Thank you for the question.
I should begin by saying that the need to demonstrate the need for the living organism isn't a departure from the risk assessment; it's in addition to the risk assessment. Let's be clear on that. We definitely do need to have risk assessments.
When we think about living organisms that have wild counterparts, there are considerations that go far beyond the purview of those doing the risk assessments. Those are considerations of a social, cultural and economic nature that are held by, in the case of the AquAdvantage salmon, first nations, who fear for the cultural integrity of their peoples if the salmon are lost, and fishermen, who fear for the genetic integrity and resilience of the stocks.
There's an even better example of why we should think about demonstrable needs, and that is the example of the aquarium Glofish that has now colonized rivers throughout Brazil. It's a small thing, and nobody knows what damage it's doing in the environment, but it has literally colonized rivers throughout that country. It's been spotted in rivers elsewhere. Did we need to put nature at risk to that extent in order to make a coloured aquarium fish? That is a poster case of a situation in which demonstrable need ought to have been demonstrated.