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Monday, March 25, 2002 - Page updated at 12:00 AM

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Biotech watch: Should we drink cloned milk? FDA will decide

The Associated Press

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Got cloned milk?

Infigen, a DeForest, Wis., biotechnology company, does. With 34 of its 170 cloned cattle 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 thousands 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 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. An intellectual-property dispute over rights to the process is before the U.S. Patent and Trademark Office.

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's been drinking the milk for months 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 expected to help set the tone at the FDA for regulating cloned-derived food.

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 the fall.

The agency is 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.

"We clone without genetic enhancement," said ProLinia President Mike Wanner. ProLinia, backed by a $1 million investment from the country's No. 1 pork producer, hopes to sell its cloning technology to the beef and pork industries. "It's the same as having an identical twin."

But even if the FDA allows cloned-derived products with minimal oversight, the biotechnology companies still have to win over a skeptical public while convincing agricultural companies the technology will improve their bottom lines.

An increasing number of consumers are become wary of genetically engineered and biologically altered food. Some already avoid purchasing milk produced by cows injected with bovine growth hormone, which is approved by the FDA.

The dairy industry's largest trade organization said it is waiting for the academy's report.

"Any new technology needs to be deemed safe," said Susan Ruland of the Washington, D.C.-based International Dairy Foods Association, which represents 85 percent of the dairy-based companies in the $70 billion-a-year industry.

What's more, each company generally charges between $12,500 and $25,000 to clone a single animal. Studies have shown that only 5 percent of cloning attempts lead to a live birth. Other studies have suggested that cloned animals also suffer more health problems than naturally born ones.

Bull semen for artificial insemination, in contrast, costs about $50 per unit and is the industry standard for breeding better animals.

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