By Kristen Philipkoski
The Food and Drug Administration soon will decide whether the meat in your Philly cheese steak or your barbecue spareribs could come from a cloned animal.
Because of safety concerns, the FDA has barred the handful of companies that clone farm animals from selling them for meat. But since early this year, those companies have been submitting data -- generated by independent research firms -- to the FDA.
The specifics of the data will remain confidential until Oct. 20 when the FDA plans to post the research online for public review. But the majority of companies say that, in general, the research shows no significant difference between regular and cloned animals, suggesting that cloned meat would be perfectly safe for human consumption. Consumer watchdog groups are skeptical, and say cloned meat should at least be labeled.
The FDA will hold a public meeting on the topic Nov. 4 at its Center for Veterinary Medicine in Rockville, Maryland.
Studies have shown differences between cloned and regular animals, including a higher incidence of genetic and physiological abnormalities in clones. But scientists say these differences don't pose a threat to someone who eats cloned meat.
"It's up to the FDA to determine (whether cloned meat is safe), but our research shows no material difference between non-cloned animals and cloned animals," said Ray Page, chief scientific officer of Cyagra, an agricultural cloning company and a recent spinoff of Advanced Cell Technology.
"All of the clones we have looked at, at ViaGen and Prolinia (a subsidy of ViaGen), have appeared to be just like normal animals," said Scott Davis, president of ViaGen, an animal genetics company.
A 2002 National Academy of Sciences report said there was no evidence that cloned meat was dangerous to eat, but more data was needed to be certain.
The genetic differences in clones arise mainly during the development of the embryo and are negligible by the time the cow is ready for slaughter or milking, said Eric Hallerman, an associate professor at Virginia Tech who co-authored the study.
"Scientists are unanimous (as far as I know) that (cloned animals) are indeed safe," said Michael West, CEO of Advanced Cell Technology, in an e-mail. Researchers at the company published a paper in Science in November 2001 titled, "Cloned Cattle Can Be Healthy and Normal."
It costs $19,000 to have your favorite cow cloned by Cyagra. The more you clone, the cheaper the procedure becomes: Six clones cost $72,000. Discount or no, it would not be practical for farmers to clone all their cattle rather than breed them normally.
But Cyagra and other companies that clone animals say cloning select cattle can promote strong, disease-free genes in the clones' progeny. A farmer might want to clone a particularly productive dairy cow, or a very healthy steer. Cloning eliminates the trial and error inherent in regular breeding.
Only about 1 percent of a herd would be clones, and it's not likely they'd be first to the slaughter, researchers say.
"I think the issue is essentially irrelevant because you're not going to be eating the cloned animals," said Robert Lanza, vice president of medicine and scientific development at Advanced Cell Technology. Lanza said he believes that if the FDA determines cloned meat to be safe, consumers still would be able to choose whether or not to eat the cloned products.
John Matheson, the FDA toxicologist in charge of determining any risks that might come from eating cloned meat, said if the agency finds cloned meat is as safe as conventional meat, it won't require companies to label the products.
But watchdog groups say health problems could evolve over time, and consumers should know if they're eating a clone.
"Certainly I think there should be labels," said Joseph Mendelson, legal director of the Center for Food Safety. "I think overwhelmingly consumers would want that information and I think there's reason to give it to them."
Public reaction to genetically modified foods in the United States is significantly milder than in Europe, where protests, some violent, are much more prevalent. But Mendelson said that's because most Americans are unaware that they're already eating genetically modified organisms.
One FDA focus group found that when Americans learned this fact, they were amazed and outraged.
But whether consumers want the information isn't the FDA's main concern. Rather, the agency must determine what risks exist and then decide how to manage them. Matheson said he hopes to achieve the first part of that goal at the Nov. 4 meeting, and the management part by January 2004.
Animal welfare is another concern. In cattle, from 10 percent to 50 percent of cloned embryos become healthy cows. The numbers can be much lower in other animals, and animal rights groups protest the fact that many clones that don't survive to adulthood are born sick and malformed.
The 2002 National Academy of Sciences report was more concerned about the environmental impact of cloned animals than the potential health effects upon people who might eat clones. The scientists said the potential for cloned or genetically engineered animals to escape into the wild is worrisome.