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concern. Unintended secondary effects are already a big issue with sin-
gle gene insertions of first-generation GM crops, but the number and
significance of genomic changes in the forthcoming generation of crops
increase the likelihood of unintended effects and the associated uncer-
tainties, all of which will need to be addressed by regulation. This is
because these plants are likely to include several genetic modifications
at the same time - some of which might interfere to a larger extent
with plant metabolism. Resistance genes might be introduced to avoid
problems with pests, pathogens, and weeds that would otherwise require
applying pesticides and herbicides. These substances might cause con-
cerns as drug contaminants. Moreover, genetic modification for easy
and unambiguous visual identification of seeds and plants are suggested
that would enable a simple differentiation of plants, seeds, or fruits not
intended for consumption. 38 In addition, molecular confinement tech-
nologies are being introduced involving several complex changes in the
plant genome. Molecular confinement aims at avoiding gene dispersal
via pollen or rendering plants infertile. 39
Whether this would translate into higher health and environmental
risks would, however, depend on the particular case and also on the
category. With many PMIs - in contrast to PMPs - there might be no
intention of a biological effect in humans or animals. Nevertheless, haz-
ardous properties could also be associated with this category. Avidin,
for instance, which is presently produced as a fine chemical, is toxic to
many insects and might cause Vitamin H deficiency in higher animals and
humans. Aprotinin, to take another plant-derived fine chemical, is con-
sidered a reproductive hazard. In contrast, enzymes like lipases or trypsin
might pose less health risks in case of food contamination, because
38 U. Commandeur et al., The Biosafety of Molecular Farming in Plants. 5 AgBiotechNet
1-9 (2003). N. C. Ellstrand, Going to “Great Lengths” to Prevent the Escape of Genes
that Produce Specialty Chemicals. 132 Plant Physiology 1770-1774.
39 H. Daniell, Molecular Strategies for Gene Containment in Transgenic Corps, 20
Nature Biotechnology 581-586 (2002).
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