Food Safety Assessment. Kevin Greenlees, PhD, DABT Kathleen Jones, PhD. What are the risks of direct or indirect adverse outcomes associated with the consumption of the GE animal as food or feed?. What are the direct and indirect risks posed to the GE animal?
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Kevin Greenlees, PhD, DABT
Kathleen Jones, PhD
What are the risks of direct or indirect adverse outcomes associated with the consumption of the GE animal as food or feed?
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?)
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?
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 claimFood/Feed Safety
What hazards/risks have been identified in the hierarchical review?
The food safety standard is reasonable certainty of no harm – NOT absolute safety
Toxicological testing of whole foods in animal models is challenging
Identify and characterize hazards
Direct Adverse Effect (Food Safety) adverse outcome resulting from human consumption of edible products from the rDNA animal coming into contact with the construct or its gene product(s)
Indirect Adverse Effect (Food Safety) adverse outcome resulting from human consumption of edible products from the rDNA animal that contain hazards due to the construct or gene product perturbing the food animal’s physiology
Intended effects changes in the rDNA animal brought about deliberately by introduction of the rDNA construct and its predicted gene product(s). These may or may not pose direct or indirect effects on food safety.
Unintended effects changes in the rDNA animal resulting from the interaction of the rDNA construct or its gene product(s) with the physiology of the animal such that its metabolism is altered. These may or may not pose direct or indirect effects on food safety.
Metabolic Δ such that consumption of edible tissue may pose risk
(altered levels of expected nutrients, inherent metabolites or sequestered xenobiotics)
Consumption of edible product containing GP causes toxicity
(allergenicity, GI disturbance, other tox)
Insertional Mutagenesis in structural or regulatory region
None (DNA is GRAS)
Animal identification; facilities; containment procedures
Animal and product disposition methods and records
“Regulatory Method” procedures for transgene identification for animals and edible tissues
Plan likely to ensure that GE animals will not enter the food or feed supply
Regulatory method adequate to identify animals/meat
No food/feed from this lineage of GE animals will enter food/feed supplyFood/Feed Safety of