FDA has approved a new animal drug application concerning AquAdvantage
Salmon, a genetically engineered Atlantic salmon. Documents related to
this approval are available on the
FDA website, last updated on 11-19-15.
The “new animal drug application” approval affirms the FDA’s
position that the salmon, genetically engineered to grow faster and larger
than the salmon we are familiar with, is just as safe to eat as any natural
approval letter states: “The approval is for a single copy of the α-form of the
opAFP-GHc2 recombinant DNA (rDNA) construct at the α-locus in the EO-1α
lineage of triploid hemizygous, all-female Atlantic salmon (Salmo salar) known as AquAdvantage Salmon (AAS) under the conditions of use specified
in the application. This rDNA construct at this specific site in the genome
is the new animal drug (“the article”) that is the subject
of the new animal drug application (NADA) approval. For ease of reference,
this Appendix will refer to “AAS,” or “the article,”
or “the product” when referring to the drug.”
We all have the opportunity to become test cases for this “new animal
drug product”. There have been no human studies, to my knowledge,
on the results of eating this “new animal drug product”, no
dosage calculations, no longitudinal human safety studies.
The new food product was developed using genetic engineering techniques
developed in the 1980s to insert a gene which increases the production
of an anti-freeze protein into the fish, so that it can continue to grow
year round, instead of resting for a season and only reproducing in the
spring, as naturally developed fish do. An additional gene from an ocean
pout – a member of the eel family – was then introduced to
enable the fish to continue to grow far larger than its natural cousins.
The genetic alteration does appear to be stable in the offspring of these
engineered fish for at least 6 generations, according to the published
The Aquabounty company has assured us that their fish are all sterile.
However, published literature shows that the fish can indeed breed with
other fish and produce hybrid offspring. The trout-salmon hybrid suppressed
both natural salmon and natural trout populations. “Transgenic hybrids
appeared to express competitive dominance and suppressed the growth of
transgenic and non-transgenic (wild-type) salmon by 82 and 54 per cent,
Since the new animal drug product can escape its confines in the farms
where it is raised, and since it can potentially breed with wild salmon
to produce hybrid progeny, there is no guarantee that any salmon will
be free of the genetic modification introduced in this commercially bred
new animal drug product.
I have decided that my only option is not to eat salmon and possibly also
trout at all.
Each of us will have to make our own decision in this matter.
Key words: GMO fish, GMO salmon, food safety
 Hemizygous – having only a single copy of a gene. All genes on the
male’s single X chromosome are hemizygous.