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Matthew R. Kain
On December 28, 2006, the Food and Drug Administration (FDA) released Animal Cloning: A Draft Risk Assessment (“DRA”) which concludes, based on available scientific data, that cloned beef is not biologically different from non-cloned meats currently on the market. This Comment explores the FDA's authority and jurisdiction to regulate cloned foods. First, this Comment provides background information regarding the cloning process; the FDA's jurisdiction; the Federal Food, Drug, and Cosmetic Act; and the Organic Foods Production Act of 1990. Then, this Comment discusses how domestic and international labeling requirements for genetically modified foods might apply to cloned beef. Finally, after examining the DRA and accompanying documents, this Comment attempts to justify the FDA's lack of authority to impose mandatory labeling requirements on cloned beef.
Cite as 8 N.C. J.L. & Tech. 303 (2007) |
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I. Introduction
The year is 2010. As James drives home from his office, he is thinking about his weekend plans: yard work, his college alma mater's rivalry football game, and a romantic dinner with his wife on Saturday night. He mentally goes over the menu: Caesar salad, steak, baked potatoes, asparagus, and croissant rolls. James stops by his local grocery store to purchase the food for Saturday night. In the meat department, James discovers that his local grocery has quite an impressive selection, including the premium: a 16-ounce, two-inch thick, tender, juicy, prime cut rib-eye with marbling the likes of which James has never seen before. It's the perfect steak, but is it too perfect?
What James doesn't realize is that his “perfect steak” is in fact cloned beef, the creation of scientists using very advanced cloning techniques. Actually, this steak was not cut from a cloned cow. Rather, the cow that provided this steak is probably the offspring of a cloned cow named Elvis
or Full Flush 5.
James does not notice any labels about his rib-eye being cloned beef, not due to lack of attention, but because there are currently no labeling or disclosure requirements for meats derived from cloned bloodlines that would alert a consumer like James. On December 28, 2006, the United States Food and Drug Administration (FDA) released Animal Cloning: A Draft Risk Assessment (“DRA”), which concludes, “the composition of meat . . . and milk from bovine clones consistently indicates that there is no biologically relevant differences between the composition of food from clones . . . [and] food commonly consumed from these species on a daily basis.”
As a result of this conclusion that cloned beef is not materially different from meats produced using other reproductive techniques, the FDA decided a labeling requirement is not warranted.
Yet, what about James and the consuming public? Do they not have the right to know? Would they care if they knew? According to a 2002 Gallup poll, “66 percent of American consumers said that cloning animals was 'morally wrong.'”
Similarly, a survey conducted by the International Food Information Council in March 2005 reported that “63 percent of consumers would likely not buy food from cloned animals, even if the FDA determined the products were safe.”
In October of the same year, a study conducted on behalf of ViaGen, Inc., the leading cloning company in the United States, found that “one-third of respondents were willing to buy meat and milk from the offspring of cloned animals, one-third were willing to consider it once they learned more, and one-third said they would never buy it.”
After extensive review of scientific experiments and peer-reviewed articles, the FDA determined that meat from cloned animals is safe for the consuming public.
The FDA spent several years compiling data and analyzing hundreds of experiments and reports written by scientists.
Yet, why is the public still unreceptive to eating cloned beef? Perhaps it can be attributed to a lack of information within the consuming public. Perhaps it is fear of the unknown. After all, very little longitudinal research has been found concerning the potential long-term effects of eating cloned meat.
In an effort to respond to these concerns, the FDA has pledged to stay actively involved by monitoring scientific literature and continuing to evaluate the scientific process.
Based on the conclusions in the DRA, however, the FDA has found that cloned beef products warrant no additional regulation or labeling requirements at this time.
This Comment explores the FDA's authority and jurisdiction to regulate cloned foods. Part II explores the cloning process as well as concerns about human consumption of cloned beef. Part III provides background information regarding the FDA's jurisdiction and pertinent sections of the Federal Food, Drug, and Cosmetic Act (“FDCA”), from which the FDA derives its power to potentially regulate food products from cloned animals, as well as pertinent sections of the Organic Foods Production Act of 1990 (“OFPA”). Part IV describes the key issues raised by genetically modified foods and illustrates how some of the domestic and international labeling requirements for genetically modified foods, along with the policies and reasoning behind them, might apply to cloned beef. Part V summarizes the DRA and accompanying Animal Cloning: Proposed Risk Management Plan for Clones and Their Progeny (“PRMP”) and Draft Guidance for Industry: Use of Edible Products from Animal Clones or Their Progeny for Human Food or Animal Feed (“DGI”). Finally, in Part VI, this Comment attempts to justify the FDA's lack of authority to impose mandatory labeling requirements on both a regulatory interpretation basis and by analogy to the lack of domestic labeling requirements for genetically modified foods. While there is criticism of the FDA's recommendation on many levels, this Comment focuses on the FDA's limited jurisdiction and the scientific evidence that supports the Agency's finding.
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