FDA has issued a draft of revised guidance clarifying its regulatory approach to genetically modified animals.
Using animals that fall under the affected categories for food or food supply requires an Investigational Food Use Authorization. The authorization can be granted for animals subject to slaughter inspection by the USDA Food Safety and Inspection Service (FSIS); FDA will grant the authorization if its safety concerns are met. The guidance recommends scheduling a teleconference or in-person meeting with FDA to determine which classes of animals may be used in food.
The guidance deals with animals whose genomes have been intentionally altered, including by nucleotide insertions, substitutions or deletions. Recent genetic modification technology involves editing genomes to introduce specific alterations, as opposed to previous methods that could result in more random alterations. The guidance applies to both the originally altered animal and its lineage.
The guidance can be found at www.fda.gov/RegulatoryInformation under “Recently Posted Guidance Documents.”