The guidance document is intended to clarify FDA's regulatory authority in this field, as well as the requirements and recommendations for producers of GM animals and products derived from GM 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The comment period for the draft guidance, titled "The Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs," runs for 60 days and closes Nov. 18. The 25-page document is available online at www.fda.gov/cvm/GEAnimals.htm.

"GE animals hold great promise for improving human medicine, agriculture, the environment and the production of new materials, and FDA has long been involved in their scientific evaluation," said Dr Randall Lutter, deputy commissioner for policy.

"Our guidance provides a framework for both GE animals and products made from them to reach the market."

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 fibres; 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).

Using the animal drug provisions of the Federal Food, Drug & Cosmetic Act, 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 US food supply unless the FDA has authorized such use.

The US Department of Agriculture's Animal & Plant Health Inspection Service (APHIS) is also seeking information from the public and industry about whether additional consideration is needed when genetically engineered animals are imported or moved across the country.