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Risk Assessment generated by a regulatory process (RA)
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BCH-RA-PH-46826-6   |   PDF   |   Print   |  
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published: 18 Sep 2008 last updated: 26 Mar 2025
General Information
Determination for the Safety Assessment of Potato RBMT 21-129, RMBT 21-350 and RBMT 22-82 for Direct Use as Food, Feed and for Processing
EN
24 Sep 2004
Risk assessment details
  • NMK-89684-1 - New Leaf™ Plus Russet Burbank potato
    | Monsanto | Resistance to antibiotics (Kanamycin), Resistance to diseases and pests (Insects, Coleoptera (beetles), Viruses, Potato leaf roll virus (PLRV))
  • NMK-89896-6 - New Leaf™ Plus Russet Burbank potato
    | Monsanto | Resistance to diseases and pests (Insects, Coleoptera (beetles), Viruses, Potato leaf roll virus (PLRV)), Resistance to herbicides (Glyphosate)
  • NMK-89185-6 - New Leaf™ Plus Russet Burbank potato
    | Monsanto | Resistance to antibiotics (Kanamycin), Resistance to diseases and pests (Insects, Coleoptera (beetles), Viruses, Potato leaf roll virus (PLRV))
Methodology and points to consider
EN
New Leaf Plus Potatoes showed that the nutritional properties of the potato tubers were substantially equivalent to those of the conventional Russet Burbank and similar white potato varieties as shown by the analyses of key nutrients including proximates (ash, moisture, calories), total solids, sugars, vitamin c, soluble protein and natural glycoalkaloid toxicants. The results of compositional analysis showed that genetic improvement through the Agrobacterium mediated transformation of New Leaf Plus Potatoes did not alter nutrient composition from that of conventionally bred potatoes. New Leaf Plus Potatoes are as safe for consumption as conventional potatoes. There are no differences in taste or suitability for processing for New Leaf Plus Potato and the conventional potato. These imply that transformed tubers are substantially equivalent to conventional potatoes.There is a long history of human exposure to the PLRV replicase protein through the consumption of PLRV-infected potatoes, without any reported adverse effects. There is no significant similarity between the PLRV replicase and any known protein toxins. On the basis of this evidence, animal studies of the toxicity of the PLRV replicase protein are considered to be unnecessary and it is concluded that the PLRV replicase protein, as expressed in the New Leaf® Plus potatoes, is non-toxic to humans.
EN
In terms of the potential allergenicity of the four new proteins, it has previously been concluded that Cry3A, NPTII and CP4 EPSPS are unlikely to be allergenic to humans.Neither of the Cry3A nor PLRV replicase proteins shares amino acid sequence homology with any known protein toxins.  The Cry3A and PLRV replicase proteins do not possess characteristics typical of known protein allergens.  There were no regions of homology when the amino acid sequences of these introduced proteins were compared to the amino acid sequences of known protein allergens and unlike known protein allergens, the Cry3A protein was rapidly degraded by simulated gastric or intestinal fluids.  It was determined that these two proteins were highly unlikely to be allergenic.Potato Events RBMT 21-129, RBMT 21-350 and RBMT 22-82 are substantially equivalent as its conventional counterpart.
EN
Potato Events RBMT 21-129, RBMT 21-350 and RBMT 22-82 applied for direct use is safe for human food, livestock feed and for processing as its conventional counterparts. 
EN
A biosafety permit for Potato Events RBMT 21-129, RBMT 21-350 and RBMT 22-82 and all progenies derived from crosses of the product with any conventionally-bred potato and potato containing approved-biotech events for direct use as food, feed or for processing was issued to Monsanto Philippines Inc.  Potato Events RBMT 21-129, RBMT 21-350 and RBMT 22-82 are found to be as safe as its conventional counterpart and do not pose any significant risk to human and health.
EN
Potato Events RBMT 21-129, RBMT 21-350 and RBMT 22-82 are found to be as safe as its conventional counterpart and do not pose any significant risk to human and health.
EN
This application is not for propagation of Potato events RBMT 21-129, RMBT 21-350 and RBMT 22-82. This LMO will be directly used for food, feed and for processing. 
EN
Qualitative diagnostic lateral flow strips, ELISA and PCR for routine qualitative and semi-quantitative detection of transgenes. For higher sensitivity, real-time PCR.
EN
Information sharing with other databases
Yes
Yes
Yes
Yes
Yes
Additional information
Potato events RBMT21-129 RBMT 21-350 and RBMT 22-82 are intended for direct use as food, feed and for processing.

All relevant references submitted by the technology developer in their application; other references requested by the Scientific and Technical Review Panel (STRP) members during the evaluation of these events.

All relevant references submitted by the technology developer in their application; other references requested by the Scientific and Technical Review Panel (STRP) members during the evaluation of these events.
EN
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