What exactly does the review process of a GE animal entail?
The guidance recommends a review process that includes seven categories: • Product definition: a broad statement characterizing the GE animal and the claim being made for the GE animal; • Molecular characterization of the construct: a description of the rDNA construct and how it was made; • Molecular characterization of the GE animal lineage: a description of the rDNA construct that was introduced into the animal, and whether it is passed to the offspring in a predictable way; • Phenotypic characterization of the GE animal: information describing the GE animal, including comprehensive data on the health of the animal; • Durability plan: demonstrates that the offspring (over multiple generations) continue to inherit the rDNA construct and that they continue to express the new trait; • Environmental and food/feed safety: the assessment of any environmental impacts, and for GE animals intended for food, that food from those GE animals is safe to eat for humans and/or animals; • Claim vali
