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Risk Assessment generated by a regulatory process
(RA)
published: 15 Sep 2008
last updated: 11 Oct 2012
Determination for the Safety Assessment of the Combined Trait Product Corn: LY 038 x MON 810 for Direct Use as Food , Feed and for Processing
EN
09 Aug 2006
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Competent National Authority:Department of Agriculture ()Elliptical Road, DilimanQuezon City,
1100, PhilippinesPhone: (02) 8928-8741 to 64 local 2118, 2214, 2215, 2240,Fax:Website: http://www.da.gov.ph,
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REN-ØØØ38-3 × MON-ØØ81Ø-6 - Mavera™YieldGard™ maize| Monsanto Japan Limited | Changes in quality and/or metabolite content (Lysine content), Resistance to diseases and pests (Insects, Lepidoptera (butterflies and moths), European corn borer (Ostrinia nubilalis))
- DA-BPI Biotech Website [ English ]
EN
The likelihood of an interaction between cDHDPS and Cry1Ab is highly unlikely because they have different mechanisms of action and are not involved in the same metabolic pathway. Thus, the production of a new allergen or a new toxin as a result of an interaction is also highly unlikely. The two gene products accumulate in different subcellular compartments of the corn plant cells and expression levels of the individual products are the same as the individually approved transformation events.
The concentration of free lysine in stacked trait variety is comparable to that of the single trait variety. Based on the experimental results obtained from bioefficacy studies of the combined trait product, the activities of cDHDPS and cry1Ab genes are not affected by potential interactions with one another.
EN
The concentration of free lysine in stacked trait variety is comparable to that of the single trait variety. Based on the experimental results obtained from bioefficacy studies of the combined trait product, the activities of cDHDPS and cry1Ab genes are not affected by potential interactions with one another.
There are no possible unexpected effects of the stacked genes on the metabolism of the plant based on previous safety assessments of individual transformation events.Based on the experimental results obtained from bioefficacy studies on Lysine Maize x Yield Gard Corn Borer Corn, the activities of cDHDPS and cry1Ab genes are not affected by potential interactions with one another.
EN
The combined trait product corn, LY 038 x MON 810 and all progenies derived from crosses of the product with any conventionally-bred corn, and corn containing approved-biotech events for direct use as food or feed or for processing is as safe and substantially equivalent to its unmodified counterpart. Monsanto’s combined trait product corn LY 038 x MON 810 has no evidence of interaction leading to unintended effects and/or over expression/under expression of the two novel gene products. LY 038 x MON 810 corn is as safe for human food, livestock feed and for processing as its conventional counterparts.
EN
A biosafety notification for the combined trait product corn LY 038 x MON 810 and all progenies derived from crosses of the product with any conventionally-bred corn and corn containing approved-biotech events for direct use as food and feed or for processing was issued to Monsanto Philippines Inc. Corn LY 038 x MON 810 is found to be as safe as its conventional counterpart and does not pose any significant risk to human and animal health and the environment.
EN
Corn LY 038 x MON 810 is found to be as safe as its conventional counterpart and does not pose any significant risk to human and animal health and the environment.
EN
This application is not for propagation of the combined trait product corn: LY 038 x MON 810. This LMO will be directly used for food, feed and for processing.
EN
For the individual events MON 810 and LY 038 in the combined trait product LY 038 x MON 810, diagnostic lateral flow strips, ELISA and PCR for routine qualitative and semi-quantitative detection of transgenes. For higher sensitivity, real-time PCR.
EN
The combined trait product corn: LY 038 x MON 810 is 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 this combined trait product.
EN
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 this combined trait product.
- OECD Consensus Document on Corn [ English ]
| Record type | Field | Record(s) | |
|---|---|---|---|
| Country's Decision or any other Communication | Risk assessment | 1 | |
