aquaculture - FAO.org

253 Pages·2009·2.59 MB·English

1
PART 1
CONTRIBUTED PAPERS
ON
UNDERSTANDING AND APPLYING RISK
ANALYSIS IN AQUACULTURE
3
General principles of the risk
analysis process and its application
to aquaculture
J. Richard Arthur
FAO Consultant
Box 1216
Barriere, B.C., Canada V0E 1E0
[email protected]
Arthur, J.R. 2008. General principles of the risk analysis process and its application
to aquaculture. In M.G. Bondad-Reantaso, J.R. Arthur and R.P. Subasinghe (eds).
Understanding and applying risk analysis in aquaculture. FAO Fisheries and
Aquaculture Technical Paper. No. 519. Rome, FAO. pp. 3–8.
ABSTRACT
Governments and the private sector must often make decisions based on incomplete
knowledge and a high degree of uncertainty and where such decisions may have far-
reaching social, environmental and economic consequences. Risk analysis is a process
that provides a flexible framework within which the risks of adverse consequences
resulting from a course of action can be evaluated in a systematic science-based manner.
It permits a defendable decision to be made on whether a particular risk is acceptable or
not, and the means to evaluate possible ways to reduce a risk from an unacceptable level
to one that is acceptable.
Risk analysis is now widely applied in many fields, for example, in decisions
about risks due to chemical and physical stressors (natural disasters, climate change,
contaminants in food and water, pollution, etc.); biological stressors (human, plant and
animal pathogens; plant and animal pests; invasive species, invasive genetic material);
social and economic stressors (public security (including risk of terrorism), construction
and engineering (building safety, fire safety, military applications), and business (project
operations, insurance, litigation, credit, cost risk maintenance, etc.).
The general framework for risk analysis consists of four major components:
• Hazard identification – the process of identifying hazards that could potentially
produce consequences.
• Risk assessment – the process of evaluating the likelihood that a potential hazard
will be realized and estimating the biological, social and/or economic consequences
of its realization.
• Risk management – the seeking of means to reduce either the likelihood or the
consequences of it going wrong; and
• Risk communication – the process by which stakeholders are consulted, information and
opinions gathered and risk analysis results and management measures communicated.
Some basic principles that appear to be common to all types of risk analysis include
those of common sense, uncertainty, precaution, objectivity, transparency, consistency,
scientific validation, stakeholder consultation, stringency, minimal risk management,
unacceptable risk and equivalence.
4 Understanding and applying risk analysis in aquaculture
Risk analysis has wide applicability to aquaculture. It has mainly been applied in
assessing risks to society and the environment posed by hazards created by or associated
with aquaculture development. These include the risks of environmental degradation;
introduction and spread of pathogens, pests and invasive species; genetic impacts; unsafe
foods; and negative social and economic impacts. The use of risk analysis can provide
insights and assist in making decisions that will help to avoid such negative impacts, thus
helping aquaculture development to proceed in a more socially and environmentally
responsible manner.
Risk analysis is less commonly used to achieve successful and sustainable aquaculture
by assessing the risks to aquaculture posed by the physical, social and economic
environment in which it takes place. These include reduction of environmental risks (e.g.
due to poor siting or severe weather events), biological risks (infection by pathogens via
transfer from native stocks, predation by seals and sharks; red tides, etc.), operational
risks (poor planning, work-related injuries), financial risks (e.g. market changes, currency
fluctuations, emergence of new competitors, etc.) and social risks (negative image and
resulting product boycott, lack of skilled manpower, competition from other sectors).
There exists, therefore, considerable scope to develop and expand the use of risk
analysis for the benefit of aquaculture and the social and physical environments in which
it takes place.

INTRODUCTION
Governments and the private sector must often make decisions based on incomplete
knowledge and a high degree of uncertainty. Such decisions may have far-reaching
social, environmental and economic consequences. Risk analysis is a process that
provides a flexible framework within which the risks of adverse consequences resulting
from a course of action can be evaluated in a systematic, science-based manner. The
risk analysis approach permits a defendable decision to be made on whether the risk
posed by a particular action or “hazard” is acceptable or not, and provides the means
to evaluate possible ways to reduce the risk from an unacceptable level to one that is
acceptable.
Risk analysis is now widely applied in many fields that touch our daily lives. These
include decisions about risks due to chemical and physical stressors (natural disasters,
climate change, contaminants in food and water, pollution etc.), biological stressors
(human, plant and animal pathogens; plant and animal pests; invasive species, invasive
genetic material), social and economic stressors (unemployment, financial losses, public
security, including risk of terrorism), construction and engineering (building safety,
fire safety, military applications) and business (project operations, insurance, litigation,
credit, cost risk maintenance etc.). Risk analysis is thus a pervasive but often unnoticed
component of modern society that is used by governments, private sector and individuals
in the political, scientific, business, financial, social sciences and other communities.
THE CONCEPT OF RISK
The definition of “risk” varies somewhat depending on the sector. Most definitions
incorporate the concepts of:
• uncertainty of outcome (of an action or situation),
• probability or likelihood (of an unwanted event occurring), and
• consequence or impact (if the unwanted event happens).
Thus “risk” is the potential for realization of unwanted, adverse consequences
to human life, health, property or the environment. Its estimation involves both the
likelihood (probability) of a negative event occurring as the result of a proposed action
and the consequences that will result if it does happen. As an example, taken from
pathogen risk analysis, the Aquatic Animal Health Code (OIE, 2007) defines risk as:
General principles of the risk analysis process and its application to aquaculture 5
“Risk – means the likelihood of the occurrence and the likely magnitude of the
consequences of an adverse event to public, aquatic animal or terrestrial animal health
in the importing country during a specified time period.”
While some sectors incorporate consideration of potential benefits that may result
from a “risk” being realized (e.g. financial risk analysis), others specifically exclude
benefits from being taken into account (e.g. pathogen risk analysis).
WHAT IS RISK ANALYSIS?
“Risk analysis” is usually defined either by its components and/or its processes.
The Society for Risk Analysis www.sera.org offers the following definitions of “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;
• an analytical process to provide information regarding undesirable events;
• the process of quantification of the probabilities and expected consequences for
identified risks.
In can also be defined as an objective, systematic, standardized and defensible
method of assessing the likelihood of negative consequences occurring due to a proposed
action or activity and the likely magnitude of those consequences, or, simply put, it is
“science-based decision-making”.
The risk analysis process
In simple terms, a risk analysis typically seeks to answer four questions:
• What can go wrong?
• How likely is it to go wrong?
• What would be the consequences of its going wrong?
• What can be done to reduce either the likelihood or the consequences of its going
wrong? (see MacDiarmid, 1997; Rodgers, 2004; Arthur et al., 2004).
The general framework for risk analysis typically consists of four major components:
• Hazard identification – the process of identifying hazards that could potentially
produce consequences;
• Risk assessment – the process of evaluating the likelihood that a potential hazard
will be realized and estimating the biological, social and/or economic consequences
of its realization;
• Risk management – the seeking of means to reduce either the likelihood or the
consequences of it going wrong; and
• Risk communication – the process by which stakeholders are consulted,
information and opinions gathered and risk analysis results and management
measures communicated.
The risk analysis process is quite flexible. Its structure and components will vary
considerably depending on the sector (e.g. technical, social or financial), the user (e.g.
government, company or individual), the scale (e.g. international, local or entity-level)
and the purpose (e.g. to gain understanding of the processes that determine risk or
to form the basis for legal measures). It can be qualitative (probabilities of events
happening expressed, for example, as high, medium or low) or quantitative (numerical
probabilities).
THE CONCEPT OF “HAZARD”
All risk analysis sectors involve the assessment of risk posed by a threat or “hazard”.
The definition of “hazard” depends on the sector and the perspective from which risk
is viewed (e.g. risks to aquaculture or risks from aquaculture). A hazard thus can be:
6 Understanding and applying risk analysis in aquaculture
• a physical agent having the potential to cause harm, for example:
– a biological pathogen (pathogen risk analysis);
– an aquatic organism that is being introduced or transferred (genetic risk
analysis, ecological risk analysis, invasive alien species risk analysis);
– a chemical, heavy metal or biological contaminant (human health and food
safety risk analysis, environmental risk analysis); or
• the inherent capacity or property of a physical agent or situation to cause adverse
affects, as in
• social risk analysis,
• financial risk analysis, and
• environmental risk analysis.
Risk analysis terminology
The terminology used by some risk analysis sectors is well established (e.g. pathogen
risk analysis, food safety, environmental risk analysis), and there is often considerable
differences in how individual terms are defined. An attempt at cross-sectoral
standardization of terms is thus probably futile, and it is thus important that that terms
used by the various risk analysis sectors be fully defined at the outset.
SOmE GENERAL PRINCIPLES
Some basic principles that appear to be common to all types of risk analysis are presented
below. These involve the broader concepts of common sense, uncertainty, precaution,
objectivity, transparency, consistency, scientific validation, stakeholder consultation,
stringency, minimal risk management, unacceptable risk and equivalence.
• The Principle of Common Sense – In assessing risks, the use of “common
sense” should prevail. In many cases, the outcomes of a risk analysis are obvious
and uncontroversial, and a decision can be made without resulting to a full risk
analysis, which can be a lengthy and expensive process.
• The Principle of Uncertainty – All risk analyses contain an element of uncertainty.
A good risk analysis will seek to reduce uncertainty to the extent possible.
• The Principle of Precaution – Those involved in the aquaculture sector have a
responsibility to err on the side of caution, particularly if the outcomes of a given
action may be irreversible. If the level of uncertainty is high, the Precautionary
Principle can be applied to delay a decision until key information is obtained.
However, steps must be taken to obtain the information in a timely manner.
• The Principle of Objectivity – Risk analyses should be conducted in the most
objective way possible. However, due to uncertainty and human nature, a high
degree of subjectivity may be present in some risk analyses. A risk analysis should
clearly indicate where subjective decisions have been made.
• The Principle of Transparency – Risk analyses, particularly those conducted by
public sector agencies, should be fully transparent, so that all stakeholders can
see how decisions were reached. This includes full documentation of all data,
sources of information, assumptions, methods, results, constraints, discussions
and conclusions.
• The Principle of Consistency – Although risk analysis methodology continues
to evolve, it is important that decisions, particularly those made by government,
are reached via standardized methods and procedures. In theory, two risk analysts
independently conducting the same risk analysis should reach roughly similar
conclusions.
• The Principle of Scientific Validation – The scientific basis of a risk analysis and
the conclusions drawn should be validated by independent expert review.
• The Principle of Stakeholder Consultation – If the results of a risk analysis are
likely to be of interest to, or impact upon others, then stakeholder consultations
General principles of the risk analysis process and its application to aquaculture 7
should be held. This is accomplished by risk communication, the interactive
exchange of information on risk among risk assessors, risk managers and other
interested parties. Ideally, stakeholders should be informed/involved throughout
the entire risk analysis process, particularly for potentially contentious risk
analyses (e.g. ecological, genetic and pathogen risk analyses for the introduction
of new aquatic species).
• The Principle of Stringency – The stringency of the risk management measures
to be applied should be in direct proportion to the risk involved.
• The Principle of Minimal Risk Management – Risk management measures that
impinge on the legitimate activities of others should be applied only to the extent
necessary to reduce risk to an acceptable level.
• The Principle of Unacceptable Risk – If the level of risk is unacceptable and no
effective or acceptable risk management measures are possible, then the activity
should not take place.
• The Principle of Equivalence – Risk management measures proposed by trading
partners that meet the acceptable level of risk should be accepted by the importing
country.
APPLICATION OF RISK ANALYSIS TO AQUACULTURE
Risk analysis has wide applicability to aquaculture. So far, it has mainly been
applied in assessing risks to society and the environment posed by hazards created
by or associated with aquaculture development (Box 1). These include the risks of
environmental degradation; introduction and spread of pathogens, pests and invasive
species; genetic impacts; unsafe foods; and negative social and economic impacts. The
use of risk analysis can provide insights and assist in making decisions that will help
to avoid such negative impacts, thus helping aquaculture development to proceed in a
more socially and environmentally responsible manner.
Risk analysis is less commonly used to
achieve successful and sustainable aquaculture
by assessing the risks to aquaculture posed by BOX 1
the physical, social and economic environment Examples of risks to society from
in which it takes place Box 2. These include aquaculture
reduction of environmental risks (e.g. due to
poor siting or severe weather events), biological Environmental risks
risks (infection by pathogens via transfer • pollution from feeds, drugs, chemicals,
from native stocks, predation by seals and wastes
sharks; red tides etc.), operational risks (poor • alteration of water currents & flow
planning, work-related injuries), financial risks patterns
(e.g. market changes, currency fluctuations, Biological risks
emergence of new competitors, etc.) and social • introduction of invasive alien species,
risks (negative image and resulting product exotic pests & pathogens
boycott, lack of skilled manpower, competition • genetic impacts on native stocks
from other sectors). • destruction/modification of ecosystems
There exists, therefore, considerable scope and agricultural lands (mangrove
to develop and expand the use of risk analysis deforestation, salination of ricelands)
for the benefit of aquaculture and the social and Financial risks
physical environments in which it takes place. • failure of farming operations
• collapse of local industry/sector
CONCLUSIONS Social risks
An integrated approach to risk analysis will • displacement of artisanal fishers
assist the aquaculture sector in reducing risks Human health risks
to successful operations from both internal • food safety issues
and external hazards and can similarly help
8 Understanding and applying risk analysis in aquaculture
to protect the environment, society and
BOX 2 other resource users from adverse and often
Examples of risks to aquaculture from unpredicted impacts. This could lead to
society and the environment improved profitability and sustainability of
the sector, while at the same time improving
Environmental risks the public’s perception of aquaculture as a
• severe weather patterns responsible, sustainable and environmentally
• pollution (e.g. agricultural chemicals, oil friendly activity.
spills)
Biological risks REFERENCES
• pathogen transfer from wild stocks Arthur, J.R., Bondad-Reantaso, M., Baldock,
• local predators (seals, sharks etc.) F.C., Rodgers, C.J. & Edgerton, B.F. 2004.
• toxic algal blooms, red tide Manual on risk analysis for the safe movement
Operational risks of aquatic animals (FWG/01/2002). APEC/DoF/
• poor planning NACA/FAO, APEC Publ. No. APEC #203-FS-
• poor design 03.1. 59 pp.
• workplace injuries MacDiarmid, S.C. 1997. Risk analysis, international
Financial risks trade, and animal health. In Fundamentals of risk
• market changes analysis and risk management. pp. 377–387. Boca
• inadequate financing Raton, CRC Lewis Publications.
• currency fluctuations OIE. 2007. Aquatic animal health code. 10th Edn.
• emergence of new competitors World Organisation for Animal Health, Paris
Social risks (available at: www.oie.int).
• negative image/press Rodgers, C.J. 2004. Risk analysis in aquatic
• lack of skilled manpower animal health. In J.R. Arthur & M.G. Bondad-
• competition for key resources from other Reantaso, eds. Capacity and awareness building
sectors on import risk analysis for aquatic animals.
• theft, vandalism Proceedings of the Workshops held 1–6 April
2002 in Bangkok, Thailand and 12–17 August
2002 in Mazatlan, Mexico. APEC FWG 01/2002,
Bangkok, NACA.
9
Food safety and public health
risks associated with products of
aquaculture
Iddya Karunasagar
Fish Products and Industry Division
Fisheries and Aquaculture Department
Food and Agriculture Organization of the United Nations
Viale delle Terme di Caracalla
00153 Rome, Italy
[email protected]
Karunasagar, I. 2008. Food safety and public health risks associated with products
of aquaculture. In M.G. Bondad-Reantaso, J.R. Arthur and R.P. Subasinghe (eds).
Understanding and applying risk analysis in aquaculture. FAO Fisheries and
Aquaculture Technical Paper. No. 519. Rome, FAO. pp. 9–25.
ABSTRACT
The Sanitary and Phytosanitary (SPS) Agreement within the framework of the World
Trade Organization emphasizes the need to apply risk analysis as a basis for taking
any SPS measure. With the adoption of the food-chain approach for food safety, the
responsibility for the supply of safe food is shared along the entire food chain from
primary production to final consumption. Thus the application of risk analysis to the
aquaculture sector, which produces nearly half the fish that is consumed worldwide, has
become very important. Guidelines for performing risk analysis have been brought out
by the Codex Alimentarius Commission or Codex. Risk analysis is a process consisting
of risk assessment, risk communication and risk management. Risk assessment is the
scientific evaluation of known or potential adverse health effects resulting from human
exposure to foodborne hazards. This consists of four steps: hazard identification, hazard
characterization, exposure assessment and risk characterization. The output of risk
assessment may be a qualitative or a quantitative (numerical) expression of risk as well
as attendant uncertainties. Hazard identification considers epidemiological data linking
the food and biological/chemical agent to human illness and the certainty associated with
such effects. At the hazard characterization step, a qualitative or quantitative description
of the severity and the duration of the adverse health effect that may result from the
ingestion of the micro-organism/toxin/chemical contaminants is made. During exposure
assessment, an estimate of the number of bacteria or the level of a biotoxin or chemical
agent consumed through the concerned food is made. The Codex defines the risk
characterization step as the process of determining the qualitative and/or quantitative
estimation including attendant uncertainties of the probability of occurrence and the
severity of the known or potential adverse health effect in a given population based on
hazard identification, exposure assessment and hazard characterization. As an example of
a risk assessment, the Food and Agriculture Organization of the United Nations/World
Health Organization risk assessment for choleragenic Vibrio cholerae in warmwater
shrimp in international trade is presented. Risk management is the process of weighing
10 Understanding and applying risk analysis in aquaculture
policy alternatives in the light of the results of risk assessment and if required, selecting
and implementing appropriate control options, including regulatory measures. Risk
communication is an interactive process of exchange of information and opinion on
risk among risk assessors, risk managers and other interested parties. Examples of risk
management measures adopted based on risk assessment are presented.
INTRODUCTION
Outbreaks of food-borne illnesses continue to be a major problem worldwide,
and international trade in food products is increasing. According to World Health
Organization (WHO) estimates, 1.8 million deaths related to contaminated food
or water occur every year. Traditionally, food safety programmes have focused on
enforcement mechanisms for final products and removal of unsafe food from the
market instead of a preventive approach. In such a model, the responsibility for safe
food tends to concentrate on the food-processing sector. The Food and Agriculture
Organization of the United Nations (FAO) is recommending a food-chain approach
that encompasses the whole food chain from primary production to final consumption.
In such a system, the responsibility for a supply of food that is safe, healthy and
nutritious is shared along the entire food chain by all involved in the production,
processing, trade and consumption of food. Stakeholders include farmers, fishermen,
processors, transport operators (raw and processed material) and consumers, as well
as governments obliged to protect public health. In order to protect public health
and facilitate international food trade, the member countries of the World Trade
Organization (WTO) have signed the Sanitary and Phytosanitary (SPS) Agreement.
Under this agreement, member countries have a right to take measures to ensure that
consumers are supplied with safe food, but they also have the obligation to ensure that
their food safety regulations are based on risk analysis and are not arbitrary and used
as a means to protect domestic producers from competition. Considering that nearly
50 percent of the fish traded in international markets comes from aquaculture, it is
important to ensure that the aquaculture sector is producing safe food. The food-chain
approach to food safety is based on five important aspects:
• The three fundamental concepts of risk analysis – risk assessment, risk management
and risk communication – should be incorporated into food safety. There
should be an institutional separation of science-based risk assessment from risk
management, which is the regulation and control of risk.
• Traceability from the primary producer (including fish feed) through post-
harvest treatments, food processing and distribution to the consumer should be
improved.
• Harmonization of food safety standards is necessary; this implies increased
development and wider use of internationally agreed-upon, scientifically based
standards. The Technical Barriers to Trade (TBT) Agreement of WTO tries
to achieve this by ensuring that arbitrary standards do not become barriers to
international trade.
• Equivalence of food safety systems that achieve similar levels of protection
against food-borne hazards, whatever means of control are used. This is a
requirement under the SPS Agreement.
• Increased emphasis on risk avoidance or prevention at source within the whole
food chain – from farm or sea to plate – is necessary to complement conventional
food safety management based on regulation and control.
Complementing the current emphasis on regulation and control of the food safety
system with preventive measures to control the introduction of contamination at
source requires the adoption of practices in food production, handling and processing
that reduce the risk of microbiological, chemical and physical hazards entering the food
Food safety and public health risks associated with products of aquaculture 11
FIGURE 1
The risk analysis process
Risk analysis
Risk assessment Risk management Risk communication
Hazard identification Hazard characterization Exposure assessment
Risk characterization
chain. There are some hazards such as chemical contaminants and biotoxins in shellfish
that cannot be simply removed from foodstuffs. The adoption of sound practices along
the food chain based on principles defined in Good Aquaculture Practices (GAP) and
in-plant control of food processing based on hazard analysis and critical control point
(HACCP) analysis is important to prevent such hazards from entering the system.
By using a risk-based approach to the management of food safety, food control
resources can be directed to those hazards posing the greatest threat to public health
and where the potential gains from risk reduction are large relative to the resource use.
Establishing risk-based priorities requires sound scientific knowledge and effective
systems for reporting the incidence of food-borne diseases.
Guidelines for performing risk analysis have been brought out by the Codex
Alimentarius Commission (CAC). According to Codex, risk analysis is a process
consisting of risk assessment, risk management and risk communication. Risk
assessment is a scientifically based process involving the following four steps: hazard
identification, hazard characterization, exposure assessment and risk characterization
(Figure 1).
THE RISK ANALYSIS PROCESS
Hazard identification
This involves identification of biological or chemical agents capable of causing adverse
health effects that may be present in a particular food or group of foods. Products of
aquaculture include freshwater and marine finfish as well as shellfish (molluscs and
crustaceans). Hazard identification considers epidemiological data linking the food
and biological/chemical agent to human illness (CCFH, 1998) and the certainty and
uncertainty associated with such effects. Data from national surveillance programmes,
microbiological and clinical investigations, and process evaluation studies are important
(Fazil, 2005). At the hazard identification step, a qualitative evaluation of available
information is carried out and documented. The characteristics of the organism/toxin/
chemical agent, including its effects on the host and mode of action, are considered.
Table 1 lists known or potential hazards associated with products of aquaculture.
Based on epidemiological evidence, only a few microbial agents are known to be
involved in foodborne illnesses; however, only a small number of outbreaks have
been adequately investigated. Therefore, limitations of hazard identification with
respect to biological agents include the expense and difficulty involved in outbreak
investigations, and the difficulties involved in the isolation and characterization of
certain pathogens such as viruses. However, for most chemical agents, clinical and
epidemiological data are unlikely to be available. Since the statistical power of most