NDSU Policy on Biotech Research
&
GM Wheat Update
Duane Hauck
Assistant Director – Ag & Natural Resources
NDSU
NDSU Extension Service
Agriculture
NDSU Policy on Biotech Research
Purpose of NDAES:
“to develop and disseminate technology
important to the production and utilization
of food, feed, and fuel from crop and
livestock enterprises”
NDSU
Agriculture
NDSU Policy on Biotech Research
• Indicates controlling authorities
• Guide NDSU scientists
• Communicate to the public
NDSU
Agriculture
Key points of NDSU Policy on
Biotech Research
NDAES will…
Continue to pursue new
technologies for enhancing
farming, food quality and
the environment.
NDSU
Agriculture
NDAES will…
Promote the co-existence
of various production and
marketing systems.
NDSU
Agriculture
NDAES will…
Continue to develop
genetically improved
and environmentally
adapted crops.
NDSU
Agriculture
NDAES will…
Manage development and
propagation of new
varieties to insure the
availability of pure seed to
the fullest extent possible.
NDSU
Agriculture
NDAES will…
Follow research protocols
that exceed APHIS
standards when testing
regulated biotech crops.
NDSU
Agriculture
Decision Making Process
• The NDSU Institutional Biosafety Committee will give
additional oversight to the approval process for testing
regulated biotech material.
• All regulated biotech research pre-approved by the NDAES
Director.
• All non-regulated biotech research communicated to the
Director prior to planting.
NDSU
• Policy regarding biotech research at all NDAE locations set by
the NDAES Director.
Agriculture
NDAES will…
Continue to utilize public
variety release meeting
for reviewing plant
material considered for
commercial release.
NDSU
Agriculture
NDSU policies on biotech research do not
supercede established rules. However, they
may be more restrictive or precautionary.
NDSU
Agriculture
GM Wheat Trait Research
Preliminary analysis/interpretation
Data from Monsanto, North Dakota and South
Dakota are still being developed
Extensive research on GM Wheat and much
beyond RRW and Monsanto
Sources
NDSU
 www.health.gov.au/ogtr/gmorecord/ir.htm
 www1.oecd.org/ehs/biobin/
 www.inspection.gc.ca/english/plaveg/pbo/pbobbve.shtm
 www.nbiap.vt.edu/cfdocs/fieldtests1.cfm
Agriculture
Number of World GM Wheat Field
Trials by Year
35
30
25
20
WorldWheatTrils/Year
15
10
5
NDSU
0
19
1
9
9
1
3
9
9
1
4
9
9
1
5
9
9
1
6
9
9
1
7
9
9
2
8
9
0
2
9
0
0
2
0
0
0
1
02
Agriculture
Number of World GM Wheat Field
Trials by Country, 1993-2002
90
80
70
60
50
TotalWheatTrils
40
30
20
10
NDSU
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Agriculture
NDSU
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VirusReistance
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FungalResitance
HerbicdeTolrant
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TotalWheatTrils
Number of World GM Wheat Field
Trials by Trait, 1993-2002
70
60
50
40
30
20
10
0
Agriculture
NDSU
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TotalWheatTrils
Number of World GM Wheat Field
Trials by Organization, 1993-2002
25
20
15
10
5
0
Agriculture
NDSU
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TotalWhetTrials
Number of World GM Wheat Field
Trials by Type of Organization, (Public
vs Private) 1993-2002
25
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20
15
10
5
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Agriculture
Major Points
US is dominant, albeit not the only player
HT is only one trait under development,
followed by
Product quality
Fusarium Resistance...etc
Diverse organizations in GM wheat with
no one likely dominating
NDSU
Agriculture
U.S. HRS Exports and GM
Aversion
NDSU
Agriculture
Percent of U.S. HRS Use (Domestic
Consumption and Exports), 1999-00
NDSU
Agriculture
Biotech Products Require
Different Oversight
Regulation should be commensurate with risk,
but new technologies often necessitate
more rigorous regulation
NDSU
Bob Peterson
Agricultural & Biological Risk Assessment
Montana State University
Agriculture
Three-Agency Approach
USDA = Is it Safe to Grow?
EPA = Is it Safe to the Environment?
FDA = Is it Safe to Eat?
NDSU
Bob Peterson
Agricultural & Biological Risk Assessment
Montana State University
Agriculture
Determining Risk
Gene/Protein Risk
Food, Feed, and
Environmental
Risk
• Product Characterization
–
–
–
–
–
Gene source(s)
Molecular characterization
Insert / copy number / gene
integrity
Function / specificity / mode of
action
Levels in plant
• Toxicology / Allergenicity
–
–
–
Bob Peterson
Agricultural & Biological Risk Assessment
Montana State University
• Environmental Safety
–
–
–
–
Ecotox, Avian, Aquatic
Soil invertebrates, Soil
degradation
Non-Target Risk Assessment
Insect Resistance Management
• Crop Characteristics
–
–
Morphology
Yield
• Food / Feed Composition
•
Proximate analysis
• Key nutrients
• Key anti-nutrients
NDSU
–
Digestibility
Homology to allergens
Acute Oral - mice / rat
History of safe use and
consumption
Crop Risk
Agriculture
Biotechnology Crop
Regulatory Requirements
Conventional Crop
NO Regulatory Requirements
Product Characterization
Gene source(s)
Crop Safety
Molecular characterization
Insert, copy number, gene integrity Crop development
Crop yield
Function, specificity, mode of action
Protein levels in plant
Toxicity/Allergenicity
Digestibility of protein
Food Composition
Heat stability of protein
Similarity to known allergens
Acute toxicity – mouse, rat
History of safe use and consumption
Nutrients
Anti-nutrients
EPA, FDA, or USDA can remove the crop or food
from the market if there is a question of safety for
consumers or the environment
Environmental Safety
Ecotoxicity, Birds, Mammals, Fish
Soil & aquatic invertebrates,
Soil degradation, Beneficial insects
Insect Resistance Management
Bob Peterson
Agricultural & Biological Risk Assessment
Montana State University
NDSU
EPA, FDA, or USDA can remove the crop or food
from the market if there is a question of safety for
consumers or the environment
Agriculture
Bringing in New Technologies to Wheat
• NDSU, SDSU, U of M and Technology
Providers meet on a regular basis to discuss
progress of biotech wheat research
• Roundup Ready wheat will be introduced
when the following commercialization
milestones have been achieved:
NDSU
Agriculture
Commercialization Milestone……..
The food, feed and
environmental safety of
Roundup Ready wheat is
demonstrated, resulting in
regulatory approvals in the
United States, Canada and
Japan
NDSU
*The intent is to commercialize in the U.S.
and Canada simultaneously.
Agriculture
Commercialization Milestone……..
Appropriate regulatory
trade approvals,
thresholds or marketing
agreements are in place
in major export markets.
NDSU
Agriculture
Commercialization Milestone……..
Appropriate grain
handling protocols and
standardized sampling
and detection methods
are developed and
implemented
NDSU
Agriculture
Commercialization Milestone……..
Comprehensive
agronomic stewardship
programs and best
management practices
are developed
NDSU
Agriculture
Commercialization Milestone……..
Varieties meet or exceed
industry standards for
grain end-use quality
NDSU
Agriculture
Commercialization Milestone……..
Buyers are identified
who will procure and
use wheat ingredients
with biotech traits
NDSU
Agriculture
Purpose of NDAES:
“to develop and disseminate technology
important to the production and utilization
of food, feed, and fuel from crop and
livestock enterprises”
NDSU
Agriculture
Questions & Discussion
NDSU
Agriculture