Although no U.S. law bars the use of cloned animals for food, companies have been voluntarily withholding sales of clone-derived food pending a Food and Drug Administration review. Now, the FDA has issued documents on the safety of animal cloning. While the agency's conclusions don't exactly herald the invasion of the farm-animal snatchers, they do provide an open opportunity for companies that are well-positioned in the industry.
In an 800-page FDA draft risk assessment report, the agency concludes that there is no difference between cloned and conventionally produced food and that meat and milk from clones of adult cattle, pigs, and goats -- and their offspring -- are as safe to eat as food from conventionally bred animals. Due to limited data on sheep clones, the FDA recommends in the draft guidance that sheep clones not be used for human food. The assessment was peer-reviewed by a group of independent scientific experts in cloning and animal health who agreed with the methods the FDA used to evaluate the data.
In the draft guidance, the FDA does not recommend any special measures relating to the use of offspring of clones of any species as food for humans. This is because clones will be used primarily for breeding; almost all of the food that comes from the cloning process is expected to be from sexually reproduced offspring and descendents of clones, and not the clones themselves.
Rule Breakers may recognize the potential of this technology. Although it could take years for cloned food to reach grocery shelves, this report seems to pave the way for the use of cloned animals for any purpose. Privately held ViaGen has been awaiting the FDA decision for four years and stands to benefit most. The company controls most of the key patents in the field, including the one issued to the researchers behind the first cloned mammal, Dolly the sheep.
Currently, ViaGen is involved in cloning show animals, such as horses (at a cost of about $150,000) and competition cattle (at $15,000 a head). The company cloned 67 animals in 2006. ViaGen also developed AnguSure, a genetic test for Angus beef, and stores the DNA of nonprimate mammals, including cats and dogs. ViaGen doubled its capacity in 2003 by acquiring competitor ProLinia; sales hit $2.2 million in 2006, according to Dun & Bradstreet.
Some critics are worried about the long-term safety of food from cloned animals, while others complain that cloning results in more deaths and deformed animals than other reproductive technologies. However, the technology of cloning is different than that of the feared genetic engineering, which involves altering, adding, or deleting DNA. Cloning is closer to the reproductive technologies already commonly used in the industry, such as in vitro fertilization and artificial insemination. A clone is more akin to making a twin of the donor animal; it does not change the gene sequence of the animal.
Most cloning today uses a process called somatic cell nuclear transfer (SCNT). As in the case of in vitro fertilization, an immature egg -- or oocyte -- from a female animal is manipulated to remove the nucleus (which contains the egg's genes). This leaves behind the other components necessary for an embryo to develop. A nucleus containing the desirable traits from the donor is then injected into the egg. After manipulation, the donor nucleus and egg fuse, start dividing, and an embryo begins to form. The embryo is then implanted in the uterus of a surrogate, which carries it to term. The clone animal is delivered just as any other baby animal.
There appear to be no complications that are unique to cloning, and any problems that arise are also seen in animals born from natural mating or other assistive reproductive technologies. There is a higher rate of incidence, but this seems to be a result of the manipulations taking place outside the natural uterine environment. Still, there is a perception that manipulating the reproduction of animals could have unknown side effects. A Pew Initiative for Food and Biotechnology poll earlier this month showed 64% of Americans were uncomfortable with animal cloning, with 46% saying they were strongly uncomfortable.
A bigger issue may be the further decline of agricultural biodiversity. Genetically uniform populations are more susceptible to mass casualties, such as from pathogens. While cloning may be used to quickly introduce desirable genes into a population of animals, it could also lead to the introduction of deleterious genes, or to the development of entire populations that are missing a trait that provides resistance to some disease. To combat such a possibility, government regulators could require conservation cloning to establish a network of DNA repositories.
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Fool contributor Stephen Albainy-Jenei is a patent attorney at Frost Brown Todd LLC, serving up chat at PatentBaristas.com. Feel free to write him with comments or questions. Stephen doesn't own shares of any company mentioned in this article. The Fool's disclosure policy is a moooooover and a shaker.