Contents - Faperta

Biosafety of Food from Genetically Modifi ed Crops 459
Conclusions
Concerns have been raised about the biosafety of food produced through genetically
modifi ed organisms. Genetically modifi ed organisms have a better predictability of gene
expression than the conventional breeding methods, and transgenes are not conceptually
different than the use of native genes or organisms modifi ed by conventional technologies.
The focus of biosafety regulations needs to be on safety, quality, and effi cacy. The need and
extent of safety evaluation may be based on the comparison of the new food and the analogous
food, if any, and the interaction of the transgene with the environment. The overall
safety evaluation is conducted under the concept known as “substantial equivalence,”
which is enshrined in all international crop biotechnology guidelines. This provides a
framework for a comparative approach to identify the similarities and differences between
the transgene product and its comparator, which has a known history of safe use. A rigorous
safety-testing paradigm has been developed for transgenic crops, which utilizes a
systematic, stepwise, and holistic approach. The resultant science-based process focuses
on a classical evaluation of the toxic potential of the introduced novel trait and the wholesomeness
of the transformed crop. The lack of any adverse effects resulting from the
production and consumption of transgenic crops grown on more than 100 million hectares
supports the conclusions that food derived from genetically modifi ed plants is safe for
human consumption. Risks to human health associated with the use of specifi c viral DNA
sequences in genetically modifi ed plants are negligible. Given the long history of DNA
consumption from a wide variety of sources by animals and humans, it is likely that such
consumption poses no signifi cant risk to human health, and that additional ingestion of
DNA of genetically modifi ed crops will have no adverse effect. It may not be necessary or
feasible to subject all genetically modifi ed foods to the full range of evaluations, but those
conditions that have to be satisfi ed should be defi ned. Research should be undertaken to
develop modern profi ling techniques and to defi ne the “normal” composition of conventional
plants. The procedures to assess allergy should be expanded to encompass inhalant
as well as allergy to food. Labeling of food derived from transgenic or other sources will
remain a challenge, as much of the food produced in developing countries is consumed in
unprocessed and unpackaged form locally.
References
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