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F.D.A. Says Food From Cloned Animals Is Safe From New York Times Jan. 15 2008

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By ANDREW MARTIN and ANDREW POLLACK

Published: January 16, 2008

After years of debate, the Food and Drug Administration on Tuesday declared that food from cloned animals and their progeny is safe to eat, clearing the way for milk and meat derived from genetic copies of prized dairy cows, steers and hogs to be sold at the grocery store.

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The decision was hailed by cloning companies and some farmers, who have been pushing for government approval in hopes of turning cloning into a routine agricultural tool. Because clones are costly, it is their offspring that are most likely to be used for producing milk, hamburgers or pork chops, while the clones themselves are reserved for breeding.

“This is a huge milestone,” said Mark Walton, president of ViaGen, a leading livestock cloning company in Austin, Tex.

Farmers had long observed a voluntary moratorium on the sale of clones and their offspring into the food supply. The F.D.A. on Tuesday effectively lifted that for clone offspring. But another government agency, the Agriculture Department, asked farmers to continue withholding clones themselves from the food supply, saying the department wanted time to allay concerns among retailers and overseas trading partners.

“We are very cognizant we have a global environment as it pertains to movement of agricultural products,” said Bruce I. Knight, under secretary of agriculture for marketing and regulatory programs. He said it was his goal to have the transition last months, not years.

Animal breeding takes time, so even with Tuesday’s actions, it is likely to be several years before products from the offspring of clones are at the grocery store in appreciable quantity.

While acknowledging that consumer acceptance remains a hurdle, proponents of cloning technology say it could have a major impact on the livestock industry by providing meat and milk that is better and more consistent.

“When you buy a box of Cheerios in New York and one in Champaign, Illinois, you know they are going to be the same,” said Jon Fisher, president and owner of Prairie State Semen in Illinois. “By shortening the genetic pool using clones, you can do a similar thing.”

“It could improve the quality of meat in the supermarket,” Mr. Fisher added. “It depends if customers allow it.”

Consumer groups immediately lambasted the F.D.A.’s report, saying that the science remains inadequate and that many consumers oppose cloning for religious or ethical reasons. Some members of Congress had sought to delay a decision until further studies were completed.

“It flies in the face of Congress’s wishes. It flies in the face of consumer wishes,” said Hansen, a senior scientist at Consumers Union, the advocacy group that publishes Consumer Reports.

But Sundlof, director of the F.D.A. Center for Food Safety and Applied Nutrition, said food from cloned animals was “indistinguishable” from that of conventionally bred animals.

“It is beyond our imagination to even have a theory for why the food is unsafe,” he said.

The F.D.A.’s approval extends to cloned cows, pigs and goats but not other farm animals like sheep; the agency cited insufficient data on cloned sheep. The F.D.A. said meat and milk from cloned animals and their offspring would not be labeled because it was the same as conventional food and did not pose a safety risk.

However, Representative DeLauro, Democrat of Connecticut, has introduced legislation to require labels on cloned products, and consumer groups suggested that labeling would be a battleground in the near future.

The F.D.A.’s announcement came with an asterisk, given the Agriculture Department’s request for a continued moratorium on the sale of clones into the food supply. That request is likely to have little effect, since producers are not looking to sell clones; each still costs thousands of dollars. But it could force a few owners of dairy clones to dispose of milk from the animals rather than sell it.

“That doesn’t cause me any particular heartburn,” Mr. Walton said of the extended moratorium.

It remains to be seen how widely the technology will be adopted. Interest from the food industry has been tepid, with some companies declaring that they will not sell milk or meat from cloned animals or their offspring. Other types of reproductive technology, such as artificial insemination, faced resistance on farms when they were first developed but eventually became widespread.

Tuesday’s decision means cloning technology could move into commercial use little more than a decade after the world learned of Dolly the sheep, the first mammal cloned from an adult cell, in Scotland.

To create Dolly, scientists took an unfertilized sheep egg and removed the genetic material. They then inserted the genetic material from an adult cell. Machinery within the egg somehow reset the clock on the adult genes, and the new cell, after implantation into a surrogate mother sheep, developed into Dolly.

This technique has since become routine in laboratories, with clones produced in numerous species — not including humans, so far as is known. In public discussion, the technology is sometimes confused with other techniques that involve genetic manipulation, such as the transfer of genes into animals from unrelated species. But cloning is simply the creation of an identical genetic copy.

The F.D.A. tentatively declared food from cloned animals safe in 2003 and then came to the same conclusion after a draft risk assessment at the end of 2006.

The agency said it received more than 30,500 comments on that risk assessment, many of them form letters. It took some of those comments into account and added data from new studies to come out with the final risk assessment issued Tuesday.

The agency said that while some cloned animals have birth defects, presumably because genes are turned on or off at the wrong times, the ones that survive past a few weeks appear to be as healthy as conventional animals. And whatever those genetic abnormalities are, it said, they are not passed on to the conventionally bred offspring of clones.