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FDA Proposes Regulations for Genetically Engineered Animals
Date:9/18/2008

Producers must provide safety and efficacy data before market approval

THURSDAY, Sept. 18 (HealthDay News) -- The prospect of foods and other products from so-called genetically engineered animals moved a step closer to reality Thursday, as U.S. regulators said producers of such animals will have to prove they are safe to eat.

The U.S. Food and Drug Administration said it was proposing new guidelines for genetically engineered animals. These guidelines lay out the agency's position on its authority to regulate the burgeoning industry of genetically engineered animals and spell out requirements and recommendations to producers of these animals.

"Genetic engineering is no longer a new technology. It has been widely used in agriculture to make crops resistant to certain pests or herbicides or with improved nutritional qualities," Randall Lutter, deputy commissioner for policy at the FDA, said during a morning teleconference.

"Many kinds of genetically engineered animals are in development, but none has yet been approved by the agency for marketing," he said.

Genetic engineering in animals refers to the use of what scientists call recombinant DNA techniques to introduce new characteristics or traits, often adding a genetic trait from one animal to another.

Proponents 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.

Opponents say the practice could unleash unintended consequences by altering the traditional genetic structures of animals.

Lutter said that "in food production, 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, he added.

Some of the genetically engineered an
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