Biotechnology

In

Food and Agriculture
1

An Overview of Biotechnology Derived Food
FOR THE

Association of Food Journalists October 7, 2004
Teresa A. Gruber, Ph.D., J.D. Council for Agricultural Science and Technology www.cast-science.org

2

CAST Mission Statement
CAST assembles, interprets, and communicates science-based information regionally, nationally, and internationally on food, fiber, agricultural, natural resource, and related societal and environmental issues to our stakeholders-legislators, regulators, policy makers, the media, the private sector, and the public.
3

What Is Biotechnology?
The use of biology to produce products that are of use to society "New" Biotechnology – the use of the cellular and molecular processes to solve problems or make products.

4

Crop Evolution and Human Civilization
• Humans Have Always Guided the Evolution of Crops! • A small sample of wild plants were chosen and domesticated • 10,000 years of Selection. • All crops we grow today were once wild plants. But no crop would survive in the wild any more. • Crops, strains and genes have moved around the globe.

Teosinte Teosinte

Hybrids Hybrids

Modern Corn Modern Corn

5

Improving Our Crop Plants
• Developing Modern Varieties of Crops
– Hybridization
• Crosses with Wild Relatives • Hybrids

– Mutation
• Irradiation • Chemicals

– Cell Culture
• Embryo Rescue • Somaclonal variation
6

Modern Genetic Modification
Inserting one or few genes to achieve desired traits. Transfer of Genes into Crop Plants
– – – – Relatively Precise and Predictable Changes are Subtle Allows Flexibility Expeditious

7

Traditional Breeding vs. Biotech Traditional plant breeding
Traditional donor
DNA is a strand of genes, much like a strand of pearls. Traditional plant breeding combines many genes at once. Desired Gene

Commercial variety

New variety
(many genes are transferred)

X
(crosses)

=
Desired gene

Plant biotechnology
Using plant biotechnology, a single gene may be added to the strand.

Desired gene

Commercial variety

New variety
(only desired gene is transferred)

=
(transfers) Desired gene

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“The newer rDNA biotechnology techniques offer the potential to rapidly and precisely improve the quantity and quality of food.”
Institute of Food Technologists Expert Report on Biotechnology and Foods

9

Why Biotech Foods?
• Better Quality Foods • Better Testing Foods • Healthier Foods with Improved Nutritional Characteristics • Greater Processing Yields

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Benefits of Biotech on Human Health
• Less Mycotoxin in Bt Maize • Hypoallergenic Wheat and Peanut • Low Cyanide in Cassava • Healthier Oil, Sugar and Starch • Increased food supply to support growing population and shrinking land

11

More Benefits of Biotechnology
• Post Harvest Quality - Prolong Shelf Life of Fruits, Vegetables and Flowers • Extend Crop Area and Season • Stress Tolerance - Drought, Acidity, Salinity, Heat. Flooding

12

But Consumers Want to Know…
• • • Are Biotech Foods Safe? Are Biotech Foods Regulated? What are the Benefits & Risks of Biotech Foods? Basic Consumer Preferences Vary Little Around the World

13

Challenges to Evaluating Biotechnology
• Concerns about environmental and human health risks are already prominent in society. • Most people have limited understanding of science and agriculture. • Food is emotional and very personal. • Sensationalized media coverage raises fears and sets the public agenda. • Activists are successful in generating fear and funds. • Data to support safety of the technology and products are often generated by those who stand to profit. • Biotechnology raises complex ethical and social issues.
14

Public Understanding of Science
% Correct What is DNA? What is the Internet? What is a molecule? Does smoking cause cancer? Is the center of the earth very hot? 29 13 13 93 81
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National Science Foundation, 2000

Public Policy Paradigms Perpetuate Polarization
• • • • Public Perception vs. Reality Precautionary Principle vs. Risk Assessment Certainty vs. Uncertainty Public vs. Private Funding
– Who benefits vs. who pays – Who owns the profits vs. who pays for mistakes – Trust & transparency vs. timely and trustworthy
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A Glance Back – Biotechnology Benchmarks
1974: The NIH forms a Recombinant DNA Advisory Committee 1980: The U.S. Supreme Court approves principle of patenting life 1984 : Federal government establishes the “Coordinated Framework” 1986 USDA approves the first field tests of genetically engineered plants • 1987: USDA – Federal Plant Pest Act • 1992: FDA declares that GM foods are not inherently different and do not need special regulation or labeling • 1994: EPA - FIFRA • • • •

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Public Acceptance of New Technologies
Risk Paradigm 1. Risk Assessment (Scientists) 2. Risk Management (Government) 3. Risk Communications (Everyone) All Three are Critical for Public Acceptance of New Technologies, be they Pasteurization, Microwave Ovens, Cell phones, PCs, or Biotechnology

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1999 Key Commodity Crop Approvals in select markets
USA Corn Soy Canola Potato Cotton Beet 16 11 6 17 5 2 CANADA EU 11 4 18 17 3 0 4 1 3 0 0 0 JAPAN 13 2 12 2 1 1
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Biotech Crops in the U.S. Food Supply
Ä 25% of 2000 U.S. corn acreage planted Ä 54% of 2000 U.S. soybean acreage planted Ä 61% of 2000 U.S. cotton acreage planted Ä 70% of 2000 Canadian canola acreage planted Ä Multiple international markets planting biotech seed products:

90% of soybeans in Argentina; 10-30% in Brazil Adoption in China, former Soviet Union, India

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Risk Assessment
• Standard - “Reasonable certainty that no harm will result from intended uses under the anticipated conditions of consumption.” • Food is not inherently safe. • Considered to be safe based on experience. • Not absolute but relative safety:
.. .. .. “as safe as” .. .. .. “as safe as”
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Comprehensive safety assessments
Integrated (coordinated) framework involves three federal agencies in reviewing biotech product safety. FDA: Feed and food safety.

USDA: Environmental safety. EPA: Environmental, food and feed safety for pestprotected product registration and sales.

Public participation is solicited by these agencies at several steps in the process, from small-scale testing to commercialization.
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Public Input in Regulatory Process
Nine Chances for Go/No Go Decisions
• 1. 2. 3. 4. • 5. • 6. • 7. • 8. 9. Biosafety Committee - NIH Biosafety Guidelines* USDA greenhouse approval USDA field trial authorization USDA authorization transport for field trials USDA permission to commercialize* EPA experimental use permit approval* EPA determination of food tolerance or tolerance exemption* EPA product registration * FDA review process
 opportunity for public input 23

Determining Safety of Biotech Crops
• Food/Feed Safety • Environmental Risk Assessment –Molecular characterization – Potential for out-crossing –Protein safety assessment – Impact on non-target including history of safe use, organisms marker gene safety, allergenicity and safety to non-target – Resistance management organisms – Agronomic Performance –Nutritional equivalence – Ability to compete and survive in the environment –Toxicological assessment – Crop carry over issues including identification of key anti-nutrients and toxicants

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Risk assessment of biotech plants
• • • • • • Potential for toxicity Potential for allergenicity Safety of antibiotic resistance markers Retention of nutritional value Equivalence of composition Absence of unintended effects

25

Safety of Biotech Products is Reviewed at Multiple Levels
• Gene(s) – Source(s) – Molecular characterization – Insert / copy number / gene integrity • Protein(s) – History of safe use and consumption – Function / specificity / mode of action – Levels – Toxicology / allergenicity testing

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Compositional Equivalence is Examined for: » Fatty acids » Amino acids » Vitamins » Minerals » Anti-nutrients
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Compositional Equivalence: Proximate Analyses
90 80 70 60 50 40 30 20 10 0
P H

P H

P H

P H

P H

Protein

Fat

Ash

Carbohydrate Crude Fiber

6 U.S. Field sites in 1994 Control MO N 810 H Reported low P Reported high
Range of experim entally determined values

These results have been generated on Event MON810. Data showing similar proximate analyses have been generated on the other corn events.
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Safety of the Genes
 Detailed map of vector  Identity of all genetic components of vector  Portion and size of inserted sequences  The function of the genetic component in the plant  The source of the genetic component  Inheritance and stability of trait

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Safety of the Proteins

Indicate if there are changes in the amino acid sequence from the native protein. expressed as expected.

 Submit data indicating if the protein is  Compare novel protein sequence to known

toxins and allergens.
 Acute/Chronic testing, mouse.

In vitro digestibility assay.
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Comparison to toxins or allergens
• The protein is compared to proteins in

large global databases

• A “Macro” comparison looks at the whole

More than 100,000 different proteins are searched

protein • A “Micro” comparison looks at small stretches of the protein
– –

As few as 8 amino acids are compared For the Cry proteins more than 600 searches are performed across the entire protein length

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Allergenicity Evaluations
True Food Allergies affect 1-2% of the adult population worldwide
“Big Eight” Major Food Allergens •Peanut •Milk •Soy •Wheat •Shellfish •Fish •Eggs •Tree Nuts
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Allergenicity Screen
Homology Search Prevalence (1 – 10%) In food Disulfide bonds Heat stability Digestible None w/known oral allergens < 0.3% None Heat stable Not readily digested
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Toxicity Assessment:
• Once protein safety established, EPA tests

for all other secondary metabolic activities that result from protein expression • e.g.: changing oil composition of canola from changing a protein • These kinds of products would be labeled

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Mouse Oral Acute Toxicity
Protein (mg/kg)
Cry1Ac 4200 NPTII 5000 Cry3A 5200 Cry1Ab 4000 CP4 EPSPS 572 GUS

Crop
Cotton, Tomato Cotton, Potato, Tomato Potato Corn

Dose

Soybean, Cotton, Canola, Sugarbeet
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Soybean, Sugarbeet

Agronomic properties of biotech crops are thoroughly characterized:
• Evaluated in thousands of field trials in the

United States, Europe, Canada and South America. • Evaluated for a broad range of agronomic traits during the entire life cycle of the plant. • Identical to their conventional counterpart except for the introduced trait(s).
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Livestock and Feed Questions
• • • • Is biotech grain safe for livestock feed? Is the feed performance the same between biotech crops and conventional crops? Are the proteins/DNA present in milk, meat and eggs? What studies have been conducted?
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The composition of these biotech crop products is similar to their conventional counterparts
Grain
Protein Fat Fiber Starch Amino acid composition Fatty acid composition Ash Sugars Calcium Phosphorous

Forage
- Protein - Fat - Fiber
The composition of biotech crops is compared to the equivalent conventional variety and to the range of conventional varieties

38

DNA and Protein Digestion
 DNA and proteins are natural and abundant

components of our diet
 All DNA and proteins – including those from plants

improved through biotechnology
are made up of the same building blocks subject to the same digestion conditions  The normal digestion conditions rapidly break down

DNA and proteins into smaller pieces that serve as important nutrients
 Simulated gastric digestibility of introduced proteins is

a part of the product safety assessment
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Results to Date (35 Feeding Studies):

Animals perform in a comparable manner when fed biotech crops as compared to conventional counterparts.

40

Biotech product studies conducted
Trait H.T. H.T. H.T. H.T. H.T. H.T. H.T. H.T. B.t. B.t. B.t. B.t. B.t. B.t. B.t. Crop Corn Corn Corn SBM SBM SBM Canola Sugar beets Corn Corn Corn Corn Forage Forage/Corn Forage/Corn Animal Chicken- broilers Beef cattle Swine Chicken-broilers Dairy Cows Catfish Chickens - broilers Sheep Chicken - broilers Chicken - layers Catfish Swine Sheep Dairy cows Beef cattle Studies Completed In Progress 2 1 1 2 1 1 4 2 1 4 2 1 1 1 1 4 1 5
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B.t.: Insect protection

H.T.: Herbicide tolerance

Considerations for detecting transgenic DNA/proteins in animal products

 Not deemed a safety issue by regulatory agencies (US, Canada, Japan, EU, other countries worldwide)  Characterization of livestock products may have implications for trade and/or labeling  Testing methods such as ELISA and PCR are extremely complex and sensitive - critical to safeguard against contamination and false positives
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Livestock and Feed Conclusions
Animal performance - no differences when fed biotech crops Transgenic proteins – none detected in animal products -milk, meat, eggs In contrast, endogenous plant chloroplast DNA fragments may be detected in mammalian systems
Cattle, Poultry Seem to be primarily associated with immune system

Transgenic DNA -- none detected in animal products -milk, meat, eggs
43

Determining Safety of Biotech Crops
• Food/Feed Safety
– Molecular characterization – Protein safety assessment including history of safe use, marker gene safety, allergenicity and safety to non-target organisms – Nutritional equivalence – Toxicological assessment including identification of key anti-nutrients and toxicants

• Environmental Risk Assessment
– Potential for out-crossing – Impact on non-target organisms – Resistance management – Agronomic Performance – Ability to compete and survive in the environment – Crop carry over issues
44

Ecological Impact Assessment Process
• throughout the life cycle of a product
C = coordinated screening and testing of product concepts R = regulatory review of prescribed tests and field trial data O = other scientists’ experiments and field trials (universities, etc.) P = performance feedback from farmers S = stewardship and monitoring to ensure the product is used in a
responsible manner.

• Process description –

http://www.castscience.org/biotechnology/index.html

45

Ecological Analysis for Plants-Tier I
• Experimental Data (Laboratory and Field)
– – – – – – – – – compositional analysis germination / dormancy seed bank longevity volunteer assessment growth/reproduction data (fitness potential) assessment of competition allelopathic potential susceptibility to management (risk management) 46 field observations and surveys

Ecological Analysis for Plants - Tier II
• Experimental Data (Laboratory and Field)
– Outcrossing or gene flow
» prepare hybrids from compatible species and perform Tier I assessment » field evaluation of gene flow

– Allele persistence
» field trials to assess selective advantage

– Secondary Effects
» morphological character analysis » multiple crossing experiments

– Higher level field experiments

47

Ecological Impact Assessment
• Stewardship and monitoring to ensure the products are used in a responsible manner – Insect Resistance Management – performance oriented – Non-target Populations – Programs target high-risk areas where insects have developed resistance to chemical insecticides in the past – Monitoring to ensure use according to registration requirements
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Identification of a potential hazard:

Transgenic pollen harms monarch larvae.
Nature 399:214. Losey, J. E., L. S. Raynor and M. E. Carter. 1999

50

Financial Support:
• U.S. Environmental Protection Agency (EPA) • U.S. Department of Agriculture (USDA) • Canadian Food Inspection Agency (CFIA) • Environment Canada • Industry
51

Risk Assessment Process:
Bt Corn
Production and Distribution Pollen Characterization
Bt expression Pollen Shed
Timing, Duration, Intensity

Monarch
Occurrence & Distribution
Region Landscape Habitat

Environmental Dispersal

Behavior
Oviposition Feeding

Environmental Exposure
Risk Milkweed
Occurrence and Distribution
Region Landscape Habitat

Monarch
Effect
Lethal Sub lethal
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Research conclusions: Bt/ Monarch Butterfly
• Bt corn pollen shedding overlaps with emergence of monarch caterpillars in a few areas of the north west and Canada • Amount of pollen on milkweed leaves in the fields is below the level harmful to monarch caterpillars
– True for Mon 810 and Bt 11 – Event 176 being phased out

• Original Risk Assessment for Bt corn was protective and a model for the future
(Hellmich, Sears, Dively et al, submitted for publication 2001)
53

Response to Wolfenbarger and Phifer, 2000

• Benefits and risks do “vary spatially, temporally and according to trait and cultivar modified.” • Need options to to have solutions to changing conditions.
» SCIENCE December 2000
54

Response to Wolfenbarger and Phifer, 2000 • When a higher standard of care is not enough…
– Ignores large volume of data submitted to regulatory agencies, which does not appear in the academic peer-review literature – Ignores the peer review by agencies and their advisors – Regulatory vs. Absolute Certainty
» SCIENCE 27 April 2001
55

Precautionary Approach
 Look before you leap
Caution when unknowns exist

 Three approaches to the Precautionary Principle
• Shield • Sword • Incorporated into risk assessment approach • www.cast-science.org

56

Precautionary Approach
• Confusing use of terms
– Rio Declaration – Cartagena Protocol

• Five tenants of the Precautionary Approach
– Taking precautionary measures in the absence of scientific certainty of cause and effect – Goal setting – Considering alternative approaches – Shifting the burden of proof for financial responsibility & the duty to monitor – Implementing democratic decision-making
57

Incorporating Precautionary Approach into Risk Assessments
• Evolving concept • 2 applications
– Product evaluation – International environmental agreements

58

Biotech Testing: What’s needed
• Standardized and validated sampling and testing methods • Quantitative assays for setting tolerances • Accurate and reliable tests (low false positives and false negatives) • Simple, multi-trait testing format • Agreement on when to use DNA vs. protein detection methods • Reasonable cost per test

59

Risk Assessment: Biotech Foods
• Consensus that biotech foods are as safe as their conventional counterparts
World Health Organization U.N. Food & Agriculture Organization Org. for Economic Cooperation & Development National academies of science • Australia, Canada, India, Mexico, U.K., U.S. …. – 3,000+ scientists from throughout the world – – – –

60

Risk Assessment: Biotech Foods
• Consensus that biotech foods are as safe as their conventional counterparts
– National Governments
Argentina, Canada, China, So. Africa, United States

– European Commission – U.S. Scientific Institutions & Societies
• • • • • National Academy of Science American Medical Association American Nutrition Association Council for Agricultural Science & Technology Institute of Food Technologists

61

Risk Assessment: Biotech Foods
World Health Organization (WHO) and U.N. Food & Agriculture Organization (FAO)

“The newer biotechnology techniques open up very great possibilities of rapidly improving the quantity and quality of food available. The use of these techniques does not result in food which is inherently less safe than that produced by conventional ones.” Joint Report (1991)

62

Risk Assessment: Biotech Foods
British Food Standards Agency
“[There is] no evidence currently available [that] GM foods have any adverse effect on human health.” Sir John Krebs, Chairman

French Pasteur Institute
“We’ve never had the least incidence with GMOs – not a single incident in 25 years of research and use. So, if [policies are] followed, I conclude it’s safe.” Maurice Hofnung, Director

63

Risk Assessment: Biotech Foods
European Commission
“Right around the world, the scientific evidence is that there is no problem with GMOs over and above any other food.” David Byrne Commissioner for Health and Consumer Protection
64

Risk Assessment: Biotech Foods
U.S. National Academy of Science
“Crops modified by molecular and cellular methods should pose risks no different from those modified by classic genetic methods for similar traits.” Academy Report, 1992

65

Risk Assessment: Biotech Foods
Australian/New Zealand Food Authority
“To date, [the Australian/New Zealand Food Authority] has found no evidence that GM foods are less safe than their conventionally produced counterparts – a finding supported by food agencies around the world.” Public Statement, 2000
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Risk Assessment: Biotech Foods
FORMERLY “I’m quite confident that, when the public is properly informed about biotech, they will realize that the positive benefits are far away any potential negative benefits. In fact, we don’t really know of any negative aspects for GMOs but we do know of many positive ones, both socially and environmentally.” Dr. Patrick Moore Founder & Former President Greenpeace International New Scientist, December 25, 1999

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"Biotechnology's been around almost since the beginning of time. It's cavemen saving seeds of a high-yielding plant. It's Gregor Mendel, the father of genetics, crosspollinating his garden peas. It's a diabetic's insulin, and the enzymes in your yogurt.... Without exception, the biotech products on our shelves have proven safe."
U.S. Agriculture Secretary Dan Glickman March 13, 1997
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Risk Management: Biotechnology
• International Frameworks
– – – – International Plant Protection Convention (Seed) Codex Alimentarius (Food Safety) Biosafety Protocol (Environment Impacts) World Trade Organization (Trade)

• National Governments
– United States
• USDA/Animal Plant Health Inspection Service (APHIS) • EPA/Office of Pesticides • FDA/Center for Food Safety & Nutrition
69

Risk Management: Biotech Food Labeling
• FDA Labeling Policy
– Compositional Change – Nutritional Change – Health Issue (Allergenicity) – Mandatory – Applies to All Foods, including Biotech Foods – Truthful, Non-misleading
70

Risk Management: Biotech Food Labeling
• Recognizes that Consumers Get Information From a Variety of Sources • Preserves the Label for the Most Important Information: Safety & Nutrition Data • Recognizes Potential to Mislead Consumers by Suggesting that Biotech Foods are Somehow Different
71

Risk Management: Biotech Food Labeling
FDA Guidance* for Voluntary Biotech Claims Provide for Consumer Choice in Truthful, nonmisleading manner – “Genetically Modified” – “GMO” – “GM-Free” – US Gov’t Organic Label – Industry Allergy Guidelines (Draft, Jan 2001)

72

Risk Communication:
• No Food Safety Threat
– Biotech foods substantially equivalent to conventional foods – “as safe as”

• No Need to Label
– FDA labeling policy reserves label for safety and nutritional information

• FDA Draft Voluntary Labeling Guidelines
– Provides for consumer choice
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Avoid Fear based on Misinformation & Theatre

“ad” campaigns targeting brands

74

Risk Communication: Biotechnology
• Is There a Role for More Information? • Absent readily available information about the safety and regulation of biotechnology, consumers will doubt its safety, demand labeling and reject innovation in order to minimize perceived risk
75

Biotech Food Realities
• Consumers want to know more about the foods they eat, including (but not limited to) those derived from biotechnology • Consumers are willing to receive that information in whatever form, and there is evidence that many prefer “off-label”

76

Consumers Want Information …
80 70 60 50 40 30 20 10 0 Biotech Pesticides Imported Farming Methods Crossbreeding

PERCENT

Center for Science in the Public Interest, 2001 77

… but are unwilling to pay for information?
50 45 40 35 30 25 20 15 10 5 0 Pay Nothing Pay $10/Year Pay $50/Year Pay $250/Year

Center for Science in the Public Interest, 2001 78

If Not a Label, Then What?
81% of American consumers agree “it would be better for food manufacturers, the government, health professionals and others to provide more details through toll-free phone numbers, brochures and web sites”

International Food Information Council
79

Consumer choices
• Identity preservation and segregation will increase the cost of food • Most consumers will be unwilling to pay added cost for labeling without a tangible benefit • Voluntary labeling for consumers wishing to avoid biotech and willing to pay price premiums • Truthful and non-misleading labeling language • Alternatives to labeling for consumer education

80

Evaluating Risks and Benefits
• Risks and Benefits differ by crop, region, pest pressure • Assessing risks and benefits is an on-going process • Benefits, risks, and risk mitigation strategies need to be assessed on a case by case basis • We don’t have all the answers BUT we must have enough answers (certainty) to regulate appropriately

81

We can reap the greatest benefits:
• Through the integration or selection of various cropping systems - conventional, organic and biotech farming
– Examples:
• Enhanced crop productivity, quality and nutrition from genetic gains • Double crop production on the same area of land
– Save forests and biodiversity

• Reduce external inputs
– Pesticides, fertilizers, and water

• Increase the stability of yield through better control of environmental and social stressors
– the cause of past famines

• Through the integration of historical and new diagnostic tools
– Example: reduce time to identify crop disease
82

The future of agricultural and food biotechnology depends on …
• • • • • • Continued grower support Food industry and retailer unanimity Government consistency Illustration of compelling benefits Consumer education and acceptance International harmonization

83

Prospects for the Future Depend on:
Public perceptions/public acceptance Our understanding of the risks, benefits, safety, and utility of the various technologies available to us A recognition that food and agricultural biotechnology is not a silver bullet; it just provides another useful set of options A case by case determination whether biotech options are the best options or not
84

Prospects for the Future Depend on:
Us…scientists and journalists, clearly and responsibly communicating the risks, the benefits, and the potential for this powerful tool
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Need More Information?
• • • • • • • • • www.agbios.com www.agbioworld.org www.bio-scope.org www.cast-science.org http://cspinet.org/biotech www.ific.org www.isaaa.org www.lifesciencesnetwork.com www.whybiotech.com

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Thank you…
For listening, for sharing your passion for food with others, and for thinking now and then all the way down the line to those farmers and ranchers who produced it.
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