Sarah Copper


intentional genomic alterations, IGAs, Food and Drug Administration, FDA, United States Department of Agriculture, USDA, genetically engineered animals

Document Type



Intentional genomic alterations in animals or genetically engineered animals have existed in their modern form since the 1980s. However, the introduction of these animals into our food supply has been a more recent development. The federal government has taken steps in an attempt to regulate these products in a streamlined and efficient manner but has faced criticism in their approach. While the Food and Drug Administration (“FDA”) is currently responsible for the regulation of intentional genomic alterations (“IGAs”) in animals, there is significant effort behind transferring that oversight to the United States Department of Agriculture (“USDA”). However, in the meantime, there are products currently approved and on the market. These products are facing legal hurdles as well as consumer backlash. This paper will address what intentional genomic alterations in animals are, the framework that established the regulatory structure surrounding these products, the current relevant regulatory guidance, the IGA products currently on the market and the legal issues facing these products.