title: Evolution of risk assessment strategies for food and feed uses of stacked GM events.
abstract: 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 ×  GA21, Bt11 ×  MIR604, MIR604 ×  GA21, Bt11 ×  MIR604 ×  GA21, Bt11 ×  MIR162 ×  GA21 and Bt11 ×  MIR604 ×  MIR162 ×  GA21), 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.
authors.affiliation: Syngenta Crop Protection LLC., Research Triangle Park, NC, USA.
authors.forename: Catherine
authors.initials: C
authors.lastname: Kramer
authors.affiliation: Syngenta Crop Protection LLC., Research Triangle Park, NC, USA.
authors.forename: Phil
authors.initials: P
authors.lastname: Brune
authors.affiliation: Syngenta Crop Protection LLC., Research Triangle Park, NC, USA.
authors.forename: Justin
authors.initials: J
authors.lastname: McDonald
authors.affiliation: Syngenta Crop Protection LLC., Research Triangle Park, NC, USA.
authors.forename: Monique
authors.initials: M
authors.lastname: Nesbitt
authors.affiliation: Syngenta Crop Protection LLC., Research Triangle Park, NC, USA.
authors.forename: Alaina
authors.initials: A
authors.lastname: Sauve
authors.affiliation: Syngenta Crop Protection AG, Basel, Switzerland.
authors.forename: Sabine
authors.initials: S
authors.lastname: Storck-Weyhermueller
mesh_terms: D001709:Biotechnology; D005504:Food Analysis / Q000379:methods*; D030821:Plants, Genetically Modified / Q000235:genetics / Q000378:metabolism*; D018570:Risk Assessment / Q000639:trends; D003313:Zea mays / Q000235:genetics / Q000378:metabolism*
keywords: biotechnology; genetically modified; problem formulation; risk assessment; stacks