Throw Another Cloned Steak on the Barbie: Examining the Fda's Lack of Authority to Impose Mandatory Labeling Requirements for Cloned Beef

• Publication year: 2006

Matthew R. Kain⁰

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.

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 Elvis¹ or Full Flush 5.² 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."³ 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.⁴

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.'"⁵ 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."⁶ 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."⁷

After extensive review of scientific experiments and peer-reviewed articles, the FDA determined that meat from cloned animals is safe for the consuming public.⁸ The FDA spent several years compiling data and analyzing hundreds of experiments and reports written by scientists.⁹ 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.¹⁰ 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.¹¹ 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.¹²

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.¹³

II. Cloning—An Overview

One may assume that breeders raise animals for food consumption by allowing their animals to mate and reproduce naturally. However, for years, scientists have been using what is referred to as Assisted Reproductive Technologies ("ART") to breed animals with desired traits.¹⁴ Some of the techniques used include artificial insemination,¹⁵ embryo transfer,¹⁶ and in vitro fertilization.¹⁷ However, these techniques are limited because breeders are unable to guarantee that the offspring will have certain characteristics.¹⁸

What if scientists and breeders could more accurately predict certain characteristics of the offspring? "Cloning" is defined as "the propagation of genetically exact duplicates (clones) of an organism by means other than sexual reproduction."¹⁹ Although several cloning techniques have been developed, most animals are cloned by way of nuclear transfer, most notably somatic cell nuclear transfer ("SCNT").²⁰ Generally, this is achieved by removing the nucleus or genetic material of a donor cell and transferring it into a recipient cell from which the original genetic material was removed; the resulting embryo is then implanted in a surrogate mother.²¹ From the breeder's perspective, the advantage of cloning technology is that cloning essentially produces an identical copy of an animal with superior traits.²² Imagine having a healthy herd of prize-winning cattle that is immune to disease and produces high-quality and nutritious meat or dairy products.

The advantages of animal cloning are numerous and most are premised on the ability of breeders to predict better the characteristics of the offspring.²³ First, breeders will continuously be able to improve the overall quality of their products.²⁴ The public desires "a nutritious and wholesome product provided to them in a repeatable and reliable manner . . . ."²⁵ Although consumer tastes vary, many consumers would prefer a lean, tender steak.²⁶ Thus, with the ability to predict better the characteristics of offspring, a breeder can propagate superior genetics from one animal into future generations, thereby continuing to provide consumers with the kinds of foods they desire: "high-quality meat and dairy products."²⁷

Another benefit of animal cloning is the ability to clone naturally disease-resistant cattle.²⁸ Breeding disease resistance into herds of cattle is advantageous from both an animal wellness and an economic standpoint. These cattle will be healthier and, ultimately, cloning can "help eliminate major diseases in livestock."²⁹ From an economic standpoint, cattle possessing a propensity to withstand illness will increase production time and decrease veterinary costs—savings which can be passed along to consumers.³⁰ other noted advantages include reducing the number of veal calves³¹ and enlarging the uses of cloning for potentially valuable biotechnological and medical uses.³²

on the other hand, the prospect of cloning cattle poses several concerns. one apprehension expressed by groups supporting animal rights is that cloning is too inefficient.³³ Reasoning that cloning essentially amounts to cruelty to animals, these groups have also expressed worries about the health of the pregnant mother and surviving clones.³⁴ While some groups disapprove of the inefficiencies and harmful effects to animal health, other critics are concerned that cloning could create herds of cattle that are actually more susceptible to disease.³⁵ Reducing the overall genetic diversity of the nation's cattle population could leave them susceptible to being wiped out entirely by a disease.³⁶ Additionally, cloning cattle is expensive, roughly in the range of $8,000 to $20,000 per cow.³⁷ The sheer cost of each clone could lead to increased, rather than decreased, prices for consumers.

Most notable is the concern over human health and safety risks associated with consuming cloned food products. However, extensive research has been conducted to determine the human safety risks associated with cloned food...