Transcript Document
12 th 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
certain amount of
risk.”
involves a
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
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: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 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.
93 78 73 70 63
Factors Affecting Consumer Attitudes Toward Food Technology
Awareness
Information Sources
Education
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.
Trust
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% Taste Price Healthfulness Convenience Sustainability 52% 0 20 40 60
Ref: International Food Information Council (IFIC) – 2011 Food & Health Survey
66% 58% 80 79% 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 Risk vs. benefit (trade offs) Control Catastrophic or Chronic Can it Happen to Me?
Is the Risk New or Familiar?
Risks to Children Choice Natural or Human-made?
Pain and Suffering Uncertainty Personification Fairness
Ref: David Ropeik, How Risky Is It Really? Why Our Fears Don’t Always Match the Facts, McGraw Hill, 2010
Risk Perception Factors Fea r
• 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 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
Pesticides in food Bovine growth hormone in cows to increase milk production
All 3 Involve uncertainty:
“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 Scientific Probabilistic Acceptable risk Changing knowledge Comparative risk Population averages A death is a death Public Intuitive Yes / No Safety Is it or isn’t it?
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 Sandman’s formula!
Safety / Risk Assessments Emotional Response (Perceived)
Risk =
0
(Hazard)
(
Outrage)
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
www.fsra.eu/secure/unit1.ppt
;
in the veges.
From now on I’m going to have to eat
Ref: Willem Gerritsen, Unit 1: Consumer Perception of Food Risks, April 2004; p 72
chips, burgers and pizzas.”
Consumer Mapping Risk and Benefits High Skeptical Risk Low Uninterested Trade-Off 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 “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
Port Sunlight UK Vlaardingen The Netherlands Colworth UK
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Trumbull USA Shanghai China Bangalore India
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Unilever’s Safety Governance Set out in Code of Business Principles
Consumers:
Employees:
Environment
:
Innovation:
Products safe for their intended use Safe & healthy working conditions Promote environmental care Sound science / rigorous product safety standards
Safety
Safety is our No. 1 Priority Safety decisions independent of commercial considerations
Wide-ranging Expertise Deploying & developing capability in:
• • •
Hazard characterization Exposure assessment Risk & impact assessment for Consumer Safety
•
Microbiology, Toxicology, Physical Hazards Occupational Safety (Safety at Work)
•
Process Safety, Occupation Hygiene 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 Building safety and compliance in design Preliminary Risk Evaluation Management of Risk Plan Charter Gate Contract Gate Project Risk Identification & Plan Market Ready Gate Launch Confirming Safety & Compliance Audits / Inspections Maintaining Safety & Compliance Project Leader manages 2 plans: - Project Milestone Plan - Risk Plan – goal is to minimize risks 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
Check-list compliance
Unnecessary testing
Doesn’t consider how product is used
Yes / no decisions
Overly conservative Risk-based
Expertise & evidence-driven
Essential testing only
Product use / exposure determines outcome
Options to manage risks
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 Consumer habits Frequency of use Route of exposure Amount of product 3. Exposure assessment Retention factor 1. Hazard identification 2. Hazard characterization Toxicology data Safe history of use Human data QSAR Biological equivalence 4. Risk characterization Overall safety evaluation – define acceptability and risk management measures
(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
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 Identify critical end point(s) for risk assessment 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 Assessment Risk Management Risk Communication Decision(s) by risk managers
Policy Level of risk (PL): ALOP 1 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
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Product criteria: pH, salt, acid, etc HACCP Control measures: e.g., refrigeration, control of cross-contamination, education
General Controls & Preventive Controls – specified by Product and Factory
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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 Lag time and growth rate of surviving spores, at chilled temperatures Temperature of pre retail fridges 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 ….