12th Annual Fera / JIFSAN Joint Symposium
June 15-17, 2011, Maryland
Role of Science, Uncertainty
& Risk Perception in Making
Informed Decisions –
An Industry Perspective
Patrizia Barone, Ph.D.
Regulatory Affairs Director – North America
“Decision making is a process of sufficiently reducing
uncertainty and doubt about alternatives to allow a
reasonable choice to be made among them…
Very few decisions are made with absolute certainty
because complete knowledge about all the alternatives
is seldom possible. Thus, every decision involves a
certain amount of risk.”
Robert Harris
Ref.: Robert Harris, Introduction to Decision Making, 2 Dec-09; http://www.virtualsalt.com/crebook5.htm
“Science is uncertainty…
theories are subject to revision;
observations are open to a variety of
interpretations, and scientists
quarrel among themselves.”
Isaac Asimov
Consumers
sometimes
are confused
by conflicting
scientific
information
Huge Challenges Facing
Our Food System
World population in 2007:
World population in 2050:
6.7 Billion
9.2 Billion
*******************************
“… global agricultural production must grow by 70% by
2050 in order to feed an additional 2.3 billion people
…most gains in production will be achieved by increasing
yield growth…in land-scarce countries, almost all growth
would need to be achieved by improving yields. This
necessitates "pushing the agricultural technology
frontier outwards" on a number of fronts.”
Ref: “The Technology Challenge" Food & Agriculture Organization (FAO) of the United Nations, 2009
The Evolution of Food Science
Ref.: Original C.J.K. Henry, Proc. Nutrition Soc 56:855-863, 1997;
2011 IFIC Communication Summit – Dave Schmidt, “Alliance to Feed the Future, 24 May 2011
Rapid growth in adoption of
biotechnology crops continues
% of Acres
100
93
78
73
70
63
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.
Ref.: 2011 IFIC Communication Summit – Jennie Schmidt, “Ag Sustainability on the Family Farm, 24 May 2011.
Factors Affecting Consumer
Attitudes Toward Food Technology

Awareness

Information Sources

Education

Trust

Perceptions on Food Safety

Terminology


43% of participants in IFIC
Food & Health survey believe
that advances in modern food
technology have provided, or
will provide, future benefits
for themselves and their
families.
“Biotechnology” – not “GMO”
Distinguish terms (ex. sustainable ≠ local)
Ref: International Food Information Council (IFIC) – 2011 Food & Health Survey
Factors Influencing
Purchasing Decisions
Taste continues to be the main driver of purchasing foods and beverages,
but price continues to rise as a significant factor
87%
Taste
79%
Price
66%
Healthfulness
58%
Convenience
52%
Sustainability
0
20
40
60
Ref: International Food Information Council (IFIC) – 2011 Food & Health Survey
80
100
Risk Perception Factors
Fear
Ref: David Ropeik, How Risky Is It Really? Why Our Fears Don’t Always Match the Facts, McGraw Hill, 2010
Risk Perception Factors
Trust
Catastrophic or Chronic
Risk vs. benefit
(trade offs)
Can it Happen to Me?
Control
Is the Risk New or
Familiar?
Choice
Risks to Children
Natural or
Human-made?
Personification
Pain and Suffering
Fairness
Uncertainty
Ref: David Ropeik, How Risky Is It Really? Why Our Fears Don’t Always Match the Facts, McGraw Hill, 2010
Risk Perception Factors
• Risk Perception Factors:
• Can make our fears go up or down
Fear
• 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 that
make each of us unique.
Ref: David Ropeik, How Risky Is It Really? Why Our Fears Don’t Always Match the Facts, McGraw Hill, 2010
Uncertainty plays a big role in fear

What do the following
hazards have in
common?


All 3 are human-made not
natural

They are risks that are
imposed on us

All 3 Involve uncertainty:
Pesticides in food

Bovine growth hormone in
cows to increase milk
production

“I can’t detect it” (we can’t
see, smell, taste, hear, or
feel any of them)

Radiation from cell phone
towers

“I don’t understand it” unless
you are a scientist

“Nobody knows” – we just
don’t have the answers yet
Ref: David Ropeik, How Risky Is It Really? Why Our Fears Don’t Always Match the Facts, McGraw Hill, 2010
Risk Assessment –
Differences in Approaches
Expert
Public
Scientific
Intuitive
Probabilistic
Yes / No
Acceptable risk
Safety
Changing knowledge
Is it or isn’t 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 79
www.fsra.eu/secure/unit1.ppt
Risk Evaluation –
Perception Differences
Expert
Public
Rely on risk assessment
Rely 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 80
www.fsra.eu/secure/unit1.ppt
Consumers are being “bombarded” with
FEAR Communication
U.S. facing 'grievous harm' from chemicals
in air, food, water, panel says (May 7, 2010)
Eat at Your
Own Risk
98% Of Apples Have
Pesticide Residues, USA
Yet, we heard yesterday that
1 Billion meals are served in the
USA without incident!
Peter Sandman’s formula!
Safety / Risk
Assessments
(Perceived)
Emotional
Response

Risk =  (Hazard) (Outrage)
0
If the outrage is high, even though the hazard is
insignificant, people may NOT get the message
we are communicating
EWG’s Shopper’s Guide to
Pesticides in Produce (Jun-11)
The Dirty Dozen list
1. Apples (98% had
pesticide residue)
2. Celery
3. Strawberries
4. Peaches
5. Spinach
6. Nectarines (imported)
7. Grapes (imported)
8. Sweet bell peppers
9. Potatoes
10. Blueberries
11. Lettuce
12. Kale/collard greens
The Clean 15 list
1. Onions
2. Corn
3. Pineapples
4. Avocado
5. Asparagus
6. Sweet peas
7. Mangoes
8. Eggplant
9. Cantaloupe (domestic)
10. Kiwi
11. Cabbage
12. Watermelon
13. Sweet potatoes
14. Grapefruit
15. 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 of
eating 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 were
within recommended limits.
“I feel ill Mum. I think it’s the pesticides in the veges.
From now on I’m going to have to eat chips, burgers
and pizzas.”
Ref: Willem Gerritsen, Unit 1: Consumer Perception of Food Risks, April 2004; p 72
www.fsra.eu/secure/unit1.ppt; http://www.cartoonstock.com/lowres/sea0172l.jpg
Consumer Mapping
Risk and Benefits
High
Skeptical
Trade-Off
Uninterested
Relaxed
Risk
Low
High
Low
Benefit
Reference: Risk Perception: Science, Public Debate and Policy Making; Brussels 4-5 Dec-03
George Gaskell, London School of Economics, Risk Perception and GM Foods: a decision theoretic approach
Prop 65 sign in California
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 a
product category

Despite being uncertain, they often remain reluctant
to active information search and processing
Ref: Win Verbeke et al. (2007). Analytica Chimica Acta 586: 2-7.
Information overload

Information overload yields
uncertainty

Best strategy for consumers
to make a decision:





Ignore the information?
Process the information
systematically?
Seek and use easy decision
rules: brand, label, claim?
Avoid and search for an
alternative / substitute?
?
Ref. Wim Verbeke; ILSI Europe 2011 Annual Symposium, Brussels, 24-25 Mar-11: Public attitudes to emerging
food technologies.
WARNING
WARNING
WARNING
“THERE’S NOTHING TO EAT!”
Cartoon reference: http://www.hospitalityguild.com/cartoon2.htm
Our task is to educate and build trust
From:
Fear
To:
Confidence
Cartoon: www.panicbuster.com/grfx/phobias/jpg
Photo: http://www.thedailygreen.com/environmental-news/latest/organic-food-tips-47-040801
Each day, 2 billion consumers in over half the
world’s household use a Unilever product
Six Major R&D Centres
29
Port Sunlight
UK
Vlaardingen
The Netherlands
Colworth
UK
Trumbull
USA
Shanghai
China
Bangalore
India
Unilever’s 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
Safety is our No. 1 Priority
Safety decisions independent of commercial considerations
Wide-ranging Expertise
Consumer Safety
• Microbiology, Toxicology, Physical
Hazards
Occupational Safety (Safety at Work)
Deploying & developing
capability in:
• Hazard characterization
• Exposure assessment
• Risk & impact assessment
• Process Safety, Occupation Hygiene
for
Environmental Safety
• Ecotoxicity
Sustainability
• Eco-design, Life Cycle Assessment,
Environmental Sustainability
Unilever’s Innovation Process
GENERIC PROJECT ROAD MAP – INNOVATION FUNNEL
Idea Phase
Feasibility Phase
Capability
Phase
Market Ready
Phase
Post Launch
Evaluation Phase
Audits / Inspections
Building safety and
compliance in design
Preliminary
Risk
Evaluation
Charter Gate
Maintaining Safety &
Compliance
Management of
Risk Plan
Contract Gate
Project Risk
Identification
& Plan
Market
Ready Gate
Launch
Project Leader manages 2 plans:
- Project Milestone Plan
- Risk Plan – goal is to minimize risks
Confirming Safety &
Compliance
Monitoring Safety & Compliance
A Risk-based Approach to facilitate
Safe Innovation
We use scientific evidence-based risk assessment
methodologies to ensure that the risk of adverse health
and/or environmental effects from exposure to chemicals
used in our products is acceptably low.
Hazard-based
Risk-based

Check-list compliance
 Expertise & evidence-driven

Unnecessary testing
 Essential testing only

Doesn’t consider how product
is used
 Product use / exposure
determines outcome

Yes / no decisions
 Options to manage risks

Overly conservative
 Uncertainties explicit
Roles & Responsibilities follow
Risk 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
?
Unacceptable
Risk
Acceptable Risk
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 evaluating
consumer safety of ingredients
Product
type
Ingredient
level
Amount of
product
Toxicology
data
1. Hazard
identification
Consumer
habits
Safe history
of use
Human data
Frequency
of use
Route of
exposure
3. Exposure
assessment
2. Hazard
characterization
QSAR
Biological
equivalence
Retention
factor
4. Risk
characterization
Overall safety evaluation –
define acceptability and
risk management measures
(QSAR = quantitative structure-activity relationship)
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
 Run
control during manufacture
tracing & tracking system
 Monitor
38
& Review as appropriate
Verification in design
A series of tests are carried to verify that the
proposed product meets the consumer
requirements and delivers on the Project Brief
• Efficacy Testing
Does the product meet the claims?
• Analytical / Micro / Quality specs
Does the product meet the specs?
• Process Scale-Up
Can the factory produce the product?
• Stability/Compatibility Testing
Is the product (formula & packaging) developed robust?
• Consumer Acceptance
Does the product meet consumer expectations?
Exposure Based Safety Assessment
Process for Consumer Products
Consider product
type and consumer
habits
Identify available
toxicology data
Determine route and
amount of exposure
Identify supporting
safety data (e.g.
QSAR, HoSU)
Identify toxicological
endpoints of
potential concern
Evaluate required vs.
available support
Identify critical end
point(s) for risk
assessment
Conduct toxicology
testing as required
Conduct risk
assessment for each
critical endpoint
Overall safety evaluation
for product – define
acceptability and risk
management measures
Risk Management decision-making
Risk Level (RL)
RISK ANALYSIS
Decision(s) by risk managers
Risk
Risk
Assessment Management
Risk
Communication
Policy Level of risk
(PL): ALOP1 or
public health goal
PO
1:
ALOP, Appropriate Level Of Protection
PO = Performance Objective; FSO = Food Safety Objective
FSO
Risk-based metrics
Step 2
Incoming
Hazard level
Primary
production
(Step 1)
Step 2
Performance
Criterion (PC)
Process 1
Process 2
Step 2
Performance
objective
(PO)
Packaging
Transport
(Step 3)
Retail
(Step 4)
Manufacturing (step 2)
Process criteria: e.g., pasteurisation or sterilisation time/temp
HACCP
Product criteria: pH, salt, acid, etc
Control measures: e.g., refrigeration, control of cross-contamination,
education
42
General Controls & Preventive Controls – specified by
Product and Factory
Example: Exposure Assessment Key components
Bacterial concentration in raw materials
Heat treatment
Bacterial heat resistance
Prevalence and Bacterial concentration in processed food
Time in pre-retail
(transport +
warehouse)
Time in retail (local
market,
supermarket)
Time in consumer
fridge
43
Temperature of preretail fridges
Lag time and
growth rate of
surviving
spores, at
chilled
temperatures
Temperature of retail
fridges
Temperature of
consumer fridges
Building Consumer Confidence
Safety
Safety – integral part of
Innovation process
Quality
Regulatory/
Legal
Compliance
Communication
On pack, Ads, leaflets, 800 #, Websites, social media, etc.
Is our engine for growth
Our business depends
on our ability to build
and maintain…
Something to think about!
In the beginning ….