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
If you have questions about an animal biotechnology process or product, please contact the agency at AskCVM-Biotech@fda.hhs.gov. For information on other product types or for all other general inquiries, contact AskCVM@fda.hhs.gov.