	Introduction

The U.S. Food and Drug Administration (FDA) released two recent documents that renewed public and congressional interest in animal biotechnology in general and animal cloning in particular. On January 15, 2009, the agency released final guidance representing its current thinking on the regulation of genetically engineered (GE) animals for food or drugs. FDA did so under its existing statutory authority and regulations. A year earlier, on January 15, 2008, FDA had unveiled its final risk assessment and industry guidance on the safety of milk and meat from cloned animals and their offspring. The first U.S. approval of a commercial product from a GE animal is for the drug ATryn, an anticoagulant agent being produced in the milk of transgenic goats. FDA announced its approval on February 6, 2009. As technologies move toward commercialization, Congress is being asked to examine these issues and possibly to refine the current federal regulatory structure governing the technologies and their agricultural products. With the development in the 1970s and patenting in the 1980s of recombinant DNA techniques, and the subsequent analysis of genes, their resulting proteins, and the role played by the proteins in animal biochemical processes (functional genomics), modern biotechnology is increasingly equipped with a set of sophisticated tools holding the promise of transforming the selective breeding of animals. The anti-clotting agent in goat milk is the first such application to be approved by FDA (March 2009). Regulation and Oversight

The basic federal guidance for regulating the products of agricultural biotechnology is the Coordinated Framework for Regulation of Biotechnology (51 Fed. In the approval of GE sugar beets, which was primarily a USDA Animal and Plant Health Inspection Service action, FDA also reviewed the application and concluded that the sugar from GE beets posed no dangers to human health. FDA Guidance on GE Animals

On January 15, 2009, FDA's CVM released its industry guidance on how it plans to regulate GE animals. In other words, it is illegal to introduce food from a GE animal into the food supply that has not been approved by FDA. Congressional Members have raised concerns about FDA's approval process. In addition to concerns about the adequacy of the data supporting the safety for human consumption of the GE salmon, Members also expressed their concerns that the GE fish could pose serious risks to the wild population of fish, such as Atlantic, Coho, and Chinook salmon. U.S. Department of Agriculture (USDA)

Several USDA agencies, operating under a number of statutory authorities, also have at least potential roles in the regulation of transgenic and cloned animals and their products. Cloning in animal agriculture is generally not applied in isolation from other biotechnologies such as genetic engineering. The risk assessment also focused only on cloning from non-transgenic cells. The final risk assessment concluded—as had the December 26, 2006, draft—that the meat and milk of clones of adult cattle, pigs, and goats, and the meat and milk from the offspring of these clones, were as safe for human consumption as the food from conventionally bred animals. The agency said it would not require any special measures (including labeling) relating to the use of food products or animal feed derived from cloned cattle, goats, and pigs because they are "no different from food derived from conventionally bred animals. In October 2006, a coalition formally petitioned FDA to impose a moratorium on producing foods from cloned animals, and to establish rules for mandatory pre-market review and approval of cloned foods by regulating clones as new drugs under the food and drug act. FDA is currently discussing this and other environmental issues as they consider approving GE salmon. Meanwhile, USDA has reminded stakeholders that products from cloned animals are not eligible to be labeled as organic, under its National Organic Program (NOP). Some scientists have countered that animal welfare problems have been exaggerated and tend to recede, particularly as the technologies are perfected. H.R. 6636 would have required the labeling of all foods produced with GE material. 521 / S. 230 ) would prevent FDA from approving the GE salmon. The bills would amend the Federal Food, Drug, and Cosmetic Act to state that GE fish "shall be deemed unsafe."
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.
On January 15, 2009, the U.S. Food and Drug Administration (FDA) released final guidance on how it is to regulate GE animals and products. Consistent with the Coordinated Framework for Regulation of Biotechnology, FDA will do so under its existing statutory authority and regulations. Generally, GE-derived foods, for example, will be regulated like non-GE foods; if their composition does not differ from their conventional counterparts, they will not have to be labeled. Nonetheless, developers of GE animals and of GE-derived products must gain FDA pre-market approval.
On February 6, 2009, FDA announced the first approval of a drug from a GE animal. The drug is a human anti-clotting agent produced in the milk of transgenic goats. FDA is also currently considering approval of the first genetically modified animal for human consumption, having declared in August 2010 that a GE salmon—AquaAdvantage Salmon—is safe to eat and poses no threat to the environment. FDA is considering environmental and labeling issues, and has not issued a final decision on the commercialization of the GE salmon. In letters from both houses, 40 Members have asked the FDA Commissioner to halt the approval process for the GE salmon, citing serious concerns with FDA's review and approval process. The congressional letters have been endorsed by over 50 consumer and environmental groups.
Although animal biotechnology involves many techniques other than cloning, this latter technology has attracted widespread attention. A final risk assessment and industry guidance on the safety of meat and milk from cloned cattle, pigs, and goats and their offspring were released January 15, 2008, by FDA. The documents generally echoed FDA's December 28, 2006, draft risk assessment, which found that such products are as safe to eat as those of conventionally bred animals. FDA also concluded 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 agency said it was no longer asking industry to refrain voluntarily from marketing the products of cloned animals and their offspring, although the U.S. Department of Agriculture (USDA) did ask that it be continued for products from clones (but not from the offspring of clones).
Bills on animal cloning introduced in the 110th and 111th Congresses would have required all food from cloned animals or their offspring to be labeled, and prohibited food from cloned animals from being labeled as organic. The bills have not been reintroduced in the 112th Congress. A bill that would amend the Food, Drug, and Cosmetic Act to prevent the approval of genetically engineered fish (H.R. 521/S. 230) was introduced in the 112th Congress.