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Risk Assessment
Record information and status
Record ID
46710
Status
Published
Date of creation
2008-09-15 03:54 UTC (estaciojulietafe@gmail.com)
Date of last update
2012-08-16 05:26 UTC (tluzaransoriano@yahoo.com)
Date of publication
2012-08-16 12:43 UTC (estaciojulietafe@gmail.com)

General Information
Country
  • Philippines
Title of risk assessment
Determination for the Safety Assessment of  Potato RBMT15-101, SEMT 15-02 & SEMT 15-15 for Direct Use as Food,  Feed and for Processing
Date of the risk assessment
2008-12-22
Competent National Authority(ies) responsible for the risk assessment
Department of Agriculture
Elliptical Road, Diliman
Quezon City
Philippines, 1100
Phone:+632 920-3986,+632 924-1278 local 2802
Fax:+632 920-3986
Email:osec.da@gmail.com
Url:DA
Risk assessment details
Living modified organism
NMK-8993Ø-4 - Shepody NewLeaf™ Y potato
Resistance to antibiotics - Kanamycin, Streptomycin Resistance to diseases and pests - Insects - Coleoptera (beetles), Viruses - Potato virus Y (PVY)
NMK-89653-6 - New Leaf™ Y Russet Burbank potato
Resistance to antibiotics - Kanamycin Resistance to diseases and pests - Insects - Coleoptera (beetles), Viruses - Potato virus Y (PVY)
NMK-89935-9 - Shepody NewLeaf™ Y potato
Resistance to antibiotics - Kanamycin, Streptomycin Resistance to diseases and pests - Insects - Coleoptera (beetles), Viruses - Potato virus Y (PVY)
Scope of the risk assessment
  • LMOs for direct use as feed
  • LMOs for direct use as food
  • LMOs for processing
Risk assessment report / Summary
Methodology and points to consider
Likelihood that the potential adverse effects will be realized
The glycoalkaloid levels of the New Leaf® Y potato tubers are equivalent to those of the non-transformed control lines and are within the literature reported ranges for commercialpotato varietiesNeither of the Cry3A protein nor the PVY CP shares amino acid sequence homology with any known protein virus toxins.  Both proteins do not possess characteristics typical of known protein allergens.  The inserted protein is not present as major protein components in the potato.The consumption of PVY-infected tubers appears to be quite widespread among the human population. It can be concluded that the PVY coat protein, as expressed in the New Leaf® Y potatoes, is unlikely to be allergenic to humans.New Leaf® Y potato lines are compositionally equivalent to other commercial varieties of potato.
Possible consequences:
For Cry3A and NPTII it was concluded that both proteins are within the size range of known allergens, however, neither of the proteins is glycosylated and both are rapidly degraded in the proteolytic and acid conditions of simulated gastric fluid suggesting they would not survive mammalian digestion. None of the proteins have any significant similarity to known allergens, nor are they present in large amounts in potato tubers. It was concluded that Cry3A and NPTII are unlikely to be allergenic to humans.The only known anti-nutrient present in potato is trypsin inhibitor. Trypsin inhibitors are classed as anti-nutrients because they interfere with the digestion of proteins leading to decreased animal growth. Trypsin inhibitors are heat labile and are destroyed during the cooking process or during processing when heat treatment is applied. As heating inactivates trypsin inhibitor, its presence is only an issue when raw potatoes are consumed. Humans rarely consume raw potatoes due to the indigestibility of the ungelatinised starch.
Estimation of the overall risk
Potato Events RBMT15-101, SEMT 15-02 and SEMT 15-15 applied for direct use is safe for human food, livestock feed and for processing as its conventional counterparts. 
Recommendation(s)
A biosafety permit for Potato Events RBMT15-101, SEMT 15-02 and SEMT 15-15 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 RBMT15-101, SEMT 15-02 and SEMT 15-15 are found to be as safe as its conventional counterpart and uncertainty on the level of risk is not a concern.
Need(s) for further information on specific issues of concern
Potato Events RBMT15-101, SEMT 15-02 and SEMT 15-15 are found to be as safe as its conventional counterpart and uncertainty on the level of risk is not a concern.
Receiving environment(s) considered
This application is not for propagation of potato events RBMT15-101, SEMT 15-02 & SEMT 15-15. This LMO will be directly used for food, feed and for processing. 
LMO detection and identification methods proposed
Quantitative diagnostic lateral flow strips, ELISA and PCR for routine quantitative and semi-quantitative detection of transgenes.  For higher sensitivity, real-time PCR.
Additional Information
Additional Information
Potato Events RBMT15-101, SEMT 15-02 and SEMT 15-15 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.
Other relevant website address or attached documents

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