On September 18, the Food and Drug Administration (FDA) issued a press release on a document regulating the use of genetically modified (GM) animals and products in the United States1. This document is open for public comment until November 18 and can be read here. In it, it states that GM animal developers are required to prove such animals are safe to the environment and for human consumption, as in the case of milk, cheese or meat2. Moreover, they must prove that the DNA change that has occurred in the animal as well as any products or repercussions from such a change is safe for the animal itself and the human population. Since this is a relatively new area with unknown implications, and the animals are changed on a genetic level, the FDA is proposing referring to these animals as “animal drugs.” According to Randall Lutter, the FDA’s deputy commissioner for policy, “the technology has evolved to a point where commercialization of these animals is no longer over the horizon3.”
What exactly is a GM animal, and what possible contributions could it make to our society? Achieved in the 1980s, GM animals are similar in many respects to GM plants. They both carry laboratory introduced DNA, or a gene, that is supposed to provide some benefit to the plant or animal. For plants, the new gene could provide insect or pesticide resistance. For animals, a new gene could increase the rate of maturity or have increased levels of important nutrients3. Other animals, referred to as “biopharm animals,” could be used to produce medicines for human diseases. Other versions, labeled “xenotransplant animals,” could provide tissue and organs so similar to human material that the chance of rejection would be minimal4,5. Even more categories of GM animals exist; however, they have been refused entrance to the consumer market. Aside from the obvious safety issues, many are afraid of what ecological damage could be done if one of these GM animals escaped into the wild.
Environment and Health Concerns
In 2002, the U.S. National Academies’ National Research Council grew concerned that the accidental introduction of one of these creatures could upset the current environmental balance6. If these GM animals were able to survive better and reproduce more quickly, they could push out the non-GM versions. Some are concerned not only about the environment but also their health, especially since the FDA has refused to require foods made with GM animals to be labeled as such, the same way they have refused to label food from GM crops5.
So far, only one GM animal has been released into the public realm. Although animals intended for food have not been released, in 2003, the fish Zebra danio was5. This fish was not meant to be eaten but to be seen. These modified fish, called GloFish, were able to glow in the dark and were something interesting for aquatic hobbyists. Animals meant for food could be released, however, if found to be safe. This could be particularly welcome if it could alleviate food shortages occurring around the world. Considering that most of the world, however, looks at GM crops with disdain and even horror, it is unlikely that GM animals would be received any more warmly.
If GM animals can succeed at the level GM crops have, even with so many people’s misgivings, prospects are optimistic indeed. In 2001, Bt cotton, for example, was able to grow with 50% less pesticide, or 10,500 metric tons, because it simply didn’t need it. Bt cotton allowed for more yield as well, increasing it by 25% in South Africa and 5% to 10% in China. For China, this equated to a gain of $500 million per hectare and $750 million nationally. In 2005, Syngenta, an agricultural biotechnology giant which sells GM seed, generated $8.1 billion while Monsanto believes their profits will climb to $8.5 billion in the next four years.
As for animals, cows have recently been genetically manipulated to prevent infection from mad cow disease. Considering the fear, both abroad and recently at home, of meat contaminated with this, resistant GM cows might deserve serious consideration. Furthermore, since the global population is expected to reach nine billion by 2040, the gains provided by GM crops and animals may become a necessity to continue feeding, clothing and medicating the world. With the apparently large amount of money that is on the brink of being realized by such an endeavor, there are sure to be numerous companies who will try to cash in on the idea.
1 – FDA press release on GM Animals
2 – Draft Guidance of GM Animals
3 – Science, September 18, 2008, FDA Issues Guidelines for GE Animals
4 – FDA GE Animal Fact Sheet
5 – FDA Consumer Q&A
6 – Science, August 23, 2002, Environmental Impact Seen as Biggest Risk