ndsu agriculture ndsu policy on biotech research & gm wheat update duane hauck assistant...
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Agriculture
NDSU Policy on Biotech Research&
GM Wheat Update
Duane Hauck
Assistant Director – Ag & Natural Resources
NDSU Extension Service
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NDSU Policy on Biotech Research
“to develop and disseminate technology important to the production and
utilization of food, feed, and fuel from crop and livestock enterprises”
Purpose of NDAES:
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NDSU Policy on Biotech Research
• Indicates controlling authorities
• Guide NDSU scientists
• Communicate to the public
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Key points of NDSU Policy on Biotech Research
Continue to pursue new technologies for enhancing farming, food quality and the environment.
NDAES will…
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Promote the co-existence of various production and marketing systems.
NDAES will…
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Continue to develop genetically improved and environmentally adapted crops.
NDAES will…
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Manage development and propagation of new varieties to insure the availability of pure seed to the fullest extent possible.
NDAES will…
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Follow research protocols that exceed APHIS standards when testing regulated biotech crops.
NDAES will…
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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.
• Policy regarding biotech research at all NDAE locations set by the NDAES Director.
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Continue to utilize public variety release meeting for reviewing plant material considered for commercial release.
NDAES will…
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NDSU policies on biotech research do not
supercede established rules. However, they
may be more restrictive or precautionary.
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GM Wheat Trait ResearchGM Wheat Trait Research
Preliminary analysis/interpretationData from Monsanto, North Dakota and South Dakota are still being developed
Extensive research on GM Wheat and much beyond RRW and Monsanto
Sources 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
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Number of World GM Wheat Field Number of World GM Wheat Field Trials by YearTrials by Year
1993 1994 1995 1996 1997 1998 1999 2000 2001 20020
5
10
15
20
25
30
35
Wo
rld W
he
at T
rials
/Ye
ar
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Number of World GM Wheat Field Number of World GM Wheat Field Trials by Country, 1993-2002Trials by Country, 1993-2002
ArgentinaAustralia
BelgiumCanada
EgyptItaly
SpainSwitzerland
UKUS
0
10
20
30
40
50
60
70
80
90
Tota
l Wh
ea
t Tria
ls
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Number of World GM Wheat Field Number of World GM Wheat Field Trials by Trait, 1993-2002Trials by Trait, 1993-2002
Ag
ron
om
ic P
rop
ert
ies
Fu
ng
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rbic
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alit
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Vir
us
Re
sis
tan
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0
10
20
30
40
50
60
70
Tota
l Whe
at T
rials
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Number of World GM Wheat Field Number of World GM Wheat Field Trials by Organization, 1993-2002Trials by Organization, 1993-2002
AG
ER
IA
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vo
Ap
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an
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0
5
10
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Tota
l Whe
at T
rials
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Number of World GM Wheat Field Number of World GM Wheat Field Trials by Type of Organization, (Public Trials by Type of Organization, (Public vs Private) 1993-2002vs Private) 1993-2002
AG
ER
I
Ag
rEvo
Ap
plie
d P
hyt
olo
gic
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S (
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DA
)
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Can
ada
Bio
gem
ma
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Lim
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gill
CE
FO
BI
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mp
ania
Nav
ara
Pro
du
cto
ra
Co
nse
jo S
up
erio
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vest
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nes
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tre
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sas
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te U
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nta
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te U
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Far
m C
rop
s L
td.
Nic
kers
on
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cem
No
vart
is S
eed
s
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nt
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tech
no
log
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stit
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Pla
nt
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tem
s
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enta
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f Id
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iver
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scie
nce
0
5
10
15
20
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Tota
l Whe
at T
rials
Public Private
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Major PointsMajor Points
US is dominant, albeit not the only playerHT is only one trait under development, followed byProduct qualityFusarium Resistance...etc
Diverse organizations in GM wheat with no one likely dominating
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U.S. HRS Exports and GM U.S. HRS Exports and GM Aversion Aversion
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Percent of U.S. HRS Use (Domestic Percent of U.S. HRS Use (Domestic Consumption and Exports), 1999-00Consumption and Exports), 1999-00
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Biotech Products Require Biotech Products Require Different OversightDifferent Oversight
Regulation should be commensurate with risk, Regulation should be commensurate with risk, but new technologies often necessitate but new technologies often necessitate
more rigorous regulation more rigorous regulation
Bob PetersonAgricultural & Biological Risk AssessmentMontana State University
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Three-Agency ApproachThree-Agency Approach
USDA = Is it Safe to Grow?
EPA = Is it Safe to the Environment?
FDA = Is it Safe to Eat?
Bob PetersonAgricultural & Biological Risk AssessmentMontana State University
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Determining RiskDetermining Risk
Food, Feed, and Food, Feed, and Environmental Environmental
Risk RiskGene/Protein Risk Crop Risk
• Product Characterization– Gene source(s)– Molecular characterization– Insert / copy number / gene
integrity– Function / specificity / mode of
action– Levels in plant
• Toxicology / Allergenicity– Digestibility – Homology to allergens– Acute Oral - mice / rat– History of safe use and
consumption
• 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
Bob PetersonAgricultural & Biological Risk AssessmentMontana State University
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Product CharacterizationGene source(s)
Molecular characterizationInsert, copy number, gene integrityFunction, specificity, mode of action
Protein levels in plant
Toxicity/AllergenicityDigestibility of protein Heat stability of protein
Similarity to known allergensAcute toxicity – mouse, rat
History of safe use and consumption
Environmental SafetyEcotoxicity, Birds, Mammals, Fish
Soil & aquatic invertebrates, Soil degradation, Beneficial insects
Insect Resistance Management
Crop SafetyCrop development
Crop yield
Food CompositionNutrients
Anti-nutrients
Biotechnology CropRegulatory Requirements
Conventional CropNO Regulatory Requirements
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
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
Bob PetersonAgricultural & Biological Risk AssessmentMontana State University
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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:
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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
*The intent is to commercialize in the U.S. and Canada simultaneously.
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Commercialization Milestone……..
Appropriate regulatory trade approvals, thresholds or marketing agreements are in place in major export markets.
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Commercialization Milestone……..
Appropriate grain handling protocols and standardized sampling and detection methods are developed and implemented
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Commercialization Milestone……..
Comprehensive agronomic stewardship programs and best management practices are developed
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Commercialization Milestone……..
Varieties meet or exceed industry standards for grain end-use quality
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Commercialization Milestone……..
Buyers are identified who will procure and use wheat ingredients with biotech traits
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“to develop and disseminate technology important to the production and
utilization of food, feed, and fuel from crop and livestock enterprises”
Purpose of NDAES:
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Questions & Discussion