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BIOTECH UPDATE . NDSU Policy on Biotech Research & GM Wheat Update. Duane Hauck Assistant Director – Ag & Natural Resources NDSU Extension Service.

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BIOTECH UPDATE

NDSU Policy on Biotech Research

&

GM Wheat Update

Duane Hauck

Assistant Director – Ag & Natural Resources

NDSU Extension Service


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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”

NDSU Policy on Biotech Research

Purpose of NDAES:


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Indicates controlling authorities the production and utilization of food, feed, and fuel from crop and livestock enterprises”

Guide NDSU scientists

Communicate to the public

NDSU Policy on Biotech Research


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Continue to pursue new technologies for enhancing farming, food quality and the environment.

Key points of NDSU Policy on Biotech Research

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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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.

Decision Making Process


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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 reviewing plant material considered for commercial release.

supercede established rules. However, they

may be more restrictive or precautionary.


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GM Wheat Trait Research reviewing plant material considered for commercial release.

  • 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

    • 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 Trials by Year reviewing plant material considered for commercial release.


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Number of World GM Wheat Field Trials by Country, 1993-2002 reviewing plant material considered for commercial release.


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Number of World GM Wheat Field Trials by Trait, 1993-2002 reviewing plant material considered for commercial release.



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Number of World GM Wheat Field Trials by Type of Organization, (Public vs Private) 1993-2002


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Major Points Organization, (Public vs Private) 1993-2002

  • 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


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U.S. HRS Exports and GM Aversion Organization, (Public vs Private) 1993-2002



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Biotech Products Require Different Oversight 1999-00

Regulation should be commensurate with risk, but new technologies often necessitate more rigorous regulation

Bob Peterson

Agricultural & Biological Risk Assessment

Montana State University


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USDA = 1999-00Is it Safe to Grow?

EPA = Is it Safe to the Environment?

FDA = Is it Safe to Eat?

Three-Agency Approach

Bob Peterson

Agricultural & Biological Risk Assessment

Montana State University


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Product Characterization 1999-00

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

Food, Feed, and Environmental Risk

Gene/Protein Risk

Crop Risk

Determining Risk

Bob Peterson

Agricultural & Biological Risk Assessment

Montana State University


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Conventional Crop 1999-00

NO Regulatory Requirements

Biotechnology Crop

Regulatory Requirements

  • Product Characterization

    • Gene source(s)

    • Molecular characterization

    • Insert, copy number, gene integrity

    • Function, specificity, mode of action

    • Protein levels in plant

  • Crop Safety

    • Crop development

    • Crop yield

  • Toxicity/Allergenicity

    • Digestibility of protein

    • Heat stability of protein

    • Similarity to known allergens

    • Acute toxicity – mouse, rat

    • History of safe use and consumption

Food Composition

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

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 Peterson

Agricultural & Biological Risk Assessment

Montana State University


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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:

Bringing in New Technologies to Wheat


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Commercialization Milestone…….. regular basis to discuss progress of biotech wheat research

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…….. regular basis to discuss progress of biotech wheat research

Appropriate regulatory trade approvals, thresholds or marketing agreements are in place in major export markets.


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Commercialization Milestone…….. regular basis to discuss progress of biotech wheat research

Appropriate grain handling protocols and standardized sampling and detection methods are developed and implemented


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Commercialization Milestone…….. regular basis to discuss progress of biotech wheat research

Comprehensive agronomic stewardship programs and best management practices are developed


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Commercialization Milestone…….. regular basis to discuss progress of biotech wheat research

Varieties meet or exceed industry standards for grain end-use quality


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Commercialization Milestone…….. regular basis to discuss progress of biotech wheat research

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 the production and utilization of food, feed, and fuel from crop and livestock enterprises”


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