Jeff Stein

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• Jeff Stein
• Director of Regulatory Affairs
• Syngenta Seeds - NAFTA

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Syngenta Seeds, Inc.
Corn, oilseeds and other field crops worldwide
Sugar beet worldwide
Vegetables in Europe, Africa Asia, flowers and
young plants worldwide
Vegetables in the Americas
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Genesis of a Biotech Product

• Research
• Identify and introduce genes into plants that
  deliver a desirable phenotype
• Development
• Evaluate the performance over a range of
  conditions
• Regulatory Affairs
• Seek obtain commercial approvals from
  regulatory authorities
• Sales Marketing
• Responsible for commercial sales
• USDA Field testing and environmental safety
• EPA Environmental, food and feed safety for
  pest-protected product registration and sales
• FDA Feed and food safety
• Public participation is solicited by these
  agencies at several steps in the process, from
  small-scale testing to commercialization

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Role of Regulatory Affairs

• Provide a regulatory analysis and preliminary
  safety assessment on prospective gene products to
  research and business teams at very early stages
  of development
• Conceive safety testing strategy and oversee
  its conductance seek concurrence on proposed
  strategy from authorities
• Advise research teams business of any
  potential regulatory hurdles that may impact
  anticipated commercial launch date
• Regularly correspond with regulatory
  authorities of any adverse effects noted during
  the data development phase
• Submit and represent safety data files to
  regulatory authorities
• Provide post-market support as needed to ensure
  compliance with conditions of regulatory approval
• USDA Field testing and environmental safety
• EPA Environmental, food and feed safety for
  pest-protected product registration and sales
• FDA Feed and food safety
• Public participation is solicited by these
  agencies at several steps in the process, from
  small-scale testing to commercialization

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Composition of Regulatory Team

• Regulatory Scientists data generation
• Animal toxicology
• Environmental toxicology
• Protein and small molecule purification
• Analytical sciences
• Regulatory Affairs
• Data interpretation
• Risk assessments
• Regulatory agency interactions
• USDA Field testing and environmental safety
• EPA Environmental, food and feed safety for
  pest-protected product registration and sales
• FDA Feed and food safety

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Comprehensive Safety Assessment

• Integrated (coordinated) regulatory framework
  involves three federal agencies to ensure biotech
  product safety
• USDA Field testing and environmental safety
• EPA Environmental, food and feed safety for
  pest-protected product registration and sales
• FDA Feed and food safety
• Public participation is solicited by these
  agencies at several steps in the process, from
  small-scale testing to commercialization

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Comprehensive environmental, food and feed safety
assessments are integral components of the
product development and registration processes
Trait Discovery
Product Development
Commercialization
Post Market
Line Selection
Variety Development
Transfor- mation
Gene Discovery
GH Field Evaluation
Product Concept
Field Production
Market
USDA
Early safety evaluation
EPA
FDA
Product stewardship
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Safety Testing

• Environmental Safety
• Food and Feed Safety

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Environmental Safety

• Speed of soil degradation
• Impact on soil invertebrates
• Earthworms
• Impact on aquatic invertebrates
• Daphnia
• Impact on beneficial insects
• Ladybugs, parasitic wasps and lacewings

• Impact on fish
• Trout
• Impact on birds
• Quail
• Impact on mammals
• Mice
• Insect resistance management

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Food and Feed Safety Testing

• Toxicity
• Acute mouse toxicity study
• Similarity to known toxins
• Previous history of exposure
• Allergenicity
• Similarity to known allergens
• Evaluation in animal models
• Digestibility in a simulated gastric environment
• Nutritional composition and feed performance