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Molecular Characterizations

Molecular Characterizations. Jeff Jones, DVM, PhD. What hazards/risks have been identified in the hierarchical review?.

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Molecular Characterizations

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  1. Molecular Characterizations Jeff Jones, DVM, PhD

  2. What hazards/risks have been identified in the hierarchical review? Are there sequences that are likely to contain potential hazards to the animal, humans, or animals consuming food from that animal, or the environment? e.g., does the construct contain mobilizable sequences from viruses that may be endemic in that species? Describes the animal, construct, and proposed claim Molecular Characterization: Construct

  3. Molecular Characterization: Construct • What is the construct? • How is it made? • Is the construct as intended?

  4. What is the construct? Many different components are typically included in construct Hazard identification requires understanding all components or Molecular Characterization: Construct

  5. Are there potential hazards associated with the components? Substances of toxicological concern (includes allergens)? Other bioactive molecules? “Junk” that we don’t know much about? Novel sequences/proteins? Molecular Characterization: Construct

  6. Molecular Characterization: Construct What is the construct? • Mobilizable elements (or parts) may provide unique hazards.

  7. Molecular Characterization: Construct How was it made?

  8. Molecular Characterization: Construct • Is the construct as intended?

  9. Molecular Characterization of Construct What is the construct? How is/was it made? Data/Information Reviewed • Source and description of rDNA • Construction, including method • Sequence Conclusions • Data adequate • No hazards intrinsically in the construct

  10. Does the insertion of the rDNA construct pose a hazard to the animal, humans, other animals by feed, or the environment? Are there sequences that are likely to contain potential hazards to the animal, humans, or animals consuming food from that animal, or the environment? e.g., does the construct contain mobilizable sequences from viruses that may be endemic in that species? Describes the animal, construct, and proposed claim Molecular Characterization: GE Animal Lineage What hazards/risks have been identified in the hierarchical review?

  11. Molecular Characterization: GE Animal Lineage What was the result of integration?

  12. Molecular Characterization: GE Animal Lineage What was the result of integration?

  13. Molecular Characterization: GE Animal Lineage Supporting data?

  14. Molecular Characterization of GE Animal Lineage What was the result of integration? Data/Information Reviewed • Description • Detection of the construct • Structure and copy number • Multiple generations • DNA sequence • Expression of the transgene • Characterization of the expression product Conclusions • Data adequate • No hazards posed by this integration event • Stable over multiple generations

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