MRA in practice Application of MRA in the industry

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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]

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People in food safety management & control

Government

Research institutes/universities

Industry

Food Industry:

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

Supply chain of food production

X

At different levels :

farm

production

preparation

consumption

Where to control a Hazard?

Control is the responsibility of the different stakeholders

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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

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HACCP concerns a specific product, manufactured on a

specific location/production-line

HACCP - industry level

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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?

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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

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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

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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


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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


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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


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


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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


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.


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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


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.


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Safe and stable product and process design

HACCP plan Implementation Monitoring, verification

Industry

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Outbreak due to unsafe design

1998: 27 cases of botulism in Preston andBlackpool

Reformulated canned hazelnutconserve used to manufacture dietyoghurt

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Cause:

reformulated conserve received the samepasteurization treatment

....but.....

spores were now able to germinateand grow in final product

Outbreak due to unsafe design

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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

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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?

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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

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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);


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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


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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


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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

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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


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Models are never perfect

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careful choice in experimental set up

validate the model predictions in real products!!

ask expert opinion and apply additional rules

Overcome the problems:

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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

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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

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E.g. specific knowledge water droplets in oil: physical barrier micro. growth

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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

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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

Documents

MRA in practice Application of MRA in the industry