Thus, different types of uncertainty come into play in import risk analysis which can be
treated to some extent. Many of the treatments, at least for epistemic uncertainty, have a
probabilistic element.
In the interests of accurately portraying uncertainty, two types of probability should be
recognised, after Kaplan and Garrick (1981) and Burgman (2005).
6.5.4.1 Frequency probability
The common or classical interpretation of probability is that it is a statistical concept used to
describe the relative frequency of an event that results from a chance process.
If the process that generates the event is repeated a sufficient number of times under the
same conditions, a proposition about its expected occurrence or non‐occurrence when the
process occurs again can be made in empirical, quantitative terms. The outcomes
anticipated when a dice is rolled or when a coin is flipped are examples of frequency
probability.
Frequency probabilities operate independently and regardless of knowledge of the
processes that give rise to them. However, the more that is known about the process and
the more it is repeated, the more amenable it is to use of statistical methods to quantify the
chance. Frequency probabilities are about data.
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Relative frequency data are integral to several aspects of import risk analysis. For instance,
the efficacy of a particular chemical, heat, or irradiation treatment in killing a pest may be
represented as a statistical probability with associated confidence limits.
The chance of finding a contaminant seed in a sample drawn from a bulk lot of imported
grain using a particular sampling strategy can likewise be expressed in statistical frequency
terms, as can the chance of a trained person detecting disease in a flock, an orchard, or a
tray of fruit.
6.5.4.2 Degree of belief probability
The other interpretation of probability that is in many circumstances, more relevant to
import risk analysis, concerns states of confidence or reasonable degrees of personal belief.
This applies when the chance of something occurring is unknown or unknowable. As many of
the questions that arise in the course of import risk analysis are concerned with things that
are unknown, or unknowable, there is typically a high reliance on subjective opinion.
Subjective opinion expresses beliefs about the chance of something happening and is based
on experience, as well as available knowledge and inferences or hypotheses based on that
knowledge. Whereas frequency probability is concerned with data, degree of belief
probability is about lack of data.
6.5.4.3 Types of probability and import risk analysis
The importance of distinguishing between frequency probability and degree of belief
probability in an import risk analysis is two‐fold.
The difference helps explain a misconception that lack of empirical data precludes use of
statistical probability theory and techniques. North (2005) observes that the use of
probability theory to describe and reason about uncertainty caused by absence of frequency
data is not only legitimate, but the only logically consistent option.
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Second, confusion also arises because both types of probabilities can be represented and
handled numerically using probability theory and rules. Yet clearly assignment of a 90%
degree of belief to an event encapsulates information other than and different to, that used
to assign a 90% empirical probability.
If the type of probability employed is not specified, there may be ambiguity about the nature
of the risk. If one type of probability is inadvertently portrayed as the other, the analysis will
be less rigorous, and communication about the risks could be misleading. In particular, a
probability may be assumed to be empirical, when it represents someone’s subjective
estimate. If the probability is disputed, such an interpretation would cast it as a matter of
measurement, when it is a difference of opinion.
Degree of belief probabilities are not necessarily less rational or credible than empirical
probabilities. However, the two are fundamentally different and need to be handled and
portrayed accordingly.
North’s (2005) advice is that uncertainty can be usefully discussed by using probability
statements but that everyone participating in the discussion must understand when the
numbers are representations of frequency, and when they are not, and that the latter may
reflect subjective bias.
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6.5.5 Quality of evidence
The preceding discussion concerns evidence used to inform an import risk analysis, since
that is where uncertainty occurs. Type and source of evidence can be used as broad criteria
for highlighting which types of uncertainty may be more important to a risk analysis.
The following schema provides an indicative guide to how import risk evidence might be
weighted. It does not cover all types of evidence and the order is not strictly fixed. The
schema is modified from that followed by the Australian Office of the Gene Technology
Regulator (Office of the Gene Technology Regulator 2009). In order of decreasing weight,
evidence can be categorised as:
• Adequately reported studies using experimental or observational data about the
biology and ecology of the pest in Tasmania or in temperate or other environments
similar to Tasmania, or in relation to the import of concern (ie. direct empirical
evidence);
• Expert opinion about pest biology, ecology, environmental or economic impact that
is elicited in a manner designed to reduce subjective bias;
• Adequately reported empirical studies about a related pest, or similar import of
concern (ie. extrapolated or surrogate evidence);
• Adequately reported theories or models from which the likely biology and ecology
of the pest in Tasmania, or its potential environmental or economic impact may be
inferred (ie. inferred evidence);
• Commissioned research or reports about pest biology, ecology or impact that have
not been validated (ie. grey literature);
• Expert opinion that is elicited in an ad hoc manner;
• Information from websites, newsletters, fact sheets, etc. that has not been
validated (ie. grey literature).
While the schema is a useful prompt to considering evidence type and quality, in practice
empirical studies are rare, or if available, suffer from small sample size and other limitations
imposed by time or funding constraints. The remaining evidence option and the one used
routinely in import risk analysis, is expert opinion.
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6.6 Eliciting expert opinion
The indicative ranking of evidence in the previous section attributes to expert opinion more
or less value depending on whether potential for subjective bias has been addressed. The
psychological factors underlying risk perception, and the undesirable biases these can
introduce to judgements of risk were outlined earlier in this chapter.
Extracting expert opinion in forms that can be used with relative confidence in an import risk
analysis, and in ways that are practical and efficient, can be challenging. A structured
approach targeting issues that commonly arise, such as whom to ask, what to ask, how to
ask it and how to synthesise disparate or conflicting responses, may be useful.
Burgman (2005) identifies steps for engaging successfully and efficiently with experts. Some
recent work from the Australian Centre of Excellence in Risk Analysis (ACERA) is also
illuminating.
Protocols for eliciting expert opinion in biosecurity risk analysis are at an early stage of
development. Nonetheless, the summary below highlights points that might be considered
in import risk analysis. Again, the amount of effort devoted to planning and incorporating
expert elicitation should be proportionate to the importance of the import risk problem and
what data are available.
6.6.1 Identify and gather relevant experts
A single person is unlikely to possess the range of knowledge and experience relevant to an
import risk problem. In most cases, expert assistance is required. Experts are people who
have relevant knowledge, and the most useful of these are those who:
• Use their knowledge to solve problems with a good rate of success;
• Are able to solve problems quickly;
• Are aware of their own limitations and willing to indicate they cannot solve a
problem.
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Applying these criteria to identify useful experts is difficult in practice. Furthermore, when
the pool of experts is small and time is short, there may be no standout choices.
Import risk analysis experts are not limited to people with scientific or technical training. A
local industry specialist who may or may not have a science background, may be better
equipped to judge potential pathways or economic impact of a particular pest than someone
with taxonomic expertise.
Once an appropriate range of expertise is identified, the elicitation mode should be decided.
This may involve individual consultations, face‐to‐face or by remote, establishment of a
working group or a combination of both. Group‐based approaches are often preferable
because group judgements moderate propensity for subjective bias. Risk estimates are
generally more reliable than ones made by individuals. Expert groups generally work best
with between four and nine people, and diversity of group members (technical background,
stakeholder group, gender, etc.) also reduces potential for motivational and other subjective
bias.
6.6.2 Elicit information and reach agreement
This involves estimating and achieving consensus about the risk scenario, the most relevant
parameters, and values that might be assigned to them. The expert group should be
provided with a preliminary background summary as a starting point.
The approach to import risk scenario modelling is described more fully in Chapter Seven.
Achieving agreement on the model is important because it forms the reference point for
subsequent discussion, but it should not be considered inviolate. As group deliberation
proceeds, it is possible that information or ideas will be introduced that make changes to the
model necessary.
Subjective values can be assigned to each model parameter (eg. likelihood of a pest surviving
transport, etc.). Kent scales are often used to help arrive at a common understanding of
descriptive categories of likelihood.
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Speirs‐Bridge et al. (2008) describe a technique for reducing bias due to overconfidence, a
main cause of unreliable expert judgement. It requires experts to express estimates as a
triangular distribution and then provide a rating between 0 and 100% of how confident they
are that the interval they have nominated will capture the true value of the variable.
Similarly, Copp et al. (2005) suggest single value estimates could be augmented by a rapid
assessment of confidence (eg. ‘The level of confidence I place in my estimate is:
low/medium/high’). They also suggest that the proportion of ‘don’t know’ responses in a
questionnaire that seeks value estimates could be used an overall measure of uncertainty.
However it is done, the main point is that experts invited to participate in an analysis are
given an opportunity to think about and revisit the reliability of their value estimates, and
adjust as necessary.
6.6.3 Evaluate the information
Options for evaluating expert opinion include calibrating with another pool of experts, or
against direct data that comes to hand as the analysis proceeds.
In the (likely) absence of these, confidence in expert opinion can be enhanced by careful
selection of experts, disaggregating questions into manageable ‘chunks’, identifying and
portraying uncertainty clearly, and coordinating group interactions such that individual views
are transparent, and given a fair hearing.
6.6.4 Aggregate information from different experts
Stratification of an expert group moderates potential for unreliable judgements, but also
increases the chance of disagreement.
There is a large body of theory concerning rational consensus and achieving agreement on
the ‘best’ position. Many of these approaches employ iterative feedback methods in which
people are provided information, asked for initial thoughts, provided with a summary of the
views of others and given an opportunity to adjust their own, in a non‐confrontational, non‐
adversarial setting.
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Delphi and related techniques are sometimes used for complex problems. A modified Delphi
technique outlined below (Burgman 2005) emphasises achieving a common understanding
of the risks, attendant uncertainties and relations between various components of a risk
scenario. While the final position may not be considered ideal by everyone, people are less
likely to feel that they have not been heard, or that agreement has been forced or coerced.
The steps are:
• Gather relevant background information and circulate prior to first meeting;
• Bring experts together for initial brainstorming session to develop risk scenario,
identify variables;
• Encourage discussion about uncertainties in the risk scenario and variables;
• Discuss scenarios that would produce extremely undesirable events, however
unlikely (ie. a local species extinction, the closure of a business);
• Take meeting notes and circulate afterwards for comment and confirmation;
• Analyst contacts individuals to further discuss risk scenario and variable options, and
degree of uncertainty;
• Group reconvenes to discuss and attempt to resolve important differences of
opinion. This may need to happen more than once; and
• Residual differences of opinion presented clearly in the group’s analysis.
Delphi and related methods are behavioural approaches to combining divergent expert
opinions. There are also numerical techniques. The use of Bayes’ theorem to achieve
consensus is a numerical technique discussed briefly in the next chapter.
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Chapter Seven Import risk analysis
method
Optimisation works well in rocket science
D. Warner North, Keynote speech to International Conference on Sanitary and Phytosanitary Risk Assessment Methodology: Optimisation of the SPS Regulatory Toolbox, Washington 2005
7.1 Risk analysis model
The convention for import risk analysis involves establishing the context, identifying hazards
relevant to the problem (or risk scenario), assessing the risks and identifying risk
management options. Risk communication occurs throughout, as required. Planning an
analysis around these five components is consistent with relevant OIE and IPPC guidance,
the approach used by Biosecurity Australia, and the Australian and New Zealand Standard on
Risk Management, AS/NZ 4630:2004 (Standards Australia 2004).
The import risk analysis planning model (Figure 3) outlined in this framework also embodies
adaptive management principles, and reflects the risk management cycle (Burgman 2005,
North 2005, Cook et al. 2008). The cycle emphasises the iterative nature of import risk
management, the importance of monitoring in uncertain or changeable circumstances, and
of stakeholder participation and communication. The model also deals explicitly with
uncertainty by specifying assumption‐setting and sensitivity analysis as distinct steps. Each of
these can have significant impacts on the reliability and acceptability of import risk
regulation. A comparison of the import risk planning model in this framework, and OIE and
IPPC frameworks is at Appendix 2.
Though the planning model has discrete steps, these overlap in practice. For example,
problem formulation can occur at the same time context is being determined and extends to
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conceptual model building. Data gathering will be ongoing across several steps. Therefore,
the sequence of steps as presented need not be followed rigidly.
The model also incorporates main administrative elements (in italics), flagging when these
should occur and their relation to technical elements. Again, the sequence is a guide and
may be altered depending on the situation. Administrative procedures are elaborated in
Chapter Eight.
The import risk analysis planning model is intended to provide broad guidance for
addressing all import risk analysis questions, regardless of size or complexity. The effort
invested in each stage should be proportional to the priority of the problem.
Components of the model and how to undertake them as an integrated, iterative exercise
are described in the rest of this Chapter.
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Figure 3 Import risk analysis model
COLLECT INFORMATION & SPECIFY ASSUMPTIONS
Assemble pest profile/s, identify uncertainties in information and set analysis assumptions. Consult stakeholders, peers and confirm with supervisors, as
necessary.
ASSESS THE RISKS Estimate likelihood of pest entry, establishment and spread, and magnitude of consequences. State critical
uncertainties in estimated risk. Identify plausible alternatives. Rank estimated risk against ALOP. Consult stakeholders, peers and confirm with
supervisors, as necessary
IDENTIFY MANAGEMENT OPTIONS If ALOP is exceeded, identify and evaluate risk mitigation options. Show expected influence on level of risk. State critical uncertainties in risk
mitigation. Assess cost‐effectiveness of alternatives. Consult stakeholders, peers and
confirm with supervisors as necessary.
TEST SENSITIVITY & FINALISE ANALYSIS Use peer review to check standard of reasoning in
the analysis. Finalise risk analysis report with stakeholders and confirm with supervisors, as necessary. Submit report to decision‐maker.
DECIDE Decision‐maker determines regulatory and
monitoring requirements. Appeals, notification, phase‐in, implementation, document filing.
MONITOR AND UPDATE Changes to context, problem parameters,
knowledge are monitored by analysts, decision‐makers and barrier staff. Notify supervisors and stakeholders if changes likely to necessitate
decision review, as necessary.
ESTABLISH THE CONTEXT Identify reason for import risk analysis, consider existing policy, gather preliminary data, identify and advise local stakeholders, as necessary. Assign initial priority, select oversight and decision‐
making arrangements, estimate resources, set indicative schedule
DEFINE THE PROBLEM Determine objective, scope, timeframe, data needs. Conduct pest hazard screening. Consult stakeholders as necessary. Confirm priority and project plan (eg.
oversight, schedule, resources, consultation arrangements)
ESTABLISH THE RISK MODEL Identify risk scenario, (pathway/vector/species complex), build conceptual model. Consult
stakeholders, peers and confirm with supervisors, as necessary
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7.2 Establish the context
7.2.1 Purpose
Context comprises the broad parameters of the import risk problem which must be
understood to address the problem with a level of effort and within a timeframe
commensurate with its priority. This stage of the analysis should resolve ‐ What type of
import risk problem is this, how complex and how important is it likely to be?
7.2.2 Initiation
Import risk problems may be classed according to the situations that trigger them. These are
likely to be policy‐related, associated with a particular pest, or with new or altered pathways
or vectors by which pests may be introduced to Tasmania.
Situations that result in the initiation of an import risk analysis include but are not limited to:
• A Tasmanian import policy is due for routine review;
• A Tasmanian import policy gap becomes apparent;
• A new Tasmanian Government strategic policy priority emerges;
• A new pest management technology becomes available which influences a risk
estimate underpinning an existing Tasmanian import regulation;
• An incursion response or surveillance program in Tasmania requires import risk
estimates;
• A Tasmanian import policy is disputed;
• Biosecurity Australia invites comment on its import risk analysis work;
• A national or multi‐jurisdictional initiative requires import risk input from Tasmania;
• Access to Tasmanian markets for a new plant, animal or plant or animal product is
requested;
• Trade or distribution of a new plant, animal or plant or animal product in Tasmania
for research purposes is requested;
• Trade to Tasmania from a new area is proposed;
• A new pathway into Tasmania for a regulated pest is identified;
• A new pest or vector is reported in an area that exports animal or plant hosts or host
products to Tasmania;
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• A new pest vector is identified in Tasmania;
• A change in host susceptibility to a pest of significance to Tasmania is reported;
• A change in the virulence of a pest of significance to Tasmania is reported; or
• A pest or vector is intercepted with increasing frequency at the Tasmanian barrier or
incursions are detected repeatedly in the Tasmanian environment.
Clarity about the reason for an analysis is relevant to its priority from a public governance
perspective. Criteria for prioritising import risk analysis work are set out below. These should
be applied once the reason for the analysis is settled, and associated backgrounding work
has been done.
7.2.3 Preliminary research
A scan of relevant background information is necessary to help judge the complexity of the
problem. Preliminary research is generally a desktop exercise, and need not involve
extensive stakeholder or other external communications. It should include, as appropriate:
• Existing regulatory status, SPS measures or other import policy relevant to the pest,
the import, the pathway or a comparable class of pest, import, or pathway for
Tasmania, Australia and perhaps elsewhere;
• Any risk analyses that underpin relevant existing policy;
• Key papers about the taxonomy, biology, ecology, adverse impacts and management
of the pest, or pathway control;
• Economic impact assessments or other loss estimates for affected areas;
• Identification of potentially affected Tasmanian environments, native species or
industries; or
• Preliminary identification of relevant stakeholders and relevant experts (in and
outside Tasmania, government and non‐government).
This information should be summarised in a form appropriate to the problem. If the problem
appears simple, or if the need for external stakeholder or expert involvement is not critical, a
file note copied to the analyst’s supervisor may suffice.
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If the problem appears complex, or there is a requirement for early stakeholder and expert
consultation, the information may be used to inform a background paper suitable for
distribution to prospective participants in the risk analysis. Background briefs and notes can
be adjusted for later use as introductory material in the import risk analysis report.
7.2.4 Assigning priority
Once the nature and likely complexity of the import risk problem is understood, the
importance of analysing it relative to other risk analysis work can be considered. This
exercise should be undertaken via consultation across the responsible business unit or units,
and generally cannot be performed by an analyst in isolation. Chapter Eight provides further
comment. The following criteria, adapted from Biosecurity New Zealand (2006) may be used
to establish import risk analysis priority.
• Strategic benefit – Is the risk problem directly related to a specific DPIPWE or other
State policy priority? Is there a threat to a particularly valuable Tasmanian natural
asset or industry? How imminent is that threat? What are the risks of not analysing
the risk problem soon?
• Technical feasibility (of the analysis) – Is there likely to be enough information to be
able to estimate risk reliably, and recommend appropriate management? If not, what
could be done to acquire essential information? Is the potential impact so significant
that certain measures may be warranted, without for example, confirmation of pest
identity or presence/absence?
• Practicality ‐ Can the analysis be adequately resourced? Do resources need to be
reallocated from other activities? What is the likely impact on other work and how
will it be managed?
• Cost effectiveness ‐ Is the cost of doing the analysis likely to be offset by benefit to
biosecurity? What is the potential cost to biosecurity of not doing the analysis?
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• Public good value – Which groups have a stake in the import risk analysis? How many
people will benefit from undertaking the analysis and by how much?
The outcome of this stage provides the rationale for continuing an analysis, including how
much public resource to invest, and should be adequately recorded. Alternatively, the
criteria may indicate low priority, in which case the analysis may be discontinued or set aside
for a later date. Such a decision should also be adequately recorded. It is possible that even
an import risk problem that appears important at the outset may be assigned a low priority
due to the need to complete current work, resource constraints or other factors.
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7.3 Define the problem
7.3.1 Purpose
Once the broad bounds of the import risk problem are understood, and the importance of
investigating it has been agreed, the objective of the analysis can be formulated. The
objective is intimately connected to the type of decision required. Problem definition asks ‐
What decision needs to be made, and what information is required to make it?
7.3.2 What type of decision?
Decisions by government for import problems are primarily regulatory and generally take
one of three forms:
• Introduce or do not introduce a new import regulation;
• Revoke, amend, or maintain unchanged, an existing import regulation;
• Grant or do not grant an exemption from compliance with an existing import
regulation.
A decision not to regulate does not necessarily or even usually equate to doing nothing.
Non‐regulatory measures (education, fortuitous surveillance, etc.) may be useful to import
risk management in circumstances where regulation is not warranted on risk or cost‐
effectiveness grounds. These circumstances are elaborated later in this chapter.
Even if the decision that needs to be made seems self‐evident, in the interests of
transparency, it is important to represent it clearly in the analysis. Each type of decision may
entail different degrees and forms of loss or gain for affected parties.
The objective cannot be finalised until the second part of the problem definition question
has been addressed. The type of information required to make the decision will relate
primarily to problem scope and the pest hazards encompassed within that scope.
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7.3.3 Scoping the analysis
7.3.3.1 Definition
The scope of the analysis is usually determined by the analysis trigger. That is, the analysis
may focus on a specific import (commodity, conveyance or other inward bound item) from a
particular place (eg. request for market access), a specific pest (eg. review of existing
regulation) or a specific pathway via which one or more pests may be introduced (eg.
tourism to Tasmania’s off‐shore islands, product passing through a mainland freight facility).
Notwithstanding initiation of the analysis occurred in a particular way, problem formulation
provides an opportunity to consider whether the coverage of the analysis could be
constrained or expanded to better effect. Whether the import question indicated by the
trigger is the best one that can be asked in the circumstances will depend on the balance of
potential biosecurity benefit, and resource and time constraints.
For example, efficiencies may be gained by analysing the risk of a group of taxonomically
similar pests, rather than a single species. Several potential pests which might be expected
to access the same pathway might be assessed, rather than the single species for which
routine review is scheduled. The suite of pests that might be significant to a particular
Tasmanian habitat or crop might be examined. Approaches to risk evaluation and
management using guild, functional group and species assemblage theory are described
shortly.
7.3.3.2 Scoping criteria
The scope of the problem can be defined according to the following criteria as relevant,
adapted from Biosecurity New Zealand (2006). Analysis scope can be presented in tabular
form in the risk analysis report (see Scope Template at Appendix 3):
• potential pest hazard (see below ‐ the hazard may be one or several pests);
• type of import (eg. seedlings, fruit, fresh meat, grain, live animals, used animal
husbandry or veterinary equipment, conveyances such as containers, packaging,
pallets, machinery);
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• import source (eg. outside Tasmania, outside Australia, returning Tasmanian product,
plants or animals);
• import condition (eg. raw, green, semi‐processed, shorn, juvenile, mature,
neutered);
• method of production, handling, transport and storage (including relevant quality
assurance programs or other product testing and verification, veterinary care history,
eg. vaccinated, unvaccinated, transported with bedding);
• pathways and vectors (eg. as bulk or container cargo, mail, on earthmoving or
agricultural machinery and equipment, vessels, personal baggage, natural dispersal,
as packaging, or deliberate introductions by researchers, hobbyists);
• proposed or potential distribution and use in Tasmania (eg. general distribution,
research or processing facilities, planting, breeding, recreation, consumption,
packaging and re‐export);
• the area of Tasmania for which risks are to be considered (eg. all of Tasmania, off‐
shore islands, Macquarie Island);
• the timeframe over which risks are to be estimated;
• the anticipated import volume or frequency of inbound movement for the period of
the analysis, including seasonal or other cyclical features.
Most of these points prompt a decision about whether a thing will be included or excluded
from the analysis. Scope decisions often reflect time and resource constraints. Whatever
the reasons, decisions should be clearly documented in the analysis report. It is as important
to be explicit about what is out of scope as what is in, although brief explanations for both
will suffice.
In addition, a scoping exercise will also suggest what data and other information are likely to
be required for the analysis. As the scope of the analysis firms up, hazard identification can
commence. In practice, the two activities run side by side.
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7.3.4 Hazard identification
7.3.4.1 Definition
A hazard is a situation that may result in harm without reference to the likelihood of it
happening. Hazards are the subject of a risk analysis, the things for which risk is estimated
and management is considered.
Consequently, identifying the range of hazards that could occur is critical, as are choices
about whether to analyse some or all of them. Hazard identification is therefore a systematic
appraisal of what can go wrong. It is a screening procedure that separates hazards that are
worth analysing in more depth from those that are not, within available time and resources.
The generic hazard that is common to all import risk analyses for Tasmania is:
A pest that is not present in Tasmania or present but not widespread, enters in the course of
trade or other inward movement and diminishes the health of plants, animals, humans or
natural environments resulting in negative impacts to native biodiversity, primary production
or the Tasmanian community.
The generic hazard definition expands upon and is broadly consistent with the concept of
quarantine pest articulated by the IPPC (Food and Agriculture Organisation 2008) and applies
equally to pest threats to animal health, where the analogous OIE concept is potential
hazard.
The hazard identification process can begin with a list of many organisms and end with a
smaller list of potential pests, risks of which are subsequently assessed in greater detail. The
original list will be derived according to the circumstances. For example, if a new plant
product is to be imported from the Australian mainland, all organisms known to be
associated with it that are present on the mainland may be screened. Alternatively, only the
subset of that group that are declared under Tasmania’s plant health legislation may be
examined. Hazard identification may also begin with a single organism and end with a
conclusion about whether it needs to be further assessed or not.
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If the screening process does not indicate a potential pest hazard exists, the import risk
analysis does not proceed to detailed pest assessment. This does not necessarily mean the
risk analysis stops or that no action is taken. Consistent with an adaptive management
approach, a strategy may be recommended to monitor for significant change in hazard
potential.
In circumstances where information is lacking to the extent there would be little point
proceeding with detailed pest assessment, the import may be prohibited, or generic
measures (eg. observation in post‐entry quarantine) may be applied. For example, a recent
assessment of risks to Australia posed by imported ornamental red rainbow fish did not
identify pest hazards warranting detailed analysis (Panaquatic ®Health Solutions Pty Ltd
2007). However, and although it recommended that these fish be permitted entry, BA has
proposed import subject to general quarantine measures (Biosecurity Australia 2009b).
7.3.4.2 Hazards, precaution and a tiered approach to risk analysis
It is critical that hazard screening is done thoroughly to avoid wrong decisions about which
organisms to include or exclude from an analysis. Inclusion of organisms that do not warrant
it results in wasted effort. Exclusion of organisms that do warrant it may lead to harm. In
large or complex cases, it may be necessary to run the hazard screening more than once.
A precautionary approach is necessary. If screening does not allow a conclusive
determination of no potential hazard, the organism should be listed for further assessment,
rather than excluded. This applies particularly if there is any suggestion that impacts may be
severe or irreversible. If exclusion of an uncertain pest from further assessment must occur
for resource or other practical reasons, those should be clearly documented, along with any
monitoring contingencies.
The application of precaution in the hazard screening stage is part of a tiered approach to
dealing with uncertainty. It also guards against unjustifiable use of precaution, from a cost
benefit perspective and in terms of SPS rules. Imprudent use of precaution may occur
because the precautionary principle, strictly applied, may inherently favour decisions which
support the status quo. This confers a type of asymmetry upon decision‐making that can
lead to suboptimal outcomes (Cohen 2005).
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For instance, in the case of an application to import a new plant or animal product to
Tasmania where the pest hazard is uncertain, strict application of the precautionary principle
is likely to require that new product is not allowed because it might introduce new risks,
hence maintaining the status quo. The question “Why would we want to take this (new) pest
risk?” is at the fore.
Conversely, if the pest risk of products that are currently imported and in some way essential
(eg. food, feed, materials) is being reviewed, application of the precautionary principle may
tend to support a decision to keep allowing those imports, so that availability is not affected.
The question “How can we manage without this product?” indicates a different set of
considerations is at the fore.
The problem with reaching status quo conclusions too quickly is that potential risk has not
been transparently considered against alternative decisions (eg. allow the new import or
stop an existing import respectively). Hence the status quo decision is open to charges of
bias in the treatment of uncertainty.
This can be avoided using a two‐tiered assessment process, of which hazard screening
represents the first tier, and where necessary, conducting more than one screening round. In
the first round pessimistic (but plausible) rather than optimistic assumptions should be made
when considering the organism against hazard criteria (see below). Since pessimistic
assumptions will overstate risk, organisms found to pose acceptable risk can be excluded
from further assessment with relative confidence.
While the use of pessimistic assumptions may allow the removal of plausibly non‐hazardous
organisms during the screening stage, it does not mean that those that remain present
unacceptable risk.
When no further exclusions can be made using information available at the screening stage,
the remaining organisms pass to the more detailed second tier risk estimation described
below. The assumptions made in the second tier will be refined according to whatever
additional information is gathered, and should be less pessimistic than those used for the
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hazard screening stage. If new information supports assumptions that are more pessimistic,
the screening process will need to be rerun.
7.3.4.3 Screening criteria
While the OIE calls the screening process ‘hazard identification’, the analogous IPPC term is
‘pest categorisation’. In practice, the criteria used to screen for pest hazards, whether for
plant or animal health issues, are similar.
All but the first two criteria listed below represent decision‐points at which a potential pest
may be excluded from further assessment. The screening criteria should be addressed in the
order presented. However, it is not always necessary to consider all criteria. For example,
when deliberate importation of an organism that is a potential pest is considered, presence
in the country of export and association with an import are irrelevant. Equally, other
screening criteria may be developed if appropriate.
The screening exercise is just that and should not entail lengthy investigations of each pest.
Information sufficient to addressing the criteria may already have been collected during
context establishment or the scoping exercise. Hazard screening results are generally
presented in tabular form in the risk analysis report (see Potential Hazard Template at
Appendix 3). The screening criteria, adapted from Department of Agriculture, Fisheries and
Forestry (2001) and Biosecurity New Zealand (2006) are:
• Taxonomy: Scientific name, including authority and synonyms, and common names.
List references (databases, keys, published taxonomies, etc.). Organisms are
generally described to species level but genera or sub‐species taxonomy may also be
used if necessary.
Taxonomic difficulties or disagreement should be noted as a potential source of
uncertainty. This can be common for invertebrate pests and pathogens of native flora
or fauna which may be less well characterised than those of primary production
systems.
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• Regulation status: The organism’s current regulatory status in Tasmania should be
stated, and its regulatory status in Australia (under other State, Territory or national
legislation) should be determined. It may be useful to note regulatory status in other
countries, including those to which Tasmania exports.
Whether the organism has been previously assessed and a decision not to regulate
for Tasmania was taken, should be determined where possible.
Regulatory status and existing import policy are important because they provide
clues about pest significance, and also prompt thinking about cumulative risk.
Existing policy (including decisions not to regulate) should be checked to establish
whether risk associated with particular pest that has been deemed acceptable for
several discrete importation activities, could be accumulating such that the collective
risk posed by those activities may be increasing.
Regulation status for Tasmania and elsewhere can be classified as regulated (risk
analysis documented), regulated (risk analysis not documented), unregulated (based
on risk assessment), or unregulated (risks not assessed).
• Presence in Tasmania: Relevant Tasmanian databases should be consulted for
presence, absence and distribution information, and checked against local expert
knowledge within or outside government.
Potential for uncertainty (eg. measurement, subjectivity) should be noted and
(pessimistic) assumptions should be articulated. For example, assumptions will vary
according to whether the organism is known not to occur (ie. survey data collected in
a robust manner for a suitable period suggest it is not present), or not known to
occur (ie. survey data are insufficient but there are no agency records of
occurrences).
The organism should be categorised as present (no apparent quarantine concern),
present (apparent quarantine concern), absent or status uncertain.
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The first two categories are distinguished on the following sub‐criteria ‐ an organism
that is present in Tasmania is eligible for further assessment if:
o It is already under official control; or
o Its distribution is limited and there may be cause for official control (ie. it has
demonstrated a lag phase elsewhere, followed by population expansion and
impact); or
o It is comprised of genetic variants (eg strains, biotypes) that do not occur in
Tasmania, but which may pose greater risk than existing Tasmanian
populations (eg. different host associations) or enhance their pest potential
through interbreeding; or
o It is a vector of a pathogen or parasite that is not present in Tasmania; or
o Its risk profile would change considerably as a result of the import activity (eg.
importation may distribute the organism more widely and rapidly than spread
from existing populations); or
o Little is known about the organism or its potential for adverse consequences
(may be particularly relevant to environmental pests).
If an organism is present in Tasmania but does not fit any of these sub‐criteria, it is
excluded from further analysis. If it is present and fits one or more sub‐criteria, or
absent, or its status is uncertain, the screening process continues.
• Presence in the region from which an import originates: Relevant databases (eg.
Australian Plant Pest Database, terrestrial or aquatic plant or animal censuses) should
be consulted for presence, absence and distribution data. Jurisdictional authorities
may provide additional information.
Claims of pest freedom must be adequately supported. Relevant international
guidance on the standard of information for claiming pest freedom should be
consulted. The distinction should be made as to whether the organism is known not
to occur, or not known to occur in the export region.
Potential for uncertainty (eg. measurement, subjectivity) should be noted and
(pessimistic) assumptions used to make the categorisation should be articulated.
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Changing trade patterns and climate change are likely to make potential for
uncertainty in this criterion more important over time.
The organism should be categorised as present, absent or status uncertain. If the
organism is absent from the export region, it is excluded from further analysis. If the
organism is present or its status there is uncertain, the screening process continues.
• Association with the proposed import: This criterion addresses entry pathways and
vectors deemed within scope. Host associations can be investigated from relevant
literature and databases, as can hitchhiker or contaminant associations with the
import or trash that may be with it, or the conveyances used to bring it in.
Sub‐clinical, latent, carrier status or other cryptic manifestations may be known.
In some cases, it will be necessary to commission work (eg. using Koch’s postulates)
to test whether the organism is the cause of particular disease symptoms. However,
establishing cause and effect can take time. If serious effects are apparent or
plausible, a cause and effect relationship should be assumed, but revisited as test
results become available.
If a plant or animal product (eg. fruit, gametes, meat, logs), or other potential
conveyance is proposed for import, the association with that specific product should
be examined, including the lifecycle stage of the potential pest that may be present.
Potential for uncertainty (eg. natural variation, measurement, subjectivity) should be
noted and (pessimistic) assumptions used to make the categorisation should be
articulated. For example, methods of production, processing, handling and storage
should be broadly appraised for influence on the organism’s survival. The general
quality of the proposed import may also be relevant. If it is bulk, lower‐ grade or
uncontracted product (ie. speculative imports), quality systems for pest management
may not be as stringent, and it may be appropriate to assume the pest may be
present with the import.
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Association with the import and hence potential pathway can be categorised as
plausible or implausible. If an association with the proposed import is implausible,
the organism is excluded from further assessment. If an association is plausible, the
screening process continues.
• Potential for establishment and spread in Tasmania: The basic biology and ecology
of the organism should be considered in regard to:
o Hosts in Tasmania and their distribution as native, domestic, feral or farmed
animals, or native, crop or amenity plants, or weeds;
o Whether the organism is an effective competitor or predator and under what
conditions;
o Broad climatic suitability;
o Barriers to lifecycle completion or dispersal (absence of key pollinators, hosts
for different lifecycle stages, vectors).
Potential for uncertainty should be noted (eg. natural variation, measurement,
subjectivity) and (pessimistic) assumptions used to make the categorisation should
be articulated. For example, judgements about host or vector presence in Tasmania
may be uncertain because the range of hosts or vectors is not well studied.
Potential for establishment and spread can be categorised as feasible, not feasible, or
uncertain. An organism for which establishment and spread is not feasible is
excluded from further analysis. If establishment and spread is feasible or uncertain,
the screening process continues.
• Potential for adverse environmental, economic or social impacts in Tasmania: This
may also be appraised from relevant literature, databases, or from environmental or
industry pest management information. Considerations include:
o Whether native species, particularly keystones, are hosts or susceptible to
predation or competition;
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o Whether native species, populations or communities that are threatened are,
or include, hosts or species likely to be susceptible to predation or
competition;
o Whether one or more Tasmanian industries depends on host plants or
animals, or plants or animals likely to be susceptible to predation or
competition, and their approximate value;
o Whether the organism is a vector of disease;
o Whether the organism has zoonotic potential or other potential human
health implications linked to animal or plant health (eg. it bites or stings, is a
parasite requiring a human host);
o Demonstrated environmental, social amenity or economic impact elsewhere.
Potential for uncertainty (eg. natural variation, measurement, subjectivity) should be
noted and (pessimistic) assumptions used to make the categorisation should be
articulated. For example, the organism may be an aggressive pathogen of sub‐
tropical native plants of a certain taxa but infection of cool temperate members of
the same family found in Tasmania is plausible.
Potential for adverse impacts can be categorised as feasible, not feasible or
uncertain. If impact is not feasible, the organism is excluded from further analysis. If
there is potential for adverse impact, or uncertainty about this, the organism
qualifies as a potential hazard and is listed for detailed risk analysis.
7.3.5 Articulate the objective of the analysis
The adverse impact criterion signals the end of the hazard screening process after which the
objective of the analysis can be confirmed. Any format is acceptable that is clear, explicit
and logical, for instance:
The aim of this analysis is to inform a review of import conditions for feed grain from the
Australian mainland in regard to List A pests under the Tasmanian Plant Quarantine Act
1997.
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7.3.6 Stakeholder and expert participation
For complex or sensitive import risk problems, stakeholder involvement at this early stage
should be facilitated so that all affected parties are clear about the hazards that are to be
analysed (or not) and what type of decision needs to be made. Broader participation can
also increase the rigour of hazard screening. Industry stakeholders for instance, may have
knowledge about plausible hazards that is not available in the published literature.
Stakeholders and experts may be invited to participate in a working group convened for the
specific import risk problem, or their input may be sought through less formal approaches.
Either way, sufficient background information should be provided prior to seeking and
documenting their views. For less complex import risk problems, stakeholder and expert
participation may be deferred until later in the analysis.
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7.4 Collect information and specify assumptions
7.4.1 Purpose
This stage of the analysis involves researching each of the potential pests identified during
hazard screening in greater depth. It comprises information gathering and appraisal but does
not involve evaluating risk.
The pertinent question is ‐ What is known about the potential pest that is relevant to this
import risk problem and what are the important knowledge gaps or other scientific and
technical uncertainties?
Further information gathering may reduce or reaffirm uncertainties revealed during hazard
identification, and shed light on their relative importance. When significant uncertainties
are identified, the range of plausible interpretations should be considered, after which the
assumptions on which the rest of the analysis will be based, can be decided.
7.4.2 Pest profile
The common way of organising information about a potential pest is to create a summary
for use over subsequent stages of the analysis.
This is known as a pest profile, and generally includes detail about taxonomy, geographical
distribution, environmental tolerances or preferences, lifecycle, epidemiology, natural and
human assisted dispersal or transmission modes, transport pathways and vectors, available
quarantine treatments, management in affected areas, impacts, and so on (see Pest Profile
Template Appendix 3).
Any type of relevant information may be included, however its source must be identified (eg.
published paper, subjective opinion) so that it can be considered accordingly.
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If only one or a few pests are to be assessed, the profile/s may be inserted in the body of the
risk analysis report. When many organisms are to be assessed, profiles can be appended to
the report.
If the search for pest‐specific information beyond that used for the hazard screen is
unfruitful, it may be feasible to generate a profile that covers more than one taxon without
sacrificing analytical rigour.
For example, if certain categorised species form a guild (group of species that exploit the
same resource in a similar way – eg. bovine blood suckers) or a functional group (species
with similar body plan, life history, behaviour – eg. perennial weeds with fleshy fruit) there
may be potential to construct a profile on the basis of the most well known taxa, and apply it
to less well known ones, on the basis of guild and functional group theory.
Hayes (2005) describes an approach used by the United States Department of Agriculture
(USDA) to assess fungi and insects potentially associated with proposed imports of Chilean
timber. The USDA analysts looked at each of the niches provided by the timber (bark,
sapwood, heartwood) and assumed that if mitigation measures could be devised that dealt
effectively with insects and fungi with known adverse impacts that inhabited those niches,
then similar but less well known insects and fungi would succumb to the same measures.
Similarly, Worner and Gevrey (2006) hypothesised that groups of pest species that occur in
the same place at the same time, are non‐random entities that can be used to efficiently
prioritise hazards and assess biosecurity risk. They propose that species assemblages
contain hidden predictive information about complex biotic and abiotic factors, including a
range of human mediated influences (eg. trade, cultivation, quarantine).
Worner and Gevrey gathered presence and absence data for more than 800 insect pests
across nearly 450 geographical large‐scale regions, and used a neural network approach to
identify consistent species groupings. They used these groupings to create risk maps
indicating where certain insect pest assemblages were most likely to be successful. Species
invasive rank by region was also established and predictive accuracy tested, albeit in a
limited way, for New Zealand.
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For instance, their model ranks Chrysomphalus aonidium as a relatively high invasion risk.
Subsequently, that species was detected in New Zealand. Conversely, the model indicates
Thrips palmi, an insect not recorded in New Zealand, is unlikely to occur there because it is
not strongly associated with the New Zealand insect pest assemblage. And yet, considerable
resources had gone into evaluating the likelihood that it would establish. The authors
suggest that risk analysis resources might be better placed by considering species
assemblages in the first instance.
Real et al. (2008) undertook a similar cluster analysis of thirteen vertebrate pest chorotypes
(assemblages of species with similar ranges) to identify favourable establishment areas in
Spain, and also recommend this as an efficient alternative to investigating individual species.
While biosecurity risk analysis may be fundamentally a species‐specific endeavour (Hayes
2005) functional group, guild and species assemblage approaches appear to have potential
to assist pest identification, prioritisation, and assessment. As all involve inference and use
of surrogate data, careful application is important.
7.4.3 Relevance and expected value of further information
In seeking information on categorised pests, the matter of when to stop arises. In practice,
information gathering and appraisal can continue until the final stages of the analysis,
provided two criteria are satisfied.
The information should be strictly relevant to the import risk problem. This may seem
obvious, however it is not unknown for material to be included in analysis reports that is not
germane to risk, through carelessness, because analysts are troubled by what little evidence
they have been able to find, or because they believe stakeholders will be persuaded by more
information per se.
Information that is not relevant to risk is not merely superfluous or benign. It has potential
to confuse and obscure the analysis and make the results difficult to communicate. This can
have damaging consequences for stakeholder confidence in the process, and the
effectiveness of the regulatory decision.
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In some cases, dearth of relevant information may be so pronounced that a reliable analysis
is not possible. Main options are either to terminate the analysis (but take precautionary
action commensurate with the prospect of harm), or undertake targeted empirical research
to address critical information gaps and narrow the uncertainties. Research could include
surveys to establish pest or host status, host/pathogen challenge testing, or analysis of the
economic value of potentially affected local industries. Appraisal of the likely worth of the
proposed research is necessary.
The difference between the current state of knowledge and what might be gained from a
given strategy to improve it (eg. research) is known as expected value of information
(Burgman 2005).
North (2005) describes it as an exercise in anticipating how additional information could
change a decision, and how likely the change would be. Hence, expected value of further
information is the expected value, taken over the possible outcomes of the research, of the
net benefits of the best decision based on the new information, less net benefit of the best
decision based on current information.
North also illustrates a method for calculating and comparing the expected dollar benefit of
research aimed at resolving an uncertainty (eg. is pest A able to use crop B as a host?)
against the cost of conducting it. There are several techniques for working out the expected
value of further information. However, having regard to the following may be sufficient:
• How fundamental is the proposed research to the import risk decision that has to be
made? (eg. basic economic impact research may be more critical than detailed
taxonomic research, or inoculation experiments on secondary hosts);
• What type of uncertainty does the proposed research address? (eg. research may
help counter uncertainty about questions of measurement but may be less able to
address uncertainty caused by natural variation);
• Does the proposed research rely on any kind of sample analysis and if so, can a
sample size (number) be achieved that is sufficient to allow robust conclusions? ; and
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• How long will the proposed research take and how does this align with the current
schedule and priority of the import risk analysis? (eg. extending the timeframe may
be reasonable in the case of an analysis that informs an important decision, but less
so in the case of routine decisions, although decision urgency will also have to be
considered).
The concept of expected value of further information is typically applied to experimental
research however the points above might also be useful for deciding literature search,
expert contact and other types of information gathering effort.
7.4.4 Alternative explanations and setting assumptions
At this point there should be a reasonable appreciation of what information is available,
where the key uncertainties lie, the nature of those uncertainties and what can (or can’t) be
practically done to reduce them. Assuming the lack of information is not so debilitating as to
preclude further analysis, and since uncertainties will not have been completely eliminated,
assumptions will need to be set on the basis of which the rest of the analysis proceeds.
Developing assumptions involves describing the uncertainty in sufficient detail, including its
type and magnitude. Assumptions can be organised with reference to each of the five
‘decision‐point’ hazard criteria at least (ie. presence in the area, where the import originates,
association with the import, potential for establishment and spread, etc.) and by stating the
specific risk question, its importance, what has been done to answer it and what remains
uncertain. In other words, the chain of logic that has led to the assumption should be laid
out. An hypothetical example is:
Presence of greater black slug in Tasmania
Whether or not greater black slug is established in Tasmania is important because a decision
to regulate the importation of mainland cabbages that may carry it could be a less effective
use of resource if it is already present in this State.
The slug is not recorded in any DPIPWE records. The Tasmanian Farmers and Graziers
Association Vegetable Group has not received reports of pest slugs for the past five years.
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Nonetheless, no formal surveys for greater black slug have been conducted and given that
importation of fresh untreated cabbages from slug‐affected mainland areas has occurred for
10 years, the possibility of populations in Tasmania cannot be ruled out.
Therefore, the presence of greater black slug in Tasmania is currently uncertain. For the
purpose of this analysis it is assumed that it is either not present in Tasmania or present at
low levels.
Sometimes, more than one assumption is required to deal effectively with uncertainty.
Information that is uncertain may be open to different but equally plausible interpretations.
It is important to scan for alternative explanations, including those that may lie beyond
conclusions put forward by authors of published papers and other research. These different
interpretations and the assumptions that flow from them should be transparently recorded
in the risk analysis report.
Analysts need not be concerned about accommodating more than one interpretation of data
in an import risk analysis. The WTO Appellate Body has explicitly stated that risk assessments
can set out both the prevailing view representing the mainstream of scientific opinion, as well
as opinions of scientists taking a divergent view (World Trade Organisation 2009).
7.4.5 Stakeholder and expert participation
For complex or sensitive situations, stakeholder participation in information collection,
discussion about uncertainty, alternative explanations and appropriate assumptions is
advisable and can be facilitated through a working group structure. See Chapter Six for
guidance on selecting participants and bringing them together. Again, it is important to
document stakeholder input.
It is also generally necessary to seek expert opinion at this stage, regardless of complexity or
sensitivity. Experts may be able to critique the data or access additional sources, and
comment on uncertainty. Again judgments about whether expert opinion is required can be
made on a case‐by‐case basis.
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7.5 Establish the risk model
7.5.1 Purpose
The purpose of this stage is to construct a conceptual model of the import risk problem
which reflects the information and uncertainties revealed during information gathering.
Establishing the risk model does not involve estimating risk. It concerns setting up a
framework within which reliable risk estimates can be made. It addresses the question ‐
What are the critical components of this import risk problem, how do they vary and what
factors and processes influence and link them?
7.5.2 Definition
Risk modelling can be either quantitative or qualitative. The risk modelling approach
described below is qualitative and not founded on mathematical equations, simulations or
other techniques intended to yield numerical or event frequency‐based predictions of risk.
Imperfect knowledge about the way complex import systems work, and subjective
interpretation of knowledge and knowledge gaps may largely preclude use of quantitative
models in import risk analysis. For parts of a risk problem for which mathematical models
might be employed (see below for import volume and period) the attendant assumptions
can be susceptible to violation, which means results may only be used with caution. Reliable
use of quantitative modelling also requires particular skills, and lack of these is often the
factor that leads to the choice of qualitative options (M. Burgman pers comm.).
Instead, the import risk modelling approach recommended here involves creating a diagram
that summarises the risk scenario ‐ the system that potentially allows a pest associated with
a particular importation activity to have adverse effects in Tasmania.
The diagram makes apparent known relevant parts and their interrelations and
dependencies. Its aim is to approximate reality qualitatively but plausibly, without
attempting, or giving the impression of, numerical precision. Qualitative modelling does not
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always preclude use of numbers. Subjective, degree of belief probabilities can be employed,
as will be summarised shortly.
Modelling can be considered the final, synthesising part of the problem formulation exercise
that began with scoping and hazard screening. Dambacher et al. (2007) note that while
modelling complex biosecurity‐related problems can be difficult, thoroughness is
nonetheless vital to avoid incomplete, vague or ambiguous risk assessments.
Qualitative modelling is also a critical problem communication device because analysts,
decision‐makers and other stakeholders do not require advanced mathematical skills to
interpret diagrams. In addition, diagrams are often superior to textual descriptions in making
a problem comprehendible. Generally, a good diagram of the risk model and clear
accompanying text is the best way of communicating an import risk problem and should be
presented in the risk analysis report.
7.5.3 What can be modelled?
7.5.3.1 Types of import risk scenario
There are two broad types of import risk scenario. One involves unintentional introductions.
These generally begin when an association is formed between a pest and the item proposed
for import that may result in the pest being inadvertently transported to the receiving
environment.
This relationship can begin in the place where the import originates, or in transit to the
receiving environment. The import risk scenario concludes with an adverse outcome or
endpoint. The pest leaves the imported item, establishes on a fresh host or in a new place in
the receiving environment and proceeds to damage animal, human, plant or environmental
health.
The other type of risk scenario involves deliberate introductions of organisms with perceived
utility that subsequently become invasive (eg. garden plants, pasture species, pets, display or
research animals) or cause other harm in the receiving environment.
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In theory, all parts of either import risk scenario can be modelled in detail. Relevant events,
factors and processes can be identified for pest entry to the receiving environment,
establishment, spread, and for environmental, economic and social impact.
In practice, import risk modelling tends to focus on the entry component, reflecting the
imperative of understanding this part of the risk scenario to prevent a potentially significant
pest crossing a quarantine barrier in the first place. For deliberate introductions, the entry
pathway is sufficiently known and generally need not be modelled, although frequency or
volume estimates may be useful.
Other parts of the import system may also be worth modelling. Bioclimatic modelling for
pest establishment potential may be possible (eg. using CLIMEX or CLIMATE). Models for
pest spread and dispersal can be useful. Sound environmental and economic impact
modelling may also enhance the reliability of an analysis.
7.5.3.2 Pathways, vectors and species
Potential for entry is examined in relation to the pathways and vectors with which a pest is
thought to be associated. The pathway/vector/species complex is at the crux of many import
risk problems. The first two terms can be used ambiguously and are defined as follows.
A pathway is the physical route between the source of the pest and a suitable receiving
environment or susceptible host (Lockwood et al. 2007). It describes the location of the pest
at a given moment in the risk scenario which, depending on what happens there, may
influence the number and variety of viable pests that access the receiving environment or
susceptible host.
For example, a weed species may be associated with grain proposed for import to Tasmania
for use as stock feed. The pathway could be described as: grain crop grown in New South
Wales, harvest goes to Victorian bulk handler, lots are shipped to Devonport, trucked to a
distributer’s premise, bagged for sale to Tasmanian farms.
The factors that influence whether the weed is also present and viable in Tasmanian
paddocks include, whether it occurs in New South Wales and the grower/s properties,
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whether the bulk handler cleans the grain or tests for the weed and segregates lots
accordingly, whether the grain is processed at the Tasmanian distributer’s premise, whether
farmers feed out in sheds or paddocks and so on.
A vector is the thing in or on which a pest is transported along the pathway, either
intentionally (eg. as food, for biocontrol, amenity enhancement purposes, etc.) or
unintentionally (eg. as a result of the movement of something else).
Vectors can be a conveyance or the imported item itself. Examples of the former include
vessels, ballast, containers, mail, packaging, people, shoes, water used to transport live fish
or plants, soil and equipment.
Vectors may also influence the chance of a viable pest remaining with the imported item. In
some cases meta‐analyses exist which indicate which vector/pest combinations appear to be
most important for a given geographic region (eg. Lockwood et al. 2007).
Other studies indicate aspects of vector condition can be strong determinants of pest risk.
For example, Floerl et al. (2005) investigated marine pests conveyed by yachts and
confirmed that the age of anti‐fouling paint on hulls is the principal factor in hull fouling risk.
7.5.3.3 Importation and distribution modelling
The pathway/vector/species complexes relevant to pest entry may be broken down into two
sub‐models for convenience. The first concerns importation, the sequence of ‘offshore’
events commencing with the source of the import and ending with passage through the
Tasmanian quarantine barrier.
The importation model depicts factors that influence whether a pest occurs on and survives
along the import pathway, and goes undetected in the course of routine inspection at the
Tasmanian barrier.
These include presence/absence at the import origin, pre‐import processing or treatment,
handling (eg. unpack/repack activities), opportunities for cross‐contamination, and storage
and transport conditions.
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Importation is analogous to the ‘release’ phase under the OIE standard, and is part of the
‘entry’ phase under the IPPC framework (ie. ISPM 11). Figure 4 is an hypothetical example of
an importation scenario for a pest potentially associated with ware potatoes from the
Australian mainland. The pathway is in red and factors potentially affecting presence and
survival of the pest are in blue.
Figure 4 depicts the pathway factors relevant to adequately visualising and communicating
the association between the pest and the import. It is possible to disaggregate these further.
For example, pest status at a source farm is likely to be a function of the particular regime of
monitoring and preventative management to which it is subject, which may vary from none
to an independently audited pest‐specific trapping program. An alternative to adding more
components to the diagram is to supplement it with text that describes pathway or factor
variation. Either way, the main aim should be to describe system detail sufficient and
appropriate to the importance and complexity of the import risk question. The parsimony
principle is relevant.
Text accompanying the model should also incorporate relevant assumptions identified in the
previous stage of the analysis. For instance, in Figure 4 an assumption may have been made
that the pest may occur on ware potatoes because this is biologically plausible, even if not
well described in the literature.
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Figure 4 Importation scenario for an hypothetical pest of ware potatoes from the Australian mainland
The second sub‐model for entry concerns distribution, the sequence of ‘onshore’ events
which occur after the import passes the barrier and is made available in the receiving
environment.
The distribution model depicts factors that influence whether a pest remains in a viable state
with the imported product or waste material derived from it, and whether it is exposed to a
susceptible host or suitable environment, and transfers to it.
Transfer may occur prior to the import being used (eg. escape in transit or from storage),
during use (eg. escape from plantings, susceptible wild animal contacts infected imported
animal) or after use (eg. aquarium, garden, processing waste dumped into open
environment).
Mainland ware potato source farms
Mainland potato distributer premise
Mainland storage and dispatch premises
Bass Strait transport
On arrival inspection Tasmania
Cross contamination from soil or infested potatoes from other farms in reused bins, bags or
crates
Release of potato tubers from quarantine
Visual detectability of pest
Quality control and brush, wash, pack system
Storage temperature and humidity
Transport temperature and humidity
Pest monitoring and preventative management
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Factors that influence distribution include import use, (intended and unintended), means by
which waste or by‐product is disposed of, the presence and proximity of hosts or suitable
receiving environments, and whether the pest is inherently equipped to escape the import
or there are vectors that can facilitate this. In addition, the number of places to which the
import is sent, and the range and location of hosts or suitable environments will also
influence the distribution scenario.
Distribution is analogous with the ‘exposure’ phase under the OIE standard, and is part of
the ‘entry’ phase under the IPPC framework. Continuing the hypothetical example in Figure
4, a distribution scenario is depicted in Figure 5 with the pathway in red and factors
potentially affecting presence and survival of the pest in blue.
Again, the number of pathway steps and influencing factors could be further detailed as
necessary, either by expanding the diagram or in the text of the risk analysis report.
Assumptions, for example, about survival in cold storage, the susceptibility of potential hosts
that are weeds or native plants in Tasmania and so on, should be presented in accompanying
text.
Figure 5 Distribution scenario for an hypothetical pest of ware potatoes from the Australian mainland
Potatoes released from quarantine
Storage at Tasmanian merchant or retail outlet
Consumer premises
Survival after cooking and consumption
Survival during storage, quality check, packing
Pest transfers to susceptible crop, weed or native plant host
Uncooked potatoes or parts (eg. peel) released to environment and proximal to susceptible hosts
Consignment spills en route (eg. at port, roadside).
Survival in Tasmanian environment
Potatoes cooked and consumed
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Importation, distribution and any other risk scenario modelling provides an opportunity to
check scope of the analysis and ensure vectors and pathways that are not accounted for
have been deliberately excluded for a reason, and not because no one has thought of them.
Hayes (2005) notes this can be a particular problem of the deductive approaches common to
import risk analysis in which the approach to predictions about what can happen rely largely
on information about what has happened. This has potential to lead the analysis and may
prevent consideration of a broader array of plausible possibilities.
In particular, import risk analyses can become focussed on the intended use of an imported
item because applications to import are generally framed around the whole system designed
to facilitate that use. And yet alternate uses may be where the highest risk lies.
7.5.4 BBNs, DAGs, CPTs and DNs,
As shown, importation and distribution (or release and exposure) scenarios can be
conveniently represented using simple tree diagrams.
Scenario trees are one kind of qualitative chain‐of‐event logic model which begin with an
initiating event (ie. pest associates with proposed import) and follow causal pathways
through to the relevant endpoints (ie. transfer to receiving environment). The conventions
(eg. boxes representing components and variables and one‐way arrows showing the
direction of influence) are straightforward and can be understood by most people.
There are other problem modelling approaches, each with their own graphical rules, that are
less often employed for biosecurity purposes but which may also be useful. Burgman (2005)
describes several environmental risk modelling options that could be tested for import risk
problems.
Bayesian network analysis, which is commonly used to investigate natural resource
management issues, may be gaining traction in biosecurity, especially for predicting entry,
establishment and spread potential.
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Bayesian network analysis takes its name and essence from Bayes Theorem which is a
predictive, mathematical expression concerned with the probability that a hypothesis is true,
given the data. Bayes Theorem relies on prior probabilities which are degree‐of‐belief
probabilities about the value of a parameter expressed by experts at the start of the
analysis, including in the absence of empirical data (Burgman 2005).
Bayes Theorem can be used to combine subjective opinion and other types of information
such that its reliability can be weighted appropriately through hypothesis testing and belief
(prior probability) updating that occurs as the analysis continues. The predictive analysis can
also be replicated independently if the same data are used.
Dambacher et al. (2007) provide a beginners’ explanation of the Bayesian approach to risk
modelling, and describe two case studies which demonstrate how it can be applied in
biosecurity.
In summary, a Bayesian Belief Network (BBN) is a diagrammatic schema that reveals the
main variables in a system and the cause and effect relations between them. BBNs are
comprised of ‘nodes’ that represent the variables and arrows that represent dependencies
between one variable (the ‘parent’ node is at the start of the arrow) and another or others
(the ‘child’ node/s are at the end of the arrow).
BBNs can also be extended to incorporate decision‐making criteria, in which case they are
called Decision Networks (DNs). DNs include either or both of a special type of node.
Decision nodes represent alternative management actions. Utility nodes represent an
outcome to which a value has been assigned. (eg. monetary cost or benefit).
The rule for constructing a BBN is that arrows between nodes are one‐way only. Any
feedback between variables must be dealt with separately. This gives the BBN a
unidirectional, acyclic character. When BBNs are drawn, the resulting diagrams are known as
Directed Acyclic Graphs (DAGs).
BBNs appear to have much in common with scenario trees, however there is a distinction.
The arrows between BBN variables represent conditional probability distributions (also
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called prior probabilities). The value of a child node is conditional upon every possible
combination of values of the parent node that gives rise to it. Conditional probability tables
(CPTs) are assigned to each variable and are completed and updated using an iterative
process. Frequently, CPTs are based entirely on subjective opinion from different people.
BBNs therefore differ from scenario trees in that they require the assignment of degree of
belief probabilities to each system variable. Dambacher et al. (2007) show that by this
means, BBNs are capable of synthesising subjective or other ambiguous information into
comprehendible conceptual models that are amenable to statistical verification and
updating, and which yield results that can be reproduced.
Therefore, BBNs are flexible in terms of the information that can be encompassed, and can
satisfy the three criteria that define sound scientific analysis. That is, the analysis is
transparent, results are reproducible, and the hypotheses on which it is built are
experimentally or statistically testable.
This does not mean Bayes nets always produce more accurate risk predictions than purely
qualitative approaches. Like any model, the quality of input data is paramount. If subjective
probabilities are not elicited in ways that reduce potential for bias (see Chapter Six), or if the
model structure is flawed (eg. key parameters are missing), the risk predictions are likely to
be less reliable even if they are statistically sound.
Dambacher et al. (2007) note several disadvantages of Bayesian network analysis. In
particular, and although commercial software is available (Netica at
http://www.norsys.com/), BBNs can be laborious in terms of time, expertise and data
requirements, especially for system feedback.
Overall, Dambacher et al. (2007) conclude that BBNs have promise as a predictive technique
for biosecurity risk problems. They suggest that BBN approaches should be developed as
complementary tools for current biosecurity risk assessment methods.
Bayesian network analysis is also being combined with other approaches, creating
potentially wider applications in biosecurity problem modelling. For example, info‐gap
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analysis is focussed on achieving minimally acceptable outcomes in the face of substantial
uncertainty. The aim is to ‘satisfice’ rather than optimise decisions. Burgman et al. (2008)
used a Bayesian net as the process model for eradication of red imported fire ant in eastern
Australia, and applied info‐gap theory to investigate the uncertainties in the Bayes net.
Multi Criteria Decision Analysis (MCDA) which investigates the perceptions of stakeholders
and trade‐offs represented in alternative decisions, may be promising for evaluating pest
impact. Baker and Stuckey (2008) proposed a broad two‐part pest prioritisation framework
for biosecurity decision‐making that combines Bayesian network analysis of pest
establishment and spread potential with MCDA for impact assessment.
Modelling innovation can confound those not directly and routinely involved in it. The
salient point is that the flow of ideas into biosecurity risk modelling is healthy and may well
yield effective analytical tools that, with appropriate training, may be suitable for wider use.
7.5.5 Import volume and period
Volume and import duration are other fundamental import system factors that can be
considered during the risk modelling stage.
The basic assumed relationship is: the greater the quantity of an import potentially carrying
a pest, or the longer the term of importation, the greater the likelihood of that organism
entering the receiving environment. That is, importation period can be used as a surrogate
for volume and the probabilities associated with each part of a risk model are conditioned
on either a time period (which implies a volume of trade) or a volume of trade (which
implies a time period).
Biosecurity Australia generally applies a standard one year volume of trade when estimating
the likelihood of pest entry because this accommodates consideration of seasonal variations
in pest presence, incidence and behaviour. BA asserts that this does not mean that any
quarantine measure subsequently recommended for that organism is only good for one year
because the risk estimation matrix in which the entry likelihood estimate is used also
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implicitly reflects consideration of establishment, spread and consequence over more than
one year (Biosecurity Australia 2009c).
This however, leads to risk being estimated for an indeterminate, unspecified period which
gives rise to ambiguity about the meaning of the risk estimate. In particular it raises doubt
about whether an estimate of ‘very low’ equates to community expectations for acceptable
risk not warranting specific SPS measures. By way of analogy, a person who is informed his
risk of losing a leg in the next two years as a result of engaging in a particular activity is ‘very
low’, (but not negligible) may choose a different course of action than if the prospect of
amputation was estimated as ‘very low’ over 25 years.
McCarthy et al. (2007) reviewed the treatment of trade duration and volume in import risk
analyses, including those conducted by Biosecurity Australia. Guidelines developed by BA
(Department of Agriculture, Fisheries and Forestry 2001) emphasise the importance of
considering potential effects of volume on likelihood of entry, establishment and spread. For
plant health questions, the probability of a pest entering, establishing and spreading in a
receiving environment in association with importation of a certain quantity is expressed as:
PEES annual = 1 – (1‐PEES)VT
Where:
PEES annual is the probability of entry, establishment and spread as a result of importation
over one year;
PEES is the probability of an organism entering, establishing and spreading in a receiving
environment with one basic unit of trade (ie. 1‐ PEES is the probability of an organism not
entering, establishing and spreading with one unit of trade); and
VT is the volume of trade expressed as the number of trade units imported during 1 year.
A similar formula was developed for animal health related analyses but focuses on entry and
exposure probability. In both cases, a basic unit of trade must be chosen that is appropriate
to the import question. It could be a single animal, a tray of fruit or seedlings, pallet of boxed
meat, a 25 tonne container of grain and so on.
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The formula is known as the geometric model because the volume at which an incursion is
likely to occur follows a geometric distribution. That is, the probability of an incursion
increases toward certainty (p=1.0) with volume, at a rate determined by infestation level of
the basic unit.
The ability of the geometric model to make robust predictions relies on two assumptions.
One is that the probability of an incursion is the same for each unit of trade, and the other is
that the probability of an incursion is independent from year to year. McCarthy et al. (2007)
demonstrate how plausible dependencies can violate and undo these assumptions, leading
to under or overestimation of incursion likelihood.
McCarthy et al. (2007) did not identify a superior analytical approach among those currently
used to account for volume and period considerations. They agreed that assessments over
shorter time frames (eg. one year) are less vulnerable to uncertainty than predictions made
over longer periods, and so suggest that the geometric model could provide a reasonable
approximation of likelihood.
But they also concluded that ideally, volume of trade and associated risks should be
evaluated over periods that are relevant to decision‐making but which also reflect aspects
specific to the import problem at hand, such as the biology and ecology of the organism.
They acknowledged the need for a mechanism to convert estimates to a common timeframe
to support consistent decision‐making. However, in practice and as Biosecurity Australia has
moved from quantitative to qualitative assessment of risk, it is not clear whether it still uses
the geometric model.
The approach recommended in this framework is to specify volume and period factors in the
text of the analysis. The period over which risk estimates can be expected to hold must be
specified. For practical purposes, periods of less than 5 years should be avoided unless a
more frequent review schedule is clearly necessary.
Expected volume may be approximated through discussion with the prospective importer/s
or other biosecurity authorities that have experience with the import or a similar class of
imports. Monitoring strategies should be capable of detecting actual import volumes that
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are substantially out of the estimated range. Explanations of period and volume
specifications for the analysis should appear in the text accompanying the risk model.
7.5.6 Stakeholder and expert participation
Again, for complex problems, it is preferable for stakeholders and relevant experts to be
closely involved in import risk model building, since it is entirely possible for people to apply
alternative but equally valid logic to a problem, even when possessed of the same
information. These alternative views may be essential to subsequent estimation of
consequences. The benefits of using diagrams to pave the way for consolidated and
consensus‐based thinking about multiple cause and effect relations and attendant
uncertainties, were emphasised above.
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7.6 Assess the risks
7.6.1 Purpose
The purpose of this stage is to estimate the pest risk posed to Tasmania by a proposed
import or other inbound movement and compare it to Tasmania’s ALOP of ‘very low’ risk.
In the case of unregulated import activity (new or existing), the estimate is made in the
absence of specific SPS measures, and hence is often referred to as unrestricted risk.
However, if regulated import activity is being reviewed, the estimate may either ignore
current controls, or factor them into the assessment. Either way, the choice needs to be
made clear so that a cogent argument can subsequently be made for maintaining, removing,
reducing or strengthening existing controls.
The key question is ‐ Is the biosecurity risk to Tasmania acceptable?
7.6.2 Risk ranking method
Given resource and time constraints, a risk estimation method is desirable that can be
executed with relative ease and speed by government analysts with basic scientific and
problem‐solving skills. The method must also be capable of yielding reliable results, the logic
of which can be made apparent to everyone, even if elements of the risk problem are
uncertain. A qualitative risk ranking approach fits these criteria.
Risk ranking uses quantitative data when available, but typically relies on subjective expert
opinion. Opinion and other data are used to generate qualitative estimates of risk within a
descriptive, ordinal scale established by the risk ranking matrix in Table 6 (identical to Table
3).
Risk estimates are evaluated against Tasmania’s ALOP of ‘very low’ risk, the risk threshold at
the conservative end of the scale. Estimates that fall at or below ‘very low’ represent
acceptable pest risk, while those that exceed it indicate risks that are not acceptable.
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Risk ranking employs a language and a logic structure that is now used widely in society and
is therefore generally familiar to most stakeholders – ie. likelihood, consequences, and how
they can be considered together to suggest the significance of a potential hazard.
Likelih
ood of entry, estab
lishm
ent an
d spread
(L)EES High
likelihood
Negligible
risk
Very low
risk
Low risk Moderate
risk
High risk Extreme
risk
Moderate Negligible
risk
Very low
risk
Low risk Moderate
risk
High risk Extreme
risk
Low Negligible
risk
Negligible
risk
Very low
risk
Low risk Moderate
risk
High risk
Very low Negligible
risk
Negligible
risk
Negligible
risk
Very low
risk
Low risk Moderate
risk
Extremely
low
Negligible
risk
Negligible
risk
Negligible
risk
Negligible
risk
Very low
risk
Low risk
Negligible
likelihood
Negligible
risk
Negligible
risk
Negligible
risk
Negligible
risk
Negligible
risk
Very low
risk
Negligible
impact
Very low Low Moderate High Extreme
impact
Consequences of entry, establishment and spread
Table 6 Risk ranking matrix
A method for risk analysis that revolves around likelihood and consequence estimation
seems at odds with the earlier observation that it is counterproductive to think about risk in
these narrow terms. The strategy adopted here is to infuse the risk ranking approach with
insights about risk perception, uncertainty and opinion elicitation, and so enhance the
reliability of estimates and decisions while retaining relative methodological simplicity.
The risk ranking method described below aligns generally with the relevant international
standards (See Appendix 2), noting there are some dissimilarities between IPPC and OIE risk
assessment standards that reflect differences in the evolution of epidemiological thinking in
plant and animal health respectively.
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7.6.3 Estimation of likelihood
Likelihood estimation is conducted for three components ‐ entry, establishment and spread ‐
which represent a logical disaggregation applicable to many import risk problems.
Choice of these parameters is consistent with IPPC (Food and Agriculture Organisation 2006)
and OIE guidance noting that OIE requires separate estimates for release at the importing
country’s barrier and subsequent post‐barrier host exposure while the IPPC equivalent is a
single estimate of likelihood of entry.
7.6.3.1 Likelihood of entry
Likelihood of entry concerns the chance of a categorised pest being imported to Tasmania
and being subsequently distributed such that it transfers in a viable state to a host or other
suitable part of the environment.
Successful entry events may be few or numerous, frequent or sporadic, heterogeneous or
homogenous, depending on the proportion of viable individuals that survive importation and
distribution, the number of opportunities for distribution in the vicinity of hosts or suitable
environments, and the variety and location of those hosts and environments.
The factors that influence the chance of pest entry will be identified in the pest profile,
represented in introduction and distribution scenario trees. The text accompanying each
scenario tree can be concluded with a separate qualitative estimate of likelihood for
importation and distribution.
Likelihood of importation and distribution is expressed according to the descriptive scale
presented in Table 7, and can be written, for example, as L(Importation) = low. The
nomenclature is the same as that used by Biosecurity Australia.
BA also, though not always, supplements each likelihood description with the same
indicative probability ranges set out in Table 7 (eg. Biosecurity Australia 2009c, 2009d). The
indicative probability ranges are intended to provide clarity about the boundaries of the
description and promote consistency across risk analyses.
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This helps avoid some of the psychological and linguistic pitfalls that can arise when words
alone are relied upon, as described in Chapter Six. Use of indicative probability ranges does
not make an analysis quantitative or semi‐quantitative. It is possible to undertake a reliable
analysis without reference to indicative probability ranges however the reasoned arguments
upon which the likelihood estimates are based must be carefully presented.
Table 7 Nomenclature for descriptive likelihoods
Likelihood (L) Description Indicative Probability (P) Range
High The event would be very likely to occur
0.7 < P ≤ 1.0 (probability between 70 % ‐ 100%)
Moderate The event would occur with an even possibility
0.3 < P ≤ 0.7 (probability between 30% ‐ 70%)
Low The event would be unlikely to occur
0.05 < P ≤ 0.3 (probability between 5% ‐ 30% )
Very Low The event would be very unlikely to occur
0.001 < P ≤ 0.05 (probability between 0.1% ‐ 5% ie. between one in a thousand and one in twenty)
Extremely Low
The event would be extremely unlikely to occur
0.000001 < P ≤ 0.001 (probability between 0.0001% ‐ 0.1%, ie. between one in a million and one in a thousand)
Negligible The event would almost certainly not occur
0 ≤ P ≤ 0.000001 (probability less than one in a million)
To recap, the main criteria to be considered when estimating importation (or release)
likelihood are, as adapted from Biosecurity New Zealand (2006) and Department of
Agriculture, Fisheries and Forestry (2001):
• incidence or prevalence in the area from which the import originates, including area‐
free and low pest prevalence status;
• quality of official surveillance programs in the place of origin;
• seasonal factors;
• occurrence of a life or infective stage that would be associated with the import,
including conveyances;
• vulnerability to contamination;
• existence of latent states, convalescent carrier or other sub‐clinical manifestations;
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• quality control, cultural or veterinary practices in the place of origin (chemical sprays,
vaccinations may mask the presence of pathogens);
• effect of processing, storage and transport on survival (eg. efficacy, temperature and
humidity regimes, duration in relation to lifecycle of pest);
• effect of existing zoo or phyto sanitary procedures or treatments on survival; and
• effect of any of the above on ability to detect the pest or disease symptoms during
routine quarantine inspection.
The main criteria to be considered when estimating distribution (or exposure) likelihood are,
as adapted from Biosecurity New Zealand (2006) and Department of Agriculture, Fisheries
and Forestry (2001):
• ability of the pest to escape the import including by its own dispersal or transmission
mechanisms, or facilitated by a vector in the receiving environment;
• proximity to susceptible hosts or suitable environments either on entry, in transit, at
import destination or where import waste or by‐product is disposed of;
• intended and alternative import use;
• number of destinations to which the import, its wastes or by‐products are sent;
• range of hosts or susceptible environments;
• seasonal factors; and
• volume.
7.6.3.2 Likelihood of establishment
Likelihood of establishment describes the chance of a pest that has entered Tasmania
developing populations capable of perpetuating in the foreseeable future.
This is consistent with the IPPC definition of establishment (Food and Agriculture
Organisation 2008). OIE incorporates likelihood of establishment into consequence
assessment. Likelihood of establishment is also expressed in qualitative terms according to
the descriptive scale presented in Table 7 and can be written, for example, as L(Es) =
moderate.
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An estimate of establishment likelihood involves considering whether a pest is suited to
sustained survival in Tasmania without deliberate human assistance, and over more than
one generation. Establishment is typically considered for open environments however it can
be relevant to closed or protected environments such as glass or polyhouses, poultry sheds,
land‐based aquaculture facilities and so on.
Some pests need not establish in order to have impacts. Certain parasites of humans,
poisonous or toothed/clawed display or novelty animals, for example, may cause serious and
unacceptable harm regardless of whether they have an opportunity to reproduce.
Establishment likelihood is estimated by revisiting the pest profile. This should contain
information that allows a comparison of factors relevant to pest establishment elsewhere,
with factors in Tasmania. This comparison and other relevant logic should be articulated in
the import risk analysis report immediately after likelihood of entry is discussed. The
assumptions used to make the comparison should be clearly described.
The criteria relevant to estimating likelihood of establishment include, as adapted from
Biosecurity New Zealand (2006) and Department of Agriculture, Fisheries and Forestry
(2001):
• host, vector and mutualist abundance, distribution and demography, including
secondary, intermediate or alternate hosts or vectors, feral hosts that amplify
disease;
• environmental suitability, including physical conditions and ranges (temperature,
moisture, soil, etc.) and biotic factors (competitors, predators, parasites, etc.);
• adaptability of the pest to different environmental conditions (eg. polymorphism,
plasticity, polyphagy, host specificity);
• reproductive strategy (generations per year, latent, subclinical or other cryptic
stages, cysts, spores or other resting stages, self‐crossing, parthenogenisis,
hybridisation potential);
• disease transmission mode (horizontal via contact, air, water, coitus, ingestion,
biological vectors or intermediate hosts, vertical from mother to embryo);
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• threshold population levels (information may be available about the minimum
number of individuals required to maintain a persistent population); and
• cultural, husbandry or other management practices.
Pest establishment modelling may be undertaken, including use of bioclimatic, niche or
other modelling software, when resources permit.
There is also a large body of invasive species research that may prompt thinking about
factors in receiving environments that facilitate or inhibit pest establishment. Lockwood et
al. (2007) for example, discuss the problems of understanding establishment in natural
environments. A major obstacle is that establishment is often subtle, or difficult to detect,
and therefore hard to study and collect predictive data about. While useful information may
be gained, there are ethical issues with releasing pests beyond contained environments.
Nonetheless, Lockwood et al. (2007) provide a solid summary of biotic interactions that
influence establishment success of non‐native species in natural environments.
Bomford (2008) has devised a score‐based risk ranking system for deliberately imported
vertebrates that identifies criteria most important to the establishment of mammals and
birds, reptiles and amphibians, and freshwater fish respectively. This system was also built
with reference to invasion theory and recognises that establishment success across the
classes of vertebrate is a function of propagule pressure, climate match, history of
establishment elsewhere and taxonomic group.
7.6.3.3 Likelihood of spread
Likelihood of spread describes the chance of, and the extent to which, a pest could increase
its geographical distribution across Tasmania, either through localised expansion around a
point of establishment, or by long distance dispersal from a point of establishment.
This is consistent with the IPPC definition of spread (Food and Agriculture Organisation
2008). OIE considers likelihood of spread as part of consequence assessment. Likelihood of
spread is also expressed in qualitative terms listed in Table 7 and can be written, for
example, as L(S) = high.
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While estimates of establishment likelihood relate to the proportion of the new
environment is suitable for development of self‐sustaining populations, estimation of spread
likelihood involves examining whether the pest is likely to access other suitable areas, and
initiate additional populations.
Estimation is made by revisiting the pest profile. This should contain information that allows
a comparison of factors relevant to dispersal and spread elsewhere, with factors in
Tasmania. This comparison and other relevant logic should be articulated in the import risk
analysis report immediately after likelihood of entry is discussed. The assumptions used to
make the comparison should be clearly described.
Spread criteria include, as adapted from Biosecurity New Zealand (2006) and Department of
Agriculture, Fisheries and Forestry (2001):
• inherent mobility characteristics and strategies (eg. largely sessile or capable of flight,
wind, water, vector assisted movement);
• presence of barriers to natural movement from likely point of establishment (eg. too
cold outside glasshouse environment, host populations are very far apart, vector
distribution is limited, competitors, predators, parasites and other enemies are
widely distributed, suitable soils are restricted);
• suitable physical and biotic environmental conditions for dispersal (natural vectors or
mutualists present, host populations distributed within natural dispersal range,
roadside disturbance, prevailing wind strength and direction, water flow);
• potential for human‐assisted dispersal (on clothing, equipment, vehicles, via
movement of the import, import waste or by‐product or things conveying them);
• intended and alternative uses of the import; and
• lag time and boom‐bust cycles.
Again, a variety of mathematical models for pest spread is available (eg. reaction diffusion
models and variants), which may be valuable for certain import risk problems. In some cases,
simple distributional data (eg. outbreak records) may be available for similar environments
which can be usefully mapped to indicate potential rate of spread, as well as provide clues
on mode of spread (eg. human assisted vs natural).
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7.6.4 Likelihood combination rules
The likelihood assessment yields four descriptive estimates (for introduction, distribution,
establishment and spread). These are combined to generate an overall likelihood for entry,
establishment and spread where:
L(Importation) x L(Distribution) = L(En) = overall likelihood of entry and;
L(En) x L(Es) x L(S) = the overall likelihood of entry (En), establishment (Es) and spread (S)
= L(EES)
The rules for combining descriptive likelihoods (Table 8) are adopted from Biosecurity
Australia’s schema (eg. Biosecurity Australia 2009d).
Table 8 Rules for combining descriptive likelihoods High Moderate Low Very low Extremely
low Negligible
High High Moderate Low Very low Extremely low
Negligible
Moderate Low Low Very low Extremely low
Negligible
Low Very low Very low Extremely low
Negligible
Very low Extremely low
Extremely low
Negligible
Extremely low
Negligible Negligible
Negligible
Negligible
For example, when:
L(Importation) = moderate and L(Distribution) = low, L(En) = low; and when
L(En) = high and L(Es) = low and L(S) = (low), L(EES) = very low
7.6.5 Rare event likelihoods
Of special interest to import risk analyses are rare events with potentially large adverse
consequences. The condition of rarity means information is likely to be similarly rare, there
will be temptation to stretch what little data there are or resort to marginally relevant
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information. Subjective opinion will be highly uncertain. This can lead to rare events either
being ignored or otherwise poorly handled in import risk analysis.
Franklin and Sisson (2007) reviewed strategies for assessing extreme risks in a variety of
applications (banking, flooding, nuclear reactor failures etc) as well import situations. Their
recommendations include:
• training for risk practitioners in Extreme Value Theory, Bayesian approaches and
imprecision/robustness concepts;
• further study of the advocacy model of public policy setting, and whether it allows
better identification, evaluation and communication of extreme risks compared with
the adversary model; and
• adoption of more transparent attribution policies for authors of import risk analysis
reports to increase accountability.
These points demonstrate there is room for further development in analysis of rare import
risk events. In the meantime, the general approach recommended in this framework is to at
least identify rare, potentially significant events, discuss them openly with risk analysis
participants and treat with a level of precaution commensurate with the degree of
uncertainty and severity of potential consequences.
7.6.6 Estimation of consequences
Estimating the adverse consequences of a potential pest associated with an import or other
inward movement is typically a three‐stage process.
It involves identifying the type of impact and appraising the magnitude of impact of each
pest, followed by combining individual assessments into an overall pest impact estimate.
Each of these components is complex and together represent an area that also continues to
evolve.
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ISPM No. 11 states that in cases for which there is wide agreement that economic
consequences, including environmental impacts, will be unacceptable, detailed evaluation
may not be necessary (Food and Agriculture Organisation 2006).
However, there is a practical need to undertake the best impact analysis possible in the
circumstances to effectively prioritise across regulatory efforts. Even for routine import risk
problems, understanding costs and benefits is critical for resource allocation at the
quarantine barrier and equitable distribution of costs among stakeholders and the general
public. This is discussed in the next section.
Another fundamental feature of impact assessment is that it is value‐laden. While technical
experts may be able to make sound estimates of, for example, the dollar cost of market loss,
or likely percentage population decline for a native species, they have no particular ability to
judge the importance of those impacts. This is a matter for all participants in the analysis.
7.6.6.1 Kind of impact
Negative pest impacts upon natural environments, the economy or people are described in
IPPC and OIE guidance as direct or indirect. Direct and indirect impact categories are listed
below, as adapted from Biosecurity New Zealand (2006) and Department of Agriculture,
Fisheries and Forestry (2001):
Direct consequences result in harm to:
• native and non‐native animal health, life or welfare (eg. mortality, morbidity, sterility,
carrier status, animal welfare decline, stress, behaviour changes, or predation,
competition, hybridisation or other genetic impacts);
• native and non‐native plant health or life (eg. infestation or infection, or predation,
competition, hybridisation or other genetic impacts);
• human health, life or welfare (eg. toxicity, allergencity, mortality, morbidity, latent
infection, sterility, carrier status, injury, stress);
• other biota (eg. effects on soil and water microflora and microfauna)
• the physical environment (eg. altered water quality and hydrology, changed soil or
dune formation).
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Indirect consequences follow from direct impacts and will often interrelate. Three sub‐
categories are identified.
Indirect economic consequences including:
• costs of new or revised eradication or control programs, and underpinning research;
• costs of new or revised surveillance and monitoring strategies or programs, and
underpinning research;
• costs of loss of pollinators, mycorrhizae, mutualists or other beneficial organisms
killed as a result of pest control;
• compensation for affected parties and other incursion recovery costs (eg.
counselling, strategies to repair community cohesion after an outbreak);
• reduced tourism revenue;
• costs of repairing lost or damaged amenity (water quality and quantity, safe access)
or infrastructure (buildings, roads, irrigation and hydro‐electricity facilities);
• declines in property value;
• costs of environmental rehabilitation or restoration;
• domestic trade or industry losses including declines in consumer demand and effects
on allied industries (eg. those supplying inputs to, or using outputs from, directly
affected industries);
• international trade effects, including loss of markets, embargoes, trade sanctions,
need to meet stricter technical requirements to maintain current markets or access
future ones, and decline in international consumer demand; and
• reduced rural and regional economic viability.
Indirect environmental consequences including:
• side effects, onsite and offsite, of control measures (eg. off‐target effects of chemical
treatments, susceptibility to erosion increased, susceptibility to other pests
increased);
• effects on native species not directly affected by the pest (eg. food chains or
reproductive cycles disrupted through loss of prey or pollinators respectively);
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• synergistic or cumulative effects of different pest impacts (eg. one invader may
facilitate the success of another by eliminating predators, or providing a food or
shelter resource);
• effects on native community structure (eg. transforming weeds);
• alteration of ecosystem processes and characters such as hydrology, soil formation,
nutrient cycling, susceptibility to fire, and disturbance regimes; and
• effects on especially sensitive or protected environments (eg. receiving environment
is already vulnerable, contains iconic or keystones species).
Indirect social consequences including:
• reduction of environmental amenity, recreational, social, cultural or aesthetic value
(eg. existence, experiential or bequest value lost, cultural or recreational activity
prevented);
• long‐term psychological problems (eg. post traumatic stress disorder in parties
directly affected by a pest incursion, and emergency responders); and
• family or community break‐down.
7.6.6.2 Magnitude of impact
How serious the impact of a pest might be is central to any import risk problem and may
dominate the thinking of analysis participants perhaps more so than likelihood
considerations, because it is directly concerned with prospective loss.
Potential magnitude of impact may be estimated for each direct and indirect impact for each
potential pest. Estimation techniques are used that are appropriate to the anticipated type
of impact and the importance of the regulatory decision.
Making reliable predictions about the size of any type of pest impact is frequently
problematic. For instance, whether an impact is direct or indirect generally has little bearing
on its significance. The size of an indirect effect may substantially exceed that of the direct
effect that gave rise to it.
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An example is the Foot and Mouth Disease (FMD) outbreak in the United Kingdom in 2001.
Most infected animals recover fully and livestock mortality rates are modest, within the
vicinity of 1% and 8%. However, because FMD has OIE priority status, detection leads to
immediate trade cessation, and often, the killing of all infected and potentially infected
animals. The costs to the UK of market loss, the outbreak response, compensation to
affected farmers and impacts on tourism ran to billions of pounds (Cook et al. 2008) and
caused the OIE to rethink its policy, especially in relation to vaccination.
In addition, consequential economic costs that are further removed from direct impacts can
be large. The 2007 Equine Influenza incursion in Australia had diverse knock‐on effects to the
horse racing industry. Australian Government funding of Aus$110 million ensued, a large
part of which comprised compensation or other financial assistance to various industry
groups affected by the incursion response.
While direct losses to producers, control costs and export revenue losses are generally
calculated, environmental and economy‐wide costs are all too often excluded from
consideration because they are hard to estimate (Tanner 2003).
Declines in environmental or social amenity condition and values largely defy meaningful
quantification. Adamson (2006) describes evaluation techniques for non‐market impacts as
resource hungry, regularly challenged, and still at a developmental stage. This is concerning
because, as some surveys indicate (eg. Waage et al. 2004), non‐market impacts may be the
dominant component of overall harm caused by a pest associated with trade.
Faced with these constraints to reliably estimating impact magnitude, the strategy to adopt
is the same as for dealing with uncertainties about likelihood of pest entry, establishment
and spread. Gather relevant information, advice and assistance with available resources and
apply precaution commensurate with the nature and magnitude of uncertainty and impact.
Tasmania’s particular biosecurity risk profile should be recalled.
For routine analyses, it may be sufficient or only practically possible to make limited
conclusions about magnitude of impact based, for example, on net value of potentially
affected industries and aggregate production loss and control cost information from places
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where the pest occurs. However, for more complex import risk questions, a greater
analytical effort is necessary to allow conclusions to be drawn on a wider range of impacts.
For instance, evaluation of production loss and control costs for a potential crop pest will
generally involve establishing impact on crop profit margin. Values can be multiplied up to a
farm, regional, or State scale, as necessary. Key data may include:
• range of host crops grown in the potentially affected area;
• number of enterprises growing those crops;
• relative dependence of those enterprises on the host crops (ie. the enterprise is
entirely based on the crop, year to year, or the crop is a minor component grown
occasionally);
• range of current annual profit margins of those enterprises for those crops per unit
volume of production (ie. in the absence of the pest);
• proportion of host crop loss in places where the pest is present, with and without
control;
• existing cultivation methods or pest management in the potentially affected area
that could be expected to significantly mitigate the effects of the pest, were it to
occur;
• cost of additional pest control measures; and
• potential for crop substitution and costs associated with that.
Assumptions will typically need to be placed around findings for each of these criteria, and
should be specified, along with other method limitations. For instance, the considerations
listed above do not take into account costs incurred when the host plant is also grown in
non‐commercial situations (eg. home gardens), which could result in a substantial
underestimation of impact magnitude.
There may be modelling tools for predicting other economic costs of a pest incursion which
could be adapted for broader use. Cook et al. (2007) report a method for estimating costs
incurred from loss of crop pollination services provided by honey bees (Apis mellifera) in the
event of varroa bee mite (Varroa destructor) establishment in Australia. They conclude that
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costs of Aus$21.3‐50.5 million per annum will be avoided by maintaining quarantine
measures to prevent varroa mite entry over the next 30 years.
Bomford (2008) reviewed factors associated with adverse impact for imported vertebrates
and suggests increased risk is generally likely if the species:
• has adverse impacts elsewhere;
• has close relatives with similar behavioural and ecological strategies that cause
adverse impacts elsewhere;
• is a generalist feeder;
• is predatory;
• destroys or modifies vegetation or otherwise causes major habitat change;
• harbours or transmits harmful diseases or parasites;
• has potential to hybridise with close relatives among native species; and
• is known to spread rapidly following release to a new environment.
7.6.6.3 Scale considerations
It may be useful and possible to characterise the magnitude of impact, for example, at
different geographic scales. Definitions, adapted from Biosecurity Australia’s import risk
analysis guidelines (Department of Agriculture, Fisheries and Forestry 2001) are:
Local – a single or small number of neighbouring properties or enterprises;
• District ‐ an aggregate of properties or enterprises usually within the same local
government area (eg. Oatlands, Forest, Cygnet);
• Regional – a geographically associated collection of districts within one or more local
government areas (eg. Tamar Valley, Huon Valley, D’Entrecasteaux Channel,
Furneaux Islands);
• State ‐ more than one region or the whole of Tasmania
It may be appropriate and possible to consider impact at each of the four geographic scales,
at fewer than four, or only one (usually State‐wide). Whatever the choice, it should be
specified and explained. In addition, and consistent with the argument advanced in Chapter
Five, it may be prudent to consider separate risk assessments for regions within Tasmania
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that have a risk profile that differs from the remainder of the State and which are capable of
being managed to exclude the pest in question. Off‐shore islands may qualify.
Another form of scaling can be applied by considering the relative consequences of pest
occurrence at one, several or many locations in Tasmania. Whereas it may generally be
sufficient to estimate impacts of establishment across the entire potential range, this is a
finer grained approach which identifies plausible scenarios that could precede range‐wide
establishment, and which could also have significant impact. ISPM No. 11, for example,
highlights this approach as useful for estimating economic consequences, including when
combined with information about potential rates of spread.
Scenarios across which impact could be considered and compared include:
• Detection in traps, sentinel plants, hives or other animal populations maintained for
early detection purposes, but nowhere else in the State;
• Detection in a proportion of its potential range (eg. 10%, 50%,100%), or a number of
locations (one, several, many) after which the pest is eradicated;
• Detection in a proportion of its potential range, or a number of locations, after which
the pest is contained but not eradicated; and
• Detection in a proportion of its potential range, or a number of locations, and neither
eradication nor containment is attempted or achieved.
7.6.6.4 Period considerations
The need to specify the time frame over which risk analysis estimates can be expected to
remain valid was outlined in the earlier description of problem modelling and likelihood
estimation.
Clarity about time frame is equally important to impact assessment because impacts are
expressed with, and may change, over time. International standards (eg. ISPM No. 11)
appear to allow for consequence estimation over indeterminate periods, but also suggest
other timeframes should be considered.
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In comparing different pests, one study demonstrated that impacts assessed as high or low
in a ten‐year period may cross over and reverse over 20 years (Waage et al. 2004). This is
particularly relevant to some environmental pest impacts which tend to be initially slow but
accelerate over time, compared with pests of primary production, which may be more likely
to give rise to high initial costs that moderate as production systems adapt.
The dilemma of balancing investment in preventing immediate impacts with investment in
preventing impacts that may accrue to future generations is substantial. In estimating
magnitude of impact, comment on the likely course over time is useful.
7.6.6.5 Irreversible impacts
Another fundamental consideration relevant to estimating impact magnitude is reversibility.
If an impact cannot be remediated in practical terms and is likely to be significant, the
impact is assigned more weight than would otherwise be the case. Precaution is applied
commensurate with the nature and degree of uncertainty, and of impact severity.
7.6.6.6 Impact rating
After each type of direct and indirect impact criterion is identified and characterised, a
descriptive rating can be assigned to each, as adapted from Biosecurity Australia’s import
risk analysis guidelines (Department of Agriculture, Fisheries and Forestry 2001) and more
recent IRA work undertaken by BA.
• indiscernible ‐ impact is not usually distinguishable from normal day‐to‐day variation in
the criterion, or unlikely to be noticeable;
• minor significance ‐ impact is not expected to threaten economic viability, but would
lead to a minor increase in mortality/morbidity or a minor decrease in production. For
environmental or social amenity criterion, the impact is not expected to threaten
intrinsic value, though the value of the criterion would be considered ‘disturbed’.
Effects generally expected to be reversible;
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• significant ‐ impact would threaten economic viability through a moderate increase in
mortality/morbidity, or a moderate decrease in production. For environmental or
social amenity criteria, intrinsic value could be expected to be significantly diminished
or threatened. Effects may not be reversible;
• highly significant ‐ impact would threaten economic viability through a large increase
in mortality/morbidity, or a large decrease in production. For environmental or social
amenity criteria, intrinsic value could be expected to be severely or irreversibly
damaged.
The descriptive ratings may be translated into a score (A–G) using the schema in Table 9 (or
variation thereof depending on number of scales used). The result will be a list of direct and
indirect economic, environmental and social impacts of various magnitudes for each
categorised pest, along the chosen scale.
Table 9 Magnitude of local, district, regional and State consequences
G Highly significant Highly significant Highly significant Highly significant
Impa
ct score
F Highly significant Highly significant Highly significant Significant
E Highly significant Highly significant Significant Minor significance
D Highly significant Significant Minor significance Indiscernible
C Significant Minor significance Indiscernible Indiscernible
B Minor significance Indiscernible Indiscernible Indiscernible
A Indiscernible Indiscernible Indiscernible Indiscernible
Local District Regional State
7.6.7 Combination rules for consequence magnitude ratings
The series of letter codes (A – G) generated for each of the indirect and direct consequences
may be aggregated according to ‘consequence combination rules’.
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The rules are mutually exclusive, and are addressed in the order below. For example, if the
first set of conditions does not apply, the second set should be considered. If the second set
does not apply, the third set should be considered ..., and so on until one of the rules applies.
The rules are adapted from Biosecurity Australia’s import risk analysis guidelines
(Department of Agriculture, Fisheries and Forestry 2001) and its more recent IRA work.
• Where any impact is ‘G’ or more than one criterion is ‘F’ or one criterion is ‘F’ and the
rest are ‘E’, the overall consequence rating is ‘extreme’.
• Where any impact is ‘F’ or all impacts are ‘E’, the overall consequence rating is ‘high’.
• Where any impact is ‘E’ or all impacts are ‘D’, the overall consequence rating is
‘moderate’.
• Where any impact is ‘D’ or all impacts are ‘C’, the overall consequence rating is ‘low’.
• Where any impact is ‘C’ or all impacts are ‘B’, the overall consequence rating is ‘very
low’.
• Where one or more but not all impacts are ‘B’ and the rest are ‘A’, the overall
consequence rating is ‘negligible’.
Impact scores and the combination rules provide useful structures that help people involved
in the analysis systematically and consistently consider different impacts. However, it may
be appropriate, depending on the problem, to assign a consequence rating without
reference to either, provided the reasoning behind the estimate is well presented and
readily followed by stakeholders.
7.6.8 Risk estimation
Once overall likelihood of entry, establishment and spread, and overall magnitude of
consequences have been evaluated, the risk for each potential pest is estimated using the
risk ranking matrix at Table 6.
To reiterate, the estimated risk indicated by the matrix is interpreted against Tasmania’s
ALOP of ‘very low’. If the estimate for an individual pest is ‘negligible’ or ‘very low’, risk is
considered acceptable. If all categorised pests are assessed as posing acceptable risk, the
proposed import may be recommended for approval without specific regulation.
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However, a finding of acceptable risk does not preclude the application of generic or
standard quarantine measures such as inspection on arrival, remedial action if the pest is
intercepted in large numbers in/on the import, and so on. However, the nature of these
standard measures will depend on the circumstances, including the type of uncertainty
attending the risk problem and whether a generic regime of controls is already imposed
upon a similar class of imports.
For example, Biosecurity Australia recommends that ornamental red rainbow fish should be
permitted entry subject to an existing regime for imported ornamental fish comprising pre‐
entry quarantine, pre‐export veterinary certification, inspection on arrival and post‐entry
quarantine (Biosecurity Australia 2009b). BA made this recommendation despite a review
that did not identify risk above Australia’s ALOP, largely because lack of information
precluded analysis beyond the pest categorisation stage.
If the estimated risk for any pest falls into a rank above ‘very low’, the threat posed by
import is unacceptable and risk management options specific to the pest will need to be
investigated.
7.6.9 Stakeholder and expert participation
For complex or sensitive problems, stakeholders and relevant experts should be closely
involved in import risk estimation. The basic principles and techniques for expert elicitation
and consensus building described in Chapter Six should be revisited. By this stage,
participants should have sufficient grasp of the available information, understand the model
the analysis is built around, including its limitations, and be able to discuss differences of
opinion and reach conclusions in rational, respectful and constructive ways.
It is important to note that while consensus‐building is desirable, it is not always achievable.
Failure to agree a common view on risk does not indicate failure of the analysis process.
If discussion on likelihood and consequence brings forth opinions that remain divergent
throughout the analysis and gives rise to different estimates of risk, that divergence and the
different risk estimates should be faithfully recorded in the analysis. While it is unusual for a
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risk analysis to present more than one estimate of risk, it is noteworthy that the WTO
Appellate Body interprets the SPS Agreement as providing for both majority and minority
conclusions on risk, provided both derive from qualified and respected sources. The
Appellate Body has expressly stated that it does not believe a risk assessment needs to come
to a monolithic conclusion that coincides with the scientific conclusion or view implicit in the
SPS measure (World Trade Organisation 2009).
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7.7 Identify management options
7.7.1 Purpose
The purpose of this stage is to identify which SPS measure or combination of measures is
likely to reduce risk estimated as unacceptably high to Tasmania’s ALOP of ‘very low’ risk.
The key question is – What regulatory interventions are available that have a rational
relationship with the estimated risk and would reduce it to ‘very low’?
The answer will be either that there are none, in which case import prohibition will need to
be recommended, or that a measure or several measures together can be expected to
mitigate risk to a level that meets ALOP.
7.7.2 Management option principles
ISPM No. 1 articulates principles relevant to selecting the form of intervention most
appropriate to reducing a pest risk to an acceptable level. The ISPM No. 1 principles can be
applied to pests of animals and animal products, and are combined below with some
observations about risk management by New Zealand biosecurity authorities (Biosecurity
New Zealand 2006):
• SPS measures must be cost‐effective;
• SPS measures must be technically and operationally feasible (eg. facilities exist which
can meet the specified treatment standards, treatments do not injure or kill live plant
or animal imports, nor significant reduce commodity quality parameters such as
shelf‐life);
• SPS measures must relate directly to the pest risk in question and should be
sufficiently precise to avoid unintentional restriction on imports or movement
outside the scope of the risk analysis;
• SPS measures recommended by OIE and IPPC must be considered, where
appropriate;
• SPS measures must not be more trade restrictive than necessary and should be
applied to the minimum area necessary;
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• No additional SPS measures must be imposed if existing measures are adequate;
• Different SPS measures with the same effect must be accepted as alternatives. (If use
of an alternative measure is not consistent with other Tasmanian Government public
health, animal welfare or environmental protection policy, advice should be sought
from senior managers);
• If the pest under consideration is established in Tasmania but of limited distribution
or under official control, the SPS measures in relation to import must not be more
stringent than those applied within Tasmania. Likewise SPS measures should not
discriminate between export areas of the same pest status;
• Potential harm to the Tasmanian environment, public health and occupational health
and safety must be considered when SPS measures are devised (eg. Residue effects,
inspection regimes involving heights or sea diving); and
• A precautionary approach to the selection of SPS measures must be adopted with
offshore measures generally preferred to onshore measures to effect pre‐barrier
pest exclusion.
In addition to abiding by these principles, it is important that the analysis identify whether
the recommended SPS measures are provisional in nature, or not. Under SPS Agreement,
provisional measures may be imposed in situations of insufficient scientific evidence.
However, imposition of provisional measures comes with an obligation to seek further
information and undertake reviews, in a reasonable time.
7.7.3 Types of management options
There are three classes of risk management option, apart from import prohibition. The idea
for each is to investigate whether there are options for reducing risk that have a rational
relationship with pest risk in the context of the specific import risk problem. Risk
management options may be more or less suitable for different pests and for different
import risk situations.
In line with applying a precautionary, preventative approach, the first class of measures
(importation‐related intervention) is generally preferred while the second (distribution‐
related intervention) might be applied in certain circumstances. The third class
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(consequence magnitude reduction) complements other measures, and is typically less
effective on its own but may be suitable when appropriate and cost‐effective entry‐related
regulatory options are not available.
7.7.3.1 Regulation of importation pathway and vectors
The aim of regulatory intervention along the importation pathway is pest exclusion or
elimination prior to the animal, plant or product arriving at the Tasmanian quarantine
barrier.
The importation scenario should be revisited since this will indicate relevant intervention
opportunities. A variety of regulatory options is listed below but in all cases, the confidence
that can be placed in the efficacy of any measure should be checked and considered before
judgements are made about the degree to which likelihood of entry will be reduced, and
hence whether ALOP will be met. The risk analysis report should be explicit in explaining the
expected effect of the measure on the estimated risk.
Pest profiles should be revisited but it may also be useful to survey the quarantine literature
for guidance.
For instance, Follet and Neven (2006) review trends in quarantine entomology and provide a
summary of different approaches and technical factors relevant to selecting SPS measures
intended to eliminate or reduce insect pest loads in host commodities.
A single post‐harvest treatment is still the most common approach. However, there is
potential for commodity damage during treatment and a single, post‐harvest treatment may
constitute risk management overkill in certain situations. For example, use of the probit 9
quarantine standard (dose/response relationship using a statistical method that indicates
when 99.9968% kill efficacy is achieved) may not be technically justified when the infestation
rate is likely to be low (eg. product is a poor host for the pest per se or the product is mature
green).
Follet and Neven (2006) discuss an alternative post‐harvest treatment efficacy approach
which focuses on the probability that a mating pair or reproductive individual (eg. gravid
female) will survive in a shipment of the commodity. They also highlight alternatives to post‐
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harvest treatments such as establishing non‐host status, pest‐free areas and systems
approaches.
The last is receiving particular attention in Australia, and probably worldwide, with the
review and imminent removal of regulatory approvals for chemicals that have been relied
upon for quarantine purposes for some time, but which are now recognised as posing
untenable environmental and human health risks.
Systems approaches do not necessarily exclude post‐harvest treatments. Rather, these rely
on a sequence and combination of strategies that cumulatively reduce the likelihood of
viable pests being present on importation, and safeguards against failure of any individual
component. Methods include trapping and sampling, pre‐harvest treatments, specification
of resistant hosts, cultural practices, post‐harvest treatments, limiting harvest period, and
limiting host product distribution and use.
That a systems approach will be harder to manage than a single post‐harvest treatment is
obvious. While some systems approaches appear to work well as an alternative to single
post‐harvest treatments, they are typically expensive to develop. This relates mostly to
research that is likely to be required concerning the specific pest/host relationship, and how
it can be manipulated. Audit costs are likely to be significant too. Nonetheless, systems
approaches may be practically and successfully applied in some circumstances (Follet and
Neven 2006).
In addition, in the case of deliberately imported plants or animals, management guidelines
may be available that complement those provided by OIE and IPPC. For example, FAO and
the Network of Aquaculture Centres in the Asia‐Pacific have developed procedures for
responsible movement of live aquatic organisms which gives overarching guidance on
quarantine measures, health certification inter alia that enhances the application of disease‐
specific codes produced by OIE (Food and Agriculture Organisation and Network of
Aquaculture Centres in the Asia‐Pacific 2001).
Management options for reducing the likelihood that a pest will be imported include the
following. Most but not all can be certified by the relevant authority in the place of export.
For plants or plant products:
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• Area freedom consistent with IPSM 4;
• Pest‐free place of production, consistent with IPSM 10. Note that not all pests have
characteristics that are compatible with establishing pest‐free places of production or
pest‐free production sites. IPSM 10 should be consulted for a list of pest criteria
relevant to determining whether pest‐free places of production are likely to be
achievable ;
• Post‐harvest treatment (eg. chemical, physical, penetrating or surface dis‐
infestation);
• Import restricted to pest or vector‐free period at source;
• Import restricted to pest‐resistant varieties where these have been adequately
demonstrated;
• Import type or condition restricted (eg. climacteric (mature, green) fruit only,
dormant trees not in bud);
• Pre‐harvest treatment under supervision;
• Pre‐import inspection by qualified person according to credible sampling and testing
protocols (eg. pre‐harvest crop inspections, tube stock inspections to specified
inspection plan);
• Maximum allowable consignment volume specified;
• Systems approach including a combination of the above;
• Secure chain of quarantine to Tasmanian barrier required in addition to any one or
more of the above (eg. Post‐treatment packaging in sealed or insect proof containers,
no unpack/repack in transit to Tasmania unless under specified conditions); and
• On‐arrival quarantine at approved facility, which may include a treatment facility.
For animals or animal products:
• Area or property freedom;
• Inspection, treatment and quarantine regime;
• Restriction on breed, age, sex, reproductive ability;
• Restriction on condition (shorn, clipped, vaccinated);
• Empty‐out period specified;
• Maximum allowable consignment volume specified;
• Systems approach including a combination of the above specified;
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• Secure chain of quarantine to Tasmanian barrier required in addition to any one or
more of the above (eg. Post‐treatment packaging in sealed containers, no
unpack/repack in transit to Tasmania unless under specified conditions, isolation
from other individuals); and
• On‐arrival quarantine at approved facility.
Veterinary advice must be sought on animal welfare implications of any proposed
zoosanitary measure (eg. waiting times for physical inspection and the suitability of holding
facilities). In some cases, phytosanitary measures may also have direct animal welfare
impacts (eg. restrictions on bedding and feed of animals in transit) which will require
attention.
For conveyances and associated items:
• hygiene to specified standard (eg. clean container inspection, vehicles and machinery
pressure cleaned, boats dry docked and hulls de‐fouled, gear disinfected); and
• bedding and feed restrictions for animals in transit (eg. rubber mats as alternatives to
straw, surplus feed to be disposed of to quarantine waste stream, on arrival).
7.7.3.2 Distribution
Post‐barrier intervention along the distribution pathway may be appropriate and cost‐
effective in some circumstances for reducing the likelihood that a pest will be placed in the
vicinity of a host or suitable environment in Tasmania.
Management of import distribution may entail some level of supervision by Quarantine
Tasmania staff and should be discussed with quarantine managers to confirm practicality
and resource availability. For example, some consignments may need to be followed to an
approved premise to check load security, or the integrity of packages containing soil or other
diagnostic samples may need to be confirmed at the barrier prior to forwarding to a
laboratory. The distribution scenario should be revisited since this will indicate opportunities
for management intervention.
Management options which target the distribution pathway include:
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• Post‐barrier transport restricted to approved carriers, or types of conveyance (eg.
sealed containers, certain types of tarpaulin);
• Import distribution restricted to approved premises based on ability to manage risk
(eg. potatoes to approved processing facility, specimens to research and diagnostic
organisations with accredited laboratories, post‐barrier fumigation facility);
• Import use restricted (eg. product intended for consumption to be labelled as such
and not to be used as bait, for planting etc);
• Disposal of import by‐product or waste restricted (eg. autoclaving, incineration, deep
burial etc); and
• A systems approach incorporating several of the above.
7.7.3.3 Mitigating magnitude of consequence
There may be scope to reduce risk by undertaking in Tasmania measures that minimise
potential magnitude of consequences. Some are mandatory in nature and others are not.
The latter may complement regulatory measures but effectiveness clearly depends on
factors beyond the control of government, and highlights the importance of shared
responsibility for biosecurity.
Several of these measures are closely connected to Tasmania’s Biosecurity Emergency
Preparedness Program (BEPP) because they involve surveillance and aim to reduce
eradication and control costs through early detection and response. If a pest incursion
response is mounted, certain measures that are normally non‐mandatory may become
mandatory for the period of the response.
Management options for reducing potential impacts of pests in Tasmania include:
• Mandatory reporting requirements for prohibited pests;
• Mandatory pest control programs or management plans, including surveillance and
monitoring, containment of pests with limited distribution;
• Declaration of quarantine protected areas in which certain activities are prohibited or
into which certain types of movement are prohibited, or by permit only (eg. TWWHA,
other parks and nature reserves, off‐shore islands, marine reserves);
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• Voluntary industry biosecurity programs, surveillance programs, containment
programs for pests with limited distribution, hygiene codes of practice and other
awareness raising;
• Natural area surveillance, voluntary hygiene codes of practice for recreational and
other users, and other awareness raising;
• Public awareness (signage, media, etc.) regarding hygiene in natural areas, reporting
of new pests in home gardens and other domestic situations; and
• Targeted research.
7.7.4 Costs and benefits of regulatory intervention
7.7.4.1 Rationale for regulation
The overarching economic rationale for governments to impose quarantine controls is
sometimes lost in SPS‐fixated dialogue about limiting regulatory intervention in the name of
free trade (Binder 2002, Tanner 2003).
Basically, although economic theory predicts that competitive markets will effectively
manage risks in the absence of government involvement, there are plenty of instances when
markets fail to do this, and which result in socially undesirable outcomes. These are called
‘externalities’ or ‘un‐priced impacts’. Pests in trade are one situation in which less than
robust voluntary risk management can be expected because the ‘price signals’ that would
lead markets to do otherwise, are typically faint. In the case of trade in plants and animals
that may be invasive species in the receiving jurisdiction, the price signals favouring risk
management can be negligible against signals for profiting from novelty value.
Price signals for good voluntary risk management are generally weak because the costs of
incursions are primarily borne by people other than importers, such as local producers,
landowners, consumers and the general public.
Since it is often difficult to determine how an incursion occurred, people who bear the costs
are unable to recover them from those who introduced the pest. In addition, costs are
dissipated and distributed such that it is hard for individual consumers to tell they are paying
for a pest and accepting a liability not of their own making. There is little economic incentive
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for importers to manage risks to avoid future compensation claims or other forms of redress
because the chance these will occur is small.
This does not apply to all importers. Some will be highly motivated to manage pest risks well.
However, as an economic explanation for why government intervention is justifiable, the
above is generally valid. Nonetheless, in making decisions about specific import risk
problems, the general rationale is not enough. Some kind of appraisal of costs and benefits
to determine whether a particular regulation is welfare‐enhancing or not seems reasonable,
because most measures are associated with costs to society in general.
This is particularly so because quarantine protection in Australia at least, is vulnerable to
regulatory capture. In an export‐oriented economy, domestic producer groups have
considerable incentive and have become skilled in successfully lobbying governments for
strict import regulation (Tanner 2003).
For SPS measures, the principle costs and benefits to which monetary values can generally
be assigned are listed in Table 10. The listed costs are a subset of the broader range of
potential economic impacts identified in the previous section of this chapter.
7.7.4.2 Cost Benefit Analysis
Cost benefit analysis (CBA) involves assigning values to each cost and benefit variable for the
import problem at hand, determining net benefits (or net cost) to the community from
implementing the proposed regulatory measure, ranking the benefit (or cost) against that of
alternative actions (eg. a different kind of measure, no measures), and then selecting the
option with the highest net benefit (or lowest cost). CBA seeks to identify the welfare‐
maximising option.
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Table 10 Main economic costs and benefits relevant to quarantine regulation (adapted from Binder 2002 and Tanner 2003)
COSTS BENEFITS
CATEGORY 1 COSTS (PEST) Production losses Costs of control or eradication Decline in export revenue due to lost premiums, market closure environment Economy‐wide costs
CATEGORY 1 BENEFITS (GOODS) Availability of wider range of goods Availability of cheaper goods
CATEGORY 2 COSTS (REGULATORY) Costs of compliance with the regulation Costs of administering the regulation Costs of monitoring regulation effectiveness
CATEGORY 2 BENEFITS (REGULATORY) Improved trade relations and fewer trade disputes
CATEGORY 3 COSTS (COMPETITION) Losses to producers from increased competition
CATEGORY 3 BENEFITS (COMPETITION) Economy‐wide impact of increased specialisation and allocation of resources to the most profitable use
It is incumbent upon governments to identify, assess and review the full scope of costs and
benefits of any proposed regulations, and there is established practice for doing this. The
Tasmanian Government’s Legislative Review Program aims to facilitate compliance with
national competition policy and to further the objectives of its own regulatory reform
agenda, including that regulations must provide for the best alternative with the greatest
net benefit (Department of Treasury and Finance 2006).
A number of studies affirm that application of CBA to quarantine regulation can produce
substantially different outcomes compared with import risk analysis based largely on science
and in which more detailed economic evaluation is typically eschewed (Binder 2002 and
Tanner 2003).
For example, a CBA conducted in the late 1990s indicated Australia in general would be
$Aus100 million per annum better off from allowing imported bananas, even if the domestic
banana industry folded as a result.
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Conversely, Cook (2008) used cost benefit analysis to estimate net economic welfare impacts
to Western Australia of a decision by the Australian Government to allow the importation of
Chilean table grapes. He found consumer benefits are unlikely to outweigh the cost of
expected pest damage. In this case, the relation was indirect, with pest impacts anticipated
from table grapes grown in eastern Australia as producers there push for market access to
Western Australia as a result of competition from Chilean product.
Given potential for disparate outcomes, Binder (2002) explored scope for incorporating a
broader economic perspective into import risk analysis using cost benefit analysis. She
concluded that while there are potential community welfare gains and conceptual merit,
several issues make CBA problematic in the absence of testing in the WTO. These include
practical and technical limits imposed by data availability as well as legal and policy
constraints. Legal issues relate to potential non‐compliance with the SPS Agreement and
include:
• CBA could lead to divergent results for products from two countries with similar pest
status if supply and demand conditions in the importing country are different, thus
leading to a breach of Article 2.3 which prohibits discrimination where similar
conditions prevail;
• CBA generates different appropriate levels of protection in different situations which
could be interpreted as distinctions in the level of acceptable risk, and therefore in
breach of the consistency requirement in Article 5.5;
• Article 5.3 specifies inclusion of production losses and control costs in risk
assessment, but is silent about net benefits to consumers (eg. trade benefits minus
losses to producers) of potentially lower prices. This is typically, given the intent of
the SPS Agreement, interpreted as meaning inclusion of consumer benefits would
constitute a breach of Article 5.3.
The policy issue identified by Binder (2002) relates to potential for CBA, by accident or
design, to be used as another form of protectionism. This would defeat the purpose of the
SPS Agreement.
Hence, this framework recommends that those costs that are not Category 1 or Category 2
costs as per Table 10, and any form of benefit, should not be assessed or incorporated into
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the import risk analysis report. Category 1 Costs are the consequences that would have been
estimated earlier in the analysis. Category 2 Costs are relevant to determining appropriate
SPS measures to mitigate potential impacts on the basis of cost‐effectiveness.
7.7.4.3 Cost‐Effectiveness Analysis
Article 5.3 permits cost‐effectiveness to be taken into consideration when alternative
measures for limiting risks are evident. This presents some scope for taking better account of
economic factors.
Cost‐effectiveness analysis involves comparing the costs of different measures aimed at
achieving the same objective (eg. pest exclusion). The least expensive measure is the
preferred one. It is a more limited approach than CBA but is nonetheless welfare‐relevant
and consistent with SPS rules.
In terms of costs listed in Table 10, cost‐effectiveness analysis is applicable to Category 2
Costs – costs of compliance with a regulation and costs to the public purse of administering
the regulation at the barrier. In an adaptive risk management model, costs of post‐barrier
and other surveillance work which provides essential feedback on the need for and
effectiveness of regulation might also be included in cost‐effectiveness calculations.
One issue with the use of cost‐effectiveness analysis is that policy preferences for offshore
risk mitigation may be challenged in the event onshore options producing equivalent
reduction in risk are cheaper.
Apart from that, and although it does not address community welfare thoroughly, an
evaluation of the cost‐effectiveness of measures identified as potentially reducing risk to
acceptable levels will bring greater transparency to the choice that is ultimately made.
This is important to accountable use of public funds, and for communicating to prospective
importers or other direct beneficiaries the basis of the quarantine costs they will need to
either absorb or pass on to consumers.
7.7.4.4 In the future
Binder (2002) and Cook (2008) observe that Article 5.3 does not explicitly preclude
consideration of net consumer welfare, and that until this is tested through WTO dispute
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resolution processes, there is some doubt about whether use of CBA in determining import
regulation would actually contravene the SPS Agreement, notwithstanding that this might be
generally inferred.
Cook and Fraser (2008) consider this problem in detail, given the importance of a regulator’s
responsibility to impose laws that benefit society as a whole, and without favour. They have
developed an economic analysis model which takes into account consumer and producer
welfare, and which they argue has potential to inform import regulation with more socially
desirable outcomes, and that also complies with the SPS Agreement. The analysis identifies
the particular importance of costs associated with imposing quarantine measures and the
differential risk of an outbreak associated with restricted trade, compared with no trade.
It is noteworthy that in an otherwise relatively detailed guide to WTO jurisprudence in
relation to the SPS Agreement (World Trade Organisation 2009) the section on Article 5.3 is
very brief.
7.7.5 Stakeholder and expert participation
Tasmanian Government quarantine managers should be consulted to ensure proposed
measures are feasible from an operational and technical perspective. The basic guidance on
expert elicitation and stakeholder consensus building described in Chapter Six should
continue to be applied.
The identification of management options also represents the point at which the tangible
outcomes of the import risk analysis become apparent. Burgman (2005) notes it is common
for people to revise their estimates of parameters once they have seen the consequences of
their beliefs.
Therefore, this part of the analysis can also be used as an opportunity for participants to
check the anticipated effectiveness and acceptability of management recommendations, and
revisit the underpinning logic if necessary. Comments about divergent views on risk among
stakeholders made in the previous section also apply.
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7.8 Test sensitivity and finalise the analysis
7.8.1 Purpose
When the regulatory and other options for reducing import risk to ALOP are selected, the
next action is to validate those choices.
This part of the analysis seeks to answer the question ‐ How wrong does the analysis need to
be before the import risk management recommendations must be changed?
The sensitivity of risk estimates generated by quantitative analyses or qualitative approaches
involving Bayesian probabilities to changes in assumptions or model parameters is amenable
to statistical analysis. If the estimates vary significantly with small changes in the
assumptions (ie. one only needs to be a little bit wrong for a different management choice to
be preferable), the analysis may have to be refined and a cautious approach to decision‐
making is justified. If the estimates stay much the same (ie. one needs to be very wrong),
they can be considered robust, and the decision indicated can be taken with relative
confidence.
The qualitative approach to import risk assessment recommended here does not lend itself
to statistical sensitivity analysis. Nonetheless, the peer review process can be used to
determine the standard of reasoning embodied in the analysis. This is a broader approach to
sensitivity testing but can identify flaws in an analysis and moderate the influence of
subjective bias. In this way, peer review can help ensure the set of management
recommendations that is most acceptable and effective under the circumstances can be
forwarded to the person charged with making the decision.
Peer review is also necessary in the event analysis of an important or sensitive import risk
problem finds no unacceptable risk, to evaluate the conclusion that specific regulation or
other management is not warranted.
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7.8.2 Peer review conduct
Peer review for an import risk analysis involves gathering the views of people who have so
far not participated but who have sufficient expertise to make a credible appraisal.
Peer review establishes the standard of reasoning of the analysis and whether logical,
defensible arguments have been made, given the available evidence. Peer review is not an
exercise in confirmation. Guidance presented in Chapter Six for eliciting expert opinion is
relevant to peer review.
When the analysis is to be offered as a document for public comment, it may be useful to
seek the assistance of someone who has no special knowledge of pests but who has good
written communication and logic skills.
Peer review should be conducted with a level of effort appropriate to the needs of the
import risk analysis. It is rarely adequate to provide the import risk analysis report and
simply ask for comment. Some basic planning is required to safeguard against getting
feedback that is not useful, wasting everyone’s time and making it harder to access good
reviewers next time around. General and problem‐specific approaches are possible and each
has merit.
A general approach involves providing the reviewer with broad terms of reference, without
highlighting deliberately or inadvertently, particular matters of concern to the analyst or
other participants. This allows the reviewer to formulate his or her opinion free of influence
of the subjective preferences of those involved in the analysis. A template for questions that
might be asked in a general approach to import risk analysis peer review is at Appendix 4.
Problem‐specific approaches involve posing questions about issues for which the analyst and
other participants in the analysis consider further opinion is required. The questions may be
in regard to the risk model (eg. is it reasonable to exclude pathway X on the basis of Y?), or a
specific estimate (eg. likelihood of spread is estimated at ‘very low’ because vector X is
absent. Are there other vectors?). It is important to pose specific questions in a neutral way
that does not play to potential preferences of reviewers.
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7.8.3 Finalisation of risk analysis report
Once feedback from reviewers has been submitted, it must be dealt with transparently, or
else a reason provided for why this was not done. For instance, there may be little benefit in
airing certain internal feedback, or external reviewers may request anonymity. Where such
considerations are not important, comments should be recorded, along with the response of
those conducting the analysis, and any modifications that were made to the risk estimates,
regulatory or other management recommendations, as a result.
At this point the analysis report can be finalised. The need for clarity, strict relevance and
conciseness is paramount throughout but especially in the articulation of recommendations.
Recommendations must be identified as such. They should describe the specific regulatory
and non‐regulatory actions that the decision‐maker is asked to consider, and be
accompanied by a brief statement of the essential findings of the import risk analysis that
provides the rationale for the proposed action (or inaction).
If new conditions and restrictions are proposed, it may be appropriate to draft them in a
form relevant to the legislation and legal instrument that may be used to make them.
Existing instruments (eg. a special authority under the Animal Health Act 1995, Section 68
notice under the Plant Quarantine Act 1997, a permit under the National Parks and Reserves
Management Act 2002) should be consulted. If an amendment or exemption to an existing
import regulation is recommended, the existing regulation and the proposed amended
version should be presented in full. The same applies to existing regulations for which
revocation is recommended.
Recommendations should be made in the context of the time frame covered by the analysis.
They should include an explicit review schedule and describe the stakeholder
communication, monitoring, research and other updating activities that need to occur
between implementation and the next scheduled review. A phase‐in period for measures
may need to be specified. It may be useful to identify events that would trigger an
immediate change to the recommended management measures, irrespective of scheduled
review.
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7.9 Decide
7.9.1 Purpose
At this stage an authorised person makes a decision. This is a seemingly straightforward
undertaking if an import risk analysis report reflects careful and rigorous process and
reasoning. However, decision‐making, even if the analysis is technically and logically sound,
is not always straightforward.
7.9.2 Other considerations in import risk regulation
On occasion, decisions may reflect factors in addition to those revealed by the import risk
analysis. In particular, the regulatory option recommended in an analysis, even if it is shown
to be the most cost‐effective, may be amended or not supported because to do so would
invite unacceptable resource consequences.
The sum of agency business priorities should not be pre‐empted in an import risk analysis,
nor should attempts be made to obtain a forward commitment about what is affordable,
and work this into the ranking of management options. The danger is that the assessment of
management options will be clouded by factors unrelated to risk or relative cost‐
effectiveness.
Expectations for decisions following on from an import risk analysis should be made clear to
all working group participants. That is, their job is to conceive, assess and make
recommendations about the import risk problem. If an import risk analysis is done well, and
the uncertainties are such that robust recommendations can be made, these are likely to be
implemented.
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7.10 Monitor and update
7.10.1 Purpose
This stage completes the import risk analysis planning cycle and initiates the next iteration.
Its purpose is to answer the question ‐ Is the level of biosecurity protection anticipated in the
SPS measures being achieved, are the measures still needed, and what would it take for
either to change?
In other words, the import risk system that was conceived through preceding parts of the
analysis is checked for its response to the management measures that were implemented,
and for changes that would either substantially reduce the ability of management actions to
mitigate risk to acceptable levels, or substantially alter the need for risk mitigation. Similar
checks are also required if a decision not to regulate was made.
This is consistent with a principle articulated in ISPM No. 1 (Principles of plant quarantine as
related to international trade) which applies equally to animal and animal product imports. It
is:
As conditions change, and as new facts become available, phytosanitary measures shall be
modified promptly, either by inclusion of prohibitions, restrictions or requirements necessary
for their success, or by removal of those found to be unnecessary.
The concepts of monitoring and adjusting are not new but these activities are prone to being
treated as secondary to the objective of making a decision and implementing it, and may be
forgotten, or ad hoc and reactive.
By positioning monitoring and updating as a distinct and last step in the planning cycle,
import risk management is more likely to be genuinely adaptive and therefore better
equipped to cope with and anticipate the system change inherent to biosecurity. Giving
adaptive risk management greater prominence and practical expression is increasingly
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recognised as integral to meeting contemporary challenges to biosecurity (eg. Cook et al.
2008).
7.10.2 Types of Monitoring
In practice, monitoring and updating strategies are mapped out as import risk management
options are finalised, and undertaken alongside other measures.
Type I and Type II errors (false positives and false negatives respectively) are typically the
focus of monitoring and updating strategies. An example of a Type I error is a prediction that
a pest will cause significant harm when it does not, leading to unwarranted expenditure on
regulation. A Type II error would occur when a pest was judged not to pose unacceptable
risk, but goes on to cause significant damage.
For the qualitative risk analysis approach outlined here, the statistical methods for detecting
Type I and Type II errors are largely ruled out. If part of the qualitative analysis includes
monitoring components that are amenable to statistical analysis, Burgman (2005) should be
consulted for an overview of options.
Otherwise, monitoring options include:
• Mainland premise and system compliance audits;
• Random, on‐arrival visual inspection by quarantine staff according to accepted
protocols (eg. 1 in 600 unit inspection for fruit);
• Random, on‐arrival animal inspections by veterinarians;
• Random on‐arrival validation sampling by quarantine staff and testing by relevant
diagnosticians (eg. feed grain samples searched for weed seeds by seed analysts);
• Glass house or infield crop inspections by entomologist, pathologists or virologists;
• Trapping and other surveillance activities by quarantine staff and relevant
diagnosticians;
• Literature scanning by risk analysts;
• Analyst membership of relevant pest internet List‐servers and alert services; and
• Biosecurity practitioner network interrogation, including stakeholder networks.
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Monitoring results need to be interpreted correctly. Results may indicate different things
including compliance failure, a flaw in the risk analysis (eg. an assumption is wrong), or a
change in an import system parameter (eg. expected volume of import has substantially
increased, a new vector has entered the risk scenario, etc.), each of which will require a
different adaptive response.
For instance, a compliance failure may warrant more intensive communication with the
exporter, a regime of targeted validation sampling and testing to restore confidence in the
quality system, an infringement notice or prosecution.
If a pest assumed to be absent or not widely distributed in Tasmania is found in multiple
locations and individuals show an age‐structure suggesting population establishment over
several years, the import risk analysis will need to be revised. SPS measures will probably
need to be revoked.
If a new vector or pathway is identified, stricter measures may need to be imposed. As noted
earlier, post‐barrier pest detection may not necessarily indicate increased risk. The import
risk analysis should be revisited, and a response tailored on a problem specific‐basis.
It is also critical to establish and maintain systems (survey and interception data handling
protocols, templates, etc.) for adequately recording monitoring results. If existing systems
do not accommodate the capture of monitoring data relevant to the import risk question,
the risk analysis report will need to suggest alternatives.
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Chapter Eight Import risk analysis
administration • All we have to do is get the numbers right
• All we have to do is tell them the numbers
• All we have to do is explain what we mean by the numbers
• All we have to do is show them they have accepted similar risks in the past
• All we have to do is show them that it’s a good deal for them
• All we have to do is treat them nice
• All we have to do is make them partners
• All of the above
Developmental stages in risk management, Fischhoff 1995
8.1 Concepts for import risk governance
8.1.1 Risk governance trends
Governance is defined by the European Commission as the rules, processes and behaviour
that affect the way powers are exercised..., particularly as regards openness, participation,
accountability, effectiveness and coherence (De Marchi 2003).
This 2001 definition reflects movement in the broader sphere of democratic governance,
and particularly in areas of environmental and human health protection, away from
characterising the relation between science and community concerns about how risk is
regulated as one of ‘knowledge deficit’. In this traditional model, the path to better risk
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regulation administration lies in educating the public about science so that concerns are
moderated and decisions made by regulators on behalf of everyone else become less
contested. Attempts to remedy the knowledge deficit typically occur in the management
stage of risk analysis, shortly before a decision is taken and then as part of ongoing
explanation of why a particular course was chosen.
Many brochures and fact sheets later, it is now generally acknowledged that this approach
does not always work, and that managing the science/policy interface effectively in
situations of risk and uncertainty requires more than one‐way information dissemination at
the end of a technical assessment. The risk perception paradigm presented in Chapter Six
explains why this is so. Society in general makes calculations of risk that are broader than
those allowed for in a purely technical risk analysis. Science may not be the important issue
for many stakeholders.
Risk governance is an evolving, highly debated area and because the knowledge deficit
approach is known to be limited, the biggest debates occur around how to manage public
participation. There appear to be no best tried and tested models. Allowing for greater
public participation can be complicated, expensive, time consuming, requires a particular
skill set, and is situation dependent.
Furthermore, public participation does not automatically justify itself. Comprehensive public
participation is not warranted in all risk management situations, and in some may lead to
unnecessary decision‐making delays and other costs that hinder the attainment of outcomes
that support the public good. The objective of any attempt to seek public input must be clear
to all concerned if the outputs are to have practical use in decisions about risk regulation.
While education and awareness‐raising are critical to sharing the state of knowledge about
risk issues among people with an interest in them, the search is on for approaches that are
less concerned with telling people why and how something will be done and more
concerned with cross‐fertilisation of ideas and experiences about risk to achieve better ways
of cooperatively reducing it. The prompts for stakeholder inclusion in the components of the
analysis planning model described in Chapter Seven, and the administrative structures and
processes outlined below are part of that search.
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8.1.1 Risk communication
Fischhoff used the schema presented at the start of this chapter to describe risk
communication lessons over twenty years, with a view to helping newcomers to risk analysis
avoid the same mistakes and make better use of what has been learned. He envisioned good
risk communication as a type of insurance against more serious damage.
Applied to import risk analysis, Fischhoff’s schema speaks to the importance of finding
relevant and credible data about pest hazards, of being able to explain the data and its
limits, of being explicit about the distribution of costs and benefits, and of engaging with
people affected by import risk regulation in respectful, cooperative ways. It combines the
ideas of sound, evidence‐based reasoning and democratic participation and hence embodies
the concept of ‘risk governance’ consistent with the trend described above (De Marchi
2003).
The schema positions communication at the core of import risk management. Furthermore,
because it is essentially about creating efficient feedback loops across the community, and
engendering collective responsibility, it resonates with emergent notions of adaptive
biosecurity (eg. Cook et al. 2008) encouraged in this framework which cast risk governance
as a process of ongoing adjustment, rather than one focussed on reaching a final position.
While emphasised in the two preceding chapters, effective risk communication is also clearly
central to the administration of import risk analysis. Good communication within and across
government agencies, and between agencies and non‐government stakeholders is the
vehicle through which import risk regulation that is transparent, efficient, ethical, cohesive
and accountable is achieved.
The rest of this Chapter describes administrative structures and processes used in the
Tasmanian Government for import risk regulation in which the concepts of good risk
governance and communication are embedded.
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8.2 Regulatory authority and import risk analysis structures
8.2.1 Agency import risk regulation responsibilities
Regulatory responsibilities for managing import risks lie across several divisions and entities
of the Department of Primary Industries, Parks, Water and Environment (DPIPWE).
The Biosecurity and Product Integrity Division (BPID) is responsible for a large share of
Tasmanian import policy because the statutory positions or delegations for administering
the principal animal and plant health legislation are located in BPID business units.
The Chief Veterinary Officer has statutory carriage for imported animal and animal product
related matters under the Animal Health Act 1995 and may impose conditions and
restrictions accordingly. The CVO is supported by Animal Health and Welfare, and
Quarantine Services Branches.
The position of Chief Plant Health Manager is located in Biosecurity and Plant Health Branch
however it is not a statutory appointment. Authority to regulate plants and plant product
imports under the Plant Quarantine Act 1997 is delegated from the Secretary, DPIPWE, to
the General Manager, BPID and senior Biosecurity and Plant Health Branch officers.
Biosecurity and Plant Health, and Quarantine Services Branches coordinate import risk
analyses for plants and plant products.
Officials within the Resource Management and Conservation Division (RMCD) also have
delegated authority to limit importation activities which may undermine the Tasmanian
Government’s environmental protection objectives. The impending prescription of a range
of invertebrates as ‘controlled animals’ in new regulations under the Nature Conservation
Act 2002 is one example.
The Director of the Inland Fisheries Service is authorised to regulate the importation of live
freshwater fish and other pest threats to Tasmanian freshwater environments under the
Inland Fisheries Act 1995. The importation of trout is also tightly regulated to limit
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uncontrolled distribution and potential for disease incursions that may affect Tasmania’s
fisheries and salmonid industries.
BPID and Water and Marine Resources Division (WMRD) staff with marine pest expertise
provide risk advice for development application assessments under the Crown Lands Act
1976 and the Environmental Management and Pollution Control Act I994. WMRD staff also
provide risk advice to the Minister for Primary Industries and Water who may issue
directions under the Living Marine Resources Management Act 1995 to prevent the
introduction or re‐introduction to State waters of any harmful pest or disease. Harmful pests
or diseases are those known or reasonably suspected of threatening any fish, fishery or
other part of the marine environment.
The Director of Tasmania’s Parks and Wildlife Service may impose import controls in respect
of land that is reserved land under the Tasmanian National Parks and Reserves Management
Act 2002. This is typically achieved through prohibiting or restricting access, or requiring
biosecurity measures, consistent with any statutory management plan that has been
developed for a particular area. Many of Tasmania’s offshore islands and geographically
remote areas are reserved under this legislation.
Responsibility for implementing import policy developed across the Tasmanian Government
generally rests with the Quarantine Services Branch in BPID. However, quarantine staff may
be assisted by officers authorised under other Tasmanian legislation in the discharge of
barrier and post‐barrier duties and in certain cases play a secondary role themselves. For
example, principal responsibility for implementing import and movement controls under the
National Parks and Reserves Management Act 2002 lies with the Parks and Wildlife Service,
assisted by RMC’s Wildlife Management Branch.
8.2.2 Import risk analysis structures
Tasmanian Government officials with authority to regulate importation for pest and disease
prevention rely on advice generated by a variety of administrative structures. Many of these
involve the formation of working groups. As highlighted in Chapter Six, working groups are a
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means of capturing the range of scientific, technical, economic, operational and policy
expertise relevant to import risk analysis that a single person cannot be expected to possess.
Working groups also foster broader ownership of biosecurity problem‐solving and
cooperative relations between Government and stakeholders, and at intra‐agency and inter‐
agency levels. Principal types of working group that undertake import risk analysis work in
the DPIPWE or to which DPIPWE staff contribute risk advice are:
Biosecurity Technical Group Working Groups
Biosecurity Technical Group (BTG) working groups generally investigate import risk
situations that are difficult or sensitive, and may apply to animal or plant health or nature
conservation issues. These working groups are convened at the direction of the BTG Chair
and may include people other than Government employees with specialist skills or
knowledge, including relevant industry representatives with access to specialist knowledge.
BTG Working Groups are chaired by the Manager, Biosecurity and Plant Health Branch, the
Chief Veterinary Officer or delegate to either.
The import risk analysis report produced by a BTG working group is presented to BTG for
consideration. On receipt of advice from BTG informed by the working group’s report, the
Secretary, DPIPWE makes a policy decision.
BTG working groups may also be formed which address less sensitive or critical issues that
do not require the Secretary’s consideration. In these cases, the working group’s findings
inform a policy decision by the relevant authorised officer.
Animal Health Review Panels The Chief Veterinary Officer convenes internal panels to
review General Authorities that prescribe conditions for importing animals or animal
products. The review panels are comprised largely of DPIPWE field veterinary staff and there
is liaison with Quarantine Services Branch.
The CVO generally refers novel animal or animal product importation requests to agency
staff with relevant expertise for discussion, prior to taking a decision.
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Staff within Animal Health and Welfare Branch may also conduct reviews of biosecurity
arrangements for animals including in relation to importation issues, from time to time.
Assistance from industry or non‐Government specialists is generally via external consultation
rather than working group membership, though the latter will be invited, if required.
Biosecurity and Plant Health Branch (BPHB) Working Groups
BPHB Working Groups are convened and chaired by the Manager, BPHB or delegate. These
groups undertake review work or new investigations, mostly in relation to plant health
issues. BPHB working groups typically include members from Quarantine Services Branch.
Assistance from industry or non‐Government specialists is generally via external consultation
rather than working group membership, though the latter will be invited, if required.
BPHB working group import risk analyses underpin advice to the Manager, BPHB or the
General Manager, BPID, both of whom have authority to make plant health related policy
decisions and regulations.
Controlled Animal Assessment Panel A cross‐divisional panel assesses applications to
import animals that are ‘controlled animals’ under Tasmania’s Nature Conservation Act
2002. Controlled animals are mammals, birds, amphibians, reptiles and any other animal
prescribed as a controlled animal in the subordinate legislation.
The panel provides advice to the General Managers of Resource Management and
Conservation, and Biosecurity and Product Integrity Divisions in relation to the issue of
permits to import controlled animals. It comprises members of the Wildlife Management
and Biodiversity Conservation Branches of Resource Management and Conservation Division
and the Office of the Chief Veterinary Officer. The panel co‐opts specialist expertise as
required.
Marine Pest Import Risk Advice Marine Farming Branch staff in the Water and Marine
Resources Division (WMRD) prepare advice on marine pest risks for panels that assess
development applications with a marine component.
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Many development applications that involve movement of sea vessels, occur on crown land.
The Crown Land Services Technical Advisory Group within DPIPWE’s Land and Information
Services Division considers these applications, and also seeks input from the Public Benefits
Advisory Committee.
Development applications that concern Level 2 activities under Tasmanian environmental
protection law are assessed by the Environment Division of the DPIPWE on behalf of the
Tasmanian Environmental Protection Authority. The Director of the Environment Division is
authorised to approve or reject applications to undertake Level 2 activities.
Marine pest and other risks are addressed in conditions incorporated into Marine Pest
Management Plans (MPMPs) that are subject to approval by the Director of the Environment
Division. External consultants may be appointed to prepare and coordinate consultation
arrangements for MPMPs. Marine aquarium imports proposals are dealt with under special
authority under inland fisheries legislation. WMRD staff also deal with imports (and exports)
of fish species that are either marine pests or where there is a risk of marine pest transfer.
Freshwater pest fish assessments Inland Fisheries Service staff conduct risk analyses in
response to applications to import freshwater fish into Tasmania, generally for aquarium or
other pet‐related use. Staff refer to materials (eg. species lists) and methods developed
under the national ornamental fish management strategy, adapting these to the Tasmanian
context, and consult with industry as required.
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8.3 Administrative processes
Due to the spread and variety of import risk regulation responsibilities and structures across
the Tasmanian Government, a single administrative process is not practical. However,
elements likely to be important to any specific administrative process are outlined below.
8.3.1 Prioritisation of import risk analysis work
The priority of import risk analysis work is generally determined according to how it was
initiated and which business units are undertaking it. In the case of the Biosecurity and Plant
Health Branch for example, import regulation review work is scheduled and prioritised in
annual branch business planning. The Secretary may determine the priority of BTG working
group activities, as issues or emergencies arise. Business units that undertake import risk
analysis for applications to import will be expected to prioritise in a way that meets agency
customer service policy requirements for timely response.
As emphasised in Chapter Seven, the priority of import risk work should be established early
because it is critically related to estimating the level of public resource likely to be required
for the analysis, and for communicating that investment transparently. In addition, the
approach to deciding priorities must be responsive to shifting circumstances. The priority of
an import risk analysis may need to be monitored and revised as it is being conducted.
8.3.2 Project planning
Project planning consistent with the latest version of the Tasmanian Government Project
Management Guidelines available at http://www.projectmanagement.tas.gov.au is
recommended for all import risk analysis work. Planning templates should be adopted and
other resources at that site are also useful. Planning of import risk analyses that inform
emergency responses should occur consistent with DPIPWE’s Biosecurity Emergency
Planning Program protocols.
The planning effort is determined by the priority of the import risk analysis. In practice,
prioritisation and early planning activities (eg. project sizing, scoping) occur together.
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For example, BTG working group import risk analyses generally require comprehensive
project planning, and include at least, a project brief, stakeholder and issues registers,
communications plan, and project closure report.
Oversight arrangements should also be clear. In general, the BTG Chair endorses the project
brief and communications plan before work commences, and is responsible for seeking
consensus from BTG on recommendations flowing from a working group import risk analysis
report. The BTG Chair also oversees subsequent advice to the Secretary, DPIPWE, and
approves Briefing Notes or Minutes to the Minister for Primary Industries and Water.
BPHB and other working group import risk analyses require project planning, but this will
depend on the scope and complexity of the work. In some cases, comprehensive project
planning will be necessary, but in others, a project plan and a brief closure report will suffice.
The requirement for clear project documentation is not eliminated in the case of simpler
work.
8.3.3 Public participation
Wider consultation outside working group arrangements should be undertaken according to
need and determined as part of project planning.
For example, it may be appropriate to release a discussion paper for a particularly difficult
import risk problem, including formal terms of reference for submissions.
There may be efficiencies in convening meetings for stakeholder groups that are diverse and
large, or for which there is no identifiable or adequately representative peak body, or in
emergency response situations.
A call for public comment on any import risk issue, and at any stage of an analysis can be
issued via the online biosecurity stakeholder register maintained by the Biosecurity and
Plant Health Branch. The call for comment should also be distributed to relevant Australian
Government, State and Territory government biosecurity authorities, either direct or via an
appropriate national committee.
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It should explain the regulatory objective of the import risk analysis, the anticipated
schedule, and may highlight specific matters of interest about which input is sought.
Arrangements for confidentiality must be specified. The call for comment must be issued
consistent with DPIPWE public notification requirements.
Whatever means is used to seek stakeholder or broader public input, it must be
acknowledged (eg. letter/email advising receipt of a written submission). Feedback must
also be accurately recorded, along with a description of how it was treated. A summary
appended to the import risk analysis report may be sufficient. Alternatively, the summary
may be filed with other consultation documents such as originals submissions and meeting
records, preferably on the agency’s electronic filing system, Document One.
8.3.4 Notification of decision
Import risk analysis outcomes should be notified to relevant stakeholders in a reasonable
timeframe appropriate to the immediacy of the import risk situation. In the case of certain
classes of import, Tasmania may have agreed to follow specific consultation and notification
protocols, developed with other government and other stakeholders. For example, a
consultation protocol that includes notification requirements has been developed for new or
amended State or Territory import requirements for plants or plant products.
A notice should state the nature of the regulatory decision (eg. import conditions imposed,
amended or revoked) and the relevant legislation. The DPIPWE’s Quality Control Over Legal
Documents Better Practice Guide should be referred to for notices issued under Tasmania’s
animal or plant health legislation or environmental protection legislation.
In the event conditions are imposed, the notice should specify any transitional arrangements
(eg. a phase‐in period) as relevant. It should include a contact number or address to which
enquiries can be directed, and specify arrangements for accessing the import risk analysis
report. It should state the grounds for appealing the regulatory decision and the timeframe
within which appeals will be accepted.
Stakeholders who should be notified may include:
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• Tasmanian Biosecurity Committee (advise out of session or report at biannual
meetings);
• Tasmanian Biosecurity Technical Group (advise out of session or report at biannual
meetings);
• Biosecurity Australia/DAFF (specific protocol applies);
• National animal or plant health or environmental protection committees as
appropriate (eg. Domestic Quarantine and Market Access Working Group – specific
protocol applies)
• Relevant stakeholders who have registered on the Tasmanian Biosecurity
Stakeholder Register (post notification directly a decision is made).
The Biosecurity communications officer within the Biosecurity and Plant Health Branch
should also be advised directly a decision is made and may be able to assist if news media,
newsletter or other articles are required.
8.3.5 Appeals
Appeals against an import risk decision for scientific or technical reasons will be entertained
when provided for in the relevant legislation. However appeals on the grounds that the
process did not reasonably provide for adequate stakeholder participation will be
considered.
Appeals must be made in writing to the Secretary, DPIPWE, within the period stated on the
decision notice. The Secretary will determine whether to accept or reject the appeal by
considering the grievance against consultation processes recorded in the import risk analysis
report, project planning documents and other relevant documents (eg. meeting minutes
etc.). He or she may undertake any other activity to inform a decision on an appeal.
The Secretary will inform the appellant and the General Manager of the Division within
which the import risk analysis occurred of his or her decision, in writing. If the appeal is
accepted, the import risk regulatory decision will be suspended, pending consideration of
the stakeholder input that was not reasonably provided for in the first iteration of the
analysis.
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If the appellant is not satisfied with the outcome of this process, he or she has recourse to
existing legislative appeal processes. These are appeal to the Administrative Appeals Division
of the Magistrates Court (which may or may not be provided for in an individual Act) or
judicial appeal which is available to everyone through the Judicial Review Act 2000, but only
has regard to the legality of the decision.
8.3.6 Analysis documentation and filing
All documents and correspondence relating to an import risk analysis must be filed,
preferably on Document One. Some business units within the DPIPWE have developed filing
checklists which can be consulted to ensure thorough and consistent documentation.
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Glossary The definition below are taken or adapted for the purpose of this framework, from glossaries in Burgman 2005, Food and Agriculture Organisation of the United Nations 2009, World Organisation for Animal Health (OIE) 2009 and Biosecurity Australia 2009c. Analysts should refer specifically to internationally accepted plant (IPPC) and animal health (OIE) definitions when preparing import risk analysis reports and related documents.
Ambiguity Uncertainty arising when a word can have more than one meaning and it is not clear which meaning is intended.
Anchoring The tendency to be influenced by initial data, or estimates made by others, particularly those perceived to have greater authority.
Appropriate Level of Protection
The level of protection deemed appropriate by a World Trade Organisation Member establishing a sanitary or phytosanitary (SPS) measure to protect human, animal or plant life or health within its territory.
Area of low pest prevalence
An area, whether all of a country, part of a country, or all or parts of several countries, as identified by the competent authorities, in which a specific pest occurs at low levels and which is subject to effective surveillance, control or eradication measures.
Bayesian analysis Provides a mechanism for combining knowledge from subjective sources with current information to produce a revised estimate of a parameter.
Bayesian networks (also called probability networks, influence networks and Bayes’ belief nets) Graphical models that represent relationships among uncertain variables, in which probabilities may be estimated subjectively and updated using Bayes’ theorem.
Biosecurity Australia The unit within the Biosecurity Services Group, Australian Government Department of Agriculture, Fisheries and Forestry. Biosecurity Australia responsible for recommendations for the development of Australia’s biosecurity policy.
Biosecurity risk profile Social, environmental and economic characteristics of a place that influence how the consequences of pest entry and establishment manifest there.
Consensus A means of achieving closure in which the experts agree that a particular position is ‘best’.
Containment Application of control measures in and around an infested area to prevent spread of a pest.
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Cost‐Benefit analysis Examination, usually in economic terms, of the advantages and disadvantages of a particular course of action.
Delimiting survey Survey conducted to establish the boundaries of an area considered to be infested by or free from a pest.
Delphi technique A form of behavioural aggregation that consists of questionnaires, elicitation, combining results, review of combined results by experts and iteration of feedback until consensus is achieved.
Detection survey Survey conducted in an area to determine if a pest is present.
Endangered area An area where ecological factors favour the establishment of a pest whose presence in the area will result in economically important loss.
Entry (of a pest) Movement of a pest into an area where it is not yet present or present but not widely distributed and being officially controlled.
Epistemic uncertainty Reflects incomplete knowledge (incertitude), including measurement error, systematic error, model uncertainty; and subjective judgement.
Equivalence (of SPS measures)
The situation where, for a specified pest risk, different sanitary or phytosanitary measures achieve a jurisdiction’s appropriate level of protection.
Eradication Application of SPS measures to eliminate a pest from an area.
Establishment Perpetuation, for the foreseeable future, of a pest within an area after entry.
Expected value of information
The difference between the current state of knowledge and what might be learned from a given strategy.
Expert Someone who has knowledge, skill, experience, training or education about an issue at an appropriate level of detail and who is capable of communicating their knowledge.
Harmonization The establishment, recognition and application by different countries of sanitary or phytosanitary measures based on common standards.
Hazard A situation that in particular circumstances could lead to harm.
Hazard identification Screening process used in import risk analysis to identify and separate organisms that warrant further assessment from those that do not, in a given import situation.
Host A species of plant or animal capable, under natural conditions, of sustaining a specific pest.
Host range Species capable, under natural conditions, of sustaining a specific pest or other organism.
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Import Risk Analysis An administrative process through which quarantine policy is developed or reviewed, incorporating hazard identification, risk assessment, risk management and risk communication.
Inspection Official visual examination of imported articles to determine if pests are present and/or to determine compliance with sanitary or phytosanitary regulations.
Interception (of a
pest)
The detection of a pest during inspection or testing of an imported consignment.
Linguistic uncertainty Arises because language is not exact, including vagueness, context dependence, ambiguity and under‐specificity.
Measurement error Error caused by imprecise and inaccurate instruments and operators.
Model uncertainty Uncertainty arising from the fact that, often, many alternative assumptions and models could be constructed that are consistent with data and theory, but which would generate different predictions.
Monitoring Sampling and analysis to determine compliance with a standard or deviation from a target or prediction, or to measure the state and response of the system to management strategies.
Natural variation Environmental change (with respect to time, space or other variables) that is difficult to predict. A cause of uncertainty in import risk analysis.
Official control The active enforcement of sanitary or phytosanitary regulations and the application of mandatory procedures with the objective of eradication or containment of pests.
Outbreak A recently detected pest population, including an incursion, or a sudden significant increase of an established pest population in an area.
Pathogen Micro‐organism causing disease.
Pest Any species, strain or biotype of plant, animal, or pathogenic agent injurious to animals, plants or their products.
Pest categorisation The process used in import risk analysis for determining whether an organism has or does not have the characteristics of a potential pest. See hazard identification.
Pest risk
The probability of introduction and spread of a pest and the magnitude of the associated potential economic consequences.
Pest status (in an area) Presence or absence, at the present time, of a pest in an area, including where appropriate its distribution, as officially determined using expert judgement on the basis of current and historical pest records and other information.
Sanitary or phytosanitary Any legislation, regulation or official procedure having the
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measure purpose to prevent the introduction and/or spread of, or to limit the economic impact of pests.
Probability The statistical frequency (or relative frequency) with which an event is expected to occur, or the degree of belief warranted by evidence.
Provisional measure A sanitary or phytosanitary regulation or procedure established without full technical justification owing to current lack of adequate information. A provisional measure is subjected to periodic review and full technical justification as soon as possible.
Restricted risk Estimate of risk made in situations where risk management measures are being applied.
Risk The chance, within a time frame, of an adverse event with specific consequences.
Risk analysis Process comprising hazard identification, risk assessment, risk management, and risk communication
Risk assessment Evaluation of the likelihood and biological and economic consequences of entry, establishment and spread of a hazard within an importing jurisdiction.
Risk management Process of identifying, selecting and implementing measures to reduce the level of risk
Risk ranking Risk assessment that relies on qualitative, usually subjective estimates of likelihoods and consequences to rank hazards.
Small island economy Category of economy characteristic of island jurisdictions that are small in size and population, and remote from major markets.
Spread Expansion of the geographical distribution of a pest within an area.
Stakeholder Generally, in risk analysis, anyone who has an interest in an issue, or anyone who shares the burden of the risk of a wrong decision.
Subjective belief Personal judgement in the truth of a proposition.
Surveillance A process which collects and records data on pest occurrence or absence by survey, monitoring or other procedures.
Survey A procedure conducted over a defined period of time to determine the characteristics of a pest population or to determine which species occur in an area.
Systematic error Errors that occur when measurements are biased (non‐random); the difference between the true value of a parameter and the value to which the mean of the measurements converges as sample sizes increase.
Systems approach The integration of different pest risk management measures, at
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least two of which act independently, and which cumulatively achieve the appropriate level of protection.
Type I, type II errors Monitoring systems should: (1) tell us there is a serious problem when one exists (thus avoiding overconfidence, called ‘false negatives’ or type II errors) and (2) tell us there is not a serious problem when there isn’t one (thus avoiding false alarms, called ‘false positives’ or type I errors).
Under‐specificity Occurs when there is unwanted generality in language.
Unrestricted risk Estimate of risk made in the absence of risk management measures.
Vagueness Arises because language permits borderline cases.
Zoonosis Any disease or infection that is naturally transmissible from animals to humans.
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References
Adamson, D. (2006) Implementing economics into biosecuritry risk analysis. Paper to Australian Society for Risk Analysis Conference, Melbourne University 17‐19 July Anderson, K., Mc Rae, C. and Wilson, W. (eds) (2001) The Economics of Quarantine and the SPS Agreement. Centre for International Economic Studies, Adelaide and AFFA Biosecurity Australia, Canberra Australian Bureau of Statistics (1988) Human quarantine. The Australian approach to a world problem. 1301.0 Year Book Australia, 1988 Australian Bureau of Statistics (2007) Value of principal agricultural commodities produced, preliminary, 2006‐07. 7501.0 Australian Bureau of Statistics (2008) Regional population growth Australia, 2007‐08. 3218.0 Australian National Insect Collection database. Downloaded from http://www.csiro.au 15 October 2008 Baker, R., Cannon, R., Bartlett, P. and Barker, I. (2005) Novel strategies for assessing and managing the risks posed by invasive alien species to global crop production and biodiversity. Annals of Applied Biology. 146:177‐191 Baker, J. and Stuckey, M. (2008) Principles for prioritising exotic pests. Final Project Report (draft) 07/07, Australian Centre of Excellence for Risk Analysis, Melbourne Beale, R., Fairbrother, J., Inglis, A. and Trebeck, D. (2008) One biosecurity – a working partnership. Commonwealth of Australia, Canberra Binder, M. (2002) The role of risk and cost‐benefit analysis in determining quarantine measures. Productivity Commission Staff Research Paper, Ausinfo, Canberra Bigsby, H.R. (2001) The appropriate level of protection: a New Zealand perspective. In Anderson, McRae and Wilson (eds) 2001 The Economics of Quarantine and the SPS Agreement. Centre for International Economic Studies, Adelaide and AFFA Biosecurity Australia, Canberra Biosecurity Australia (2009a) Biosecurity Australia Advice 2009/14 Update to the Import risk Analysis Handbook 2007. Commonwealth of Australia
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Biosecurity Australia (2009b) Biosecurity Australia Advice 2009/24 Importation of rainbow fish for ornamental purposes Biosecurity Australia (2009c) Draft import risk analysis report for fresh apple fruit from the United States of America Pacific Northwest states. Biosecurity Australia, Canberra Biosecurity Australia (2009d) Importation of freshwater ornamental fish: review of the biosecurity risks associated with gourami iridovirus and related viruses – Draft import risk analysis report. Biosecurity Australia, Canberra, Australia Biosecurity New Zealand (2006) Risk analysis procedures. Version 1. 12 April 2006. New Zealand Ministry of Agriculture and Forestry Bomford, M. (2008) Risk assessment models for establishment of exotic vertebrates in Australia and New Zealand. Project 9.D.1, Invasive Animals Cooperative Research Centre, Canberra Breen, S.M. (2001) Contested places. Tasmania’s northern districts from ancient times to 1900. Centre for Tasmanian Historical Studies, School of History and Classics, University of Tasmania Bureau of Infrastructure, Transport and Regional Economics (2008) A regional economy: a case study of Tasmania. Report 116. Australian Government Department of Infrastructure, Transport, Regional Development and Local Government Burgman, M. (2005) Risks and decisions for conservation and environmental management. Cambridge University Press Burgman, M., Fidler, F., McBride, M., Walshe, T. and Wintle, B. (2006) Eliciting expert judgments: literature review. Project 11. Australian Centre of Excellence for Risk Analysis, Melbourne Burgman, M.A., Wintle, B.A., Thompson, C.A., Moilanen, A., Runge, M.C. and Ben‐Haim, Y. (2008) Reconciling uncertain costs and benefits in Bayes nets for invasive species management. Final Report 0601 and 0611. Australian Centre of Excellence for Risk Analysis, Melbourne Burke, T. (2009) New Council to help protect Australia’s biosecurity. Media release 367B 21 December 2009, Department of Agriculture, Fisheries and Forestry, Canberra Carey, J. and Burgman, M. (2008) Linguistic uncertainty in qualitative risk assessment and how to minimize it. In W.T Tucker, S. Ferson, A.M. Finkel and D. Slavin (2008) Strategies for risk communication. Annals of the New York Academy of Sciences, 1128
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Chomel, B.B., Belotto, A., Meslin, F‐X. Wildlife, exotic pets, and emerging zoonoses. Emerging Infectious Diseases [serial on the Internet]. 2007 Jan [date cited]. Available from http://www.cdc.gov/ncidod/EID/13/1/6.htm. Downloaded 4 November 2008 Cohen, J. (2005) Criteria for risk assessments to aid in decisions to import agricultural products. Paper to the International Conference on Sanitary and Phytosanitary Risk Assessment Methodology: Optimisation of the SPS Regulatory Toolbox. Washington August 9‐11, 2005 Cook, D. (2001) An economic evaluation of interstate quarantine protocols for mangoes entering Western Australia. Australasian Agribusiness Review. 9. Downloaded from www3.agrifood.info/review/2001, on 18 December 2008 Cook, D.C., Thomas, M.B., Cunningham, S.A., Anderson, D.L. and De Barro, P.J. (2007) Predicting the economic impact of an invasive species on an ecosystem service. Ecological Applications 17(6): 1832–1840 Cook, D.C. (2008) Benefit cost of an import access request. Food Policy. 33: 277‐285 Cook, D.C. and Fraser, R.W. (2008) Trade and invasive species risk mitigation: Reconciling WTO compliance with maximizing the gains from trade. Food Policy. 33: 176‐184 Cook, D., Henry, D., Sheppard, A. and Lonsdale, M. (2008) Transition to resilient social communities and cities: Biosecurity. In: Newton, P.W. (ed) Transitions: Pathways Towards Sustainable Urban Development in Australia. CSIRO, Canberra. 269‐282 Copp, G.H., Garthwaite, R. and Golzan, R.E. (2005) Risk identification and assessment of non‐native freshwater fishes: concepts and perspectives on protocols for the UK. Science Series Technical Report No. 129. Cefas Lowestoft Dambacher, J.M., Shenton, W.S., Hayes, K.R., Hart, B.T. and Barry, S. (2007) Qualitative modeling and Bayesian network analysis for risk‐based biosecurity decision making in complex systems. Final Project Report 06/01. Australian Centre of Excellence for Risk Analysis, Melbourne Davey and Maynard Agricultural and Resource Management Consulting. (2007) The Contribution of agriculture to the Tasmanian economy. Tasmanian Farmers and Graziers Association and Tasmanian Agricultural Productivity Group De Marchi, B. (2003) Public participation and risk governance. Science and Public Policy 30(3), 171‐176
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de Swart, C. and Donker, R.A. (2005) Towards a FSO/ALOP based food safety policy. Food Control. 16: 825‐830 Department of Agriculture, Fisheries and Forestry (Biosecurity Australia) (2001) Guidelines for import risk analysis. Draft September 2001. Commonwealth of Australia Department of Agriculture, Fisheries and Forestry (2002) Primary Industries Ministerial Council Record and Resolutions. First Meeting Hobart 2 May 2002. Downloaded from http//www.mincos.gov.au 2 November 2008 Department of Agriculture, Fisheries and Forestry (2007) Import risk analysis handbook 2007. Commonwealth of Australia Department of Economic Development and Tourism, Tasmania (2007) Place‐of‐origin business case. Department of the Environment, Water, Heritage and the Arts (undated) Environment Protection and Biodiversity Conservation Act 1999 (EPBC Act) Fact Sheet. Downloaded from http//:www.environment.gov.au/epbc 3 November 2008 Department of Finance and Trade. www.dfat.gov.au Department of Health and Ageing and enHealth Council (2002) Environmental health risk assessment. Guidelines for assessing human health risks from environmental hazards. Commonwealth of Australia Department of Health and Ageing Office of the Gene Technology Regulator (2009) Risk Analysis Framework April 2009. Commonwealth of Australia Department of Primary Industries, Water and Environment, Tasmania (2000) Tasmanian Marine Protected Areas Strategy. Department of Primary Industries and Water, Tasmania (2005) Tasmanian food industry scorecard 2004‐2005. Downloaded from http://www.dpiw.tas.gov.au 30 October 2008 Department of Primary Industries and Water, Tasmania (2007a) Tasmanian Government Policy on Biosecurity Department of Primary Industries and Water, Tasmania (2007b) Tasmanian Biosecurity Strategy Department of Primary Industries and Water, Tasmania (2008) Annual Report 2007‐2008
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Department of Treasury and Finance, Tasmania (2006) Legislation Review program. Procedures and guidelines manual. Epps, T. (2008) Reconciling public opinion and WTO rules under the SPS Agreement. World Trade Review. 7(2):359‐392 Eslake, S. (2008) The role of parks in Tasmania’s economy. Tasmanian Parks and Wildlife Service Annual Conference, 30 September 2008. Downloaded from http://www.tasmaniantimes.com 3 November 2008 Fischhoff, B. (1995) Risk perception and communication unplugged: Twenty years of process. Risk Analysis. 15 (2): 137‐145 Fisher, E. (2006) Beyond the science/democracy dichotomy: The World Trade Organisation Sanitary and Phytosanitary Agreement and administrative constitutionalism. In C. Joerges and E. Petersmann (Eds) (2006) Constitutionalism, multilevel trade governance and social regulation. Hart Publishing. Oxford and Portland, Oregon Floerl, O., Inglis, G.J. and Hayden, B.J. (2005) A risk‐based predictive tool to prevent accidental introductions of non‐indigenous marine species. Environmental Management. 35 (6): 765‐778 Follet, P.A. and Neven, L.G. (2006) Current trends in quarantine entomology. Annual Review of Entomology. 52: 359‐385 Food and Agriculture Organisation (2006) International Standards for Phytosanitary Measures. ISPM No. 11 Pest risk analysis for quarantine pests including analysis of environmental risks and living modified organisms. Rome Food and Agriculture Organisation (2009) International Standards for Phytosanitary Measures. ISPM No. 5 Glossary of phytosanitary terms. Rome Food and Agriculture Organisation and Network of Aquaculture Centres in Asia‐Pacific (2001) Manual of procedures for the implementation of the Asia Regional technical guidelines on health management for the responsible movement of live aquatic animals. Rome Franklin, J. and Sisson, S. (2007) Assessment strategies for evaluating extreme risks. Final Report 0602. Australian Centre of Excellence for Risk Analysis, Melbourne Gorrie, G. (2004) Gorrie Review of quarantine systems and biosecurity management. Department of Primary Industries, Water and the Environment, Tasmania
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Gray, G.M., Allen, J.C., Burmaster, D.E., Gage, S.H., Hammit, J.K., Kaplan, S., Keeney, R.L., Morse, J.G., North, D.W., Nyrop, J.P., Stahevitch, A. and Williams, R. (1998) Principles for the conduct of pest risk analysis: Report of an expert workshop. Risk Analysis. 18 (6): 773‐780 Gruszczynski, C.L. (2008) The SPS Agreement within the framework of WTO law. The Rough Guide to the Agreement’s applicability. The Selected Works of Lukasz A Gruszczynski at: http://works.bepress.com/lukasz_gruszczynski/5 Harris, K.L. (2004) The globalisation of the consumer – how the law is responding. Proceedings of International Trade Law Conference, 23 September 2004, Canberra Hayes, K.R. (2005) Biosecurity and the role of risk assessment. In Gregory M. Ruiz and James T. Carlton (eds) Invasive species. Vectors and management strategies. Island Press, Washington Hellstrom, J. (Undated) Position Statement on the application of precaution in managing biosecurity risks associated with the importation of risk goods under the Biosecurity Act 1993. Biosecurity New Zealand. Biosecurity Council. Downloaded from http://www.biosecurity.govt.nz 27 February 2008 Henderson, W.R. (2008b) Research on wildlife disease preparedness in Australia. Invasive Animals Cooperative Research Centre, Canberra Hilton, M. (2003) Potential new invasive plants of coastal dunes: bad news from Australia. Protect. Summer 2002‐2003, MAF Hulme, P.E. (2009) Trade, transport and trouble: managing invasive species pathways in an era of globalisation. Journal of Applied Ecology. 46: 10‐18 Ireson, J.E., Davies, J.T., Friend, D.A., Hollloway, R.J., Chatterton, W.S., Van Putten, E.I. and McFadyen, R.E.C. (2006) Weeds of pastures and field crops in Tasmania: economic impacts and biological control. Technical Series no. 13, CRC for Australian Weed Management, Adelaide Kahneman, D. (2003) A perspective on judgement and choice. American Psychologist. 58 (9): 697‐720 Kaplan, S. and Garrick, B.J. (1981) On the quantitative definition of risk. Risk Analysis. 1 (1): 11‐27 Kirkpatrick, J.B. and Bridle, K.L. (2007) People, sheep and nature conservation. CSIRO Publishing, Australia
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Lockwood, J.L., Hoopes, M.F. and Marchetti, M.P. (2007) Invasion ecology. Blackwell Publishing Ltd Low, T. (1999) Feral Future. The untold story of Australia’s exotic invaders. Viking. Penguin Books Australia Mack, R.N. (2003) Global plant dispersal, naturalisation, and invasion: pathways, modes and circumstances. In M. Ruiz and J.T. Carlton (eds) Invasive species. Vectors and management strategies. Island Press Washington DC McCarthy, M., Burgman, M. and Gordon, I. (2007) Review of the use of period of trade and trade volume in import risk analysis. Final Project Report 0702. Australian Centre of Excellence for Risk Analysis, Melbourne Murray, N. (2003) Import risk analysis. Animals and animal products. New Zealand Ministry of Agriculture and Forestry, Wellington Nairn, M.E., Allen, P.G., Inglis, A.R. and Tanner, C. (1996) Australian Quarantine: a shared responsibility. Department of Primary Industries and Energy, Canberra Natural Resource Management Ministerial Council (2006) A Strategic approach to the management of ornamental fish in Australia. Commonwealth of Australia, Canberra Niu, H.C. (2007) Can Article 5.7 of the WTO SPS Agreement be a model for the precautionary principle? Scripted. 4 (4) DOI: 10.2966/scrip.040407.367 North, D.W. (2005) The use of risk analyses in decision‐making and the role of scientific research. Keynote speech to the International Conference on Sanitary and Phytosanitary Risk Assessment Methodology: Optimisation of the SPS Regulatory Toolbox. Washington August 9‐11, 2005 Panaquatic ® Health Solutions Pty Ltd (2007) Scientific review of the biosecurity risks associated with the importation of rainbow fish for ornamental purposes – Final Report prepared for Biosecurity Australia Parks and Wildlife Service (2004) State of the Tasmanian Wilderness World Heritage Area – an evaluation of management effectiveness. Report No. 1 (Summary report) Department of Tourism Parks Heritage and the Arts, Hobart, Tasmania Peel, J. (2004) Risk Regulation under the WTO SPS Agreement: Science as an international normative yardstick? Jean Monnet Working Paper 02/04. New York University School of Law
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Philips, A. and Driessen, M. (2008) Strategy for managing wildlife disease in Tasmanian Wilderness World Heritage Area. Department of Primary Industries and Water, Hobart Phillips, D. (2008) Import risk analysis of fox entry pathways into Tasmania. Department of Primary Industries and Water Pittock, B. Ed. (2006) Climate change: An Australian guide to the science and potential impacts. Australian Greenhouse Office, Canberra Real, R., Marquez, A., Estrada, A., Munoz, A.R. and Vargas, J.M. (2008) Modelling chorotypes of invasive invertebrates in Spain. Diversity and Distributions. 14: 364‐373 Roberts. D. (2001) The integration of economics into SPS risk management policies: issues and challenges. In Anderson, McRae and Wilson (eds) 2001 The Economics of Quarantine and the SPS Agreement. Centre for International Economic Studies, Adelaide and AFFA Biosecurity Australia, Canberra Rootes, G. (2008) A Chaotic State of Affairs? The Permissive System of Local Government in Rural Tasmania 1840‐1907. University of Tasmania, School of History and Classics PhD Thesis Rose, K. (2008) Impacts of disease in native fauna in Australia. In W.R. Henderson (ed), Workshop proceedings: Review of wildlife exotic disease preparedness in Australia. 2‐3 April 2008, Canberra. Invasive Animals Cooperative Research Centre, Canberra Rudman, T. (2002) Weed Status Report: Sea‐wheat grass (Thinopyrum junceiforme) in Tasmania. Department of Primary Industries, Water and Environment Sandin, P., Peterson, M., Hansson, S.O., Ruden, C. and Juthe, A. (2002) Five charges against the precautionary principle. Journal of Risk Research. 5(4): 287‐299 Sinden, J., Jones, R., Hester, S., Odom, D., Kalisch, C., James, R. and Cacho, O. (2004) The economic impact of weeds in Australian agriculture. In Proceedings of the 14th Australian Weeds Conference, eds. B.M. Sindel and S.B. Johnson (Weed Society of New South Wales) Slovic, P. (2002) The perception of risk. Earthscan Publications Ltd, London Speirs‐Bridge, A., Fidler, F., McBride, M., Flander, M., Cumming, G. and Burgman, M. (2008) Eliciting reliable expert judgements for ecological models/Reducing overconfidence in the interval judgements of experts. Final Project Report 0611. Australian Centre of Excellence for Risk Analysis, Melbourne Standards Australia (2004) AS/NZS 4360:2004. Risk Management. Standards Australia International and Standards New Zealand, Sydney and Wellington.
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Stern, P.C. and Fineberg, H.V. (eds) (1996) Understanding risk. Informing decisions in a democratic society. National Academy Press, Washington D.C. Stratford, E. (2008) Islandness and struggles over development: A Tasmanian case study. Political Geography. 27: 160‐175 Tanner, C. (2003) The economics of quarantine measures. Paper to Outlook 2003 Conference, National Convention Centre, Canberra, 4 March 2003 Tasmanian Government (2008) Australian Government’s independent review of Australia’s quarantine and biosecurity functions. Tasmanian Government submission. Department of Primary Industries and Water, Tasmania Tasmanian Planning Commission (2009) State of the Environment Report: Tasmania 2009, Tasmanian Planning Commission, Tasmania Waage, J.K., Fraser, R.W., Mumford, J.D., Cook, D.C. and Wilby, A. (2004) A new agenda for biosecurity. Draft Report for the Department for Food, Environment and Rural Affairs, August, Faculty of Life Sciences, Imperial College London Weiss, L., Thurbon, E. and Mathews, J. (2004) How to kill a country. Australia’s devastating trade deal with the United States. Allen and Unwin, Australia World Organisation for Animal Health (OIE) (2009) Terrestrial Animal Health Code, Paris, France World Trade Organisation (2000) The WTO Agreements Series 4 sanitary and phytosanitary measures. World Trade Organisation (2001) The treatment of precaution in the SPS Agreement. Statement by Canada at the meeting of 14‐15 March 2001. Committee on Sanitary and Phytosanitary Measures. 27 April 2001. G/SPS/GEN/246 World Trade Organisation (2009) Guide to WTO law and practice – Agreement on Sanitary and Phytosanitary Measures (downloaded 10 June 2009 www.wto.org.english/res_e/booksp_e/analytic_indexe/sps_01_e.htm) Worner, S.P. and Gevrey, M. (2006) Modelling global insect pest species assemblages to determine risk of invasion. Journal of Applied Ecology. 43: 858‐867
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Recommended reading
International biosecurity policy and perspectives Epps, T. (2008) Reconciling public opinion and WTO rules under the SPS Agreement. World Trade Review. 7(2):359‐392 Peel, J. (2004) Risk Regulation under the WTO SPS Agreement: Science as an international normative yardstick? Jean Monnet Working Paper 02/04. New York University School of Law World Trade Organisation (2009) Guide to WTO law and practice – Agreement on Sanitary and Phytosanitary Measures www.wto.org.english/res_e/booksp_e/analytic_indexe/sps_01_e.htm http//:www.wto.org http//:www.ippc.int https//:www.oie.int
Australian biosecurity policy and perspectives Beale, R., Fairbrother, J., Inglis, A. and Trebeck, D. (2008) One biosecurity – a working partnership. Commonwealth of Australia, Canberra Nairn, M.E., Allen, P.G., Inglis, A.R. and Tanner, C. (1996) Australian Quarantine: a shared responsibility. Department of Primary Industries and Energy, Canberra
Tasmanian biosecurity policy and perspectives Gorrie, G. (2004) Gorrie Review of quarantine systems and biosecurity management. Department of Primary Industries, Water and the Environment, Tasmania Department of Primary Industries and Water (2007) Tasmanian Government Policy on Biosecurity Department of Primary Industries and Water (2007) Tasmanian Biosecurity Strategy
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Risk perception, analysis and communication Burgman, M. (2005) Risks and decisions for conservation and environmental management. Cambridge University Press Dambacher, J.M., Shenton, W.S, Hayes, K.R., Hart, B.T. and Barry, S. (2007) Qualitative modeling and Bayesian network analysis for risk‐based biosecurity decision making in complex systems. Final Project Report 06/01. Australian Centre of Excellence for Risk Analysis Fischhoff, B. (1995) Risk perception and communication unplugged: Twenty years of process. Risk Analysis. 15 (2): 137‐145 North, D.W. (2005) The use of risk analyses in decision‐making and the role of scientific research. Keynote speech to the International Conference on Sanitary and Phytosanitary Risk Assessment Methodology: Optimisation of the SPS Regulatory Toolbox. Washington August 9‐11, 2005 Slovic, P. (2002) The perception of risk. Earthscan Publications Ltd, London Stern, P.C. and Fineberg, H.V. (eds) (1996) Understanding risk. Informing decisions in a democratic society. National Academy Press, Washington D.C. Lockwood, J.L., Hoopes, M.F. and Marchetti, M.P. (2007) Invasion ecology. Blackwell Publishing Ltd Binder, M. (2002) The role of risk and cost‐benefit analysis in determining quarantine measures. Productivity Commission Staff Research Paper, Ausinfo, Canberra Cook, D.C., Thomas, M.B., Cunningham, S.A., Anderson, D.L. and De Barro, P.J. (2007) Predicting the economic impact of an invasive species on an ecosystem service. Ecological Applications. 17(6): 1832–1840 Cook, D.C. (2008) Benefit cost of an import access request. Food Policy. 33: 277‐285 Cook, D.C. and Fraser, R.W. (2008) Trade and invasive species risk mitigation: Reconciling WTO compliance with maximizing the gains from trade. Food Policy. 33: 176‐184 Tanner, C. (2003) The economics of quarantine measures. Paper to Outlook 2003 Conference, National Convention Centre, Canberra, 4 March 2003
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Administration and governance De Marchi, B. (2003) Public participation and risk governance. Science and Public Policy. 30(3): 171‐176 Fisher, E. (2006) Beyond the science/democracy dichotomy: The World Trade Organisation Sanitary and Phytosanitary Agreement and administrative constitutionalism. In C. Joerges and E. Petersmann (Eds) Constitutionalism, multilevel trade governance and social regulation. Hart Publishing. Oxford and Portland, Oregon Stratford, E. (2008) Islandness and struggles over development: A Tasmanian case study. Political Geography. 27: 160‐175
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Appendix 1 The World Trade Organisation Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) (from www.wto.org)
Members,
Reaffirming that no Member should be prevented from adopting or enforcing measures necessary to protect human, animal or plant life or health, subject to the requirement that these measures are not applied in a manner which would constitute a means of arbitrary or unjustifiable discrimination between Members where the same conditions prevail or a disguised restriction on international trade;
Desiring to improve the human health, animal health and phytosanitary situation in all Members;
Noting that sanitary and phytosanitary measures are often applied on the basis of bilateral agreements or protocols;
Desiring the establishment of a multilateral framework of rules and disciplines to guide the development, adoption and enforcement of sanitary and phytosanitary measures in order to minimize their negative effects on trade;
Recognizing the important contribution that international standards, guidelines and recommendations can make in this regard;
Desiring to further the use of harmonized sanitary and phytosanitary measures between Members, on the basis of international standards, guidelines and recommendations developed by the relevant international organizations, including the Codex Alimentarius Commission, the International Office of Epizootics, and the relevant international and regional organizations operating within the framework of the International Plant Protection Convention, without requiring Members to change their appropriate level of protection of human, animal or plant life or health;
Recognizing that developing country Members may encounter special difficulties in complying with the sanitary or phytosanitary measures of importing Members, and as a consequence in access to markets, and also in the formulation and application of sanitary or phytosanitary measures in their own territories, and desiring to assist them in their endeavours in this regard;
Desiring therefore to elaborate rules for the application of the provisions of GATT 1994 which relate to the use of sanitary or phytosanitary measures, in particular the provisions of Article XX(b) (1);
NOTES:
1 In this Agreement, reference to Article XX(b) includes also the chapeau of that Article.
2 For the purposes of paragraph 3 of Article 3, there is a scientific justification if, on the basis of an examination and evaluation of available scientific information in conformity with the relevant provisions of this Agreement, a Member determines that the relevant international standards, guidelines or recommendations are not sufficient to achieve its appropriate level of sanitary or phytosanitary protection.
3 For purposes of paragraph 6 of Article 5, a measure is not more trade‐restrictive than required unless there is another measure, reasonably available taking into account technical and economic feasibility, that achieves the appropriate level of sanitary or phytosanitary protection and is significantly less restrictive to trade.
4 For the purpose of these definitions, “animal” includes fish and wild fauna; “plant” includes forests and wild flora; “pests” include weeds; and “contaminants” include pesticide and veterinary drug residues and extraneous matter.
5 Sanitary and phytosanitary measures such as laws, decrees or ordinances which are applicable generally.
6 When “nationals” are referred to in this Agreement, the term shall be deemed, in the case of a
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Hereby agree as follows:
Article 1 General Provisions
1. This Agreement applies to all sanitary and phytosanitary measures which may, directly or indirectly, affect international trade. Such measures shall be developed and applied in accordance with the provisions of this Agreement.
2. For the purposes of this Agreement, the definitions provided in Annex A shall apply.
3. The annexes are an integral part of this Agreement.
4. Nothing in this Agreement shall affect the rights of Members under the Agreement on Technical Barriers to Trade with respect to measures not within the scope of this Agreement.
Article 2 Basic Rights and Obligations
1. Members have the right to take sanitary and phytosanitary measures necessary for the protection of human, animal or plant life or health, provided that such measures are not inconsistent with the provisions of this Agreement.
2. Members shall ensure that any sanitary or phytosanitary measure is applied only to the extent necessary to protect human, animal or plant life or health, is based on scientific principles and is not maintained without sufficient scientific evidence, except as provided for in paragraph 7 of Article 5.
3. Members shall ensure that their sanitary and phytosanitary measures do not arbitrarily or unjustifiably discriminate between Members where identical or similar conditions prevail, including between their own territory and that of other Members. Sanitary and phytosanitary measures shall not be applied in a manner which would constitute a disguised restriction on international trade.
4. Sanitary or phytosanitary measures which conform to the relevant provisions of this Agreement shall be presumed to be in accordance with the obligations of the Members under the provisions of GATT 1994 which relate to the use of sanitary or phytosanitary measures, in particular the provisions of Article XX(b).
Article 3 Harmonization
1. To harmonize sanitary and phytosanitary measures on as wide a basis as possible, Members shall base their sanitary or phytosanitary measures on international standards, guidelines or recommendations, where they exist, except as otherwise provided for in this Agreement, and in particular in paragraph 3.
separate customs territory Member of the WTO, to mean persons, natural or legal, who are domiciled or who have a real and effective industrial or commercial establishment in that customs territory.
7 Control, inspection and approval procedures include, inter alia, procedures for sampling, testing and certification.
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2. Sanitary or phytosanitary measures which conform to international standards, guidelines or recommendations shall be deemed to be necessary to protect human, animal or plant life or health, and presumed to be consistent with the relevant provisions of this Agreement and of GATT 1994.
3. Members may introduce or maintain sanitary or phytosanitary measures which result in a higher level of sanitary or phytosanitary protection than would be achieved by measures based on the relevant international standards, guidelines or recommendations, if there is a scientific justification, or as a consequence of the level of sanitary or phytosanitary protection a Member determines to be appropriate in accordance with the relevant provisions of paragraphs 1 through 8 of Article 5.(2) Notwithstanding the above, all measures which result in a level of sanitary or phytosanitary protection different from that which would be achieved by measures based on international standards, guidelines or recommendations shall not be inconsistent with any other provision of this Agreement.
4. Members shall play a full part, within the limits of their resources, in the relevant international organizations and their subsidiary bodies, in particular the Codex Alimentarius Commission, the International Office of Epizootics, and the international and regional organizations operating within the framework of the International Plant Protection Convention, to promote within these organizations the development and periodic review of standards, guidelines and recommendations with respect to all aspects of sanitary and phytosanitary measures.
5. The Committee on Sanitary and Phytosanitary Measures provided for in paragraphs 1 and 4 of Article 12 (referred to in this Agreement as the “Committee”) shall develop a procedure to monitor the process of international harmonization and coordinate efforts in this regard with the relevant international organizations.
Article 4 Equivalence
1. Members shall accept the sanitary or phytosanitary measures of other Members as equivalent, even if these measures differ from their own or from those used by other Members trading in the same product, if the exporting Member objectively demonstrates to the importing Member that its measures achieve the importing Member's appropriate level of sanitary or phytosanitary protection. For this purpose, reasonable access shall be given, upon request, to the importing Member for inspection, testing and other relevant procedures.
2. Members shall, upon request, enter into consultations with the aim of achieving bilateral and multilateral agreements on recognition of the equivalence of specified sanitary or phytosanitary measures.
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Article 5 Assessment of Risk and Determination of the Appropriate Level of Sanitary or Phytosanitary Protection
1. Members shall ensure that their sanitary or phytosanitary measures are based on an assessment, as appropriate to the circumstances, of the risks to human, animal or plant life or health, taking into account risk assessment techniques developed by the relevant international organizations.
2. In the assessment of risks, Members shall take into account available scientific evidence; relevant processes and production methods; relevant inspection, sampling and testing methods; prevalence of specific diseases or pests; existence of pest — or disease — free areas; relevant ecological and environmental conditions; and quarantine or other treatment.
3. In assessing the risk to animal or plant life or health and determining the measure to be applied for achieving the appropriate level of sanitary or phytosanitary protection from such risk, Members shall take into account as relevant economic factors: the potential damage in terms of loss of production or sales in the event of the entry, establishment or spread of a pest or disease; the costs of control or eradication in the territory of the importing Member; and the relative cost‐effectiveness of alternative approaches to limiting risks.
4. Members should, when determining the appropriate level of sanitary or phytosanitary protection, take into account the objective of minimizing negative trade effects.
5. With the objective of achieving consistency in the application of the concept of appropriate level of sanitary or phytosanitary protection against risks to human life or health, or to animal and plant life or health, each Member shall avoid arbitrary or unjustifiable distinctions in the levels it considers to be appropriate in different situations, if such distinctions result in discrimination or a disguised restriction on international trade. Members shall cooperate in the Committee, in accordance with paragraphs 1, 2 and 3 of Article 12, to develop guidelines to further the practical implementation of this provision. In developing the guidelines, the Committee shall take into account all relevant factors, including the exceptional character of human health risks to which people voluntarily expose themselves.
6. Without prejudice to paragraph 2 of Article 3, when establishing or maintaining sanitary or phytosanitary measures to achieve the appropriate level of sanitary or phytosanitary protection, Members shall ensure that such measures are not more trade‐restrictive than required to achieve their appropriate level of sanitary or phytosanitary protection, taking into account technical and economic feasibility.(3)
7. In cases where relevant scientific evidence is insufficient, a Member may provisionally adopt sanitary or phytosanitary measures on the basis of available pertinent information, including that from the relevant international organizations as well as from sanitary or phytosanitary measures applied by other Members. In such circumstances, Members shall seek to obtain the additional information necessary for a more objective assessment of risk and review the sanitary or
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phytosanitary measure accordingly within a reasonable period of time.
8. When a Member has reason to believe that a specific sanitary or phytosanitary measure introduced or maintained by another Member is constraining, or has the potential to constrain, its exports and the measure is not based on the relevant international standards, guidelines or recommendations, or such standards, guidelines or recommendations do not exist, an explanation of the reasons for such sanitary or phytosanitary measure may be requested and shall be provided by the Member maintaining the measure.
Article 6 Adaptation to Regional Conditions, Including Pest — or Disease — Free Areas and Areas of Low Pest or Disease Prevalence
1. Members shall ensure that their sanitary or phytosanitary measures are adapted to the sanitary or phytosanitary characteristics of the area — whether all of a country, part of a country, or all or parts of several countries — from which the product originated and to which the product is destined. In assessing the sanitary or phytosanitary characteristics of a region, Members shall take into account, inter alia, the level of prevalence of specific diseases or pests, the existence of eradication or control programmes, and appropriate criteria or guidelines which may be developed by the relevant international organizations.
2. Members shall, in particular, recognize the concepts of pest — or disease‐free areas and areas of low pest or disease prevalence. Determination of such areas shall be based on factors such as geography, ecosystems, epidemiological surveillance, and the effectiveness of sanitary or phytosanitary controls.
3. Exporting Members claiming that areas within their territories are pest — or disease‐free areas or areas of low pest or disease prevalence shall provide the necessary evidence thereof in order to objectively demonstrate to the importing Member that such areas are, and are likely to remain, pest— or disease—free areas or areas of low pest or disease prevalence, respectively. For this purpose, reasonable access shall be given, upon request, to the importing Member for inspection, testing and other relevant procedures.
Article 7 Transparency
Members shall notify changes in their sanitary or phytosanitary measures and shall provide information on their sanitary or phytosanitary measures in accordance with the provisions of Annex B.
Article 8 Control, Inspection and Approval Procedures
Members shall observe the provisions of Annex C in the operation of control, inspection and approval procedures, including national systems for approving the use of additives or for establishing tolerances for contaminants in foods, beverages or feedstuffs, and otherwise ensure that their procedures are not inconsistent with the provisions of this Agreement.
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Article 9 Technical Assistance
1. Members agree to facilitate the provision of technical assistance to other Members, especially developing country Members, either bilaterally or through the appropriate international organizations. Such assistance may be, inter alia, in the areas of processing technologies, research and infrastructure, including in the establishment of national regulatory bodies, and may take the form of advice, credits, donations and grants, including for the purpose of seeking technical expertise, training and equipment to allow such countries to adjust to, and comply with, sanitary or phytosanitary measures necessary to achieve the appropriate level of sanitary or phytosanitary protection in their export markets.
2. Where substantial investments are required in order for an exporting developing country Member to fulfil the sanitary or phytosanitary requirements of an importing Member, the latter shall consider providing such technical assistance as will permit the developing country Member to maintain and expand its market access opportunities for the product involved.
Article 10 Special and Differential Treatment
1. In the preparation and application of sanitary or phytosanitary measures, Members shall take account of the special needs of developing country Members, and in particular of the least‐developed country Members.
2. Where the appropriate level of sanitary or phytosanitary protection allows scope for the phased introduction of new sanitary or phytosanitary measures, longer time‐frames for compliance should be accorded on products of interest to developing country Members so as to maintain opportunities for their exports.
3. With a view to ensuring that developing country Members are able to comply with the provisions of this Agreement, the Committee is enabled to grant to such countries, upon request, specified, time‐limited exceptions in whole or in part from obligations under this Agreement, taking into account their financial, trade and development needs.
4. Members should encourage and facilitate the active participation of developing country Members in the relevant international organizations.
Article 11 Consultations and Dispute Settlement
1. The provisions of Articles XXII and XXIII of GATT 1994 as elaborated and applied by the Dispute Settlement Understanding shall apply to consultations and the settlement of disputes under this Agreement, except as otherwise specifically provided herein.
2. In a dispute under this Agreement involving scientific or technical issues, a panel should seek advice from experts chosen by the panel in consultation with the parties to the dispute. To this end, the panel may, when it deems it appropriate, establish an advisory technical experts group, or consult the relevant international organizations, at the request of either party to the dispute or on its own initiative.
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3. Nothing in this Agreement shall impair the rights of Members under other international agreements, including the right to resort to the good offices or dispute settlement mechanisms of other international organizations or established under any international agreement.
Article 12 Administration
1. A Committee on Sanitary and Phytosanitary Measures is hereby established to provide a regular forum for consultations. It shall carry out the functions necessary to implement the provisions of this Agreement and the furtherance of its objectives, in particular with respect to harmonization. The Committee shall reach its decisions by consensus.
2. The Committee shall encourage and facilitate ad hoc consultations or negotiations among Members on specific sanitary or phytosanitary issues. The Committee shall encourage the use of international standards, guidelines or recommendations by all Members and, in this regard, shall sponsor technical consultation and study with the objective of increasing coordination and integration between international and national systems and approaches for approving the use of food additives or for establishing tolerances for contaminants in foods, beverages or feedstuffs.
3. The Committee shall maintain close contact with the relevant international organizations in the field of sanitary and phytosanitary protection, especially with the Codex Alimentarius Commission, the International Office of Epizootics, and the Secretariat of the International Plant Protection Convention, with the objective of securing the best available scientific and technical advice for the administration of this Agreement and in order to ensure that unnecessary duplication of effort is avoided.
4. The Committee shall develop a procedure to monitor the process of international harmonization and the use of international standards, guidelines or recommendations. For this purpose, the Committee should, in conjunction with the relevant international organizations, establish a list of international standards, guidelines or recommendations relating to sanitary or phytosanitary measures which the Committee determines to have a major trade impact. The list should include an indication by Members of those international standards, guidelines or recommendations which they apply as conditions for import or on the basis of which imported products conforming to these standards can enjoy access to their markets. For those cases in which a Member does not apply an international standard, guideline or recommendation as a condition for import, the Member should provide an indication of the reason therefor, and, in particular, whether it considers that the standard is not stringent enough to provide the appropriate level of sanitary or phytosanitary protection. If a Member revises its position, following its indication of the use of a standard, guideline or recommendation as a condition for import, it should provide an explanation for its change and so inform the Secretariat as well as the relevant international organizations, unless such notification and explanation is given according to the procedures of Annex B.
5. In order to avoid unnecessary duplication, the Committee may decide, as appropriate, to use the information generated by the procedures, particularly for
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notification, which are in operation in the relevant international organizations.
6. The Committee may, on the basis of an initiative from one of the Members, through appropriate channels invite the relevant international organizations or their subsidiary bodies to examine specific matters with respect to a particular standard, guideline or recommendation, including the basis of explanations for non‐use given according to paragraph 4.
7. The Committee shall review the operation and implementation of this Agreement three years after the date of entry into force of the WTO Agreement, and thereafter as the need arises. Where appropriate, the Committee may submit to the Council for Trade in Goods proposals to amend the text of this Agreement having regard, inter alia, to the experience gained in its implementation.
Article 13 Implementation
Members are fully responsible under this Agreement for the observance of all obligations set forth herein. Members shall formulate and implement positive measures and mechanisms in support of the observance of the provisions of this Agreement by other than central government bodies. Members shall take such reasonable measures as may be available to them to ensure that non‐governmental entities within their territories, as well as regional bodies in which relevant entities within their territories are members, comply with the relevant provisions of this Agreement. In addition, Members shall not take measures which have the effect of, directly or indirectly, requiring or encouraging such regional or non‐governmental entities, or local governmental bodies, to act in a manner inconsistent with the provisions of this Agreement. Members shall ensure that they rely on the services of non‐governmental entities for implementing sanitary or phytosanitary measures only if these entities comply with the provisions of this Agreement.
Article 14 Final Provisions
The least‐developed country Members may delay application of the provisions of this Agreement for a period of five years following the date of entry into force of the WTO Agreement with respect to their sanitary or phytosanitary measures affecting importation or imported products. Other developing country Members may delay application of the provisions of this Agreement, other than paragraph 8 of Article 5 and Article 7, for two years following the date of entry into force of the WTO Agreement with respect to their existing sanitary or phytosanitary measures affecting importation or imported products, where such application is prevented by a lack of technical expertise, technical infrastructure or resources.
ANNEX A DEFINITIONS (4)
1. Sanitary or phytosanitary measure — Any measure applied:
(a) to protect animal or plant life or health within the territory of the Member from risks arising from the entry, establishment or spread of pests, diseases, disease‐carrying organisms or disease‐causing organisms;
(b) to protect human or animal life or health within the territory of the Member
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from risks arising from additives, contaminants, toxins or disease‐causing organisms in foods, beverages or feedstuffs;
(c) to protect human life or health within the territory of the Member from risks arising from diseases carried by animals, plants or products thereof, or from the entry, establishment or spread of pests; or
(d) to prevent or limit other damage within the territory of the Member from the entry, establishment or spread of pests.
Sanitary or phytosanitary measures include all relevant laws, decrees, regulations, requirements and procedures including, inter alia, end product criteria; processes and production methods; testing, inspection, certification and approval procedures; quarantine treatments including relevant requirements associated with the transport of animals or plants, or with the materials necessary for their survival during transport; provisions on relevant statistical methods, sampling procedures and methods of risk assessment; and packaging and labelling requirements directly related to food safety.
2. Harmonization — The establishment, recognition and application of common sanitary and phytosanitary measures by different Members.
3. International standards, guidelines and recommendations
(a) for food safety, the standards, guidelines and recommendations established by the Codex Alimentarius Commission relating to food additives, veterinary drug and pesticide residues, contaminants, methods of analysis and sampling, and codes and guidelines of hygienic practice;
(b) for animal health and zoonoses, the standards, guidelines and recommendations developed under the auspices of the International Office of Epizootics;
(c) for plant health, the international standards, guidelines and recommendations developed under the auspices of the Secretariat of the International Plant Protection Convention in cooperation with regional organizations operating within the framework of the International Plant Protection Convention; and
(d) for matters not covered by the above organizations, appropriate standards, guidelines and recommendations promulgated by other relevant international organizations open for membership to all Members, as identified by the Committee.
4. Risk assessment — The evaluation of the likelihood of entry, establishment or spread of a pest or disease within the territory of an importing Member according to the sanitary or phytosanitary measures which might be applied, and of the associated potential biological and economic consequences; or the evaluation of the potential for adverse effects on human or animal health arising from the presence of additives, contaminants, toxins or disease‐causing organisms in food, beverages or feedstuffs.
5. Appropriate level of sanitary or phytosanitary protection — The level of protection deemed appropriate by the Member establishing a sanitary or
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phytosanitary measure to protect human, animal or plant life or health within its territory.
NOTE: Many Members otherwise refer to this concept as the “acceptable level of risk”.
6. Pest— or disease‐free area — An area, whether all of a country, part of a country, or all or parts of several countries, as identified by the competent authorities, in which a specific pest or disease does not occur.
NOTE: A pest— or disease‐free area may surround, be surrounded by, or be adjacent to an area — whether within part of a country or in a geographic region which includes parts of or all of several countries ‐in which a specific pest or disease is known to occur but is subject to regional control measures such as the establishment of protection, surveillance and buffer zones which will confine or eradicate the pest or disease in question.
7. Area of low pest or disease prevalence — An area, whether all of a country, part of a country, or all or parts of several countries, as identified by the competent authorities, in which a specific pest or disease occurs at low levels and which is subject to effective surveillance, control or eradication measures.
Annex B Transparency Of Sanitary And Phytosanitary Regulations
Publication of regulations
1. Members shall ensure that all sanitary and phytosanitary regulations (5) which have been adopted are published promptly in such a manner as to enable interested Members to become acquainted with them.
2. Except in urgent circumstances, Members shall allow a reasonable interval between the publication of a sanitary or phytosanitary regulation and its entry into force in order to allow time for producers in exporting Members, and particularly in developing country Members, to adapt their products and methods of production to the requirements of the importing Member.
Enquiry points
3. Each Member shall ensure that one enquiry point exists which is responsible for the provision of answers to all reasonable questions from interested Members as well as for the provision of relevant documents regarding:
(a) any sanitary or phytosanitary regulations adopted or proposed within its territory;
(b) any control and inspection procedures, production and quarantine treatment, pesticide tolerance and food additive approval procedures, which are operated within its territory;
(c) risk assessment procedures, factors taken into consideration, as well as the determination of the appropriate level of sanitary or phytosanitary protection;
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(d) the membership and participation of the Member, or of relevant bodies within its territory, in international and regional sanitary and phytosanitary organizations and systems, as well as in bilateral and multilateral agreements and arrangements within the scope of this Agreement, and the texts of such agreements and arrangements.
4. Members shall ensure that where copies of documents are requested by interested Members, they are supplied at the same price (if any), apart from the cost of delivery, as to the nationals (6) of the Member concerned.
Notification procedures
5. Whenever an international standard, guideline or recommendation does not exist or the content of a proposed sanitary or phytosanitary regulation is not substantially the same as the content of an international standard, guideline or recommendation, and if the regulation may have a significant effect on trade of other Members, Members shall:
(a) publish a notice at an early stage in such a manner as to enable interested Members to become acquainted with the proposal to introduce a particular regulation;
(b) notify other Members, through the Secretariat, of the products to be covered by the regulation together with a brief indication of the objective and rationale of the proposed regulation. Such notifications shall take place at an early stage, when amendments can still be introduced and comments taken into account;
(c) provide upon request to other Members copies of the proposed regulation and, whenever possible, identify the parts which in substance deviate from international standards, guidelines or recommendations;
(d) without discrimination, allow reasonable time for other Members to make comments in writing, discuss these comments upon request, and take the comments and the results of the discussions into account.
6. However, where urgent problems of health protection arise or threaten to arise for a Member, that Member may omit such of the steps enumerated in paragraph 5 of this Annex as it finds necessary, provided that the Member:
(a) immediately notifies other Members, through the Secretariat, of the particular regulation and the products covered, with a brief indication of the objective and the rationale of the regulation, including the nature of the urgent problem(s);
(b) provides, upon request, copies of the regulation to other Members;
(c) allows other Members to make comments in writing, discusses these comments upon request, and takes the comments and the results of the discussions into account.
7. Notifications to the Secretariat shall be in English, French or Spanish.
8. Developed country Members shall, if requested by other Members, provide
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copies of the documents or, in case of voluminous documents, summaries of the documents covered by a specific notification in English, French or Spanish.
9. The Secretariat shall promptly circulate copies of the notification to all Members and interested international organizations and draw the attention of developing country Members to any notifications relating to products of particular interest to them.
10. Members shall designate a single central government authority as responsible for the implementation, on the national level, of the provisions concerning notification procedures according to paragraphs 5, 6, 7 and 8 of this Annex.
General reservations
11. Nothing in this Agreement shall be construed as requiring:
(a) the provision of particulars or copies of drafts or the publication of texts other than in the language of the Member except as stated in paragraph 8 of this Annex; or
(b) Members to disclose confidential information which would impede enforcement of sanitary or phytosanitary legislation or which would prejudice the legitimate commercial interests of particular enterprises.
ANNEX C CONTROL, INSPECTION AND APPROVAL PROCEDURES (7)
1. Members shall ensure, with respect to any procedure to check and ensure the fulfilment of sanitary or phytosanitary measures, that:
(a) such procedures are undertaken and completed without undue delay and in no less favourable manner for imported products than for like domestic products;
(b) the standard processing period of each procedure is published or that the anticipated processing period is communicated to the applicant upon request; when receiving an application, the competent body promptly examines the completeness of the documentation and informs the applicant in a precise and complete manner of all deficiencies; the competent body transmits as soon as possible the results of the procedure in a precise and complete manner to the applicant so that corrective action may be taken if necessary; even when the application has deficiencies, the competent body proceeds as far as practicable with the procedure if the applicant so requests; and that upon request, the applicant is informed of the stage of the procedure, with any delay being explained;
(c) information requirements are limited to what is necessary for appropriate control, inspection and approval procedures, including for approval of the use of additives or for the establishment of tolerances for contaminants in food, beverages or feedstuffs;
(d) the confidentiality of information about imported products arising from or supplied in connection with control, inspection and approval is respected in a way no less favourable than for domestic products and in such a manner that legitimate
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commercial interests are protected;
(e) any requirements for control, inspection and approval of individual specimens of a product are limited to what is reasonable and necessary;
(f) any fees imposed for the procedures on imported products are equitable in relation to any fees charged on like domestic products or products originating in any other Member and should be no higher than the actual cost of the service;
(g) the same criteria should be used in the siting of facilities used in the procedures and the selection of samples of imported products as for domestic products so as to minimize the inconvenience to applicants, importers, exporters or their agents;
(h) whenever specifications of a product are changed subsequent to its control and inspection in light of the applicable regulations, the procedure for the modified product is limited to what is necessary to determine whether adequate confidence exists that the product still meets the regulations concerned; and
(i) a procedure exists to review complaints concerning the operation of such procedures and to take corrective action when a complaint is justified.
Where an importing Member operates a system for the approval of the use of food additives or for the establishment of tolerances for contaminants in food, beverages or feedstuffs which prohibits or restricts access to its domestic markets for products based on the absence of an approval, the importing Member shall consider the use of a relevant international standard as the basis for access until a final determination is made.
2. Where a sanitary or phytosanitary measure specifies control at the level of production, the Member in whose territory the production takes place shall provide the necessary assistance to facilitate such control and the work of the controlling authorities.
3. Nothing in this Agreement shall prevent Members from carrying out reasonable inspection within their own territories.
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Appendix 2 Comparison of OIE and IPPC import risk analysis frameworks with Tasmanian import risk analysis planning model (adapted from Biosecurity New Zealand 2006)
Tasmanian import risk analysis planning model (Figure 5 this document)
IPPC Framework (after ISPM 11)
OIE Framework (after Chapter 2 Animal
Health Code)
Establish the context Identify trigger, consider existing policy, priority and complexity Commence project planning
Stage 1: Initiation Describe pest risk assessment (PRA) initiation (eg. request to import, pathway change, policy review) and scope Identify PRA area Collect information, including list of candidates for screening Check previous policy and PRAs
Risk analysis initiation Describe commodity or animal proposed for import and likely annual quantity
Define the problem Identify type of decision required and scope of risk analysis Screen and categorise organisms as potential hazards or not Confirm project planning Confirm stakeholders and experts and mode of participation in the import risk analysis
Stage 2: Pest risk assessment Screen and categorise organisms as potential pests or not
Hazard Identification Develop list of potential hazards Screen and categorise organisms as potential hazards or not
Collect detailed information and specify assumptions Assess information, identify uncertainty and assumptions used to address it Establish conceptual risk model Determine introduction and distribution scenarios and consider value of establishment and spread modelling, as relevant Consult stakeholders and experts as required
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Assess risk Entry, establishment and spread assessment Consequence assessment Estimate risk and rank against ALOP Consult stakeholders and experts as required
Assessment of likelihood of entry and establishment (introduction) and spread Assessment of potential economic consequences (including environmental impact) Risk estimation Describe uncertainty, note use of expert judgement in the risk analysis
Risk assessment Release assessment Exposure assessment Consequence assessment Risk estimation Document uncertainties and assumptions
Identify management options Identify risk mitigation options targeting introduction and distribution pathways consistent with management option principles Assess cost‐effectiveness of options, if more than one, including prohibition Consult stakeholders and experts as required
Stage 3: Pest risk management Level of risk and risk acceptability – compare estimated risk with ALOP Identify and select appropriate risk management options Phytosanitary certificates and other compliance measures – specify export certification requirements Select phytosanitary measures Monitoring and review of phytosanitary measures
Risk management Risk evaluation‐ compare estimated risk with ALOP Option evaluation‐ identify feasibility and efficacy of measures Implementation‐ make decision about measures Monitoring and review‐ continuous audit of measures against desired results
Test sensitivity and finalise analysis Peer review Finalise import risk analysis report Decide Make a decision about measures, hear appeals, notify stakeholders Monitor and Update Implement monitoring to facilitate responsiveness and adaptation to changing risk Advise stakeholders as necessary
Documentation of pest risk analysis Communicate the rationale for phytosanitary measures as transparently as possible within analysis documentation
Risk communication Gather information and opinions during the risk analysis process and communicate the outcomes to decision‐makers and other interested or affected parties. Includes communication of
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uncertainties and assumptions in the risk model and peer review An iterative process that runs from the start to the finish of an import risk analysis
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Appendix 3 Import Risk Analysis Templates 3A Scope Template This template can be used in conjunction with section 7.3.3 of this document and may be inserted into the body of an import risk analysis report. If a criterion is not relevant, enter ‘Not Applicable’. Where appropriate, comment briefly on exclusions.
CRITERION
DESCRIPTION
Pest, or class of pests
Import type
Source
Condition
Method of production, handling, storage and transport
Pathways and vectors
Proposed distribution in Tasmania
Area of Tasmania for which risks are considered
Timeframe to which risk estimate will apply
Anticipated volume or amount of import
Other comment on scope
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3B Hazard Screening Template This template can be used in conjunction with section 7.3.4 of this document, and may be inserted into the body of an import risk analysis report. Hazard screening criteria are considered for each pest. If multiple pests are screened, a summary table should be inserted into the body of the import risk analysis report. The screening result for each species can be appended to the report. If a criterion is not relevant, enter ‘Not Applicable’.
CRITERION ASSESSMENT RESULTTaxonomy
Scientific name, synonyms, common name/s
Regulation status, Tasmania and elsewhere
Regulated (risk analysis documented/not documented), unregulated (based on risk analysis or not)
Presence in Tasmania
Present (import concern apparent or not)/absent/status uncertain
Presence in region from which import originates
Present/absent/status uncertain
Association with import
Plausible/implausible
Potential for establishment and spread in Tasmania
Feasible/not feasible/uncertain
Potential for environmental, economic, human health impacts in Tasmania
Feasible/not feasible/uncertain
Further assessment required?
Yes/No
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3C Pest Profile Template This template of headings can be used in conjunction with section 7.4.2 of this document, and may be inserted into the body of an import risk analysis report. If a heading is not relevant, enter ‘Not Applicable’. The template is adapted from CBA International, 2006. Crop Protection Compendium. Wallingford UK. www.cabicompendium.org/cpc Taxonomy and common names Include:
• preferred scientific name and author
• synonyms
• common name/s
• taxonomic classification from Phylum to Family, or as per other convention
• brief notes about relevant taxonomic issues Sanitary or phytosanitary significance Summarise the regulatory status of the pest in Tasmania, Australia and elsewhere. Include conditions and restrictions on imports, prohibitions, notification requirements. Morphology Describe the organism’s form, consistent with animal, plant or microbial convention. Include life stages, resting structures, sexual and asexual forms, as relevant. Include diagrams or images. Geographic distribution Describe the organism’s distribution status in Tasmania, Australia and overseas. Include:
• native and introduced range
• whether previously recorded in an area and now absent
• prevalence (ie. widespread or restricted, seasonal factors)
• duration of presence
• maps, if available Biology and ecology The biology and ecology of the organism should be described consistent with animal, plant or microbial convention, and with reference to section 7.6.3 of this document. Relevant matters could include:
• Lifecycle (include diagram if available)
• Abiotic limits, and environmental preferences and requirements (including adaptability, plasticity)
• Reproductive strategy (including potential for hybridisation, self‐crossing, reliance on pheromones or other attractants)
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• Dispersal or transmission modes (mobility characteristics, natural and human mediated dispersal, vertical and horizontal transmission, pathways and vectors)
• Host range, symptoms (including hosts of different life stages, variations in susceptibility, sub‐clinical manifestations)
• Pest or disease vector status (Is the organism a vector for disease or is it a parasite host?)
• Natural enemies (parasitoids, predators, parasites, competitors)
• Population biology (eg. threshold levels, lag times, generations per year,) Impact Describe the direct and indirect consequences of the pest, with reference to sections 7.6.6 and 7.7.4 of this document. Relevant matter could include:
• Direct impacts on animal health or life
• Direct impacts on plant health or life
• Direct impacts on human health or life
• Direct impacts on other biota
• Indirect environmental consequences
• Indirect social consequences
• Indirect economic consequences
• Irreversibility of impact
• Immediacy of impact
• Scale of impact
Management Describe management options for reducing risk at importation and distribution stages with reference to section 7.7.3 of this document. Include options for post barrier consequence mitigation. Check whether options are consistent with principles set out in section 7.7.2 of this document. Detection and monitoring Identify strategies and methods for detecting the pest in an area or with an imported item, either in Tasmania or elsewhere, as relevant to monitoring and updating Tasmanian regulations. Refer to section 7.10.2 of this document. Considerations could include:
• Detectability at low density or low prevalence
• Detectability in the presence of controls (including ability of vaccines or chemical treatments, pruning to mask presence of the pest)
• Seasonal factors affecting detectability
• Detection in production areas in which hosts are found (including survey and monitoring activity, notification requirements)
• Detection in suitable natural environments (including vulnerable or valuable areas)
• Detection along post‐border pathways (ie. trapping or inspection at points of entry to Tasmania, in urban areas and waterways, roadsides)
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• Detection at place of host production (eg. nurseries, farms, including trapping, veterinary testing and other monitoring strategies)
• Detection by visual inspection of import (including inspection rates per unit import)
• Diagnosis by microscopic examination
• Diagnosis by molecular methods
• Desktop literature and network monitoring for changes or new information about pest or disease agent distribution, pathways and vectors, biology or ecology
Uncertainty check All entries into a pest profile should be referenced such that the nature of the information source is clear. Attendant epistemic uncertainties should be made apparent. Information entered into profiles should also be checked for linguistic clarity. See section 6.5 of this document.
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Appendix 4 Peer review questions The following may be used to guide general requests for peer review:
• Is the purpose and scope of the import risk analysis made clear in the introductory section of the report? Has the import risk problem and the context in which it occurs been sufficiently explained?
• Has pest hazard screening been conducted thoroughly and consistent with the scope of the import risk analysis? Have potential hazards been missed or prematurely excluded?
• Comment on the quality of the pest profile/s. Has the state of knowledge and attendant uncertainty been portrayed correctly and transparently? Are the assumptions made in regard to uncertainty rational?
• Does the risk model appear to be sufficiently comprehensive for the problem at hand? Are significant parameters (ie. pathways, vectors) missing or have parameters been included that are of marginal significance?
• Are the estimates for likelihood of entry, establishment and spread within reasonable bounds and is the underpinning logic sufficiently explained?
• Are the estimates for magnitude of direct or indirect consequences within reasonable bounds and is the underpinning logic sufficiently explained?
• Is the conclusion about the risk estimate in relation to ALOP based on a clear and reasonable chain of logic?
• If the risk estimate exceeds ALOP, have all reasonable risk mitigation options been identified?
• Do the recommended management options appear feasible, cost‐effective and likely to reduce risk to ALOP, but not by more than is necessary?
• Are the recommended monitoring strategies likely to facilitate an adequate level of responsiveness to changing risk, or new information?
• Has stakeholder participation in the import risk analysis been clearly documented?
• Is the import risk analysis report easy to read and understand?
A FRAMEWORK OF CONTEXT, CONCEPTS , METHODS AND ADMINISTRATIVE PROCEDURES
Biosecurity and Plant Health [email protected]
Impor t RiskAnalysis