Public Meetings on Genetically Engineered Atlantic Salmon

On September 19-21, 2010, the FDA will hold two public meetings on AquAdvantage Salmon, a genetically engineered (GE) Atlantic salmon intended to be used for food.

On September 19-20, the FDA will hold a meeting of the agency's Veterinary Medicine Advisory Committee (VMAC), which will address science-based issues associated with AquaBounty Technologies’ application. The Sept. 19 session is an orientation for VMAC members on the technology of producing GE animals and the FDA’s regulatory process for evaluating these animals. On Sept. 20, the FDA will present information on animal health, food safety, environmental concerns, and data supporting the claim that AquAdvantage Salmon grow faster than conventionally bred Atlantic salmon. Both days of the VMAC meeting are open to the public.

On September 21, 2010, the FDA will hold a public hearing at which it will present the relevant legal principles for food labeling and describe information made available prior to the hearing about AquAdvantage Salmon. Although it will be FDA’s responsibility to determine if any special labeling is required in accordance with federal law, the hearing will offer the public an opportunity to comment on the application of the relevant food labeling principles to foods that might be made from the AquAdvantage Salmon.

At each meeting, interested persons may present data, information, or views, orally or in writing. Because the two meetings are held by different Centers within the FDA, the comment processes and deadlines differ.

• Individuals who wish to make an oral presentation at the VMAC and the Part 15 hearing must register in advance.
• Advance registration to attend the VMAC and the Part 15 hearing is strongly encouraged, so that the FDA may plan accordingly for space.
• Instructions on how to register or apply to present are included in the links below.

Please see the following links for more information.

Veterinary Medicine Advisory Committee (VMAC)

• September 19-20, 2010: Veterinary Medicine Advisory Committee Meeting Announcement
• Federal Register Notice of September 19-20, 2010 Veterinary Medicine Advisory Committee Meeting (PDF - 48KB)
• 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
• Briefing Packet for AquAdvantage Salmon Veterinary Medicine Advisory Committee (PDF - 2506KB) 
• Environmental Assessment for AquAdvantage Salmon (Aqua Bounty Technologies, Inc.) (PDF - 1095KB)
  Persons using assistive technology may not be able to fully access information in this document. For assistance, please call 781-899-7755.
• AquAdvantage Salmon Application Review: Questions and Answers
• Charge to the VMAC for the AquAdvantage Salmon Meeting
• Key Facts Commonly Misunderstood about FDA’s Upcoming Review of the AquAdvantage Salmon
• 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 20, 2010 Veterinary Medicine Advisory Committee Meeting (PDF - 647KB)
• Transcript for the September 19, 2010 Veterinary Medicine Advisory Committee Meeting (PDF - 267KB)

Part 15 Hearing

• Constituent Update for the Public Hearing
• Federal Register Notice of Public Hearing re: Labeling of Food Made from AquAdvantage Salmon; Request for Comments (PDF - 126KB)
• Background Document: Public Hearing on the Labeling of Food Made from the AquAdvantage Salmon