An Evolutionary Approach to Agricultural Biotechnology : Litigation Challenges to the Regulatory and Common Law Regimes for Genetically Engineered Plants

Much of the early scholarship relating to the introduction of genetically engineered plants focused on the potential liability of farmers resulting from the contamination of neighboring fields. A second line of scholarship explored the trade-related implications of commingled export shipments and the United States-led World Trade Organization (WTO) challenge to the European Union’s approval regime. Meanwhile, adoption of biotechnology, both domestically and abroad (especially in South America), expanded at a rapid pace resulting in the development of a common law of biotechnology that seemingly placed the legal burden of segregation upon those seeking to exclude genetically engineered DNA from their product — a “fence-out” rather than a “fence-in” scenario. The StarLink genetically engineered corn litigation, and resulting multi-million dollar liability, did little to alter the prevailing view that conventional or organically produced crops must yield to their genetically engineered counterparts. A trio of cases in 2009 and 2010, however, rejected not only the assumed legal duty to “fence-out,” but forced the United States Department of Agriculture (USDA) to substantially reconsider its regulatory approach to new product approval. This represents a fundamental shift in the domestic legal status of genetically engineered crops during a period in which many in the biotechnology industry predicted increased expansion into international markets and new product approval. Although these cases are unlikely to reverse the general trend toward increased use of genetic engineering in agriculture, collectively they have disrupted the acquiescence of the regulatory system, forced a reexamination of private responsibilities and potential liability for contamination and, perhaps more importantly, provided an opportunity for reconsideration of the impact of genetic engineering on the food supply chain