Table 2 Analysis of arguments in papers supporting standpoint 1 (S1)
Authors | Overall arguments | Premises including Biological Background Assumptions | Conclusions | Main Relevant Evidence |
|---|---|---|---|---|
Weber et al., 2012 Steiner et al., 2013 Kok et al., 2014 Kramer et al., 2016 | Although involving randomness, conventional breeding is a safe procedure that introduces no novel safety issues. Selection for stability is intrinsic of conventional breeding and further guarantees its safety. GM stacking process does not produce a new level of risk in respect to the risk level of parental stable GM (single). | P1) Conventional breeding of conventional plants produces no novel food and feed safety issues P2) Equivalence of biological process | GM stacking produces no novel food and feed safety issues | Safe history of use of crops obtained through conventional breeding |
Steiner et al., 2013 Kok et al., 2014 Kramer et al., 2016 | Risk assessment of parental GM (single) includes holistic analyses, such as phenotypic, nutritional, compositional comparison between the GM (single) plants and their unmodified counterparts. Such analyses account also for the interactions between the transgenic components and the rest of the plant (domestic components). These interactions result in a GM (single) that can be bred with a conventional variety without provoking change in the phenotype, despite inherent variation (stable GM single). No new level of risk is plausible In GM (single) x GM (single) in comparison to GM (single) x conventional plant. | P1) In the parental GM (single) there are interactions between transgenic genes (and their products) and domestic genes (and their products) P2) Such interactions do not provoke any new range of variability or instability respect to conventional counterparts P3) Equivalence of entity behavior | Transgenes and their products do not provoke any new range of variability or instability, compared to conventional counterparts, when they interact with domestic genes and their products in a GM stack. | Parental GM (single) are phenotypically stable, meaning that the cross GM (single) X conventional generates new GM (single) with phenotype comparable to the parental plant 22 GM Stacks were assessed by EFSA so far. No variation was found that is outside the range of variation in parental GM (single). Data from individual studies about single events and stacks containing two, three and four Syngenta event combinations were compared. The variation of compositional analysis and protein expression in the stacked event was mostly within the prediction intervals derived from data relative to single events. |
Steiner et al., 2013 Kok et al., 2014 | Since parental GM (single) are phenotypically stable, safety assessments for the parental stable GM (single) are directly applicable to the GM stack. The only remaining safety question that the individual event assessments do not address is that of interactions between the products of the combined transgenes. | P1) GM (single) plants are safe and stable. P2) Equivalence of entity behavior | Genes and their products that were proven safe and stable in GM (single) will be maintained in the same range in GM stacks. | Risk assessment of parental GM (single) |
Steiner et al., 2013 Kok et al., 2014 Kramer et al., 2016 | Knowledge from risk assessment of parental GM (single) and knowledge of transgenic proteins gives valid prediction of interactions between transgenic proteins coming from different parental GM (single), and the metabolic pathways of the GM stack. | P1) Behavior of transgenic proteins in the parental GM (single) is known. P2) Metabolic pathways of the parental GM (single) are known P3) Equivalence of entity behavior | Interactions between the transgenic proteins and the metabolic pathways of the GM stack are predictable. | Risk assessment of parental GM (single) |
Steiner et al., 2013 Kok et al., 2014 | Potential interactions between the transgenic proteins that get stacked in the same plant are predictable. The overall development of a hypothesis for such interactions relies on knowledge of the plant variety and previous characterizations of the parental GM (single). | P1) Transgenic product behaviors in parental GM (single) are known. P2) Equivalence of entity behavior P3) Transgenic product interaction in GM stack is predictable | Potential interactions between the events within the GM stack can be predicted | Risk assessment of parental GM (single) |
Weber et al., 2012 | Parental GM (single) derive from an artificial process of genetic transformation. Such process could provoke undesired mutations in either of the two parental GM (single) or both. However, unintended effects of such mutations have already been evaluated and excluded during the safety assessment of the GM (single). In the GM stack there will be no unintended effects due to mutations in one of both parental GM (single). | P1) There might be mutations in the genome of parental GM (single). P2) There is no unintended effect of such mutations in the parental GM (single). P3) Equivalence of entity behavior | There is no unintended effect of potential mutations in the GM stack | Risk assessment of parental GM (single) |