IV. Genetically Modified Foods-The Plant Equivalent of Animal Cloning

Traditionally, plants have been bred to enhance desired traits through a process known as cross-fertilization;91 however, this conventional method is time-consuming, often inaccurate, and is becoming obsolete.92 Technological advances, such as genetic engineering, gene splicing or recombinant DNA,93 now allow scientists to isolate desired traits much more accurately and quickly.94 “Genetically modified food,”95 often used interchangeably with the term “genetically modified organism,”96 is a term used to describe foods created using these rapid, accurate, and precise techniques.97 Essentially, scientists are able to transfer genetic material from one organism to another in order to express certain traits in the modified organism.98 Today, “most, if not all, cultivated food crops have been genetically modified.”99

Genetically modified foods offer numerous advantages over traditionally grown crops. Scientists can genetically engineer crops to be more resistant to diseases and insect pests, thereby requiring farmers to use little or no environmentally-hazardous, chemical pesticides.100 Additionally, engineering crops to be tolerant of powerful herbicides will minimize the impact on the environment as lesser amounts of herbicides are needed to kill weeds.101 Genetic modification can also improve adaptability to harsh growing conditions and increase tolerance for cold, frost, drought and salinity.102 Moreover, worldwide malnutrition could be alleviated by genetically engineering crops to contain additional vitamins and minerals.103 Finally, genetic modification has applications in improved functionality,104 pharmaceuticals,105 and phytoremediation.106

However, critics of genetically modified foods are concerned that the foods may produce pesticide-resistant insects, thereby resulting in an actual reduction in the overall effectiveness of pesticides.107 Growing genetically modified crops could unintentionally damage other organisms108 as well as accidentally cross-breeding herbicide-tolerance into weeds.109 From an economic standpoint, critics are concerned that if large agricultural companies patent genetic engineering technologies, the price of both seeds and foods will dramatically increase, thereby having a detrimental economic impact on small, domestic farmers and developing countries.110 Opponents are also concerned about human health risks associated with genetically modified foods, which could include both known, life-threatening allergies and unknown, potential health effects.111 Critics argue that, at a minimum, people have a right to know that the food they are purchasing has been modified.112 It is the concern for human health that could give the FDA the authority to regulate genetically modified foods.

A. United States Regulation-“Genetically modified foods welcome, no labeling requirement here”

On May 29, 1992, the FDA issued its “Statement of Policy: Foods Derived from New Plant Varieties.”113 This document clarified the FDA's view of the FDCA with respect to genetically modified foods. Citing to both 21 U.S.C. § 343(a) and § 321(n), the FDA stated that the consumer “must be informed . . . if a [genetically modified food] differs from its traditional counterpart,”114 and accordingly, the label must disclose all material facts.115 For example, due to the common allergies associated with peanuts, the FDA would consider a tomato seed spliced with a peanut protein to be a material fact.116 As a result, disclosure on the tomato's label would be required to alert individuals allergic to peanuts.117 However, disclosure of the technique used to genetically modify the tomato would not be necessary. Since there are no data or evidence that foods created using these techniques differ significantly from, or lead to any greater safety risk than, other foods, the FDA has never considered the technological processes by which such foods are created to be material information.118 Because the FDA concluded that “[genetically modified] foods are substantially equivalent to unmodified 'natural' foods,”119 a mandatory labeling requirement is not required by the FDCA. However, labeling would be required when a food is genetically modified to introduce a known allergen or when a genetically modified food's nutritional content is significantly different.120

A mandatory labeling requirement has several downsides. First, the labeling requirement would have to follow the food through the entire food processing chain; it would not be as simple as slapping a sticker on at the end.121 Second, requiring companies to label all genetically modified foods would not be cost-effective, and the consumers would ultimately carry the burden of a price increase.122 FDA implementation and enforcement would be difficult, requiring at a minimum: definition of acceptable limits for genetically modified food contamination; monitoring companies for compliance; detection and prevention of cross-contamination; and public education.123 Third, public perception is the most important, and arguably, the most volatile factor; the central concern is “how to educate and inform the public without damaging the public trust and causing alarm or fear of [genetically modified] food products.”124

B. International Regulation-“If you want to genetically modify the food, you had better label it as such”

Unlike in the United States, the general consensus in the international community is that genetically modified foods should be labeled.125 For example, the Food Standards Code of Australia and New Zealand mandates labeling for genetically modified organisms126 stating, “the label on a package of genetically modified food must include the statement 'genetically modified' in conjunction with the name of that food or ingredient or processing aid.”127 Another example can be found in the latest set of European Union regulations.128

To fulfill its objective of protecting “human life and health, animal health and welfare, environment and consumer interests in relation to genetically modified food and feed,”129 the European Parliament also decided to require labeling for genetically modified foods.130 The scope of Article 12 of the GM Food and Feed Regulation applies to foods that either contain genetically modified organisms or are produced from genetically modified organisms.131 However, due to drafting,132 the labeling requirements only apply to foods produced “from” genetically modified organisms and not foods produced “with” a genetically modified organism.133 Thus, the regulation creates labeling requirements for genetically modified foods (grains, fruits, and vegetables), but does not require labeling for products produced with the help of a genetically modified enzyme (cheese), nor food derived from animals fed with genetically modified feed (meat, milk, and eggs).134

C. Organic Foods Equates to Non-Genetically Modified Foods

While the United States does not require mandatory labeling of genetically modified foods, consumers can nonetheless know they are not buying genetically modified food when they purchase organic foods. The FDA, under the authority granted by the FDCA, must focus on the safety of the food product; consequently, based on the scientific evidence, genetically modified foods do not necessitate a mandatory labeling requirement. However, under the authority of the OFPA, the USDA may focus on the process by which organic foods are grown. Organic foods, by definition, do not include genetically modified foods.135 Congress mandated in the OFPA that in order for a farm to be certified as growing organic foods, “producers on such farm shall not . . . engage in practices on seeds or seedlings that are contrary to, or inconsistent with, the applicable organic certification program.”136 Consequently, the NOP, in promulgating regulations, decided that genetically modifying seeds was inconsistent with organic certification. Within the excluded methods of producing organic foods is any “variety of methods used to genetically modify organisms . . . [including] . . . recombinant DNA technology . . . .”137 Because genetically modified foods fall outside the definition of organic foods, a consumer can be assured of not consuming genetically modified foods when purchasing an organically labeled food. Thus, organic food labeling is the next best alternative to mandatory labeling of genetically modified foods.