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.
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