Genetically modifi ed plants have been released worldwide, but the regulations governing the use of transgenic plants vary considerably in different countries. Existing regulations may be applied to the production and release of genetically modifi ed plants, but some of these regulations may not be adequate to address the potential environmental effects of the transgenic plants (FAO, 1986; UNIDO, 1991; Tzotzos, 1995). For genetically engineered plants with resistance to insects to gain acceptance, decisions that address the concerns associated with the application of biotechnology in agriculture must be science based. Regulatory agencies should assure credibility, and use a rational basis for decision making (Tiedje et al., 1989; Tzotzos, 1995; Sharma et al., 2002a, 2002b; Clark, 2006). Science and legal processes are inextricably linked for regulations that evaluate biological products for human and animal consumption. Review of any particular product should be based on scientifi c criteria relevant to the product. Advances in biotechnology should determine the changes that might have occurred at the molecular and biochemical levels to scrutinize the product safety, and the effect of product modifi cation on food safety. The approach to review biosafety of transgenic plants is constantly evolving due to new types of products and the availability of scientifi c information. New technologies have regularly been utilized to develop new gene pools for crop improvement, including artifi cial manipulation of chromosome number, development of addition and substitution lines for specifi c chromosomes, chemical and radiation treatments to induce mutations and chromosome rearrangements, and cell and tissue culture (embryo rescue, in vitro fertilization, and protoplast fusion) to allow recovery of interspecifi c and generic hybrids (Simmonds et al., 1999). The genetic gains from the integration of these technologies in crop improvement
have resulted in improved yield, environmental adaptation, resistance to specifi c diseases and insect pests, and quality attributes preferred by farmers, the food industry, and the consumers. Scientifi c advances in cell and molecular biology have now culminated in genetic modifi cation of crops resulting in novel germplasm that allows plant breeders to respond more quickly to increasing consumer demands. Despite numerous promises, there is a multitude of concerns about the impact of genetically modifi ed crops on the environment. Key issues in the environmental assessment of genetically modifi ed crops are: non-target effects on natural enemies, development of resistance, invasiveness, vertical or horizontal gene fl ow, effects on biodiversity, and the biosafety of food and food products (Conner, Glare, and Nap, 2003; Clark, 2006). The biosafety issues arising as a result of deployment of transgenic plants include:
Risk to animal and human health: Toxicity and food quality/safety, allergenicity, and resistance to antibiotics.