Cloned Food: More Study Needed

Cloned Food Off Market Until FDA Rules on Safety

From the WebMD Archives

Nov. 5, 2003 -- Cloning may be a useful tool in food production -- but more study is needed, an FDA advisory panel says.

The FDA's Veterinary Medicine Advisory Committee was expected to rubber-stamp the agency's preliminary finding that there's no reason to think cloned animals wouldn't be safe to eat.

Instead, the 10-member panel wasn't sure the FDA properly characterized the possible risks posed by cloning livestock. Most of the panel agreed that cloned animals are probably safe as food. But the experts weren't willing to unequivocally endorse cloned food as safe or humane, says Stephen F. Sundlof, DVM, PhD, director of the FDA's Center for Veterinary Medicine.

"These are scientists, and scientists as a group don't like to be pinned down to a yes/no answer -- especially when they don't have sufficient information," Sundlof tells WebMD. "And that is what we heard from many members. They needed more information to come to an informed decision on whether they could declare these foods absolutely safe, and safe to the animals, too."

The cloning industry -- yes, Virginia, there is a food cloning industry -- has said it will comply with the FDA's request to keep cloned foods off the market while the agency studies the issues involved.

The big question is whether the FDA will regulate cloned foods at all.

"How we eventually use the panel's input is largely the result of whether we decide these products need to be regulated," Sundlof says. "If we consider this just another step in the evolution of modern animal agriculture and they are essentially equivalent to normal food, there may be a limited role for the FDA to play. If it is more akin to an animal drug, where we require drugs be safe for consumers and the animals themselves, then FDA regulation may be appropriate."

Much of the panel's indecision is the FDA's own fault. Its full report on the safety of cloned food wasn't finished in time for the panel's Nov. 4 meeting. Panel members saw only a draft of the report's executive summary and some supporting documents. Sundlof says the 300-page report will be ready later this year and will be distributed to panel members.

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"Once we get all the information out, we will solicit comments and the public will be free to provide comments," Sundlof says. "Once we do that, we will go out with a final risk-assessment document. This will say, 'Based on the risks we have identified, here is how we would consider managing any of those risks.' It may be same as traditional foods, or it may be greater if we determine there are hazards that require regulatory oversight."

Will Clone for Food

Today's method of animal cloning has only been around since 1996. It involves a process called somatic cell nuclear transfer, in which genetic information from one animal is inserted into an egg that has had its nucleus removed. The resulting embryo is implanted into a surrogate mother, which carries the fetus to birth. Dolly the sheep -- who passed away in February 2003 -- was created in 1996 using this technology.

In the U.S., several hundred cattle have been cloned, says rancher and veterinarian Donald Coover, DVM, of Galesburg, Kan. Cloned pigs, goats, and sheep may join them some day on America's dinner table.

Five of the cattle clones were described as "normal and healthy as any calves I've ever raised," says Coover in an FDA news release. The calves, born in 2001, will soon be ready to propagate herds of high-quality beef cattle.

"Clones are biological copies of normal animals," Larisa Rudenko, PhD, a molecular biologist and risk assessor in the FDA's Center for Veterinary Medicine, says in a news release. "In theory, they're pretty close to identical twins of an adult animal."

Indeed, over the last two years, the National Academy of Sciences (NAS) has found that food products derived from animal clones and their offspring are likely to be as safe as food from their nonclone counterparts.

The NAS found that healthy adult animal clones are virtually indistinguishable from "normal" animals, based on the evidence available.

It's unlikely that you will eat a cloned animal anytime soon. At a cost of $20,000 each to produce, clones are used for breeding -- not for food. But some scientists and farmers are looking at the descendants of cloned cattle, pigs, goats, and sheep as potential sources for food and clothing, if the FDA gives the OK.

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Sources

SOURCES: Stephen F. Sundlof, DVM, PhD, director, Center for Veterinary Medicine, FDA. "Animal Cloning: A Risk Assessment, Draft Executive Summary," FDA, Oct. 21, 2003. FDA news releases. FDA report: "Cloning: Revolution or Evolution in Animal Production?"
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