The guidance, titled "The Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs," clarifies the FDA's statutory and regulatory authority, and provides recommendations to producers of GE animals to help them meet their obligations and responsibilities under the law.

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 is 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.

“This guidance will help the FDA efficiently review applications for products from GE animals to ensure their safety and efficacy ," said Randall Lutter, Ph.D., deputy commissioner for policy.

The FDA released the draft guidance in September 2008 with a 60-day public comment period, and received about 28,000 comments. The agency has summarized and responded to these comments on the Web site listed below.

The FDA's Center for Veterinary Medicine (CVM) says it has been working with developers of GE animals on both early stage and more mature applications.

“At this time, it is our intent to hold public scientific advisory committee meetings prior to making decisions on GE animal-related applications" said Bernadette Dunham, D.V.M., Ph.D., director of CVM.

Relating to food animals, the document says: "if you wish to introduce investigational animals or animal products into the food or feed supply, you must request an Investigational Food Use Authorization (21 CFR 511.1(b)(5)). For those animals subject to slaughter inspection by the USDA Food Safety and Inspection Service (FSIS), we will inform FSIS if our safety concerns are met and we grant you an Investigational Food Use Authorization".

FSIS has oversight of most meat, poultry, and egg products, and enforces tolerances (maximum allowable amounts) set by FDA on new animal drug residues in such products.

Further Reading

	-	View the FDA's Genetically Engineered Animals information page by clicking here.
	-	Alternatively, for more information, read: Brave New Farm: GE Food Animals in the USA by clicking here.