A Clone Sandwich, Anyone?

Laurel

Kitty Mama
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U.S. Studying Safety of Animal Clones As Food

WASHINGTON (Reuters) - U.S. regulators said on Tuesday they have urged companies that clone livestock to apply for their permission before they put the animals' meat or milk into the food supply.

The Food and Drug Administration (news - web sites) is developing policy guidelines on whether cloned animals that are not genetically modified should be tightly regulated like drugs.

The agency plans to issue its position after the National Academy of Sciences (news - web sites) completes a report assessing if cloned animals pose any hazards to animals, human health or the environment. The report is due out early next year.

In the meantime, the FDA has advised a handful of companies that clone sheep, cows or pigs to file an application with the agency if they want to sell cloned animals as food.

``If people insist on putting them into the food supply ... before the report is out, we would recommend that they come into us with an investigational application first, just to be on the safe side,'' said John Matheson, a senior regulatory scientist at the FDA's Center for Veterinary Medicine.

Companies involved in animal cloning include PPL Therapeutics, creator of Dolly the sheep, Infigen Inc. and Advanced Cell Technology.

Infigen spokesman Peter Steinerman said its first cloned cows whose milk might go into the food supply are due to be born in September. The cattle are clones of a prized dairy cow named Mandy with above-average milk production.

Infigen has told customers it will not release the cows until it has regulators' support, Steinerman said. The company is preparing a study of the milk produced by the clones, and plans to share results with the FDA.

``We look forward to working with the FDA and any other regulatory agency to address concerns,'' Steinerman said.

Scientists clone animals by taking DNA from an adult cell and placing it in a female egg stripped of its own genetic material. The embryo is implanted into a surrogate mother, and the resulting baby animal is a clone.

Such cloned animals are genetic copies of another animal, and they do not pose the same concerns as animals whose genes have been modified.

``In theory these animals should be fine, but we want to make sure there isn't any risk associated with them,'' Matheson said.

At a congressional hearing in March, experts reported high rates of failures in animal cloning attempts and birth defects as arguments against cloning people.

The FDA commissioned the National Academy study to help regulators decide whether cloned animals should require ''pre-market'' approval as drugs do, or if they should be classified like in-vitro fertilization, which is more loosely regulated.

``We're trying to make a science-based decision on whether unmodified cloned livestock should be regulated on a pre-market approval basis,'' Matheson said.

Elsewhere, a doctor at the University of Tennessee reported Tuesday that a 9-month-old Jersey calf that was the first of the breed cloned in the United States from an adult cell was found dead from unknown causes.

http://dailynews.yahoo.com/h/nm/20010605/sc/food_cloning_dc_2.html
 
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