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Article Excerpt
Introduction
As the relative merits and dangers of recent advances in biotechnology are debated, questions of risk assessment and governance have become increasingly important. The perceived uncertainty surrounding biotechnological developments has instilled in the lay public a high degree of anxiety and apprehensiveness. Particularly with respect to food, which is such a fundamental requirement for human survival, the call for strong regulatory frameworks to govern the new technology and to protect human health and the environment has been widespread. Efforts to develop such regulatory regimes, however, necessarily raise a number of important questions: How do we conceptualize, measure, and assess risk? What level of risk is acceptable? And how do we develop and maintain regulatory structures of governance that will ensure any future developments in biotechnology achieve their intended purpose without unanticipated or undesirable consequences? These are the questions at the heart of efforts to develop new regulatory frameworks for biotechnology, and their importance is recognized not just by a skeptical public, but by biotechnology's advocates as well, for whom such regulatory regimes might serve to allay growing public concerns. For example, Perry Adkisson, Chair of the U.S. National Academy of Science's Committee on Modified Pest-Protected Plants, argues that "Public acceptance of these [biotech] foods ultimately depends on the credibility of the testing and regulatory process" (National Academies of Science, 2000). Similarly, Dan Glickman, U.S. Secretary of Agriculture under the Clinton administration, noted that "With all that biotechnology has to offer, it is nothing if it's not accepted. That boils down to a matter of trust--trust in the science behind the process ... trust in the regulatory process" (Glickman, 1999).
Already new regimes have been established at the international level to coordinate divergent national policies and address some of the questions of biotech governance in fields as diverse as intellectual property rights (e.g., the Trade Related Intellectual Property Rights Agreement and the Union for the Protection of New Plant Varieties), access and benefit sharing (e.g., the Convention on Biological Diversity), and biosafety (e.g., the Cartagena Protocol). But national governments, particularly in the developing world, continue to face substantial challenges in their effort to balance legal, political, commercial, social, ethical, and environmental priorities and obligations. Weak capacity undermines efforts to establish strong domestic regulations, while small but vocal lobbies on both sides of the biotech issue have polarized debates. In such a complex regulatory environment, frameworks to govern biotechnology and establish access and benefit sharing regimes over biodiversity, not surprisingly, have been slow to develop.
At the same time, the complexity of the policy environment within which new governance arrangements are developing is beginning to be recognized, and traditional models of regulation--and more broadly of the role of science in public policy--are increasingly subject to intense critique. The academic literature on the topic has long recognized that regulation is not merely a technical activity in which scientific assessment is unproblematically applied to a specific issue-area to develop frameworks that minimize potential risks and dangers (Blowers, 1997; Bradbury, 1989). Instead, regulation necessarily involves ethical judgments concerning the nature of risk and scientific knowledge and implicates broader questions of social organization and structure (Beck, 1992; Leach, Scoones, & Wynne, 2005; Levidow & Carr, 2000). Debates over policy are framed by the media and political actors, as each side attempts to set the terms of the discussion in ways that favor their preferred outcome. Further, as the literature from the field of risk communication reminds us, even where there is general scientific agreement regarding the potential dangers posed by a specific technology, it may be difficult to convince the lay public of the accuracy of the scientific frame, as the public often employs a fundamentally different conception of risk than do the scientists and policy makers (Groth, 1998; Scholderer & Frewer, 2003; Slovic & Fischhoff, 1982; Slovic, 1987; Slovic, 2001). Indeed, the greater the uncertainty, and the more involuntary and invisible the danger, the more hesitant the public is to accept that risk--regardless of the likelihood or magnitude of the risk event (Kasperson & Stallen, 1991; Slovic, 1992). Governance structures have consequently been slow to adapt and, in general, regulatory practice continues to be founded on the perception of scientific neutrality and expertise to the exclusion of lay knowledge and the artificial separation of science and policy making (Marris, Wynne, Simmons, & Weldon, 2001; Ravetz, 2005).
An analysis of the process by which regulatory frameworks to govern biotechnology are developed thus affords a unique opportunity to assess both the nature of risk and the role of science and participation in policy formation in an environment characterized by complexity and uncertainty. To that end, I take as my point of departure the emerging debates around the nature of regulation and the role of science in policy formation. In the context of biotechnology, such debates have largely been articulated in the form of trade disputes between the United States and the European Union over the justification for restrictions on trade in genetically engineered foods and food products. I begin by briefly contrasting the nature of and justification for regulatory frameworks in the United States, which legitimizes its policy through discursive claims to "risk management" and "sound science," and the European Union, which relies on the "precautionary principle." In addressing competing justifications for regulatory policies in the developed world, I seek to demonstrate that, despite regular and repeated reference to the need for "scientific neutrality" and "expertise" in policy formation, policy decisions vis-a-vis biotechnology are fundamentally political decisions grounded in the specific social formations, histories, and political economies of individual countries and regions. Local social values thus play a key role in shaping decisions of technology management and regulation. While such norms and preferences may be mutable, unstable, and even subject to manipulation by the media or political actors, they nevertheless must represent the beginning point for any discussion of food safety and regulation. If it is to be recognized and accepted as adequate by the lay public, regulatory policy must transcend simple discursive claims of "expertise," or even more general assertions regarding the potential benefits of biotechnology, and must instead build from existing social norms, judgments, and preferences.
Science and Public Policy in the United States and in the European Union
The development of regulatory frameworks governing agricultural biotechnology in Europe and in the United States has proceeded along apparently antithetical paths. Although the two regulatory regimes share the common objectives (e.g., ensuring a safe and plentiful supply of food, encouraging rural development, and promoting environmental sustainability) and have similar discursive formations (e.g., basing regulation on risk measured through established scientific assessment procedures), the regulation of biotechnology in the United States and in the European Union has, since 1990, diverged significantly in practice. While the United States has encouraged continued private innovation in agricultural biotechnology, strong public resistance in the European Union encouraged the development of stricter regulatory standards and consequently slowed adoption and acceptance of some biotechnological innovations. As a result, debates over the nature of risk and uncertainty, particularly in the context of agricultural biotechnology, have become increasingly common. The transatlantic rift over trade in genetically modified food therefore appears to be intensifying.
Perhaps the most significant institutional difference between the United States and the European Union rests in the choice of the lead regulatory agency for agricultural biotechnology. Rather than imposing strict regulations on biotech research, U.S. regulatory policy was intended to promote the widespread production and adoption of biotechnology--especially agricultural biotechnology--as an area of U.S. competitive advantage. Strict regulation, it was felt, would create unnecessary and counterproductive barriers to the commercialization of biotechnological innovations. Industry...
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