In conducting the risk assessment, GMAC identified potential hazards, and then added a value/rank for the likelihood of each hazard as well as its consequences. The likelihood of each hazard occurring was evaluated qualitatively on a scale of 1 to 4, with 1 for ‘highly unlikely’, and 4 for ‘highly likely’. The consequences of each hazard, if it were to occur, were then evaluated on a scale of 1 to 4, with 1 for ‘marginal’ and 4 to denote a ‘major consequence’. A value was finally assigned for the overall risk from the identified potential hazard. The general formula: Overall Risk = Likelihood x Consequence was employed. GMAC also proposed risk management strategies for potential hazards, where appropriate. This methodology of assessment follows the procedure of Risk Assessment in Annex III of the Cartagena Protocol on Biosafety.

GMAC has previously evaluated the safety of PAT and PMI proteins in the context of several other applications and found no indication that would suggest an adjuvant effect of the individual proteins or mixture in this event. The Cry1B.34 protein has not been assessed previously by GMAC.