FDA Issues Final Regulations for Genetically Engineered Animals
THURSDAY, Jan. 15 -- 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.
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.
Opponents say the practice could unleash unintended consequences by altering the traditional genetic structures of animals.
During the comment period, many consumer groups asked the FDA to require labels identifying food as coming from genetically engineered animals.
However, FDA officials said Thursday that while a genetically engineered animal has to be labeled as such, any food products from that animal do not.
"All genetically engineered animals have to be accompanied by labeling so that they can be distinguished from non-genetically engineered counterparts," Larisa Rudenko, senior advisor for biotechnology in the Center for Veterinary Medicine, said during the teleconference.
"[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.
Genetically engineered food production has been around for a long time. Genetically engineered yeast is used in baking and brewing, and other products from genetically engineered microbes are used in cheese-making. Genetically engineered microbes are also widely used in medicine to produce drugs.
Certain animals are being genetically altered to be used in human transplantations -- for instance, providing cells, tissues or organs that are less likely to be rejected by the human immune system. These include islet cells to help diabetics, skin grafts for burn victims, and liver, kidney or heart replacements for the critically ill.
The safety of genetically engineered animals intended for use as food will be decided on a case-by-case basis, Dunham said. Producers of these animals will have to demonstrate that the new genetic traits perform as claimed, the agency added.
For more on genetically engineered animals, visit the U.S. Food and Drug Administration.
Posted: January 2009
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