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Development & Approval Process

• Genetic Engineering

• Genetically Engineered Animals

• Genetically Engineered Salmon

Resources for You

• CVM GFI #187 Regulation of Genetically Engineered Animals Containing Heritable Recombinant DNA Constructs (PDF - 149KB)

Genetically Engineered Salmon

FDA has issued for public comment a draft environmental assessment (EA) related to the agency’s review of an application concerning AquAdvantage Salmon, a genetically engineered Atlantic salmon. FDA’s preliminary finding is that an approval of this application, under the specific conditions proposed in the application, would not have a significant impact (FONSI) on the U.S. environment. AquAdvantage Salmon is a product of AquaBounty Technologies (AquaBounty), of Maynard, Mass. 

Environmental Documents

• Notice of Draft Environmental Assessment and Preliminary Finding of No Significant Impact Concerning a Genetically Engineered Atlantic Salmon
• AquAdvantage Salmon Draft Environmental Assessment (PDF - 5.4MB)
• AquAdvantage Salmon Preliminary Finding of No Significant Impact (PDF - 51KB)

Public Hearing on the Labeling of Food Made from AquAdvantage Salmon - September 21, 2010

• FDA to Convene Public Hearing on the Labeling of Food Made from AquAdvantage Salmon
• Federal Register Announcement of the Public Hearing
• Background Document: Public Hearing on the Labeling of Food Made from the AquAdvantage Salmon

Veterinary Medicine Advisory Committee - September 19-20, 2010

• September 19-20, 2010: Veterinary Medicine Advisory Committee Meeting Announcement
• Federal Register Notice of Sept 19-20, 2010 Veterinary Medicine Advisory Committee Meeting
• An overview of Atlantic salmon, its natural history, aquaculture, and genetic engineering
• Background Document: The VMAC Meeting on Science-Based Issues Associated with AquAdvantage Salmon
• Agenda for the AquAdvantage Salmon Veterinary Medicine Advisory Committee Meeting
• Meeting Participants for Aquadvantage Salmon Veterinary Medicine Advisory Committee
• Charge to the VMAC for the AquAdvantage Salmon Meeting
• Briefing Packet for AquAdvantage Salmon Veterinary Medicine Advisory Committee (PDF - 2.7MB)
• Environmental Assessment for AquAdvantage Salmon (Aqua Bounty Technologies, Inc.) (PDF - 1.1MB)
• Questions and Answers
• Key Facts Commonly Misunderstood
• Presentations from the September 20, 2010 Veterinary Medicine Advisory Committee Meeting
• Chairman's Report for the September 20, 2010 Veterinary Medicine Advisory Committee Meeting (PDF - 100KB)
• Transcript for the September 19, 2010 Veterinary Medicine Advisory Committee Meeting (PDF - 267KB)
• Transcript for the September 20, 2010 Veterinary Medicine Advisory Committee Meeting (PDF - 647KB)

Page Last Updated: 12/26/2012
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