Genetically engineered meat could be on the table after U.S. review

— -- After more than seven years of discussion, the Food and Drug Administration Thursday proposed regulations that would allow the commercial use of genetically engineered animals.

Such animals are genetically altered — their genes are either changed or genes from another animal are added — for a specific purpose. The FDA states that such animals either produce drugs; serve as models for human disease; produce industrial or consumer products, such as fiber; or have improved food-use qualities, such as being more nutritious.

The only genetically engineered creature available for sale in the USA is an aquarium fish that glows in the dark. Examples currently in the laboratory stage include:

•Salmon that grow more quickly and efficiently.

•Goats that produce drugs in their milk or blood.

•Chickens that produce drugs in the whites of their eggs.

•Cows that cannot get the brain-wasting mad cow disease.

•Pigs engineered to make their organs transplantable into humans without rejection.

•Hypoallergenic dogs and cats.

The proposed regulations would require FDA review of each application to ensure that any food sold for human consumption is safe and that the animal's health would not be damaged in the process.

Each use would have to be approved separately, so a goat that made insulin in its milk would be one application. That same goat engineered to also be resistant to udder infections would be another.

It's expected that once a company creates an animal with the exact right genetic makeup, more animals would be made by cloning to preserve the genetics.

While the potential is huge, the actual number of groups working on animals like this is small, says Jaydee Hanson from the non-profit Center for Food Safety. "You're talking maybe five or so companies and 10 or so universities."

The FDA will take public comment until Nov. 18, then finalize the regulations.

Although opposed by some, genetically engineered plants are widely used in U.S. agriculture. Genetically engineered microorganisms are commonly used to produce drugs. But engineered animals have been much more controversial, with the term "Frankenstein animals" bandied about. These regulations have been in the works since the last days of the Clinton administration.

The rules don't require the labeling of meat or milk from engineered animals approved by the FDA, something the advocacy group Consumers Union finds "incomprehensible." The group is also concerned that milk from cows engineered to produce antibiotics that help them avoid udder infections will not be labeled, says senior scientist Michael Hansen.

The FDA is instituting the rules under the New Animal Drug portion of the Food, Drug and Cosmetic Act. In effect, the agency is saying that adding genes is like giving drugs to animals.

Because companies creating new drugs generally don't want their competitors to know what they're working on, the rules consider all applications proprietary. So the FDA can't tell the public what applications have been made or what the companies want to do, says Alison Van Eenennaam, a professor of animal genomics at the University of California at Davis.

That's not going to work when it comes to genetically engineered farm animals, says Gregory Jaffe, director of the Biotechnology Project at the non-profit Center for Science in the Public Interest in Washington D.C. "FDA's going to need to find a way to make that process transparent and involve the public, because otherwise consumers aren't going to want to eat these products," he says.