WORKING GROUP EXERCISE ON RISK ASSESSMENT

Objective: The objective of the working group exercise is to give opportunity to participants to
learn practical lesson on risk assessment utilizing available information. It is expected that the
approach used in the exercise can be applied in each member country.

Method: This exercise will cover both chemical and microbiological risk assessment. Since the
approach in doing the assessment is slighlt different between these two, the Working Group
will be devided into two sub-WGs. One sub-WG will be doing the exercise on chemical risk
assessment and the other sub-WG on microbiological risk assessment. Each sub-WG will be
doing the step-by-step exercise, as follows: (1) Hazard identification (WG exercise 3), (2) Hazard
characterization (WG exercise 4), (3) Dietary exposure assessment (WG exercise 5), (4) Risk
characterization (WG exercise 6). Each sub-WG will be given a risk assessment template to be
used during the exercise, completed and presented at the end of WG exercise in plenary.

Definitions (FAO & WHO, 2006, “Food Safety Risk Analysis: A guide for national food safety
authorities”, FAO Food and Nurition Paper 87):

Hazard: A biological, chemical or physical agent in, or condition of, food with the potential to
cause an adverse health effect.
Risk: 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: A process consisting of three components : risk assessment, risk management
and risk communication.
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 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.
Risk Assessment Policy: Documented guidelines on the choice of options and associated
judgements for their application at appropriate decision points in the risk assessment such that
the scientific integrity of the process is maintained.
Risk Profile: The description of the food safety problem and its context.
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.

Dedi Fardiaz FAO Risk Assessment Practical Training New Delhi, India, 17-21 June 2013
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.
Food Safety Objective (FSO): The maximum frequency and/or concentration of a hazard in a
food at the time of consumption that provides or contributes to the appropriate level of
protection (ALOP).
Performance Criterion (PC): The effect in frequency and/or concentration of a hazard in a food
that must be achieved by the application of one or more control measures to provide or
contribute to a PO or an FSO.
Performance Objective (PO): The maximum frequency and/or concentration of a hazard in a
food at a specified step in the food chain before the time of consumption that provides or
contributes to an FSO or ALOP, as applicable.
Acceptable daily intake (ADI): An estimate of the amount of a substance in food or drinking
water, expressed on a bodyweight basis, that can be ingested daily over a lifetime without
appreciable risk (standard human = 60 kg). The ADI is listed in units of mg per kg of body
weight.
Maximum level (ML): The Codex maximum level (ML) for a contaminant in a food or feed
commodity is the maximum concentration of that substance recommended by the CAC to be
legally permitted in that commodity.
Maximum residue level (MRL): The maximum concentration of residue in a food or animal feed
resulting from use of a veterinary drug or a pesticide, (expressed in mg/kg or μg/kg on a fresh
weight basis).
Tolerable daily intake (TDI): Analogous to Acceptable Daily Intake. The term Tolerable is used
for agents which are not deliberately added such as contaminants in food.

Table. 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
from production to consumption.
The prevalence and concentration of
hazard changes markedly at different
points along the food production chain.
Health risks are usually acute and result
from a single edible portion of food.
Hazards usually enter foods in the raw food or
ingredients, or through certain processing steps
(e.g. acrylamide or packaging migrants).
The level of hazard present in a food after
the point of introduction often does not
significantly change.
Health risks may be acute but are generally
chronic.

Individuals show a wide variability in Types of toxic effects are generally similar from
health response to different levels of person to person, but individual sensitivity may
hazard. differ.

Dedi Fardiaz FAO Risk Assessment Practical Training New Delhi, India, 17-21 June 2013
RA Template:
Risk Assessment Steps
Hazard Identification (WG exercise 3)

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

Information Needed Information Collected*

• Characteristics of hazard Collect information from official resources such as FAO, WHO, Codex, JECFA,
• Endpoints of concern JEMRA, JMPR, IPCS, FDA, EFSA, and other related agencies.
• Susceptible populations
• Food considered
• Incidence: Outbreaks; Sporadic
Cases; Seasonality
• Others (if any)

Hazard Characterization (WG exercise 4)

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 is
performed. For biological or physical agents, a dose-response assessment should be performed if the data are
obtainable.

Information Needed Information Collected*

Microbiological RA Collect information from official resources such as FAO, WHO, Codex, JECFA,
JEMRA, JMPR, IPCS, FDA, EFSA, and other related agencies.
Data:

• Human clinical studies

• Surveillance
• Host susceptibility

Modeling:

• Dose-response curves
Adjustment factor(s)

Chemical RA

• ADI, TDI, PMTDI, PMTWI

• Surveillance data

Exposure Assessment (WG exercise 5)

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. If necessary, the exposure assessment may divided into four
modules: Pre-Harvest, Harvest, Post-Harvest, and Consumption.

Information Needed Information Collected*

Microbiological RA
Data: (may be modified according
to microorganism and food
characteristics)
Collect information from official resources such as FAO, WHO, Codex, JECFA,
JEMRA, JMPR, IPCS, FDA, EFSA, and other related agencies (for exercise
purposes). Use your own primary exposure assessment data for your real risk
assessment case study.

• Water temperature
• Total vs pathogenic
• Time-to-refrigeration
• Air temperature
• Growt rates

Dedi Fardiaz FAO Risk Assessment Practical Training New Delhi, India, 17-21 June 2013
• Food considered
consumed/serving
• Others?

Modeling: (may be modified

according the food characteristics)

• Pathogenic levels in food at

harvest
• Growth between harvest and
refrigeration
• Pathogenic in food at
consumption
• Others?
Chemical RA

Dietary exposure of chemicals

present in food, consumption
survey data, etc.

Risk Characterization (WG exercise 6)

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.
Information Needed Information Collected*

• Number of illnesses: per serving Collect information from official resources such as FAO, WHO, Codex, JECFA,
and per annum JEMRA, JMPR, IPCS, FDA, EFSA, and other related agencies.
• Severity of illness (examples:
gastroenteritis vs. septicemia)
• Uncertainty and variability
analysis
• Model validation

Risk Management or Risk Mitigation (WG exercise 7)

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.

Information Needed Information Collected*

‘What-If’Scenario: The followings

are example for microbiological
risk mitigation

• 4.5-log 10 reduction (heat; ultra

high pressure)
• 2-log reduction (freezing) 10
approximately
• 1-log 10 reduction (immediate
cooling)
• Impact of time-to-refrigeration
after harvest
• Sample-based control plan

Another scenario maybe revision

of food safety standards

*Note: Write all information colllected in this column (Font: calibri, 10 pt), and extent the column as necessary.

Dedi Fardiaz FAO Risk Assessment Practical Training New Delhi, India, 17-21 June 2013