Door Opens Slightly: Recent European Union Regulations on Genetically Modified Products and the Ongoing United States-European Union GM Product Dispute, The

Georgetown International Environmental Law Review, Winter 2004 by Rafferty, Brian P

I. INTRODUCTION

On July 15, 2003, in a bold public display of dissatisfaction with genetically modified (GM)1 foods, supporters of jailed farmer and activist Jose Bove sat down in front of bicyclists competing in the Tour de France to protest Bove's imprisonment for destroying GM crops.2 Only thirteen days earlier, on July 2, 2003, the European Parliament adopted new regulations on the labeling and sale of GM foods and other products within the European Union (EU).3 The new regulations are projected to end the de facto ban on approval of new GM products for sale in the EU that has been in place since 1998. These new regulations impose stringent regulations on the sale of GM products and have not been characterized as a victory by GM product advocates.4 The United States government as well as U.S. agricultural businesses are highly critical of the EU's regulation of GM products.5 It remains to be seen whether these new regulations will in the long run reduce the transatlantic tension over GM products or just provide another dimension to the ongoing debate.

The ongoing dispute over GM products is often pointed to as evidence of the differing European and American approaches to regulation, and particularly that while the precautionary principle plays an important role in the formulation of regulatory policy in the EU, it does not in the United States.6 While definitions differ, the precautionary principle as stated in Principle 15 of the Rio Declaration on Environment and Development dictates that "where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation."7

This note argues that differing levels of precaution and adherence or lack of adherence to the precautionary principle can not and do not explain the U.S.-EU divide over GM products. Both the United States and the EU recognize a version of the precautionary principle; the divide over GM products is caused by regulatory and government structures that constrain choices differently and by different society-specific past regulatory experiences. By examining the roles precaution, risk assessment, and regulation play in American and European culture, and by looking at a sampling of regulatory experiences, this note will demonstrate that these factors, and not a belief or lack thereof in the precautionary principle, best explain the transatlantic GM debate.

In the second part of this note, a brief background on GM products and the methods by which they are defined is provided. The third part lays out a history of GM product regulation, primarily in the EU, and describes the new EU regulations. The role that precaution plays in U.S. regulation and how the U.S. government and regulatory structure shape that role are issues explored in the fourth part. Past U.S. experiences with the regulation of risks are also examined. The fifth part explores the EU's government and regulatory structures as well as its past experiences with risk regulation. In the sixth and final part, the possibility of finding a common ground is explored, and in particular whether the Cartagena Protocol on Biosafety to the Convention on Biological Diversity (Cartagena Protocol) will provide that ground.

II. GENETICALLY MODIFIED PRODUCTS

Genetic modification occurs when scientists use their ability to isolate genes from an organism and, after manipulation in the laboratory, place them in another organism.8 Much of the GM seed currently on the market seeks to increase the yield of farmers, while decreasing the inputs of pesticides, water, and fertilizer previously required.9 While there is general agreement as to what genetic modification is, there is little agreement on what constitutes a GM product. This lack of consensus is one of the major points of tension between the United States and the EU as to GM products.10

In the United States, the definition of GM products is product centered." This product-oriented approach dictates that if a GM product is not fundamentally different from a conventional product it does not require separate regulatory treatment.12 Referred to as the permissive strategy, this approach only requires that the GM product be as safe to use and consume as conventional varieties.13 By looking at the condition of the product when deciding what is a GM product, the U.S. position only considers products that exhibit different risk characteristics to be GM products. The U.S. focus on the end product differs significantly from the EU approach, which instead focuses on the process by which the product was produced.

In the EU, the definition of GM products is process oriented. The processoriented regulatory regime is based on the premise that different production processes require different regulatory treatment.14 If GM materials are used in the production process, the final product requires treatment different from that for conventional products, even if the final product is demonstrated to pose no risks different from those posed by the conventional product.15