The U.S. Food and Drug Administration, part of the Department of Health and Human Services, today released for public comment draft guidance on the regulation of genetically engineered (GE) animals.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.

The comment period for the draft guidance, titled "The Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs," runs for 60 days and closes Nov. 18, 2008. The 25-page document is available online at www.fda.gov/cvm/GEAnimals.htm.

Genetic engineering generally refers to the use of recombinant DNA (rDNA) techniques to introduce new characteristics or traits into an organism. When scientists splice together pieces of DNA and introduce a spliced DNA segment into an organism to give the organism new properties, it's called rDNA technology. The spliced piece of DNA is called the rDNA construct. A GE animal is one that contains an rDNA construct intended to give the animal new characteristics or traits.

GE animals can be divided into several classes, based on their intended use. They include animals that produce human or animal pharmaceuticals (biopharm animals); animals that serve as models for human diseases; animals that produce high-value industrial or consumer products, such as fibers; and food-use animals with new traits such as improved nutrition, faster growth or lower emission levels of environmentally harmful substances (such as phosphate in their manure).

Genetic engineering already is widely used in agriculture to make crops resistant to pests or herbicides. In medicine, genetic engineering is used to develop microbes that produce drugs and other therapeutic products for use in humans. In food, genetic engineering is used to produce microorganisms that aid in baking, brewing, and cheese-making.

Using the animal drug provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA's Center for Veterinary Medicine (CVM) has been working with developers of GE animals to make them aware of their responsibilities to ensure that food from these animals does not enter the U.S. food supply unless the FDA has authorized such use.

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