Are all GE animals subject to regulation under the new animal drug provisions of the Act?
Yes, any animal containing an rDNA construct intended to alter its structure or function is subject to regulation by FDA prior to commercialization. However, based on risk, there are some GE animals for which the agency may not require an approval. In general, these include laboratory animals used for research. On a case-by-case basis, the agency may consider exercising enforcement discretion for GE animals of very low risk, such as it did for an aquarium fish genetically engineered to fluoresce in the dark. The agency does not anticipate exercising enforcement discretion for any GE animal of a species traditionally consumed as food, and expects to require approval of all GE animals intended to go into the human food supply. Q. Why is the agency taking a different approach for GE animals from the one taken for clones? A: In the case of clones, the agency first needed to determine whether food from clones posed any additional risks compared with food from more conventionally bred animal
