Open AccessEvolution of risk assessment strategies for food and feed uses of stacked GM events
Author(s) -
Kramer Catherine,
Brune Phil,
McDonald Justin,
Nesbitt Monique,
Sauve Alaina,
StorckWeyhermueller Sabine
Publication year - 2016
Publication title -
plant biotechnology journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.525
H-Index - 115
eISSN - 1467-7652
pISSN - 1467-7644
DOI - 10.1111/pbi.12551
Subject(s) - biology , microbiology and biotechnology , genetically modified organism , risk assessment , event (particle physics) , insert (composites) , genetically modified crops , transgene , genetics , computer science , gene , engineering , mechanical engineering , physics , computer security , quantum mechanics
Summary Data requirements are not harmonized globally for the regulation of food and feed derived from stacked genetically modified ( GM ) events, produced by combining individual GM events through conventional breeding. The data required by some regulatory agencies have increased despite the absence of substantiated adverse effects to animals or humans from the consumption of GM crops. Data from studies conducted over a 15‐year period for several stacked GM event maize ( Zea mays L.) products (Bt11 × GA 21, Bt11 × MIR 604, MIR 604 × GA 21, Bt11 × MIR 604 × GA 21, Bt11 × MIR 162 × GA 21 and Bt11 × MIR 604 × MIR 162 × GA 21), together with their component single events, are presented. These data provide evidence that no substantial changes in composition, protein expression or insert stability have occurred after combining the single events through conventional breeding. An alternative food and feed risk assessment strategy for stacked GM events is suggested based on a problem formulation approach that utilizes (i) the outcome of the single event risk assessments, and (ii) the potential for interactions in the stack, based on an understanding of the mode of action of the transgenes and their products.