Risk Assessment

UNIT 7 RISK ASSESSMENT

Structure
7.0 Objectives
7.1 Introduction
7.1.1 Risk Assessment and the WTO SPS Agreement
7.1.2 Relative Positions of Risk Assessment and Risk Management
7.2 Definitions Related to Risk Assessment
7.3 Principles of Food Safety Risk Assessment
7.4 Scientific Approaches for Assessing Risks
7.4.1 Risk Assessment
7.4.2 Use of Ranking Tools
7.4.3 Epidemiology
7.4.4 Combination of Approaches
7.5 Responsibilities of Risk Managers in Commissioning and Guiding a
Risk Assessment
7.5.1 Forming the Risk Assessment Team
7.5.2 Specification of Purpose and Scope
7.5.3 Questions to be Addressed by Risk Assessors
7.5.4 Specification of Form of the Outputs
7.5.5 Time and Resources
7.6 General Criteria of Risk Assessment
7.6.1 Objectivity and Transparency
7.6.2 Functional Separation of Risk Assessment and Risk Management
7.6.3 Structured Process
7.6.4 Basis in Science
7.6.5 Dealing with Uncertainty and Variability
7.6.6 Peer Review
7.7 Risk Assessment Methodology
7.7.1 Basic Components of a Risk Assessment
7.7.2 Qualitative or Quantitative?
7.8 Risk Assessment for Chemical Hazards
7.8.1 Hazard Identification
7.8.2 Hazard Characterization
7.8.3 Exposure Assessment
7.8.4 Risk Characterization
7.8.5 Application of Toxicological Guidance Values
7.9 Risk Assessment for Biological Hazards
7.9.1 Hazard Identification
7.9.2 Hazard Characterization
7.9.3 Exposure Assessment
7.9.4 Risk Characterization
7.10 Biotechnology Risk Assessment
7.11 Sensitivity Analysis
7.12 Validation
7.13 Establishment of ‘Targets’ in the Food Chain as Regulatory Standards
7.14 Let Us Sum Up
7.15 Key Words
7.16 Answers to Check Your Progress Exercises
7.17 Suggested Reading

7.0 OBJECTIVES
After studying this unit, we shall be able to:
• describe risk assessment in the context of SPS agreement;
• define key terms related to key risk assessment terms;
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Risk Analysis
• explain scientific approaches for assessing risk;
• describe generic Codex risk assessment framework;
• identify general characteristic of risk assessment; and
• explain basic components of risk assessment.

7.1 INTRODUCTION
Risk assessment can generally be described as assessment of intensity and
frequency of the potential adverse effects to life and health resulting from
exposure to hazards over a specified time period. It is well recognized
internationally that increased scientific, legal and political demands are being
made on the standards, guidelines and other recommendations elaborated by
international setting organizations like Codex Allementrius Commission. This
is, in part, due to increased consumer interest in food safety, the WTO's SPS
and TBT Agreements, harmonization initiatives, calls for increased scientific
rigour and the need for transparency. To respond to these increasing demands,
the greater application of risk assessment in the standard decision-making
process is essential. Risk assessment is the central scientific component of risk
analysis and has evolved primarily because of the need to make decisions to
protect health with the available scientific knowledge and prevailing scientific
uncertainty. Risk management and risk assessment are separate but closely
linked activities, and ongoing, effective communication between those
carrying out these separate functions is essential. As described in Unit 6, risk
managers applying the risk management framework must decide whether a risk
assessment is possible and necessary. If this decision is affirmative, risk
managers commission and guide the risk assessment, carrying out tasks such as
describing the purpose of risk assessment and the food safety questions to be
answered, establishing risk assessment policy, setting time schedules and
providing the resources necessary to carry out the work. While the main focus
is on application of risk assessment methodology as defined by Codex (i.e.
systematic application of the four steps listed in Section 7.7.1), a broader view
of risk assessment is also taken. All methods for assessing risks described here,
use the best scientific knowledge available to support risk-based standards or
other risk management options. Individual risk assessments should be “fit-for-
purpose” and can generate estimates of risks in various forms. Where they are
feasible, quantitative risk assessments have the additional advantage of being
able to model the effects of different interventions and this probably is their
greatest strength. Scientific approaches that combine risk assessment,
epidemiology1 and economics are likely to be most useful to risk managers
trying to integrate and balance risks and benefits.

7.1.1 Risk Assessment and the WTO SPS Agreement

WTO members are bound by the provisions of the SPS Agreement, which
places risk assessment within a coherent SPS system for developing and
applying standards for food in international trade. The scope of the SPS
Agreement in the context of this study material covers risks to human life and
health, and requires that WTO members:
• shall ensure that any measure is applied only to the extent necessary to
protect human life and health.
• shall base their measures on risk assessment, taking into account the
techniques developed by the relevant international organizations.
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• may implement a measure that differs from international norms where a Risk Assessment
higher “appropriate level of health protection” is necessary and
scientifically justified.
• shall apply the principles of equivalency where a different measure in an
exporting country achieves their appropriate level of protection.
These provisions reflect the notion that the scientific conclusions of a risk
assessment must reasonably support the SPS measure in question, and this in
turn is the essence of the explanation of a “risk-based standard” presented in
Unit 6 (Box 6.8).

7.1.2 Relative Positions of Risk Assessment and Risk

Management
The place occupied by risk assessment during an application of the risk
management framework by risk managers is described in Unit 6. Although risk
managers commission and guide the risk assessment and evaluate its outputs,
the risk assessment itself is generally an external product, independently
produced by scientists.

7.2 DEFINITIONS RELATED TO RISK

ASSESSMENT
Risk assessment: A scientifically based process consisting of the following
steps: (i) hazard identification, (ii) hazard characterization, (iii) exposure
assessment, and (iv) risk characterization.
Risk assessment policy: given in Unit 6.
Risk profile: given in Unit 6.
Risk characterization: The qualitative and/or quantitative estimation,
including attendant uncertainties, of the probability of occurrence and severity
of known or potential adverse health effects in a given population based on
hazard identification, hazard characterization and exposure assessment.
Risk estimate: The quantitative estimation of risk resulting from risk
characterization.
Hazard identification: The identification of biological, chemical and physical
agents capable of causing adverse health effects and which may be present in a
particular food or group of foods.
Hazard characterization: The qualitative and/or quantitative evaluation of the
nature of the adverse health effects associated with biological, chemical and
physical agents which may be present in food. For chemical agents, a dose
response assessment should be performed. For biological or physical agents, a
dose-response assessment should be performed if the data are obtainable.
Dose-response assessment: The determination of the relationship between the
magnitude of exposure (dose) to a chemical, biological or physical agent and
the severity and/or frequency of associated adverse health effects (response).
Exposure Assessment: The qualitative and/or quantitative evaluation of the
likely intake of biological, chemical, and physical agents via food as well as
exposures from other sources if relevant.
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Risk Analysis
7.3 PRINCIPLES OF FOOD SAFETY RISK
ASSESSMENT
Principle 1- Health and safety aspects of Codex decisions and recommenda-
tions should be based on a risk assessment, as appropriate to the circumstances.
Principle 2- Food safety risk assessment should be soundly based on science,
should incorporate the four steps of the risk assessment process, and should be
documented in a transparent manner.
Principle 3- There should be a functional separation of risk assessment and
risk management, while recognizing that some interactions are essential for a
pragmatic approach.
Principle 4- Risk assessment should use available quantitative information to
the greatest extent possible and risk characterizations should be presented in a
readily understandable and useful form.

# Check Your Progress Exercise 1

Note: a) Use the space below for your answers.
b) Check your answers with those given at the end of the unit.
1) Define the following term as per Codex
• Hazard identification
• Hazard Characterization
• Dose response Assessment
• Exposure Assessment
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2) Enumerate various general principles of food safety risk assessment?

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7.4 SCIENTIFIC APPROACHES FOR ASSESSING

RISKS
When addressing a particular food safety issue, an early risk management
decision concerns the scientific approach that will be taken (see section 6.4.1,
Step 3). While this unit is focused on risk assessment as an input to the risk
management framework, there are many situations at the national level where
no risk assessment of any form is available or feasible. In other situations, an
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active decision may be taken to use a scientific approach that does not include Risk Assessment
risk assessment. Obviously, the advantages that flow from using risk
assessment to set food safety control measures (see Section 7.1.3) cannot be
realized in such scenarios; nevertheless, choices to apply other scientific
approaches are likely to be reasonable and appropriate in their own right.
It is important to recognize that a range of approaches can lead to a risk based
standard. This brings flexibility to the issue of the level of risk assessment
rigour needed in low-risk situations.
In developing an approach to use of risk assessment methodology, the risk
management framework process should always include a risk profile of some
sort. In applying the risk management framework, risk managers may directly
use the information in the risk profile to identify and select food standards.
Present example(s) illustrating the direct use of a risk profile as a basis for risk
management decisions in cases where it was either unnecessary or not feasible
to carry out a risk assessment given below. While basing risk management
decisions on a risk profile may be fully justifiable in particular circumstances,
the resulting standards are not ordinarily considered to be risk-based.
Example of direct use of a risk profile to establish food safety standards
• In the 1990s, microbial resistance to a range of antibiotics used in both
animal health and human medicine was found to be widespread. Risk
profiles indicated the proportion of resistant pathogens in surveys of food
animal and human populations, and identified the unique value of certain
individual antibiotics in treating human infections as well as the
availability of substitute antibiotics. As a result, some countries took steps
to deregister certain antibiotics for animal health uses, even though as yet
no measurable change in the incidence of human disease has convincingly
been linked to those uses.
• The recent discovery in Sweden that acrylamide, a substance known to
cause cancer in laboratory animals, is formed through normal heat-
treatment of baked and fried starchy foods, led to widespread recognition
of significant exposure of consumers via a range of food types. Scientific
studies showed that reducing cooking temperatures and/or times can lower
consumer exposure levels. Modification of commercial food processes was
instituted on this basis, even though the actual risk and the impact of
process changes on risk reduction are still not fully known.

The Canadian approach to regulating Listeria monocytogenes in ready-to-

eat foods
When the Canadian government did a risk profile of this problem they
recognized that contamination by Listeria monocytogenes could be reduced,
but not eliminated from the final product or the environment. Risk
management policy focuses inspection, testing and compliance action on
ready-to-eat foods that are capable of supporting growth of Listeria
monocytogenes. Specific attention is paid to those foods that have been linked
to food-borne illness, and those with more than a ten day shelf life. In this
approach, ready-to-eat foods are placed in one of three categories:
• Category 1 foods have been directly linked to human illness and are most
intensively regulated. The presence of any Listeria in Category 1 foods
results in a Class I recall that may include a public alert.
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Risk Analysis
• Category 2 foods are capable of supporting Listeria growth and have a
shelf life of more than 10 days; presence of Listeria in Category 2 foods
requires a Class II recall with possible consideration of a public alert.
Category 2 foods also have second highest priority in inspection and
compliance activity.
• Category 3 contains two types of ready-to-eat products: those supporting
growth with less than a ten day shelf life, and those not supporting growth.
These products receive the lowest priority in terms of inspection and
compliance, and the action level for presence of the hazard in food is 100
organisms per gram.

Note: The Canadian Food Inspection Agency assigns numerical designations

to a particular product recall to indicate the relative degree of health hazard
presented by the product being recalled. Class I is “a situation in which there is
a reasonable probability that the use of, or exposure to, a violative product will
cause serious adverse health consequences or death”. Class II is “a situation in
which the use of, or exposure to, a violative product may cause temporary
adverse health consequences or where the probability of serious adverse health
consequences is remote”. See
http://www.hc-sc.gc.ca/fn-an/securit/eval/reports-rapports/fers-siua_08_e.html
for further information.

7.4.1 Risk Assessment

Risk assessment incorporating, in one way or another, the four analytical steps
described by Codex (see Fig. 7.1) is the main focus of this unit. The way those
steps are applied differs somewhat for microbiological and chemical hazards.
For microbiological hazards, the occurrence and transmission of the hazard at
various stages from food production to consumption is evaluated, thus moving
“forward” through the various stages of the food chain to arrive at an estimate
of risk. While the accuracy of estimated risks is often limited by uncertain
dose-response information, the greatest strength of such risk assessments
arguably lies in their ability to model the relative impacts of different food
control measures on risk estimates.
In contrast, for chemical hazards, “safety evaluation3” is a standard risk
assessment methodology. In that approach, maximum exposure levels are
identified to fit a “notional zero risk” outcome (a dose level that is reasonably
certain to pose no appreciable risk to the consumer). This approach does not
produce precise estimates of risk versus dose and cannot model the impact of
various interventions in terms of risk reduction. These differences are explored
further in Section 7.8.6

3
The term “safety evaluation” is often used in regard to chemical hazards because the chief output is a
definition of a presumptive “safe” exposure level, without detailed assessment of how risk varies with
exposure to differing doses.
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 Risk Assessment

Hazard Identification
The identification of biological, chemical and physical
agents capable of causing adverse health effects and which
may be present in a particular food or group of foods.

Hazard Characterization Exposure Assessment

The qualitative and/or quantitative The qualitative and/or quantitative
evaluation of the nature of the adverse evaluation of the likely intake of
health effects associated with biological, biological, chemical and physical
chemical and physical agents, which may agents via food, as well as exposures
be present in food. For chemical agents, a from other sources if relevant.
dose-response assessment is performed.
For biological or physical agents, a dose-
response assessment should be performed
if the data are obtainable.

Risk Characterization
The qualitative and/or quantitative estimation, including
attendant uncertainties, of the probability of occurrence
and severity of known or potential adverse health effects
in a given population based on hazard identification,
hazard characterization and exposure assessment.

Fig. 7.1: Generic Description of the Components of Risk Assessment

7.4.2 Use of Ranking Tools

Risk ranking, using tools that rely on knowledge of risk factors to rank risks
and prioritize regulatory controls, is often commissioned by risk managers
(given below). Such rankings may or may not be based on risk assessments.
Some tools categorize a food business against specified risk factors, e.g. by
type of food, type of food preparation, type of business, compliance record,
and food user sub-population.
Examples of risk ranking tools
• The Business Food Safety Classification Tool developed by the Australian
Government Department of Health and Aging is a software programme
that incorporates a decision tree to assess the potential public health risk
from different types of food businesses and food producers. This tool
identifies those food industry sectors/businesses that are candidates for
priority regulatory control and verification.

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Risk Analysis
• The Risk Categorizing Model for Food Retail/Food Service Establishments
developed by the Canadian Federal Provincial Territorial Food Safety
Policy Committee categorizes food establishments so that the competent
authority can give greater attention to those where a failure of regulatory
controls would cause the greatest potential risks to consumers.
• The Food Safety Research Consortium in the United States is developing a
model to produce rankings by pathogens, by food, and by pathogen/food
combination, using five criteria for ranking impact on public health:
number of cases of illness, number of hospitalizations, number of deaths,
monetary valuations of health outcomes, and loss of Quality Adjusted Life
Years.
• The National Institute for Public Health and the Environment in the
Netherlands applied a quantitative methodology (developed by WHO) to
calculate disease burden using Disability Adjusted Life Years and cost-of-
illness in monetary terms in order to assist risk managers in prioritizing
regulatory activities according to pathogen.
• Risk Ranger, a software programme developed at the University of Hobart,
Australia, extends the above risk ranking tools to allow risk ranking of
hazard-food combinations in national settings. Categories used in the tool
include rankings for hazard severity and susceptibility of the consumer,
probability of exposure to the food and probability of the food containing
an infectious dose. Comparative risk in the population of interest is
expressed as a relative ranking between zero and 100.
Other tools are used to rank hazard-food combinations in a national context by
deriving a “comparative risk” scoring system. While risk ranking methods not
based on risk assessments assist risk-based food regulation, their use of scoring
systems (which inevitably have subjective, arbitrary elements) to derive
regulatory standards has inherent shortcomings. Thus, they are not a good
substitute for ranking methodologies that do incorporate risk assessment.

7.4.3 Epidemiology
Epidemiology is increasingly being used in food safety to study the links
between the frequency and distribution of adverse health effects in specific
populations and specific food-borne hazards. This includes observational
studies of human illness such as case-control, analysis of surveillance data, and
focused research (see given below). The usefulness of epidemiology depends
on the availability of data.
Examples of food source attribution supporting the development of risk-
based standards for microbiological hazards in foods.
• Many shellfish toxins have been identified and regulatory interventions
initiated only after epidemiological studies linked shellfish with outbreaks
of human illness; e.g. domoic acid in shellfish in Canada, azaspiracids in
shellfish in Ireland.
• Case-control studies carried out by the United States Centers for Disease
Control and Prevention (CDC) have implicated ground beef as an
important risk factor in Escherichia coli O157:H7 infection in humans, and
outbreak reports continue to be associated with this pathogen. Control
efforts have focused on both slaughterhouse/processing plant hygiene and
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 educating consumers as to proper preventive food handling and cooking Risk Assessment
methods.
• New Zealand does not have the recognized antibiotic multi-resistant
Salmonella serotypes in food animals that can cause severe disease in
humans. However, there are similar levels of antibiotic susceptible
serotypes to those in other countries. Faced with applications for
importation of foods from countries with multi-resistant serotypes, a source
attribution model was used to apportion any potential increase in risks from
imported foods against risks introduced via other transmission pathways
(e.g. domestically-produced food, travelers, imported live animals,
migratory birds, pet food). This model allows decisions to be made on
import health standards that are proportional to risks and non-
discriminatory to trade.

7.4.4 Combination of Approaches

Distinctions are drawn in this Unit between risk assessment approaches based
on the four analytical steps described by Codex, the use of ranking tools and
the use of analytical epidemiological techniques. However, as a practical
matter these various approaches are often used in combination or feed into
each other (e.g. epidemiological data feed into hazard identification and hazard
characterization steps of any risk assessment). Ways in which they can be
integrated vary widely on a case-by-case basis, but all are subject to the
general principles and guidelines described in the sections that follow.

7.5 RESPONSIBILITIES OF RISK MANAGERS IN

COMMISSIONING AND GUIDING A RISK
ASSESSMENT
The decision to proceed with a risk assessment is to be taken by risk managers
based on factors such as the health risk priority ranking, urgency,
regulatory needs and availability of resources and data.
It is likely that a risk assessment will not be commissioned when:
• the risk is well described by definitive data,
• the food safety issue is relatively simple,
• the food safety issue is not of regulatory concern or not subject to
regulatory mandate, and
• an urgent regulatory response is required.
It is likely that a risk assessment will be commissioned when:
• the hazard exposure pathway is complex,
• data on the hazard(s) and/or health impacts are incomplete,
• the issue is of significant regulatory and/or stakeholder concern,
• there is a mandatory regulatory requirement for a risk assessment, and
• there is a need to verify that an interim (or precautionary) regulatory
response to an urgent food safety problem is scientifically justified.

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Risk Analysis Risk managers, in consultation with risk assessors, should fulfil several tasks
when commissioning a risk assessment and seeing it through to completion
(given below) as per steps given below.
General responsibilities of risk managers in commissioning and guiding a
risk assessment
• Risk managers should request the relevant scientific bodies to assemble the
risk assessment team or, where this is not possible, establish the risk
assessment team.
• Risk managers, in consultation with risk assessors, should:
− identify food safety issue including purpose and scope of the risk
assessment;
− prepare risk profile;
− develop questions that need to be addressed by the risk assessment;
− establish a risk assessment policy; and
− specify form of the outputs of the risk assessment.
• Risk managers should ensure that sufficient time and resources are
available to complete the risk assessment.

7.5.1 Forming the Risk Assessment Team

A risk assessment team should be appropriate to the circumstances. When
strategic and large scale risk assessments are undertaken, the general criteria
described below relating to risk assessment teams apply. A large-scale risk
assessment generally requires a multidisciplinary team that may include, as
appropriate, experts with biological, chemical, food technology,
epidemiological, medical, statistical and modelling skills, among others.
Small-scale and straightforward risk assessments may be undertaken by very
small teams or even by individuals, especially where a primary risk assessment
is already available and the scientific work involves mostly adaptation using
local data.
Risk managers need to take care to ensure that the assembled team satisfies the
general criteria that require that the team is:
• objective, balanced in terms of scientific perspectives;
• free from undue biases and conflicts of interest; and
• free from potential financial or personal conflicts of interest that could bias
an individual’s scientific judgment.

7.5.2 Specification of Purpose and Scope

Risk managers should prepare a “purpose statement” for a risk assessment,
which should identify the specific risk or risks to be estimated and the broad
risk management goal(s). The “scope” portion of the risk assessment
description should identify the parts of the food production chain that are to be
evaluated and should establish boundaries for risk assessors with regard to the
nature and extent of scientific information to be considered.
Risk managers addressing specific food safety issues at the national level
should also be aware of international risk assessments (see Unit 5, Section
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5.3.3) and other pre-existing scientific efforts on relevant subjects before they Risk Assessment
commission new work). By considering existing risk assessments in
consultation with their risk assessors, risk managers may be able to
substantially narrow the scope of the work and the data needed.

7.5.3 Questions to be Addressed by Risk Assessors

Risk managers, in consultation with risk assessors, should formulate the
specific questions that need to be answered by the risk assessment. Depending
on the scope of the risk assessment needed and the resources available,
considerable discussion may be required to arrive at clear and realizable
questions which will yield answers to guide risk management decisions. As
with the statement on purpose and scope, questions to be addressed by the risk
assessment often flow from the broad risk management goal(s) agreed on when
the risk assessment is commissioned. Examples of questions that risk managers
might ask risk assessors to answer are illustrated given below. The questions
asked by the risk managers can have an important influence on the choice of
risk assessment methodologies used to answer them.
Examples of questions to be addressed by risk assessors
In the example of Campylobacter in broiler chickens used in Unit 6, risk
assessors could be asked to address any of the following questions:
• Quantify relative impacts of specified food safety controls for
Campylobacter in broiler chickens, either alone or in combination, on
levels of consumer risk.
• Quantify influence of different levels of hazard control at specified steps in
the food production chain (including prevalence at the farm level) on risk
estimates (e.g. what is the impact on risk to consumers if flock prevalence
is reduced by 50 per cent?).
• Estimate the likely proportions of human campylobacteriosis transmitted
by broiler chickens compared to other food transmission pathways.
In the case of aflatoxin contamination of a particular crop, risk assessors could
be asked to address any of the following questions:
• Quantify the comparative lifetime cancer risk from consumption of the
crop where the mean concentration of aflatoxin was reduced from 10 ppb
to 1 ppb.
• Quantify the comparative lifetime cancer risk from consumption of the
crop in the same scenario but for an exposed population with a significant
level of liver damage from hepatitis A.
• Assess the proportionate lifetime cancer risk from current aflatoxin levels
in the crop compared with other significant sources of aflatoxin in the diet
(e.g. other types of crops and nuts).
While risk assessment is fundamentally an objective, scientific activity, it
inevitably contains some elements of policy and subjective scientific judgment.
For example, when scientific uncertainty is encountered in the risk assessment,
gaps in scientific knowledge are bridged through a set of inferences and
“default assumptions.” At other points in a risk assessment, assumptions may
be required that are driven by values-based, social consensus, often developed
through long experience with how such issues should be handled. Below
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Risk Analysis presents some examples of each of these types of choices that might arise in a
food safety risk assessment. Documentation of all such default assumptions
contributes to the consistency and transparency of risk assessments.
Examples of choices that might be part of a risk assessment policy
Policies governing values-based choices:
• Where a chemical hazard may be deliberately introduced into the food
supply (e.g. as a food additive or technological aid) use should be limited
to levels where there is “notionally zero risk” to consumers, i.e. the amount
permitted should be without any appreciable human health risk.
• Hazard characterization in microbiological risk assessment should include
description of the type and severity of adverse health effects and categorize
these in risk estimates.
• When calculating an acceptable daily intake for a chemical hazard, it is
appropriate to start with the dose at which no adverse effect is observed in
appropriate animal tests for the most sensitive relevant end-point (toxic
effect), and to apply a 100-fold safety factor: a ten-fold factor to account
for possible differences between humans and test animals in sensitivity to
toxic effects, and a second ten-fold factor to account for variability in
susceptibility of individuals or subgroups of the population to the toxic
effect.
Policies governing science-based choices:
• When animal test data are available from relatively high-dose exposures to
carcinogenic chemicals but these are considered insufficient to define the
shape of the dose-response curve in the low-dose region and extrapolation
is needed, a linear model may be deemed appropriate for public health
protection purposes.
• Microbiological risk assessments should be constructed in modular form so
that food chain parameters can be changed, or new modules added, to
estimate the impact on risk.
• Toxicological reference values for carcinogenic chemicals should be based
on a combination of epidemiological and animal data where available.

7.5.4 Specification of Form of the Outputs

Outputs of a risk assessment may be sought in non-numerical (qualitative) or
numerical (quantitative) form (see also Section 7.7.2). Non-numerical risk
estimates provide a less definitive basis for decisions but are adequate for
several purposes, such as establishing relative risks or evaluating relative
impacts on risk reduction of different control measures. Numeric estimates of
risk can take one of two formats:
• Point estimate, which is a single numerical value representing for example
the risk in a worst case scenario.
• Probabilistic risk estimates, which include variability and uncertainty (see
Section 7.6.5) and are presented as a distribution reflecting more real-life
situations.
To date, point estimates have been more common outputs of chemical risk
assessments while probabilistic outputs are the usual product of
50 microbiological risk assessments.
 Risk Assessment
7.5.5 Time and Resources
While it is desirable to maximize scientific inputs and commission specific
research to fill data gaps when conducting a risk assessment, all risk
assessments are inevitably constrained in some ways. In commissioning a risk
assessment, risk managers must ensure that sufficient resources (e.g. time,
money, personnel and expertise) are available relative to the purpose and
scope, and establish a realistic timetable for completion of the work.

Check Your Progress Exercise 2 "

Note: a) Use the space below for your answers.
b) Check your answers with those given at the end of the unit.
1) State various basis used in risk ranking tools? Give one example using any
of these basis.
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2) What are the specific tasks of risk managers while commissioning risk
assessment?
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3) Who is responsible for ensuring sufficient resources in terms of time and

funds for carrying out risk assessment?
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7.6 GENERAL CRITERIA OF RISK ASSESSMENT

Irrespective of the context, risk assessments generally share a number of basic
criteria (given below). While these attributes are described comprehensively in
the sections that follow, in some situations a specific risk assessment is a
relatively simple and straightforward exercise. In such cases, the general
criteria can be substantially modified; for instance, it may sometimes be
possible for experts within a government food safety agency to conduct an
adequate risk assessment quickly and efficiently, without the need to assemble
a multidisciplinary risk assessment team.

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Risk Analysis General criteria of food safety risk assessments
• A risk assessment should be objective, transparent, fully documented and
available for independent scrutiny.
• The functions of risk assessment and risk management should be carried
out separately to the extent practicable.
• Risk assessors and risk managers should engage in an interactive and on-
going dialogue throughout risk assessment.
• Risk assessment should follow a structured and systematic process.
• Risk assessment should be based on scientific data and should take into
account the whole “production-to-consumption” food pathway.
• Uncertainties in risk estimates and their origins and impacts should be
clearly documented, and explained to risk managers.
• A risk assessment should be subject to peer review if considered
appropriate.
• A risk assessment should be reviewed and updated as new information
permits or requires.

7.6.1 Objectivity and Transparency

A risk assessment should be objective and unbiased. Opinions or value
judgements on issues other than science (for instance on economic, political,
legal or environmental aspects of the risk) should not be allowed to influence
the outcome and risk assessors should explicitly identify and discuss any
judgements on the sufficiency of the science that was relied on.
Above all, a risk assessment must be transparent and in documenting the
process the risk managers should:
• describe the scientific rationale,
• reveal any biases that may affect the conduct or results of the risk
assessment,
• identify clearly and concisely all scientific inputs,
• clearly state all assumptions,
• provide an interpretive summary for lay readers, and
• where possible, make assessments available to the public for comment.

7.6.2 Functional Separation of Risk Assessment and Risk

Management
In general, the functions of risk assessment and risk management should be
carried out separately to the extent practicable, so that the science remains
independent from regulatory policy and values. Functional separation may be
more obvious when different bodies or officials are responsible for risk
assessment and risk management tasks. However, functional separation can
also be achieved in countries with limited resources and personnel where risk
assessments are undertaken by people who act as both risk assessors and risk
managers. What is important in these cases is to have conditions in place
which ensure that risk assessment tasks are carried out separately from risk
management tasks (see Unit 6). In such cases, particular attention should be
52
devoted to ensuring that the risk assessment meets the criteria. Communication Risk Assessment
between risk assessors and risk managers is also a critical element in the
process, as described in more detail in Unit 8.

7.6.3 Structured Process

Risk assessments should follow a structured and systematic process; see
Section 7.7 on risk assessment methodology.

7.6.4 Basis in Science

It is a primary tenet that risk assessment be soundly based on scientific data.
Data of sufficient quality, detail and representativeness must be located from
appropriate sources and assembled in a systematic manner. Descriptive and
computational elements should be supported with scientific references and
accepted scientific methodologies, as appropriate.
When a risk assessment is commissioned, there often are insufficient data
available to complete the assignment. Scientific information to support many
food safety risk assessments is available from a variety of sources, both
national and international (given below). FAO and WHO administer
international panels of experts on chemical (JECFA and JMPR) and
microbiological hazards (JEMRA) to provide risk assessments as the basis for
Codex standards (see Unit 5, Section 5.3.3). These assessments are also used
by risk assessors and risk managers at the national level.
Sources of scientific information for risk assessments
• Published scientific studies.
• Specific research studies carried out (by the government agency or external
contractors) in order to fill data gaps.
• Unpublished studies and surveys carried out by industry, such as data on
the identity and purity of a chemical under consideration as well as toxicity
and residue studies carried out by the chemical’s manufacturer*.
• National food monitoring data.
• National human health surveillance and laboratory diagnostic data.
• Disease outbreak investigations.
• National food consumption surveys, and regional diets e.g. those
constructed by FAO/WHO.
• Use of panels to elicit expert opinion where specific data sets are not
available.
• Risk assessments carried out by other governments.
• International food safety databases.
• International risk assessments carried out by JECFA, JMPR and JEMRA
(see Unit 8, Section 8.5.1).

* Manufacturers often may agree to supply data only if it remains confidential. Risk managers
must judge the need to trade off transparency so as to obtain relevant and sufficient data.

53
Risk Analysis
7.6.5 Dealing with Uncertainty and Variability
Definitive data needed to derive quantitative risk estimates are often lacking,
and sometimes there are significant uncertainties inherent in biological or other
models used to represent the processes that contribute to risk. Uncertainty
about the available scientific information is often addressed in a risk
assessment by using a range of possible data values.

Two distinct characteristics of scientific information are relevant in this

context. Variability is a characteristic of phenomena that differ from one
observation to the next; for example, people eat different amounts of a food,
and the level of a particular hazard present in a food also can vary widely from
one serving of food to another. Uncertainty is the quality of being unknown,
for example because inadequate data exist, or because the biological
phenomena involved are not well understood. For instance, in assessing a
chemical hazard scientists may need to rely on data from toxicity tests in
rodents because insufficient human epidemiological data exist. For examples
of each kind of uncertainty (given below).

Examples of uncertainty and variability in risk assessments

• Methylmercury in fish: The two best-designed large epidemiological

studies have yielded results interpreted by some scientists as inconsistent.
In the United States, risk assessors relied on only the study yielding
stronger evidence to assess the risk, and risk managers adopted a Tolerable
Daily Intake (TDI) with a 10-fold default uncertainty margin. At the
international level, JECFA integrated exposure data from both studies and
applied a 6.4-fold data-derived uncertainty factor in recommending a
somewhat higher Provisional Tolerable Weekly Intake (PTWI). The
uncertainty factors applied in each case were in response to the known
variability of individuals in susceptibility to harm from methylmercury.

• Listeria in ready-to-eat food: A preliminary risk assessment in the United

States revealed substantial uncertainties regarding the relative risks posed
by Listeria monocytogenes in different foods. Risk managers chose to
collect more data and carry out a much more detailed risk assessment,
which suggested substantially clearer regulatory priorities. Variability in
hazard levels, food consumption and human susceptibility to harm were
included and accounted for in the detailed assessment.

The risk estimate should, wherever possible, include a numerical expression of

uncertainty, and this must be conveyed to risk managers by the risk assessors
in a readily understandable form so that the full implications of the range of
uncertainty can be included in decision-making.

7.6.6 Peer Review

Peer review reinforces transparency and allows wider scientific opinion to be
canvassed in relation to a specific food safety issue. External review is
especially important where new scientific approaches are being applied. Open
comparison of the outcomes of similar risk assessments where different
scientific approaches and other judgements have been used can yield useful
insights.

54
Check Your Progress Exercise 3 " Risk Assessment

Note: a) Use the space below for your answers.

b) Check your answers with those given at the end of the unit.
1) What are the general characteristics of risk assessment?
………………………………………………………………………………
………………………………………………………………………………
…………………………………………………………………………….…
……………………………………………………………………………….

2) State various sources which can be used for scientific information for risk
assessment?
………………………………………………………………………………
………………………………………………………………………………
………………………………………………………………………………
…………………………………………………………………………….…

3) How risk assessment can be more transparent?

………………………………………………………………………………
………………………………………………………………………………
………………………………………………………………………………
…………………………………………………………………………….…

7.7 RISK ASSESSMENT METHODOLOGY

Different risk assessment methods are used in different countries and within
countries, and different methods may be used to assess different kinds of food
safety problems. Methods vary according to the class of hazard (i.e. chemical,
biological or physical hazard), the food safety scenario (e.g. concerning known
hazards, emerging hazards, new technologies such as biotechnology, complex
hazard pathways such as for antimicrobial resistance) and the time and
resources available.

Differences in risk assessment methodology are most apparent for chemical

compared with microbiological hazards (see Section 7.4.1). This is partly due
to intrinsic differences between the two classes of hazards (given below). The
differences also reflect the fact that for many chemical hazards, a choice can be
made as to how much of the chemical may enter the food supply, e.g. for food
additives, residues of veterinary drugs and pesticides. Use of these chemicals
can be regulated or restricted suitably so that residues at the point of
consumption do not result in risks to human health. Microbial hazards, in
contrast, are very common in the food chain, they grow and die, and despite
control efforts, they often can exist at the point of consumption at levels that do
present obvious risks to human health.

55
Risk Analysis Some characteristics of microbial and chemical hazards that influence the
choice of risk assessment methodology

Microbial Hazard Chemical Hazard

• Hazards can enter foods at many points • Hazards usually enter foods in the raw
from production to consumption. food or ingredients, or through certain
processing steps (e.g. acrylamide or
packaging migrants).

• The prevalence and concentration of • The level of hazard present in a food

hazard changes markedly at different after the point of introduction often does
points along the food production chain. not significantly change.

• Health risks are usually acute and result • Health risks may be acute but are
from a single edible portion of food. generally chronic.

• Individuals show a wide variability in • Types of toxic effects are generally

health response to different levels of similar from person to person, but
hazard. individual sensitivity may differ.

7.7.1 Basic Components of a Risk Assessment

The risk assessment process is generally represented as consisting of four
steps, described by Codex (see Fig. 7.1 in section 7.4.1 above). Following
identification of the hazard(s), the order in which these tasks can be carried out
is not fixed; the process is normally highly iterative, with steps repeated as data
and assumptions are refined.
a) Hazard identification: Specific identification of the hazard(s) of concern
is a key step in risk assessment and begins a process of estimation of risks
specifically due to that hazard(s). Hazard identification may have already
been carried out to a sufficient level during risk profiling (see Unit 6); this
generally is the case for risks due to chemical hazards. For microbial
hazards, the risk profile may have identified specific risk factors associated
with different strains of pathogens, and subsequent risk assessment may
focus on particular subtypes. Risk managers are the primary arbiters of
such decisions.
b) Hazard characterization: During hazard characterization, risk assessors
describe the nature and extent of the adverse health effects known to be
associated with the specific hazard. If possible, a dose-response
relationship is established between different levels of exposure to the
hazard in food at the point of consumption and the likelihood of different
adverse health effects. Types of data that can be used to establish dose-
response relationships include animal toxicity studies, clinical human
exposure studies and epidemiological data from investigations of illness.
Response parameters may be categorized according to the risk management
questions that are asked of risk assessors; for example, for chemical
hazards, type of adverse health effects induced by different doses of
chemical hazards in animal tests; for microbial hazards, infection,
morbidity, hospitalization and death rates associated with different doses.
Where economic analyses are undertaken, hazard characterization should
include the large impact of food-borne illness that is due to complications
following the acute phase.
56
c) Exposure assessment: Exposure assessment characterizes the amount of Risk Assessment
hazard that is consumed by various members of the exposed population(s).
The analysis makes use of the levels of hazard in raw materials, in food
ingredients added to the primary food and in the general food environment
to track changes in levels throughout the food production chain. These data
are combined with the food consumption patterns of the target consumer
population to assess exposure to the hazard over a particular period of time
in foods as actually consumed. Characterization of exposure may vary
according to whether the focus is on acute or chronic adverse health
effects.
Risks from chemical hazards are typically assessed against long-term or
lifetime chronic exposure to the hazard, often from multiple sources. Acute
exposures are also frequently considered for certain contaminants and
pesticide and veterinary drug residues. Risks from microbial hazards are
typically evaluated in terms of single exposures to a contaminated food.
The level of a hazard in a food at the time of consumption is often very
different from that when the food is being produced. Where necessary,
exposure assessment can scientifically evaluate changes in levels of hazard
throughout the production process to estimate the likely level at the time of
consumption. In the case of chemical hazards in foods, there may be
relatively little change from levels in raw materials. In the case of
microbiological hazards in foods, marked changes in levels can occur due
to pathogen growth and heat treatment, and cross-contamination at the time
of final preparation for consumption may add to the complexity of the
evaluation.
d) Risk characterization: During risk characterization, outputs from the
previous three steps are integrated to generate an estimate of risk.
Estimates can take a number of forms and uncertainty and variability must
also be described if possible (see Unit 6, Section 6.6.5). A risk
characterization often includes narrative on other aspects of the risk
assessment, such as comparative rankings with risks from other foods,
impacts on risk of various “what if” scenarios and further scientific work
needed to reduce gaps.
Risk characterization for chronic exposure to chemical hazards does not
typically include estimates of the likelihood and severity of adverse health
effects associated with different levels of exposure. A “notional zero risk”
approach is generally taken and where possible the goal is to limit exposure
to levels judged unlikely to have any adverse effects at all (see section
7.8.4 below).

7.7.2 Qualitative or Quantitative?

Risk assessment outputs can range from qualitative (non-numerical) to
quantitative (numerical) with various intermediate formats (see Fig. 7.2). The
characteristics of risk assessments presented above apply to all types. In
qualitative risk assessments, outputs are expressed in descriptive terms such as
high, medium or low. In quantitative risk assessments, the outputs are
expressed numerically and may include a numerical description of uncertainty.
In some cases, intermediate formats are referred to as semi-quantitative risk
assessments. For instance, one semi-quantitative approach may be to assign
scores at each step in the pathway and express outputs as risk rankings.

57
Risk Analysis Factors influencing the type of risk assessment undertaken: The most
common factors which are considered by risk managers (see Fig. 7.2) before
deciding the type of risk assessment to be carried out are (a) time available;
(b) resources; (c) resolution of out put. Essentially, the good risk assessment is
one that answers the risk questions within these constraints- i.e. it is fit for
purpose.

Type length of time required resources required resolution

Qualitative low few low

Quantitative-
Deterministic

Quantitative-
Probabilistic

high many high

Fig. 7.2: Illustrations of the Factors that Influence that Decision to Undertake a
Particular Type of the Risk Assessment

7.8 RISK ASSESSMENT FOR CHEMICAL

HAZARDS
Chemical hazards in foods include food additives, environmental contaminants
such as lead, mercury and dioxins, natural toxicants in food, such as glycol
alkaloids in potatoes and aflatoxins in peanuts, acrylamide, and residues of
pesticides and veterinary drugs. Adverse health effects are usually predicted
for long-term exposure to chemicals. For certain chemicals, such as some
mycotoxins, marine toxins, pesticides and veterinary drugs, both acute and
chronic health effects need to be considered.

7.8.1 Hazard Identification

Hazard identification describes the adverse effects of the substance, the
possibility of causing an adverse effect as an inherent property of the chemical,
and the type (age group, gender, etc.) and extent of the population that may be
at risk. Because sufficient human data from epidemiological studies are often
not available, risk assessors frequently rely on results from toxicological
studies in experimental animals and in vitro studies.

7.8.2 Hazard Characterization

Hazard characterization describes and evaluates dose-response relationships
for the most critical adverse effects reported in the available studies. This
includes consideration of mechanistic aspects (e.g. whether the mechanism of
action of the chemical observed in often high-dose experimental studies is also
relevant to human exposure at lower levels). In cases where the toxic effect
results from a mechanism that has a threshold, hazard characterization usually
58 results in the establishment of a safe level of intake, an acceptable daily intake
(ADI) or tolerable daily intake (TDI) for contaminants. For some substances Risk Assessment
used as food additives the ADI may not need to be specified, i.e. no numerical
ADI is considered necessary. This may be the case when a substance is
assessed to be of very low toxicity, based on the biological and toxicological
data, and the total dietary intake of the substance, arising from the levels
permitted in foods to achieve the desired function does not represent a hazard.

7.8.3 Exposure Assessment

Exposure assessment describes the exposure pathway or pathways for a
chemical hazard and estimates total intake. For some chemicals, intake may be
associated with a single food. For others the residue may be present in multiple
foods, as well as in drinking water, and sometimes in household products, such
that food accounts for only a portion of total exposure.
For chemicals, exposure assessment often uses values at certain points on the
continuum of exposure, such as the mean. Such point estimates are referred to
as deterministic models. Some exposure models are emerging, such as for
intake of pesticide residues, that takes into account the distribution of food
consumption by a population. These models, generally called probabilistic,
provide more details on the distribution of exposed consumers, but are not
inherently more accurate than deterministic models. If the level of exposure as
determined by the exposure assessment is lower than the ADI or TDI, the
chemical in foods is within safe limits.

7.8.4 Risk Characterization

Risk characterization in chemical risk assessment primarily takes the form of
defining a level of exposure presumed to pose a “notional zero risk.”
Quantitative risk assessment methodologies have only rarely been applied for
chemical hazards thought to pose no appreciable risk below certain very low
levels of exposure (i.e. those with mechanisms of toxic action believed to
exhibit a threshold), probably because the approach described above has
generally been considered to provide an adequate margin of safety without a
need to further characterize the risk. In contrast, quantitative risk assessment
models have been applied by some governments as well as by international
expert bodies (JECFA) for effects that are judged to have no threshold, i.e. for
genotoxic carcinogens. These models employ biologically-appropriate
mathematical extrapolations from observed animal cancer incidence data
(usually derived from tests using high doses) to estimate the expected cancer
incidence at the low levels typical of ordinary human exposure. If
epidemiological cancer data are available, they also can be used in quantitative
risk assessment models.

7.8.5 Application of Toxicological Guidance Values

Toxicological guidance values can be Acceptable Daily Intake (ADI) for food
additives, pesticides and veterinary drugs, and Tolerable Daily Intake (TDI),
Provisional Tolerable Weekly Intake (PTWI) and Provisional Tolerable
Monthly Intake (PTMI) for other contaminants.
For veterinary drug and pesticide residues, maximum residue levels (MRLs)
are derived from controlled studies and are generally established so that the
theoretical maximum daily intake of residues (calculated by any of several
accepted methods) does not exceed the ADI. For environmental contaminants
59
Risk Analysis and other chemicals that appear in food, regulatory standards often define
“permissible levels” (or maximum levels (MLs) established by risk managers).
In assessing the risks of these hazards it is recognized that as a practical matter
it is often neither economically nor technically feasible to apply the same
“notional zero risk” model to unavoidable contaminants as to other chemicals
in the food supply. MLs are generally set so that the estimated intake does not
exceed the TDI or PTWI. Risk managers may ask the risk assessors to compare
the health protection impact of different proposed MLs. In such cases, the risk
assessors focus on the exposure assessment to provide a more in-depth
scientific basis for the risk management choices.

7.9 RISK ASSESSMENT FOR BIOLOGICAL

HAZARDS
Biological hazards are generally assessed in terms of a single exposure
resulting in an acute health risk4. Biological risk assessments typically use a
quantitative model to describe the baseline food safety situation and estimate
the level of consumer protection currently afforded. Then, some of the inputs
into the model are changed, such as the level of the hazard in the raw food at
the time of primary production, the conditions of processing, the temperature at
which packaged material is held during retail and in the home. Changing inputs
in a series of simulations enables the risk assessors to predict the impacts of the
various control measures on the level of risk compared to that estimated in the
baseline model.

7.9.1 Hazard Identification

A wide range of biological hazards can cause food-borne illness. Long-familiar
hazards include microbes, viruses, parasites and toxins of biological origin, but
new hazards are continually being identified, such as Escherichia coli
O157:H7, the prion agent of BSE, and multi- antibiotic resistant strains of
Salmonella. In a given case, a risk profile may have identified specific strains
or genotypes of pathogens that pose risks in a particular situation, and
assessment may focus on these.

7.9.2 Hazard Characterization

A wide range of hazard factors (e.g. infectivity, virulence, antibiotic resistance)
and host factors (e.g. physiological susceptibility, immune status, previous
exposure history, concurrent illness) affect hazard characterization and its
associated variability. Epidemiological information is essential for full hazard
characterization. While dose-response data are essential for quantitative
biological risk assessment, such data are often difficult to obtain for specific
hazards.

7.9.3 Exposure Assessment

A food-chain exposure pathway model up to the point of consumption is
developed for the hazard so that a human dose-response curve can be used to
generate estimates of risk (Fig. 7.3).
4
Note that many natural toxins such as mycotoxins and marine toxins need insight into biology as well as
chemistry for their risk assessment.

60
 Risk Assessment

Farm Slaughter Processing Retail Home

and
dressing

Fig. 7.3: Typical Modular Structure for estimating Exposure to Microbial Hazards from
Meat Products

Consideration of the whole food chain, while not always necessary, should be
encouraged to the extent required to answer the risk managers’ questions. The
level of human exposure depends on many factors including: the extent of
initial contamination of the raw food, characteristics of the food and the food
processes in terms of the hazard organism’s survival, multiplication or death,
and storage and preparation conditions before eating. Some transmission
pathways, for instance those for Campylobacter in poultry, may involve cross
contamination at retail or in the home.

7.9.4 Risk Characterization

Risk estimates can be qualitative, e.g. high, medium or low rankings for a
pathogen, or presented in quantitative terms, e.g. cumulative frequency
distributions of risk per serving(s), annual risks for targeted populations, or
relative risks for different foods or different pathogens. Biological
characteristics of the pathogen/host relationship are often uncertain and
modelling the exposure pathway from production to consumption often suffers
from substantial data gaps. Due to this, risk characterization for microbial
hazards may be somewhat inaccurate, but the greater strength of microbial risk
assessment lies in its ability to model different food control measures and their
impact on estimates of relative risks. Modelling “what-if” scenarios, such as
changing the assumed prevalence of infection in the live animal population
from which the food is derived, is also an essential part of economic analysis.

7.10 BIOTECHNOLOGY RISK ASSESSMENT

Risk analysis principles and food safety assessment guidelines have recently
been elaborated by Codex for foods derived from “modern biotechnology”, i.e.
those containing, derived from or produced using genetically modified
organisms. Potential adverse health effects that require assessment include
transfer of, or creation of new, toxins or allergens into foods with introduced
genetic traits. Safety assessment is carried out to identify whether a hazard,
nutritional or other safety concern is present, in which case information on its
nature and severity should be collected and analysed. The safety assessment
should include a comparison between the whole food derived from modern
biotechnology (or component thereof) and its conventional counterpart, taking
into account both intended and unintended effects.

7.11 SENSITIVITY ANALYSIS

Sensitivity analysis is a tool that can help risk managers select those controls
that best achieve risk management goals. Sensitivity analysis, as a scientific
process, shows the effects of changes in various inputs (data or assumptions)
on the outcomes of a risk assessment. One of the most useful insights gained
from a sensitivity analysis is estimating how much the uncertainty or

61
Risk Analysis variability associated with each input factor contributes to the overall
uncertainty and variability in the risk estimate. Input distributions where
uncertainty has the greatest impact on the outcome can be identified, and this
process also can help set priorities for research to reduce uncertainty.

7.12 VALIDATION
Model validation is the process of evaluating a simulation model used in a risk
assessment for its accuracy in representing a food safety system, e.g. by
comparing model predictions of food-borne disease with human surveillance
data, or by comparing model predictions on hazard levels at intermediate steps
in the food production chain with actual monitoring data. While validation of
the outputs of a risk assessment is desirable, this activity is not always
practical.

7.13 ESTABLISHMENT OF “TARGETS” IN THE

FOOD CHAIN AS REGULATORY
STANDARDS
The concept of setting food safety “targets” at various points in the food
production chain as flexible implementation tools was described in Unit 6.
Developing and evaluating specific, quantitative microbiological metrics, such
as performance objectives and performance criteria were described in Unit 6,
and these can be can be incorporated in regulations.
Risk assessors are involved in developing risk-based microbiological targets by
simulating their impacts in risk models. In most cases, the goal of such
simulations is to develop practical risk-based metrics than can be directly
incorporated (and monitored) in HACCP plans, such as process criteria,
product criteria and microbiological criteria. However, considerable
methodological challenges remain in this area.
The concept of regulatory targets is equally applicable to chemical hazards.
Currently, standards for chemical hazards in foods are often generic, such as
requiring use of a pesticide or veterinary drug according to good agricultural
practice (GAP) and good veterinary practice (GVP). MRLs developed from
this process are not directly related to health outcomes. An appropriate
performance target developed from a quantitative risk assessment could be the
level of chemical hazard that is permissible at a specified step in the food
chain, weighted relative to the ADI.

# Check Your Progress Exercise 4

Note: a) Use the space below for your answers.
b) Check your answers with those given at the end of the unit.
1) How various characteristics of hazards influence choice of risk assessment
methodology?
………………………………………………………………………………
………………………………………………………………………………
…………………………………………………………………………….…

62 ……………………………………………………………………………….
2) Describe various components of risk assessment? Risk Assessment

………………………………………………………………………………
………………………………………………………………………………
………………………………………………………………………………
…………………………………………………………………………….…
3) How hazard characterization is carried out for chemical hazards?
………………………………………………………………………………
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………………………………………………………………………………
…………………………………………………………………………….…

7.14 LET US SUM UP

Risk assessment is the scientific foundation of risk analysis. This Unit takes a
broad view of risk assessment methodologies and their essential
characteristics. The four steps in the Codex risk assessment system are fully
explored, together with risk ranking and epidemiological approaches. The
responsibilities of risk managers in commissioning and guiding risk
assessment are described and differences between risk assessment approaches
for chemical compared with microbiological hazards are illustrated. The
relative merits of qualitative and quantitative approaches are examined, as are
recent approaches using probabilistic models of risks.

7.15 KEY WORDS

Dose-Response : The determination of the relationship between
Assessment the magnitude of exposure (dose) to a chemical,
biological or physical agent and the severity
and/or frequency of associated adverse health
effects (response).
Exposure Assessment : The qualitative and/or quantitative evaluation of
the likely intake of biological, chemical, and
physical agents via food as well as exposures
from other sources if relevant.
Hazard : The qualitative and/or quantitative evaluation of
Characterization the nature of the adverse health effects
associated with biological, chemical and
physical agents which may be present in food.
For chemical agents, a dose response assessment
should be performed. For biological or physical
agents, a dose-response assessment should be
performed if the data are obtainable.
Hazard Identification : The identification of biological, chemical, and
physical agents capable of causing adverse
health effects and which may be present in a
particular food or group of foods.
63
Risk Analysis
Risk Characterization : The qualitative and/or quantitative estimation,
including attendant uncertainties, of the
probability of occurrence and severity of known
or potential adverse health effects in a given
population based on hazard identification, hazard
characterization and exposure assessment.
Risk Estimate : The quantitative estimation of risk resulting from
risk characterization.

7.16 ANSWERS TO CHECK YOUR PROGRESS

EXERCISES
Your answer should include following points:

Check Your Progress Exercise 1

1) ● Hazard Identification: The identification of biological, chemical, and
physical agents capable of causing adverse health effects and which
may be present in a particular food or group of foods.
• Hazard Characterization: The qualitative and/or quantitative
evaluation of the nature of the adverse health effects associated with
biological, chemical and physical agents which may be present in food.
For chemical agents, a dose response assessment should be performed.
For biological or physical agents, a dose-response assessment should be
performed if the data are obtainable.
• Dose-Response Assessment: The determination of the relationship
between the magnitude of exposure (dose) to a chemical, biological or
physical agent and the severity and/or frequency of associated adverse
health effects (response).
• Exposure Assessment: The qualitative and/or quantitative evaluation of
the likely intake of biological, chemical, and physical agents via food
as well as exposures from other sources if relevant.
2) ● Principle 1- Health and safety aspects of Codex decisions and
recommendations should be based on a risk assessment, as appropriate
to the circumstances.
• Principle 2- Food safety risk assessment should be soundly based on
science, should incorporate the four steps of the risk assessment
process, and should be documented in a transparent manner.
• Principle 3- There should be a functional separation of risk assessment
and risk management, while recognizing that some interactions are
essential for a pragmatic approach.
• Principle 4- Risk assessment should use available quantitative
information to the greatest extent possible and risk characterizations
should be presented in a readily understandable and useful form.

Check Your Progress Exercise 2

1) Risk arising out of type of food, type of food preparation, type of business,
compliance record, and food user subpopulation are ranked based on their
64
 severity. For more details may see details given in section 7.4.2. Example Risk Assessment
of risk ranking tools.
2) a) Forming the risk assessment team
b) Specification of purpose and scope
c) Questions to be addressed by risk assessors
d) Establish risk assessment policy
e) Specification of forms of outputs
f) Time and resources
3) Risk manager is responsible for providing necessary time and resources for
carrying out risk assessment.

Check Your Progress Exercise 3

1) ● A risk assessment should be objective, transparent, fully documented
and available for independent scrutiny.
• The functions of risk assessment and risk management should be
carried out separately to the extent practicable.
• Risk assessors and risk managers should engage in an iterative and on-
going dialogue throughout risk assessment.
• Risk assessment should follow a structured and systematic process.
• Risk assessment should be based on scientific data and should take into
account the whole “production-to-consumption” food pathway.
• Uncertainties in risk estimates and their origins and impacts should be
clearly documented, and explained to risk managers.
• A risk assessment should be subject to peer review if considered
appropriate.
• A risk assessment should be reviewed and updated as new information
permits or requires.
2) ● Published scientific studies.
• Specific research studies carried out (by the government agency or
external contractors) in order to fill data gaps.
• Unpublished studies and surveys carried out by industry, such as data
on the identity and purity of a chemical under consideration as well as
toxicity and residue studies carried out by the chemical’s manufacturer.
• National food monitoring data.
• National human health surveillance and laboratory diagnostic data.
• Disease outbreak investigations.
• National food consumption surveys, and regional diets e.g. those
constructed by FAO/WHO.
• Use of panels to elicit expert opinion where specific data sets are not
available.
• Risk assessments carried out by other governments.
65
Risk Analysis
• International food safety databases.
• International risk assessments carried out by JECFA, JMPR and
JEMRA.
3) ● Describe the scientific rationale.
• Reveal any biases that may affect the conduct or results of the risk
assessment.
• Identify clearly and concisely all scientific inputs.
• Clearly state all assumptions.
• Provide an interpretive summary for lay readers.
• Where possible, make assessments available to the public for comment.

Check Your Progress Exercise 4

1) The most common characteristics of microbial and chemical hazards that
effect the choice of risk assessment are:
a) The point of entry of hazard in food chain.
b) The changes in level of hazard during processing.
c) Whether the hazard has acute or chronic effect on health.
d) Response factor in human due to presence of hazard.
2) a) Hazard identification
b) Hazard characterization
c) Exposure assessment
d) Risk characterization
3) Details of hazard characterization as described in Section 7.8

7.17 SUGGESTED READING

European Food Safety Authority. 2006. Transparency in Risk Assessment
carried out by EFSA: Guidance Document on Procedural aspects. EFSA
Journal (2006) 353, 1-16 (available at:
http://www.efsa.europa.eu/en/science/sc_commitee/sc_documents/1494.html).
FAO/WHO. 1999. Principles and Guidelines for the Conduct of
Microbiological Risk Assessment. Codex Alimentarius Commission. CAC/GL
30-1999 (available at:
http://www.codexalimentarius.net/web/standard_list.do?lang=en).
FAO/WHO. 2002. Risk assessments of Salmonella in eggs and broiler
chickens. Microbiological Risk Assessment Series, No. 2 (available at:
ftp://ftp.fao.org/docrep/fao/005/y4392e/y4392e00.pdf).
FAO/WHO. 2003. Hazard Characterization for Pathogens in Food and
Water. Guidelines Microbiological Risk Assessment Series, No. 3 (available
at: ftp://ftp.fao.org/docrep/fao/006/y4666E/y4666E00.pdf).

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FAO/WHO. 2004. Risk Assessment of Listeria Monocytogenes in Ready-to- Risk Assessment
eat Foods. Technical Report. Microbiological Risk Assessment Series, No. 5
(available at: http://www.fao.org/ag/agn/jemra/listeria_report_en.stm).
FAO/WHO. Risk Assessments Reports and Other Publications of JECFA,
JEMRA and JMPR are available on the FAO and WHO websites:
JECFA: http://www.fao.org/ag/agn/jecfa/index_en.stm
http://www.who.int/ipcs/publications/jecfa/en/index.html
JEMRA: http://www.fao.org/ag/agn/jemra/riskassessment_en.stm
http://www.who.int/foodsafety/micro/jemra/en/index.html
JMPR: http://www.fao.org/ag/agp/agpp/pesticid/
http://www.who.int/ipcs/publications/jmpr/en/

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