American Journal of Law & Medicine

Genetically Modified Foods at the Intersection of the Regulatory Landscape and Constitutional Jurisprudence

An ecosystem ... [y]ou can always intervene and change something in it, but there's no way of knowing what all the downstream effects will be or how it might affect the environment. We have such a miserably poor understanding of how the organism develops from its DNA that I would be surprised if we don't get one rude shock after another. (1)

I. INTRODUCTION

Breakthrough advancement in genetic engineering has ushered in a new era. An era where, unbeknownst to us, our diets may contain food derived from genetically engineered ("GE") substances or genetically modified organisms ("GMOs"). Such genetically modified ("GM") foods (2) have been introduced into the existing food distribution system without adequate warning to consumers. This inability to know about the foods consumers eat or the health risks they face is the stark reality of our contemporary food pyramid system. Within this system, the consumer resembles the participant in a blind experiment; the participant neither knows of nor consents to the participation. Emboldened by a two-prong transformation process, gene transfer between species and adapting bio-technological research into everyday application, modern agriculture manifests itself in a pervasive commoditization of GM foods. The resulting uncertainty faced by the consumers of such commoditization can be traced to two distinct legal inadequacies: the supervisory regulatory mechanism's inability to protect public interest and existing law's inadequacy to issue appropriate labeling information for GM foods.

Lack of labeling for GM products is a serious concern for both consumers and farmers. Rampant usage of genetic engineering and widespread tinkering with biopesticides has greatly enhanced the risk of diseases that creep in through transgenic pathways while posing a real danger to the food distribution system. (3) With an abundance of GE crops flooding the U.S. food chain, consumers have become all too familiar with the alarming realities of the underlying regulatory process. First, the current process is not exhaustive enough to fully evaluate the long-term effects of GE foods on human health and the natural environment. Second, the regulatory approval mechanism lacks an adequate safety analysis to ward off the various calamitous consequences of human consumption. This failure to adequately balance the cost to both human and environmental health with the benefit of production efficiency of GE foods certainly calls for procedural safeguards, specifically in the form of enhanced disclosures.

Consumer protection calls for more disclosures than currently exist in the United States. These disclosures could range from additional nutritional information to content of GE products, to enhancing statutory warnings on GE foods. Absence of such enhanced disclosures on food labels has prompted legislative and executive responses in the United States. This has resulted in a new development. The perceived failure of the existing regulatory regime has ushered in the emergence of a new consumer-driven statutory framework. Poised to challenge the status quo of corporate dominance in food marketing, this framework has turned its focus to the adequacy of food labeling. This article examines how an emerging regulatory paradigm based on legislative enactments at the state level may be on a collision course with the existing corporate status quo.

Fundamentally, food law's contour must evolve through the interactive lens of procurement ease and process efficiency. Observing that process efficiency is a function of corporate ownership of the value chain, the inadequacy of the GM food regulatory regime invites us to take an introspective look at potential solutions. When legislators and governments respond by proposing a consumer-friendly regulatory regime through statutory enactments, (4) such initiatives immediately become subject to judicial scrutiny. (5) Legal challenges range from opposition based on the legislative enactment's potential conflict with the commercial speech doctrine under the First Amendment jurisprudence. (6) This opens up many queries. Do the perceived failures and inefficiencies of the Food and Drug Administration ("FDA") provide a legitimate basis for the government to shape consumer dietary habits? Should the government step in to protect consumer interests? Does it matter that advertisers may have subjugated consumers in "marketing" their vision about consumer dietary habits? Do legislators have expertise with complex issues at the intersection of food safety and corporate interest? This article seeks to explore emerging food labeling issues residing at the intersection of constitutional jurisprudence and regulatory landscape.

This Article proceeds as follows. Part I has provided a backdrop on the current tension between lack of regulation on GM foods and consumers' fundamental right to know. Part II dissects the anatomy of the resulting food safety and its attendant security concerns. This discussion then sets the stage for presenting the applicable regulatory landscape in Part III, which leads into dissecting their inadequacy in Part IV. This then leads into providing the appropriate context for Vermont's GM labeling law in an attempt to chart a future course of regulatory actions in Part V, and Part VI provides a brief conclusion.

II. FOOD SAFETY AND SECURITY

Genetically modified crops arrived at the scene via scientific advancement in biotechnology. Despite concerns about the safety of genetic modification, the promise of solving world hunger by bringing efficiency in food production allowed its seamless introduction into the global food chain. (7) As GM crops began flooding the food system, the federal food safety regulations failed to cope with the growing sophistication of biotechnology. Issues arose. First, uncertainty over safety caused consternation among the consumers and trade safety groups. (8) Second, taking advantage of loopholes in intellectual property law, biotechnology companies began consolidating their stranglehold in food production, particularly in the seed industry. (9) This resulted in widespread usage of genetic engineering, (10) paving the way for rampant and unsafe tinkering with bio-pesticides. (11) With the risk of diseases creeping in through transgenic pathways, the food distribution system faced significant danger. (13) While the risk of disease and the threat to food safety affect the U.S. food distribution system, the underlying problem is the supervisory regulatory framework. The absence of robust regulatory oversight within the current framework has subjected consumers to corporate interests. Despite GM crops dominating the market, consumers have been largely kept in the dark about the content of such food source.

GM crops are a relatively new food source. (14) A new food source should have adequate labeling so that consumers can make informed decisions based on their understanding of the health implications that such labeling might reveal. Long beholden to corporate interests, the current regulatory framework imposes no such labeling requirement. (15) Such regulatory inadequacy ushered in a food regime where corporate interests predominated over the consumer safety and food security. (16) For example, GM crops were allowed to flood the U.S. food chain without prior studies on the long-term effects of their consumption on human health and the environment. (17) By advancing an unproven promise of production efficiency, food production companies created a consumption paradigm that bypassed many procedural safeguards to ensure sustained corporate profit.

A large question exists as to whether the pursuit of food security may have unleashed a global health and environmental catastrophe. Given the practical reality of the GM food regulatory regime, we may even ponder whether the future of U.S. food safety has been compromised. Fundamentally, the lack of a robust consumer rights framework at the federal level precludes consumers from enjoying an effective food-labeling paradigm. Certainly, the absence of such labeling has thrown both farmers and consumers into a distribution system with unsafe and insecure food. (18) Lack of adequate labeling can have many consequences. Without adequate labeling of GM food, consumers remain unaware of threats from the unknown effects of biopesticides. (19) The pervasive use of genetic engineering in consumer food crops is well documented. (20) When the genetic makeup of crop seeds is tinkered with, sometimes to eliminate undesirable traits found in nature and sometimes to make them resistant to bio-pesticides, it introduces undesirable, poisonous, and disease-prone traits. (21) Without adequate labeling, we are therefore left with food sources that are largely unregulated within the supply chain. (22) This safety issue is the product of an inadequate and fragmented regulatory framework that currently oversees the entire food procurement system. Next, I highlight reasons this regulatory framework suffers from the inertia of moving lockstep with technology's advancement.

III. REGULATORY LANDSCAPE OF GM FOOD SYSTEM

Reacting to growing concern about GM food, governmental agencies across the globe have resorted to a wide range of rearguard actions. Such actions have ranged from creation of specific regulatory bodies to enactment of GM specific statues to labeling requirements on GM products. (23) European GM food regulations have been stringent and restrictive in providing for a high level of safety for protection of human life, health, animal welfare, and environmental sustenance--all of which contribute to a broader consumer interest. (24) On the other hand, the U.S. regulatory paradigm seems to have stalled into a confusing conundrum of inertia and corporate dominion. Shaped in part by corporate interests, and prompted in part by their own inefficiencies, the U.S. regulatory agencies have creatively manufactured regulatory authority based on arcane statutes. (25) Residing within these agencies' constant struggle to legitimize their oversight function has been a systemic and deep-rooted weakness of statutory incompleteness. …

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