Peaceful Coexistence

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Peaceful Coexistence

• Mike Gumina
• Vice President - Pioneer Hi-Bred International,
  Supply Management

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What is Adventitious Presence?

• It is the technically unavoidable, naturally
  occurring, presence of foreign materials in a
  product.
• In our case, we are mainly worried about foreign
  genetic material.
• Physical mixing
• Pollen Flow

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Federal Seed Act

• AP is considered the same as as long as the
  kind of crop does not change. (ref 201.9)
• AP of kind or variety less than 5 of the hybrid
  does not need to be labeled. (ref 201.11a)
• The challenges with AP have increased with
  herbicide traits and the new traits authorized in
  one country but not yet globally authorized.

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ASTA View

• Coexistence is an economic issue, not a safety
  issue.
• It has been the responsibility of the individual
  grower, agri-production chain, or the contracting
  party producing specific products to implement
  management practices to reach the quality
  standards necessary to market a differentiated
  product.

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RD Isolation Distance Requirements
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Seed Corn Production - Map
Z8C
7CP
7CH
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Steps to Minimizing AP

• Quality Management Systems applied to the
  process, allowing for continuous improvement
• Parent Seed Sourcing and Testing
• New Isolation Standards
• New Sourcing Strategies
• Temporal isolation, e.g. New Male Delay and Male
  Population practices.
• Harvest Prioritization
• Aggressive Testing Programs

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Testing Programs to verify that the Process is
Working

• Bioassays spray tests (inexpensive, minimal
  technology needed, vary in time response
  depending upon phenotype response)
• ELISA Sticks and wells (medium expense, fast
  response, some technology development needed,
  protein specific)
• PCR DNA based (high technology investment,
  medium response time, can be gene specific)
• Error rates are a problem
• 5.8 false positives
• 4.8 false negatives

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Statistical Model
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Predicted Adventitious Presence at Various Market
Penetrations of Biotech
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Looking Forward to the Questions! Thanks