Milk and meat from cloned animals are safe to eat, the Food and Drug Administration has tentatively concluded, a finding that eventually could clear the way for such products to reach supermarket shelves and for cloning to be widely used to breed livestock.
The agency's conclusions are being released today in advance of a public meeting on the issue Tuesday in Rockville, Md. Agency officials said that after receiving public comments, they hope by next spring to outline their views on how, if at all, cloning would be regulated, including whether food from cloned animals should be labeled.
But if the preliminary conclusion stands, labeling would not be needed and there would be little regulation, Stephen Sundlof, director of the agency's Center for Veterinary Medicine, said in an interview.
"There appears to be few if any safety concerns," Sundlof said. "If we consider them materially the same as traditional foods, the role for the FDA would be minimal."
There are now only several hundred cloned cattle in the nation's total of about 100-million, so experts do not expect a big influx of food from cloned animals if it were allowed. Cloning an animal can cost about $20,000, much too expensive to use to make an animal just for its milk or meat.
"That would make about a $100 hamburger," said John C. Matheson, a senior FDA regulatory scientist who led the agency's assessment.
The major safety concern is that cloning results in many failed animal pregnancies and abnormal babies that are larger than normal and have other medical problems, raising the risk that milk or meat from such animals could be tainted. But the FDA said clones that survive past early childhood appear to be as healthy as other animals and therefore food from them should be safe.
Still, any move to allow food from cloned animals or their offspring is expected to face opposition. Some critics say the evidence of safety is not sufficient. Even the FDA concedes its conclusions are based on limited data, particularly for animals other than cows. Other critics say there are concerns to consider besides food safety, like the ethical implications of cloning, its effects on animal welfare and on farming.
"I think it warrants a discussion that goes beyond the narrowest scientific issues," said Carol Tucker Foreman, director of food policy at the Consumer Federation of America.
She said polls have shown U.S. consumers are ill at ease with animal cloning. "When you say animal cloning, many people react as if you are at least opening the door to human cloning," she said.
Some food companies also are cautious, worried that such food, even if it is safe, might be shunned by consumers.
"It's fine to get the stamp of approval from the FDA, but we also need to get the stamp of approval from consumers," said Kathleen Nelson, senior director for legislative affairs at the International Dairy Foods Association, which represents companies that sell milk, cheese and ice cream. She said that while biotechnology offers benefits for the food industry, the FDA needs to build "a strong and impressive body of science on the safety of the products."
Cloning involves using a cell from an animal to make a nearly genetically identical copy of that animal. Dolly the sheep, the first clone of an adult mammal, was born in 1996. Since then cows, pigs, goats and horses, among others, have been cloned.
But the regulatory status of food from cloned animals has been in limbo. In June 2001 the FDA asked cloning companies and farmers to voluntarily keep off the market the milk and meat produced from clones, and from the more conventionally bred offspring of clones, so it could assess the potential risks.
That has contributed to financial struggles for the handful of small companies hoping to make a business out of cloning. And it has frustrated farmers and breeders who own clones, who now have to dump milk from cloned cows and cannot sell semen from cloned bulls.
"You milk it, you dump it," said Karyn Schauf, owner of Indianhead Holsteins, a breeder and dairy farm in Barron, Wis., that has two clones of a now deceased prized dairy cow but cannot sell their milk. "Not being able to treat them as regular animals really puts a cap on their value.".
Experts say the first use of cloning will be not for food but to make copies of prize animals for breeding.
Donald P. Coover of Galesburg, Kan., who sells semen for breeding, said that this year alone he sold $100,000 worth of semen _ enough to inseminate 2,000 cows _ from an Oklahoma bull named Full Flush. With that kind of profit, it made sense to make clones of Full Flush to carry on providing the semen after the original animal dies.
Some experts say a major use of cloning will be to help in making genetically engineered animals, like those that can produce pharmaceuticals in their milk, or animals with genes to make them disease resistant or their food more nutritious.
The FDA safety analysis did not look at genetically engineered animals, whether produced using cloning or not, only at clones that are copies of conventional animals. Genetic engineering introduces additional risks and the agency wanted to tackle the simpler issue of cloning first, officials said.
The FDA today will release an 11-page summary of a larger risk assessment it hopes to publish in the coming months. In its analysis, it assumes that obviously malformed animals produced through cloning would be rejected as sources of milk or meat. That left the question of whether there could be more subtle abnormalities that might, for instance, change the nutritional quality or safety of the meat or milk.
FDA officials said they have been assessing the situation ever since the first cows were cloned. Matheson said the agency asked for a voluntary moratorium because "that's all we needed to do," to keep the animals off the market.