1

Biotechnology Biotechnology

InIn

Food and Food and AgricultureAgriculture

2

An Overview ofAn Overview ofBiotechnology Derived FoodBiotechnology Derived Food

FOR THEFOR THEAssociation of Food JournalistsAssociation of Food Journalists

October 7, 2004October 7, 2004

Teresa A. Gruber, Ph.D., J.D.Council for Agricultural Science and Technology

www.cast-science.org

3

CAST Mission StatementCAST 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.

4

What Is Biotechnology?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.

5

Crop Evolution and Human CivilizationCrop 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.

6

Improving Our Crop PlantsImproving Our Crop Plants

• Developing Modern Varieties of Crops– Hybridization

• Crosses with Wild Relatives• Hybrids

– Mutation • Irradiation• Chemicals

– Cell Culture• Embryo Rescue• Somaclonal variation

7

Modern Genetic ModificationModern Genetic Modification

Inserting one or few genes to achieve desired traits.

Transfer of Genes into Crop PlantsTransfer of Genes into Crop Plants– Relatively Precise and PredictableRelatively Precise and Predictable– Changes are SubtleChanges are Subtle– Allows FlexibilityAllows Flexibility– ExpeditiousExpeditious

8

Desired gene

Traditional plant breedingTraditional plant breedingDNA is a strand of genes, much like a strand of pearls. Traditional plant breeding combines many genes at once.

Traditional donor Commercial variety New variety

Desired Gene

X =(crosses)

(many genes are transferred)

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

Desired gene Commercial variety New variety

(transfers)

=

Desired gene

(only desired gene is transferred)

Traditional Breeding vs. BiotechTraditional Breeding vs. Biotech

9

“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

10

Why Biotech Foods?Why Biotech Foods?

• Better Quality Foods• Better Testing Foods• Healthier Foods with Improved

Nutritional Characteristics• Greater Processing Yields

11

Benefits of Biotech on Human HealthBenefits 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

12

More Benefits of BiotechnologyMore 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

13

But But Consumers Want to Know…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

14

Challenges to Evaluating BiotechnologyChallenges 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.

15

Public Understanding of Science

% Correct

What is DNA? 29

What is the Internet? 13

What is a molecule? 13

Does smoking cause cancer? 93

Is the center of the earth very hot? 81

National Science Foundation, 2000

16

Public Policy Paradigms Perpetuate PolarizationPublic 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

17

A Glance Back – Biotechnology A Glance Back – Biotechnology BenchmarksBenchmarks

• 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

18

Public Acceptance of New TechnologiesPublic Acceptance of New Technologies

Risk Paradigm1. 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

20

Biotech Crops in the U.S. Food SupplyBiotech Crops in the U.S. Food Supply

25% of 2000 U.S. corn acreage planted 54% of 2000 U.S. soybean acreage planted 61% of 2000 U.S. cotton acreage planted 70% of 2000 Canadian canola acreage planted Multiple international markets planting biotech

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

Source: USDA/FAS

21

• 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:

Risk Assessment

. . . “as safe as” . . .

22

Comprehensive safety assessmentsComprehensive 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 pest- protected product registration and sales.

Public participation is solicited by these agencies at several steps in the process, from small-scale testing to commercialization.

23

Public Input in Regulatory ProcessPublic Input in Regulatory ProcessNine Chances for Go/No Go Decisions • 1. Biosafety Committee - NIH Biosafety Guidelines*

2. USDA greenhouse approval 3. USDA field trial authorization 4. USDA authorization transport for field trials

• 5. USDA permission to commercialize* • 6. EPA experimental use permit approval* • 7. EPA determination of food tolerance or tolerance

exemption* • 8. EPA product registration *

9. FDA review process opportunity for public input

24

Determining Safety of Biotech CropsDetermining 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

25

Risk assessment of biotech plantsRisk 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

26

Safety of Biotech Products is Reviewed Safety of Biotech Products is Reviewed at Multiple Levelsat 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

27

Compositional Equivalence is Compositional Equivalence is Examined for:Examined for:

» Fatty acids » Amino acids» Vitamins» Minerals» Anti-nutrients

28

Compositional Equivalence: Proximate Analyses

These results have been generated on Event MON810. Data showing similar proximate analyses have been generated on the other corn events.

H H H

H

H

PP P

P

P

Protein Fat Ash Carbohydrate Crude Fiber0

102030405060708090

Control MON 810 H Reported low P Reported highRange of experimentally determined values

6 U.S. Field sites in 1994

29

Safety of the GenesSafety 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

30

Indicate if there are changes in the amino acid sequence from the native protein. Submit data indicating if the protein is expressed as expected. Compare novel protein sequence to known toxins and allergens. Acute/Chronic testing, mouse. In vitro digestibility assay.

Safety of the Proteins

31

Comparison to toxins or allergensComparison to toxins or allergens• The protein is compared to proteins in

large global databases– More than 100,000 different proteins are

searched• A “Macro” comparison looks at the whole

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

32

Allergenicity Evaluations

True Food Allergies affect 1-2% of the adult population worldwide

“Big Eight” Major Food Allergens

ShellfishFishEggsTree Nuts

PeanutMilkSoyWheat

34

Toxicity Assessment: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

36

Agronomic properties of biotech crops Agronomic properties of biotech crops are thoroughly characterized: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).

37

Livestock and Feed QuestionsLivestock 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?

42

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

43

Livestock and Feed Conclusions

Animal performance - no differences when fed biotech Animal performance - no differences when fed biotech cropscropsTransgenic proteins – none detected in animal products -- Transgenic proteins – none detected in animal products -- milk, meat, eggsmilk, meat, eggsIn contrast, endogenous plant chloroplast DNA fragments In contrast, endogenous plant chloroplast DNA fragments may be detected in mammalian systemsmay be detected in mammalian systems

Cattle, PoultryCattle, PoultrySeem to be primarily associated with immune systemSeem to be primarily associated with immune system

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

44

Determining Safety of Biotech CropsDetermining 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

45

• throughout the life cycle of a productC = 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.cast-science.org/biotechnology/index.html

Ecological Impact Assessment Process

46

• 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)– field observations and surveys

Ecological Analysis for Plants-Tier I

47

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

48

Ecological Impact AssessmentEcological 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

49

50

Identification of a potential hazardIdentification of a potential hazard::

Transgenic pollen harms monarch larvae.

Nature 399:214. Losey, J. E., L. S. Raynor and M. E. Carter. 1999

51

Financial Support:Financial Support:

• U.S. Environmental Protection Agency (EPA)

• U.S. Department of Agriculture (USDA)

• Canadian Food Inspection Agency (CFIA)

• Environment Canada

• Industry

53

Research conclusions: Bt/ Monarch ButterflyResearch 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)

56

Precautionary ApproachPrecautionary Approach

Look before you leapCaution when unknowns exist

Three approaches to the Precautionary Principle• Shield• Sword• Incorporated into risk assessment approach

• www.cast-science.org

57

Precautionary ApproachPrecautionary 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

58

Incorporating Precautionary Incorporating Precautionary Approach into Risk AssessmentsApproach into Risk Assessments

• Evolving concept• 2 applications

– Product evaluation– International environmental agreements

59

Biotech Testing: What’s neededBiotech 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

60

Risk Assessment: Biotech FoodsRisk 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

61

Risk Assessment: Biotech FoodsRisk 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

62

Risk Assessment: Biotech Foods 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) 

 

63

Risk Assessment: Biotech Foods 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

64

Risk Assessment: Biotech Foods 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 ByrneCommissioner for Health and Consumer Protection

65

Risk Assessment: Biotech Foods 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

 

66

Risk Assessment: Biotech Foods 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

67

Risk Assessment: Biotech Foods Risk Assessment: Biotech Foods

FORMERLY

“I’m quite confident that, when the public is properlyinformed about biotech, they will realize that thepositive benefits are far away any potential negativebenefits. In fact, we don’t really know of any negativeaspects for GMOs but we do know of many positiveones, both socially and environmentally.” Dr. Patrick MooreFounder & Former PresidentGreenpeace International New Scientist, December 25, 1999

 

68

"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, cross-

pollinating 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 GlickmanU.S. Agriculture Secretary Dan Glickman

March 13, 1997 March 13, 1997

69

Risk Risk ManagementManagement: Biotechnology: 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

70

Risk Management: Biotech Food LabelingRisk 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

71

Risk Management: Biotech Food LabelingRisk 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

72

Risk Management: Biotech Food LabelingRisk 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)

73

Risk Communication: 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

74

Avoid Fear based on Misinformation & Theatre Avoid Fear based on Misinformation & Theatre

“ad” campaigns targeting brands

75

Risk Communication: BiotechnologyRisk 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

76

Biotech Food RealitiesBiotech 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”

77

Consumers Want Information …Consumers Want Information …

01020304050607080

Biotech Pesticides Imported FarmingMethods

Cross-breeding

Center for Science in the Public Interest, 2001

PER

CE

NT

78

… … but are unwilling to pay for information?but are unwilling to pay for information?

Center for Science in the Public Interest, 2001

05

101520253035404550

Pay Nothing Pay $10/Year Pay $50/Year Pay $250/Year

79

If Not a Label, Then What?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

80

Consumer choicesConsumer 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

81

Evaluating Risks and BenefitsEvaluating 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

82

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

83

The future of agricultural and food The future of agricultural and food biotechnology depends on …biotechnology depends on …

• Continued grower support• Food industry and retailer unanimity• Government consistency• Illustration of compelling benefits• Consumer education and acceptance• International harmonization

84

Prospects for the Future Depend on:Prospects for the Future Depend on:

Public perceptions/public acceptanceOur understanding of the risks, benefits, safety, and

utility of the various technologies available to usA 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

85

Prospects for the Future Depend on: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

86

Need More Information?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

87

Thank you…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.