Biosafety and regulatory issues
Concerns have been raised about the safety of GM foods in relation to environment and human health. Although there is no scientific evidence that current modified foods involve any new or magnified risks, certain environmentalists and consumers are still not convinced (Smyth and Phillips, 2003). The general public concern about the potential health and environmental risks associated with the PMF crops (not the products) is being viewed at two levels; in that, not onlyare they engineered to accumulate all sorts of proteins with medicinal properties at very high concentration, which may affect the host plants (Badri et al., 2009), but also that their biologically active products are meant to elicit physiological responses in humans and in animals (Spök, 2007; Spök et al., 2008). Additionally, there are specific concerns, including the lack of communication among the regulatory bodies involved in research, biosafety and trade, further hampers the developments in this field (Ramessar et al., 2008b). The regulation of pharmaceutical crops is in its infancy and there are several challenges ahead for the regulatory agencies. There is a lot of pressure from pharmaceutical industry, food industry, environmental and consumer organizations against GM crops and regulations are strict and turn out to be very costly. There is a requirement to regulate the pharmaceutical crops on case by case basis. The regulatory challenges posed ahead for the molecular farming and how they are different from those for first generation transgenic crops, have been reviewed recently (Spok, 2007; Spok et al., 2008). The strategies used for risk assessment need to be reviewed. The most important issue is to segregate the GM crops from non-GM crops to prevent intermixing. A variety of approaches including physical containment as well as genetic strategies like seed sterility, maternal inheritance, male sterility, selective elimination by engineering sensitivity to chemicals, etc. have been postulated to address this question (Howard and Donnelly, 2004; Lee and Natesan, 2006; Lin et al., 2008) and threshold limits of accidental contaminations have been suggested. Like for the GM food and feed crops, several regulations are being developed, to increase the biosafety of the plant bioreactors, even though, one knows that, there is no fool-proof system, as there might be some elements of human errors and natural accidents, which are beyond control.