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MRA basic awareness course
Topic 3 - Lecture 1
Microbiological Risk Assessment:Principles and concept
http://www.sp-lab.net/fao/MRA/
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Slide 2Topic 3 - Lecture 1 - Microbiological Risk Assessment:
Principles and concept
Purpose of lecture
� Understand Microbiological Risk Assessment
(MRA) principles
� Explain the purpose of MRA
� Illustrate various outcomes of MRA
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Slide 3Topic 3 - Lecture 1 - Microbiological Risk Assessment:
Principles and concept
Codex Risk Analysis Framework
Risk Communication
Risk ManagementRisk Assessment
• Hazard Identification• Hazard Characterization• Exposure Assessment• Risk Characterization
Science based
Policy based
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Slide 4Topic 3 - Lecture 1 - Microbiological Risk Assessment:
Principles and concept
What is MRA?
Microbiological Risk Assessment is a
science based process
driven by governments to assess
the severity of illness
and its probability of occurrence
as a consequence of
the exposure to a certain
food/pathogen combination
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Slide 5Topic 3 - Lecture 1 - Microbiological Risk Assessment:
Principles and concept
Purposes of MRA in MRM
Provide support to governments
• To assess risks to public health posed by a hazard
in a food
• to evaluate the need for mitigation measures and
options for mitigation
• to design food safety improvement programmes
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Slide 6Topic 3 - Lecture 1 - Microbiological Risk Assessment:
Principles and concept
Fitting MRA in the MRM structure
� Preliminary MRM activities (Topic 2)
� Evaluation of MRM options (Topic 5)
� Implementation of MRM decisions (Topic 6)
� Monitoring and review
MRA
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Slide 7Topic 3 - Lecture 1 - Microbiological Risk Assessment:
Principles and concept
MRA attributes
In order to answer a management question, the data should be:
� structuredto clearly tell what we know
� descriptiveto characterize how well we know it
� transparentto reveal any bias
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Slide 8Topic 3 - Lecture 1 - Microbiological Risk Assessment:
Principles and concept
MRA terms
� Hazard Agent causing an adverse effect
� Exposure Estimation of likely intake
� Severity The extent of the adverse health effect
� Risk A Combination of the probability of an
adverse effect and its severity
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Slide 9Topic 3 - Lecture 1 - Microbiological Risk Assessment:
Principles and concept
Risk and hazard
Hit likely ?
Effect serious ?
Hazard
Risk
Exposure
Hazard
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Slide 10Topic 3 - Lecture 1 - Microbiological Risk Assessment:
Principles and concept
Major Risk Assessment Models
Biology Chemistry Epidemiology Toxicology Medicine Genetics Cytology Other
Probability StatisticsDecision
TheoryEconomics
Ranking
MethodsTree Models PSAs
Monte CarloSensitivity
AnalysisKnowledge
Dose
Response
Expert
Opinion
Animal
Studies
Food Additive Safety
Assessment
Microbial Risk Assessment
Pesticide ResidueRisk Assessment
Genetically Modified Foods of Plant Origin
Chemical Risk
Assessment
Microbial Risk
Assessment
Bio-technology
Risk Assessment
Pesticide Residue
Risk Assessment
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Slide 11Topic 3 - Lecture 1 - Microbiological Risk Assessment:
Principles and concept
Chemical hazards
•Most effects are not acute
•Many hazards can be effectively controlled at the farm level
•Manufacturing has little effect on many chemical hazards
•Acceptable levels have been defined for many chemical hazards
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Slide 12Topic 3 - Lecture 1 - Microbiological Risk Assessment:
Principles and concept
Safety factor in chemical RA
Rat Man
Dose
NOAEL ?
100(0)
Safe level
A safety factor is applied to deal with uncertainty
Effect
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Slide 13Topic 3 - Lecture 1 - Microbiological Risk Assessment:
Principles and concept
� Most effects are acute
� Many hazards cannot be effectively controlled at the farm level
� Manufacturing, commercialisation, preparation and use have a large effect on many microbiological hazards
� Acceptable levels have not been defined for most microbial hazards
� In risk characterisation, no safety factors are applied
Microbiological hazards
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Slide 14Topic 3 - Lecture 1 - Microbiological Risk Assessment:
Principles and concept
Acceptable level?
A MRA does not provide information whether the risk associated
with the level (prevalence and/or concentration) of a microbe in
a food is acceptable or not
This is a decision that Risk Managers need to make, with input from stakeholders
(regulators, consumers, industry)
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Slide 15Topic 3 - Lecture 1 - Microbiological Risk Assessment:
Principles and concept
Microbiological risk assessment is performed
for pathogen/food combinations that are
associated with food-borne illness(single pathogen, one product type, whole chain)
Listeria monocytogenes
Salmonella
Campylobacter
Escherichia coli O157
Vibrio parahaemolyticus
Microbiological risk assessment
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Slide 16Topic 3 - Lecture 1 - Microbiological Risk Assessment:
Principles and concept
Inputs to MRA
� Science (multidisciplinary)• Data
• Knowledge
• Experts
� Tools• Statistics
• Ranking
• Simulation (e.g. Monte Carlo)
• Knowledge elicitation
� Infrastructure• Epidemiology
• Food consumption
• Outbreak investigation
• Consumer behaviour
� Framework• Risk analysis
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Slide 17Topic 3 - Lecture 1 - Microbiological Risk Assessment:
Principles and concept
Types of MRAs
� Product Pathogen Pathway risk assessment� One pathogen/one food - absolute risk estimate
� Risk ranking� One pathogen/multiple foods - relative risk estimate
� Geographical risk estimate� Risk of introduction into a region (e.g. BSE / TSE)
� Risk/Risk trade-off� Nitrites versus C. botulinum in sausages
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Slide 18Topic 3 - Lecture 1 - Microbiological Risk Assessment:
Principles and concept
1. The chance for a person of falling ill by consuming a food serving
2. The estimated number of illnesses (e.g. per 100.000/year in a country) due to consumption of a specific food/pathogen combination
3. The relative risk posed by a pathogen in different food products or uses
4. Risk estimates for different processing, distribution and consumer use conditions and risk reduction scenarios
Outcomes of MRAs
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Slide 19Topic 3 - Lecture 1 - Microbiological Risk Assessment:
Principles and concept
Example of outcome (1)
The estimated chance that a person in the USA
would get Salmonellosis by eating a serving of
shell eggs is 3.3 x 10-6
(Attendant uncertainties not mentioned)
USA MRA
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Slide 20Topic 3 - Lecture 1 - Microbiological Risk Assessment:
Principles and concept
Example of outcome (2)
It is estimated that circa 30 cases of listeriosis
per year in the USA (280 Mio inhabitants)
are caused by eating cold frankfurters
USA MRA
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Slide 21Topic 3 - Lecture 1 - Microbiological Risk Assessment:
Principles and concept
Example of outcome (3)
Predicted relative risks associated with food categories for the USA population based on the median predicted cases of listeriosis per 100 million Servings.
P = Pátê and Meat Spreads
SS = Smoked Seafood;
FS = Fresh Soft Cheese
DM =Deli Meat
PF = Preserved Fish
DS = Deli Salads
SC = Soft Mold-Ripened Cheese
PM =Pasteurized Fluid Milk
UM =Unpasteurized Fluid Milk;
MD =Miscellaneous Dairy Products
RS = Raw Seafood;
PC = Heat-Treated Natural Cheese
V = Vegetable
F = Fruits
AC = Aged Chees
IC = Ice Cream
(CFSAN, FDA, USDHHS, FSIS, USDA, 2001)
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Slide 22Topic 3 - Lecture 1 - Microbiological Risk Assessment:
Principles and concept
Example of outcome (4a)
0
0.5
1
1.5
2
2.5
3
3.5
Salmonellosis cases
Baseline Shelf-life
14 days
Shelf-life
7 days
Cooling
7°C
x 10-6
Probability of illness per serving of shell eggs
FAO/WHO
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Slide 23Topic 3 - Lecture 1 - Microbiological Risk Assessment:
Principles and concept
Example of outcome (4b)
of chicken
FAO/WHO
Probability of salmonellosis before and after changing cooking practices
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Slide 24Topic 3 - Lecture 1 - Microbiological Risk Assessment:
Principles and concept
MRA in MRM
A governmental MRA
considers all foods
consumed in a specific
country, whether produced
locally or imported
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Slide 25Topic 3 - Lecture 1 - Microbiological Risk Assessment:
Principles and concept
Examples of MRAs
Canada
Campylobacter jejuni in fresh poultry
Salmonella spp. in cracked eggs
L. monocytogenes in raw milk cheese
E. coli O157:H7 in ground beef
Toxoplasma gondii in pork
FAO/WHO
Salmonella Enteritidis in eggs
Salmonella spp. in broilers
L. monocytogenes in ready-to-eat foods
Vibrio spp. in seafood
Campylobacter spp. in broilers
USA
Salmonella in shell eggs
Vibrio parahaemolyticus in raw oysters
Listeria in ready-to-eat retail foods
E. coli O175:H7 in ground beef
Netherlands
Bacillus cereus in pasteurised milk
Campylobacter spp. in broiler chicken
E. coli in steak tartare
B. cereus in vegetable puree
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Slide 26Topic 3 - Lecture 1 - Microbiological Risk Assessment:
Principles and concept
MRAs must report
� Key assumptions
� Inconclusive or controversial scientific information
� Estimates of risks with attendant uncertainties
� An indication of the degree of variability and scientific uncertainty
� Possible undertakings to complete the data so that the MRA may be improved, if necessary
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Slide 27Topic 3 - Lecture 1 - Microbiological Risk Assessment:
Principles and concept
FAO/WHO Expert Committees
Risk Assessment is done and advise on acceptable levels for chemical hazards is given by
The Joint FAO-WHO Expert Committee on Food Additives (JECFA)
The Joint FAO/WHO Meeting on Pesticide Residues (JMPR)
Risk Assessment is done but no advise on acceptablelevels for microbial hazards is given by
The Joint FAO-WHO Expert Meeting on Microbiological Risk Assessment (JEMRA)
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Slide 28Topic 3 - Lecture 1 - Microbiological Risk Assessment:
Principles and concept
JEMRA output CCFH use
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Slide 29Topic 3 - Lecture 1 - Microbiological Risk Assessment:
Principles and concept
Codex principles of
microbiological risk assessment
� The Codex Commission has published The principles and guidelines for the conduct of MRA [CAC/GL-30 (1999)]
� The principles are described in the following slides
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Slide 30Topic 3 - Lecture 1 - Microbiological Risk Assessment:
Principles and concept
Key Points
� MRA is a well defined process
� MRA is done to answer questions formulated by
Microbiological Risk Managers
� These questions can be very different in nature,
thus also the outcomes of MRA may be
presented in many forms
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MRA basic awareness course
Topic 3 - Lecture 2
Microbiological Risk Assessmentmethodology
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Slide 32Topic 3 - Lecture 2 - Microbiological Risk Assessment:
methodology
Purpose of lecture
� Understand the four steps/stages of
Microbiological Risk Assessment (MRA)
� Explain some problems and issues that need to
be considered
� Explain probabilistic approach
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Slide 33Topic 3 - Lecture 2 - Microbiological Risk Assessment:
methodology
MRA
� A scientifically based process consisting of the
following components
� Hazard identification
� Hazard characterization
� Exposure assessment
� Risk characterization
� Codex Alimentarius
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Slide 34Topic 3 - Lecture 2 - Microbiological Risk Assessment:
methodology
Hazard Identification (1)
Determination of the agent / food combination that will be the subject of the MRA and description of the microorganism
and/or its toxin
Purpose
Normally Risk Managers will include part of this
in their briefing of the Risk Assessors
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Slide 35Topic 3 - Lecture 2 - Microbiological Risk Assessment:
methodology
Hazard Identification (2)
Reactive
a case or an outbreak of foodborne disease has occurred, the causative
microorganism has been identified and the risk of its occurrence in one or
more foods has to be estimated
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Slide 36Topic 3 - Lecture 2 - Microbiological Risk Assessment:
methodology
Proactive
a microorganism is suspected to be a hazard, a link to foodborne
disease is not definitely established, the likelihood that this
microorganism in a food is causing an adverse health effect has to be
estimated
Society has not experienced the hazard before and the possible extent of
the problem is not known
Hazard Identification (3)
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Slide 37Topic 3 - Lecture 2 - Microbiological Risk Assessment:
methodology
The qualitative and/or quantitative evaluation of the nature,
severity and duration of the adverse effects associated with one
or different levels (frequencies / numbers) of microbiological
agents that may be present in the food of concern
Hazard characterization (1)
Purpose
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Slide 38Topic 3 - Lecture 2 - Microbiological Risk Assessment:
methodology
Factors influencing risk
� the food (e.g. fatty, liquid)
� the pathogen (e.g. number, pathogenicity)
� the host (e.g. age, health status)
Hazard characterization (2)
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Slide 39Topic 3 - Lecture 2 - Microbiological Risk Assessment:
methodology
Hazard characterization (3)
At least two categories of consumers have to be
distinguished
� “normal” population
� “susceptible” individuals
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Slide 40Topic 3 - Lecture 2 - Microbiological Risk Assessment:
methodology
Susceptible consumers
Young
Old
Diseased
Immuno-compromised
Malnourished
Tourists
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Slide 41Topic 3 - Lecture 2 - Microbiological Risk Assessment:
methodology
L.m. dose – response curves for susceptible persons
0 4 8 12
0.0
0.2
0.4
0.6
0.8
1.0
0 4 8 12
-10
-8
-6
-4
-2
0
Probabilityof illness
Log probabilityof illness
Dose (Log L.m. cells)
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Slide 42Topic 3 - Lecture 1 - Microbiological Risk Assessment:
Principles and concept
Dose response curves with attendant
uncertainties for salmonellosis
0 1 2 3 4 5 6 7 8 9 10Log dose
1.0
0.9
0.8
0.7
0.6
0.5
0.4
0.3
0.2
0.1
0.0
Pro
ba
bilit
y o
f s
alm
on
ello
sis
FAO/WHO
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Slide 43Topic 3 - Lecture 2 - Microbiological Risk Assessment:
methodology
� Availability and use of epidemiological data
� Use of animal models and data
� Use of human feeding trials data
� Pathogen virulence data
� Pathogen-food matrix knowledge
� Data concerning susceptibility of consumers
� and more ...
Issues in hazard characterization
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Slide 44Topic 3 - Lecture 2 - Microbiological Risk Assessment:
methodology
Exposure Assessment
The estimation of the likely intake of a hazard and/or
certain levels of a hazard in a certain food
by the population or part of the population
Purpose
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Slide 45Topic 3 - Lecture 2 - Microbiological Risk Assessment:
methodology
Pathogen / Product / Pathway analysis (1)
Determination and quantification of
prevalence in raw materials survival during
processing recontamination growth survival
during preparation contamination and growth
prior to consumption
The data are used in mathematical models
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Slide 46Topic 3 - Lecture 2 - Microbiological Risk Assessment:
methodology
Product / Pathogen / Pathway analysis (2)
� Ho - Σ R + Σ IRC+G = Hp
Starting level
Reduction
Hazard level
in product *
I =Increase due to:
RC=Recontamination
G =Growth
* FSO and PO are
more precise expressions
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Slide 47Topic 3 - Lecture 2 - Microbiological Risk Assessment:
methodology
Exposure Assessment example
•Hypothetical production process
� Frequency of contamination
� Level of contamination
� Factory:� mixing� pasteurisation� cool/freeze� packing
� Distribution� time/temperature
� Use of product� child / healthy adult� portion size� consumption frequency
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Slide 48Topic 3 - Lecture 2 - Microbiological Risk Assessment:
methodology
Issues in Exposure Assessment (1)
� Consumer use and dietary intakes often not well known
� Data are scarce (non-existent) for certain food categories/outlets (e.g. retail, catering, street vending, small kitchens) or for new food categories/markets
� Some data have been collected as a result of an outbreak, this is not a normal situation
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Slide 49Topic 3 - Lecture 2 - Microbiological Risk Assessment:
methodology
Issues in Exposure Assessment (2)
� Available data and models on inactivation and/or growth of pathogens do not apply across the whole food chain up to the point of consumption
� Recontamination after production or preparation often not considered
� Uncertainty and variability in data and models are often not transparent
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Slide 50Topic 3 - Lecture 2 - Microbiological Risk Assessment:
methodology
The quantitative and/or qualitative estimation of the probability
of occurrence and severity of defined adverse health effects in a
given population due to the consumption of a certain
pathogen/food combination
Risk characterization
Purpose
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Slide 51Topic 3 - Lecture 2 - Microbiological Risk Assessment:
methodology
0
0.2
0.4
0.6
0.8
-1.5 -0.5 0.5 1.5 2.5 3.5 4.5 >4.5
Risk Characterization curve
Log No L.m. per serving
No
of
illn
esse
s/
10
0,0
00
in
th
e U
SA
Based on FAO/WHO report
(based on current market conditionsand eating habits in the USA)
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Slide 52Topic 3 - Lecture 2 - Microbiological Risk Assessment:
methodology
� Use of worst case scenarios
� (biological) variability and attendant uncertainties are
often not considered or expressed
� Validation of the models
Issues in Microbiological Risk characterization
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Slide 53Topic 3 - Lecture 2 - Microbiological Risk Assessment:
methodology
� Define microorganism and its virulence
� Define target consumer group and effect
� Use specific dose-response data
� Determine fate of microorganism during production,
distribution, preparation & use
� Determine consumption practices
� Calculate risk estimate with attendant uncertainties
(assumptions specified!)
Calculation of Risk Estimate
HC
EA
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Slide 54Topic 3 - Lecture 2 - Microbiological Risk Assessment:
methodology
Precision of estimate
Three factors of influence
1. variability
2. uncertainty
3. lack of data
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Slide 55Topic 3 - Lecture 2 - Microbiological Risk Assessment:
methodology
Variability
Variability is a property of nature, the diversity of things. Cannot be reduced through further study or additional measurements.
Lammerding, 1999
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Slide 56Topic 3 - Lecture 2 - Microbiological Risk Assessment:
methodology
Uncertainty
???Uncertainty is our ignorance -
lack of knowledge.
In many cases, it can be
reduced through further
study or expert information.
Lammerding, 1999
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Slide 57Topic 3 - Lecture 2 - Microbiological Risk Assessment:
methodology
Types of calculations
Deterministic
� point estimates of (absolute) risk level
Probabilistic
� distributions of (absolute) risk level
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Slide 58Topic 3 - Lecture 2 - Microbiological Risk Assessment:
methodology
Point estimates and distribution of growth
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Slide 59Topic 3 - Lecture 2 - Microbiological Risk Assessment:
methodology
MEAN VALUES
Organism, Concentration= 2.0 log CFU/g
Organism, Growth= 3.5 log CFU/g
Organism, Inactivation= 4.5 log CFU/g
cont. level = 1.0 log CFU/gAmount Consumed
= 53 gExposure=2.7 log or 530 CFU/serving
WORST CASE (95%)
Organism, Concentration= 3.0 log CFU/g
Organism, Growth= 4.5 log CFU/g
Organism, Inactivation= 3.5 log CFU/g
cont. level = 4.0 log CFU/gAmount Consumed
= 85 gExposure=5.9 log or 850000 CFU/serving
[Concentration + Growth - Inactivation] x Amount Eaten
Point Estimates
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Slide 60Topic 3 - Lecture 2 - Microbiological Risk Assessment:
methodology
Probabilistic Risk Assessments
� Calculate risk as a function of the distributions of input
values
� Generate a distribution of risk
� Characterise the likelihood of events
� Reflect the variability and uncertainty in the risk estimate
� Recognise the variation that exists in the real world
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Slide 61Topic 3 - Lecture 2 - Microbiological Risk Assessment:
methodology
Monte-Carlo simulation
� sampling from probability distributions which describe variation and uncertainty
� distributions based on actual data or assumptions
� repeated large number of times (iterations)
Probabilistic Risk Assessments
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Slide 62Topic 3 - Lecture 2 - Microbiological Risk Assessment:
methodology
Probabilistic estimates
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Slide 63Topic 3 - Lecture 2 - Microbiological Risk Assessment:
methodology
0.0000
0.0200
0.0400
0.0600
0.0800
0.1000
0.1200
-28 -26 -24 -22 -20 -18 -16 -14 -12 -10 -8 -6 -4 -2 0
Log Probability of Illness
Safe level?
Range of possible outcomes
Likelihood of various outcomes
Probabilistic Risk estimate
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Slide 64Topic 3 - Lecture 2 - Microbiological Risk Assessment:
methodology
Requirements for Risk Assessment
Risk Assessments generally require
� experienced risk assessors
� significant effort
� large volumes of a variety of data
� mathematical modelling approaches
� resilience to dig through complexity
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Slide 65Topic 3 - Lecture 2 - Microbiological Risk Assessment:
methodology
What Makes a Good Risk Assessment?
� Good questions from the risk manager!
� Appropriate team composition
� Magnitude of effort in line with task
� Open attitude, no up-front bias
� Sound science
� Informed and transparent assumptions
� Reliable data
� Limited, articulated uncertainty
� Good documentation
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Slide 66Topic 3 - Lecture 2 - Microbiological Risk Assessment:
methodology
Key Points
� Although the structure of MRA is easy to understand, experts are needed to use the methodology
� Models for growth and inactivation as well as for dose/response relationships are needed in quantitative MRA
� Good data are needed to perform a reliable PPP analysis
� When no such data are available assumptions have to be made, these should be presented as part of the outcome