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Interesting. Next time I'm ordering in a restaurant, I can truly say, "I want
what he's having!"
Sandy

FDA Is Set To Approve Milk, Meat From Clones

By Rick Weiss
Washington Post Staff Writer
Tuesday, October 17, 2006; A01

Three years after the Food and Drug Administration first hinted that it might
permit the sale of milk and meat from cloned animals, prompting public 
reactions
that ranged from curiosity to disgust, the agency is poised to endorse 
marketing
of the mass-produced animals for public consumption.

The decision, expected by the end of this year, is based largely on new data
indicating that milk and meat from cloned livestock and their offspring pose 
no
unique risks to consumers.

"Our evaluation is that the food from cloned animals is as safe as the food we
eat every day," said Stephen F. Sundlof, the FDA's chief of veterinary 
medicine,
who has overseen the long-stalled risk assessment.

Farmers and companies that have been growing cloned barnyard animals from 
single
cells in anticipation of a lucrative market say cloning will bring consumers a
level of consistency and quality impossible to attain with conventional 
breeding,
making perfectly marbled beef and reliably lean and tasty pork the norm on
grocery shelves.

But groups opposed to the new technology, including a coalition of powerful 
food
companies concerned that the public will reject Dolly-the-Lamb chops and 
clonal
cream in their coffee, have not given up.

On Thursday, advocacy groups filed a petition asking the FDA to regulate 
cloned
farm animals one type at a time, much as it regulates new drugs, a change that
would drastically slow marketing approval. Some are also questioning the 
ethics
of a technology that, while more efficient than it used to be, still poses 
risks
for pregnant animals and their newborns.

"The government talks about being science-based, and that's great, but I think
there is another pillar here: the question of whether we really want to do 
this,"
said Carol Tucker Foreman, director of food policy at the Consumer Federation 
of
America.

That there is a debate at all about integrating clones into the food supply is
evidence of the remarkable progress made since the 1996 birth of Dolly, the
world's first mammalian clone, created from an udder cell of an anonymous ewe.

Scientists have now applied the technique successfully to cattle, horses, 
pigs,
goats and other mammals. Each clone is a genetic replica of the animal that
donated the cell from which it was grown.

Cloning could solve a number of long-standing farm problems. Many prize males 
are
not recognized as such until long after they have been tamed by castration. 
With
cloning, that lack of semen would not matter. Cloning also allows farmers to 
make
many copies of exceptional milk producers; with natural breeding, cows have 
only
one offspring per year, and half are males.

In the eyes of many in agriculture, cloning is simply the latest in a string 
of
advances such as artificial insemination and in vitro fertilization that have
given farmers better control over animal reproduction.

"Clones are just clones. They are not genetically engineered animals," said
Barbara Glenn, chief of animal biotechnology at the Biotechnology Industry
Organization.

The FDA agrees with that distinction, Sundlof said. The agency has already 
said
it will regulate transgenic animals -- those that have been engineered by 
adding
specific, valuable genes -- in much the way it regulates pharmaceuticals, 
under a
new category called "New Animal Drugs." No such animals are currently on the
market.

By contrast, proponents say, clones are simply twins, albeit born a generation
apart.

It was October 2003 when the FDA released its first draft document concluding
that clones and their offspring are safe to eat, prompting several cloning
companies to scale up their operations.

But an agency advisory panel and the National Academies, while generally
supportive, raised flags, citing a paucity of safety data.

That, and opposition led largely by the International Dairy Foods Association,
which represents such large, brand-sensitive companies as Kraft Foods, Dannon,
General Mills and Nestlé USA, put FDA approval on hold. For years the agency 
has
asked producers to keep clones off the market voluntarily while the issues got
sorted out, a delay that bankrupted one major company and has left others
increasingly frustrated.

But now a large collection of new data submitted to the FDA has revitalized 
the
effort, according to government officials and others.

The biggest new study is a detailed comparison of meat from the offspring of
cloned and conventional boars created by Austin-based ViaGen Inc., a major
producer of cloned farm animals. Company scientists agreed to share key 
results
with a reporter but withheld details as required by the journal 
Theriogenology,
which will publish the full report in its January issue.

Semen from four clones and three conventional boars was used to inseminate 89
females. A total of 404 progeny (242 from clones) were raised identically by
government scientists at the U.S. Department of Agriculture's Meat Animal
Research Center in Clay, Neb., and slaughtered when they reached market size.
(Because clones are so valuable, companies for now anticipate sending only 
their
offspring to market.) Of the 14,036 measures of protein composition, fatty 
acid
profiles and other meat components done on the offspring of clones by an
independent lab, all but three were within the same range as those of the
conventional animals, and only one was outside what the Agriculture Department
considers normal.

The other large research report came from Cyagra, a cloning company in
Elizabethtown, Pa.

In that study, 80 blood and urine measures, including various hormone levels,
were taken in 10 newborn, 46 weanling and 18 adult clones. Results were
indistinguishable from those obtained from conventional animals. Then 79
biochemical measurements from three cuts of meat taken from five male and six
female adult clones were compared with those from matched cuts from 
conventional
animals. Again, no differences were found, said Cyagra's director of 
marketing,
Steve A. Mower. The results have been submitted to the FDA and are being 
reviewed
by a scientific journal.

"The data are very clear," said ViaGen President Mark Walton. "You really 
can't
tell them apart."

In light of the new findings, and the FDA's near completion of a complicated,
interagency review demanded by the White House Office of Management and 
Budget,
Sundlof anticipates releasing a formal draft risk assessment by the end of the
year, along with a proposed "risk management" plan. Those documents would 
allow
the marketing of clones and their offspring for food and milk after a final
period of public comment.

Unless, that is, the opponents manage to stop the process, which they are 
trying
to do on two fronts.

One is the petition filed Thursday by the Washington-based Center for Food
Safety. It asks the FDA to regulate clones, not just transgenics, as New 
Animal
Drugs. It also calls for environmental impact statements to evaluate the
environmental and health effects of each new proposed line of clones.

"The available science shows that cloning presents serious food safety risks,
animal welfare concerns and unresolved ethical issues that require strict
oversight," the petition states.

Industry scientists derided the petition's safety concerns, built largely on a
theoretical possibility that subtle genetic changes seen in some clones may 
alter
the nutritional nature of meat. If those genetic changes were significant, 
Mower
said, they would cause biochemical changes in milk or meat, none of which have
been found.

But issues of ethics and public acceptance are not easily dismissed, several
experts said.

Surveys show that more than 60 percent of the U.S. population is uncomfortable
with the idea of animal cloning for food and milk. The single biggest reason
people give is "religious and ethical," with concerns about food safety 
coming in
second, said Michael Fernandez, executive director of the Pew Initiative on 
Food
and Biotechnology, a nonpartisan research and education project.

Those sentiments are a big concern to dairy companies, which fear that any
association with cloning could harm milk's carefully honed image of 
wholesomeness.

Confidential documents from the International Dairy Foods Association, 
obtained
by The Washington Post, indicate the group has played a key role in slowing 
FDA
action and propose a strategy for blocking any future FDA approval.

Association spokeswoman Susan Ruland said the group opted not to adopt the
lobbying strategy described in those documents, which included using friends 
in
Congress and "continued outreach to the White House."

In any case, Sundlof said, the FDA has no authority to make decisions based on
ethics concerns. Nor is it inclined to call for labeling of products from 
clones,
as some have demanded. For one thing, clonal meat or milk would be impossible 
to
authenticate, since there is no way to distinguish them from conventional
products.

The FDA may already be too late. Several owners of clones have been selling 
semen
to farm clubs and others vying to grow prize-winning cattle. Most of those
animals end up being slaughtered, sold and eaten, experts said.

"That you can go online today to any number of different Web sites and 
purchase
semen from cloned bulls tells you there are cloned sires out there fathering
calves in the food supply," Walton said.

Like it or not, Walton and others said, the clones are out of the barn.

© 2006 The Washington Post Company

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