Patrizia Barone, Ph.D. Regulatory Affairs Director – North America

1. 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

2. “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

3. Isaac Asimov “Science is uncertainty…theories are subject to revision; observations are open to a variety of interpretations, and scientists quarrel among themselves.”

4. Consumerssometimes are confused by conflictingscientificinformation

5. Huge Challenges Facing Our Food System World population in 2007: 6.7 Billion World population in 2050: 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

6. 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

7. % of Acres 100 80 60 40 20 0 93 78 73 70 63 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 areavailable in the ERS data product, Adoption of Genetically Engineered Crops in the US, Tables 1-3. Rapid growth in adoption of biotechnology crops continues Ref.: 2011 IFIC Communication Summit – Jennie Schmidt, “Ag Sustainability on the Family Farm, 24 May 2011.

8. Factors Affecting Consumer Attitudes Toward Food Technology 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. • 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

9. 87% 79% 66% 58% 52% 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 Ref: International Food Information Council (IFIC) – 2011 Food & Health Survey

10. Fear Risk Perception Factors Ref: David Ropeik, How Risky Is It Really? Why Our Fears Don’t Always Match the Facts, McGraw Hill, 2010

11. Risk Perception Factors Ref: David Ropeik, How Risky Is It Really? Why Our Fears Don’t Always Match the Facts, McGraw Hill, 2010

12. Fear Risk Perception Factors • 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

13. What do the following hazards have in common? Pesticides in food Bovine growth hormone in cows to increase milkproduction Radiation from cell phone towers All 3 are human-made not natural They are risks that are imposed on us All 3 Involve uncertainty: “I can’t detect it” (we can’t see, smell, taste, hear, orfeel any of them) “I don’t understand it” unless you are a scientist “Nobody knows” – we just don’t have the answers yet Uncertainty plays a big role in fear Ref: David Ropeik, How Risky Is It Really? Why Our Fears Don’t Always Match the Facts, McGraw Hill, 2010

14. Risk Assessment – Differences in Approaches Ref: Willem Gerritsen, Unit 1: Consumer Perception of Food Risks, April 2004; p 79www.fsra.eu/secure/unit1.ppt

15. Risk Evaluation – Perception Differences Ref: Willem Gerritsen, Unit 1: Consumer Perception of Food Risks, April 2004; p 80www.fsra.eu/secure/unit1.ppt

16. U.S. facing 'grievous harm' from chemicals in air, food, water, panel says (May 7, 2010) Eat at Your Own Risk Consumers are being “bombarded” with FEAR Communication 98% Of Apples Have Pesticide Residues, USA

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

18. 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

19. The Dirty Dozen list 1. Apples (98% had pesticide residue) 2. Celery3. Strawberries4. Peaches5. Spinach6. Nectarines (imported) 7. Grapes (imported) 8. Sweet bell peppers9. Potatoes10. Blueberries11. Lettuce12. Kale/collard greens The Clean 15 list 1. Onions2. Corn3. Pineapples4. Avocado5. Asparagus6. Sweet peas7. Mangoes8. Eggplant9. Cantaloupe (domestic) 10. Kiwi11. Cabbage12. Watermelon13. Sweet potatoes14. Grapefruit15. Mushrooms EWG’s Shopper’s Guide to Pesticides in Produce (Jun-11) 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.

20. “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 72www.fsra.eu/secure/unit1.ppt; http://www.cartoonstock.com/lowres/sea0172l.jpg

21. Consumer MappingRisk and Benefits High Skeptical Trade-Off Risk Uninterested Relaxed Low High Low Benefit 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

22. Prop 65 sign in California

23. 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.

24. 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 emergingfood technologies.

25. WARNING WARNING WARNING “THERE’S NOTHING TO EAT!” Cartoon reference: http://www.hospitalityguild.com/cartoon2.htm

27. Our task is to educate and build trust From: FearTo: Confidence Cartoon: www.panicbuster.com/grfx/phobias/jpg Photo: http://www.thedailygreen.com/environmental-news/latest/organic-food-tips-47-040801

28. Each day, 2 billion consumers in over half the world’s household use a Unilever product

29. Six Major R&D Centres Port Sunlight UK Vlaardingen The Netherlands Colworth UK Bangalore India Trumbull USA Shanghai China 29

30. Unilever’s Safety Governance Safety 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 30

31. Safety is our No. 1 Priority Safety decisions independent of commercial considerations

32. Wide-ranging Expertise Consumer Safety • Microbiology, Toxicology, Physical Hazards Occupational Safety (Safety at Work) • Process Safety, Occupation Hygiene Deploying & developing capability in: • Hazard characterization • Exposure assessment • Risk & impact assessment for Environmental Safety • Ecotoxicity Sustainability • Eco-design, Life Cycle Assessment, Environmental Sustainability

33. 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 Maintaining Safety & Compliance Management of Risk Plan Preliminary Risk Evaluation Project Leader manages 2 plans: - Project Milestone Plan - Risk Plan – goal is to minimize risks Launch Market Ready Gate Charter Gate Contract Gate Project Risk Identification & Plan Confirming Safety & Compliance Monitoring Safety & Compliance

34. A Risk-based Approach to facilitate Safe Innovation Hazard-based Check-list compliance Unnecessary testing Doesn’t consider how product is used Yes / no decisions Overly conservative 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. Risk-based • Expertise & evidence-driven • Essential testing only • Product use / exposure determines outcome • Options to manage risks • Uncertainties explicit

35. 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 Arerisk-based & sound science-founded Transparent:accessible data & expertise ? Unacceptable Risk Acceptable Risk

36. 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

37. Producttype Ingredient level Toxicology data Amount of product Safe history of use 1. Hazard identification Consumer habits Human data Frequency of use QSAR 3. Exposure assessment 2. Hazard characterization Route of exposure Biological equivalence Retention factor 4. Risk characterization Overall safety evaluation – define acceptability and risk management measures Risk based approach for evaluating consumer safety of ingredients (QSAR = quantitative structure-activity relationship)

38. 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

39. 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?

40. Exposure Based Safety Assessment Process for Consumer Products Consider product type and consumer habits Identify available toxicology data Identify supporting safety data (e.g. QSAR, HoSU) Determine route and amount of exposure Identify toxicological endpoints of potential concern Evaluate required vs. available support Identify critical end point(s) for risk assessment Conduct toxicology testing as required Overall safety evaluation for product – define acceptability and risk management measures Conduct risk assessment for each critical endpoint

41. RISK ANALYSIS Risk Risk Management Assessment Risk Communication Policy Level of risk (PL): ALOP1 or public health goal FSO Risk Management decision-making Risk Level (RL) Decision(s) by risk managers PO 1: ALOP, Appropriate Level Of Protection PO = Performance Objective; FSO = Food Safety Objective

42. Process criteria: e.g., pasteurisation or sterilisation time/temp Product criteria: pH, salt, acid, etc HACCP Control measures: e.g., refrigeration, control of cross-contamination, education Risk-based metrics Step 2 Incoming Hazard level Step 2 Performance Criterion (PC) Step 2 Performance objective (PO) Primary production (Step 1) Retail (Step 4) Process 1 Process 2 Packaging Transport (Step 3) Manufacturing (step 2) General Controls & Preventive Controls – specified by Product and Factory 42

43. 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) Temperature of pre-retail fridges Lag time and growth rate of surviving spores, at chilled temperatures Time in retail (local market, supermarket) Temperature of retail fridges Time in consumer fridge Temperature of consumer fridges 43

44. Building Consumer Confidence Safety Safety – integral part of Innovation process Quality Regulatory/ Legal Compliance Communication On pack, Ads, leaflets, 800 #, Websites, social media, etc.

45. Is our engine for growth Our business depends on our ability to build and maintain…

47. Something to think about!In the beginning ….