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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

http://www.virtualsalt.com/crebook5.htmhttp://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

http://www.fsra.eu/secure/unit1.ppthttp://www.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

http://www.fsra.eu/secure/unit1.ppthttp://www.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.

http://www.medicalnewstoday.com/articles/228313.phphttp://www.medicalnewstoday.com/articles/228313.php

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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

http://www.hospitalityguild.com/cartoon2.htmhttp://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

29

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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

30

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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

38

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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

42

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

43

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 .