The American Anti-Vivisection Society (AAVS), in conjunction with the Center for Food Safety (CFS) and several other animal welfare, consumer, and environmental organizations, filed a legal petition with the Food and Drug Administration (FDA) on October 12, 2006 to regulate cloned animals. As of now, there is only a voluntary moratorium on the sale of cloned animals and cloned animal products. However, animal cloning presents serious ethical concerns, as well as concerns for animal welfare, human health safety, and environmental safety that have not been adequately investigated or discussed. It is the duty and responsibility of the FDA to implement a regulatory process so that these issues can be thoroughly reviewed before any cloned animal or clone animal product is marketed to consumers.

The petition requests that Health and Human Services (the agency that oversees the FDA) establish an ethics Advisory Committee to address the numerous ethical concerns raised by animal cloning, including threats to animal welfare, before food from cloned animals is allowed on the market. The committee is of utmost importance in ensuring public involvement and debate over the ethical challenges presented by animal cloning.

The petition also requests that, if food from cloned animals is to be made available for human consumption, the FDA regulate cloned animals in a similar way to transgenic animals by requiring the submission of a new animal drug application for each cloned food product. The FDA has decided to adopt a broad, admittedly stretched definition of the term 'drug' as "articles (other than food) intended to affect the structure or any function of the body of man or other animals." Thus, the inserted genetic material involved in producing a transgenic animal qualifies as a drug, and so, too, should the genetic manipulations involved in cloning.

If cloned animals are regulated under the new animal drug provisions of the Federal Food Drug and Cosmetics Act as transgenic animals are, then anyone wanting to sell cloned milk or meat would have to demonstrate that the technology is safe and effective for animals, and that the product is safe for human consumption. Moreover, we are petitioning the FDA to require an Environmental Impact Statement to be prepared to thoroughly investigate the impacts that animal cloning could have on the environment. Until such regulatory oversight is provided, the petition calls on the FDA to replace the existing voluntary moratorium on food from cloned animals with a mandatory moratorium.

AAVS unequivocally opposes the use of animals in research, education, and testing and does not support animal cloning in any way. Use of cloning technology serves to further objectify and commodify animals, treating these living sentient beings as mere machines for human manufacture. AAVS believes that the petition to regulate cloned animals will bring attention to the ethical concerns and serious threats to animal welfare posed by cloning, and will allow these issues to be examined and discussed by the public in a manner that will help to prevent the growth of the animal cloning industry.

The petition to regulate cloned animals was submitted on October 12, 2006, and the FDA will be receiving comments on the petition. Please take a moment to let the FDA know that you support this petition and would like the human safety, animal welfare, and serious ethical concerns associated with animal cloning to be thoroughly addressed before a cloned animal product is marketed.

The groups that have joined the petition, in addition to CFS and AAVS: Consumer Federation of America, Food and Water Watch, Friends of the Earth, the Humane Society of the United States, the Religious Coalition for Reproductive Choice, and the Center for Environmental Health.