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4 Risk Assessment
CONTENTS

4.1 Introduction.....................................................................................................41
4.2 Definition of Risk ...........................................................................................41
4.2.1 Role of Risk Assessment Models.......................................................42
4.2.2 Epidemiological Risk Assessment......................................................43
4.2.3 Standard Risk Assessment..................................................................43
4.3 Conclusions.....................................................................................................47
4.4 References.......................................................................................................47

4.1 INTRODUCTION
Risk assessment has become increasingly important to public health in recent years.
Indeed, the requirement to do formal assessments of the risk to water supply from
cryptosporidiosis has recently been enshrined in British Law.1 When one considers
the risk to public health from biofilm formation, there are very few sources of direct
evidence. Consequently, one has to use one or more of the various models of risk
assessment. The National Academy of Sciences defined risk assessment as the use
of the factual base to define the health effects of exposure of individuals or popu-
lations to hazardous materials and situations.2 This definition does not, however,
give much insight into the nature of risk and the processes involved in risk assess-
ment. A further problem is that much of the information to do adequate risk assess-
ments does not exist.
This chapter discusses risk assessment by first defining risk and looking at the
role of risk assessment and then by describing some approaches to risk assessment
that are applicable to the water industry.

4.2 DEFINITION OF RISK

Risk means very different things to different people. In the chapter on epidemiology,
we have already come across several definitions of risk. More generally, risk was
defined as the number of new cases of disease in a population of a known size over
a given period of time (i.e., the incidence of disease). We also defined relative risk
(the ratio of incidence in an exposed and nonexposed population) and attributable
risk (the incidence owing to exposure to a specific factor).
More generally, risk can be defined as the possibility of loss, harm, or injury.
This definition contains within it two concepts, harm and probability. This brings
us to our first risk assessment model. Risk can be thought of as a two-dimensional
matrix, which includes probability and severity of harm. This is shown graphically

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42 Microbiological Aspects of Biofilms and Drinking Water

Severity

High

Low

Low High
Probability of occurrence
FIGURE 4.1 Probability/severity matrix.

in Figure 4.1. Clearly, any potentially adverse event can be placed on this matrix
given its known or estimated probability of occurrence and severity. Once placed on
the matrix, it is easier to identify those risks that need to be addressed most urgently
(high probability, high severity). Low probability–low severity risks have low priority
and the other classifications have intermediate priority.
The advantage of this particular model is that it is conceptually simple and can
be used in developing inputs to a variety of other risk assessment models. It is also
very good for the rapid modelling of a large number of potential hazards. On the
other hand, the exact probabilities are often unknown and thus the placing of
individual hazards into the matrix still has a large amount of subjectivity. Although
rarely explicitly used in this form, this model is central to all risk assessments. In
the authors’ view, the value of risk assessments would be enhanced if this model
were used explicitly more often.

4.2.1 ROLE OF RISK ASSESSMENT MODELS

Now that we have been introduced to the concept of risk and one risk assessment
model, we should consider the role of risk assessment, particularly in the water
industry. There have been many different reasons put forward for undertaking risk
assessment. Nevertheless, the main reason should be to improve the safety of our
water supplies. To be most effective, risk assessment must be part of a process that
leads to risk communication and, in turn, risk reduction.
Some of the many potential uses of risk assessment in the water industry include

To predict the burden of waterborne disease in the community under outbreak

and nonoutbreak conditions. This is helpful in determining the impact of
improvements in water supply on health and acts as a driver toward tech-
nological improvement.
To help set microbiological standards for drinking water supplies that will give
acceptable levels of illness within the populations drinking that water.
To identify the most cost-effective option to reduce microbiological health
risks to drinking-water consumers.

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Risk Assessment 43

To help determine the optimum treatment of water to balance microbial risks

against chemical risks from disinfection by-products.
To provide a conceptual framework to help individuals and organisations
understand the nature and risk to and from their water and how those risks
can be minimised.

4.2.2 EPIDEMIOLOGICAL RISK ASSESSMENT

We have already mentioned the epidemiological definitions of risk, relative risk, and
attributable risk. Defining these risks requires one or more epidemiological studies.
Once the risks have been assessed by epidemiological investigations, the information
produced can be thought of as the Holy Grail of risk assessment. Unfortunately, as
with the legendary Holy Grail, the goal is rarely achieved. Epidemiological data is
often costly to collect, requiring descriptive studies, surveys, or cohort studies.
Furthermore, all epidemiological studies may be subject to one of various biases,
and even if the end result is correct, this does not give any understanding of the
components of the risk. On the other hand, epidemiological estimates of risk are
still commonsense estimates of the real world risk. There have been many epidemi-
ological studies of waterborne disease of varying quality reported in the scientific
literature. Some of these studies are discussed in the chapter on waterborne disease,
others are reviewed elsewhere.3

4.2.3 STANDARD RISK ASSESSMENT

This is probably the most frequently used risk assessment model in the water
industry. It consists of four stages: hazard identification, exposure assessment,
dose–response assessment, and risk characterisation (Figure 4.2).4,5
The first stage in the process is always hazard identification. Unless the inves-
tigator believes he or she has identified a hazard, the rest of the assessment exercise
is pointless. A hazard is any agent that has the potential to cause harm to a population
and to which the population has been or may be exposed. Thus the risk assessor has
to answer two questions:

Hazard
Identification

Dose-Response Exposure
Assessment Assessment

Risk
Characterisation

FIGURE 4.2 The risk assessment process.

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44 Microbiological Aspects of Biofilms and Drinking Water

1. Has the population been exposed to the agent or is it likely to be exposed

in the future?
2. Does what is known about the agent suggest that it could cause harm?

Evidence for use in hazard assessment may come from a variety of sources. The
results of properly conducted epidemiological studies will provide high quality
evidence of hazard. If this is not available, evidence can be obtained from the
published results of animal studies. If these are not available, the risk assessor may
have to fall back on assumptions from knowledge of the toxicity and pathogenicity
of related chemical pathogens. Despite the huge amount of literature on toxicology,
epidemiology, and pathogenicity of microbial and chemical agents, the answers to
these questions are frequently qualitative rather than quantitative.
Once the hazard has been identified, the next two stages of exposure assessment
and dose–response assessment are instigated.
During the exposure assessment phase, the risk assessor has to identify, and
wherever possible, quantify the various potential routes of exposure to the agent
under investigation. When interested in the water route, the main outcome of this
phase will be to identify the actual or probable dose of chemical or pathogen to
which the population may be exposed in their drinking water. Clearly, various factors
need to be taken into account, such as water consumption behaviour in the exposed
population (amount and duration), what is known of the actual concentrations of
agent in water supply, and what are the probable concentrations during some sort
of adverse event. For chemical agents, the risk assessor is likely to be interested in
the lifetime average daily dose (LADD). However, for infectious agents, LADD is
not likely to be relevant. Instead, the number of bacteria consumed at a single time
will be the best predictor of disease.
The dose–response assessment phase involves assessing the likelihood of ill
health for various levels of exposure. Where information is available on the effect
of various doses on health, it usually comes from animal studies which may have
little or no relevance to humans. Furthermore, these studies usually use doses in
greater excess than the levels expected to be found in the environment. Consequently,
for real world situations, one has to extrapolate from existing information down to
very low doses. There are various approaches to extrapolating down to low doses,
but the choice of which method to use is still often fairly subjective. As such, the
presumption of adverse health effects at low levels remains, at best, an educated
guess.
The final phase is the formal risk characterisation which pulls together all the
information gathered in the earlier three phases. Ideally, one should present the data
in a standardised numerical form, such as the risk of one extra cancer in a population
of 1 million. It is very important that the risk assessor presents the results along
with an estimation of the uncertainty of results.
This model of risk assessment has been used extensively for chemical agents.
Its use has, however, been more limited for microbial pathogens. Indeed, there are
significant additional difficulties in applying the model to microbial pathogens. For
example, the susceptibility of individuals in a population varies markedly throughout
life and, once infected, whether by the water or another route, people develop

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Risk Assessment 45

Probability of infection

50%

ID50
Dose
Probability of infection

50%

ID50
Dose
FIGURE 4.3 Effect of model on extrapolating to low doses when infectious dose is not
known with certainty.

immunity. Furthermore, an accurate knowledge of the dose–response is further

complicated because animal susceptibility to certain pathogens varies considerably
from human susceptibility. This is complicated further because there is often con-
siderable variation in infectiousness between different strains of the same microbial
species. Figure 4.3 shows how the effect of two different approaches to extrapolating
to low doses affects the calculated risk of illness. This figure also shows the impact
on different estimations of infectious doses by the two models. It can be seen that
the greatest percentage effect on probability of illness would be at low pathogen
levels as would be the case in water supplies.
These difficulties have not stopped people from estimating the probability of
infection from various doses of microbial pathogens (Table 4.1). Moynihan7 argues
that to get these figures, several unlikely assumptions have to be accepted, namely,

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46 Microbiological Aspects of Biofilms and Drinking Water

TABLE 4.1
Risk Infection from Exposure to One Organism and Minimum Doses Required
to Obtain a 1% Infection within the Community for a Range of Pathogens
Minimum Dose
Risk Infection from Exposure (No. of Organisms)
Microorganism to a Single Organism Required for 1% Infection

Bacteria
Vibrio cholerae 7 × 10–6 1428
Salmonella 2.3 × 10–3 4.3
Shigella 1.0 × 10–3 10
Campylobacter 7 × 10–3 1.4
Virus
Poliovirus 1 1.49 × 10–2 0.67
Rotavirus 3.1 × 10–1 0.03
Protozoa
Giardia lamblia 1.98 × 10–2 0.5
Entamoeba histolytica 2.8 × 10–1 0.04

Source: Reprinted from Water Science Technology, 24, Rose, J. P. and Gerba, C. P., Use of risk assessment
for the development of microbial standards, 29–34, Copyright 1991, with permission from Elsevier Science.

that organisms are randomly distributed, the consumer population is equally suscep-
tible to a single organism exposure, and the exposure is defined as the consumption
of 2 l of water per day.7 The authors would agree with Moynihan’s scepticism and
would further suggest such estimates are, at best, educated guesses.
An example where the model has been used is in a paper by Rusin and col-
leagues.8 This group set out to develop a risk assessment for various microbial
pathogens and potential pathogens, Pseudomonas, Acinetobacter, Xanthomonas,
Aeromonas, Moraxella, Mycobacterium avium, and Legionella. Most of these patho-
gens rarely, if ever, cause disease in otherwise healthy humans, although all have
caused disease in compromised patients. The authors suggested on the basis of their
calculations that several of these pathogens could cause community and hospital-
acquired disease in humans through drinking water, although case numbers may be
very low (less than 1 in 10,000).
More recently, risk assessment models have become considerably more mathe-
matically sophisticated.9,10 The number of variables in the various mathematical
formulae are increasing and the manipulation of these variables has become more
complex. For example, in one model, over 20 variables are included, many of which
have wide confidence limits.9 Clearly, the calculated risk has to be so extremely
wide that the outputs cannot be accepted as accurate representations of reality.
Nevertheless, these models should not be discounted. Even if the outputs are
only estimates of reality with wide confidence intervals, the construction of the
models provides a valuable insight into the drivers of risk and their relative impor-
tance. Even in the absence of any mathematical or numerical accuracy, the process
of thinking through these issues can generate considerable insight into risk.

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Risk Assessment 47

4.3 CONCLUSIONS
There are varying approaches and models of risk assessment. As the reader will have
already discovered, the authors favour the epidemiological approach to risk assess-
ment as being the most realistic. Nevertheless, good epidemiology is difficult to do
and can be subject to bias. The mathematical risk assessment models certainly have
an important role to play, provided one is not seduced by the apparent accuracy of
numerical values.
A potentially significant advance in risk assessment for the water industry would
be the introduction of Hazard Analysis and Critical Control Points (HACCP).11
HACCP has become one of the most useful tools for improving food safety world-
wide and has been found invaluable in a range of other industries. Yet despite this
success, HACCP has not yet been used to any great extent in the water industry. A
more detailed discussion of HACCP will be found elsewhere. This discussion will
be restricted to listing the basic principles of HACCP.

1. Conduct a hazard analysis.

2. Determine the critical control points (CCP).
3. Establish critical limits.
4. Establish a system to monitor control of the CCPs.
5. Establish the corrective action to be taken when monitoring indicates that
a particular CCP is not under control.
6. Establish procedures for verification to confirm that the HACCP system
is working effectively.
7. Establish documentation concerning all procedures and records appropri-
ate to these principles and their applications.

The advantages of HACCP are that it involves people closest to the process, identifies
the component of the process that contributes to risk, and identifies mechanisms for
risk reduction. Whilst it can truthfully be said that many of these principles have
been implemented within the water industry, the authors are not aware of the full
process being used. Linking HACCP to existing risk assessment practices would be
a major advance in risk assessment.

4.4 REFERENCES
1. Department of the Environment, Transport and the Regions, 1999, The Water Supply
(Water Quality) (Amendment) Regulations 1999, Cryptosporidium in Water Supplies,
HMSO.
2. National Research Council, National Academy of Sciences, 1983, Risk Assessment
in the Federal Government: Managing the Process, National Academy Press, Wash-
ington, D.C.
3. Hunter, P. R., 1997, Water-Borne Disease: Epidemiology and Ecology, Wiley, Chichester.
4. Hertz-Picciotto, I., 1995, Environmental risk assessment, in Introduction to Environ-
mental Epidemiology, Talbott, E. O. and Craun, G. F., Eds., Lewis Publishers, Boca
Raton, FL.

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48 Microbiological Aspects of Biofilms and Drinking Water

5. U.S. Environmental Protection Agency, 1986, Guidelines for cancer risk assessment,
Fed. Regist., 51, 33992.
6. Rose, J. P. and Gerba, C. P., 1991, Use of risk assessment for the development of
microbial standards, Water Sci. Technol., 24, 29.
7. Moynihan, M., 1992, Emerging issues for the microbiology of drinking water, M.Sc.
thesis, University of Dublin, Dublin, Ireland.
8. Rusin, P. A., Rose, J. B., Haas, C. N., and Gerba, C. P., 1997, Risk assessment of
opportunistic bacterial pathogens in drinking water, Rev. Environ. Contam. Toxicol.,
152, 57.
9. Eisenberg, J. N., Seto, E. Y. W., Olivieri, A. W., and Spear, R. C., 1996, Quantifying
water pathogen risk in an epidemiological framework, Risk Anal., 16, 549.
10. Perz, J. F., Ennever, F. K., and LeBlancq, S. M., 1998, Cryptosporidium in tap water:
comparison of predicted risks with observed levels of disease, Am. J. Epidemiol.,
147(3), 289.
11. Mortimore, S. and Wallace, C., 1998, HACCP: A Practical Approach, Blackie Aca-
demic and Professional.

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