Lecture pack

1
MRA in practice Application of MRA in the industry
Suzanne van Gerwen
Leon Gorris
UNILEVER SEAC - Risk Analysis Group Colworth
House, Sharnbrook, UK, MK44 1LQ LEON.GORRIS_at_UNILEV
ER.COM
UNILEVER Unilever RD Vlaardingen Olivier van
Noortlaan 120 Vlaardingen, The Netherlands SUZANNE
-VAN.GERWEN_at_UNILEVER.COM
2
People in food safety management control
Government
Industry
Research institutes/universities
3

• Food Industry
• Producers, manufacturers, processors, handlers,
  vendors etc. of all sizes and in all phases of
  the supply chain

4
Supply chain of food production
X
5
Where to control a Hazard?

• At different levels
• farm
• production
• preparation
• consumption

Control is the responsibility of the different
stakeholders
6
Risk assessment - government level
7
HACCP - industry level
8
Application of MRA in the industry
But how does Risk Analysis impact on food safety
management by food industry in practice?

• 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
MRA by FAO/WHO etc. support
POLICY
POLICY
PLANNING
RISK ANALYSIS
IMPLEMENTATION
Derived from ILSI-Europe, 1998
10
MRA by FAO/WHO etc. support

• 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

Presented at FAO/WHO Expert Consultation, 18 -22
March 2002
11
MRA by FAO/WHO etc. support

• 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 industrys or producers
  capabilities and capacities

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
Industry

• Safe and stable product and process design
• HACCP plan
• Implementation
• Monitoring, verification

17
Outbreak due to unsafe design

• 1998
• 27 cases of botulism in Preston and
• Blackpool
• Reformulated canned hazelnut
• conserve used to manufacture diet
• yoghurt

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Outbreak due to unsafe design

• Cause
• reformulated conserve received the same
• pasteurization treatment
• ....but.....
• spores were now able to germinate
• and grow in final product

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Basic principle

• Identification Control of
• microbial hazards
• at Product Process design
• is first step to
• Ensure quality
• and
• realise consumer safety
• From QC to QA

20
Risk Characterisation - how to interpret outcome?
Hypothetical production process
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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
MRA predictive modelling

• 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)

23
MRA predictive modelling

• Does it matter which type of model
• is chosen?
• Yes what do we want to know?
• 1. growth/no growth boundaries
• 2. inactivation in formulation
• 3. Lag time, growth rate
• 4. Inactivation by heat

24
MRA predictive modelling

• 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

25
MRA predictive modelling

temperature
Growth.xls,Ecoli garlic,pH7,aw0.99
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MRA predictive modelling

Growth.xls,Lmono garlic,pH7,aw0.99
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Models are never perfect
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Overcome the problems

• careful choice in experimental set up
• validate the model predictions in real
  products!!
• ask expert opinion and apply additional rules

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
Specific and generic knowledge
Product type 3
Product type 1
Product type 2
Product type 1
Product type 2
Expert system
Expert system
Ingredient rules
Generic rules
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E.g. specific knowledge water droplets in oil
physical barrier micro. growth

32
Objective expert system

• Help the operating companies
• design
• microbiological safety and stability
• into their products and processes
• Thus
• Consumer safety re microbiology
• Increase speed to market

33
Sums up, Thumbs up

• 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

Structured analysis of product safety and
stability