Environmental Safety Assessment. Eric Silberhorn, PhD, DABT. What are the risks of direct or indirect adverse outcomes associated with the consumption of the GE animal as food or feed?. Direct or indirect effects from introduction of the GE animal into the environment?.
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Eric Silberhorn, PhD, DABT
What are the risks of direct or indirect adverse outcomes associated with the consumption of the GE animal as food or feed?
Direct or indirect effects from introduction of the GE animal into the environment?
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 claimEnvironmental Safety
What hazards/risks have been identified in the hierarchical review?
For a specific GE animal (population) containing a specific rDNA construct….
Considered in context of appropriate comparator on a case-by-case basis.
Able to Survive
Able to Reproduce
Direct and Indirect Effects
Spread of Transgene(s)
Impact on Target Resources in Accessible Environments (habitats, wildlife)
Consideration of the following factors:
Overall concern is a product (and not the sum) of these three variables
Genetic contribution by an individual’s descendants to future generations of a population
Fitness depends on both survival and reproduction
Net fitness components include
Juvenile and adult viability
Age at sexual maturity
Female fecundity/male fertility/mating success
* These characteristics are used to assess fitness regardless of an animal’s GE statusFitness*
Does incorporation of the rDNA construct alter the animal’s fitness?
Potential examples of altered fitness
General Risk Questions
Note: EA/FONSI posted