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Will the FDA Approve a Genetically Engineered Fish for the First Time?

The U.S. Food and Drug Administration (FDA) released a statement announcing that AquaAdvantage salmon “will not have any significant impacts on the quality of the human environment of the United States.”[1]

AquaAdvantage salmon is a genetically engineered fish that grows faster than normal salmon. This is due to the fact that the salmon contains opAFP-GHc2 recombinant DNA construct.

AquaAdvantage filed a New Animal Drug Application (NADA) with the FDA asking to allow its genetically engineered salmon be sold in the U.S. market. FDA’s Environmental Assessment supports the NADA for the genetically engineered salmon. Furthermore, FDA concluded that AquaAdvantage’s genetically engineered salmon is “as safe as food from conventional Atlantic salmon, and that there is a reasonable certainty of no harm from consumption.”[2]

The FDA’s draft Environmental Assessment and preliminary Findings of No Significant Impact (FONSI) are available for public comment for 60 days, until February 25, 2013.

If FDA approves the NADA for AquaAdvantage’s genetically engineered salmon, AquaAdvantage would have permission to produce and grow-out the salmon in the physically contained freshwater culture facilities specified in the NADA. This would be the first time FDA approved a genetically engineered food for sale in the U.S. market. AquaAdvantage salmon would be the first genetically altered animal approved for food anywhere in the world. If allowed, this could have significant impact on the food and beverage industry.

There are also food labeling questions with AquaAdvantage salmon. Currently, the FDA does not require genetically modified food to be declared genetically engineered in the labeling.

After the end of the comment period, FDA will review the comments and announce its decision. For now, the food and beverage industry will have to wait to see if AquaAdvantage’s genetically engineered salmon is approved.

[1] http://www.gpo.gov/fdsys/pkg/FR-2012-12-26/pdf/2012-31118.pdf
[2] http://www.fda.gov/downloads/AnimalVeterinary/DevelopmentApprovalProcess/GeneticEngineering/GeneticallyEngineeredAnimals/UCM333105.pdf