FDA Struggles to Judge Safety of Cloned Food

Dec. 4, 2003
By ANDREW MARTIN, Chicago Tribune

WASHINGTON - The U.S. Food and Drug Administration is in a quandary over cloned animals.

The agency tentatively concluded in late October that meat and milk from cloned animals is safe to eat, elating farmers who are developing clones of cows and other creatures. But almost immediately, one of the FDA's advisory committees sharply questioned the conclusion and the science behind it.

Now the FDA must figure out how to respond to the panel's findings and its request for more data, despite the small amount of available research from the cash-strapped cloning industry. The initial FDA report contained no studies that analyzed meat from clones and only one small study examining milk from clones.

The agency is facing strong pressure to write rules for a new, controversial and potentially exciting industry while simultaneously dealing with an unusual lack of research in the field. It is an almost unprecedented situation for the FDA, and the official in charge of the cloning review acknowledged it is struggling to come up with an answer.

"Most of the things we evaluate for safety, we can identify what the hazard might be," said Stephen Sundlof, director of the FDA's Center for Veterinary Medicine.

"When you're talking about cloning, it's very different, because we have not been able to identify a particular hazard," he said.

"Trying to ask for particular studies when you don't have a specified hazard to drill down on and evaluate, it becomes very hard for the agency to say what they would be looking for."

The FDA is planning to release a more detailed report in the spring to address the concerns of its advisory panel.

Critics contend that the FDA, responding to pressure from the food industry, relied on the flimsiest of science to rush cloned animals into the human food supply and should require more extensive tests before it moves forward with the approval process.

In evaluating food from cloned animals, the agency outlined two approaches in October.

One approach, it said, compared clones at different stages of life to healthy conventional animals to determine if they appear the same.

The second and more rigorous approach could involve tests on the meat and milk of clones.

When the FDA concluded that cloned animals appeared to be safe to eat, critics noted that the agency seemed to rely almost exclusively on the first approach.

Joseph Mendelson, legal director for the not-for-profit Center for Food Safety, called the FDA's draft report "bizarre" for its lack of research.

"Healthy animals equal safe food. I agree with that on some level," Mendelson said. "But we don't know if these animals are healthy. What if they appear healthy, and there's some metabolic difference that's caused by a genetic defect? They don't have those studies."

At the heart of the debate is the question of how much science is required to determine if cloned animals or their progeny are safe for humans to eat. As the backers of genetically engineered plants and bovine growth hormone can attest, it's a question that may have as much to do with public attitudes about new technologies as it does about science.

"You really need to have a higher bar on this one," said Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania. "Forget about what is required from a regulatory point of view. From a practical point of view, if you are not persuasive about the safety of cloned animals, you are going to be leaving the door open for critics."

The FDA's regulatory efforts come as the tiny cloning industry struggles to deliver on its initial promise and as the public remains overwhelmingly uneasy about the process of cloning animals, let alone eating them. A 2002 Gallup poll found that 66 percent of consumers considered it morally wrong to clone animals.

In the years since Dolly the sheep became the first cloned mammal in 1996, researchers have successfully cloned cattle, mice, goats and pigs, though the process remains costly because so many clones die in utero or shortly after birth.

Still, a small number of biotech companies have cloned cows and pigs in the hopes of replicating animals that produce the best meat and milk, preserving rare and endangered species and creating research herds for pharmaceutical experiments.

The FDA has imposed a voluntary moratorium on allowing cloned animals into the food supply while it creates regulations.

Greg Wiles, a dairy farmer in western Maryland, paid about $60,000 in 2000 to have two clones made of Zit, a champion Holstein that produced more than 30,000 gallons of milk a year, rich in butter fat.

"Right now, there's no benefit to us," said Wiles, referring to the clones, named Genesis Z and Cigar Z. "We are dumping the milk twice a day. Basically we're losing money. ... Our problem will be, by the time the FDA makes its decision, our two clones will probably have passed their potential."

The FDA's decision has been complicated not only by the complexity of cloning but also by questions about whether the agency has the authority to regulate cloning. The FDA does not regulate animal reproductive technologies, such as in-vitro fertilization, but it would regulate cloning if regulators decide that the process introduces something new into the food supply that can be classified as a food additive or a new animal drug.

The FDA's draft report found that animals that lived to adulthood appear to be safe to eat. The report also noted that there was little science to review about the safety of eating cloned animals.

The report said the only risks that could arise from clones "would be from an incomplete or inappropriate reprogramming of the genetic information" that would allow a clone to appear healthy but harbor subtle anomalies that could be hazardous.

To determine if such hazards posed food safety risks, the agency relied on an approach that divided the animal's life into five stages and compared development to other types of artificial reproduction. The approach "is based on the hypothesis that a healthy animal is likely to produce safe food products."

In addition, the FDA said a "compositional analysis" of food products from healthy clones could determine whether it was different from conventional meat. But because cloned animals are so expensive, the FDA said none are likely to be slaughtered for meat, so information on the composition of clone meat is very limited.

The FDA used an analysis of milk from 17 cloned cows that found their milk was similar to that of conventional cows. Differences between the two were attributed to differences between breeds and the cows' diets.

The FDA also relied on a new study from Cyagra, the cloning company that cloned Wiles' cow, which reviewed medical records from 134 cloned cows and found "healthy clones of the oldest (6-18 months) cohort evaluated are virtually indistinguishable from their comparators."

The information provided the FDA with "a high degree of confidence in judgments regarding the health of (and likely food safety of edible products derived from) bovine clones," the report said.

"In all likelihood, the products from cloned animals are perfectly safe," said John McGlone, a member of the FDA advisory panel and a professor of animal science at Texas Tech University. "We just don't have any evidence of that. ...There's no data to say that it's unsafe. And there is not enough data to say it's safe."

On Wiles' Futuraland 2020 farm, the dairy farmer wonders why the FDA hasn't tested the blood or milk from his animals. Wiles has done some research on his own, though.

"I've actually drank the milk from our clones," said Wiles, who reports no noticeable ill affects. "It tastes just the same as regular milk."

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