FDA Issues Final Regulations for Genetically Engineered Animals

Jan. 16 -- THURSDAY, Jan. 15 (HealthDay News) -- The U.S. Food and Drug Administration on Thursday issued its final regulations governing the approval of genetically engineered animals.

The rules do not require consumer labeling for foods from these animals.

Genetic engineering involves using recombinant DNA (rDNA) to introduce new characteristics or traits into an animal. The new FDA guidance tells producers of these animals what they need to do to get the newly engineered animal approved by the agency.

"It serves to reassure stakeholders that FDA has clear standards for regulatory decisions on these animals allowing us, when appropriate, to bring safe, effective products to market in a timely manner," Randall Lutter, deputy commissioner for policy in the FDA's Center for Veterinary Medicine, said during a morning teleconference.

Genetically engineered animals will require FDA approval before they can enter the marketplace, Lutter said. In addition, producers of these animals will also have to comply with the law and regulations of the National Environmental Policy Act, he said.

Although many kinds of genetically engineered animals are in development, none has yet been approved by the agency for marketing.

In September, a draft of the new regulations was made available for public comment and the final version takes into account some of these comments, Lutter said.

"This technology holds great promise for the health of both animals and humans," Dr. Bernadette Dunham, director of the FDA's Center for Veterinary Medicine, said during the teleconference.

Proponents of genetic engineering say the practice will lead to animals that can grow faster, produce healthier foods, such as heart-healthy eggs, or be resistant to certain diseases, such as mad cow disease.

In addition, genetic engineering can improve the environment by making animal waste less toxic, Dunham said. "Pigs have been genetically engineered to produce less phosphorus in their waste to address agricultural runoff," she said.