AquAdvantage Salmon

The FDA has approved AquAdvantage Salmon, a genetically-engineered Atlantic salmon that grows to market size more rapidly than their non-genetically-engineered counterpart

The genes of animals and plants have been modified by scientists for decades through selective breeding. For example, the genomes of some strains of corn in the United States have been genetically-engineered (GE) to express desired traits like pest resistance or increased sweetness, and researchers create and use GE-animals for scientific study. However, humans have yet to eat a GE-animal. This will now change with the AquaAdvantage Salmon.

The FDA, or U.S. Food and Drug Administration, has approved the GE AquAdvantage Salmon for human consumption. It is a GE-Atlantic salmon, created by AquaBounty Technologies, that grows to market size faster than non-GE Atlantic salmon, due to the insertion of a growth hormone gene from a Chinook salmon. The AquaAdvantage Salmon had to be reviewed by the FDA for safety and effectiveness because a gene inserted into the animal to alter its structure or function meets the definition of a drug according to the FDA.

Among the evidence that the FDA reviewed prior to granting regulatory approval was that food from the AquAdvantage Salmon was safe to eat, as nutritious as non-GE Atlantic salmon, and met claims that it grew more rapidly than non-GE salmon. With regard to potential environmental impacts, AquaBounty Technologies’ plan to contain the fish in land-based hatchery tanks in Canada and Panama, as well as measures to prevent escape of the fish and their eggs into the environment, also met the FDA requirements.

As a result of this approval, the FDA has published a draft recommendation guide on labelling food from AquAdvantage salmon and final guide for food from GE-derived plants. GE products or products with GE components still need to meet the same FDA requirements as other foods, and labelling a product as ‘GE’ is voluntary and only required if there is an actual difference, like nutritional profile, in comparison to the non-GE product.

With the approval of AquAdvantage Salmon, it will be interesting to see how many more groups like AquaBounty Technologies will submit applications for the approval of GE-animal consumption.

 

FDA press release:
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm472487.html

FDA GE-food labelling recommendations:
http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm469802.htm

http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm059098.htm

Additional information on the AquAdvantage Salmon (FDA website):
http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/GeneticEngineering/GeneticallyEngineeredAnimals/ucm473237.htm

http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/GeneticEngineering/GeneticallyEngineeredAnimals/ucm473238.htm

 

 

 

 

 

Written by Fiona Wong, PhD

 

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