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Food and
Agriculture
1
An Overview of
Biotechnology Derived Food
FOR THE
Association of Food Journalists
October 7, 2004
2
CAST Mission Statement
4
Crop Evolution and Human Civilization
5
Improving Our Crop Plants
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
Plant biotechnology
Desired gene Commercial variety New variety
Using plant biotechnology, a (only desired gene is transferred)
single gene may be added to
the strand.
=
(transfers)
Desired gene
8
“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?
10
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…
13
Challenges to Evaluating Biotechnology
% 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
16
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
17
Public Acceptance of New Technologies
Risk Paradigm
1. Risk Assessment (Scientists)
2. Risk Management (Government)
3. Risk Communications (Everyone)
18
1999 Key Commodity Crop
Approvals in select markets
USA CANADA EU JAPAN
Corn 16 11 4 13
Soy 11 4 1 2
Canola 6 18 3 12
Potato 17 17 0 2
Cotton 5 3 0 1
Beet 2 0 0 1
19
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
20
Risk Assessment
21
Comprehensive safety assessments
Integrated (coordinated) framework involves three
federal agencies in reviewing biotech product safety.
24
Risk assessment of biotech plants
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
26
Compositional Equivalence is
Examined for:
» Fatty acids
» Amino acids
» Vitamins
» Minerals
» Anti-nutrients
27
Compositional Equivalence: Proximate Analyses
90
P
H
80
70
60
50
40
30
20 P
10 H P P
H P
H H
0
Protein Fat Ash Carbohydrate Crude Fiber
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
29
Safety of the Proteins
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.
30
Comparison 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
31
Allergenicity Evaluations
•Peanut •Shellfish
•Milk •Fish
•Soy •Eggs
•Wheat •Tree Nuts
32
Allergenicity Screen
Homology Search None w/known oral
allergens
34
Mouse Oral Acute
Toxicity
Protein Crop Dose
(mg/kg)
Cry1Ac Cotton, Tomato
4200
NPTII Cotton, Potato, Tomato
5000
Cry3A Potato
5200
Cry1Ab Corn
4000
CP4 EPSPS Soybean, Cotton, Canola, Sugarbeet
572
35
GUS 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).
36
Livestock and Feed Questions
37
The composition of these biotech crop products
is similar to their conventional counterparts
Grain Forage
- Protein - Protein
- Fat - Fat
- Fiber - Fiber
- Starch
- Amino acid composition The composition of biotech crops
- Fatty acid composition is compared to the equivalent
conventional variety
- Ash and to the range of conventional
- Sugars varieties
- Calcium
- Phosphorous
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
40
Biotech product studies conducted
Studies
Trait Crop Animal Completed In Progress
H.T. Corn Chicken- broilers 2 -
H.T. Corn Beef cattle 1 -
H.T. Corn Swine - 1
H.T. SBM Chicken-broilers 2 -
H.T. SBM Dairy Cows 1 -
H.T. SBM Catfish 1 -
H.T. Canola Chickens - broilers 4 -
H.T. Sugar beets Sheep 2 1
B.t. Corn Chicken - broilers 4 -
B.t. Corn Chicken - layers 2 -
B.t. Corn Catfish 1 -
B.t. Corn Swine - 1
B.t. Forage Sheep 1 -
B.t. Forage/Corn Dairy cows 1 4
B.t. Forage/Corn Beef cattle 1 5
41
B.t.: Insect protection H.T.: Herbicide tolerance
Considerations for detecting transgenic
DNA/proteins in animal products
42
Livestock and Feed Conclusions
44
Ecological Impact Assessment Process
• Process description –
http://www.cast-
science.org/biotechnology/index.html 45
Ecological Analysis for Plants-Tier I
Transgenic
pollen harms
monarch
larvae.
Nature 399:214. Losey, J.
E., L. S. Raynor and M. E.
Carter. 1999
50
Financial Support:
• Environment Canada
• Industry
51
Risk Assessment Process:
Bt Corn Monarch
Production and Distribution Occurrence & Distribution
Pollen Characterization Region
Bt expression Landscape
Pollen Shed Habitat
Timing, Duration, Intensity Behavior
Environmental Dispersal Oviposition
Feeding
Environmental Exposure
Risk
Milkweed
Monarch
Occurrence and Distribution
Region Effect
Landscape Lethal
Habitat Sub lethal
52
Research conclusions: Bt/ Monarch Butterfly
53
Response to Wolfenbarger and Phifer, 2000
54
Response to Wolfenbarger and Phifer, 2000
• 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
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)
62
Risk Assessment: Biotech Foods
“[There is] no evidence currently available [that] GM foods have any adverse
effect on human health.”
Sir John Krebs, Chairman
“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
65
Risk Assessment: Biotech Foods
66
Risk Assessment: Biotech Foods
FORMERLY
67
"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."
• 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
– Mandatory
– Applies to All Foods, including Biotech Foods
– Truthful, Non-misleading
70
Risk Management: Biotech Food Labeling
71
Risk Management: Biotech Food Labeling
72
Risk Communication:
73
Avoid Fear based on Misinformation & Theatre
“ad” campaigns
targeting brands
74
Risk Communication: Biotechnology
75
Biotech Food Realities
76
Consumers Want Information …
80
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PERCENT
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20
10
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Biotech Pesticides Imported Farming Cross-
Methods breeding
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Pay Nothing Pay $10/Year Pay $50/Year Pay $250/Year
79
Consumer choices
80
Evaluating Risks and Benefits
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 …
83
Prospects for the Future Depend on:
84
Prospects for the Future Depend on:
86
Thank you…
87