An Overview of Biotechnology Derived Food (Teresa Gruber, Ph.D., J.D.)

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Transcript of An Overview of Biotechnology Derived Food (Teresa Gruber, Ph.D., J.D.)


Food and Agriculture1

An Overview of Biotechnology Derived FoodFOR THE

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


CAST Mission StatementCAST 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.


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


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

Mutation Irradiation Chemicals

Cell Culture Embryo Rescue Somaclonal variation6

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


Traditional Breeding vs. Biotech Traditional plant breedingTraditional donorDNA 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)


=Desired gene

Plant biotechnologyUsing 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


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


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


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


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


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


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 8115

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 trustworthy16

A Glance Back Biotechnology Benchmarks1974: 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


Public Acceptance of New TechnologiesRisk 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


1999 Key Commodity Crop Approvals in select marketsUSA 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 1 119

Biotech 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


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 as21

Comprehensive safety assessmentsIntegrated (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.22

Public Input in Regulatory ProcessNine 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


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


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


Compositional Equivalence is Examined for: Fatty acids Amino acids Vitamins Minerals Anti-nutrients27

Compositional Equivalence: Proximate Analyses90 80 70 60 50 40 30 20 10 0P H








Carbohydrate Crude Fiber

6 U.S. Field sites in 1994 Control MO N 810 H Reported low P Reported highRange 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.28

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


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.30

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


Allergenicity EvaluationsTrue Food Allergies affect 1-2% of the adult population worldwideBig Eight Major Food Allergens Peanut Milk Soy Wheat Shellfish Fish Eggs Tree Nuts32

Allergenicity ScreenHomology Search Prevalence (1 10%) In food Disulfide bonds Heat stability Digestible None w/known oral a