FDA to rule on cloned milk; food activists having a cow

Got cloned milk?

Infigen Inc., a DeForest, Wis. biotechnology company does. With 34 of its 170 cloned cattle currently in a "milking barn," Infigen is ready to place bottles of the herd's output on America's breakfast tables.

Instead, executives at Infigen say they dump hundreds of gallons of the milk a day awaiting a Food and Drug Administration decision on the safety of cloned-derived products for human consumption, the environment and the animals themselves.

Ranchers already "selectively breed" their herds, plucking out the best milk-producing, the healthiest and biggest animals as breeders.

Infigen and at least two other competitors -- ProLinia Inc. of Athens, Ga. and Advanced Cell Technology of Worcester, Mass. -- say cloning can more quickly improve upon the herds' gene pools.

Infigen's cloning process involves activating the unfertilized egg of a standout bovine by removing the nucleus, fusing the egg with a cell from the same animal's ear, then triggering the egg to divide and grow.

The resulting embryo is then implanted in a surrogate cow.

The other two companies use similar techniques. A tangled intellectual property dispute over rights to the process is before the U.S. Patent and Trademark Office.

'A river of milk'

All three companies have voluntarily withheld their cloned-derived food and drink from the market until the FDA decides the issue.

"We are awash in a river of milk," lamented Infigen head Michael Bishop, who said he himself even drank the milk without harm.

Food activists, though, are having a cow over all the genetic tinkering.

They argue that not enough research has been done on biotechnology's effect on the environment and human health and argue for a complete ban on all genetically modified products.

They derisively term the experimental products "Frankenfood," and fear that tinkering with genes could lead to mutated and weakened species.

The FDA expects to soon receive a report it commissioned from the National Academy of Sciences on cloned-derived goods and other animal biotechnology issues such as genetically engineered fish and poultry.

The report is widely expected to help set the tone at the FDA for regulating cloned-derived food.

Probably not until fall

Concerned about the welfare of the cloned animals as well as their safety for humans and the environment, the FDA has said it probably won't rule on cloned-derived food until sometime in the fall.

The agency is essentially deciding whether cloned animals should be treated like genetically engineered animals, which are regulated by the FDA, or like animals bred through in-vitro fertilization, which don't require FDA regulation.

Meanwhile, scientists around the world continue to genetically engineer everything from fish to loaves. They hope biotechnology can create better foods faster and cheaper.

Fish researchers are stitching genes into salmon that trigger faster growth. Wheat farmers are working with pesticide-resistant crops. Other genetic engineers work to perfect juicier dinner-table chickens, fatter pigs and drought-resistant tomatoes.

The cloning companies argue that their technology is not genetic engineering and should be considered separately -- a position that appears to have received support of some academy members writing the report.

The companies are hopeful the agency will allow cloned-derived products into the food chain without restriction.