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FDA Is Set To Approve Milk, Meat From Clones

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.

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