Author:DeGiovanni, Maria
Position:Genetically modified organisms


Genetic modification is a process used for a myriad of purposes, including the cultivation of plant species that ultimately find their way into countless food products across the world. (1) As the usage of genetically modified organisms (GMOs) has grown, so has the public debate surrounding their presence in food, and, more specifically, their undisclosed presence in food. Until recently, the United States maintained next to no regulation on the labeling of GMO products. (2) After many state legislatures began proposing and passing GMO-labeling laws, Congress passed one of its own. (3) This Note will discuss the implications of the federal labeling scheme, and posits that although the scheme may disappoint grassroots antiGMO interests, the scheme will ultimately have the effect of providing consumers with the "right to know" what is in their food, and will reduce the presence of genetically modified (GM) foods in the marketplace. Part I provides background on GMOs and explains the regulatory role of the FDA. Part II discusses GMO-labeling legislation passed by certain states, a law recently passed by Congress, and the legal challenges faced by lawmakers when passing this type of legislation. Part III argues that the federal regulatory scheme is not a death knell for consumer autonomy, and that it will do little to weaken the fight against GMOs.

  1. Birth and Development of GMO Technology

    Today, the words "genetically modified" tend to evoke divisiveness. Yet, the phenomenon of genetic manipulation existed long before the birth of genetic bioengineering just a few decades ago. Most students learn about Gregor Mendel in high school biology, the Augustinian monk who, in the mid-nineteenth century, conducted experiments by crossbreeding pea plants. (4) Mendel's studies were a systematic imitation of what farmers had done for centuries: combining the genes of different species of plants and animals to cultivate desirable traits. (5) This type of genetic modification can occur naturally or through human intervention and is now unremarkable. (6) Many of the plants and animals bred today are the products of such passive or active manipulation. (7)

    Centuries after Mendel pondered pea plant variations in his monastery garden, two American biochemists introduced recombinant-DNA (rDNA) technology, through which they isolated fragments of a gene from one bacterium and inserted it into another. (8) The foreign DNA then replicated naturally, creating an entirely new type of bacterium. (9) This discovery came at a pivotal time for a notable player in the genetic engineering game--Monsanto. The company, which at the time was solely in the chemical manufacturing business, was feeling the effects of rising oil prices and public backlash against pesticides. (10) During the seventies, Monsanto stepped tentatively into the field, allocating a small amount of resources to genetic engineering research. (11)

    But a momentous event changed the company's dallying approach. In 1980, the Supreme Court held that man-made microorganisms are patentable subject matter. (12) The decision helped to catalyze a biotechnology boom. Money surged into the industry, even funding companies who had yet to develop patentable organisms. (13) Spurred by this breakneck growth, Monsanto devoted more resources to genetic engineering and the development of its own microorganisms. (14) By 1990, Monsanto had invested over $800 million in biotech and had developed a number of products using genetic engineering. (15) The attitude of industry insiders during this period was one of rapturous optimism and their testimonies conjured Utopian prospects: bountiful crop yields untouched by chemicals and grown from soil devoid of fertilizers, which could grow as rapidly as the fabled beanstalk into a pristine atmosphere unmarred by pollution caused by the farm industry. (16) All things seemed possible, a canonical idealism perhaps best epitomized by a remark made by the president of the International Plant Research Institute in 1981: "We are going to make pork chops grow on trees." (17)

    Decades later, these lofty aspirations have yet to come to fruition. The facts and figures representing the relationship between GMOs and farm chemical use are disappointingly murky, (18) but it is certainly safe to say that pesticides and herbicides are still widely used. (19) Additionally, the agribusiness conglomerate is now faced with rancorous opposition from antiGMO activists, an effect probably not envisioned by those at the forefront of genetic engineering. A recent, extensive study corroborated the results of numerous others--all purport to find no health risks associated with GMOs. (20) This evidence has not deterred anti-GMO groups. Some of their fervent propaganda--debunked falsehoods oozing paranoia--is easy to dismiss as pure conspiracy theory, (21) while other arguments for labeling GM food come from less dubious sources. (22) Regardless of the origin of antiGMO rhetoric, it often identifies Monsanto and other companies in its industry such as Bayer and DuPont as the root of GMO evil. To fight against big agri-business, anti-GMO groups push for legislation that would impose mandatory labeling requirements on companies.

  2. The Role of the FDA, State and Federal Labeling Laws, and Legal Hurdles

    1. The FDA 's Role in GMO Labeling

      The Food and Drug Administration (FDA) is the most obvious entity to assume responsibility for promulgating GMO-food labeling requirements. However, despite encouragement to do so, it has never issued anything more than nonbinding recommendations regarding the labeling of products containing GMOs. (23) The agency's authority stems primarily from the Federal Food, Drug, and Cosmetic Act of 1938 FDCA), (24) which has been amended to augment the FDA's ability to regulate what food producers may put in their products and how they must label them. (25) Under the Food Additives Amendment of 1958, the FDA requires pre-approval before certain additives are included in food products. (26) Additives exempt from the pre-approval requirement are those "generally recognized as safe" (GRAS). (27) In 1990, Congress passed the National Labeling and Education Act (NLEA), which imposed mandatory, complete nutritional labeling, with the intent of allowing consumers to make better-educated decisions about the food they purchase. (28) Shortly after the enactment of the NLEA, the FDA indicated that foods containing bioengineered ingredients would not be subject to the labeling requirements of the NLEA nor would GM ingredients be considered food additives so as to require pre-approval. This decision gave GM foods a "presumed GRAS status." (29) Even in the present age of GMO controversy, the FDA has not significantly shifted its views regarding disclosure of bioengineered ingredients. As long as the label is not misbranded by being false or misleading, it is acceptable to the FDA. (30) This foundational principle--that product branding must be accurate and true--extends to the labeling of GMOs. (31) For instance, the FDA considers a label false and misleading if it purports that it is completely free of GMOs when it contains GM corn. (32) The FDA provides guidance for producers who wish to voluntarily label their products as containing, or not containing, bioengineered ingredients. (33) To ensure that a product is not misleading, the FDA gives numerous examples of wording that may be printed on food labels to express that the product was produced either with or without GM ingredients. (34) Some of these recommendations serve as clear pronouncements, while others are more convoluted. (35) For example, a cereal company may label a product that contains no GM ingredients (Cereal A) as "not genetically engineered," and a product that contains GM soybeans, for instance, as "genetically engineered" (Cereal B). (36) However, the FDA guidance also submits that Cereal A may be labeled with the words "[o]ur corn growers do not plant bioengineered seeds" and a statement on Cereal B may say "[s]ome of our growers plant soybean seeds that were developed through modern biotechnology to be drought tolerant." (37) In the case of Cereal A, does the label mean that although the corn is not genetically engineered, other ingredients are? The answer is unclear. The label on Cereal B uses the word "biotechnology," but does not refer to genetic modification or bioengineering. The meaning of such a statement may puzzle to even the most discerning consumers. This issue is addressed by the FDA, which warns that even a truthful statement may be misleading. (38) For example, the guidance states--

      [O]n a product made largely of flour derived from genetically engineered corn and a small amount of non-genetically engineered soybean oil, a claim that the product 'does not contain bioengineered soybean oil' could be misleading if consumers believe that the entire product, or a larger portion of it than is actually the case, is free of bioengineered material. It may be necessary to carefully qualify the statement in order to ensure that consumers understand its significance. (39) This instruction still fails to address the potential circumstance in which a product's primary ingredient is not bioengineered. If the hypothetical product in the FDA's example was composed of mostly of non-genetically engineered soybean oil and only in small part of flour derived from genetically engineered corn, would it be misleading for the producer to label the product as not containing bioengineered soybean oil? The failure of the guidance to address such a situation implies that it would be acceptable and not considered misleading to consumers. However, it seems probable that a consumer who sees such a statement would assume it means that the product contains no GM ingredients.

      The FDCA does not provide a private right of action, and the FDA cannot impose monetary penalties for misleading food labels...

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