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

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molecular characterizations

Molecular Characterizations

Jeff Jones, DVM, PhD

molecular characterization construct
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
molecular characterization construct1
Molecular Characterization: Construct
  • What is the construct?
  • How is it made?
  • Is the construct as intended?
molecular characterization construct2
What is the construct?

Many different components are typically included in construct

Hazard identification requires understanding all components

or

Molecular Characterization: Construct
molecular characterization construct3
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
molecular characterization construct4
Molecular Characterization: Construct

What is the construct?

  • Mobilizable elements (or parts) may provide unique hazards.
molecular characterization construct6
Molecular Characterization: Construct
  • Is the construct as intended?
molecular characterization of construct
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
molecular characterization ge animal lineage

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?

molecular characterization ge animal lineage1
Molecular Characterization: GE Animal Lineage

What was the result of integration?

molecular characterization ge animal lineage2
Molecular Characterization: GE Animal Lineage

What was the result of integration?

molecular characterization of ge animal lineage
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