Wired Science

Cloning Regulations Could Have Implications for the Economy and Public Health

Chances are it won't be long before our Big Macs come from cloned cows or their offspring. While it's unlikely that the beef itself will hurt us, some experts argue the issue of animal cloning is about more than just the meat on our plates. How our country handles cloning, they say, could have immediate effects on the stability of our food supply, our economy, and, as biotechnology continues to charge forward, future public safety.

Cloning involves creating an exact genetic replica of an existing animal. First, scientists extract the nucleus from an animal cell, which contains the genetic material, and insert it into an egg missing its nucleus. Using various techniques, the egg is coaxed to develop into an embryo that has the exact same genetic "program" as the original animal. Then the embryo is implanted into the womb of a surrogate animal mother. Cloning is beneficial in that it allows breeders to make copies of "star" animals and use them to potentially breed better offspring—and more of them.

But a herd comprised of a number of cloned cows and their offspring could pose some problems, especially when it comes to the stability of our food supply, says Dave Schubert, a cell biologist at the Salk Institute in California. When an epidemic passes through a population of genetically different animals, some die while others survive, thanks to their varied immunological makeups. Herd immunity, as it is called, is the biological basis for the survival of large animal populations, says Schubert. But when there is a population of cloned animals, each of which is genetically identical, herd immunity is lost. Cavendish bananas, all of which are clones, are now under serious attack from a fungal infection; something similar could happen to animals, he says.

"If every Big Mac is made by some cloned population of cows, and half the [human] population eats Big Macs every day, then all of a sudden"—if disaster strikes the cow herd—"there's going to be a lot of skinny people," he says. It's important, therefore, for breeders to limit the number of identical clones they have in any one herd.

It's also possible that our country's regulatory policies—or lack thereof—could make other countries wary of accepting our food exports, and this could spell disaster for the economy, says Debra Strauss, an assistant professor of business law at Fairfield University in Connecticut and a former Food and Drug Law Institute Scholar.

Although the US Food and Drug Administration has not yet made clear exactly how it plans to regulate products made from cloned animals and their offspring—a final regulatory policy should be announced soon—the agency considers cloning to fall under the category of assisted reproductive technology, which includes techniques like artificial insemination and relies on regulatory frameworks set up in 1986. Cloned food products will probably not be regulated any differently than food derived from these other technologies, especially given the agency's announcement earlier this year that cloned food products appear to be completely safe to eat.

"What they're doing is they're taking a new technology, or really the product of the new technology, and fitting it into an old regulatory system," Strauss says.

In addition, the FDA focuses on the concept of "substantial equivalence" to determine whether cloned food is safe, by comparing its nutritional aspects to noncloned food products. But this, Strauss says, fails to give adequate weight to potential risks inherent in the technology.

For instance, recent studies indicate that genetic "tags" called telomeres, which appear on the ends of chromosomes and are associated with aging and genome stability, are significantly shorter in the offspring of clones than in normal animals. While it's unlikely that these modifications will have health effects on people eating the meat, no one yet understands their full implications, and these types of differences would go undetected in the proposed regulatory framework.

The FDA has also indicated that the agency is unlikely to require mandatory labeling on cloned food products, and this could prove problematic if other countries pass labeling regulations, Strauss says. They may not accept foods from the U.S. if they can't be certain which ones came from cloned animals or their offspring. "There's really an interest, for the industry's sake, to do the same sort of labeling that they do overseas," she says.

Another issue surrounds the FDA's handling of transgenic, or genetically modified (GM), animal products—and the agency's handling of cloning could give us a sneak peek at what to expect. Genetic modification is considered distinct from cloning in that actual changes are made to the genetic code. For example, a team of researchers recently engineered pigs with a healthier-than-average ratio of "good" to "bad" fats.  But because such changes could potentially interfere with bodily processes and cause allergic reactions, the FDA considers foods derived from genetically modified animals and their offspring to pose more of a health risk than foods made from cloned animals.

"Transgenic animals have to be looked at one at a time," says Jorge Piedrahita, a professor of genomics at North Carolina State University. "The person who made it has to say, OK, I have added a new protein to this animal. I have to prove that that food additive is safe for human consumption."

But according to the US Regulatory Agencies Unified Biotechnology Website, there aren't any planned changes to the regulatory scheme for genetically modified animal products, either. "The United States uses health and safety laws written prior to the advent of modern biotechnology to review genetically engineered products," it says. "To date, the United States has not issued any new legislation for these products."

In the case of GM animal products, other countries are sure to raise a stink about importing them if they are not regulated carefully and labeled. To date, the FDA has not passed any regulations on the labeling of GM foods, Strauss says. The European Union has already passed regulations requiring labeling of these products; if the U.S. does not, then this could be a huge issue for international trade, she says.

Not to mention our safety. Transgenic animals could be a big headache, Schubert says. "We've seen that there's no mechanism to control the unwanted distribution of transgenic plants," he notes, referring to the recent contamination of crops and foods with non-FDA-approved transgenic rice. "So if this happens with transgenic animals in our food supply, then that's a big problem," especially if products are not labeled, as they will be untraceable, he says.

Strauss and Schubert call for mandatory labeling of both cloned and transgenic food products, because at least that allows the consumer to choose, they say. And sometimes, labeling can actually instill consumer confidence in a technology. The executive director of the European Food Safety Organization, Geoffrey Podger, has said that when GM products were first labeled in the UK, they were popular with consumers. It was only when crops began to arrive from North America in which GM and non-GM versions couldn't be distinguished that customers became wary. So labeling can actually promote acceptance, says Strauss.

"If you feel that your government, and in particular your regulatory agencies, are giving you that choice, giving you that respect, then there's much more general trust," she says.