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The myriad of litigation and class action suits surrounding Syngenta's Viptera corn covers many issues that have been well addressed in previous litigation and literature. However, the case of Syngenta v Bunge raised the fascinating issue of 'regulatory lag', i.e., a situation where there are significant delays in approval of a GM product in an emerging export market, or differences in the regulatory approval timetable between significant export markets. In this case, Syngenta argued that Bunge's blanket refusal to accept Viptera corn into its facilities because China had not yet approved the variety, even though the variety was approved in the United States and in many other larger export markets, amounted to illegal activity that would cause significant harm to Syngenta. Although the litigation was ultimately settled in December 2014 by a confidential agreement between the parties, the case raises significant issues for the technology developers, producers, handlers, processers and shippers in instances where 'regulatory lag' is occurring or is possible. This article examines the legal implications of these lags for these parties, including an examination of their potential legal obligations and liabilities.
Keywords: adventitious presence, asynchronous approvals, commercialization, liability, low-level presence, regulation, trade barriers
1.Introduction
Time is money. This time-worn axiom of business school courses and the corporate world is also particularly applicable to the regulatory world. The time required for technology development firms to receive regulatory approval for a genetically modified (GM) crop, and thus the ability to commercialize the technology, has consistently increased over the past two decades. Jaffe (2005) reported that in spite of no new traits being regulated, the United States Department of Agriculture (USDA) consultation process had more than doubled over the first decade of GM crop regulation. The average number of months to get regulatory approval in the United States between 1994 and 1999 was 5.9 months, and between 2000 and 2004 it took 13.6 months. A 2011 report released by EuropaBio that examined regulatory approval times in Brazil, Canada, the European Union and the United States documented that the average time to approve a GM crop in the United States had risen to 25 months (EuropaBio, 2011). An industry report prepared by Phillips McDougall (2011) identified that the average number of months required for a GM...