The Food and Drug Administration, the lead U.S. regulator of genetically engineered animals, issued two documents to clarify its risk-based oversight of the creatures and their developers. The agency exercises varying levels of scrutiny, ranging from full-scale review of an animal and its risk profile to instances in which developers can take an animal directly to market without consulting the FDA.
“The types of products that may be appropriate for enforcement discretion have expanded since the 2017 draft to include IGAs [intentional genomic alterations] in food-producing animals, such as SLICK cattle, in circumstances including where they have been altered to be equivalent to animals of the same species that already exist and have a history of safe use,” said the FDA.
In March 2022, the FDA cleared for meat production short-haired, gene-edited “Slick” cattle, which were developed to better tolerate hot weather than cattle with longer coats. The agency acted after a scientific review found no safety concerns. It was the FDA’s first low-risk determination for a food-bearing animal.
In a statement, the FDA encouraged developers of biotech animals to approach the agency early in the research and development phase to discuss the risk profile of the animal and which of the three levels of FDA oversight would be appropriate.
“These technologies hold great promise for many uses and public and animal health benefits, such as animal disease resistance, control of zoonotic disease transmission, improved animal husbandry, and increased food production and quality,” said Tracey Forfa, director of the FDA’s Center for Veterinary Medicine.
Besides issuing two “guidance for industry” documents, the FDA and USDA signed a memorandum of understanding on their respective responsibilities in the regulation of GE animals.