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U.S. Department of Health and Human Services

Advisory Committees

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Key Facts Commonly Misunderstood

The following is a short list of issues most likely to give rise to a misunderstanding about FDA’s upcoming review of the AquAdvantage Salmon.

 

Where will the AquAdvantage Salmon be raised?

If approved, the AquAdvantage Salmon will be raised in inland tanks. They will not be raised in ocean net pens. Any change would require a new application and approval.

 

Has FDA released all the critical information about the AquAdvantage Salmon?

Yes.  FDA has released detailed summaries of all the data and information related to the application on which we relied for our analyses.

 

Does the “drug” approval process address food safety?

Yes.  The review of the AquAdvantage Salmon, conducted under that process, includes a rigorous analysis of food safety and application of a stringent safety standard: “reasonable certainty of no harm."

 

Will people be allergic to the AquAdvantage Salmon specifically because it has been genetically engineered?

No. People who are allergic to Atlantic salmon will likely be allergic to AquAdvantage Salmon because it is a finfish (one of the eight most allergenic foods in the U.S.), not because it has been genetically engineered.

 

Are whole-food feeding studies needed to assess food safety?

No. There is an international consensus that whole food feeding trials do not provide useful information. FDA follows the international consensus approach to assessing the safety of whole foods that avoids the problems created by feeding large amounts of whole foods to test animals. See the Codex Alimentarius Commission's Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Animals (CAC/GL 68-2008).