Risk Assessment Dan HAccp
Risk Assessment Dan HAccp
Risk Assessment Dan HAccp
Article information:
Access to this document was granted through an Emerald subscription provided by 501757 []
For Authors
If you would like to write for this, or any other Emerald publication, then please use our Emerald for Authors service
information about how to choose which publication to write for and submission guidelines are available for all. Please
visit www.emeraldinsight.com/authors for more information.
The current issue and full text archive of this journal is available at
www.emeraldinsight.com/0007-070X.htm
BFJ
115,3
460
Abstract
Purpose The purpose of this paper is to review the methods for assessing food safety risk within a
food safety plan.
Design/methodology/approach The research involved analysis of both qualitative and
quantitative methods of risk assessment.
Findings Risk assessment is a key element of the HACCP approach to food safety. It requires food
business operators and those on HACCP teams to determine both the acceptable level of contamination
and the risk for the food business, and ultimately the consumer. The choice of food safety risk
assessment model is crucial to an organisation. The mechanisms to determine what is acceptable can
be a combination of scientific based and value based criteria and utilise qualitative or
semi-quantitative approaches. Whilst fuzzy logic has a place in making risk assessment more
quantitative; specific software tools are required to enable quantitative risk assessment especially
where what is acceptable at one point could, subject to other factors later in the supply chain, change to
an unacceptable level of risk to the consumer. Quantitative mechanisms are required to make these
decisions at organisational, or indeed at policy level, fully transparent.
Originality/value This research is of academic value and of value to policy makers and
practitioners in the food supply chain.
Keywords Risk, Assessment, Qualitative, Quantitative, HACCP, Food industry, Risk management
Paper type General review
1. Introduction
Food safety has been defined as the concept that food will not cause harm to the
consumer when it is prepared and/or eaten according to intended use (BSI London,
2005; CAC, 2003a). A safety hazard has been determined as a biological, chemical or
physical agent in food, or condition of food, with the potential to cause adverse health
effects. Whereas, food safety risk can be described as a function of the probability of
an adverse health effect, and the severity of that effect, consequential to a hazard(s) in
food (EC, 1997). The risk framework of the UK Foresight project offered a useful
insight into the present or future state of food safety by Tait et al. (2006) who developed
the following definitions:
.
Disease sources/emerging hazards. Phenomena or biological events that give rise
to potential new diseases.
.
Pathways. Mechanisms or routes by which a disease organism can transfer from
one host to another.
.
Drivers. Social, economic or physical factors that affect disease outcomes by
changing the behaviour of disease sources or pathways.
.
Outcomes. Diseases of plants, animals and humans.
Risk analysis is used to develop an estimate of risk to human health and safety, to identify
and implement appropriate measures to control the risk and to communicate to
stakeholders about the risk and measures applied (FAO/WHO, 2006; Toyofuku, 2006).
Risk analysis consists of three components, risk assessment, risk management and risk
communication. The interaction of the components of risk analysis that were proposed
(FAO/WHO, 2006) are as follows: risk communication encompasses the interactive
exchange of information and opinion concerning food safety risks this includes the
interaction of the components of risk assessment and risk management. Risk assessment
addresses scientific inputs whilst risk management is the actual decision making process
involving policy, systems and values. The Codex Alimentarius Commission (CAC, 2003b)
has adopted definitions of risk analysis terms relating to food safety:
.
Risk assessment is the science of understanding hazards, the likelihood of their
occurrence, and the consequences if they do occur.
.
Risk management is the mechanism of analysing policy alternatives following
risk assessment and identifying and implementing appropriate controls
including regulation.
.
Risk communication is the interactive exchange of information and opinions
concerning risk among risk assessors, risk managers, consumers and other
interested parties. Effective communication of the level of risk is critical for the
food industry, namely that food safety is communicated in a relevant way to all
sectors of the supply chain and most specifically to consumers so that they can
make well-informed decisions when purchasing food (Manning and Baines,
2004a).
BS EN ISO 1776:2002 (BSI London, 2002) defined the approaches to hazard and risk
assessment and stated that:
In many circumstances, the knowledge and expertise of experienced staff using a structured
approach may be sufficient to manage risk. Checklists are quick and easy to use, and can help
determine whether design standards and practices are met and whether previously
recognized hazards are properly addressed. Where the experience gained by industry has
been incorporated into codes and standards, a high level of safety can be achieved by
checking for compliance [. . .] Structured review techniques can be used to identify and
evaluate previously unforeseen hazards and unintended events that are not adequately
addressed by the previous methods.
Assessing food
safety risk
461
BFJ
115,3
462
The ultimate goal of risk assessment process is to estimate the probability and severity
of risk occurrence using qualitative and/or quantitative information (Coleman and
Marks, 1999; Davidson et al., 2006) and subsequently to identify opportunities for
intervention (Schlundt, 2000). However, in order to achieve this, the degree of
uncertainty must be recognised and included in any estimates of risk (Davidson et al.,
2006). Risk assessment in a food safety context has two meanings (Schlundt, 2000). The
generic meaning of risk refers to the measurement of risk and the identification of
factors that influence it (Voysey and Brown, 2000). The specific (or formalised)
meaning of risk assessment is the scientific evaluation of known or potential adverse
health effects resulting from human exposure to foodborne hazards (FAO/WHO, 1995).
Risk assessment and HACCP are related, but are fundamentally different processes.
Coleman and Marks (1999) argued that similarities exist between the inputs in the first
element of HACCP (hazard analysis) and risk assessment (hazard identification). Risk
assessment, therefore, provides support to risk managers in decision making and is
divided into qualitative, semi-quantitative and quantitative assessment (Sumner et al.,
2004, p. 1).
1.1 Qualitative risk assessment (Q)
According to CAC (2001, p. 55), qualitative risk assessment is based on data which,
while forming an inadequate basis for numerical risk estimations, nonetheless, when
conditioned by prior expert knowledge and identification of attendant uncertainties
permits risk ranking or separation into descriptive categories of risk. Hence,
qualitative risk assessment can assist a risk manager in priority setting and
policy-decision making (Coleman and Marks, 1999).
1.2 Semi-quantitative risk assessment (SQ)
Semi-quantitative risk assessment forms the bridge between qualitative and fully
quantitative methods. Values can be represented with statements and/or numeric
scales and some quantitative measures of risk are produced (Davidson et al., 2006).
1.3 Quantitative risk assessment (QRA)
According to Voysey and Brown (2000), a QRA should be carried out wherever or
whenever possible. However, if no data are available to make such inferences then a
quantitative risk assessment is not possible (Coleman and Marks, 1999). QRA are
usually carried out to evaluate microbiological hazards. A quantitative microbial risk
assessment (MRA) produces a mathematical statement that links the probability of
exposure to an agent and the probability that the exposure will affect the test
individual (Voysey and Brown, 2000). If a qualitative risk assessment has been done,
the risk estimate will be a simple statement that the risk is high/medium/low. If it is a
quantitative risk assessment, the risk estimate will be a number, such as predicted
illnesses per annum in the population, or the probability of becoming ill from eating a
serving of the food (Sumner et al., 2004, p. 21). The components of MRA are made up of
six steps (Figure 1). The emergence of MRA tools and other techniques for the analysis
of complex data have a significant impact on the decision making processes used by
risk managers in both government and industry (Buchanan and Appel, 2010).
Risk management in the food supply chain differs from inspection based controls in
that it must be science based and be developed from a set of food safety objectives.
Assessing food
safety risk
463
Figure 1.
Quantitative MRA
BFJ
115,3
464
.
Soby et al. (1993) developed a risk management cycle model in a review of risk
communication research and its relevance, mainly in relation to food-related risks
(Figure 2). This model recognised that stakeholder concerns including those of the
general public need to be recognised and addressed at each stage of the risk
management process.
BS EN ISO 17776: 2002 defined the process of risk management as a series of steps.
They are as follows:
(1) Identify the hazards.
(2) Evaluate the degree of risk and identify risk reduction measures. As further risk
reduction measures are introduced then this will in turn affect the degree of risk
with a feedback loop in place. It is at this step that screening criteria are used.
(3) Set functional requirements.
Screening criteria are the targets or standards used to judge the tolerability of an
identified hazard or effect. They are used to judge the significance of the hazards and
Figure 2.
Risk management model
effects and together with the results from the risk assessment provide the basis for risk
management decision-making. Screening criteria may include adoption of parameters
contained in codes and standards. These criteria are an important element of risk
categorisation and identifying the risk to reward ratio. Examples of screening criteria
in the context of food safety are product, process of performance criteria for example
cooking, storage, and processing temperatures; food formulation, or microbiological
specifications. These screening criteria may include a degree of safety over and above
the minimum requirements to produce safe food. During the risk management process
functional requirements also need to be determined. These are defined by BS EN ISO
1776: 2002 as the minimum criteria which should be satisfied to meet the stated health,
safety and environmental objectives. In the context of food safety these would be
termed in HACCP as critical limits, i.e. the measurable limits that separate safe from
unsafe food.
Food safety risk can arise both internally within the business and externally.
External risks are outside the control of the organisation namely social, political,
market or economic forces on a national or global scale. Management can alleviate the
effect of such risks by having contingency or disaster recovery strategies in place.
Internal risks are associated with the organisation and include food business
operator/manager and employee capabilities, as well as supplier, product and process
specific risks. These should be more controllable than external risk. Key performance
indicators (KPI) can be developed to act as an early warning mechanism to identify
when risk is not being sufficiently managed and before management of the risk is lost
and a food safety incident occurs. This is the approach taken at critical control points
(CCPs) when developing a food safety plan and developing measurable target levels
and tolerances for control of a food safety hazard as well as a critical limit which
separate safe from unsafe food. The precautionary principle is appropriate if a
potential risk has been identified where there are reasonable grounds for concern that
an unacceptable level of risk exists, but the supporting evidence may not be
sufficiently complete to enable a comprehensive risk assessment to be made. This is
especially so where a qualitative rather than quantitative risk assessment has been
undertaken. McDonnell (1993) suggested that arrangements for applying the
precautionary principle should include some process of testing scientific reliability.
The development of appropriate procedures for this is a large challenge for the future.
McDonnell highlighted the challenge of undertaking quantitative risk assessment
where many factors that impact on food safety have not in themselves been fully
quantified. Bro-Rasmussen (1999) further observed that It is necessary to deal more
actively with a principle of precautions, which differs from the risk concept. While the
latter is practiced by assessing actual data and scientifically documented information,
the precautionary principle is bound rather to deal with uncertainties of data and
inadequacies of information. He suggested that risk evaluation should rely on existing
information and on predictive modelling of data from reliable sources, i.e. be
quantitative.
Risk is not always seen purely in scientific terms. Risk perceptions represent a
persons views about the risk inherent in a particular situation. Perceptions about food
safety risk are what the individual believes would be the amount of health risk, if any,
they would face from consuming a food product (Schroeder et al., 2007). Handler
(1979), then President of the US National Academy of Sciences said: The estimation of
Assessing food
safety risk
465
BFJ
115,3
466
Table I.
Comparison of science
based and value based
approaches to evaluating
the acceptability of food
safety risk
risk is a scientific question [...] The acceptability of a given level of risk, however is a
political question to be determined in the political arena. Nestle (2003) determined that
we define a safe food as: one that does not exceed an acceptable level of risk and risk
may be assessed by either a science based or value based approach. The difference
between science based and value based approaches to evaluating the acceptability of a
food safety risk have been defined (Table I). Furthermore, Nestle (2003) argued that
safety is relative; it is not an inherent biological characteristic of a food. A food may be
safe for some people and not for others, safe at one level of intake but not at another, or
safe at one point in one time, but not later [...] Decisions about acceptability involve
perceptions, opinions, and values, as well as science. When such decisions have
implications for commercial, or other self-interested motives, food safety enters the
realms of politics. Quantitative science-based risk assessment balances risk against
benefit and cost whereas qualitative value-based risk assessment balances risk against
dread and outrage. Whilst neither method of risk assessment is mutually exclusive, the
approach used either individually, or collectively by stakeholders will act as a driver in
determining how effectively an organisation implements specific strategies such as
those addressing food safety management. The stakeholders will, depending on their
specific expectations, fit at different points on the quantitative/qualitative risk
assessment spectrum with the consumer usually at the most qualitative point whilst
other stakeholders have more quantitative measures in place.
Slovic (2000) stated that the perception of and acceptance of risk have their roots in
social and cultural factors. A number of factors will affect the individuals perception
of risk which may be value based (Table II). The interaction of these factors is complex
and it is the consumers reaction to a combination of these factors, which will
ultimately impact on their decision making at the point of purchase or consumption
especially with regard to food safety.
Prior to the mid-1970s, Cooter and Fulton (2001) suggested that food safety was not
a political, scientific or societal concern. The emergence of new hazards, e.g. Salmonella
in eggs in 1988 (Lacey, 1989); dioxins in poultry in 1999 (Verbeke, 2001); bovine
spongiform encephalopathy in cattle leading to the new variant Creutzfeldt-Jakob
disease (nvCJD) in 1988 (Palmer, 1996; Shears et al., 2001) and acrylamide in many
ready-to-eat foods like coffee and French fries in 2005 (Claus et al., 2008) has driven
both consumer buying behaviour and food policy developments (Knowles et al., 2007).
Science based
Value based
Factor
Catastrophic potential trend in
fatalities and injuries
Familiarity
Understanding of mechanisms
and processes
Certainty about risk
Controllability (personal)
Method of exposure
Effects on children
Effects manifestation
Effects on future generations
Victim identity
Dread
Reversibility of effects
Trust in institutions
Media attention
Origin
Familiar hazard
Understood
Assessing food
safety risk
467
Table II.
Factors affecting risk
perception and evaluation
BFJ
115,3
468
operators shall identify any step in their activities, which is critical to ensuring food
safety and ensure that adequate safety procedures are identified, implemented,
maintained and reviewed on the basis of the following principles, used to develop the
system of HACCP [Hazard Analysis Critical Control Point]. The Directive and a
number of private assurance schemes refer to the requirements of the CAC which
defined the key terminology and identified the 12 steps and seven principles of HACCP.
The original document in 1997 has been subsequently revised as the principles of
HACCP have further evolved to Revision four (CAC, 2003a). The CAC standards form
the baseline standard for global food safety and food hygiene legislation and food
safety system standards especially with regard to HACCP and standards of good
hygienic practice (CAC, 2003a, b, 2007, 2011).
The UK Food Safety (General Food Hygiene) Regulations 1995 (HMSO, 2995) aimed
to implement the EC Directive (93/43/EEC) and applied to all stages of food production
after primary production. The legislation defined the requirements for hazard analysis,
but not specifically the need to implement HACCP principles, as defined by the CAC,
nor to formally document the hazard analysis undertaken (Manning and Baines,
2004a). The authors determined that the benefits of a full HACCP approach cannot be
denied, especially in the manufacture of high risk foods such as cooked meats,
sandwiches and dairy products, but it requires significant resources and technical
knowledge to implement HACCP effectively. The EU Regulation 852/2004 on the
hygiene of foodstuffs applied in the EU from 1 January 2006 (European Union, 2004).
The aim of the legislation was to simplify the existing 17 food hygiene directives with
five measures including Regulation 852/2004. The common position (EC) No 1/2004 on
the adoption of an EU food hygiene directive (2004/C 48 E/01) Section 8 stated: An
integrated approach is necessary to ensure food safety from the place of primary
production up to and including placing on the market or export. Every food business
operator should ensure that food safety is not compromised. It proposed that food
hazards present at the level of primary production should be identified and
adequately controlled but that the application of HACCP principles was not yet
generally feasible. This would be reviewed within five years of the regulation being
in force. However, it was determined that guides to good practice should encourage
the use of appropriate hygienic practices at farm level (Manning et al., 2006a).
With specific emphasis on risk management the CAC (2003a) proposed that HACCP
can be applied throughout the food chain and its implementation should be guided by
scientific evidence of risks to human health, i.e. be quantitative with measurable
parameters for the determination of risk. Furthermore, managers and supervisors
should have enough knowledge of food hygiene principles and practices to be able to
judge potential risks, take appropriate preventive and corrective action, and ensure
that effective monitoring and supervision takes place. Therefore, in deciding whether a
requirement is necessary or appropriate, an assessment of the risk should be made,
preferably within the framework of the HACCP approach. As well as the identification
of hazards and the causes of their occurrence the CAC (2003a) defined hazard analysis
as the process of collecting and evaluating information on hazards and conditions
leading to their presence to decide which are significant for food safety and therefore
should be addressed in the HACCP plan. This methodology then leads to the
determination of CCPs, i.e. a [process] step at which control can be applied and is
essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level
(CAC, 2003a). In order to identify CCPs, a decision tree tool is commonly used which
determines whether a control point is a critical control point through the answering of a
set sequence of questions. The questions are listed below:
.
Are preventive measures in place for the hazard?
.
Does the process step eliminate or reduce the hazard to an acceptable level?
.
Could contamination occur at unacceptable level(s) or increase to unacceptable
level(s)?
.
Will a subsequent step eliminate or reduce the hazard to an acceptable level?
Questions two, three and four all require the determination of what is acceptable or
unacceptable in terms of levels of hazard and also net risk, i.e. the residual net level of
contaminant compared to gross level of contaminant after it has potentially been
processed out of the product or the procedures and policies in place (pre-requisite
programme) have reducing the likelihood of a hazard occurring to an acceptable level.
Whilst, in scientific terms an acceptable limit could be not detected because that is
the limit of detection of the methodology used even if this is parts per billion, this does
not in itself mean that the food is contaminant-free. As testing methodology continues
to develop the limit of detection reduces further but many monitoring and verification
techniques used cannot categorically determine absence only that a contaminant is not
detected. Decisions about acceptability involve perceptions, opinions, and values, as
well as science (Nestle, 2003) but as zero-risk is unattainable in food production, the
decision tree approach drives the risk manager to define a level of acceptable
(tolerable) presence of contaminant in food, e.g. the maximum residue level (MRL) for
pesticides levels in food, or indeed an acceptable or tolerable level of risk (Havelaar
et al., 2010). Huihui et al. (2010) concurred stating that One can mitigate, control,
transfer or evade risk but can never eliminate it even with greatest effort. Indeed, they
argued that risk is sufficiently uncertain that one may never know whether or when
risk will happen and that risks can change or increase or decrease over time. For
example, in the instance of developing antibiotic resistance in a pathogenic
microorganism, whilst the original risk assessment may have been well founded
when and where mutation will cause antibiotic resistance within that microorganism
cannot be pre-determined. The CAC (2011) define a food safety objective (FSO) as the
maximum frequency and/or concentration of a hazard in a food at the time of
consumption that provides or contributes to the appropriate level of protection
(ALOP). Further, the performance objective (PO) has been defined as the maximum
frequency and/or concentration of a hazard in a food at a specified step in the food
chain before the time of consumption that provides or contributes to an FSO or ALOP,
as applicable (CAC, 2011). These definitions recognise that the acceptable level of a
hazard may vary at different points in the production, supply and consumption of a
food product. By setting an FSO, competent authorities determine a risk-based limit
that should be achieved operationally within the food chain, while providing flexibility
for different production, manufacturing, distribution, marketing, and preparation
approaches (CAC, 2007). The WTO/SPS agreement (WHO, 1997) introduced the term
appropriate level of sanitary or phytosanitary protection (ALOP), i.e. the level of
protection deemed appropriate by a Country or Member State establishing a SPS
measure to protect human, animal or plant life or health within its borders.
Assessing food
safety risk
469
BFJ
115,3
470
In almost all studies of acceptable risk levels two factors are identified (Vrijling et al.,
1998): firstly the view of the individual who decides to undertake an activity weighing
the risks against the direct or indirect personal benefits or losses and society
considering if an activity, or in this case food, is acceptable in terms of the risk-benefit
trade-off for the total population. They further argued that an important aspect is the
degree of autonomy (voluntariness) with which the decision is taken and the risk
endured. In the case of societal decisions, as in the determination of CCPs in a food
process by an organisation in the food supply chain, the individual can still make the
appraisal in accordance with their own set of standards, but their influence on the final
outcome is democratically limited [...] the decision to accept risk is not based on the
absolute notion of one acceptable risk level but has some flexibility in judgment.
Hunter and Fewtrell (2001) suggested that a risk is acceptable when:
.
it falls below an arbitrary defined probability;
.
it falls below some level that is already tolerated;
.
it falls below an arbitrary defined attributable fraction of total disease burden in
the community;
.
the cost of reducing the risk would exceed the costs saved;
.
the cost of reducing the risk would exceed the costs saved when the costs of
suffering are also factored in;
.
the opportunity costs would be better spent on other, more pressing, public
health problems;
.
public health professionals say it is acceptable;
.
the general public say it is acceptable (or more likely, do not say it is not); and
.
politicians say it is acceptable.
Manning et al. (2006a) suggested that the food industry must recognise that the general
public wishes both food science and the probability of risk to be considered equally
with values which may be deemed irrational or emotive, otherwise a sense of suspicion
and mistrust of either the government and/or the food industry could arise. They
concluded that in order to have ethical reasoning embedded in food policy, policy
makers must be able to understand and evaluate moral arguments, and consider that
perceived risk may be based on value as well as scientific based judgments, be
fair-minded and make well reasoned decisions, otherwise they will be unable to
maintain confidence in their respective policies and strategies (Manning et al., 2006b).
What is the influence of business culture in determining the acceptable level of risk?
Griffith et al. (2010) identified a positive safety culture as a culture in which safety
is understood and accepted to be the number one customer/business priority.
However, they argued that safety culture often has to compete with opposing business
cultures including saving money or managing conflicting demands and has to
effectively manage the risk of human error. So how should the acceptable level of a
food safety hazard present in food or an acceptable level of risk be determined? How do
we demonstrate the objective element of the decision making process using the CCP
decision tree? We have to be able to quantify what is acceptable and have transparency
in demonstrating how this decision was reached.
Assessing food
safety risk
Reference
471
Table III.
Definitions of risk
Table IV.
Identification of
qualitative and
quantitative values for
determining risk
Negligible
Marginal
Catastrophic
Critical
,104
105 . C . 104
106 . C . 105
12
16
12
20
15
10
f , 102 6
102 3
f . 102 6
102 1
f . 102 1 f . 102 2
102 2
f . 102 3
5
Improbable
Qualitative
Quantitative
Where 1 incident
in 1000000
occasions frequency
(f) 102 6
.106
Organisational Cost
Quantitative
Consequences
1 Death
2 Permanent major
disability (acute or
chronic illness)
3 Permanent minor
disability
4 Temporary minor
disability
Individual
Qualitative
472
Probability
1
2
3
4
Frequent Probable Occasional Remote
BFJ
115,3
They concluded that these approaches to risk assessment reflect a range of detail of
assessment from Q (lowest) to full QRA (highest). Within the HACCP process the
traditional method of Q assessment has been using likelihood (probability) and
severity (consequence) see Figure 3. The determination of what constitutes low
medium and high categories is not numerically defined. SQ risk assessment can use
both qualitative and quantitative terms as in Table IV to determine the level of risk. BS
EN ISO 1776: 2002 defined a 5 4 risk assessment matrix which incorporated
consequence and probability. This can be adapted to develop a semi-quantitative
model (Figure 4). This methodology identifies aggregated risk by using multiplication
of the numbers assignment to particular variables to give an overall risk factor. Sadiq
and Husain (2005) suggested that Q or SQ risk assessment is not enough to explain risk
alone as the importance (intensity) of risk items is also a key element in determining
the rate of aggregative risk in process.
Several quantitative risk assessments for specific microbiological hazards in
products such as Escherichia coli O157:H7 in ground beef hamburgers (Cassin et al.,
Assessing food
safety risk
473
Figure 3.
QRA in the HACCP
process
Figure 4.
SQ risk assessment
BFJ
115,3
474
1998); Vibrio parahaemolyticus in raw oysters (FDA, 2005); and Salmonella in whole
chickens (Oscar, 2004) are shown (Table V). Cassin et al. (1998) described the behaviour
of pathogens from production through processing, handling and consumption to
predict human exposure to E. coli O157:H7 from beef hamburgers. The exposure
estimate was then used as input to a dose-response model to estimate the health risk
associated with consumption. This model predicted a probability of haemolytic uremic
syndrome (kidney failure) of 3.7 6.7-6 and a mortality of 1.9 10-7 per meal for the
very young. Meanwhile, FDA (2005) predicted the risk per serving of raw oysters as
approximately 1 10-6 (equivalent to one illness of gastroenteritis in every 1,000,000
servings). Oscar (2004) also predicted 0.44 cases of salmonellosis per 100,000
consumers per chicken serving.
QRA have the additional advantage of being able to model the effects of different
interventions and this is probably their greatest strength (FAO/WHO, 2006, p. 37).
QRA can be complex, detailed, quantitative mathematical models such as the
Monte-Carlo simulation and quantification of uncertainty (e.g. Cassin et al., 1998).
Food decision makers require tools that enable them to: identify the most significant
risks from a public health perspective; reduce risks, by taking into account the
feasibility, effectiveness and cost of possible interventions; and allocate efforts and
resources accordingly (Food Safety Research Consortium, 2003; Taylor et al., 2003).
There are a number of decision-support tools to assist in determining potential food
safety risks and infectious diseases and 11 of these tools are summarised (Table VI).
In risk assessment, probability logic, as previously described is primarily used
however fuzzy logic is increasingly being applied to the food supply chain. Fuzzy logic
is based on the assumption that a variable can be a member of more than one group
even a complement group. In the context of food safety this means that an answer
when using a decision tree might not be purely yes or no with regard to food safety,
but maybe. Fuzzy logic allows that response as an option especially with regard to
the potential for microbiological mutation or emerging pathogens. Fuzzy logic
provides a language with syntax and semantics to translate qualitative knowledge into
numerical reasoning (Sadiq et al., 2004). The authors explained that when evaluating
risk items in complex systems, decision-makers, engineers, managers, regulators and
Pathogen
Table V.
QRA models for food
pathogens
Food commodity
Escherichia coli
O157:H7
Listeria
monocytogenes
Bacillus cereus
Ground beef
hamburgers
Soft cheese
Listeria
monocytogenes
Escherichia coli
O157:H7
Vibrio
parahaemolyticus
Salmonella spp.
Smoked salmon
Probability of infection
3.7 6.7
-6
Reference
Cassin et al. (1998)
Raw fermented
sausages
Raw oysters
Whole chicken
0.44 10-5
Oscar (2004)
Chinese-style rice
Risk Ranger
Description
(continued)
Reference
Assessing food
safety risk
475
Table VI.
Risk ranking tools
A food defensive tool adapted from the military for use in the
food industry. The tool can be used to assess how vulnerable a
system or infrastructure is to an attack and focus resources on
protecting the system. CARVER is an acronym for the following
six attributes used to evaluate the attractiveness of a target for
attack:
Criticality measure of public health and economic impacts of
an attack
Accessibility ability to physically access and egress from
target
Recuperability ability of system to recover from attack
Vulnerability ease of accomplishing attack
Effect amount of direct loss due to attack
Recognisability ease of identifying target
Shock Health, economic and psychological impacts of an
attack within the food industry
Developed for quantitative risk assessment associated with
microbial hazards for food products and production processes.
SIEFE is interactive and is best used by experienced
microbiologists, as they are able to make the best use of their
knowledge and interpret the systems estimates critically
To assess and rank food safety risks across various foods and
hazards, at various points along the food chain. It assesses risk
based on consumption patterns and estimates risks per-serving
A simplified QMRA model aimed at comparing the risk of
pathogen-food product combinations using Microsoft Excel
User defines the parameters in linguistic terms or semiquantitative levels to describe initial hazard level, potential
changes during processing and consumer preparation. The
inputs are then converted to fuzzy values and interval
arithmetic is used to characterise hazards and compute risk.
The tool is useful for early stage microbial risk assessment in
food systems, especially in ranking risks based on total illness
and severity of illness
McNab (2003)
FDA (2010)
Reference
476
Description
Table VI.
BFJ
115,3
other stake-holders often view risk in terms of linguistic variables like very high, high,
very low, low etc. The fuzzy set theory is able to deal effectively with these types of
uncertainties (encompassing vagueness), and linguistic variables can be used to
approximate reasoning and subsequently manipulated to propagate the uncertainties
throughout the decision process. This led to the development of risk contours. Wang
et al. (2011) developed a fuzzy model for aggregative food safety risk assessment in
food supply chains which enables a structured risk assessment that resulted in a single
risk rating at a point in the food supply chain. Letia and Groza (2010) proposed an
argument approach based on fuzzy logic in developing a decision support system for
HACCP plans especially where more than one critical limit will deliver the same level
of safety when controlling a food hazard. Markowski and Mannan (2008) proposed, as
has been shown in this paper that a risk matrix is a proven mechanism to characterise
and rank process risks that are typically identified through one or more
multifunctional reviews (e.g. process hazard analysis, audits, or incident
investigation) and in the context of food safety through HACCP. They concluded
that a risk matrix is a very useful tool for SQ risk assessment as well as the selection of
risk control measures (preventative measures in the context of HACCP). However, they
suggested that the overall risk category (risk score) obtained in this approach of
categorising likelihood and severity is quite imprecise and vague. This can then
produce significant uncertainties concerning the actual risk category. Their research
identified that one approach to deal with such uncertainties is a fuzzy logic. In contrast
to the traditional risk matrix, all variables of the risk matrix are expressed in fuzzy sets
defined by appropriate membership functions. This allows for mapping of input data
into output results so that the final risk result obtained is more precise and reliable.
This fuzzy risk matrix application can lead to different risk surfaces which can be
used as a tool for designing more reliable food safety systems. Fuzzy logic also has a
range of applications in developing processing steps which are designed to eliminate a
food safety hazard, e.g. temperature control.
4. Discussion
Risk assessment is a key element of the risk management process. As demonstrated in
this paper, risk assessment can be undertaken at international, national and individual
business operator level. The CAC is a major driver of policy at international and
national levels especially in terms of proposing ALOP and FSOs. At an individual
business level, the HACCP approach to food safety requires food business operators,
and those who are on HACCP teams, to determine what is an acceptable level of
contamination and an acceptable level of risk for the food business and ultimately the
consumer. It is also important to have a clear definition of the goal and scope of risk
assessment in order to meet the needs of risk managers (Toyofuku, 2006). The
mechanisms to determine what is acceptable at specific steps in the manufacturing or
food preparation process, and/or at the point of consumption can be a combination of
scientific based and value based criteria utilising qualitative, semi-quantitative or fully
quantitative approaches. Whilst, fuzzy logic has a place in making risk assessment
more quantitative; the business based HACCP team would be unable to use this
methodology without specific software tools. However, it would provide a quantitative
mechanism for deeming what is acceptable especially where what is acceptable could
subject to other factors later in the supply chain change to an unacceptable level of risk
Assessing food
safety risk
477
BFJ
115,3
478
Figure 5.
Selection of different levels
of risk assessments
Assessing food
safety risk
479
BFJ
115,3
480
BSI London (2002), BS EN ISO 17776:2002 Petroleum and natural gas industries Offshore
production installations Guidelines on tools and techniques for hazard identification and
risk assessment, BSI, London.
BSI London (2005), BS EN ISO 22000:2005 Food Safety management systems Requirements
for any organization in the food chain, BSI, London.
Buchanan, R.L. and Appel, B. (2010), Combining analysis tools and mathematical modeling to
enhance and harmonize food safety and food defense regulatory requirements,
International Journal of Food Microbiology, Vol. 139, pp. S48-S56.
Cassin, M.H., Lammerding, A.M., Todd, E.C.D., Ross, W. and McColl, R.S. (1998), Quantitative
risk assessment for Escherichia coli O157:H7 in ground beef hamburgers, International
Journal of Food Microbiology, Vol. 41 No. 1, pp. 21-44.
Claus, A., Carle, R. and Schieber, A. (2008), Acrylamide in cereal products: a review, Journal of
Cereal Science, Vol. 47 No. 2, pp. 118-33.
Codex Alimentarius Commission (CAC) (2001), Principles and guidelines for the conduct of
microbiological risk assessment (CAC/GL 30-1999), Food hygiene basic texts, available
at: ftp://ftp.fao.org/docrep/fao/005/Y1579e/Y1579e.pdf (accessed 21 June 2011).
Codex Alimentarius Commission (CAC) (2003a), Hazard analysis and critical control point
(HACCP) system and guidelines for its application, Codex Alimentarius Commission
Food Hygiene Basic Texts, Revision 4, available at: www.codexalimentariusnet/
download/standards/23/cxp_001e.pdf (accessed 21 June 2011).
Codex Alimentarius Commission (CAC) (2003b), Risk analysis policies of the Codex
Alimentarius Commission, 26th Session, July.
Codex Alimentarius Commission (CAC) (2007), Principles and guidelines for the conduct of
microbiological risk management (MRM), (CAC/GL 63-2007), Food hygiene basic texts,
available at: www.codexalimentarius.net/download/standards/10741/cxg_063e.pdf
(accessed 21 June 2011).
Codex Alimentarius Commission (CAC) (2011), The 20th edition of the procedural manual of
Codex Alimentarius Commission, available at www.codexalimentarius.net/web/
procedural_manual.jsp (accessed 21 June 2011).
Coleman, M.E. and Marks, H.M. (1999), Qualitative and quantitative risk assessment, Food
Control, Vol. 10, pp. 289-97.
Cooter, R. and Fulton, R. (2001), Food matters: food safety research in the UK public sector,
1917-1990, Food Industry Journal, Vol. 4 No. 3, pp. 251-61.
Cope, S., Frewer, L.J., Houghton, J., Rowe, G., Fischer, A.R.H. and de Jonge, J. (2010), Consumer
perceptions of best practice in food risk communication and management: implications for
risk analysis policy, Food Policy, Vol. 35 No. 4, pp. 349-57.
Covello, V.T. and Merkhofer, M.W. (1994), Risk Assessment Methods, Plenum Press, New York,
NY.
Covello, V.T., Sandman, P.M. and Slovic, P. (1988), Risk Communication, Risk Statistics and Risk
Comparisons: A Manual for Plant Managers, Chemical Manufacturers Association,
Washington, DC, p. 54.
Davidson, V.J., Ryks, J. and Fazil, A. (2006), Fuzzy risk assessment tool for microbial hazards in
food systems, Fuzzy Sets and Systems, Vol. 157, pp. 1201-10.
Department of Health and Ageing (2007), Business sector food safety risk priority classification
framework, Australian Government, Department of Health and Ageing, available at:
www.health.gov.au/internet/main/publishing.nsf/Content/D838A89DCEB7348ACA25
6F190003AFC1/$File/Risk%20Profiling.ppt#328,1. Business Sector Food Safety Risk
Priority Classification Framework (accessed 5 April 2010).
Donoghue, A.M. (2000), The design of hazard risk assessment matrices for ranking occupational
health risks and their application in mining and mineral processing, Occupational
Medicine, Vol. 51 No. 2, pp. 118-23.
European Commission (EC) (1997), European Commission Scientific Committee for Food,
Brussels European Commission 1997 (93/43/EEC; expressed on 13 June 1997).
European Commission (EC) (2000), Commission of the European Communities Brussels,
02.02.2000 COM (2000) 1 Communication from the Commission on the Precautionary
Principle.
European Union (2004), Regulation (EC) No 852/2004 of the European parliament and the
Council of 29 April 2004 on the hygiene of foodstuffs, available at: http://eurlex.europa.eu/
LexUriServ/LexUriServ.do?uriOJ:L:2004:226:0003:0021:EN:PDF
Evers, E.G. and Chardon, J.E. (2010), A swift quantitative microbiological risk assessment
(sQMRA) tool, Food Control, Vol. 21 No. 3, pp. 319-30.
Food Agriculture Organisation/World Health Organisation (FAO/WHO) (1995), Application of
risk analysis to food standards issues, Report of the Joint FAO/WHO expert consultation,
Geneva, 13-17 March, available at: www.who.int/foodsafety/publications/micro/en/
march1995.pdf (accessed 24 February 2010).
Food Agriculture Organisation/World Health Organisation (FAO/WHO) (2006), Food safety
risk analysis. A guide for national food safety authorities, pp. 1-78, available at www.
who.int/foodsafety/publications/micro/riskanalysis06.pdf (accessed 5 April 2010).
Food and Drug Administration (FDA) (2005), Quantitative risk assessment on the public health
impact of pathogenic Vibrio parahaemolyticus in raw oysters, Center for Food Safety and
Applied Nutrition, Food and Drug Administration, available at: www.fda.gov/Food/
ScienceResearch/ResearchAreas/RiskAssessmentSafetyAssessment/ucm050421.htm
(accessed 8 April 2010).
FoodLaw (2006), FoodLaw reading, available at: www.foodlaw.rdg.ac.uk/f-uk-new.htm
(accessed 7 July 2011).
Food Safety Centre (2010), Risk ranger, Australias food safety information portal, available at:
www.foodsafetycentre.com.au/riskranger.php (accessed 5 April 2010).
Food Safety Research Consortium (2003), Purpose and key attributes of the foodborne illness
risk ranking model, available at: www.thefsrc.org/Model%20Purpose%20and%20Key%
20Attributes%20FORMATTED.pdf (accessed 5 April 2010).
FPTCFSP (2007), Risk categorization model for food retail / food service establishments, Health
Canada, Federal/Provincial/Territorial Committee on Food Safety Policy, available at:
www.hc-sc.gc.ca/ahc-asc/alt_formats/hpfb-dgpsa/pdf/pubs/risk_categorizationcategorisation_risques-revised_revisee-eng.pdf (accessed 5 April 2010).
Griffith, C.J., Livesey, K.M. and Clayton, D.A. (2010), Food safety culture: the evolution of an
emerging risk factor?, British Food Journal, Vol. 112 No. 4, pp. 426-38.
Handler, P. (1979), Some comments on risk assessment, National Research Council Current
Issues and Studies (Annual Report), National Academy of Sciences, Washington, DC.
Havelaar, A.H., Brul, S., de Jong, A., de Jonge, R., Zweietering, M.H. and ter Kuile, B.H. (2010),
Future challenges to microbial food safety, International Journal of Food Microbiology,
Vol. 139, pp. S79-S94.
Health and Safety Executive (HSE) (2006), HSE information sheet. Guidance on risk assessment
for offshore installations, Offshore Information Sheet No. 3/2006.
Hoornstra, E. and Notermans, S. (2001), Quantitative microbiological risk assessment,
International Journal of Food Microbiology, Vol. 66, pp. 21-9.
Assessing food
safety risk
481
BFJ
115,3
482
Houghton, J., Rowe, G., Frewer, L., Van Kleef, E., Chryssochoidis, G., Kehagia, O., Korzen-Bohr, S.,
Lassen, J., Pfenning, U. and Strada, A. (2008), The quality of food risk management in
Europe: perspectives and priorities, Food Policy, Vol. 33, pp. 13-26.
Huihui, N., An, C. and Ning, C. (2010), Some extensions on risk matrix approach, Safety Science,
Vol. 48, pp. 1269-78.
Hunter, P.R. and Fewtrell, L. (2001), Acceptable risk, in Fewtrell, F. and Bartram, J. (Eds),
Water Quality: Guidelines, Standards and Health, World Health Organization (WHO), IWA
Publishing, London, pp. 207-28.
Huss, H.H., Jorgensen, L.V. and Vogel, B.F. (2000), Control options for listeria monocytogenes in
seafoods, International Journal of Food Microbiology, Vol. 62, pp. 267-74.
ICAEW (1998), Financial Reporting of Risk: Proposals for a Statement of Business Risk, The
Institute of Chartered Accountants in England and Wales, London.
Johnson, V. and Peppas, S.C. (2003), Crisis management in Belgium: the case of Coca-Cola,
Corporate Communications: An International Journal, Vol. 8 No. 1, pp. 18-22.
Knowles, T., Moody, R. and McEachern, M.G. (2007), European food scares and their impact on
EU food policy, British Food Journal, Vol. 109 No. 1, pp. 43-67.
Krystallis, A., Frewer, L., Rowe, G., Houghton, J., Kehagia, O. and Perrea, T. (2007), A perceptual
divide? Consumer and expert attitudes to food risk management in Europe, Health, Risk
and Society, Vol. 9 No. 4, pp. 407-24.
Lacey, R. (1989), Salmonella enteritidis and eggs: the position at the end of 1988, British Food
Journal, Vol. 91 No. 2, pp. 5-8.
Letia, I.A. and Groza, A. (2010), Argumentative support for Structured HACCP Plans,
Advances in Electrical and Computer Engineering, Vol. 10 No. 2, available at: www.aece.ro/
displaypdf.php?year2010&number2&article20 (accessed 21 June 2011).
Lindqvist, R. and Westoo, A. (2000), Quantitative risk assessment for Listeria monocytogenes in
smoked or gravad salmon and rainbow trout in Sweden, International Journal of Food
Microbiology, Vol. 58 No. 3, pp. 181-96.
McDonnell, G. (1993), Risk management and the precautionary principle: coping with
decisions, in Harding, R. and Fisher, L. (Eds), The Precautionary Principle, University of
New South Wales Press, Sydney.
McElroy, D.M., Jaykus, L.-A. and Foedgeding, P.M. (1999), A quantitative risk assessment for
Bacillus cereus emetic disease associated with the consumption of Chinese-style rice,
Journal of Food Safety, Vol. 19 No. 3, pp. 209-29.
McNab, B. (2003), Food safety universe database. A semi-quantitative risk assessment tool,
Ontario Ministry of Agriculture and Food, available at: https://ozone.scholars
portal.info/bitstream/1873/6231/1/10318750.pdf (accessed 9 April 2010)
Manning, L. (2009), Food safety and brand equity, British Food Journal, Vol. 109 No. 7,
pp. 496-510.
Manning, L. and Baines, R.N. (2004a), Effective management of food safety and quality, British
Food Journal, Vol. 106 No. 8, pp. 598-606.
Manning, L. and Baines, R.N. (2004b), Globalisation. A study of the poultry meat supply chain,
British Food Journal, Vol. 106 Nos 10/11, pp. 819-36.
Manning, L., Baines, R.N. and Chadd, S.A. (2006a), Food safety management in broiler meat
production, British Food Journal, Vol. 108 No. 8, pp. 605-21.
Manning, L., Baines, R.N. and Chadd, S.A. (2006b), Ethical modelling of the food supply chain,
British Food Journal, Vol. 108 No. 5, pp. 358-70.
Markowski, A.S. and Mannan, M.S. (2008), Fuzzy risk matrix, Journal of Hazardous Materials,
Vol. 159, pp. 152-7.
Nestle, M. (2003), Safe Food: Bacteria, Biotechnology and Bioterrorism, University of California
Press, London.
Oscar, T.P. (2004), A quantitative risk assessment model for Salmonella and whole chickens,
International Journal of Food Microbiology, Vol. 93 No. 2, pp. 231-47.
Palmer, C.M. (1996), A week that shook the meat industry: the effects on the UK beef industry of
the BSE crisis, British Food Journal, Vol. 98 No. 11, pp. 17-25.
Peeler, E.J., Murray, A.G., Thebault, A., Brun, E., Giovaninni, A. and Thrush, M.A. (2007),
The application of risk analysis in aquatic animal health management, Preventive
Veterinary Medicine, Vol. 81, pp. 3-20.
Rosenbloom, J.S. (1972), Case Study in Risk Management, Prentice Hall, Englewood Cliffs, NJ,
pp. 63-7.
Ross, T. and Sumner, J. (2002), A simple, spreadsheet-based, food safety risk assessment tool,
International Journal of Food Microbiology, Vol. 77 Nos 1/2, pp. 39-53.
Sadiq, R. and Husain, T. (2005), A fuzzy-based methodology for an aggregative environmental
risk assessment: a case study of drilling waste, Environmental Modelling and Software,
Vol. 20, pp. 33-46.
Sadiq, R., Kleiner, Y. and Rajani, B. (2004), Aggregative risk analysis for water quality failure in
distribution networks, Journal of Water Supply Research and Technology: Aqua, Vol. 53
No. 4, pp. 241-61.
Schroeder, T.C., Tonsor, G.T., Pennings, J.M.E. and Mintert, J. (2007), Consumer food safety risk
perceptions and attitudes: impacts on beef consumption across countries, The B.E.
Journal of Economic Analysis and Policy, Vol. 7.
Schlundt, J. (2000), Comparison of microbiological risk assessment studies published,
International Journal of Food Microbiology, Vol. 58, pp. 197-202.
Shears, P., Zollers, F.E. and Hurd, S. (2001), Food for thought: what mad cows have wrought
with respect to food safety regulation in the EU and UK, British Food Journal, Vol. 103
No. 1, pp. 63-87.
Slovic, P. (2000), The Perception of Risk, UKL: Earthscan, London.
Soby, B.A., Simpson, A.C.D. and Ives, D.P. (1993), Integrating public and scientific judgments
into a tool kit for managing food-related risks, Stage 1: literature review and feasibility
study, A report to the UK Ministry of Agriculture, Fisheries and Food, ERAU Research
Report No. 16, University of East Anglia, Norwich.
Sumner, J., Ross, T. and Ababouch, L. (2004), Application of risk assessment in the fish
industry, FAO Fisheries Technical Paper 442, pp. 1-78, available at: ftp://ftp.fao.org/
docrep/fao/007/y4722e/y4722e00.pdf (accessed 15 April 2010).
Tait, J., Meagher, L., Lyall, C. and Suk, J. (2006), Foresight. Infectious Diseases: Preparing for the
Future. T2: Risk Analysis, Office of Science and Innovation, London.
Taylor, M.R., Glavin, M.O.K., Morris, J.G. Jr and Woteki, C.E. (2003), Food safety updated:
Developing tools for a more science- and risk-based approach, available at: www.
milbank.org/reports/2003foodsafety/030731foodsafety.html (accessed 5 April 2010).
Toyofuku, H. (2006), Harmonization of international risk assessment protocol, Marine Pollution
Bulletin, Vol. 53 Nos 10-12, pp. 579-90.
Tuominen, P., Hielm, S., Aarnisalo, K., Raaska, L. and Maijala, R. (2003), Trapping the food
safety performance of a small or medium-sized food company using a risk-based model.
The HYGRAMw system, Food Control, Vol. 14 No. 8, pp. 573-8.
US Military (1993), US Military Standard: System Safety Programme Requirements
(MIL-STD-882C).
Assessing food
safety risk
483
BFJ
115,3
484
Van der Bosch, A.L.M., de Jong, M.D.T. and Elving, W.J.L. (2005), How corporate visual identity
supports reputation, Corporate Communications: An International Journal, Vol. 10 No. 2,
pp. 108-16.
van Gerwen, S.J.C., te Giffel, M.C., vant Riet, K., Beumer, R.R. and Zwietering, M.H. (2000),
Stepwise quantitative risk assessment as a tool for characterization of microbiological
food safety, Journal of Applied Microbiology, Vol. 88, pp. 938-51.
van Kleef, E., Houghton, J., Krystallis, A., Pfenning, U., Rowe, G., Van Dijk, H., Van der Lans, I.
and Frewer, L. (2007), Consumer evaluations of food risk management quality in Europe,
Risk Analysis, Vol. 27 No. 6, pp. 1565-80.
Verbeke, W. (2001), Beliefs, attitude and behavior towards fresh meat revisited after the Belgian
dioxin crisis, Food Quality and Preference, Vol. 12, pp. 489-98.
Voysey, P.A. and Brown, M. (2000), Microbiological risk assessment: a new approach to food
safety control, International Journal of Food Microbiology, Vol. 58 No. 3, pp. 173-9.
Vrijling, J.K., van Hengel, W. and Houbens, E.J. (1998), Acceptable risk as a basis for design,
Reliability Engineering & System Safety, Vol. 59 No. 1, pp. 141-50.
Wang, M. (2003), Security Investment Risk: Evaluation, Prediction and Control, Press of
University of Shanghai Finance and Economics (in Chinese).
Wang, X., Li, D. and Shi, X. (2011), A fuzzy enabled model for aggregative food safety risk
assessment in food supply chains, Production Planning and Control, 2011 iFirst, available
at: www.tandfonline.com/doi/abs/10.1080/09537287.2011.561812#preview (accessed
21 June 2011).
WHO (1997), Food Safety and Globalization of Trade in Food, a challenge to the public health
sector, WHO/FSF/FOS/97.8 Rev. 1, WHO, Geneva.
Williams, C.A. and Heins, R.M. (1985), Risk Management and Insurance, McGraw Hill, New York,
NY, pp. 7-9.
Further reading
Food and Drug Administration (FDA) (2010), CARVER Software, available at: www.fda.gov/
Food/FoodDefense/CARVER/default.htm (accessed 3 January 2011).
HMSO (1995), Food Safety (General Food Hygiene) Regulations 1995, Ref: S.I. 1763, HMSO.
Corresponding author
L. Manning can be contacted at: [email protected]