Durability Joseph W. (Jay) Cormier, PhD
Are the genotype or phenotype changing over the product lifespan in a way that would affect the risks associated with the product? Is there a plan in place to monitor those changes? What are the direct and indirect risks posed to the GE animal? (e.g., can surveying the health and other phenotypic characteristics of the animal inform us with respect to risk to the animal and potential human food safety concerns?) 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 Durability What hazards/risks have been identified in the hierarchical review?
Why Prepare a Durability Assessment and Plan? • Ensure that future animals are equivalent to those evaluated for safety and effectiveness during pre-market review • Genotypic and Phenotypic Evaluation • Durability Plan • Sponsor’s Commitment
Genotypic and Phenotypic Evaluation Are there data to suggest that the animal’s genotype and phenotype are “stable”?
Durability Plan • A plan to ensure that future animals are equivalent to today’s • Or, if the animals are not equivalent, what procedures are in place to provide a remedy for the change or to reassess the risk of/to the new animal
Durability for GTC 155-92 Durability Evaluation Multi-generation genotypic/phenotypic data assessment • Characterization of construct in animal • Animal safety assessment; product claim demonstration Durability Plan Sponsor-developed plan including • Test methods, specifications, and validation • Testing frequency, reporting of results • Lineage replacement procedures Conclusion The 155-92 demonstrated durability over 7 generations Plan ensures future consistency of the approved GE animal lineage