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Patrizia Barone, Ph.D.Regulatory Affairs Director North America
Role of Science, Uncertainty& Risk Perception in Making
Informed DecisionsAn Industry Perspective
12th Annual Fera / JIFSAN Joint SymposiumJune 15-17, 2011, Maryland
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Decision making is a process of sufficiently reducinguncertainty and doubt about alternatives to allow areasonable choice to be made among themVery few decisions are made with absolute certaintybecause complete knowledge about all the alternativesis seldom possible. Thus, every decision involves acertain amount of risk.
Robert Harris
Ref.: Robert Harris, Introduction to Decision Making, 2 Dec-09; http://www.virtualsalt.com/crebook5.htm
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Science is uncertaintytheories are subject to revision;
observations are open to a variety ofinterpretations, and scientistsquarrel among themselves.Isaac Asimov
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Consumerssometimes
are confused
by conflictingscientific
information
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Huge Challenges FacingOur Food System
World population in 2007: 6.7 BillionWorld population in 2050: 9.2 Billion
******************************* global agricultural production must grow by 70% by2050 in order to feed an additional 2.3 billion people
most gains in production will be achieved by increasing
yield growthin land-scarce countries, almost all growth
would need to be achieved by improving yields. This
necessitates"pushing the agricultural technologyfrontier outwards" on a number of fronts.
Ref: The Technology Challenge" Food & Agriculture Organization (FAO) of the United Nations, 2009
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The Evolution of Food Science
Ref.: Original C.J.K. Henry, Proc. Nutrition Soc 56:855-863, 1997;
2011 IFIC Communication SummitDave Schmidt, Alliance to Feed the Future, 24 May 2011
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Rapid growth in adoption ofbiotechnology crops continues
% of Acres100
80
60
40
20
0
1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010
Data for each crop include varieties with both HT and Bt (stacked) traits.Sources: 1996-1999 data are from Fernandez-Cornejo and McBride (2002). Data for 2000-10 are
available in the ERS data product, Adoption of Genetically Engineered Crops in the US, Tables 1-3.
93
787370
63
Ref.: 2011 IFIC Communication SummitJennie Schmidt, Ag Sustainability on the Family Farm, 24 May 2011.
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Factors Affecting ConsumerAttitudes Toward Food Technology
Awareness
Information Sources
Education
Trust
Perceptions on Food Safety
Terminology Biotechnology not GMO Distinguish terms (ex. sustainable local)
Ref: International Food Information Council (IFIC) 2011 Food & Health Survey
43% of participants in IFIC
Food & Health survey believethat advances in modern foodtechnology have provided, orwill provide, future benefitsfor themselves and their
families.
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Factors InfluencingPurchasing Decisions
0 20 40 60 80 100
Sustainability
Convenience
Healthfulness
Price
Taste87%
79%
66%
58%
52%
Ref: International Food Information Council (IFIC) 2011 Food & Health Survey
Taste continues to be the main driver of purchasing foods and beverages,
but price continues to rise as a significant factor
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Fear
Risk Perception Factors
Ref: David Ropeik, How Risky Is It Really? Why Our Fears Dont Always Match the Facts, McGraw Hill, 2010
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Risk Perception Factors
Trust Catastrophic or ChronicRisk vs. benefit
(trade offs)Can it Happen to Me?
ControlIs the Risk New or
Familiar?Choice Risks to Children
Natural orHuman-made?
Personification
Pain and Suffering Fairness
Uncertainty
Ref: David Ropeik, How Risky Is It Really? Why Our Fears Dont Always Match the Facts, McGraw Hill, 2010
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Risk Perception Factors:Can make our fears go up or down Appear to be universal across cultures,
ages, genders
Usually more than one risk perception
factors involved
Importance of factors varies over time
Perceptions also depend on our experience,
education, lifestyle, and other factors thatmake each of us unique.
Fear
Risk Perception Factors
Ref: David Ropeik, How Risky Is It Really? Why Our Fears Dont Always Match the Facts, McGraw Hill, 2010
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Uncertainty plays a big role in fear
What do the followinghazards have incommon?
Pesticides in food
Bovine growth hormone incows to increase milkproduction
Radiation from cell phonetowers
All 3 are human-made notnatural
They are risks that areimposed on us
All 3 Involve uncertainty: I cant detect it(we cant
see, smell, taste, hear, orfeel any of them)
I dont understand it unlessyou are a scientist
Nobody knows we justdont have the answers yet
Ref: David Ropeik, How Risky Is It Really? Why Our Fears Dont Always Match the Facts, McGraw Hill, 2010
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Risk AssessmentDifferences in Approaches
Expert PublicScientific Intuitive
Probabilistic Yes / No
Acceptable risk Safety
Changing knowledge Is it or isnt it?
Comparative risk Discrete events
Population averages Personal consequences
A death is a death It matters how we die
Ref: Willem Gerritsen, Unit 1: Consumer Perception of Food Risks, April 2004; p 79www.fsra.eu/secure/unit1.ppt
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Risk EvaluationPerception Differences
Expert Public
Rely on risk assessmentRely on perceptions of risk
(perception is reality)
Objective Subjective
Analytic Hypothetical
Wise Emotional
Rational Foolish
Based on real risk Irrational
Ref: Willem Gerritsen, Unit 1: Consumer Perception of Food Risks, April 2004; p 80www.fsra.eu/secure/unit1.ppt
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Eat at YourOwn Risk
Consumers are being bombarded with
U.S. facing 'grievous harm' from chemicalsin air, food, water, panel says (May 7, 2010)
FEAR Communication
98% Of Apples HavePesticide Residues, USA
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Yet, we heard yesterday that1 Billion meals are served in the
USA without incident!
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Risk = 0
(Hazard)(Outrage)
Safety / RiskAssessments
EmotionalResponse
If the outrage is high, even though the hazard isinsignificant, people may NOT get the messagewe are communicating
Peter Sandmans formula!
(Perceived)
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EWGs Shoppers Guide to
Pesticides in Produce (Jun-11)
The Dirty Dozenlist
1. Apples (98% hadpesticide residue)2. Celery3. Strawberries4. Peaches5. Spinach
6. Nectarines (imported)7. Grapes (imported)8. Sweet bell peppers9. Potatoes10. Blueberries11. Lettuce
12. Kale/collard greens
The Clean 15list
1. Onions2. Corn3. Pineapples4. Avocado5. Asparagus6. Sweet peas
7. Mangoes8. Eggplant9. Cantaloupe (domestic)10. Kiwi11. Cabbage12. Watermelon
13. Sweet potatoes14. Grapefruit15. Mushrooms
Ref: Article 13 Jun-11: http://www.medicalnewstoday.com/articles/228313.php . The report notes:You should not avoid eating fruit and vegetables, the authors of the report stress. The health benefits ofeating five servings of fruit and vegetables each day far outweigh any health risks posed by their pesticide
content. US health authorities insist that all pesticide contents in the fruit and vegetables tested werewithin recommended limits.
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I feel ill Mum. I think its the pesticides in the veges.From now on Im going to have to eat chips, burgers
and pizzas.Ref: Willem Gerritsen, Unit 1: Consumer Perception of Food Risks, April 2004; p 72www.fsra.eu/secure/unit1.ppt ; https://reader009.{domain}/reader009/html5/0509/5af27602b9dbb/5af2761061b1b.jpg
http://www.fsra.eu/secure/unit1.ppthttp://www.cartoonstock.com/lowres/sea0172l.jpghttp://www.cartoonstock.com/lowres/sea0172l.jpghttp://www.fsra.eu/secure/unit1.ppt -
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Consumer MappingRisk and Benefits
Risk
BenefitLow
Low
High
High
Uninterested
Skeptical
Relaxed
Trade-Off
Reference: Risk Perception: Science, Public Debate and Policy Making; Brussels 4-5 Dec-03George Gaskell, London School of Economics, Risk Perception and GM Foods: a decision theoretic approach
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Prop 65 sign in California
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How Consumers Behave
Concerned, even when hazards are not relevant
Overestimate some risks (technological risks)
Underestimate other risks (lifestyle risks)
Do not differentiate greatly between risks within aproduct category
Despite being uncertain, they often remain reluctantto active information search and processing
Ref: Win Verbeke et al. (2007). Analytica Chimica Acta 586: 2-7.
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Information overload
Information overload yieldsuncertainty
Best strategy for consumersto make a decision: Ignore the information? Process the information
systematically? Seek and use easy decision
rules: brand, label, claim?
Avoid and search for analternative / substitute?
?
Ref. Wim Verbeke; ILSI Europe 2011 Annual Symposium, Brussels, 24-25 Mar-11: Public attitudes to emergingfood technologies.
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THERES NOTHING TO EAT!
WARNINGWARNING WARNING
Cartoon reference: http://www.hospitalityguild.com/cartoon2.htm
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Our task is to educate and build trust
From: Fear
To: Confidence
Cartoon: www.panicbuster.com/grfx/phobias/jpgPhoto: http://www.thedailygreen.com/environmental-news/latest/organic-food-tips-47-040801
http://www.panicbuster.com/grfx/phobias/jpghttp://www.thedailygreen.com/environmental-news/latest/organic-food-tips-47-040801http://www.thedailygreen.com/environmental-news/latest/organic-food-tips-47-040801http://www.thedailygreen.com/environmental-news/latest/organic-food-tips-47-040801http://www.thedailygreen.com/environmental-news/latest/organic-food-tips-47-040801http://www.thedailygreen.com/environmental-news/latest/organic-food-tips-47-040801http://www.thedailygreen.com/environmental-news/latest/organic-food-tips-47-040801http://www.thedailygreen.com/environmental-news/latest/organic-food-tips-47-040801http://www.thedailygreen.com/environmental-news/latest/organic-food-tips-47-040801http://www.thedailygreen.com/environmental-news/latest/organic-food-tips-47-040801http://www.thedailygreen.com/environmental-news/latest/organic-food-tips-47-040801http://www.thedailygreen.com/environmental-news/latest/organic-food-tips-47-040801http://www.thedailygreen.com/environmental-news/latest/organic-food-tips-47-040801http://www.panicbuster.com/grfx/phobias/jpg -
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Each day, 2 billion consumers in over half theworlds household use a Unilever product
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Six Major R&D Centres
Shanghai
China
Trumbull
USA
Port SunlightUK
Bangalore
India
VlaardingenThe Netherlands
ColworthUK
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Unilevers Safety Governance
Set out in Code of Business Principles
Consumers: Products safe for their intended use
Employees: Safe & healthy working conditions
Environment: Promote environmental care
Innovation: Sound science / rigorous product
safety standards
Safety
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Safety is our No. 1 Priority
Safety decisions independent of commercial considerations
Wid i E i
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Wide-ranging Expertise
Consumer Safety Microbiology, Toxicology, PhysicalHazards
Occupational Safety (Safety at Work)
Process Safety, Occupation Hygiene
Environmental Safety
Ecotoxicity
Sustainability
Eco-design, Life Cycle Assessment,Environmental Sustainability
Deploying & developing
capability in:
Hazard characterization Exposure assessment Risk & impact assessment
for
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Idea Phase Feasibility Phase CapabilityPhase
Market Ready
Phase
Post Launch
Evaluation Phase
Charter Gate Contract Gate
Market
Ready Gate
Launch
GENERIC PROJECT ROAD MAP INNOVATION FUNNEL
Building safety andcompliance in design
Confirming Safety &Compliance
Maintaining Safety &Compliance
Monitoring Safety & Compliance
Unilevers Innovation Process
Project Leader manages 2 plans:- Project Milestone Plan
- Risk Plan goal is to minimize risks
PreliminaryRisk
Evaluation
Project RiskIdentification
& Plan
Management ofRisk Plan
Audits / Inspections
A Risk based Approach to facilitate
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A Risk-based Approach to facilitateSafe Innovation
We use scientific evidence-based risk assessmentmethodologies to ensure that the risk of adverse healthand/or environmental effects from exposure to chemicals
used in our products is acceptably low.
Hazard-based
Check-list compliance
Unnecessary testing
Doesnt consider how productis used
Yes / no decisions
Overly conservative
Risk-based
Expertise & evidence-driven
Essential testing only
Product use / exposuredetermines outcome
Options to manage risks
Uncertainties explicit
Roles & Responsibilities follow
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Roles & Responsibilities followRisk Analysis Principles
Roles & Responsibilities duly separated Risk Managers Decision-makers in innovation
process Risk Assessors Scientists responsible for product
safety assessments
Ensuring that innovation design safety decisions: Follow a structured, systematic process Are risk-based & sound science-founded Transparent: accessible data & expertise
UnacceptableRisk
Acceptable Risk
?
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Safe by Design & Execution
Establishing safe product design requires understanding:
Product design and intended use, e.g.:- Ingredients, processing, internal/external factors- Processing, final formulation, handling- Post-process contamination, intended use(r)
Considering the available safety benchmarks:- Guidance/guidelines from competent authorities- Regulations (e.g. standards, limits, criteria)- Industry, Internal Unilever guidance
Unacceptable
Risk
Acceptable Risk
!
Risk based approach for e al ating
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Risk based approach for evaluatingconsumer safety of ingredients
Ingredientlevel
Amount ofproduct
Route ofexposure
Retentionfactor
Consumerhabits
Producttype
Toxicologydata
Human data
QSAR
Frequencyof use
Biologicalequivalence
Safe historyof use
Overall safety evaluationdefine acceptability and
risk management measures
1. Hazardidentification
2. Hazardcharacterization
3. Exposureassessment
4. Riskcharacterization
(QSAR = quantitative structure-activity relationship)
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Safe by Design & Execution
Safe execution of the safe product design:Validate design: from lab-scale to operational-scale
Implement design in operational management systems
(using Good Practices, HACCP)
Verify control during manufacture
Run tracing & tracking system
Monitor & Review as appropriate
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Verification in design
A series of tests are carried to verify that the
proposed product meets the consumerrequirements and delivers on the Project Brief
Efficacy TestingDoes the product meet the claims?
Analytical / Micro / Quality specsDoes the product meet the specs?
Process Scale-UpCan the factory produce the product?
Stability/Compatibility TestingIs the product (formula & packaging) developed robust?
Consumer AcceptanceDoes the product meet consumer expectations?
Exposure Based Safety Assessment
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Consider product
type and consumerhabits
Determine route andamount of exposure
Identify toxicologicalendpoints of
potential concern
Identify critical endpoint(s) for risk
assessment
Identify availabletoxicology data
Identify supportingsafety data (e.g.QSAR, HoSU)
Evaluate required vs.available support
Conduct riskassessment for each
critical endpoint
Conduct toxicology
testing as required
Overall safety evaluationfor product define
acceptability and risk
management measures
Exposure Based Safety AssessmentProcess for Consumer Products
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RISK ANALYSIS
RiskAssessment
RiskManagement
Risk
Communication
Decision(s) by risk managers
Risk Level (RL)
Policy Level of risk(PL): ALOP1 or
public health goal
FSO
1: ALOP, Appropriate Level Of Protection
PO = Performance Objective; FSO = Food Safety Objective
Risk Management decision-making
PO
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Risk-based metrics
Primary
production(Step 1)
Process 2 Packaging Transport
(Step 3)
Process 1
Manufacturing (step 2)
Step 2Incoming
Hazard level
Step 2Performance
objective(PO)
Retail
(Step 4)
Step 2PerformanceCriterion (PC)
Process criteria: e.g., pasteurisation or sterilisation time/temp
Product criteria: pH, salt, acid, etc
Control measures: e.g., refrigeration, control of cross-contamination,education
HACCP
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General Controls & Preventive Controls specified by
Product and Factory
Example: Exposure Assessment -
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Example: Exposure Assessment Key components
Bacterial concentration in raw materials
Heat treatment
Time in pre-retail
(transport +
warehouse)
Bacterial heat resistance
Temperature of pre-
retail fridges
Time in retail (local
market,supermarket)
Temperature of retail
fridges
Time in consumer
fridge
Temperature of
consumer fridges
Lag time and
growth rate of
surviving
spores, atchilled
temperatures
Prevalence and Bacterial concentration in processed food
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Building Consumer Confidence
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Building Consumer Confidence
Regulatory/Legal
Compliance
Safety
Quality
Safety integral part ofInnovation process
Communication
On pack, Ads, leaflets, 800 #, Websites, social media, etc.
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Our business dependson our ability to build
and maintain
Is our engine for growth
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Something to think about!
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Something to think about!
In the beginning .