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3-Food: U.S. FDA decision on cloned meat expected soon



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TITLE:  Decision on Cloned Meat Expected Soon
SOURCE: WebMD Medical News, USA, by Todd Zwillich
        reviewed by Michael Smith, MD
        http://my.webmd.com/content/Article/107/108711.htm
DATE:   28 Jun 2005

------------------- archive: http://www.genet-info.org/ -------------------


Decision on Cloned Meat Expected Soon
FDA Soon to Rule on Safety of Cloned Animals for Food and Breeding

June 28, 2005 -- Federal regulators may soon release a decision on
whether meat and milk from cloned animals and their offspring are safe
for human consumption.

The decision is widely expected to conclude that cloned livestock pose no
risk to humans. It is being eagerly anticipated by both industries eager
to use clones to vastly cut the cost of food production and by food
safety groups who warn that declaring clones safe is premature.

FDA senior scientist John Matheson told attendees of a biotechnology
conference last week that the FDA's four-year evaluation could be
released any day. The remarks were originally reported by the Financial
Times newspaper.

"I do expect it to be very soon. 'Very soon' when you're dealing with an
FDA guidance could be this week or could be two months from now," says
Scott Davis, president of stART Licensing, Inc., a company that patents
cloning technologies for livestock, including the patent used to clone
Dolly the sheep, the first successfully cloned mammal. Davis hosted the
conference where Matheson reportedly made the comments.

"We're not ready to make an announcement," FDA spokeswoman Suzanne Luber says.

Many livestock producers have been waiting to use cloning as a way to
copy breeding animals prized for their genetic and physical traits.
Producers have so far held off using cloned animals in commercial food
production at the FDA's request.


Reports Favor Cloning

A draft FDA assessment in October 2003 stated that cattle, pigs, sheep,
and goats "derived from animal clones and their offspring are likely to
be as safe to eat as food from their nonclone counterparts, based on all
the evidence available."

The conclusion echoes a 2002 National Academy of Sciences study, which
found "no current evidence" that food derived from clones or their
offspring posed a safety risk.

Meat and dairy producers want to use clones to cut costs and to remove
much of the guesswork from choosing prime breeding animals.

A prize breeding bull can cost upwards of $130,000 at auction, while
cloning an existing bull costs about one-sixth the price, says Leah
Wilkinson, director of food policy at the National Cattlemen's Beef
Association. In addition, cloning can cut as much as three years from the
time it now takes to select prime breeding animals from herds.

"Everything we've seen is that beef from cloned offspring is safe.
There's no difference in nutrition and it's the same as regular beef,"
she says.

Cloned livestock are not genetically modified to express favorable
traits. Instead, they are copies of animals deemed the most favorable for
breeding because of the tenderness of their meat, ability to produce
milk, or other qualities.

Safety Concerns Voiced

But food safety advocates warn that it's too early to conclude that
cloned animals or their offspring are safe for human consumption. They
remain especially concerned about the process of somatic cell nuclear
transfer, in which genetic material is inserted into a host body cell,
eventually producing an exact copy of the genetic donor.

Craig Culp, a spokesman for the Center for Food Safety, says that not
enough studies directly comparing meat from animals cloned using somatic
nuclear transfer -- or their offspring -- with conventionally bred
animals have been performed.

Culp points to the "typically sickly nature" of many cloned newborn
mammals and to a lack of studies on potential abnormal genes in clones as
areas of concern. The group also questions the ethics of using cloning to
homogenize animals used in the food supply.

"There are a lot of issues that have not been addressed, and a decision
from the FDA to approve this would be highly premature," he says.

Lawrence B. Schook, PhD, a member of the 2002 NAS committee, tells WebMD
that there was "very little concern" on the panel for the safety of
nongenetically modified cloned animals or their offspring. "If the animal
grows healthy, can reproduce itself, grows and acts normal, then it is
normal," says Schook, an expert in animal genomics at the University of
Illinois, Urbana-Champaign.

Schook is also co-founder of Pryxis, a private animal genomics company.

Davis, who is also founder of the animal cloning company ViaGen Inc.,
tells WebMD that his firm submitted tests to the FDA comparing
approximately 600 cloned pigs and their offspring with conventionally
bred animals. The study found "not one" significant difference in
nutritional content, he says.

Even if the FDA approves the sales, consumers' acceptance of cloned farm
products remains an open question. Internal polling at stART suggests
about 60% of U.S. consumers are uncomfortable with cloned animals or
their offspring in the food supply. But the government's stamp of
approval on the animals lowers disapproval to around 40%.

The FDA approval will also likely set off a battle between meat producers
and consumer groups over whether clone-derived products should be labeled
as such on grocery store shelves.

"At some point I could see a labeling fight would be forthcoming," Culp says.


SOURCES:
Scott Davis, president, stART Licensing, Inc. Suzanne Luber, spokeswoman,
FDA. Leah Wilkinson, director, food policy, National Cattlemen's Beef
Association. Craig Culp, spokesperson, Center for Food Safety. Lawrence
B. Schook, professor of genomics, University of Illinois, Urbana-
Champaign; co-founder, Pryxis.




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