No FDA OK — yet — on cloned meat, milk

WASHINGTON — Taking a long-awaited stand in an emotional food fight, the Food and Drug Administration (FDA) on Thursday released a 678-page analysis concluding that milk and meat from cloned animals pose no unique risks to consumers.

The decision, subject to change after a period of public comment, stops short of approving the sale of food from clones and leaves in place a long-standing government request that farmers keep their clones off the market.

But it represents a milestone for the handful of biotech companies that see cloning as a welcome opportunity to sidestep the vagaries of sexual reproduction and mass-produce some of the nation's finest meat- and milk-producing animals.

"The higher-end breeders are going to start signing up and taking advantage of this," said Mark Walton, president of Austin, Texas-based ViaGen, which has produced about 250 cloned cattle and pigs in preparation for what the company hopes will be a robust market in farm clones.

Opponents — including some who doubt the safety of cloned food and others concerned about the welfare of the animals — vowed to fight the new momentum toward approval.

"This is a lose-lose decision for consumers and the dairy industry," said Joseph Mendelson, legal director at the Center for Food Safety, which has petitioned the FDA to regulate cloned farm animals one type at a time, much as it regulates new drugs.

Release of the so-called draft risk assessment was delayed for years, in part by a coalition of big-name dairy companies concerned that the "yuck factor" surrounding cloned animals might tarnish milk's image and undermine sales. Surveys have consistently found that a majority of consumers are wary of food from clones, with many saying they would avoid it.

Yet study after study reviewed by the FDA failed to find any scientific reason to keep meat or milk from clones off store shelves.

"Extensive evaluation of the available data has not identified any food consumption risks or subtle hazards in healthy clones of cattle, swine, or goats," the FDA risk assessment concludes.

Stephen Sundlof, the FDA's chief of veterinary medicine, declined to predict how long it might be before the agency comes to a decision. With public comment allowed through April 2 and 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 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 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.

Opponents of food from clones note that clones harbor subtle molecular differences in their DNA as a result of having been produced from a single parent. They also point to the 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.

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 than 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 coming down as techniques improve.

While some may doubt that cloned food is cost efficient — and others worry that the presence of cloned products in the U.S. food stream 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 on Thursday released a risk-management plan, which outlines how the agency would track newly emerging concerns about food from clones.

Several groups are pushing for a requirement that cloned food be labeled as such, which would allow 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.