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Abstract:
Examining the degree to which environmental concerns have or have not been incorporated into the registration requirements of Bt crops, it becomes clear that the regulatory process suffers from many ills. In approving these genetically engineered crops for market, the United States Department of Agriculture (USDA) and Environmental Protection Agency (EPA) repeatedly disregarded significant but unresolved scientific questions about these GM crops. Seed companies agreed to environmentally protective measures in their crop registrations, but assumed no responsibility for implementing those measures. Instead, the implementation burden fell exclusively on growers who, as third parties to the genetically modified organisms' registrations, were not directly subject to regulatory jurisdiction. No regulatory framework existed (or, for that matter, exists) to monitor and enforce these registration restrictions. I suggest that these defects grow directly from ill-advised fragmentation of the regulatory role and a squeamish unwillingness to engage in necessary, but politically charged, direct regulation that might slow the development of a high-tech industry. These serious regulatory deficiencies call into question the soundness of the entire biotechnology regulatory process, a question ultimately much broader than any particular GMO.

Using the actual behavior of regulators and the regulated community as a case study, this article evaluates whether the Coordinated Framework facilitates relatively safe development and introduction of these new crops. Specifically, I examine how regulatory decisions have used available scientific information and have responded to scientific uncertainty. Without advocating the elimination of Bt crops, or discounting the potential benefits of biotechnology, I conclude that the Bt case study reveals significant regulatory failures that can be remedied only through systemic changes to the regulatory process.

Keywords: genetically modified organisms, environmental law, agriculture, precautionary principle, uncertainty, risk assessment

GM crop, GMO, LMO, genetically modified organism, genetically engineered, genetic engineering, Starlink, Coordinated Framework, substantial equivalence, biopharming, administrative law, agriculture, biotechnology, FDA, USDA, EPA, precautionary principle, uncertainty, risk assessment, transgenic

Abstract:
On September 18, 2000, a coalition of consumer and environmental groups detected DNA fragments from StarLink corn in Taco Bell taco shells sold in grocery stores. StarLink corn, a genetically modified (GM) variety of corn, had only been approved for use as animal feed, and not for human consumption. Overnight, this GMO became a Frankenfood posterchild - the incarnation of a genetic engineering critics' worst nightmares. By November of 2000, the FDA exercised its enforcement authority to recall nearly three hundred types of adulterated snack chips, corn flour, and other corn foods. The ensuing crisis paralyzed an entire sector of American agriculture and food production, and badly shook consumer confidence. One company, with one genetically engineered crop, managed to contaminate food for millions of households and brought an international commodities market to a standstill. This Article explores the StarLink crisis in some detail to understand how things went so disastrously awry.

After a detailed analysis of the regulatory approval process that vetted StarLink corn, the paper uses StarLink corn to explore the structural flaws in this process and to draw lessons about how market forces can support or undercut regulatory regimes. Ultimately, the paper suggests that the deficiencies highlighted by the StarLink fiasco are part of a broader ideological struggle over the proper role of government in the marketplace. Claiming that StarLink corn experience undermined a cornerstone assumption of the United States' regulatory strategy: that voluntary self-policing can be a viable, long-term strategy for managing this revolution in agriculture, the paper proposes a new regulatory approach for agricultural biotechnology, one grounded in both science and in the realities of a market economy. This new approach is aimed at providing the regulatory oversight needed to ensure public health and safety, while still permitting an exploration of biotechnology's promise.

GM crop, GMO. LMO, genetically modified, genetically modified organism, genetically engineered, genetic engineering, Starlink, Coordinated Framework, substantial equivalence, biotechnology, biopharming, administrative law, agriculture, biotechnology, FDA, USDA, EPA, ag-biotech, biotech

Abstract:
The discourse surrounding traditional knowledge takes place on a number of levels simultaneously. Trade advocates view ownership of traditional knowledge and biological diversity through the lens of the World Trade Organization (WTO) agreements. Environmentalists approach the question with ecosystem preservation in mind. Because most of the world's remaining biodiversity exists within the territories of indigenous peoples, issues of sovereignty, identity and colonialism inevitably swirl beneath the surface. And, of course, all these dialogues occur against a backdrop of a globalizing market economy that values resources almost exclusively in terms of their monetary value.

So far, the dynamic seems to be a tug of war between two alternative property visions: state ownership of biological resources, as articulated in Article 8j of the Convention on Biological Diversity, and private ownership of these resources under the TRIPS agreement.

There is, however, a third aspectto this struggle over traditional Knowledge and biological resources. Most of the world's remaining biodiversity exists within indigenous lands and territories. Rather than as an aspect of state sovereignty over territory, or the fruits of private invention, indigenous leaders conceive of these resources as an aspect of self-determination - as a recognition of their fundamental rights to property and culture. Indigenous groups are thus trying to expand the discourse over biological resources so that it includes their interests and their hopes for wresting back control over territories, resources and heritage.

Given the resources devoted to developing comprehensive laws to ensure protection of intellectual property one might ask why the current legal system does so little to safeguard the cultural and intellectual property interests of indigenous groups. When the interests and assets of an entire group are, by definition, not embraced within the protective mantle we call property, it ought to prompt exploration of some hard questions. This article attempts to pose some of those questions and to suggest areas for further inquiry.

indigenous, traditional knowledge, TRIPS, biodiversity, property

Abstract:
The Universal Declaration of Human Rights assigns individuals, states and "organs of society" the duty to promote and protect human rights. The Nuremberg Tribunals were the first significant international attempt to prosecute grave violations of humanitarian law and human rights - rights that we now presumptively believe will be vindicated and respected by international law. Along with recognizing individuals as holders of international rights, Nuremberg recognized individuals as actors in the international arena that were capable of upholding or violating international law. This recognition is embodied in the Rome statute creating the International Criminal Court (ICC).

Just as there are individual and state international crimes against humanity, so to there should international recognition of corporate crimes against humanity, as well as corporate culpability for participation in acts of genocide or war crimes. By exploring, inter alia, United States ATCA jurisprudence, the decisions of the International Criminal Tribunals for Rwanda and the Former Yugoslavia, as well as existing multilateral treaties on a variety of subjects, this essay makes the case that the growing recognition of corporations as legal persons or juridical persons in domestic and international law supports their inclusion within international criminal law as well. In making this case, the essay traces the nascent seeds of corporate criminal liability for gross violations of human rights in existing international law.

ATCA, international law, human rights, genocide, Nuremberg, crimes against humanity, war crimes, corporation, juridical person, legal person, Geneva Convention, International Criminal Court, ICC, ICTY, ICTR

Abstract:
CERCLA was intended to solve the nation's hazardous waste disposal problems. Not only would the law clean up hazardous waste sites, but, through retroactive strict liability, it would also make polluters pay the costs associated with this cleanup. Faced with staggering cleanup costs, Potentially Responsible Parties ("PRPs") sought to reduce their liability by invoking their Comprehensive General Liability ("CGL") insurance policies. PRPs often claimed coverage under multiple insurance policies issued over the course of many years. The resulting litigation frequently involved scores of insurance policies covering numerous industrial sites for the better part of the century. A policyholder might have purchased intricate layers of insurance coverage within each policy period. As an added complexity, there were often gaps in insurance coverage.

With no statutory or contractual direction, common law courts had to fill the gaps and chart the interplay between state insurance law and federal environmental law. Unfortunately, the jurisdictions confronting this question responded fitfully and unsystematically. While nominally applying the same principles of insurance contract interpretation, courts reached disparate, if not downright contradictory, results. Further amplifying the confusion, courts almost uniformly failed to articulate the reasoning driving a particular allocation remedy, making it virtually impossible to project future outcomes. PRPs and insurers are left without predictable guidelines: facing enormous but uncertain liabilities.

This article examines several core questions in the allocation process. When is insurance triggered to cover a loss? How should responsibility for covering a loss be divvied up? Should the policyholder be assigned any share of the loss? If so, under what circumstances — any time there is a gap in coverage, or only when that gap is rooted in a decision to self-insure? These questions implicate fundamental assumptions of existing insurance jurisprudence, particularly assumptions about the nature of the contract between the parties. The answers necessarily reflect policy choices about fairness and about the purpose of insurance. I contend that the existing law can be resolved into two fundamentally different allocation models that all courts have implicitly employed. Taking a holistic approach, this article seeks to reconcile, to the extent possible, these competing models, and proposes a new allocation system that maximizes the identified goals of the allocation process, while minimizing any disadvantages.

insurance, environmental law, CERCLA, hazardous waste, cleanup, allocation, remedy

Abstract:
One of the most controversial and exciting prospects of biotechnology is biopharming - a process in which plants are genetically engineered so that they endogenously produce specialty pharmaceutical or industrial proteins. The allure of these GMOs is clear - an environmentally sustainable, and inexpensive replacement for costly drugs and petrochemicals. That allure may be obscuring the dangers lurking below the surface. Because these genetically modified crops are not food and are not intended for human consumption, there are jarring points of tension, if not outright contradiction, between widespread planting of biopharm crops and the ongoing expectation of a safe and secure food supply. This article raises a few of the more pressing public health questions that should be resolved before any more of the nation's crop lands are diverted from food production to biopharming. Part I provides an introduction to biopharming and outlines the various plans and projections for its commercial exploitation. Part II examines the existing regulatory structure, highlights some of its most critical weaknesses, and points out the serious risks this structure creates vis-a-vis the integrity of the food supply. Part III articulates the central conclusion that safe and successful exploitation of these new technologies will demand a markedly different regulatory regime than the laissez-faire system that has prevailed in conventional agricultural policy. To that end, this section proposes some alternatives that would better safeguard public health while still permitting exploration of this exciting new technology.

LMO, Food safety, ag-biotech, biopharming, biotechnology, agriculture, genetic modification, genetic engineering, GMO, pharmaceutical, bio-based, public health, transgenic

Abstract:
Drawing on insights from the social and behavioral sciences, the New Haven School of legal analysis championed by Harold Lasswell and Myres McDougal proposed a worldwide jurisprudence of human dignity. Their process-oriented jurisprudence attempted to flesh out the core values of human dignity and the processes necessary to translate those values into universal theories of authoritative decisionmaking. Of particular interest is the role they proposed for science in legal analysis. This article explores the relationship between New Haven School ideas of authoritative decision and the environmental challenges posed by sustainable development. Exploring the tensions between the malleability of sustainable development as an international principle and the precision of the multilateral environmental agreements that shape international environmental law, this article identifies how the very idea of authoritative decision is being reshaped in the context of globalization. This article suggests that some portions of the New Haven approach might help make sense of the new multiplicity of decisionmakers in the globalized arena, and might help international environmental law confront the duties owed to future generations.

Using the international debate over cost-benefit versus precautionary approaches to regulation, this article tests both the strengths and weaknesses of New Haven thinking about science, and draws the conclusion that the lessons offered for environmental problem-solving are cautionary as well as salutary. Ultimately, this article concludes that although the specific scientific matrices and analyses proposed by New Haven writings are a product of their times, many of the School's basic insights about the need for contextual, problem-oriented and multi-disciplinary analysis still ring true.

precaution, cost-benefit, environmental, sustainable development, sustainability, risk analysis, international, GMO, biotechnology, regulatory

Abstract:
Although almost every discussion of state responsibility begins with its talismanic invocation, time has not been kind to the Trail Smelter arbitration. Its primary contributions to international law have been the statement that: no State has the right to use or permit the use of its territory in such a manner as to cause [environmental] injury . . . in or to the territory of another, and its requirement that Canada pay the United States compensation for damages. While these Trail Smelter principles have become customary international environmental law, the arbitration itself is often viewed as a quaint remnant of a bygone world. Many scholars view Trail Smelter's marginalization as inevitable in light of international law's evolution from a state-to-state realm to one of multi-lateral, consensus-based actions. Others have suggested that the arbitration's impact is blunted by the fact that harm was not contested before the Arbitral Tribunal. This unique combination of characteristics leads many to conclude that Trail Smelter has little relevance for resolving the thorny transboundary environmental challenges that beset our ever-globalizing world.

I think the case has much to teach modern international environmental law, but for somewhat unconventional reasons. This chapter explores one of the arbitration's least considered facets - the decisional process itself. Hampered by a lack of scientific evidence, the Trail Smelter Tribunal crafted an adaptive decisional structure in order to fulfill its charge to be just to all parties while resolving a conflict over pollution flowing across the Canadian border and causing harm in Washington State. The Tribunal's innovative and far-reaching solution, which I am calling (semi)precautionary, was to craft an interim regime from the available but incomplete information, with a clear understanding that the interim period would be used to develop more information. The newly-developed information was then used to create a permanent regime designed to minimize harms while permitting the smelter to continue operations.

This structure - using preliminary measures to prevent harm while information sufficient to create a permanent regime fair to all parties is developed - is the Trail Smelter arbitration's (semi)precautionary legacy. Regardless of the critiques of the arbitration's holdings or its normative relevance, this (semi)precautionary legacy resonates profoundly in modern international environmental law. For example, this early case presaged much of the contemporary debate about appropriate regulation, like that surrounding genetically modified organisms (GMOs). Viewing this controversy through Trail Smelter's (semi)precautionary lens might reveal an appropriate middle ground between the competing claims for regulatory legitimacy made by advocates and opponents of the precautionary principle.

Trail Smelter, GMO, LMO, genetic engineering, biotechnology, SPS Agreement, WTO, CBD, Biosafety Protocol, Convention on Biological Diversity, Sanitary and Phtyosanitary

Abstract:
This article tells the story of the GloFish, America's first commercially available transgenic (or genetically modified GMO, also called living modified or LMO). Beginning with the scientific research that produced this transgenic fish, the article traces the GloFish through development, marketing and regulation in order to extract whatever lessons can be learned from this initial experience with a transgenic animal. I assert that the tale is a cautionary one - with agency reluctance to regulate jeopardizing public and environmental safety. Rather than engaging in heightened or even ordinary regulatory scrutiny, the Food and Drug Administration (FDA), the lead agency for regulating transgenic animals, instead announced in 2003 that it would permit GloFish to enter into interstate commerce wholly unregulated. This announcement that the FDA would not to regulate GloFish meant that no federal agency was exercising any oversight over the first commercially-available transgenic animal. Proponents of other novel transgenic organisms are already claiming that the GloFish's regulatory path sets a precedent for regulating transgenic organisms. Since the FDA is currently considering a proposal to approve widespread aquaculture of transgenic salmon, the FDA's approach to GloFish raises immediate and pressing concerns about the environmental risks likely to flow from inadequate regulation of this new biotechnology.

This article measures FDA's decision not to regulate against the applicable statutory mandates and regulatory policies. To that end, the article describes the New Animal Drug approval process and measures what the FDA actually did in the GloFish case against the statutory requirements for approving a new animal drug under the federal Food Drug and Cosmetics Act (FDCA). The Article then compares the FDA's GloFish Declaration with the FDA's responsibilities under the National Environmental Policy Act (NEPA). I argue that, in its GloFish decision, the FDA inappropriately substituted substantial equivalence, an administrative policy developed to coordinate agency oversight of biotechnology, for the applicable statutory standards under the FDCA and NEPA. Finally, the article ends by exploring the possible fallout from this decision for the FDA's pending consideration of a NAD application for transgenic salmon. In particular, this section identifies some sui generis environmental concerns associated with aquaculture of transgenic salmon and considers what the FDA's GloFish decision may tell us about the FDA's willingness to fully consider these questions.

biotechnology, transgenic, aquaculture, GMO, LMO, FDA, Food Drug and Cosmetics Act, FDCA, regulation, NEPA, New Animal Drug, Coordinated Framework, transgenic salmon, risk assessment, precautionary principle, GloFish, genetically modified organism, GM

Abstract:
The shared uses of the world's oceans includes a broad spectrum of activities. Ships routinely navigate off the shores of virtually every coastal nation and their activities run the gamut from fishing to commerce, recreation, navigation, and military activities - all of which rely on the principle of mare liberum, or freedom of the high seas. Regulating the activities of these many vessels, flying the flags of different sovereign states, on the high seas - the paridigmatic international commons - poses a unique set of challenges for the international legal system. Of these many challenges, managing the mobile fish stocks that straddle zones of national jurisdiction and the international commons is perhaps the most complicated. Managing these resources raises practical questions about who has the authority to make and enforce rules as well as more theoretical questions about the contours of a State's sovereignty over vessels flying its flags.
Taken to its logical end, mare liberum implies a right to fish straddling stock to extinction. Each State has an equal right to exploit the resources of the high seas, and no State has authority to regulate the activities of another State's nationals on the high seas. States vary in their commitment to fisheries protection, and no State wants to disadvantage its nationals in the international arena. Unless international law devises a legal framework capable of imposing consistent conservation measures on high seas straddling stocks, mare liberum will drive these stocks towards extinction, either actual or commercial.

This paper uses the interaction between the competing international norms of mare liberum and environmental stewardship in the context of high seas fisheries management to explore fundamental questions of sovereignty and of international law. In particular, I ask whether the fisheries management regime proposed by the 1995 Straddling Stock Agreement can solve this regulatory puzzle in a manner consistent with generally accepted notions of national sovereignty in an international context. In answering that question, I propose a new vision of high seas fisheries management, one that reconciles the apparent contradiction between mare liberum and environmental stewardship.

Abstract:
A healthy society needs room for genuine dialogue, particularly over issues of how to evaluate and weigh risks to public safety. When citizens do not have confidence in the regulatory systems that purport to protect them, social trust breaks down. The lack of a transparent, well-organized regulatory system threatens public trust in biotechnology and more fundamentally in government itself. The success of agricultural biotechnology depends on society's willingness to accept and consume food produced via this technology. This willingness hinges on the level of trust that the technology is being developed and used in a safe manner.

This needed trust is multilayered - the consumer must trust that the scientists know what they are doing in developing these crops, that the companies marketing and distributing the crops are operating in a legal and ethical manner, that the regulators are exercising proper oversight, that the farmers are obeying the regulations, and that the consumer is not being lied to or misled. The presence or absence of trust dramatically affects communications about and perceptions of risk. As a result, a credible oversight scheme and trust in the institutions promoting and overseeing agricultural biotechnology may be the single biggest predictors of public acceptance of this technology

Because the development, production and marketing of GM crops requires the activities of so many different parties, there are multiple levels on which this process can break down, creating suspicion and mistrust. This article explores fundamental questions about the relationship between transparency, trust and acceptability of risk and makes some recommendations about the role that public voices should play in regulatory policy.

genetically modified organism, GMO, LMO, biotechnology, agriculture, GM crops, regulation, transparency, trust

Abstract:
When regulators make decisions in the face of uncertainty, what gives legitimacy to their decisions? Trust clearly plays a role in bridging regulatory uncertainty, but what is the relationship between law and trust? This article offers framework for thinking about trust in regulatory contexts by developing a broad-based, multi-dimensional conception of the roles that trust plays in regulatory systems. Positing that "regulatory trust" is unique kind of social trust, this framework traces the reflexive relationship among regulatory trust's components, and explores means to cultivate the regulatory trust necessary to to allow regulatory agencies to govern effectively in the face of fundamental uncertainty.

trust, uncertainty, regulation, expertise, governance, regulatory system, GMO, sustainability, transparency, stewardship

Abstract:
Fin de siècle international public law focuses increasingly on the relationship between environmental degradation and economic development (sustainable or otherwise). Today there is a growing consensus that human activities are threatening the integrity of the earth's ecosystems, and that environmental degradation is among the most serious threats to global stability. As a result, no contemporary account of progress in international law can be complete without an assessment of the international community's stumbling progression toward sustainability.

This chapter measures that progression against a definition of progress Manley O. Hudson articulated in his 1932 volume Progress in International Organization. For Hudson, progress was the building of institutions which promise to serve the needs of future generations. This chapter, which is part of an edited collection entitled Progress in International Law that I co-edited with Russell A. Miller of Washington and Lee (nee Idaho), measures international moves toward sustainable development against three different conceptions of progress: rhetorical, conceptual, and material.

The overall project drew its inspiration from the lectures Manley O. Hudson delivered at the University of Idaho's inaugural session of the Borah Foundation for the Outlawry of War. The lectures were ultimately published under the title Progress in International Organization. Through these lectures, Hudson articulated a progress narrative for international law; one in which international legal organizations, led by the League of Nations, would assure peace and security to the peoples of the world.

Although the contemporary world embodies so little of his optimistic belief in the capacity of human institutions to prevent violence and injustice, Hudson's lectures did accurately predict many of the institutional developments in international law. Hudson correctly for told that the growth and development of international institutions would mean that an ever-increasing number of problems would be directed into these international channels.

progress, sustainability, sustainable, GMO, international law, sustainable development, environmental protection, international environmental law