FDA Says Clones Are Safe To Eat

Sundlof declined to predict when the agency might come to a final decision. With public comment allowed through April 2, and with the agency's need to thoroughly review those comments, a decision could come by the end of 2007, he said.

Even if a positive decision sails through, consumers will have to wait awhile for their first clone burger. Fewer than 1,000 cloned animals are living on U.S. farms, out of tens of millions of cattle and pigs. And it takes about two years to produce a cloned steer for slaughter and even longer to grow a cloned dairy cow old enough to be milked.

Moreover, with price tags up to $15,000 apiece, clones are currently too valuable to kill or milk directly. So most will initially be used as breeding stock to make high-quality offspring for slaughter or milking, a process that will take an extra couple of years.

"Everything is basically two to three years away, even if it all opens up tomorrow," said Steve Mower, director of marketing at Cyagra, a livestock-cloning company in Elizabethtown, Pa.

To make a clone, scientists take a single skin cell from an animal they want to replicate. They fuse it with a cow egg that has had its DNA removed, resulting in the creation of an embryo that can be transferred to the womb of a surrogate mother animal. The resulting newborn is a twin of the animal that donated the initial cell.

Opponents of food from clones note that the animals harbor subtle molecular differences in their DNA as a result of having been produced from a single parent. They also point to higher rates of problems during fetal development, resulting in birth defects and a high miscarriage rate, which in turn poses risks to the surrogate mother.

Some also question the economic sense of using cloning to make superproductive dairy cows.

Carol Tucker Foreman of the Consumer Federation of America said U.S. farmers produce more milk than Americans can drink, and the government must buy the surplus. "Since 1999, dairy support programs have cost taxpayers over $5 billion," she said in a statement.

Supporters counter that DNA differences in clones do not translate into discernible differences in the chemical composition of their milk or meat, as shown in many studies that have measured thousands of variables, including protein, fatty acid and vitamin levels.

The developmental problems are not different from those seen in animals produced by commonly used assisted reproductive techniques such as in vitro fertilization and artificial insemination, FDA officials said. And although the rates of those problems are higher in clones, they are declining as techniques improve.

Although some may doubt that cloned food is cost-efficient -- and others worry that the presence of cloned products in the U.S. food supply could hurt exports if other countries, none of which has approved food from clones, reject those products -- economics are not under the FDA's purview, officials said.

In conjunction with the risk assessment, the FDA yesterday released a risk-management plan, which outlines how the agency would track newly emerging concerns about food from clones in coming years. It includes a proposal to create a publicly accessible database of all new findings as companies scale up their operations.

Although ViaGen and Cyagra volunteered large amounts of data to the FDA for its risk analysis and have offered to continue cooperating, officials at both companies said this week they will have to consider whether they can promise public release of all their findings.

Several groups are pushing for a requirement that cloned food be labeled as such, allowing consumers to avoid it. Sundlof said such labels would be inconsistent with a long-standing FDA policy to reserve labels for scientifically substantive issues. But he said the agency would be open to "clone-free" labels on foods that come from other sources.

Congress could also get involved. This month, Sen. Patrick J. Leahy (D-Vt.) and six other senators wrote to Health and Human Services Secretary Mike Leavitt, asking that the FDA run the new risk assessment past an additional scientific review board and study the global trade implications.

In statements released yesterday, Leahy and Sen. Barbara A. Mikulski (D-Md.) -- who has expressed reservations about food from clones -- encouraged Americans to send their opinions to the FDA.