- Review of the information in the application submitted indicated that 7 phenotypic and 8 agronomic characteristics of potato were assessed from 3 sites in Kenya over 2 seasons. The results revealed that there were no biologically significant changes in agronomy and phenotype of the LM potatoes compared to the parent varieties and conventional counterparts, and between both LM varieties, except for the resistance to late blight (LB) disease in the LM potatoes (Highly unlikely)
-  Evidence from the biology of potato and evaluation of the information provided by the applicant show that potatoes are not weedy, invasive or persistent in nature and in Rwanda. Outside managed fields, potato seedlings are poor competitors and rarely establish, even if spread during transport, thus potato is not known to colonize unmanaged ecosystems (OECD, 1997). Further, potato plants do not persist in the soil, as they are weakened by fungal, bacterial and viral infections and die back. Therefore, these traits are not expected to change in the LM potatoes, since there is no biologically significant difference between the LM potatoes and their conventional counterparts, except for LB resistance trait. The R-genes and nptII do not confer increased spread or persistence of the LM potatoes in both agricultural fields and outside agriculture (Highly unlikely).
- There are no sexually compatible relatives of Solanum tuberosum and sexually compatible wild relatives of potato in Rwanda so the potential for gene flow into a non-cultivated population of plants is not possible (Highly unlikely).
- LB resistance traits are for plant protection specific to fungal infestation by Phytophthora infestans and the mode of action does not have any toxic effect. There are no identified non target organisms. Further, the R-genes are expressed at very low levels in the plant. Thus, there are no plausible hypotheses of unintended effects on non-target organisms. The selectable marker protein, NPTII, is also not a toxic protein, has a history of safe use, and has no effect on non-target organisms (EFSA, 2007; EFSA 2009; Nicolia et al. 2014). Therefore, this potential adverse effect is not applicable in this case (Highly unlikely).
- Findings from field trials confirmed no biologically significant differences in the phenotypic and agronomic characteristics of the LM potatoes and their conventional counterpart except the new trait. There is also no intended change in cultivation practices. Thus, change in plant responses or altered interactions with abiotic factors compared with conventional potatoes are not likely.
LB resistance traits are for plant protection specific to fungal infestation by Phytophthora infestans and the mode of action does not have any toxic effect. Therefore, there is no impact on the abiotic components of biodiversity (Highly unlikely).
- Findings from field trials and peer-reviewed publication presented by the applicants and reviewed by the NBC indicated that there is no potential for increased plant pests or pathogens, as such differences were not observed during the trials and there is no plausible mechanism for the likelihood of increased plant pests or pathogens in unmanaged ecosystems (Unlikely). 

 - Similarly, there is no agronomic and phenotypic differences were identified that might result in an increase in plant pests or pathogens in managed ecosystems (Highly unlikely).
-  Review of the findings from compositional and nutritional assessments of freshly harvested tubers confirmed that there were no statistically significant differences observed in the key analytes, including glycoalkaloids (anti-nutrients) (OECD, 2021) of the LM potatoes compared with their conventional counterparts and between both LM varieties. Also, there was no statistically significant difference observed in the level of glycoalkaloids (anti-nutrients) of the LM potatoes compared with their conventional counterparts and between both LM varieties. The levels were within the accepted safety level. Therefore, there is no plausible pathway for a potential harm from consumption of LM potatoes when consumed as their conventional counterparts are consumed (Highly unlikely).
-  Assessment of the weight of evidence regarding the safety of the three (3) R-proteins expressed in the LM potatoes confirmed protein safety. R-proteins being intractable, the following evidence was the basis of safety assessment: donor species are related potato species with a history of safe use; R-proteins are ubiquitous in plants with potatoes having at least ~1,000 different R-proteins, the 3 newly expressed R proteins are homologous to R-proteins with a history of safe use; bioinformatics showed that they are not similar to known toxins and they have a mode of action that is non-toxic; and are expressed in very low concentration in the plant tissues.  NPTll protein is ubiquitous in the environment, has a history of safe use and considered as GRAS (generally regarded as safe). Therefore, there is no plausible mechanism for a new toxin in the LM potatoes (Highly unlikely).
- Findings revealed that donor organisms are not allergenic sources and bioinformatics (whole sequence, 80-mer and 8-mer sliding sequences of identity) on the comparison of amino acid sequences of the 3 R-Proteins to known allergens showed no sequence similarity to known allergens (Highly unlikely). 

 - Potatoes are not one of the 9 listed allergenic foods (Highly unlikely).