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Risk Assessment generated by a regulatory process
(RA)
published: 18 Sep 2008
last updated: 26 Mar 2025
Determination for the Safety Assessment of Combined Trait Product Corn: 1507x 59122 for Direct Use as Food, Feed and for Processing
EN
23 Jan 2007
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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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DAS-Ø15Ø7-1 × DAS-59122-7 - Herculex XTRA™ maize| Pioneer Hi-Bred International Inc. | Resistance to diseases and pests (Insects, Coleoptera (beetles), Lepidoptera (butterflies and moths)), Resistance to herbicides (Glufosinate)
- DA-BPI Biotechnology Office [ English ]
EN
The biochemical and molecular characteristics of the Cry1F, Cry34Ab1, Cry35Ab1 and PAT proteins do not resemble the known characteristics of allergenic proteins. As shown in the data in the form of electrophoretic gels of the western blot procedure did not show any new proteins that could be new allergen or toxin produced in the 1507 x 59122 maize.
The Cry1F, Cry34Ab1, Cry35Ab1 and PAT proteins were expressed in all tissues in 1507x59122 maize plants and were not targeted to any specific organelle in individual cells. These proteins were detected in all tissues samples analyzed. In addition, Western blot provided in the application confirm that the proteins produced in 1507x59122 were the expected size and weight and no additional proteins were detected as a result of traditional breeding between the progeny of 1507 and 59122 maize.
The mode of action of each gene product is different and the products are not involved in the same metabolic pathway.
EN
The Cry1F, Cry34Ab1, Cry35Ab1 and PAT proteins were expressed in all tissues in 1507x59122 maize plants and were not targeted to any specific organelle in individual cells. These proteins were detected in all tissues samples analyzed. In addition, Western blot provided in the application confirm that the proteins produced in 1507x59122 were the expected size and weight and no additional proteins were detected as a result of traditional breeding between the progeny of 1507 and 59122 maize.
The mode of action of each gene product is different and the products are not involved in the same metabolic pathway.
The stacked genes involved function differently from each other. There are no unexpected effects of the stacked genes on the metabolism of the plant because the procedure used is conventional breeding which has been practiced in many crops and many crops and many plant in general in the long history of plant breeding.
Expression levels of the proteins, Cry1F Cry34Ab1, Cry35Ab and PAT in grain from 1507x59122maize are comparable. There is no known interaction between the cry1F, cry34Ab1, cry35Ab1 and pat genes that would affect the stability and expression level of the individual genes.
EN
Expression levels of the proteins, Cry1F Cry34Ab1, Cry35Ab and PAT in grain from 1507x59122maize are comparable. There is no known interaction between the cry1F, cry34Ab1, cry35Ab1 and pat genes that would affect the stability and expression level of the individual genes.
Combined trait corn product: 1507x59122 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. Gene products: 1507 x 59122 showed no evidence of interaction leading to unintended effects and/or over expression/under expression and is therefore approved for direct use as food, or feed or for processing.
EN
A biosafety notification for 1507x 59122 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, feed or for processing was issued to Pioneer Hi-Bred Philippines and Dow AgroSciences in the Philippines. 1507 x 59122 maize is found to be as safe as its conventional counterpart and does not pose any significant risk to human and animal health.
EN
1507 x 59122 maize is found to be as safe as its conventional counterpart and does not pose any significant risk to human and animal health.
EN
This application is not for propagation of combined trait product corn: 1507 x 59122. 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
Yes
Yes
Yes
Yes
Yes
Combined trait product corn: 1507 x 59122 is intended for direct use as food and 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 1507x59122 maize
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 1507x59122 maize
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 1507x59122 maize
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 1507x59122 maize
- OECD Consensus Document on Corn [ English ]
| Record type | Field | Record(s) | |
|---|---|---|---|
| Country's Decision or any other Communication | Risk assessment | 1 | |
