ISSN 2070-7010 Understanding And 519/1 Applying Risk Analysis In .

vii Abbreviations and acronyms ALARA ALOP ALOR ANP APEC ASEAN BMPs CAC CBD CCRF CSR EIA EIFAC ERA EU FAO FSO GAP GESAMP GISD GMO HABs HACCP ICES ICPM IPPC IRA IRR ISO ISPM ISR IUCN LIFDCs MCMD MPEDA MOTAD NACA as low as reasonably achieved (approach) appropriate level of protection acceptable level of risk analytic network process Asia-Pacific Economic Cooperation Association of Southeast Asian Nations best management practices Codex Alimentarius Commission Convention on Biological Diversity Code of Conduct for Responsible Fisheries corporate social responsibility environmental impact assessment European Inland Fisheries Advisory Commission (of the FAO) ecological risk assessment; environmental risk assessment European Union Food and Agriculture Organization of the United Nations food safety objective good aquaculture practices IMO/FAO/UNESCO-LOC/WMO/IAEA/UN/UNEP Joint Group of Experts on the Scientific Aspects of Marine Environmental Protection Global Invasive Species Database genetically modified organism harmful algal blooms Hazard Analysis And Critical Control Point Analysis International Council for the Exploration of the Sea Interim Commission on Phytosanitary Measures (of the IPPC) International Plant Protection Convention import risk analysis internal rate of return International Standards Organisation International Standards for Phytosanitary Measures International Sanitary Regulations World Conservation Union low-income food-deficit countries multicriteria decision-making Marine Products Export Development Authority ( India) minimization of total absolute deviations Network of Aquaculture Centres in Asia and the Pacific

viii NaCSA NEMESIS NIMPIS NGO NPPOs OIE ORP PAHO PRP ROI PRA RPPOs SEAFDEC SOPs SPS SRM TAADs TBT UN UNICLOS USEPA WGITMO WHO WSD WSSV WTO National Centre for Sustainable Aquaculture (India) National Exotic Marine and Estuarine Species Information System National Introduced Marine Pest Information System Non-governmental organization National Plant Protection Organizations World Organisation for Animal Health organism risk potential Pan American Health Organization pathway risk potential return on investment pathogen risk analysis Regional Plant Protection Organizations (of the IPPC) South East Asian Fisheries Development Center standard operating procedures Sanitary and Phytosanitary (Agreement) (of the WTO) social risk management transboundary aquatic animal diseases Agreement on Technical Barriers to Trade (TBT Agreement) United Nations United Nations Convention on the Law of the Sea United States Environmental Protection Agency Working Group on Introductions and Transfers of Marine Organisms (of ICES) World Health Organization whitespot syndrome disease whitespot syndrome virus World Trade Organization

ix Glossary Appropriate level of protection (ALOP) The level of protection deemed appropriate by a country establishing a sanitary or phytosanitary measure to protect identified or assessed values Acceptable level of risk (ALOR) The level of risk a country establishing a sanitary or phytosanitary measure is willing to assume to protect identified or assessed values Biosecurity A strategic and integrated approach that encompasses both policy and regulatory frameworks aimed at analyzing and managing the risks of the sectors dealing with food safety, animal life and health, plant life and health and the environment Consequence The evaluated impact an event may have on assessed values (environmental, economic, socio-political, cultural) Consequence assessment The process of evaluating the impact of an event. Cultural value Those aspects of the aquatic environment that represent an iconic or spiritual value, including those that create a sense of local, regional or national identity Delphi process A semi-quantitative method from the social sciences that is used to capture stakeholder and/or expert opinions and beliefs Economic value Components within an ecosystem that provide a current or potential economic gain or loss Environmental value Everything from the biological to physical characteristics of an ecosystem being assessed, excluding extractive (economic) use and aesthetic value Exposure assessment The process of describing the mechanism or pathway(s) necessary for an adverse event to occur and estimating the likelihood of that event occurring Food safety The process of ensuring that products for human consumption meet or exceed standards of quality to ensure that human consumption will not result in morbidity or mortality

x Food security The protection and management of biological resources for safe and sustainable human consumption Genetically modified organism (GMO) An organism in which the genetic material has been altered by human intervention, generally through use of recombinant DNA technologies Hazard An organism, action or event that can produce adverse consequences relative to the assessment endpoint Hazard identification The process of identifying events, actions or objects that can potentially cause adverse consequences to values Impact The alteration or change in value caused by a hazard Introduction The intentional or accidental transport and release by humans of any species into an environment outside its present range Invasive species An organism that causes negative impact to economic, environmental, socio-political or cultural values due to prolific growth and unmanaged population Likelihood Probability of an event occurring, ranging from rare events to likely or frequent events Non-indigenous species An organism that has been transferred to a location in which it did not evolve or in which it was not present in its historic range Pathogen An infectious agent capable of causing disease Pest An organism that causes harm to economic, environmental, socio-political or cultural values Precautionary approach An approach to risk management that takes into account the precautionary principle Precautionary principle The axiom that “a lack of full scientific certainty shall not be used as a reason for postponing costeffective measures to prevent environmental degradation” (CBD, 1992) Quarantine The isolation of a region, area or group of organisms to contain the spread or prevent the entry of something considered dangerous or likely to cause harm (e.g. a pest or pathogen) Release assessment The process of describing the pathway by which a hazard is “released” into the operating environment of the risk analysis and estimating the likelihood of this occurring

xi Risk The potential occurrence of unwanted, adverse consequences associated with some action over a specified time period Risk analysis A detailed examination including risk assessment, risk evaluation, and risk management alternatives, performed to understand the nature of unwanted, negative consequences to human life, health, property, or the environment in order to minimize the risk Risk assessment The process of assessing the likelihood and consequence of an event Risk communication The act or process of exchanging information concerning risk Risk management The pragmatic decision-making process concerned with what to do about risk Risk mitigation Actions or controls that, when put in place, will alter, reduce or prevent either the likelihood or the consequence of an event, thus acting to reduce the risk of an event Socio-political value The value placed on a location in relation to human use for pleasure, aesthetic or generational values. This value may also include human health and politics. Examples include tourism, family outings, learning and aesthetics Transfer The intentional or accidental transport and release of any species within its present range

1 1. Introduction 1.1 Background As the global population expands to exceed six billion people, ecological security has become a focal point for many national and international bodies (Homer-Dixon, 2001; Degeest and Pirages, 2003; Pirages and Cousins, 2005). Indeed, significant pressures have come to bear on the infrastructure, food security, food safety and natural resources of many nations (McMicheal, 2001). It is estimated that nearly 75 percent of the human population will live within 150 km of a coastline by 2025 (Cohen, 1995; Hinrichsen, 1995), placing significant pressure on ocean and coastal resources. In order for the current level and rate of economic growth to continue, reliance on aquatic resources to supply food products, specifically protein, will increase (GESAMP, 2008). The current intensive development of aquaculture in many countries is bridging the gap between stagnating yields from many capture fisheries and an increasing demand for fish and fishery products, such that aquaculture now contributes almost 50 percent of the global foodfish supply (FAO, 2007a). As the world’s supply of aquatic food will need to increase by at least 40 million tonnes by 2030 to sustain the current per capita consumption level, it is expected that aquaculture’s contribution to the world’s production of aquatic food will continue to increase. Thus, aquaculture will continue to strengthen its role in contributing to food security and food safety, while also offering opportunities to alleviate poverty, increase employment and community development, and reduce overexploitation of natural aquatic resources, thus creating social and generational equity, particularly in developing countries. Aquaculture encompasses a very wide range of farming practices with regard to species (seaweeds, molluscs, crustaceans, fish and other aquatic species groups), environments (freshwater, brackishwater and marine) and systems (extensive, semi-intensive and intensive), often with very distinct resource use patterns. This complexity offers a wide range of options for diversification of avenues for enhanced food production and income generation in many rural and peri-urban areas. The majority of the global aquaculture output by weight is produced in developing countries, with a high proportion originating in low-income food-deficit countries (LIFDCs). The aquaculture industry represents a solution to many of the food security issues facing the growing human population. However, it is also often in direct conflict with other users of aquatic habitats and the adjacent coastal and riparian areas, including economic, environmental and social interests. The aquaculture sector is largely private, with increasing business demands for profitability. As a consequence, the application of risk analysis to aid in identifying the various

2 Understanding and applying risk analysis in aquaculture – A manual for decision-makers business, economic, environmental and social risks has become necessary in the management of this growth sector. These include both risks to the environment and society from aquaculture and to aquaculture from the environmental, social and economic settings in which it operates. 1.2 Purpose The purpose of this manual is to provide an overview of the risk analysis process as applied to aquaculture production and to demonstrate the variety of ways in which risk can manifest in aquaculture operations and management. The intention of this document is to promote wider understanding and acceptance of the applications and benefits of risk analysis in aquaculture production and management. Therefore this manual is a high-level guiding document with resources to allow further enquiry. It is not a recipe book to be followed for instant success. Risk analysis and the resulting guidelines, frequently offered as industry best practice or standard operating procedures (SOPs), are typically developed in an explicit context and require an understanding of the risk fundamentals in order to be adapted to a new situation. To accomplish this, it is necessary that risk analysis capacity and capability in relation to aquaculture operations is developed in Food and Agriculture Organization of the United Nations (FAO) Member States and related to specifically identified outcomes. 1.3 Target Audience This manual is targeted towards senior managers and policy-makers of FAO Member States to aid in an understanding of the application of risk analysis in this growing sector of the world economy. Therefore the primary focus is on risk issues outside the domain of business, except at a macro-economic level. Policy-level risks, however, may incorporate broad elements relevant to business decisions across an industry base (e.g. prawn farmers, the salmonid industry). It is likely that some information presented in this manual will be relevant to aquaculture operators, industry organizations, non-governmental organizations (NGOs) and other groups interested in the influences on national policy relating to the aquaculture industry and the management of aquatic resources. 1.4 Scope This manual provides an overview of the considerations for risk analysis in decision making for all forms of aquaculture and includes the impacts of aquaculture operations on environmental, socio-political, economic and cultural values as well as the impacts to aquaculture from outside influences, including environmental, socio-political, economic and cultural influences. For example, hazards (and risks) will flow to production risks from market risks, often incorporating the externalities of environmental and economic factors. Seven “risk categories” have been identified in previous expert discussions, specifically at the FAO/Network of Aquaculture Centres in Asia-Pacific (NACA)

Introduction Workshop on Understanding and Applying Risk Analysis in Aquaculture, held in Rayong, Thailand from 8–11 June 2007, as having relevance. These categories were: Pathogen risks Food safety and public health risks Ecological (pests and invasives) risks Genetic risks Environmental risks Financial risks Social risks In most of the above risk categories the development of methodologies and risk-based policies is well advanced. The first two categories (pathogen risks, food safety and public health risks) are mature as a consequence of risk analysis standards developed under international agreements in application to international trade and food safety. Pathogen risk analysis is covered under the Aquatic Animal Health Code of the World Organisation for Animal Health (OIE, 2009) (see Section 2), with attempts to establish consistency across aquatic animal production systems regardless of operating environment. Food safety and public health risk analyses have also been developed in the international community under the Codex Alimentarius (see Section 2). Financial risk and social risk analyses have occurred in a variety of sectors, the most relevant of which is the insurance industry (Secretan, 2008). In contrast, ecological, genetic and environmental risk analyses have proceeded along disparate lines, with various sectors developing discrete methodologies and contrasting terminologies. In many instances, there have been limited applications to aquaculture production. 1.5 Structure of the Manual The manual contains six sections. Section 1 provides a background to the aquaculture sector and an introduction to the concepts of risk analysis; Section 2 presents the operating environment for risk analysis for the aquaculture sector by briefly reviewing the relevant international frameworks applicable to each risk category; Section 3 discusses a general risk analysis process for aquaculture; Section 4 provides brief overviews of the risk analysis process as applied in each of the seven risk categories; Section 5 briefly summarizes actions that need to be taken by FAO Member States to promote the wider use of risk analysis for aquaculture development; and Section 6 discusses future challenges to aquaculture and the role risk analysis might play in addressing them. 1.6 Concepts of Risk Analysis We live in a complex world, with various and frequently conflicting priorities requiring our attention. In most instances, our ability to make decisions is balanced between these conflicting priorities, and we rarely have all of the information necessary to develop the ideal solution. Instead we must make decisions in the face of uncertainty to ascertain the “best” outcome. Take, for example, the decision to 3

Understanding and applying risk analysis in aquaculture – A manual for decision-makers 4 immunize our children against disease. Immunization provides significant human health benefits to individuals and the general population; however, there is the slight potential for immunization to cause significant harm to any individual. We cannot know with certainty whether any one child will experience a negative reaction. In this instance, public health officials have analysed the overall benefits of immunization relative to the risks to the individual and thus support immunization programmes. This assessment is a risk analysis. In general terms, risk is the potential occurrence of unwanted, adverse consequences associated with some action over a specified time period (e.g. Arthur et al., 2004a). Risk is the possibility that a negative impact will result from an action or decision and the magnitude of that impact. 1.6.1 The risk analysis process Risk analysis is frequently used by decision-makers and management to direct actions that potentially have large consequences but also have a large uncertainty. Risk analysis1 is a structured process for determining what events can occur (identifying hazards), analyzing the probability that the event will occur (determining likelihood), assessing the potential impact once it occurs (determining consequence), identifying the potential management options and communicating the elements and magnitude of identified risks. In simple terms, risk analysis is used to determine the likelihood that an undesired event will occur and the consequences of such an event. This is generally developed in a repeatable and iterative process (MacDiarmid, 1997; Rodgers, 2004; OIE, 2009) where we seek answers to the following questions: What can occur? (Hazard identification) How likely is it to occur? (Risk assessment: likelihood assessment through release assessment and exposure assessment) What would be the consequences of it occurring? (Risk assessment: consequence assessment and risk estimation; risk management: risk evaluation); and What can be done to reduce either the likelihood or the consequences of it occurring? (Risk management: option evaluation, Implementation, Monitoring and review). The entire process includes risk communication, the communication of the risk to others in order to generate a change in management, regulation or operation. It should be not

safety and public health risks), E. Hallerman (genetic risks), M.J. Phillips and R.P. Subasinghe (environmental risks), K.M.Y. Leung and D. Dudgeon (ecological risks), L.E. Kam and P. Leung (financial risks) and P.B. Bueno (social risks). Preparation and publication of this document were made possible with financial