-Caveat Lector-

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Cloned livestock not safe for eating, FDA says

By PHILIP BRASHER
Associated Press

WASHINGTON (June 5, 2001 01:30 p.m. EDT) - The Food and Drug
Administration says meat and milk from cloned livestock should
not be sold to consumers until experts determine it is safe
and the technology won't harm the environment or the animals.

"We're trying to make a science-based decision on whether
these types of animals pose any risk or not," John Matheson,
a senior regulatory review scientist for the FDA, said Tuesday.

In a series of meetings over the past six months, FDA officials
have asked biotech companies to keep the livestock out of
the food chain until the National Academy of Sciences completes
a review of their safety and makes recommendations to FDA.
The study is expected to be finished by early next year.

The FDA is concerned about the welfare of the cloned animals
as well as their safety for humans and the environment. The
agency believes it has the authority to regulate cloned animals
under its approval process for new animal drugs.

Essentially, 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.

"We figure there is a pretty good chance there won't be a
need to regulate them," Matheson said.

One concern of scientists is that mass animal cloning could
lead to breeds that are more susceptible to disease, The
Wall Street Journal reported Tuesday.

A Holstein dairy cow cloned by Infigen Inc. of DeForest,
Wis., was sold at auction last fall in the first commercial
sale of a farm animal. Infigen also owns a herd of cloned
cattle that are used to produce genetically engineered proteins
for pharmaceutical purposes.

Infigen's cloning process involves activating an unfertilized
egg by removing the nucleus, fusing the egg with a cell from
the same animal's ear, and then using a chemical compound
to trigger a release of calcium that causes the egg to divide
and grow. The resulting embryo is then implanted in a surrogate
cow.
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