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444 Biotechnological Approaches for Pest Management and Ecological Sustainability<br />

United Nations Environment Program (UNEP), the United Nations Industrial Organization<br />

(UNIDO), and the World Health Organization (WHO), and guidelines for handling<br />

and release of genetically modifi ed organisms have been published by several agencies<br />

(UNIDO, 1991; Tzotzos, 1995).<br />

Potential effects of the transformation process should continue to be taken into consideration<br />

in the safety assessment, and phenotypic characteristics should be compared<br />

between foods derived from genetically modifi ed plants and their comparators. These will<br />

include, but may not be limited to, composition, nutritional value, allergenicity, and toxicity.<br />

It will be important to defi ne the growing conditions of the comparative plants, the scope of<br />

the comparisons, and the acceptable margins of measured differences. It may not be necessary<br />

or feasible to subject all genetically modifi ed foods to the full range of evaluations,<br />

but the conditions that have to be satisfi ed should be defi ned. Safety assessments should<br />

make use of new profi ling techniques such as microarray technology for detailed studies<br />

of mRNA expression, quantitative two-dimensional gel electrophoresis and mass spectrometry<br />

for protein analysis, and meta bolomic analyses to look at changes in all metabolites<br />

and metabolic intermediates. Application of such techniques to characterize the<br />

differences between the genetically modifi ed crop and the appropriate comparator should<br />

help provide a rigorous scientifi c basis for biosafety of food from transgenic plants.<br />

Sometimes, the genetically modifi ed food products include components that are deliberately<br />

introduced by genetic modifi cation. In this case, the genetically modifi ed food product<br />

might be regarded as “substantially equivalent” to its conventional counterpart, except for<br />

a small number of clearly defi ned differences. Assessment is then limited to examining the<br />

implications of the difference(s), perhaps by testing the novel components of the genetically<br />

modifi ed plant in isolation.<br />

Biosafety Assessment of Food from Genetically Modified Crops<br />

Historically, crop plants improved by cross-pollination have not been subjected to risk<br />

assessment, safety analysis, or risk management. Genetically modifi ed plants have a better<br />

predictability of gene expression than the conventional breeding methods, and transgenes<br />

are not conceptually different than the use of native genes or plants modifi ed by conventional<br />

technologies. The ability to synthesize genes in the laboratory and insert them into<br />

plants has raised some concerns by the general public. The potential of recombinant technologies<br />

to allow a greater modifi cation than is possible with the conventional technologies<br />

may have a greater bearing on the environment (Tiedje et al., 1989) and, therefore, the focus<br />

of biosafety regulations needs to be on safety, quality, and effi cacy (Table 15.1) (Levin,<br />

1988). The need and extent of safety evaluation may be based on the comparison of the new<br />

food and the analogous food, if any, and the interaction of the transgene with the environment<br />

(Figure 15.1). The lack of any adverse effects resulting from the production and consumption<br />

of transgenic crops grown on more than 100 million hectares supports these<br />

conclusions. Before food derived from a genetically modifi ed crop can be approved for<br />

human consumption or an animal feed, it must satisfy three criteria (Moseley, 2002).<br />

• It must be safe.<br />

• It must satisfy the consumer.<br />

•<br />

It must be nutritionally adequate.

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