Abstract
On November 19, 2015, the U.S. Food and Drug Administration (FDA) announced its long-awaited decision regarding AquaAdvantage Salmon, the first genetically engineered (GE) animal intended for food. The FDA has approved AquaBounty Technologies’ new animal drug application (NADA) for the Salmon, finding that it meets the statutory requirements under the Federal Food, Drug, and Cosmetic Act (FDCA). In particular, the FDA determined that the Salmon’s rDNA construct is safe for the fish itself, the fish reaches market size more quickly than non-GE farm-raised Atlantic salmon (as AquaBounty claimed), and food from the fish is safe to eat and as nutritious as food from non-GE salmon.
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Notes
- 1.
FDA, Comments And Agency’s Responses On The Public Hearing on The Labeling of Food Made From Aquadvantage Salmon Docket No. FDA-2010-N-0385 (Nov. 2015), p. 3 at http://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/UCM469766.pdf.
- 2.
The RFE was developed by FDA scientists at the Seafood Products Research Center (SPRC, Seattle District), and the Center for Food Safety and Applied Nutrition (CFSAN) to help federal, state, and local officials and purchasers of seafood identify species substitution and economic deception in the marketplace (available at http://www.fda.gov/Food/FoodScienceResearch/RFE/). Data in the RFE includes high-resolution photographs of the whole fish and marketed products (fillets and steaks), tissue protein patterns determined by isoelectric focusing electrophoresis gels, and mitochondrial DNA sequence determined by DNA barcoding.
- 3.
FDA, Center for Veterinary Medicine, Finding of No Significant Impact: AquaAdvantage Salmon (Nov. 12, 2015) at http://www.fda.gov/downloads/AnimalVeterinary/DevelopmentApprovalProcess/GeneticEngineering/GeneticallyEngineeredAnimals/UCM466219.pdf.
- 4.
FDA, Center for Veterinary Medicine, AquaAdvantage Environmental Assessment (Nov. 12, 2015), at http://www.fda.gov/downloads/AnimalVeterinary/DevelopmentApprovalProcess/GeneticEngineering/GeneticallyEngineeredAnimals/UCM466218.pdf.
- 5.
FDA, 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 (Nov. 19, 2015), at http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/GeneticEngineering/GeneticallyEngineeredAnimals/ucm466350.htm.
- 6.
FDA, Draft Guidance for Industry: Voluntary Labeling Indicating Whether Food Has or Has Not Been Derived From Genetically Engineered Atlantic Salmon at http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm469802.htm. Although the FDA recognized that some consumers are interested in knowing that food from AquAdvantage Salmon is produced using genetic engineering, the agency stated that such consumer interest, alone, is not a material fact within the meaning of the FDCA, and is not a sufficient basis upon which FDA can require additional labeling.
- 7.
For example, for food products or food ingredients derived from Atlantic salmon that was not genetically engineered, examples of statements that manufacturers may voluntarily use include: “Not genetically engineered;” “Not genetically modified through the use of modern biotechnology;” “We do not use Atlantic salmon produced using modern biotechnology.”
Manufacturers of food products or food ingredients derived from AquAdvantage Salmon can label their products as “Genetically engineered” or may indicate, for example, that “This salmon patty was made from Atlantic salmon produced using modern biotechnology.”
- 8.
Food & Water Watch, FDA Approves Unlabeled GMO Salmon Despite Widespread Opposition from Scientists, Consumers and Members of Congress (Nov. 19, 2015) at https://www.foodandwaterwatch.org/news/fda-approves-unlabeled-gmo-salmon-despite-widespread-opposition-scientists-consumers-and.
- 9.
Consumers Union, Consumers Union “Deeply Disappointed” by FDA Move to Approve GE Salmon without Requiring Labeling (Nov. 19, 2015), at http://consumersunion.org/news/25036/.
- 10.
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Negowetti, N.E. (2017). Textbox: FDA Approval of GE Salmon. In: Steier, G., Patel, K. (eds) International Farm Animal, Wildlife and Food Safety Law. Springer, Cham. https://doi.org/10.1007/978-3-319-18002-1_15
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