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Risk Assessment generated by a regulatory process
(RA)
last updated: 03 Apr 2025
Determination for the Safety Assessment of Corn TC1507 x MON810 for Commercial Propagation
EN
07 Aug 2014
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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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Organization:Bureau of Plant Industry (BPI)San Andres, MalateManila, Metro Manila
1004, PhilippinesPhone: 8524-9588 local 230,Fax:Email: bpibiotech@buplant.da.gov.ph,Website: https://biotech.buplant.da.com.ph/,
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DAS-Ø15Ø7-1 × MON-ØØ81Ø-6 - Maize modified for insect resistance and herbicide tolerance| Du Pont do Brasil S.A.(Du Pont - Divisão Pioneer Sementes) | Resistance to diseases and pests (Insects, Lepidoptera (butterflies and moths), European corn borer (Ostrinia nubilalis)), Resistance to herbicides (Glufosinate)
The expressed proteins may have unintended interactions, leading to adverse effects
The inserted proteins (Cry1F, Pat, Cry1Ab) will not interact to produce any new allergen or toxins. This is due to the different mode of action of each protein which is not likely to interact as their mode of action differ on the receptor sites in the insect gut, where they take action. With respect to the molecular mechanisms, these novel proteins do not act on the same metabolic pathways and do not share any intermediate metabolites in the biochemical pathways that the proteins act on or interfere with. Hence, there is no expected adverse effect on the target trait that the transgenes confer, more so, no new allergen nor toxin will be produced.
The Scientific and Technical Review Panel (STRP) stated that the claim on no interaction of the resulting products is supported by data for April 14 to October 2, 2009 growing seasons of five (5) separate sites. The study was on nutritional composition of forage and grain tissues that showed that the level on multi-stacked maize was comparable to the near-isoline controlled maize. Secondary metabolites and anti-nutrient composition is much lower than the tolerance level.
The STRP also concurred that Cry 1F & PAT are in the cytoplasm. TC 1507 and Mon 810 maize events integrated into the genome of multi-stacked products in the same way as individual maize as confirmed in corresponding protein expression levels in stacked and in individual maize event. Results of ELISA showed that Cry 1F protein concentrations in tissues derived from stacked maize were comparable to Cry 1F protein concentrations in tissues derived from 1507 maize.
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Each of the genetically modified corn parental, TC1507 and MON810 used to obtain the stacked event, was previously analyzed either separately or in combinations, and were held to be safe for human and animal health and the environment. Expression levels of proteins Cry1F, Cry1Ab and PAT were assessed in pollen, leaves, stalk, root and grain of the stacked TC1507 x MON810 corn with no records of significant differences between the values noted in comparisons with individual events.
Compositional analysis of grain and forage also showed that there is no significant difference between the stacked corn TC1507 x MON810 and the conventional control. As whole, the results revealed an absence of unexpected effects coming from unforeseen interactions on combining events TC1507 x MON810.
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The project description report (PDR) submitted by the applicant discussed the specified environmental management plan indicating the possible risk and harm to the environment and non-target organisms as well as the mitigating measures and contingency plan. Furthermore, the chances of unintended release or planting of the regulated article is very minimal and will not cause any damaging and lasting effects because the receiving environment (areas near the port, roads, railways, etc.) is not conducive for plant growth. Also, corns are very highly domesticated and does not survive well without human intervention (FAO, 2014).
The project description report (PDR) submitted by the applicant discussed the specified environmental management plan indicating the possible risk and harm to the environment and non-target organisms as well as the mitigating measures and contingency plan. Furthermore, the chances of unintended release or planting of the regulated article is very minimal and will not cause any damaging and lasting effects because the receiving environment (areas near the port, roads, railways, etc.) is not conducive for plant growth. Also, corns are very highly domesticated and does not survive well without human intervention (FAO, 2014).
Yes
Yes
Yes
Yes
Yes
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