FDA Says Hold Off on Eating Cloned Animals

FDA: Cloned Animals Not OK'd As Food
Updated: Tue, Jun 05 11:50 AM EDTBy PHILIP BRASHER,
AP Farm Writer

WASHINGTON (AP) - The Food and Drug Administration says it doesn't
want meat or milk from cloned livestock sold to consumers until it is sure the
food 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.