The US Food and Drug Administration, part of the Department of Health and Human Services, released for public comment draft guidance on the regulation of genetically engineered (GE) animals.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 The comment period for the draft guidance, titled "The Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs," runs for 60 days and closes November 18, 2008. The 25-page document is available online at http://www.fda.gov/cvm/GEAnimals.htm.

"Genetically engineered animals hold great promise for improving human medicine, agriculture, the environment, and the production of new materials, and the FDA has long been involved in their scientific evaluation," said Randall Lutter, Ph.D., deputy commissioner for policy. "Our guidance provides a framework for both GE animals and products made from them to reach the market."

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).

Under the draft guidance, in those cases in which the GE animal is intended for food use, producers will have to demonstrate that food from the GE animal is safe to eat. The FDA will review this information as part of its food safety assessment, consistent with that recommended in the recently adopted Codex Alimentarius Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Animals. Codex is a worldwide food safety organization sponsored by the United Nations.

The draft guidance also describes a sponsor's responsibility in meeting the requirements for environmental assessment under the National Environmental Policy Act.

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