British Food Journal

Mechanisms for assessing food safety risk

L. Manning J.M. Soon

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L. Manning J.M. Soon, (2013),"Mechanisms for assessing food safety risk", British Food Journal, Vol. 115 Iss 3 pp. 460 484
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BFJ
115,3

Mechanisms for assessing food

safety risk
L. Manning and J.M. Soon
Royal Agricultural College, Cirencester, UK

460
Abstract

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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

British Food Journal

Vol. 115 No. 3, 2013
pp. 460-484
q Emerald Group Publishing Limited
0007-070X
DOI 10.1108/00070701311314255

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.

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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.

The Communication from the European Commission on the Precautionary Principle

(EC, 2000) identified four components of risk assessment:
.
Hazard identification. Identifying the biological, chemical or physical agents that
may have adverse effects.
.
Hazard characterisation. Determining, in quantitative and/or qualitative terms,
the number of bacteria ingested and the nature and severity of the adverse effects
associated with the causal agents or activity (dose-response).
.
Appraisal of exposure. Evaluating in quantitative and/or qualitative terms the
probability of exposure to the agent under study.
.
Risk characterisation. Assessing based on the other three components the degree
of risk associated with the hazard.

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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.

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463

Figure 1.
Quantitative MRA

Furthermore, risk management requires a multidisciplinary approach from the

management team and integrated risk management through the supply chain will lead
to improved business sustainability (Manning and Baines, 2004b). The Institute of
Chartered Accountants in England and Wales (ICAEW, 1998) defined gross risk as the
risk affecting an enterprise before any action is taken to manage them and net risk as
the risk that remains following management actions. A food safety risk management
strategy will include:
.
Identifying and ranking the risk inherent in the products produced and activities
undertaken.
.
Evaluating the risks in terms of the likelihood of their occurrence and the impact,
or severity, if they do occur. This process is often termed risk mapping and can
be undertaken using a decision tree, graphically or in a matrix.
.
Determining the level of risk the business willing to accept by the ratio of risk
and reward.

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464
.

Determining which risks the business is not competent, or willing, to manage

and either transferring or avoiding those specific risks.
Identifying the appropriate risk management techniques and implementing the
food safety risk management system required to manage the remaining risks.
Monitoring and verifying the effectiveness of the risk management system and
developing reporting mechanisms.
Implementing the necessary preventative and corrective action to ensure
improved performance.

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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

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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

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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

Counts and calculates:

Cases;
Severity of illnesses;
Hospitalisations;
Deaths;
Costs of the risk;
Benefits of the risk;
Costs of reducing the risk;
Balance of risks to benefits;
Balances risk against benefit and cost

Assesses whether risk is:

Voluntary or imposed;
Visible or hidden;
Understood or uncertain;
Familiar or foreign;
Natural or technological;
Controllable or uncontrollable;
Mild or severe; Fairly or unfairly distributed;
Balances risk against dread and outrage

Source: Nestle (2003)

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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

Conditions associated with

increased public concern

Conditions associated with

decreased public concern

Grouped in time and space or

identifiable pattern
Unfamiliar hazard
Lack of understanding

Scattered and random

Risks unknown to science

Uncontrollable
Involuntary
At risk
Delayed effects
Risk
Identifiable as individuals or
groups
Effects dreaded
Irreversible
Lack of trust
Large amount of attention
Caused by human actions or
failures

Familiar hazard
Understood

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Risks known to science

Controllable
Voluntary
Not at risk
Immediate effects
No risk
Statistical victims
Effects not dreaded
Reversible
Institution trusted
Minimal attention
Caused by act of god or nature

Source: Adapted from Covello et al. (1988)

A series of studies were conducted to explore customers perceptions of the

effectiveness of food risk management practices (Houghton et al., 2008; van Kleef et al.,
2007; Krystallis et al., 2007). One of the most significant policy implications from the
results of the research was the need to develop risk communication strategies based on
consumer risk perceptions, concerns, information needs and preferences. Risk
communication should not be based on technical risk assessments alone. The results
also implied that consumers require information on how food risk management
decisions and practices were conducted (Cope et al., 2010).
Therefore, 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 legislative bodies and/or the food industry stakeholders could arise
(Manning et al., 2006a).
2. Managing food safety risk
The EU 93/43/EEC Council Directive on Hygiene of Foodstuffs 93/43/EEC (adopted 14
June 1993) was a horizontal food hygiene directive that focused on the use of hazard
analysis, and risk assessment to control food safety hazards within the EU. It also
makes reference to the General Principles of Food Hygiene Revision 3 (now Revision 4
CAC, 2003a). Article 2 stated that: food hygiene [...] shall mean all measures necessary
to ensure safety and wholesomeness of foodstuffs. The measures cover all stages after
primary production (i.e. after harvesting, slaughter) during preparation, processing,
manufacturing, packaging, storing, transportation, distribution, handling and offering
for sale or supply to the consumer. The directive required that, Food business

Table II.
Factors affecting risk
perception and evaluation

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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

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(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.

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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.

3. Mechanisms of risk assessment

Risk has been defined in several ways (Table III) as has the so-called risk relationship
(Donoghue, 2000) namely:

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Risk Probability Consequence:

In fact, the practice of using risk assessment matrices is widely accepted for
parameters such as health and safety and potentially allows for priorities to be set for
food safety risk assessment. These matrices work on the basis of risk being a
combination of consequence and severity as well as the degree of probability that the
incident will occur. Huihui et al.(2010) stated that only two input risk variables are
required to construct a matrix whereas the output risk index is only determined by the
severity and probability of occurrence. Each variable and the output risk index can be
divided into levels based on a numerical scale which represents qualitative descriptors
and it is this factor which creates a quantitative output risk index from
qualitative-based assessment. Donoghue (2000) has defined probability and
consequence in both qualitative terms and quantitative values (Table IV) and these
terms can be used to develop a 5 4 risk assessment matrix depending on whether the
judgment is value or scientifically based. Donoghue used the figures developed by the
US Military Standard: System Safety Programme Requirements (MIL-STD-882C) to
produce the matrix (US Military, 1993).
HSE (2006) suggested that the risk assessment methodology applied should be
efficient (cost-effective) and of sufficient detail to enable the ranking of risks in order,
for subsequent consideration of risk reduction. The rigour of assessment should be
proportionate to the complexity of the problem and the magnitude of risk. This
assessment according to HSE (2006) could be as previously described in the paper:
.
Qualitative (Q), in which frequency and severity are determined purely
qualitatively.
.
Semi-quantitative (SQ), in which frequency and severity are approximately
quantified within ranges.
.
Quantified risk assessment (QRA), in which full quantification occurs.
Definition

Reference

The uncertainty of loss

The alteration of future results under a given
circumstance in a specific period
The possibility of an adverse outcome, and
uncertainty over the occurrence, timing, or
magnitude of that adverse outcome
Combination of the probability of an event and the
consequences of the events
The possibility of unfavourable results and the
related loss of a chosen decision plan due to
various uncertainties in the decision making
process

Rosenbloom (1972) cited by Huihui et al. (2010)

Williams and Heins (1985) cited by Huihui et al.
(2010)
Covello and Merkhofer (1994) cited by Huihui et al.
(2010)

Source: Adapted from Huihui et al. (2010)

471

BS EN ISO 17776:2002 cited by Huihui et al. (2010)

Wang (2003) cited by Huihui et al. (2010)

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

Source: Adapted from Donoghue (2000) table amended for clarity

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

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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.,

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Figure 3.
QRA in the HACCP
process

Figure 4.
SQ risk assessment

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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)

1.9 10-9 to 6.4 10-8

Bemrah et al. (1998)

McElroy et al. (1999)

Raw fermented
sausages
Raw oysters

2.13 10-3 (if food is held at room

temperature of 208C)
1.3 10-4 (assuming only high-risk
population)
0.15% probability of detecting E. coli
O157:H7 in 25 g sample
1 10-6

Lindqvist and Westoo

(2000)
Hoornstra and
Notermans (2001)
FDA (2005)

Whole chicken

0.44 10-5

Oscar (2004)

Chinese-style rice

Divided into 6 categories of risk factors and characteristics of

known hazards in seafood. Based on a survey of outbreaks of
illnesses attributed to different seafood, a product was scored as
either or for each category and then ranked according
to the total number of s.
Provides guidance on the allocation of Australian food business
sectors into categories based on their likelihood of contributing
foodborne disease and the potential magnitude of that
contribution
Categorizes food establishments so that authorities can give
greater attention to those with the greatest potential risks to
consumers
Hygiene Risk Assessment Model (HYGRAM) was developed for
small and medium sized enterprises. HYGRAM consists of
background information to allow users to key in their
companys details, hygiene and hazard databank to generate
results
Allow users to rank pathogen/food risks using five criteria:
number of cases, hospitalisations, deaths, economic costs of
health outcomes and loss of Quality Adjusted Life Years
(QALY)
A food safety risk calculation tool to determine relative risks
from different product, pathogen and processing combinations.
A risk estimate is calculated, scaled between 0 and 100, where 0
represents no risk and 100 represents that the meal contains a
lethal dose of hazard

Simple scoring scheme

Risk Ranger

Foodborne Illness Risk Ranking Model

(FIRRM)

Hygiene Risk Assessment Model (HYGRAM)

system

Risk Categorization Model (RCM) for Food

Retail/Food Service Establishments

The Business Food Safety Classification Tool

Description

Risk ranking tools

(continued)

Food Safety Centre (2010), Ross and Sumner

(2002)

Batz et al. (2004), FAO/WHO (2006), Food

Safety Research Consortium (2003)

FPTCFSP (Canadian Federal/Provincial/

Territorial Committee on Food Safety Policy)
(2007)
Tuominen et al. (2003)

Department of Health and Ageing (2007)

Huss et al. (2000)

Reference

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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

CARVER Shock Tool

Swift Quantitative Microbiological Risk

Assessment (sQMRA)
Fuzzy Risk Assessment Tool (FRAT)

Food Safety Universe Database (FSUDB)

Davidson et al. (2006)

Evers and Chardon (2010)

McNab (2003)

van Gerwen et al. (2000)

FDA (2010)

Reference

476

Stepwise and Interactive Evaluation of Food

Safety by an Expert System (SIEFE)

Description

Table VI.

Risk ranking tools

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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

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Figure 5.
Selection of different levels
of risk assessments

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to the consumer. Decisions about acceptability involve perceptions, opinions, and

values, as well as science (Nestle, 2003) and these decisions made at organisational, or
indeed at policy level need to be fully transparent.
In this paper, the authors have attempted to review the qualitative and quantitative
risk assessment approaches for assessing risks at food policy level and in the
development of a supply chain or business specific food safety plan. The choice
between qualitative, semi-quantitative and quantitative approaches is largely driven
by the objectives of the decision makers (i.e. a qualitative approach may be sufficient
for their needs), and the availability of data and expertise of the analysts (Peeler et al.,
2007). The author determined that the additional benefit of a quantitative compared to
a qualitative analysis should also be judged by whether the basis for decision making
is significantly improved. If there is no data available, then a quantitative risk
assessment would not be possible. Qualitative risk assessment can assist a risk
manager, to a certain level, in priority setting and allocation of resources (Coleman and
Marks, 1999). The selection of different levels of risk assessments is shown (Figure 5).
The choice of food safety risk assessment model is crucial to an organisation. The
more transparent an organisation appears to be the more likely its stakeholders will
rely on its disclosures (Van der Bosch et al., 2005). Such trust is especially important for
product and organisational brand equity. Johnson and Peppas (2003) proposed that
protecting and preserving brand image involved identifying strengths and
opportunities for the brand but also, perhaps more crucially, identifying potential
weaknesses and threats and effectively managing and where possible minimising
them (Manning, 2009). The Food Standards Agencys independent Advisory
Committee on the Microbiological Safety of Food (ACMSF) stated that End product
testing is not a suitable instrument for guaranteeing the safety of the food and a robust
Hazard Analysis Critical Control Point (HACCP) needs to be in place (FoodLaw, 2006).
They further stated that In order to give assurance about the absence of salmonella or
any other pathogen in food a prohibitively large amount of product would need to be
tested. However, even this would not guarantee absence of the micro-organism. The
committee further acknowledged that it was difficult to quantify the actual risk to
consumers. Food safety legislation requires food businesses to deem not only what is
an acceptable level of contaminant in a food but also the acceptable level of risk to
consumers when preparing, handling and consuming that food. Therefore, at food
business level the choice of risk assessment method and its reliability is fundamental to
an organisations demonstration of due diligence.
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Corresponding author
L. Manning can be contacted at: l.manning@btinternet.com

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