The U. S. Food and Drug Administration announced formal guidelines to govern the approval of genetically engineered (GE) animals. In a statement Randall Lutter, deputy commissioner for policy at the FDA's Center for Veterinary Medicine said, "Genetic engineering is a cutting edge technology that holds substantial promise for improving the health and well being of people as well as animals."

The FDA clarified that genetic engineering involves using recombinant DNA (rDNA) to introduce new characteristics or traits into an animal, does not make clones but simply adds new characteristics or traits in them via their DNA. Under the new guidelines producers of these animals are directed on how the get approval from the agency for there newly engineered animal. Additionally, producers of these animals will also have to comply with the law and regulations of the National Environmental Policy Act.

"In this document, the agency has articulated a scientifically robust interpretation of statutory requirements. This guidance will help the FDA efficiently review applications for products from GE animals to ensure their safety and efficacy," said Lutter.

Although there are many genetically engineered animals in development none have been approved by the agency for marketing as yet. According to Dr. Bernadette Dunham, director for the FDA's Center for Veterinary Medicine all GE animals would have to undergo rigorous scientific testing before being sold on the market. "This technology holds great promise for the health of both animals and humans. We want the public to understand that food from GE animals will not enter the food supply unless FDA has determined that it is safe," she said.

The debate on genetic engineering is divided with those in favor saying this would result in animals that can grow faster, produce healthier foods, such as heart-healthy eggs, or be resistant to certain diseases, such as mad cow disease.

Dunham said that genetic engineering can also improve the environment by making animal waste less toxic. "Pigs have been genetically engineered to produce less phosphorus in their waste to address agricultural runoff," she said. Fish have already been genetically engineered to grow to market size faster, "so that the wild ocean populations will not be subject to such intensive harvest pressure," Dunham said.

Those who oppose genetic engineering do so as they feel the practice is unethical and could unleash unintended consequences by altering the traditional genetic structures of animals. The biggest concern of over 28,000 organizations and individual citizens is of genetically engineered animals entering the food system.

Under the new guidelines although the genetically altered animal would have to get a clearance before they enter the market, products from genetically engineered animals would not be labeled stating so unless the physical makeup of the animal is altered.

"All genetically engineered animals have to be accompanied by labeling so that they can be distinguished from non-genetically engineered counterparts," said Larisa Rudenko, senior advisor for biotechnology in the Center for Veterinary Medicine.

"[The] FDA is required to ask for labeling if there is a material difference in the food that comes from these animals, but we are not required by law to ask producers to indicate that food comes from genetically engineered animals," she said.

Not happy with the decision certain groups are calling for a change. "We hope the new Obama administration will reverse this ill-considered guidance and require labeling of genetically engineered meat and milk products as soon as possible after it takes office next week," said Jean Halloran, director of food policy initiatives at Consumers Union the nonprofit publisher of Consumer Reports.