As the U.S. Food and Drug Administration (FDA) considers approving a genetically modified (GM) Atlantic salmon (Salmo salar), it faces fundamental questions of risk analysis and impact assessment. The GM salmon—whose genome contains an inserted growth gene from Pacific chinook salmon (Oncorhynchus tshawytscha) and a switch-on gene from ocean pout (Zoarces americanus)—would be the first transgenic animal approved for human consumption in the United States. But the mechanism for its approval, FDA\'s new animal drug application (NADA) process, narrowly examines only the risks of each GM salmon compared with a non-GM salmon. This approach fails to acknowledge that the new product\'s attributes may affect total production and consumption of salmon. This potentially excludes major human health and environmental impacts, both benefits and risks. Regulators need to consider the full scope of such impacts in risk analyses to avoid unintended consequences, yet FDA does not consider ancillary benefits and risks from salmon market expansion, a result of what may be an overly narrow interpretation of statutes.