FDA Issues Final Guidance on Genetically Engineered Animals

The U.S. Food and Drug Administration has issued final guidance on the regulation of genetically engineered (GE) animals under the new animal drug provisions of the Federal Food, Drug and Cosmetic Act (FFDCA). The guidance clarifies FDA's authority and provides recommendations to producers of GE animals.

GE generally refers to the use of recombinant DNA (rDNA) techniques to introduce new characteristics or traits into an organism. A GE animal contains an rDNA construct intended to give the animal new characteristics or traits.

The FDA released the draft guidance in Sept. 2008 with a 60-day public comment period.

An rDNA construct that is in a GE animal and is intended to affect the animal's structure or function meets the definition of an animal drug. Developers of these animals must demonstrate that the construct and any new products expressed from the inserted construct are safe for the health of the GE animal and, if they are food animals, for food consumption.

Additional information is available at http://www.fda.gov/cvm/GEanimals.htm.

Reprinted from www.meatingplace.com