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Biotechnology in Animal Agriculture: Status and Current Issues

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Animal agriculture is being transformed by rapid advances in biotechnology -- a term that encompasses a variety of technologies, including genetic engineering (GE), genetic modification, transgenics, recombinant DNA techniques, and cloning, among others. Producers are interested in the application of biotechnology to improve productivity, consistency, and quality; to introduce new food, fiber, and medical products; and to protect the environment. Potential human health applications of transgenic animals include producing biopharmaceuticals and generating organs, tissues, and cells for xenotransplantation. Criticisms of such applications involve issues ranging from food safety and social resistance to potential negative impacts on animal welfare and on ecosystems. Questions also have arisen about the adequacy of the current regulatory structure to assess and manage any risks created by these technologies.

The tools for introducing specific new genetic material into livestock have been available since the mid-1980s. However, few transgenic animal projects to date have focused on actual agricultural issues such as animal health and production. Recently, cloned cattle capable of resisting mastitis have been touted as a first example of genetic engineering to improve animal well-being. Pigs have been engineered for increased sow milk production, which has resulted in faster-growing piglets. Transgenic fish with enhanced growth characteristics are nearing the final stages of commercialization.

On December 28, 2006, the U.S. Food and Drug Administration (FDA) released a long-awaited draft risk assessment, which finds that meat and milk from cloned cattle, pigs, and goats and their offspring are as safe to eat as those of conventionally bred animals. The FDA risk assessment also concludes that cloning poses the same risks to animal health as those found in animals created through other assisted reproductive technologies -- although the frequency of such problems is higher in cloning. (Scientists stress that cloning is an assisted reproduction technique that does not involve any transfer or alteration of genes through GE.)

The FDA said that it will take public comments on the risk assessment until April 2, 2007, but made no prediction of how long it might take to evaluate them and move to the next steps, including a final risk assessment. Meanwhile, the agency is asking livestock breeders and producers to continue to refrain voluntarily from marketing the products of cloned animals and their offspring.

The FDA draft risk assessment was released just before the start of the 110th Congress, where the first bills related to animal biotechnology were on cloning: S. 414 and H.R. 992 would require all food from cloned animals or their offspring to be labeled; and S. 536 would prohibit food from cloned animals from being labeled as organic. Congress also may be asked to play a larger role in weighing the benefits and costs of these evolving technologies, and to refine existing government oversight. This report will be updated if significant developments occur.