Problem formulation is the first step in environmental risk assessment (ERA) where policy goals, scope, assessment endpoints, and methodology are distilled to an explicitly stated problem and approach for analysis. The consistency and utility of ERAs for genetically modified (GM) plants can be improved through rigorous problem formulation (PF), producing an analysis plan that describes relevant exposure scenarios and the potential consequences of these scenarios. A properly executed PF assures the relevance of ERA outcomes for decision-making. Adopting a harmonized approach to problem formulation should bring about greater uniformity in the ERA process for GM plants among regulatory regimes globally. This paper is the product of an international expert group convened by the International Life Sciences Institute (ILSI) Research Foundation.

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Soybean ( Glycine max L.) is the world’s largest source of protein feed and the second largest source of vegetable oil. Water restriction is the main limiting factor to achieve maximum soybean yields. Therefore, development of varieties that maintain yield under environmental stresses is a major objective of soybean breeding programs. The HaHB4 ( Helianthus annuus homeobox 4) gene from sunflower encodes for a transcription factor involved in the plant´s tolerance to environmental stress. The introduction of HaHB4 in soybean led to the development of event IND-ØØ41Ø-5 (HB4® soybean), which displayed higher yield in environments having low productivity potential, compared with the parental control variety. Compositional analyses of soybean event IND-ØØ41Ø-5 were conducted both in Argentina and the United Sates. A total of 44 components were analyzed in grain and 9 components in forage. Based on the results of these studies it was concluded that soybean event IND-ØØ41Ø-5 was compositionally equivalent to its non-transgenic parental control.

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