In 1992, the United States (US) Food and Drug Administration (FDA) approved the first genetically engineered food – Calgene’s Flavr Savr Tomato – for sale and marketing in the United States. Encouraged by a favorable US regulatory system and the lack of serious domestic political challenge, US scientists have subsequently created, farmers have grown, and companies have marketed a wide range of genetically modified (GM) foods and crops.

By the end of the 1990s, in “the most rapid adoption of a new technology in the history of agriculture,” some sixty percent of processed foods available in US groceries were derived from genetically modified organisms (GMOs).1 By the end of 2003, the estimate had risen to “between 70 and 75 percent of all processed foods available in US grocery stores.”2 By 2007, approximately 89% of soybeans, 83% of cotton, and 61% of corn grown in the United States consisted of genetically modified varieties, and these figures were rising annually.3 US farmers also grow genetically engineered canola, potatoes, tomatoes, papaya, squash and sunflowers, among other foods, although to much lesser degrees.4

By contrast with the US embrace of agricultural biotechnology, European Union (EU)5 regulators and publics have taken a far more cautious approach to GMOs, treating genetically modified (GM) foods and crops as different from their conventional counterparts, and adopting increasingly strict and complex regulatory procedures for their approval and marketing. Unlike in the United States, GM foods and crops face considerable regulatory hurdles in the EU, including requirements for mandatory pre-approval of all GM products, as well as provisions on the mandatory labeling and traceability of all GM products, which have made it difficult and sometimes impossible for US farmers to export genetically modified foods to markets in Europe.

In an age of increasing international trade and economic interdependence, these sharp and persistent regulatory differences have resulted in an ongoing transatlantic dispute where economic interests and social values clash, what some political scientists have called “system friction.”6 By the late 1990s, stricter European regulations and slower European regulatory approval processes for new GM varieties raised potentially serious obstacles to the export of agricultural products from the United States. A potential international trade war loomed.

Throughout the past decade, US and EU representatives have alternatively and concurrently dueled and tried to manage the conflict over their respective approaches to biotechnology regulation. They have formed numerous bilateral networks of government officials, scientists and civil society representatives to engage in extensive bilateral consultations. They have also discussed and negotiated the issues in multiple multilateral contexts, such as before the Organization for Economic Cooperation and Development (OECD), the international food standard setting body, the Codex Alimentarius Commission; the international trade body, the World Trade Organization (WTO); and an international environmental body, the Conference of the Parties to the Convention on Biodiversity, which has resulted in a new Biosafety Protocol. Despite these efforts, the two sides have not fundamentally modified their divergent regulatory approaches and decisions, although there have been changes as we will see. After considerable internal debate and delay, the Bush Administration finally filed a legal complaint before the WTO in May 2003, maintaining that the EU’s regulatory decisions over GM crops and foods violated the EU’s international trading commitments, which finally resulted in a panel decision issued in September 2006.

Contents
Chapter 1: Introduction: Biotechnology, Risk Regulation, and Transatlantic Discord
Chapter 2: Two Roads Diverged: The Development of US and EU Agricultural Biotech Regulatory Regimes
Chapter 3: Transatlantic Regulatory Cooperation through Networks: Promise and Failure
Chapter 4: Deliberation or Bargaining: Tensions within the International Regime Complex
Chapter 5: US and EU Policies Since 2000: Change, Continuity and Convergence
Chapter 6: WTO Dispute Settlement Meets GMOs: Who Decides?
Chapter 7: Conclusion: The Implications of the US-EU Conflict: Developing Countries and the Future of Agricultural Biotechnolog

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