application of food safety risk management metrics...
TRANSCRIPT
Application of Food Safety
Risk Management Metrics at
Industry Level
Session 6. ICMSF.
12 October 2016
Leon GorrisUnilever Research Vlaardingen, NL
Outline
• Unilever’s use of risk assessment to inform risk
management
• Examples: meeting risk management metrics and use of
microbiological risk assessment (MRA)
3
….”one of the world’s
leading suppliers of “fast-
moving consumer goods”.
Unilever products are sold in
over 190 countries and used by
2 billion consumers every day.
UNILEVER
4
by
y.
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Risk Assessments support safe product
design for a highly diverse product portfolio
• Wide range of potential hazards
• Several different exposure routes
• General or some sensitive users
One central safety organization(Safety and Environmental Assurance
Centre)
“Safe by Design” 5
A) Knowing our product inside-out, e.g.:
- ingredients, final formulation, external factors
- processing, handling
- post-process contamination
- intended use and intended user (consumer group)
B) Considering the available “benchmarks” for safety:
- Regulations (e.g. standards, limits, criteria)
- Guidelines from governments
- Industry standards/guidelines
- “History of safe use data”
Key
Unilever
expertise
Public
domain
Safe by Design
Product safety is “designed in” into every
innovation before it is placed on the market
6
Steps in establishing a safe design:
- Identification of all realistic hazards (microbial/chemical/physical)
- Defining preventive measures for hazards
- Establishing effective controls for significant hazards
- Validating control measures, from lab-scale to pilot scale
Safe by Design
7
Safe Product and Process designs are executed by SC/QA:
- Implementing safe designs in GHP & HACCP
- Verifying ongoing control during manufacture
- External audits to validate operation/management
- Running Tracing & Tracking system
- Monitor performance an market and manage issues
Safe by Design & in Execution
8
Excellence in
Manufacture
Deploy
Brilliant
products
Design
Independent safety assessment by the:
Safety & Environmental Assurance Centre (SEAC)
Disruptive
Technologies
Discover
Unilever innovation funnel & independent
safety governance by SEAC
9
Independent safety assessments as part of assurance of
human safety and environmental care
• Toxicology
• Microbiology
• Contaminants
• Chemistry
• Physical Hazards
• Occupational Hygiene
• Occupational & Process Safety
• Environmental lifecycle
• Environmental management
systems
• Sustainability
Risk assessment
to inform
Risk management
Design safety
Safe performance
on the marketplace
SEAC’s role: to review the design safety
MRA in the context of industrial R&D- looking for a binary outcome
The Safety Risk Assessor
Based on this design, we
estimate the probability
of illness from pathogen X
is 1 in 50,000 per year
The Product Innovator
So, is it safe?
Yes or no?
11Slide courtesy of Alejandro Amezquita
“in many cases, effective risk management
decisions can still be made when only some of the
components of [quantitative MRA] are available,
notably exposure assessment.”
FAO/WHO. 2002. Principles and guidelines for incorporating MRA in the
development of food safety standards, guidelines and related texts.
D
R
12Slide courtesy of Alejandro Amezquita
MRA in the context of industrial
R&D- hand in hand with risk management
primary
production
manufacturing consumptiondistribution and
retail, home
storage
processing
preparationprimary
production
primary
production
processing
processing
distribution
and retail,
home storage
distribution and
retail, home
storage
distribution and
retail, home
storage
distribution and
retail, home
storage
preparation
preparation
preparation
preparation
Slide courtesy of Tom Ross13
MRA in the context of industrial
R&D- hand in hand with risk management
primary
production
manufacturing consumptiondistribution and
retail, home
storage
processing
preparationprimary
production
primary
production
processing
processing
distribution
and retail,
home storage
distribution and
retail, home
storage
distribution and
retail, home
storage
distribution and
retail, home
storage
preparation
preparation
preparation
preparation
and preparation
primary
productionproces manmanmanmanmanmanmanmanmanmanmanmanmanmanmanufaufaufaufaufaufaufaufaufaufaufaufaufaufaufactuctuctuctuctuctuctuctuctuctuctuctucturinrinrinrinrinrinrinrinrinrinrinrinrinrinringggggggggggg
distribution an
retretretretretretretretretretretretretretretailailailailailailailailailailailailailailail, h, h, h, h, h, h, h, h, h, h, h, h, homeome
storage
cessinsinsinsinsinsinsinggggggggExposure Assessment sumsumsumsumsumsumconconconconconconconconconconconconsumsumsumsumsumsumsumsumsumsum
D
R
gdistribution and
retail, home
storage
preparationcontaminants
productionproduction
primary processingprocessing distribution and
retail, home
distribution and preparation
Slide courtesy of Tom Ross14
MRA in the context of industrial R&D- Focus is on Exposure Assessment
0
0.2
0.4
0.6
0.8
1
1.2
50 60 70 80 90 100 110 120
Exposure
Assessment
Hazard
Characterisation
A
Exposure
Assessment
Hazard
Characterisation
B
15
Risk management metrics are new safety benchmarks for exposure
16©Leon Gorris (2004)
17
primary
productionmanufacturing retail Preparation / cooking for consumptiontransport
Explicit, risk-based guidance of levels of a hazard not to be surpassed
Operational actions, building onto HACCP and Good practices
Country level
Operational food chain level
Micro
criterion
Food Safety
ObjectivePerformance
Objective
Exposure
Performance
standard
Performance
Objective
Performance
criterion
Performance
criterion
Performance
criterion
©Leon Gorris (2008)
ICMSF’s conceptual equation
18
Starting hazard level
at step
Reduction
Level at moment of
consumption
H0 - Σ R + Σ I £ PO or FSO
Level at step in the food
chain
Increase (Growth, Recontamination)
1Microbiological testing in Food Safety Management, ICMSF (2002); Book 7
Σ = sum of events PO: Performance Objective FSO: Food Safety Objective
Applies in every step of the value chain
19
FarmProduction &
distributionKitchen
H0- ΣR + ΣI £ PO
H0-ΣR +ΣI £ PO
H0-ΣR +ΣI £ FSO
Meeting risk-based metrics by a safe design implemented in the GHP/HACCP system
20
Primary
production
(step 1)
Process 2 Packaging Transport
(step 3)
Process 1
Manufacturing (step 2)
Step 2
Incoming
Hazard level
(H0)
Step 2
Performance
objective
(PO)
Retail
(step 4)
Step 2
Performance
Criterion (PC)
Process criteria: e.g. pasteurisation or sterilisation time/temp
Product criteria: pH, aw, salt, acid, etc
Control measures: e.g. refrigeration, control of cross-contamination,
education
HACCP
Verifying meeting FSO/PO by using a Microbiological Criterion
21
Zwietering, M.H., L.G.M. Gorris, J.M. Farber and the Example 5A Codex Working Group (2015). Food Control, 58, 33-
42.
Outline
• Unilever’s use of risk assessment to inform risk
management
• Examples: meeting risk management metrics and use of
microbiological risk assessment (MRA)
22
Assuring “Safety by Design” – MRA utility
science-based / tiered approach
New Business Proposition
(product/process design)
Safe Operating Space
(Global Standards)
Low risk
(expert system)
Simple, semi-quantitative
estimates of exposure
Generic scenarios using
conservative point estimates
Refined assessment, increased
use of actual measured data
Probabilistic exposure
estimates
(experts)
Some examples of a safe design of product
& process meeting risk-based metrics
Simulating ‘safe’ changes to heat-processing for quality improvements
Simulating ‘safe’ shelf-life to enter new markets
Simulating consumer safety of complex or radical product innovations
Determining performance standards that would meet particular PO / FSO
24
Simulating ‘safe’ changes to
heat-processing for quality improvements
Case study 1 Optimizing thermal process based on
product & process specifics and new
benchmarksChallenging UK default process target for safety of
70°C/2min that achieves a 6 log reduction of Listeria in raw
chicken meat
Rationale:
- The target organism for a product may not be Listeria
- The level of contamination of the raw material may be
lower
- Variability exists heat resistance of pathogens; not
always worst case
- Process control may be better than “industry standard”
- Safety benchmarks based on new risk management
metrics (hypothetical FSOs)
26
E.g. Par-fried chicken – Listeriamonocytogenes
15850 cfu/g
Raw chickenFrozenstorage
(no growth)
15850 cfu/g
(2.2 log reduction)
Final product
100cfu/g
(“FSO”/”PO”)
Frying
4.2 log 4.2 log 2.0 log
(worst case)
27
E.g. Par-fried chicken – Salmonella spp.
1500 cfu/g
Raw chicken Frozen storage
(no growth)
1500 cfu/g
(4.6 log reduction)
0.04 cfu/g
(absence in 25g)
Frying
3.2 log 3.2 log -1.2 log
Final product
(“FSO”/”PO”)(worst case)
28
Assessing suitability of a safe design
for different markets
Case study 2
29
Product parameters, hazard and exposure assessment question
Key product characteristics
- Heat treatment > 90ºC-10min, in-pack
- pH= 6.0
- Aw=0.997
- Stored at chilled temperatures
Relevant hazard?
- Bacillus cereus
- Benchmark: 105 cfu/g (“PO”/”FSO”)
Safety design question
- Assess the likely failure rate to meet safety benchmark on two markets that differ in temperatures in the value-chain and/or in the consumer home.
30
31
Exposure assessment: key components
B. cereus concentration in raw materials
Heat treatment Bacterial heat resistance
Time in pre-retail
(transport +
warehouse)
Time in retail (local
market,
supermarket)
Time in consumer
fridge
Temperature of pre-
retail fridges
Temperature of retail
fridges
Temperature of
consumer fridges
Lag time and
growth rate of
surviving
spores, at
chilled
temperatures
B. cereus prevalence and concentration after processing
B. cereus prevalence and concentration in finished product
Heat treatment aspects/inactivation
B. cereus D-values at 90C
0
0.2
0.4
0.6
0.8
1
1.2
-0.5 0 0.5 1 1.5 2 2.5
D-values (log min)
Den
sit
y o
f P
rob
ab
ilit
y
Variability in spore heat resistance Variability in heat impact
32
J.-M. Membré, A. Amézquita, J. Bassett, P. Giavedoni, C. de W. Blackburn, L.G.M. Gorris. 2006. A
probabilistic modeling approach in thermal inactivation: estimation of postprocess Bacillus cereus spore
prevalence and concentration. Journal of Food Protection, 69: 118-129.
Number of surviving spores in contaminated packs
0
0.05
0.1
0.15
0.2
0.25
0.3
1 3 5 7 9 11
Number of Spores surviving the HT (cfu/g)
De
ns
ity o
f P
rob
ab
ilit
y
Post-heat treatment distribution of survivors
33
Temperatures on different markets
Consumers fridges in Europe
4.9%
13.0%
28.1%
32.1%
16.1%
5.1% 0.7%
below 0C
between 0.1 and 2.0C
between 2.1 and 4.0C
between 4.1 and 6.0C
between 6.1 and 8.0C
between 8.1 and 10.0C
above 10C
http://pelican.unilever.com/pelican/exec/Module/info
Domestic fridges: USA
21.6%
0.7%
34.1%
2.2%
8.3%
23.2%
10.0%
below 0C
between 0.1 and 2.0C
between 2.1 and 4.0C
between 4.1 and 6.0C
between 6.1 and 8.0C
between 8.1 and 10.0C
above 10C
based on data analysis, 26/07/2005 34
Predicted failure rates on different markets
for different temperature scenarios
Retail 7C
Consumer 7CRetail 7C
Consumer
10C Retail 7C
Consumer 9CRetail 8C
Consumer 8C
Market 1
100
1,000
10,000
100,000
Temperature scenarios
Market 2
Lik
eli
ho
od
of
no
t m
ee
tin
g
de
sig
n c
rite
rio
n (
1/X
)
35
Meeting risk management metrics……
- Depends on establishing a suitable safe design that is
benchmarked against an FSO or PO (or a more traditional
acceptable hazard level/limit)
- The safe design specifies the product and process parameters
(e.g. H0 and PC) that assure product safety
- The safe design parameters are then implemented into the food
safety management system of the manufacturing operation (i.e.
GHP/HACCP)
- Verification of meeting FSO/PO may be on the basis of an
associated Microbiological Criterion
Summary
36
THANK YOU!