AquAdvantage Salmon
The FDA approved a new animal drug application in November 2015, concerning AquAdvantage Salmon, a genetically engineered Atlantic salmon. Documents related to this approval are available below.
News
- Statement from FDA Commissioner Scott Gottlieb, M.D., on continued efforts to advance safe biotechnology innovations, and the deactivation of an import alert on genetically engineered salmon
- FDA Approves Application for AquaBounty Salmon Facility in Indiana
- Q&A on FDA’s Approval Related to AquAdvantage Salmon
- AquAdvantage Salmon Fact Sheet
Approval Documents
Supplemental Approval Application Documents
- AquAdvantage Salmon Supplemental NADA Approval Letter (PDF - 64KB)
- AquAdvantage Salmon Supplemental NADA Approval Letter Appendix (PDF - 390KB)
- AquAdvantage Salmon Supplemental NADA Environmental Assessment - Persons using assistive technology may not be able to fully access information in this document. For assistance, please call 240-402-7002. (PDF - 3MB)
- AquAdvantage Salmon Supplemental NADA FONSI (PDF - 80KB)
Original Approval Documents
- AquAdvantage Salmon Approval Letter and Appendix
- AquAdvantage Salmon FOI Summary (PDF - 3.7MB)
- AquAdvantage Salmon Environmental Assessment (PDF - 9.6MB)
- AquAdvantage Salmon FONSI (PDF - 252KB)
- AquAdvantage Salmon - Response to Public Comments on the Environmental Assessment
- AquAdvantage Salmon - FDA Response to Public Comments to the Veterinary Medicine Advisory Committee
- AquAdvantage Salmon - FDA Analysis of Potential Impacts on the Environments of the Global Commons and of Foreign Nations not Participating in the Action for NADA # 141-454
- Earth Justice Petition Regarding Pending Application of AquaBounty Technologies for Approval of Genetically-Engineered Salmon
- Food and Water Watch Petition that the FDA deem AquaBounty Technologies' genetically engineered AquAdvantage Salmon an unsafe food additive
Other Environmental Documents
- September 2024 Amended Environmental Assessment for Production of AquAdvantage Salmon
- Amended Finding of No Significant Impact (FONSI) for the Production of AquAdvantage Salmon
- Summary Responses to Public Comments on the November 2022 AAS Draft Amended Environmental Assessment
- Federal Register Notice: Amended Environmental Assessment for Production of AquAdvantage Salmon at the Bay Fortune and Rollo Bay Facilities on Prince Edward Island, Canada; Availability
- Notice of Draft Environmental Assessment and Preliminary Finding of No Significant Impact Concerning a Genetically Engineered Atlantic Salmon
- AquAdvantage Salmon Draft Environmental Assessment (PDF - 3.8MB)
- AquAdvantage Salmon Preliminary Finding of No Significant Impact (PDF - 62KB)
Veterinary Medicine Advisory Committee - September 19-20, 2010
Public Hearing on the Labeling of Food Made from AquAdvantage Salmon - September 21, 2010
- Federal Register Announcement of the Public Hearing
- Background on the Public Hearing on the Labeling of Food Made from AquAdvantage Salmon