The Food and Drug Administration is expected to rule soon that milk from cloned animals and meat from their offspring are safe to eat, raising the question of whether Americans are ready to welcome one of modern biology's most controversial achievements to the dinner table.
Hundreds of cloned pigs, cows and other animals are already living on farms around the country, as companies and livestock producers experiment and await a decision from the FDA.
The agricultural industry has observed a voluntary FDA moratorium on using the products of clones, but it has recently become clear that a few offspring of cloned pigs and cows are already trickling into the food supply. Many in agriculture believe such genetic copies are the next logical step in improving the nation's livestock.
Consumer groups counter that many Americans are likely to be revolted by the idea of serving clone milk to their children or tossing meat from the progeny of clones onto the backyard grill. This "yuck factor," as it's often called, has come to light repeatedly in public opinion surveys. Asked earlier this year in a poll by the International Food Information Council whether they would willingly buy meat, milk and eggs that come from clones if the FDA declared them to be safe, 63 percent of consumers said no.
Yet mounting scientific evidence suggests there is little cause for alarm, at least on food-safety grounds. Studies have shown that meat and milk from clones can't be distinguished from that of normal animals, although work is not complete and researchers say that clones do suffer subtle genetic abnormalities.
While milk from clones might reach grocery shelves, clones themselves are not likely to be eaten, since they cost thousands of dollars apiece to produce. They'd be used as breeding stock, so the real question is whether their sexually produced offspring would be safe.
The FDA has been promising a policy for three years, but hasn't produced a final version, and some biotechnology companies involved in cloning have run out of cash while waiting. Weary livestock producers have dubbed the FDA the "Foot Dragging Administration."
The FDA declined requests for an interview. In response to written questions, Stephen F. Sundlof, chief of veterinary medicine at the agency, said the FDA "really can't provide a reliable estimate on the time frame" for releasing a policy.
But there are signs the agency is preparing to move. Lester Crawford, before he abruptly resigned Sept. 23 as FDA commissioner -- for apparently unrelated reasons -- said the agency was drafting a formal scientific paper outlining its conclusions. Speaking at a conference earlier this year, John Matheson, an FDA scientist working on the issue, said the policy was under review at higher levels of the Bush administration.
"We're spending a lot of time briefing these folks, trying to make them comfortable with the technology," Matheson said. "I think that's a microcosm of what you're going to see in the public when the decision goes out."
When the birth of Dolly the sheep, the first mammal cloned from an adult cell, was announced in 1997, American farmers and ranchers were as shocked as anyone. But by now, thousands of farm families have seen clones at agricultural fairs and grown comfortable with the idea.
The producers of prime pigs and cattle shown in contests at those fairs have been among the first to embrace cloning. Show animals represent only a small portion of the food supply, but the finest are sometimes used as breeding stock to upgrade food herds. Companies have been selling clones to some show-animal producers for years, practicing their cloning techniques for the day when they can put them to use in the far larger market for food animals.
Prairie State Semen Inc. of Champaign, Ill., is active in breeding "show pigs." In an interview at his farm, the president, Jon Fisher, explained his decision to embrace agricultural cloning.
He's a merchant of boar semen, keeping about 80 valuable animals. Rural students, usually members of 4-H clubs or the Future Farmers of America, order semen from these champion animals at $50 to $150 a vial and use it to inseminate local sows in hopes of creating a winning pig.
Fisher's business took off in 1997 after he paid $43,000 for a top Hampshire boar. The boar died suddenly in 2001, but instead of mourning, Fisher sliced off an ear and sent samples to a Wisconsin cloning company.
He got back six clones, plus another clone from a different animal. He has a batch of clones on order now from ViaGen Inc. of Austin. Clones nowadays can cost as little as $6,000 apiece, far less than it would cost to buy the finest boars. Fisher and other producers have been sending semen from clones to students who breed pigs and cattle for the show circuit. Normal practice, once the shows are over, is to sell those animals for slaughter. Fisher said he has seen pigs he knew to be the offspring of clones sold to slaughterhouses that would have processed them as food. Reporting earlier this year by the Los Angeles Times showed the same thing is happening with show cattle born of clones.
The FDA's Sundlof said, in his written answers, that the agency had heard rumors of clone progeny moving into the food supply, but was "not aware of any proof."
While the number of clones on farms is low now, Fisher predicted that as soon as the FDA opened the door, producers would embrace the technique. "Within 18 to 20 months after that, there will be hundreds of thousands of clones growing" on American farms, he said.
One recent morning, two cloned calves pranced around a field outside Austin. Their progenitors were not living animals, but rather cattle that had already been butchered and hung on a hook in a slaughterhouse. The calves were selected for cloning after receiving high grades for meat quality and yield, judgments that couldn't have been made while the originals were still alive.
Priscilla, born in April, and Elvis, born in June, were created by ViaGen. They're destined to be bred together in an effort to create prime stock. If it works, ViaGen will clone a large population of once-dead cattle, aiming to sell them or their offspring for breeding. It's just one aspect of an ambitious plan to create a commercial cloning market.
While the company has gotten much of its practice cloning show animals, it's eager to expand into the far larger markets of production agriculture. And some big food producers are interested. ViaGen has a contract with Virginia's Smithfield Foods Inc., for example, to explore how cloned pigs could be used in that company's vast pork production operations.
Unlike other small companies that have come and gone in the field of cloning, ViaGen may have the deep pockets needed to turn its commercial vision into reality. The company's principal financial backer is John G. Sperling, founder of several for-profit educational establishments and one of the wealthiest men in the Southwest, with a net worth pegged by Forbes magazine this year at $1.9 billion.
Operating from spotless, light-filled offices in an office park in Austin, ViaGen hired Irina Polejaeva, one of the world's top cloning scientists, and has been pushing the technical limits of the field. In interviews recently, company officers said they had improved the efficiency of cloning and cut the price.
Cloning involves sucking the nucleus out of an egg, injecting a new nucleus from an adult cell and implanting the resulting embryo into a surrogate mother animal. Clones appear to be nearly identical genetic copies of the adult progenitor.
Studies in the United States and Japan have shown meat from the offspring of clones to be nutritionally sound, and more research is underway. A clone is "a copy of the animals we already ate," Polejaeva said. "There's nothing different about them."
There are in fact subtle genetic abnormalities even in healthy-looking clones, said Konrad Hochedlinger, a scientist at the Whitehead Institute for Biomedical Research in Cambridge, Mass., citing multiple studies in mice. Published research shows risks to the health of clones at all stages of their lives. But the genetic problems aren't likely to alter the food value of clones and aren't passed on to their sexually produced offspring, Hochedlinger said.
Asked if he'd be willing to eat clones or their offspring, Hochedlinger said: "I think I would."
So far, only scattered opposition has emerged to farm cloning. Animal-welfare groups have come out against it, saying it poses unnecessary risks to farm animals. The FDA has made clear it won't require labels on clone products, which may leave meat-eaters who want to avoid them little practical way to do so.
Some consumer groups have also balked, contending that Americans just aren't ready. "When the immediate reaction is 'yuck,' boy, you better watch out putting that in the food supply," said Carol Tucker Foreman, director of food policy at the Consumer Federation of America, in Washington.
Among those watching warily as the FDA announces a policy will be the huge conglomerates that buy agricultural products and turn them into groceries.
One group, the International Dairy Foods Association, has voiced skepticism, partly from worry that overseas markets will reject American products. But the biggest American food companies haven't weighed in publicly. The companies might have sufficient power in the marketplace to kill agricultural cloning, if they chose, by imposing ground rules on farmers and slaughterhouses.
The companies will take their cues from the public's reaction to cloned food, said Mark Nelson, vice president of scientific and regulatory policy at the Grocery Manufacturers of America, in Washington.
"We support the science," he said. "But our members are in the business of selling food to the public. If the public doesn't want to eat Velveeta made from cloned milk, it ain't gonna happen."
ViaGen and Smithfield Foods are exploring the use of cloned pigs.