1 MRA in practice Application of MRA in the industry Suzanne van Gerwen UNILEVER SEAC - Risk...
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Transcript of 1 MRA in practice Application of MRA in the industry Suzanne van Gerwen UNILEVER SEAC - Risk...
1
MRA in practice
Application of MRA in the industry
Suzanne van Gerwen
UNILEVERSEAC - Risk Analysis GroupColworth House, Sharnbrook,UK, MK44 [email protected]
Leon Gorris
UNILEVERUnilever R&D VlaardingenOlivier van Noortlaan 120Vlaardingen, The [email protected]
Food Industry:
Producers, manufacturers, processors, handlers, vendors etc. of all sizes and in all phases of the supply chain
At different levels :
farm
production
preparation
consumption
Where to control a Hazard?
Control is the responsibility of the different stakeholders
6
Risk Assessment concerns a specific product or group of
related products, manufactured by different companies on a multitude of locations and
production-lines
Risk assessment - government level
7
HACCP concerns a specific product, manufactured on a
specific location/production-line
HACCP - industry level
8
But how does Risk Analysis impact on food safety management by food industry in practice?
Application of MRA in the industry
How can MRA studies by FAO/WHO, FDA,
etc. support food safety control in the
industry?
How can the tool MRA be applied by the
industry?
9
PLANNING
Product &
processdesign
IMPLEMENTATION
- GMP/GHP- HACCP- Quality systems- TQM
Derived from: ILSI-Europe, 1998
Level of consumer protection
Food Safety Objectives
RISK ANALYSIS
RiskAssessment
Risk Management
Risk Communication
POLICY
MRA by FAO/WHO etc. & supportPOLICY
Operationalissues
10
Language and terminology Understanding governmental risk
management interventions Transparency, auditability Recording knowledge/data and rationale for
use/disregard Analysis of risk management options Analysing equivalence between food
products/categories
MRA by FAO/WHO etc. & support
Presented at: FAO/WHO Expert Consultation, 18 -22 March 2002
11
Sharing of risk assessment tools and data Tools: predictive modelling included in MRA Tools: deterministic/probabilistic modelling
techniques Use of MRA elements/tools may help
industry to become increasingly more pro-active
Depending on an industry’s or producer’s capabilities and capacities
MRA by FAO/WHO etc. & support
Presented at: FAO/WHO Expert Consultation, 18 -22 March 2002
12
Differences in PURPOSE between Governmental MRA and use of MRA tools in industry
Governmental MRA
Consumer health and safety protection & common concept for world trade issues
Basis for Risk Management decision on ALOP/TL and FSO
Means to re-evaluate current food safety practices on the market
MRA tools in Industry
Aid to built in safety and to engineer out hazards in new food products before marketing by using similar tools as used in MRA
Transparency and auditability of the assessment study and the resulting HACCP plan
Basis to re-evaluate food safety status of a product in future when necessary and for changing the HACCP plan accordingly
Presented at: FAO/WHO Expert Consultation, 18 -22 March 2002
13
Differences in SCOPE between Governmental MRA and use of MRA tools in industry
Governmental MRA
Consumer population nationally, regionally or globally
Pathogen-pathway for a range of similar food products on a market made by different producers
Risk Ranking, comparison risk of potential hazards in a foods/category or of a specific hazard in different foods/categories on the market
Often a complete food chain (primary production to consumption) is covered
MRA tools in Industry
Consumer population in the intended market for a new product
Pathogen-pathway for a specific product produced by or for a specific company
Mostly covering hazard levels from raw material up to consumption
Presented at: FAO/WHO Expert Consultation, 18 -22 March 2002
14
Differences in INPUT between Governmental MRA and use of MRA tools in industry
Governmental MRA
Detailed data/knowledge on hazard dose-response effect in consumers, epidemiology and pathogenicity of hazard
Typical or simulated data/knowledge on effect of producing, processing/product formulation/handling during and after manufacture
MRA tools in Industry
No detailed data/knowledge on hazard dose-response effect in consumers, but generic epidemiology and pathogenicity of hazard, when available for the specific product - pathogen combination
Typical/specific operational or simulated data/knowledge on raw material, effect of processing/product formulation and handling during and after manufacture, recontamination etc.
Presented at: FAO/WHO Expert Consultation, 18 -22 March 2002
15
Differences in OUTPUT between Governmental MRA and use of MRA tools in industry
Governmental MRA
A risk estimate in absolute or relative term
e.g. an estimation of the number of people in a population that may get a certain illness as the consequence of consuming a certain food containing a (certain level of a) certain pathogen
e.g. a categorisation of different foods in order of increasing or decreasing relative risk
MRA tools in Industry
The endpoint in general is the exposure assessment
Food safety benchmarking is used to compare an estimated level of a certain pathogen in the food to be marketed with a similar food already on the market with a good safety record.
Presented at: FAO/WHO Expert Consultation, 18 -22 March 2002
16
Safe and stable product and process design
HACCP plan Implementation Monitoring, verification
Industry
17
Outbreak due to unsafe design
1998: 27 cases of botulism in Preston andBlackpool
Reformulated canned hazelnutconserve used to manufacture dietyoghurt
18
Cause:
reformulated conserve received the samepasteurization treatment
....but.....
spores were now able to germinateand grow in final product
Outbreak due to unsafe design
19
Identification & Control of microbial hazards
at Product & Process design
is first step to
Ensure quality and
realise consumer safety
From QC to QA
Basic principle
20
0.E+00
2.E-05
4.E-05
6.E-05
8.E-05
1.E-04
0.E+00 2.E-06 4.E-06 6.E-06 8.E-06 1.E-05 1.E-05
risk (prob. illness per consumption)
pro
ba
bil
ity
de
ns
ity
Hypothetical production process
Risk Characterisation - how to interpret outcome?
21
MRA & predictive modelling
Rapid new product development Product diversification Prevent long shelf life testing
Efficient product innovation & process optimisation Pro-active prediction of microbial behaviour Less experiments
Risk assessment: exposure assessment
22
In a product development expert system:
Consider.....- experimental set up often inadequate; - media; - type of microorganisms used; - little information on food composition; - little information on specific preservation
parameters;- no confidence intervals; - spoilage often not observed/recorded; - interaction of parameters (e.g. spoilage/pathogens);
MRA & predictive modelling
23
Does it matter which type of model is chosen?
Yes: what do we want to know?
1. growth/no growth boundaries2. inactivation in formulation3. Lag time, growth rate4. Inactivation by heat
MRA & predictive modelling
24
Infectious pathogens: Inactivation e.g. Listeria, Salmonella, E.coli
Toxigenic pathogens: Prevent growth, inactivation e.g. Staphylococcus, C. botulinum
Spoilage: Delay & prevent growth, inactivation
e.g. Yeast, lactobacilli
MRA & predictive modelling
25
MRA & predictive modelling
E.coli
0
0.5
1
1.5
2
2.5
0 10 20 30 40
time
gro
wth
rate
gamma wocase
rosso wocase
PMP
PMP min
PMP max
rosso bestcase
Growth.xls,Ecoli garlic,pH7,aw0.99
temperature
26
0
0.2
0.4
0.6
0.8
1
1.2
1.4
1.6
1.8
2
0 10 20 30 40
gamma wocase
rosso wocase
PMP
PMP max
PMP min
FMM
rosso best-case
colworth
Growth.xls,Lmono garlic,pH7,aw0.99
MRA & predictive modelling
28
careful choice in experimental set up
validate the model predictions in real products!!
ask expert opinion and apply additional rules
Overcome the problems:
29
Example of application
Unilever expert system, systematic approach
Identification of microbial hazards
Procedure to design out the identified hazards
5 design stages identified: formulation, pack, process, storage/distrib.consumer use
Display of results in hazard matrix
30
Expert system Ingredientrules
Genericrules Expert system
Product type 1
Product type 2
Product type 3
Specific and generic knowledge
Product type 1
Product type 2
32
Help the operating companies design
microbiological safety and stabilityinto their products and processes
Thus:Consumer safety re microbiology
Increase speed to market
Objective expert system
33
Structured analysis of product safety and stability
MRA currently not a tool for most players in food supply chain Useful as a basis for advice for improvement and optimisation Comparison of risks of various products and product
categories Relevance of various phases of supply chain for risk Biggest uncertainties in supply chain wrt risks
Sums up, Thumbs up