ESR - Risk Analysis

Food safety
Is there any food with complete

freedom from risks ?
Endang S. Rahayu
Fak Teknologi Pertanian UGM
FAO/Who Expert Consultations
Related to Food Safety Matter
1995 – Risk analysis (Risk assessment)

The difference between hazard and risk
1997 – Risk Management
1999 – Risk assessment on microbiological
hazard
Outcomes – standards, guidelines,

recommendations
Endang S. Rahayu
Structure of Risk Analysis
Risk Assessment Risk Management

• Hazard Identification • Risk evaluation
• Hazard Characterization • Option Assessment
• Exposure Assessment • Option Implementation
• Risk Characterization • Monitoring and Review
Risk Communication
Endang S. Rahayu
Hazard – a biological, chemical or
physical agent in, or condition of, food with
the potential to cause harm
Risk – is an estimate of the probability

and severity of the adverse health effects in
exposed population, consequential to hazard
in food
Endang S. Rahayu
Chemical hazard
Contaminants
Food additives
Pesticides and veterinary drug residues
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Biological hazard - Enteric pathogens
• Infectious - agent
• Toxico-infectious - agents
• Toxic - agent
Endang S. Rahayu
Hazard
A condition or physical situation with a

potential for undesirable consequence, such
as harm to life or limb
A biological, chemical, or physical agent in or

property of a food that may cause a food to
be unsafe for consumption
Endang S. Rahayu
Risk
The potential for realization of unwanted,
adverse consequences to human life, health,
property, or the environment;
estimation of risk is usually based on the
expected value of the conditional probability
of the event occurring times the
consequence of the event given that it has
occurred;
The likelihood that an adverse health effect
will occur within a population as a result of
hazard in a food.
Endang S. Rahayu
Risk Analysis
a detailed examination including risk
assessment, risk evaluation, and risk
management alternatives, performed to
understand the nature of unwanted, negative
consequence to human life, health, property,
or the environment;
an analytical process to provide information
regarding undesirable event;
the process of quantification of the
probabilities and expected consequences for
identified risks
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Risk Assessment
the process of establishing information
regarding acceptable levels of a risk and/or
levels of risk for an individual, group, society,
or the environment;
process of identifying hazards and
characterizing the risk of illness
Endang S. Rahayu
Risk Management
as the process of weighing policy

alternatives in the light of the results of risk
assessment and, if required, selecting and
implementing appropriate control options,
including regulatory measures
outcome – the development standards,

guidelines, and other recommendation for
food safety
Endang S. Rahayu
Risk Management
Identification of the standards of acceptable

risk appropriate to different types of food
hazard
Establishment of procedures to ensure that

the risks are kept within the limits set by
those standard
Endang S. Rahayu
Risk Communication
as an interactive process of exchange of

information and opinion on risk among risk
assessors, risk managers, and other interest
parties
Endang S. Rahayu
Risk Estimation
The scientific determination of the
characterizations of risk, usually in as
quantitative a way as possible. These
include the magnitude, spatial scale,
duration and intensity of adverse
consequences and their associated
probabilities as well as a description of the
cause and effect links
Endang S. Rahayu
Risk Evaluation
a component of risk assessment in which
judgments are made about the significant
and acceptable of risk
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Risk Identification
Recognizing that a hazard exists and trying
to define its characteristics.
Endang S. Rahayu
Hazard analysis
Endang S. Rahayu
Background
The significant world-wide increase in food-

bore illness that has been recognized
(arising from enteric organisms) – need the
more effective control using internationally
agreed risk management method
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The Goal of Food Risk Management
To protect public health by controlling such

risk as effectively as possible through the
selection and implementation of appropriate
measure
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Safe and wholesome
Although industry and national regulators

strive for production and processing systems
which ensure that all food be safe and
wholesome, complete freedom from risks in
an unattainable goal.
Safety and wholesomeness are related to e
level of risk that society regards as
reasonable in the context, and in comparison
with other risks in everyday life.
Endang S. Rahayu
General Principles of Food Safety Risk Management
1. Risk management should follow a structures approach
2. Protection of human health should be the primary consideration
in risk management decisions
3. Risk management decisions and practices should be transparent
4. Determination of risk assessment policy should be included as a
specific component of risk management
5. Risk management should ensure the scientific integrity of the risk
assessment process by maintaining the functional separation of
risk management and risk assessment
6. Risk management decisions should take into account the
uncertainty in the output of the risk assessment
7. Risk management should include clear, interactive
communication with consumers and other interested parties in all
aspects of the process
8. Risk management should be a continuing process that takes into
account all newly generated data in the evaluation and review of
risk management decisions
Endang S. Rahayu
1. Risk management should follow a
structures approach
Elements of structured approach :

- Risk evaluation
- Risk management option assessment
- Implementation of management decision
- Monitoring and review
Endang S. Rahayu
Elements of Risk Magement
A. Risk Evaluation
- Identification of a food safety problem
- Establishing of a risk profile
- Ranking of the hazard for risk assessment and risk management priority
- Establishment of a risk assessment policy for conduct of risk assessment
- Commissioning of risk assessment
- Consideration of risk assessment result
B. Risk Management Option Assessment
- Identification of available management options
- Selection of preferred management option, including consideration of an
appropriate standard
- Final management decision
C. Implementation of Management Decision
D. Monitoring and Review
- Assessment of effectiveness of measure taken
- Review risk management and/or assessment as necessary
Endang S. Rahayu
2. Protection of human health should be
the primary consideration in risk
management decisions
Decision on acceptable levels of risk should be
determined primarily by human health
consideration (arbitrary or unjustified differences in
the risk levels should be avoided)
Other factor considerations : economic cost,
benefits, technical feasibility, and societal
preferences
Endang S. Rahayu
3. Risk management decisions and
practices should be transparent
Risk management should include the identification
and systematic documentation of all elements of
the risk management process including decision-
making, so that the rationale is transparent to all
interested parties
Endang S. Rahayu
4. Determination of risk assessment
policy should be included as a specific
component of risk management
Risk assessment policy sets the guidelines for

value judgments and policy choices which may
need to be applied at specific decision points in the
risk assessment process, and preferably should be
determined in advance of risk assessment, in
collaboration with risk assessors.
Endang S. Rahayu
5. Risk management should ensure the
scientific integrity of the risk assessment
process by maintaining the functional
separation of risk management and risk
assessment
Functional separation of risk management and risk

assessment serves to ensure the scientific integrity of the
risk assessment process and reduce any conflict of interest
between risk assessment and risk management. However, it
is recognized that risk analysis is an interactive process, and
interactions between risk managers and risk assessors are
essential for practical application
Endang S. Rahayu
6. Risk management decisions should
take into account the uncertainty in the
output of the risk assessment
The risk estimate should, whenever possible,

include a numerical expression of uncertainty, and
this must be conveyed to risk managers in a readily
understandable form so that the full implications of
the range of uncertainty can be included in
decision-making. For example, if the risk estimate
is highly uncertain the risk management decision
might be more conservative
Endang S. Rahayu
7. Risk management should include clear,
interactive communication with consumers
and other interested parties in all aspects of
the process
On-going reciprocal communication among all interested

parties is an integral part of the risk management process.
Risk communication is more than the dissemination of
information, and a major function is the process by which
information and opinion essential to effective risk
management is incorporated into decision
Endang S. Rahayu
8. Risk management should be a continuing
process that takes into account all newly
generated data in the evaluation and review
of risk management decisions
Subsequent to the application of a risk management
decision, periodic evaluation of the decision be made to
determine its effectiveness in meeting food safety objectives.
Monitoring and other activities will likely be necessary to
carry out the review effectively
Endang S. Rahayu
Background
Globalization of food trade and increasing
problems worldwide with emerging and re-
emerging food-borne disease have
increased the risk of cross-border
transmission of infectious agent
Risk assessment of
microbiological hazard in food
Endang S. Rahayu
Risk assessment
(Standards, guidelines, recommendation)
Design of import and export inspection systems

Acceptance/rejection criteria for foods
Monitoring and surveillance programmes
Development of information needed to formulate
efficacious management strategies
Overall allocation of food safety regulatory
resources proportional to all classes of hazard
in foods
Endang S. Rahayu
Safety standard
• Zero risk standard (ADI Level =Acceptable
Daily Intake)
• Balancing standards (cost-benefit, cost-
effectiveness, ALARA = as low as reasonably
achievable)
• Threshold standard (acceptable)
• Procedural standard (agreed process)
Endang S. Rahayu
Risk Assessment
Hazard Identification
Hazard Characterization
Exposure Assessment
Risk Characterization
Endang S. Rahayu
Hazard Identification
The process of determining whether

exposure to an agent can cause an increase
in the incidence of a health condition
Endang S. Rahayu
Hazard Assessment
An analysis and evaluation of the physical,

chemical, and biological properties of the
hazard
Endang S. Rahayu
Hazard Characterization
Endang S. Rahayu
Exposure assessment
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Risk Characterization
Endang S. Rahayu
Chemical Risk Assessment
Endang S. Rahayu
To access the risk that chemicals may
pose many assumption must be made,
for example :
- Uniform presence in the food
- Uniform exposure of the population
- Access of the chemicals to the target organ or tissue
- Homogenous presence of the substance through the
food
This information have generally been reasonable, as
chemical do not increase in concentration their
homogenous distribution through out the food is a likely
Endang S. Rahayu
Microbial Risk Assessment
Endang S. Rahayu
Biological agent
Infectious, toxicoinfectious, or toxigenic food-

borne organisms or their toxic product
Endang S. Rahayu
Biological agents
- Levels of microbiological agents may change

(their numbers may increase or decrease)
- Humans vary greatly in their susceptibility to biological
agents that are associated with foods
- Many foods are cooked prior to consumption –
reducing the prevalence of biological agent
Illness from biological agents in these foods (with few

exception) only occurs if an error is made, usually in
cooking or handling procedure
While chemical – few of which are destroyed by cooking
Those, illness from exposure to biological agents is
more difficult to predict than chemical hazard
Endang S. Rahayu
Risk assessment for illness caused by
food-borne biological agents
Endang S. Rahayu
Components of risk assessment for
biological agents associated with a food
Hazard identification
Exposure assessment
Dose-response assessment
Risk characterization
Endang S. Rahayu
Components of risk assessment
A. Hazard identification
Use of epidemiological, biological, and other

pertinent information and expert knowledge to
identify hazardous biological agents that may
potentially be in foods and cause illness to
consumers.
Hazard identifications should include initial
estimates of the amount, frequencies, and sources
of the biological agent(s)
Endang S. Rahayu
Hazard identification
Biological surveillance
The process of identifying potential food-borne biological
hazard associated with products and processes from
production through consumption
Epidemiologic surveillance
The active or passive monitoring of the human population
of food-borne illness
Epidemiologic investigation
The process of studying the factors that contribute to the
occurrence of food-borne illness. Information from such
investigations may include the identification of the
etiological agent, the relationship between the agent and
product contamination, the quantity of agent in the food,
attack rates, and information on severity, symptoms,
demographics, and what when wrong
Endang S. Rahayu
B. Exposure assessment
Determine the probability of consumption and the

amount of the biological agent consumed. The
levels of agent, the duration and frequency of the
exposure, and other characteristics of the exposure
are, at times, of concern and may require
consideration of :
Population demographics
Biological agent distribution
Predictive modeling
Endang S. Rahayu
C. Dose-response assessment
Estimation of the relationship between the quantity

of a biological agent and the frequency and
magnitude of adverse human health effects in a
population.
Dose-response assessment typically include
estimates of the rates of infection, morbidity, and
mortality.
Endang S. Rahayu
Dose-response assessment
Human volunteer feeding studies

Epidemic data
Animal data
Substrate (food components) effects
Physiological state of the microorganism
Physiological state of the population
Clinical and laboratory studies
Estimation of severity assessment
Sequelae – long term adverse health effect such as renal
failure, reactive arthritis, or neurological deficits)
Secondary infections – person to person transmission
Endang S. Rahayu
Severity assessment – an estimation of the
proportion of infected individuals that become
overtly ill and the proportion of overtly ill persons
that become seriously ill or die.
Characterization of illness
Mild symptom
Severe illness
Mild diarrhea
Renal failure
Death
Endang S. Rahayu
D. Risk characterization
Risk characterizations combine the information

obtained from exposure and dose-response
assessments to estimate for each hazard the
likelihood and magnitude of disease under various
conditions of human exposure.
Endang S. Rahayu

ESR - Risk Analysis

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Food safety

Is there any food with complete

1995 – Risk analysis (Risk assessment)

Outcomes – standards, guidelines,

Risk Assessment Risk Management

Risk – is an estimate of the probability

A condition or physical situation with a

A biological, chemical, or physical agent in or

as the process of weighing policy

outcome – the development standards,

Identification of the standards of acceptable

Establishment of procedures to ensure that

as an interactive process of exchange of

The significant world-wide increase in food-

To protect public health by controlling such

Although industry and national regulators

Elements of structured approach :

Risk assessment policy sets the guidelines for

Functional separation of risk management and risk

The risk estimate should, whenever possible,

On-going reciprocal communication among all interested

Design of import and export inspection systems

The process of determining whether

An analysis and evaluation of the physical,

Infectious, toxicoinfectious, or toxigenic food-

- Levels of microbiological agents may change

Illness from biological agents in these foods (with few

Use of epidemiological, biological, and other

Determine the probability of consumption and the

Estimation of the relationship between the quantity

Human volunteer feeding studies

Risk characterizations combine the information

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