The FDA released for public comment draft guidance on the regulation of genetically engineered (GE) animals. The guidance document is intended to clarify the FDA’s regulatory authority in this field, as well as the requirements and recommendations for producers of GE animals and products derived from GE animals. Among other things, the guidance requires producers to demonstrate that food from the GE animal is safe to eat if the GE animal is intended for food use. The guidance also describes a sponsor’s responsibility in meeting the National Environmental Policy Act’s environmental assessment requirement. The draft guidance also describes how the FDA may exercise enforcement discretion with regard to GE animals. The FDA will accept comments on the guidance through November 18.
