Global Regulation of Transgenic Crops

Globally, transgenic maize comprised about 25% of the 102 million hectares of transgenic cropland planted in 2006 by more than 10 million farmers in 21 countries (James 2007). These transgenic maize plants contain inserted gene(s) expressing a variety of Cry proteins that confer resistance to stem borers and rootworms. Approximately 45% of the transgenic maize planted also contains inserted gene(s) that mediate herbicide tolerance (James 2007). Transgenic crop varieties must be granted pre-market approval by regulatory authorities, and more than 43 transgenic maize varieties have been approved to date (Agbios GM Database, http://www.agbios.com/dbase.php, accessed 14 January 2008). It must be shown that novel transgenic crops are safe for agriculture and the environment prior to their commercialization and planting. Since maize is widely used as animal feed and in human food, the pre-market regulatory approval process also evaluates the safety of transgenic maize as food and feed. This chapter describes the evolution of the regulatory paradigm and regulations applied to transgenic crops around the world with emphasis on maize, briefly highlights differences in approaches between nations, details the scientific considerations of the regulatory review process, focusing primarily on food safety issues that have been of concern to consumers around the globe, and concludes with an assessment of the consequences and impact of the stringent global regulation of transgenic crops. The chapter will also review claims regarding potential adverse effects of transgenic plants that received attention in the media and which have shaped negative public perceptions about transgenic crops.