monsanto trait qa requirements2010
TRANSCRIPT
MONSANTOProduct Stewardship
- QA/QC Requirements -
IN Crop Improvement Session
October 13, 2010
Dale Aaberg
Monsanto Company Confidential2
Agenda
• Stewardship
• Trait QA/QC
• Refuge blends
• Q & A
Monsanto Company Confidential
What is Product Stewardship?
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Product stewardship is responsible management addressing:
• Safe and environmentally responsible products
• Proper and responsible use of our products
• Identity, integrity, and quality of products are maintained
• Absolute respect for all regulations and approvals
• Market impacts associated with product launches
• Product is responsibly managed in the marketplace
• Systems for sustainability
• Effective discontinuation of outdated technology
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Stewardship expectations
• Processes and verification systems to assure product integrity and maintenance of control while key regulatory approvals are pending– Documentation
• Monitor compliance to and effectiveness of stewardship efforts– Self-verification and audits
• The goal…
MATERIAL MATERIAL OUT OF PLACE
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Examples ofBiotech / Seed Products: Stewardship Program Components
• Regulatory– Conditions of registration– Bag tag declarations – Terms of use– Field trial management
• Product Identification– Naming strategies– Bag tag language
• Proper Articles of Commerce– Registered event– Plant Varietal Protection
• Product Safety Concerns Management
• Insect Resistance Management
• Seed Quality– Purity, intended/unintended– Performance
• Risk Management– Purity representation
• Market Impact Assessment and Management – Channeling– Co-existence – Diagnostics – Adventitious presence
• Phytosanitary Requirements• Product Discontinuation• Compliance and Reporting
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Transgenic event discontinuation
• MON863 event containing corn products – YieldGard® Rootworm– YieldGard® Plus– YieldGard® Rootworm with Roundup Ready® Corn 2– YieldGard® Plus with Roundup Ready® Corn 2
• Timing– Sales & distribution completed by June 25, 2011– Planting completed by July 1, 2011
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Trait QA/QC - Corn
Inbred corn seed• ‘Intended’ and ‘unintended’ event testing
Hybrid corn seed• Product performance…
one time hybrid qualification to check for background interference
encompasses trait efficacy or tolerance and commercial yield/agronomic performance
• Trait purity…levels must be tested for each seed lot produced
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Corn Trait Purity Testing
• All hybrid seed lots must meet trait purity specifications prior to commercial sale.
• Seed companies are responsible for maintaining copies of all trait purity tests including…
• Wholesale purchases• Seed produced by
– Growers– Subcontractors
• Brokers
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Corn Trait Purity Testing
• Trait Purity Testing For Corn– YieldGard® Corn Borer, Corn Rootworm– Roundup Ready® Corn 2– YieldGard® Plus and VT™ Traits– Genuity® Traits
• Stacked Trait Hybrids Must Be Tested For All TraitsGenuity® product modifications
• Each Grade Size of Each Finished Lot Must Be Tested When Trait Is On the Male
• One Test Per Finished Lot If Trait Is On the Female
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Corn Trait Purity Testing
• When a hybrid is issued a new lot number, an additional trait test is required Example:
blending several lots together to form one new lot
• Bulk/sheller run tests – Does not replace finished lot tests
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Requirements for Trait Testing – VT2P hybrid seed
• Example of a seed testing scheme to validate minimum hybrid trait purity specifications –
MON89034 (Cry2Ab and TIC105) 96%
NK603 (CP4) 98%
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Requirements for Trait Testing – VT3P hybrid seed
• Example of a seed testing scheme to validate minimum hybrid trait purity specifications –
MON88017 (CP4 and Cry3Bb) 98/96%
MON89034 (Cry2Ab and TIC105) 96%
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Requirements for Trait Testing – GenSS hybrid seed
• Example of a seed testing scheme to validate minimum hybrid trait purity specifications –
MON88017 x MON89034 x TC1507 x DAS59122-7
(CP4, Cry3Bb, TIC105, Cry2Ab, Cry1F, Cry34, Cry35, PAT)
CP4 98%
Other events 96%
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Trait QA/QC - Soybeans
Soybean varieties• Varietal performance…
‘Intended’ and ‘unintended’ event testing
one time verification of commercial tolerance to Roundup® herbicide and yield performance
• Trait purity…levels must be tested for each seed lot produced
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Soybean Trait Testing
• Verification of tolerance to Roundup® herbicide - via production– Crop stage, rate, formulation, date
• Each finished lot of Roundup Ready® and RR2Y soybeans must be trait purity tested
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Other corn & soybean requirements
• Retain a file sample of each hybrid and variety for each lot which is consistent with state/federal seed laws.
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RIB update
Note: The information above includes assumptions and projections. Actual refuge requirements and launch timelines are subject to regulatory approval .
Growers Will Have Choices…
Other RIB product introductions in the 2012-2013 timeframe anticipated.
Based on grower demand, RIB products are expected to gain rapid adoption.
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RIB -Monsanto and Industry Key Messages
• To maintain trait durability, industry is committed to ensure the blended RIB product has an adequate and viable refuge component, verified through:– Auditable blending records– Testing at the Mfg. level
• The same records will be made available to the USDA• Industry needs flexibility to choose one color or two• Product blends/mixtures have been produced and sold in
the seed industry for many years under effective policies and procedures already in use.
• Regulators should expect to see a wide variety of products
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Q&A
Contact information…
Dale Aaberg
314/694-5395
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