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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 animals in development, called biofarm animals, are designed to grow faster to reach market more quickly. Others are being developed to make food healthier, Lutter said. "For example, some pigs have been genetically engineered to contain high levels of omega-3 fatty acids," he said.

Still others are intended to produce drugs. Certain animals are being genetically altered to be used in human transplantations -- for instance, providing cells or tissues or organs that are less likely to be rejected by the human immune system, Lutter said.

"These include islet cells to help diabetics, skin grafts for burn victims, and liver or kidney or heart replacements for the critically ill," he said.

Other genetically engineered traits could help animals resist diseases such as mad cow disease. And some animals are being developed to decrease their environmental impact by decreasing harmful substances in their manure.

Lutter said the U.S. Food, Drug and Cosmetics Act gives the FDA the authority to regulate genetically engineered animals.

"Genetically engineered animals that contain a recombinant DNA segment that is intended to alter the structure or function of the animal are considered to contain a new animal drug," he said. "Genetically engineered animals will, therefore, require premarket approval by FDA prior to their introduction into the marketplace."

Dr. Larisa Rudenko, senior adviser for biotechnology at the FDA's Center for Veterinary Medicine, said the safety of genetically engineered animals intended for use as food will be decided on a case-by-case basis.

"Attention will be paid to particular risks posed by each line of animal, although the basic test will be the same for all animals," Rudenko said during the teleconference. "If the animal is intended to be used for food or feed, we will have to do a full evaluation of food and feed safety. We will also perform an environmental assessment."

Producers of these animals will have to provide proof demonstrating that the new genetic traits perform as claimed, Rudenko said. "We will also ask producers to provide a plan for how they will monitor these animals to ensure that the genetically engineered animals entering commerce in the future are equivalent to those we have approved," she said.

Consumers Union, the nonprofit publisher of Consumer Reports magazine, said it was deeply troubled that the FDA said it would only review genetically engineered animals for their safety as food and would not require any labeling.

"It is incomprehensible to us that FDA does not view these animals as different from their conventional counterparts, and therefore something that under law is required to be labeled," Jean Halloran, director of food policy initiatives at Consumers Union, said in a news release. "In our view, consumers have a right to know if the ham, bacon or pork shops they are buying come from pigs that have been engineered with mouse genes."

Supporting that view was Jaydee Hanson, a policy analyst on cloning and genetics at the Center for Food Safety, who said the new guidelines don't go far enough. "It's bad, because the FDA does not require labeling of genetically engineered animal products. It's bad, because the process is entirely confidential," Hansen said.

The only labeling the FDA requires is related to health claims producers make about their genetically engineered products.

"It's bad because the new animal drug system is only intended to look at toxicity of chemicals in the human body. It's not really intended to look at the biology of a new gene introduced into every cell in animal," Hansen said.

Hansen thinks the consequences of not disclosing which foods are genetically modified is likely to cause more problems for the FDA. "This is an ideal way to have the public lose faith in the FDA -- they've already lost it and this doesn't rebuild it," he said.

More information

For more on genetically engineered animals visit the U.S. Food and Drug Administration.



SOURCES: Sept. 18, 2008, teleconference with Randall Lutter, Ph.D., deputy commissioner for policy, Office of the Commissioner, U.S. Food and Drug Administration; Larisa Rudenko, Ph.D., DABT, senior adviser for biotechnology, Center for Veterinary Medicine, FDA; Consumers Union, news release, Sept. 18, 2008; Jaydee Hanson, policy analyst on cloning and genetics, Center for Food Safety, Wash. D.C.


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