FDA proposes GE animal rules

WASHINGTON, Sept. 18 (UPI) -- The U.S. Food and Drug Administration is offering for public comment a draft of guidelines involving the regulation of genetically engineered animals.

The FDA, part of the Department of Health and Human Services, said the guidance is intended to clarify its regulatory authority in the field, as well as the requirements and recommendations for producers of GE animals and products derived from GE animals.

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

Depending on the species of animal and its intended use, the FDA said it will coordinate with the U.S. Department of Agriculture and other federal departments and agencies.

The public comment period closes Nov. 18. Additional information is available at http://www.fda.gov/cvm/GEAnimals.htm.