Scientific advances such as genome editing have tremendous potential for the aquaculture industry. Intentional genomic alterations (IGAs) can be introduced to confer disease resistance, improve environmental tolerance, manipulate sex ratios, or increase growth rates for food production. FDA regulates IGAs in animals, including aquaculture, using a science- and risk-based approach. These IGAs are developed using a wide variety of techniques and for a wide range of intended uses. FDA evaluation ensures safety to animals, safety to humans, and that the alteration does what it is claimed to do by the developer. In this presentation, FDA will describe its risk-based approach to the oversight of IGAs, provide information about the risk assessment process, provide information about a pilot Veterinary Innovation Program for certain IGAs, clarify specific misconceptions about FDA's regulation of IGAs, and lastly, provide an overview of an example of an IGA approval in aquaculture, AquAdvantage Salmon. FDA also plans to communicate its intent to seek feedback from stakeholders to enhance transparency, predictability, and efficiency in the review process.