The responses to the questions provided in this document represent the FDA’s view in light of the conclusions and recommendations outlined in the Animal Cloning Risk Assessment, Risk Management Plan, and Guidance for Industry #179.
Myth: Cloning is a new technology.
Actually, cloning isn’t new at all. In fact, we eat fruit from plant clones all the time, in the form of bananas and grafted fruits. We’ve been cloning plants for decades, except that we refer to it as “vegetative propagation.” It takes about 30 years to breed a banana from seed, so, to speed the process of getting fruit to market, most bananas, potatoes, apples, grapes, pears, and peaches are from clones.
Some animals can reproduce themselves by vegetative propagation, including starfish and other relatively simple sea creatures. Amphibians such as frogs first underwent cloning in the 1950s. Identical twin mammals can be thought of as naturally occurring clones, but producing clones of mammals in the laboratory is relatively new. Using cells from animal embryos to make clones has been has been around since the early 1990s, but the first animal cloned from a cell from an adult animal was Dolly the sheep, who was born in 1996.
Myth: Clones are a specific animal’s DNA grafted onto another body.
Absolutely not. Despite science fiction books and movies, clones are born just like any other animal. The only difference is that clones don’t require a sperm and egg to come together to make an embryo. Clone embryos are made by using a whole cell or cell nucleus from a donor animal and fusing it to an egg cell that’s had its nucleus removed. That embryo is implanted into the uterus of a surrogate dam (a livestock term that breeders use to refer to the female parent of an animal) to grow just as if it came from embryo transfer or in vitro fertilization.
Myth: Offspring of clones are clones, and each generation gets weaker and weaker and has more and more problems.
No, not at all. A clone produces offspring by sexual reproduction just like any other animal. A farmer or breeder can use natural mating or any other assisted reproductive technology, such as artificial insemination or in vitro fertilization to breed clones, just as they do for other farm animals. The offspring are not clones, and are the same as any other sexually-reproduced animals.
Myth: Clones are always identical in looks.
Not necessarily. In fact, many clones have slight variations in coat color and markings.
Let’s think about the identical twin calves again. They have the same genes, but look a little different. That’s because of the way those genes are expressed—that is, how the information in that gene is seen in the actual animal. For example, if they’re Holstein cows, the pattern of their spots, or the shape of their ears may be different. Human identical twins also have the same genes, but because those genes are expressed differently in each person, they have different freckle and fingerprint patterns.
Myth: Clones have exactly the same temperament and personality as the animals from which they were cloned.
Temperament is only partly determined by genetics; a lot has to do with the way an animal has been raised. It’s the old “nature versus nurture” argument.
Say you want to clone your horse because of his gentle and sweet temperament. Although your horse’s clone may be easy-going, he would have to have exactly the same life experiences as your original horse in order to have the same temperament.
Your original horse isn’t afraid of loud noises because his experiences have taught him that they won’t hurt him. But if your clone has a bad experience with loud noises (for instance, a tree branch falls on him in a loud thunderstorm and hurts him), he may associate loud noises with pain and be afraid of them.
Myth: When clones are born, they’re the same age as their donors, and don’t live long.
Clones are born the same way as other newborn animals: as babies. No one really knows what causes aging in mammals, but most scientists think it has to do with a part of the chromosome called a telomere that functions as a kind of clock in the cell. Telomeres tend to be long at birth, and shorten as the animal ages.
A study on Dolly (the famous sheep clone) showed that her telomeres were the shorter length of her (older) donor, even though Dolly was much younger. Studies of other clones have shown that telomeres in clones are shorter in some tissues in the body, and are age-appropriate in other tissues. Still other studies of clones show that telomeres are age-appropriate in all of the tissues. Despite the length of telomeres reported in different studies, most clones appear to be aging normally. In fact, the first cattle clones ever produced are alive, healthy, and are 10 years old as of January 2008.
Myth: Cloning results in severely damaged animals that suffer, and continue to have health problems all their lives.
The vast majority of swine and goat clones are born healthy, grow normally, and are no more susceptible to health problems than their non-clone counterparts. During the early days of what is known as assisted reproductive technologies in livestock, veterinarians noticed that some calf and lamb fetuses grew too large during pregnancy, and had serious birth defects. This set of abnormalities is referred to as “large offspring syndrome,” or LOS. These same abnormalities have also been seen in calf and lamb clones, and have received a lot of attention because they occur at what appear to be higher rates than observed with other assisted reproductive technologies. The syndrome seems to be related to processes that take place outside the body (during the in vitro phase. As producers understand more about the cloning process, the rate at which LOS is observed in calf and lamb clones has been decreasing. The same kind of decrease in LOS rates was observed as people who used technologies such as in vitro fertilization in cattle learned more about the process. LOS hasn’t been seen in swine or goat clones.
Most clones that are normal at birth become as strong and healthy as any other young animals. Calf and lamb clones with abnormalities at birth may continue to have health problems for the first few months of life. But after the age of six months, they’re completely indistinguishable in appearance and blood measurements from conventionally bred animals of the same age.
Myth: Cow clones make human pharmaceuticals in their milk.
Lots of people get this confused. The clones we’re talking about here are “just clones.” They don’t have any new genes added to them, and they don’t make pharmaceuticals (or any other non-milk substances) in their milk. They just do the same thing as their conventionally bred counterparts. Cows that make pharmaceuticals in their milk are genetically engineered—that is, they have new genes added to them. Some of these genetically engineered animals can be reproduced by cloning, which is why some people get confused about this concept.
Myth: When a chicken clone lays eggs, the chicks that hatch are clones.
Neither chickens nor any other kind of bird have been cloned yet. So far, mice, rats, rabbits, cattle (and the closely related but endangered gaurs and bantengs), swine, sheep, goats, deer, horses, mules, cats, and dogs are the mammals that have been cloned.
Myth: Meat from clones is already in the food supply.
FDA asked clone producers and breeders to voluntarily keep milk and meat from clones out of the food and feed supplies until we finish assessing their safety. To the best of our knowledge, they have done so. After years of detailed study and analysis, FDA has concluded that meat and milk from clones of cattle, swine, and goats, and the offspring of clones from any species traditionally consumed as food, are as safe to eat as food from conventionally bred animals. We don’t expect food from clones to enter the food supply in any great amounts any time soon, as these animals will be used for breeding.
The U.S. Department of Agriculture (USDA) believes that it is unlikely that products from these animals would enter the meat supply for several years. Meat and milk products from the progeny of animal clones are several years off. USDA will convene stakeholders to discuss efforts to provide a smooth and orderly market transition, as industry determines next steps with respect to the existing voluntary moratorium.
Myth: Cloning can cure diseases in livestock.
Cloning can’t directly cure diseases in livestock, but the cloning process may be one way to make a healthy copy of a valuable animal that has contracted a disease, been injured, or died. In addition, cloning may also be a way to duplicate a disease-resistant animal, and over generations create a disease-resistant herd.
Myth: Scientists can bring back extinct species by cloning them.
Although it’s theoretically possible, at this time it’s not very likely to happen. There are multiple technical barriers to doing this. First, because of the relatively low success rate of cloning, you’d need hundreds to thousands of cells from the extinct animal. Further, those cells would have to have DNA that hadn’t degraded since the animals were last alive. Then you’d have to find a very, very closely related species to provide the egg cell whose nucleus would be removed. After that, you’d have to implant any dividing embryos into the “normal” development environment (You might be able to use an elephant to act as a surrogate dam for a wooly mammoth, but there is no modern animal comparable to a dinosaur.) Then, you’d have to hope that the surrogate dam didn’t reject the embryo as “too foreign.” So although it’s possible, we wouldn’t expect that you’d see this at this time or in the near future.
Well, okay, but how about cloning endangered species?That’s not only possible, but it’s been done in some limited cases. Scientists have cloned sheep from very small populations, members of rare cattle breeds, and the gaur and banteng, two species closely related to domesticated cattle species.
More information from FDA on Cloning.
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