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FDA seeks comment on guidance plan for genetically altered animals

September 24, 2008

Washington, D.C. -- The U.S. Food and Drug Administration (FDA) has released its guidelines for genetically engineered (GE) animals for research and food production.

Washington, D.C.

-- The U.S. Food and Drug Administration (FDA) has released its guidelines for genetically engineered (GE) animals for research and food production.

The guidelines, though aimed at industry producers could help the public gain a better understanding about the benefits and importance of a GE animal population, according to the FDA.

Some of the benefits of GE animal world is the protection of animal health by developing better genetic resistance to certain diseases, less environmental impact by engineering animals to grow quicker and require less feed therefore leaving behind less waste, and a healthier food supply through livestock developed to increase nutrients like omega-3 fatty acids, leaner milk and more milk production. Other effects of GE animals are more transplantation sources for humans, which researchers believe could result from pigs engineered for human transplant to reduce risk of immune rejection. New sources of medications also is a benefit, as the FDA believes GE "biopharm" animals can produce particular substances, like human antibodies, to make infection-fighting drugs for humans.

GE animals are regulated under the new animal drug provisions because of the rDNA construct used to change the structure of the GE animal's body. The FDA will be able to enforce discretion over its approval of GE animals for food use on a case-by-case basis, according to the guidelines.

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The American Veterinary Medical Association (AVMA) released a statement the same day as the FDA issued its guideline, applauding the federal agency.

"The development and appropriate regulation of this technology has widespread applications in advancing our knowledge of diseases, food safety, environmental conservation, and efficient food and fiber production," says Dr. W. Ron DeHaven, chief executive officer of the AVMA. "Genetic engineering has opened many doors and has the potential to provide great benefit to humans, animals and our society."

Read the full FDA guidance plan on GE animals here. Public comment on the plan can be submitted until Nov. 18 by clicking here.

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