Reconciling (or Failing to Reconcile) Regulatory Differences: The Ongoing Transatlantic Dispute over the Regulation of Biotechnology

In this paper, we examine and bring up-to-date the story of the US/EU conflict over the regulation of agricultural biotechnology. The paper is organized in six sections. In the first section, we outline briefly the respective regulatory systems put in place during the 1980s and 1990s by the US and the European Union, and we trace the emergence of the transatlantic regulatory dispute over GMOs. In the second section, we briefly examine the record of bilateral regulatory cooperation, including informal discussions among regulators, a formal Biotechnology Consultative Forum, and the activities of the transatlantic civil-society dialogues, all undertaken in an effort to find common - or at least compatible - grounds for biotech regulation. Third, we look to the various multilateral forums - the World Trade Organization, the Biosafety Protocol signed at Cartagena in 1999, and the Codex Alimentarius Commission - noting that the US and EU have attempted systematically to export their respective regulatory approaches to biotechnology in all three forums; the net effect of these efforts to date, however, has been to restate rather than resolve the fundamental conflict of regulatory approaches. In the fourth section, we turn back to the domestic level, examining the recent legislative and regulatory developments in the US and the EU, which we argue have produced, at best, modest evidence of convergence between the two systems. In both cases, however, the respective regulatory principles and procedures of the US and the EU have remained largely unchanged and starkly different. In light of these persistent differences, in May 2003 the United States brought a formal complaint before the World Trade Organization, examined in section 5 of the paper. A sixth and final section concludes by arguing that, despite initial hopes, both bilateral and multilateral negotiations between the US and the EU have yielded little evidence of genuine deliberation or convergence, and that, despite obvious risks, the current WTO complaint offers the prospect of clarification and legal certainty for parties on both sides of the dispute. While EU observers in particular have expressed optimism regarding deliberative approaches to public policy-making, most theoretical accounts of deliberative decision-making concede that genuine deliberation is most likely under certain scope conditions, including depoliticized and often in camera settings, where state representatives enter discussions in a mutual search for truth. By contrast, the regulation of GMOs is a highly politicized issue-area in which US and EU representatives negotiate in the light of strongly mobilized domestic opinion, and in which the negotiators themselves often believe strongly in the superiority of their own regulatory system. In Thomas Risse's (2000) language, these conditions are far more conducive to bargaining than to arguing (deliberation). The three multilateral negotiations examined in part 3 of this paper - namely the early WTO discussions, the Biosafety Protocol, and the Codex Alimentarius Commission - were all textbook cases of arguing, with both sides seeking to negotiate on the basis of fixed positions and both jockeying for advantage by exporting their preferred models to the global stage and thereby influence the outcome of future negotiations or litigation. In the absence of any meaningful deliberation, however, each of these forums has thus far yielded little clarification but rather inelegant compromises that obscure rather than clarify the nature of the differences in question. Against this backdrop, we find that the US complaint before the WTO Dispute Settlement Body presents significant risk of backlash against GMOs or the WTO, or both - risks of which we have warned at length. Yet the US case also holds the promise of clarification and legal certainty that nearly a decade of bilateral and multilateral negotiation has failed to produce. As we have seen, previous WTO rulings (most notably in the beef-hormones case) have already clarified the obligations of all parties in undertaking risk regulation, with particularly evident effects on the regulatory processes of the European Union. In a similar fashion, the legal setting of the Dispute Settlement Body has already forced both sides in the current dispute to argue their respective cases in the language of international law. Should the WTO panel (and, in all likelihood, the Appellate Body) produce a ruling that provides clarity about the obligations of each side without provoking a backlash in domestic public opinion and calling into question the legitimacy of the WTO itself, then the significant gamble of bringing a WTO complaint may well have paid off.