RISK ANALYSIS

Assoc. Prof. Dr. John Tang Yew Huat

Traditional Food Safety System
-Reactive approach.
-Main responsibility with
government.
-No structured risk
analysis.
-Relies on end product
inspection and testing.
Level of risk reduction:
Not always satisfactory
Modern Food Safety System
-Preventive approach.
-Shared responsibility.
-Addresses farm-to-table
continuum.
-Science based.
-Use of structured risk
analysis.
-Establishes priorities.
-Integrated food control.
-Relies on process
control.
Level of risk reduction:
Improved
Introduction
 Risk – is a function of the probability of an adverse health
effect and the severity of that effect, consequential to a
hazard(s) in food.
 Risk analysis is the ‘3rd wave’ of food safety:

1. Good Hygienic Practices in production and preparation to

reduce the prevalence and concentration of the microbial
hazard.
2. HACCP and HACCP-like approach which proactively
identifies and controls the hazard.
3. Risk analysis which focuses on the consequences to
humans of ingesting the microbial hazard, and the
occurrence of the hazard in the whole food chain (from farm
to fork).
Risk Analysis
 FAO / WHO Expert Consultation 1995 defines RA as a
process consisting of 3 components:
1. Risk Assessment
2. Risk Management
3. Risk Communication
Risk Analysis Components
1. Risk assessment:
 Identifies the risk and factors that influence it.
 It requires scientifically derived information and the
application of established scientific procedures carried out
in a transparent manner.
 However, sufficient scientific information is not always
available and so an element of uncertainty must be
associated with any decision.
Cont.
 Risk management: The process, distinct from risk assessment, of
weighing policy alternatives in consultation with all interested
parties, considering risk assessment and other factors relevant for
the health protection of consumers and for the promotion of fair
trade practices, and, if needed, selecting appropriate prevention
and control options.

 Risk communication: The interactive exchange of information and

opinions throughout the risk analysis process concerning risk, risk-
related factors and risk perceptions, among risk assessors, risk
managers, consumers, industry, the academic, community and
other interested parties, including the explanation of risk
assessment findings and the basis of risk management decisions.
Codex Framework of Risk Analysis
RISK ASSESSMENT
 In analyzing risk, we attempt to predict how the future will turn out if we
take a certain course of action (or no action….)
 2 main objectives:
1. Quantify the risk to a defined population group from consumption of a
defined product. If there is sufficient data, determine the risk from levels
and frequency of contamination at the time of consumption, the amount
of consumption (meal size and frequency) and an appropriate dose-
response relationship to translate the exposure into public health
outcomes.
2. Identify strategies and actions that can be used to decrease the level of
health risk. This usually requires the modelling of production, processing
and handling of the food and changes in the ‘farm to fork’ chain.
Subsequently, it may identify the steps in food production that are critical
to food safety, and those at which control actions or interventions would
produce the greatest reduction in risk of foodborne illness. Hence, the
potential use for critical control point identification in HACCP
implementation.
RISK QUESTIONS
1. What can go wrong?
2. How likely is that to happen?
3. What would the consequences be?
Why do risk assessment?
1. To carry out basic research to expand the knowledge base and increase
understanding about a particular risk.

2. To produce a baseline risk estimation that describes the risk in

quantitative or qualitative terms.

3. To attribute risk (i.e. to assign a portion of a known risk among competing

causes such as pathogens or foods).

4. To facilitate comprehensive risk management in response to an identified

food safety risk.

5. To produce information that can be used to support the establishment of

international food safety standards.
RISK ASSESSMENT
RISK ASSESSMENT
1. Hazard identification
2. Exposure assessment
3. Hazard characterization
4. Risk characterization
 Statement of purpose

Hazard identification
Identification of microorganisms capable of causing adverse health effects

Exposure assessment Hazard characterization

Evaluation of the degree of intake
likely to occur
Evaluation of the nature of the adverse effects
associated with microbiological hazards, which
may be present in food.
A dose-response assessment should be
performed if the data are obtainable

Risk characterization
Integration of exposure assessment and hazard characterisation
A risk estimate is made of the adverse effects likely to occur in a given
population, including attendant uncertainties and variabilities.

Formal report
Statement of purpose

 Problem formulation
 To state cause of concern, goals, breadth and
focus of risk assessment
 To include data required, uncertainties to solve
 Example of output:
 Risk estimate of illness per year
 Illness per 100,000 population
 Illness per eating
1. Hazard identification

 A qualitative description of hazard (agent), the

food and association of illness
 What agents of concern in the food?
Evidence?
 Focus depends on purpose:
 Specific pathogen
 Specific food
 Broad community group
 Specific process
 Food handling process
Cont.
Sources of information
 Epidemiological studies, surveillance
data
 Clinical trials
 Lab. Animal studies
 Ecological studies through food chain
 Expert opinion (regulators, scientists,
industry experts, etc.)
 Data collected used in exposure
assessment
2. EXPOSURE ASSESSMENT

 Evaluate the likely intake of hazard via

food/other sources if relevant
 Scope & level of detail of EA defined by
purpose and reason for doing assessment
 For most bacterial hazards, require
consideration of:
 Survivor
 Growth
 Inactivation
Factors influencing exposure
assessment
1. Characteristics of the pathogenic agent
2. Microbiological ecology of the food
3. Initial contamination of the raw material
4. Regional differences and seasonality of
production
5. Level of sanitation and process controls
6. Methods of processing, packaging, distribution
and storage of foods
7. Preparation steps such as cooking and holding
Cont.
8. Patterns of consumption
9. Consumers (socio-economic, cultural, ethnic,
demographic, food consumption preferences
and behavioral characteristics, etc.)
10. Role of food handler as source of
contamination
11. Amount of hand contact with product
12. Potential impact of abusive environment,
time or temperature relationship
Retail / consumer storage: scenarios

No growth before Some growth at refrigeration Growth with

consumption temperatures temperature abuse

Number of organisms in one serving

Example scenario for calculating exposure: dose
consumed

Concentration in food

Growth (transport/storage)

Reduction (cooking)

Amount consumed DOSE

Exposure assessment: data sources
 Published survey & experimental data
 Unpublished (government, industry surveys)
 Industry commodity associations
 Nutrition consumption studies
3. HAZARD
CHARACTERIZATION
 Qualitative &/or quantitative evaluation of nature of
adverse effects associated with hazards that may be
present in food

 If available, a dose response assessment should be

carried out

 HC provides an estimate of the nature, severity and

duration of the adverse effects following ingestion of
food containing hazards

i.e. for a given number of organism consumed at a sitting,

what is the probability of illness?
Dose response assessment
 To determine the relationship between magnitude
of exposure (dose) to the pathogen and the
severity &/ or frequency of health effects
(response)

 Sources of information:
 Human volunteer studies
 Population health statistics
 Outbreak data
 Animal trials
 Cont.

 4 possible responses to a dose pathogen:

1. Probability of infection following ingestion

2. Probability of illness following infection
3. Probability of chronic sequel following illness
4. Probability of death (mortality)
Dose-response relationship (WHO/FAO 2000):
factors to be considered

1. Organism type and strain

2. Route of exposure
3. Level of exposure (the dose)
4. Adverse effect considered (the response)
5. Characteristics of the exposed population.
4. RISK CHARACTERIZATION

 The integration of the three previous steps (hazard

identification, exposure assessment, hazard characterization)

 To obtain a risk estimate of the likelihood and the severity of

the adverse effect in a given population with attended
uncertainties
Cont.

 The final stage of risk assessment

 This can be:
 Qualitative (low, medium, high) or
 Quantitative (human infections, illnesses or
death per year or per 100,000 pop.)
Production of a formal report
 Risk assessment should be fully and
systematically documented

 To ensure transparency, report should

indicate any constraints and assumptions

 Report should be made available to

independent parties on request
RISK MANAGEMENT
Cont.
 Is a complex process, based on information from
various sources.
 First, the risk posed by a food component must be
assessed, preferably in an objective and quantitative
way.
 To do so, toxicological and epidemiological information
is needed.
 This is then followed by risk evaluation, in which the
results of risk assessment are weighed against certain
issues, such as socio-economical, political interest and
public perception.
Cont.
 This process results in setting a standard.
 Such a standard is an important tool for
risk management.
 Using the standard as a yardstick, the
toxicological risks from food components
are evaluated.
 If the standard is exceeded, the situation
may become hazardous, and appropriate
measures should be taken
Cont.
 This measures may concern risk
prevention and relief of the risk situation.
 In some cases, potential risks are regularly
control or monitored by the authorities
RISK COMMUNICATION
RISK COMMUNICATION

 The interactive exchange of information and

options concerning risks and risk
management among risk assessors, risk
managers, consumers and other interested
parties

 This process informs others of the risk and

the basis of risk management decisions.
 Effective risk communication
 Is on-going throughout the risk management process,
including between managers & assessors

 Is proactive

 Include all legitimate stakeholders

 Takes into account the different priorities and

perspectives of stakeholders

 Requires the commitment & support of all stakeholders

TQ>>>