Consumer Advocacy Groups Ask FDA to Review GE Salmon Under Food Additive Rules
Three consumer advocacy organizations have filed a petition with the Office of Food Additive Safety of the Food and Drug Administration’s (FDA’s) Center for Food Safety and Applied Nutrition requesting that ABT Technologies’ application to approve genetically engineered (GE) salmon be reviewed under the food additive provisions of the Food, Drug, and Cosmetic Act. The company’s new animal drug application for the GE salmon is currently pending before the agency’s Center for Veterinary Medicine.
According to Food & Water Watch, Consumers Union and the Center for Food Safety, the company’s GE process “significantly alters the salmon’s composition . . . in a way that is reasonably expected to alter its nutritive value or concentration of constituents, and the new substance raises safety concerns. Under the Agency’s regulations and guidelines, such a substance must be treated as a food additive and the Agency must make a closer inquiry into the safety of its consumption, including, but not limited to, subjecting it to extensive pre-market testing.”
The petitioners also ask the office to (i) review the gene expression product (GEP) of the recombinant DNA construct of the GE salmon as a food additive, (ii) render the GEP “an added substance under the Act’s adulteration provisions,” and (iii) find that neither the GE salmon nor the GEP used to create it are generally recognized as safe for human consumption. They claim that FDA “[m]ust find that the GEP is an added substance because it is a hormone removed from Chinook salmon meant to increase the speed at which Atlantic salmon grows to maturity. It is artificially added to Atlantic salmon.” To support their argument, the petitioners describe in detail how the salmon has been created and provide an overview of FDA’s food additive regulations. They also contend that the food additive review is the only way to bring the agency’s safety analysis into compliance with Codex Alimentarius Commission guidelines and that the company “did not provide adequate or well-controlled studies.”
