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 growthin 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
80

60

78 73 70 63

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

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.

Perceptions on Food Safety

Terminology

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% 79% 66%

Taste Price Healthfulness Convenience Sustainability 0 20 40

58%
52%

60

80

100

Ref: International Food Information Council (IFIC) 2011 Food & Health Survey

Risk Perception Factors

Fear

Ref: David Ropeik, How Risky Is It Really? Why Our Fears Dont Always Match the Facts, McGraw Hill, 2010

Risk Perception Factors

Trust Risk vs. benefit (trade offs)
Control Choice

Catastrophic or Chronic
Can it Happen to Me? Is the Risk New or Familiar? Risks to Children Personification

Natural or Human-made? Pain and Suffering

Fairness

Uncertainty
Ref: David Ropeik, How Risky Is It Really? Why Our Fears Dont 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 Dont 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 Radiation from cell phone towers

I cant detect it (we cant see, smell, taste, hear, or feel any of them) I dont understand it unless you are a scientist Nobody knows we just dont have the answers yet

Ref: David Ropeik, How Risky Is It Really? Why Our Fears Dont Always Match the Facts, McGraw Hill, 2010

Risk Assessment Differences in Approaches Expert

Scientific Probabilistic

Public
Intuitive Yes / No

Acceptable risk
Changing knowledge

Safety
Is it or isnt it?

Comparative risk
Population averages A death is a death

Discrete events
Personal consequences 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
Rely on risk assessment Objective Analytic Wise Rational Based on real risk

Public
Rely on perceptions of risk (perception is reality)
Subjective Hypothetical Emotional Foolish 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)

98% Of Apples Have Pesticide Residues, USA

Eat at Your Own Risk

Yet, we heard yesterday that 1 Billion meals are served in the USA without incident!

Peter Sandmans formula!

Safety / Risk Assessments Emotional Response

(Perceived)

Risk = (Hazard) (Outrage)

0

If the outrage is high, even though the hazard is insignificant, people may NOT get the message we are communicating

EWGs Shoppers Guide to Pesticides in Produce (Jun-11)

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.

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

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

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.

Consumer Mapping Risk and Benefits

High

Skeptical

Trade-Off

Risk
Low

Uninterested

Relaxed

Low

High

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

THERES 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 worlds household use a Unilever product

Six Major R&D Centres

Port Sunlight UK Vlaardingen The Netherlands Colworth UK

29

Trumbull USA

Shanghai China

Bangalore India

Unilevers Safety Governance

Set out in Code of Business Principles

Consumers: Products safe for their intended use

Employees:
Environment:

Safe & healthy working conditions

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 Deploying & developing capability in: Hazard characterization Exposure assessment Risk & impact assessment for Environmental Safety Ecotoxicity Sustainability Eco-design, Life Cycle Assessment, Environmental Sustainability Occupational Safety (Safety at Work) Process Safety, Occupation Hygiene

Unilevers Innovation Process

GENERIC PROJECT ROAD MAP INNOVATION FUNNEL
Idea Phase Feasibility Phase Capability Phase Market Ready Phase Post Launch Evaluation Phase

Building safety and compliance in design

Preliminary Risk Evaluation
Charter Gate

Audits / Inspections Maintaining Safety & Compliance

Project Leader manages 2 plans: - Project Milestone Plan - Risk Plan goal is to minimize risks

Management of Risk Plan

Market Ready Gate Launch

Contract Gate

Project Risk Identification & Plan

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
Expertise & evidence-driven Essential testing only Product use / exposure determines outcome Options to manage risks Uncertainties explicit

Check-list compliance Unnecessary testing Doesnt consider how product is used Yes / no decisions

Overly conservative

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

Toxicology data

Amount of product Consumer habits Frequency of use Route of exposure

1. Hazard identification

Safe history of use Human data

3. Exposure assessment

2. Hazard characterization

QSAR

Retention factor

Biological equivalence

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:

design: from lab-scale to operational-scale

Validate

Implement

design in operational management systems (using Good Practices, HACCP)

Verify
Run

control during manufacture

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 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 Determine route and amount of exposure Identify toxicological endpoints of potential concern Identify critical end point(s) for risk assessment

Identify available toxicology data

Identify supporting safety data (e.g. QSAR, HoSU)

Evaluate required vs. available support

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 Risk Risk Assessment Management Risk Communication

Decision(s) by risk managers

Policy Level of risk (PL): ALOP1 or public health goal

PO

FSO

1:

ALOP, Appropriate Level Of Protection

PO = Performance Objective; FSO = Food Safety Objective

Risk-based metrics
Step 2 Incoming Hazard level Step 2 Performance Criterion (PC) Step 2 Performance objective (PO)

Primary production (Step 1)

Process 1

Process 2 Manufacturing (step 2)

Packaging

Transport (Step 3)

Retail (Step 4)

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 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)

Temperature of preretail fridges Lag time and growth rate of surviving spores, at chilled temperatures Temperature of retail fridges

Time in consumer fridge

43

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 .