Safety Assessment of Foods Derived from Genetically Modified Plants

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The Impact of Food Biotechnology from Farm to
Plate Terry D. Etherton Department of Dairy and
Animal Science
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• Biotechnology Industry Facts
• There are 1,466 biotech companies in the U.S.
• Market capitalization in 2004 was 311 billion
• Employed 194,000 people
• U.S. revenues of 30 billion in 2002
• Biotech industry regulated by FDA, EPA and USDA
• Estimated that 70 of processed foods on grocery
  store shelves contain ingredients and oils from
  biotech crops

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• Biotechnology Not New
• Dates back 1000s of years -bread, wine, animal
  plant breeding
• First recorded plant hybrid - 1719
• Pasteurization - 1861
• Modern era of biotechnology -1973

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Teosinte
Modern Corn
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Why Need Biotechnology?
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World Population (billion)
12 10
8 6 4
2
1900 1925 1950 1975 2000 2025 2050 2075
2100 YEAR
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Distribution Of World Population Growth to 2010
Former Soviet Union 0
Europe 0
North America 5
Asia 51
Africa 35
South America 8
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Is Biotechnology being Adopted?
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Some Approved Agricultural Biotech Products
CottonBollgard Insect-Protected Cotton
Roundup Ready Cotton   Milk ProductionChymogen
Posilac Recombinant Bovine Somatotropin
ChyMax   PeanutsHigh Oleic Peanuts
  PotatoesNewLeaf Insect-Protected Potato
NewLeaf Plus New-Leaf Y Insect- and
Virus-Protected Potatoes   RapeseedLaurical  
SoybeansHigh Oleic Acid Soybeans Low Linolenic
Soybean Oil Low Saturate Soybean Oils Novartis
Seeds Roundup Ready Soybeans Roundup Ready
Soybeans
CanolaLibertyLink Canola InVigor Hybrid
Canola Roundup Ready Canola  
CornAttribute Bt Sweet Corn CLEARFIELD Corn
DeKalBtTM Insect-Protected Hybrid DeKalb Brand
Roundup Ready DeKalb GR Hybrid Corn Gray Leaf
Spot -Resistant Corn Hybrids G-StacTM Corn
Hybrids High pH Tolerant Corn Hybrids IMI-Corn
LibertyLink Corn NatureGard Hybrid Seed Corn
NK Knockout Corn, NK YieldGard Hybrid Corn
Roundup Ready Corn StarLink Corn YieldGardTM
Insect-Protected Corn  
SunflowersHigh Oleic Sunflower High Oleic
Sunflower Oil   Tomatoes FreshWorld Farms
Tomato FreshWorld Farms Endless Summer
FreshWorld Farms Cherry Tomatoes Increased
Pectin Tomatoes
PapayaRainbow and SunUp  
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Global Planting of Transgenic Crops
Hectares (million)
Acres (million)

• 1.7 4.3
• 11.0 27.5
• 27.8 69.5
• 39.9 98.6
• 44.2 117.8
• 2002 58.7 148.5

ISAAA, 2003
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Four Countries Accounted For 99 Percent Of The
Global Biotech Crop Area In 2001
Australia, Bulgaria, Germany, Indonesia, Mexico,
Romania, South Africa, Spain and Uruguay
accounted for the remaining 1 percent of biotech
crop acres.
Source International Service for the Acquisition
of Agri-biotech Applications
Products on the market
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Benefits of Ag Biotechnology
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Benefits of Ag Biotechnology

• Helps farmers use fewer chemicals on their crops
• Enables farmers to produce more food
• Improves productive efficiency (milk/feed
  apples/tree)
• Helps produce more nutritious food (for animals
  and humans)

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Benefits of Ag Biotechnology(Continued)

• Healthier farm animals
• Food safety
• Pharming/ Transgenic Animals/Genomics
• Economic benefits

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Benefits of Food Biotechnology

• Improved fatty acid profile of vegetable oils
• Peanuts with improved amino acid profile
• Tomatoes with higher antioxidant content
• Higher protein rice rice with increased Vitamin
  A
• Strawberries with improved freshness
• Enhanced protein quality in corn soybeans

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What Do People Know About Food Biotechnology?
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Central Dogma of Life
Met Ala Leu Trp Met Arg Leu
A U G G C U U A A U G G A U G G C U U U A

DNA
GENES
PROTEIN (amino acids)
FUNCTION
mRNA
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What Do People Know?

• Many have a poor grasp of basic biological,
  concepts
• Many have a poor understanding of the food
  system
• Only about half (49) have heard of traditional
  crossbreeding methods
• Only 28 said they had eaten a crossbred fruit or
  vegetable
• Only 41 indicated that there are any foods
  produced through genetic modification in
  supermarkets now.

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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
NSF Survey
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Opinions About Biotechnology

• Being uninformed doesnt stand in the way of
  having an opinion
• The number of respondents who report approving or
  disapproving of biotechnology typically exceeds
  the number who report knowing much about it

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The More People Know, The More They Support
Biotechnology
Percentage who support biotechnology to...
Develop new varieties of crops
Genetically modify foods
Jul. 02
CBI
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The Future of Ag Biotechnology
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The Future of Animal Biotech Regulation

• Timeline for approval/review process
• Politics of regulatory law
• Transgenic Animals
• Cloned Animals
• Unintended effects and Human Health

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Identifying and Assessing Unintended Effects of
Genetically Modified Foods on Human Health
Food and Nutrition Board (FNB), Board on
Agriculture and Natural Resources (BANR), Board
on Life Sciences (BLS), and the Committee on
Agricultural Biotechnology, Health and the
Environment (CABHE)
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Sites of Unintended Effects
Met Ala Leu Trp His Arg Leu
Metabolism of CHO
Metabolism of Vitamins
G C U U A A U G G A U G G C U U U A

Nucleotide Metabolism
Metabolism Lipids
Energy Metabolism
Metabolism of Complex CHO
Amino Acid Protein Metabolism
DNA
GENES
PROTEIN
METABOLITES
mRNA
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Compositional Changes of Food
Identification of Compositional Changes
Non-Targeted Approaches (Profiling) DNA
Microarray Proteomics Metabolomics
Targeted Approaches Macronutrients Micronutrients
Metabolites
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Arrays
Sample A mRNA
Sample B mRNA
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Proteomics 2DGE
Sample B Protein
Sample A Protein
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Challenges of Profiling Techniques

• Validated
• Comparator databases what are they?
• Criteria for determining unintended effects
• Standardizing methods, inter-lab testing
• Determining whether unintended change is
  associated with health effect

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Summary

• Approved biotech products have passed and often
  exceeded the appropriate regulatory requirements.
  
• Animal studies have confirmed safety and
  nutritional equivalence of approved biotech
  products.
• Guidelines have been proposed for consistent
  evaluation of nutritional equivalence.
• What is the regulatory future?

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The Challenges

• Regulatory timeline for approval (10 to 20
  years)
• Hidden cost of NOT developing/adopting safe,
  innovative and effective biotechnologies
• How to improve World food production?
• Consumer education
• Active engagement in public discussion by
  scientific community

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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, 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."
Former U.S. Agriculture Secretary Dan
Glickman March 13, 1997
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