FDA Panel Backs Cloning In Agriculture

11/6/2003 FDA Panel Backs Cloning In Agriculture - 11/5 Washington Post

Eight of 10 panel members said they were confident it would be safe to eat food products derived from cloned animals or their offspring, the key conclusion of a draft FDA report released last week. But some members of the Veterinary Medicine Advisory Committee, meeting in Rockville, appeared uneasy about the level of animal suffering that a large cloning industry might entail, and the panel deadlocked 5 to 5 on whether the FDA had properly characterized such risks. Several panel members said the scientific data on that issue are disturbingly thin and the question needs more research.

Even on the question of food safety, several panel members -- including some who backed the FDA's preliminary conclusion -- said the nascent animal-cloning industry needs to produce a far more convincing body of scientific work about the biology of clones before the public is likely to feel comfortable with such animals entering the food supply.

The FDA has asked companies and farmers not to sell cloned food while it studies the safety issues, and the industry says it is complying. If the agency determines cloning poses no special risks, farmers would likely be free to use clones as they see fit.

While most members of the panel emphasized that they think the FDA is right to describe cloning as safe and the risks acceptable, and that this will be proved over time, the scientific case is not in yet.

"The consumer wants more," said John J. McGlone, a researcher at Texas Tech University who made his name doing scientific studies of animal welfare. "The consumer has a fear of the unknown. The only way to confront that from a science perspective is to do the studies."

That's likely to be a difficult task for the handful of companies trying to develop a commercial cloning market. They are not well financed, and several firms founded during the stock market boom of the late 1990s have already sold out or abandoned the field. It is not at all clear that the industry can spend millions of dollars mounting complex new studies. So far, the government has not been willing to pay for much research on agricultural cloning.

The divided vote on animal welfare was an unexpected setback for the FDA's Center for Veterinary Medicine, which is analyzing whether cloning, the technique that produced Dolly the sheep, should be permitted as a routine agricultural tool. But the practical implications of the vote were uncertain last night.

The FDA usually follows the advice of its advisory panels, but it is not bound to do so. Stephen F. Sundlof, director of the agency's veterinary center, said his staff would proceed with a more detailed analysis of cloning issues for release this spring, a document that will include some additional data. He said his timetable for considering the issue had not changed, meaning a final policy could be in place next year. But if pressure builds on the FDA and cloning companies to produce a more convincing case, that could easily push a final decision into 2005 or even later.

Cloning involves using cells from an adult animal to make a more-or-less exact genetic duplicate of the original. Some breeders want to use cloning to copy elite animals, using them as breeding stock to upgrade entire herds. It would be years, if ever, before cloned meat entered the food supply directly, since cloning an animal still costs about $20,000. But milk from clones, and the first- or second-generation offspring of clones, might find its way into the food supply not long after the FDA gave the nod.

Cloning and some of the issues it poses are so new that the FDA has acknowledged it is struggling to determine what questions even need asking, much less how to answer them. Biologists have been hard-pressed to come up with hypotheses under which cloned food might pose a risk of harm to people who eat it -- but no one wants to declare cloning safe on the basis of theory alone.

"Anything we can do to reduce the uncertainty is obviously something we would support," Sundlof said. "Having said that, it seems that we're struggling in this case to even find anything we can put our hands on and say this is a hazard. It's very difficult to ask for information about a hazard you really can't identify."

As the FDA has reported, cloning does pose hazards to the animals themselves. They die in inordinate numbers in the womb, and newborn clones are less healthy, by several parameters, than normal animals. But if the clones survive the critical 48 hours after birth, their biology appears to normalize over time, and FDA scientists said yesterday that by the time they are old enough to go to market as food, they are indistinguishable from normal animals.

Committee members said yesterday they want a far more rigorous assessment of the risks and the potential level of suffering for cloned animals. It's not clear that the FDA, or any other federal agency, would have power to regulate cloning solely on the grounds of excessive animal suffering, but committee members said the public at least deserves solid information.

Consumer groups said they hoped the vote would serve as a brake on the FDA, which they had criticized as moving too rapidly to embrace cloning. The cloning industry, by contrast, has said the agency is moving too slowly.

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