Animal & Veterinary
FDA Holds Public Meeting on GE Salmon
On September 19 and 20, 2010, FDA held a Veterinary Medicine Advisory Committee (VMAC) meeting on an application for approval of AquAdvantage Salmon. This is a genetically engineered (GE) Atlantic salmon produced by AquaBounty Technologies, Inc. of Waltham, Mass. Bred to grow faster than non-GE Atlantic salmon, if approved, AquAdvantage Salmon will be the first genetically engineered animal intended for human food.
Genetically engineered animals contain altered or additional genetic material (DNA). This altered or additional piece of DNA, called the recombinant DNA construct, is introduced into the animal to produce a desirable trait. For AquAdvantage Salmon, the desirable trait is a faster growth rate.
The committee members attended an orientation session on the first day of the meeting, where FDA:
- provided information about the production of genetically engineered animals;
- described the agency’s regulatory process for evaluating applications for approvals of genetically engineered animals under the federal Food, Drug, and Cosmetic Act; and
- addressed the agency’s responsibilities under the National Environmental Policy Act (NEPA).
On the second day, FDA presented data supporting AquaBounty’s claim that AquAdvantage Salmon grow faster than conventionally bred Atlantic salmon. FDA provided information on:
- the recombinant DNA construct used to produce AquAdvantage Salmon;
- animal health;
- food safety; and
- environmental concerns.
In FDA’s commitment to increase transparency in decision-making, both days of the meeting were open to the public.
FDA has no timeline for making a decision on the AquaAdvantage Salmon application. The agency continues to review the application, the committee’s recommendations, and the public comments to the committee. The agency is also moving through the environmental (NEPA) process.