“…The information that is considered during problem formulation takes many forms, including published scientific literature, expert opinion, stakeholder deliberations and data developed by the registrants and submitted to the regulatory authority as part of the registration dossier. This information establishes the level of 'familiarity' (that is, the similarities in ecologically relevant characteristics) between the IRGM crop and nontransformed crop [15][16][17] and, together with the related concept for food of 'substantial equivalence' , serves as a starting point to focus the ERA process on potential stressors of concern 18,19 . If substantial equivalence and familiarity are established, the ERA can proceed with emphasis on narrowly defined, stressor-mediated effects that arise from the expressed trait in the IRGM crop (e.g., a Bt protein) 14,20 .…”