The FDA
has approved AquaBounty Technologies’ application for AquAdvantage
Salmon, an Atlantic salmon that reaches market size more quickly than non-genetically
engineered (GE) farm-raised Atlantic salmon, according to the FDA’s press
release here.
The Washington Post also published an article available here
and Reuters here.

The FDA
regulates GE animals under the new animal drug provisions of the Federal Food,
Drug, and Cosmetic Act, because the recombinant DNA (rDNA) construct introduced
into the animal meets the definition of a drug. In this case, the rDNA
construct introduces a trait that makes the AquAdvantage Salmon grow
faster.

“The FDA
has thoroughly analyzed and evaluated the data and information submitted by
AquaBounty Technologies regarding AquAdvantage Salmon and determined that they
have met the regulatory requirements for approval, including that food from the
fish is safe to eat,” said Bernadette Dunham, D.V.M., Ph.D., director of the
FDA’s Center for Veterinary Medicine.

Five years
ago, the FDA first declared the product, made by Massachusetts-based AquaBounty
Technologies, to be as safe as conventional farm-raised Atlantic salmon,
according to Reuters.

AquaBounty’s
product will not require special labeling because it is nutritionally
equivalent to conventional farm-raised Atlantic salmon, the FDA said on
Thursday.

AquaBounty
developed the salmon by altering its genes so that it would grow faster than
farmed salmon, and expects it will take about two more years to reach
consumers’ plates.

A Canadian
governmental risk assessment issued in 2013 also looked at both safety and
escapes, and they described the risk to human health as “low” and the risk to
the Canadian environment as “negligible,” according to The
Washington Post.

On both of
those issues, there will always be some doubt. Safety can’t be proved (we can
only infer it from absence of harm so far), and any containment system can
fail. So the questions aren’t “Is it safe?” and “Could they escape?” The
question is whether the risk in those two areas is outweighed by the benefits.

The FDA will maintain regulatory oversight over the
production and facilities, and will conduct inspections to confirm that
adequate physical containment measures remain in place. In addition, the
Canadian and Panamanian governments will also be conducting inspections of the
facilities, according to the FDA.

For more information on biotechnology, please visit the
National Agricultural Law Center’s website here.