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ABSTRACT 7th International ICABR Conference Ravello, Italy, June 29, 30 - July 1, 2 and 3, 2003 Productivity, Public Goods and Public Policy: agricultural biotechnology Potentials How foods derived from genetically modified crops are tested for safety Andrew Cockburn Francesca Tencalla, Monsanto Europe Genetic modification occurs naturally by mutation and recombination enabling man to breed from those crops having the most desirable traits such as yield or flavour. Genetic modification (GM) can also be performed in the laboratory which allows specific genes to be identified, isolated, copied and inserted into other plants with a high level of specificity. The food safety considerations for GM crops are basically the same as those arising from conventionally bred crops very few of which have been subject to any testing yet are generally regarded as being safe to eat. In contrast a novel safety testing paradigm has been developed for GM crops which utilises a systematic and stepwise holistic approach. The resultant process, based on rigorous science based principles focuses on a classical toxicological evaluation of the introduced novel trait as a defined single substance(s) as well as the safety of the new wholefood. So that every element of the process of transformation is considered a detailed hazard characterization is also undertaken on the parent crop and the gene donor. The overall safety evaluation is conducted under the concept known as substantial equivalence which is enshrined in all novel food and international crop biotechnology guidelines. This provides the framework for a comparative approach to identify the similarities and differences between the GM product and its comparator. By building a detailed profile on each component in the transformation process and by thoroughly evaluating the significance of any differences that may be detected, a very comprehensive matrix of information is constructed which enables the conclusion as to whether the GM crop or food is as safe as its traditional counterpart. The lack of any adverse effects resulting from the production and consumption of GM crops grown on more than 580 million acres over the last 7 years supports these safety conclusions.