Safety of a transgenic or genetically modified salmon : the AquAdvantage salmon

What is the product that was deemed safe for human consumption?

The salmon that was evaluated by the Food and Drug Administration of the US (US-FDA) is a genetically modified (“engineered” or also “transgenic”) Atlantic salmon. This fish, AquAdvantage Salmon, is to be produced and grown in closed inland installations, under specified conditions. The specific modification that it carries is a construct between a gene from a Chinook salmon that produces growth hormone, and a regulation sequence from ocean pout and chinook salmon, that means that the growth hormone gene is more active than in non-modified fish The objective of the project is to meet increasing demand for fish protein in light of declining stocks and diminishing capture of wild fish. Effectively, this means that production is faster since the fish reaches market size faster. These genetically modified fish are all triploid females, which means that they are effectively sterile, which is a strategy already used in aquaculture to prevent farmed fish to inderbreed with wild populations.

It is the FDA’s Center for Veterinary Medicine (CVM) that has evaluated both the direct and indirect food safety impacts of AquAdvantage Salmon.

It is the FDA’s Center for Veterinary Medicine (CVM) that has evaluated both the direct and indirect food safety impacts of AquAdvantage Salmon.

Such evaluation is a seven steps process:

1. An evaluation of the genetic construct itself that is used to modify the animal.
2. What happens to this genetic material once it is incorporated into the animal, and how it behaves over multiple generations.
3. Whether the genetic modification is safe for the animal.
4. A review of the plan of the producer to ensure that the GE animals produced in the future will be equivalent to those evaluated in the pre-approval review.
5. Whether the transgenic animals are safe to eat.
6. The potential for the GE animal to cause significant environmental impacts. This considers the risks that the animals would escape confinement, whether they can survive in the wild, and whether they can breed in the wild.
7. Finally, the producer submits information and data to support of their claims for the transgenic animal. For an animal that is intended to grow faster, the agency evaluates data to determine if the GE animals do indeed reach some size or weight more rapidly than their conventional counterparts.

What are the conclusions of the US-FDA evaluation of transgenic salmon?

Based on the evidence collected and evaluated, the US-FDA has reached the conclusion that it is reasonable to believe that approval of the AquAdvantage Salmon will not have any significant impacts on the quality of the human environment of the United States (including populations of endangered Atlantic salmon) when produced and grown under the conditions of use for the proposed action.

With respect to food safety, the US-FDA has concluded that food from this transgenic salmon is as safe as food from conventional Atlantic salmon, and that there is a reasonable certainty of no harm from consumption of food from triploid AquAdvantage Salmon. Further, the US- FDA has concluded that no significant food safety hazards or risks have been identified with respect to the phenotype of the AquAdvantage Salmon.

The US- FDA, having reviewed the materials submitted in support of an NADA for AquAdvantage Salmon, has also made a “no effect” determination under the Endangered Species Act (ESA), that approval of the AquAdvantage Salmon NADA will not jeopardize the continued existence of United States populations of threatened or endangered Atlantic salmon, or result in the destruction or adverse modification of their critical habitat, when produced and reared under the conditions described in the environmental assessment (so in closed inland facilities, in Canada and Panama).

This type of salmon was approved in November 2015 for production and human consumption:
see the FDA information page on the AquAdvantage salmon