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Risk Assessment generated by an independent or non-regulatory process
(IRA)
last updated: 20 Mar 2016
Determination of the Safety of Pioneer Hi-Bred Philippines, Inc. Combined Trait Product Maize TC1507 x DAS59122 x MON810 x MIR604 x NK603 for Direct Use as Food and Feed or for Processing
EN
28 Oct 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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Person:Ms. Merle B. PalacpacChief, Post Entry Quarantine StationEconomic GardenLos Banos, Laguna
4030, PhilippinesPhone: +63 49 536 1678,Fax: +63 49 536 1678,Email: merle.palacpac@gmail.com,Website: http://bpi.da.gov.ph,Related OrganizationBureau of Plant Industry (BPI)Government agency (National/Federal)Economic GardenLos Banos, Laguna
4030, PhilippinesPhone: +63 49 536 1678,Fax: +63 49 536 1678,Email: merle.palacpac@gmail.com,Website: http://bpi.da.gov.ph,
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DAS-Ø15Ø7-1 × DAS-59122-7 × MON-ØØ81Ø-6 × SYN-IR6Ø4-5 × MON-ØØ6Ø3-6 - Insect resistant, herbicide tolerant maize| Mannose tolerance, Resistance to diseases and pests (Insects, Coleoptera (beetles), Lepidoptera (butterflies and moths)), Resistance to herbicides (Glufosinate, Glyphosate), Selectable marker genes and reporter genes
- DA-Biotech Website [ English ]
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The proteins expressed individually in TC1507 x DAS59122 x MON810 x MIR604 x NK603 maize have no similarity in any of the sequences of known allergenic proteins. All of the inserted genes: cry1F, pat, cry34Ab1, cry35Ab1, cry1Ab, mcry3A, pmi and cp4 epsps and their gene products have history of safe use and have been assessed as safe for use as food and feed by various regulatory agencies in many countries.
Based on a weight of evidence approach, the TC1507 x DAS59122 x MON810 x MIR604 x NK603 maize is substantially equivalent to conventional maize. The protein concentration in TC1507 x DAS59122 x MON810 x MIR604 x NK603 maize is comparable to protein concentrations in the parental events. Unintended effects are no more likely to occur in a GM crop than they are in conventionally bred crops (Cellini et al. 2004). There are no reports of a novel toxin or allergen being produced as a result of conventional breeding (Steiner et al., 2013). Therefore, there is no evidence to suggest that a new allergen or toxin was produced in the TC1507 x DAS59122 x MON810 x MIR604 x NK603 maize breeding stack.
EN
Based on a weight of evidence approach, the TC1507 x DAS59122 x MON810 x MIR604 x NK603 maize is substantially equivalent to conventional maize. The protein concentration in TC1507 x DAS59122 x MON810 x MIR604 x NK603 maize is comparable to protein concentrations in the parental events. Unintended effects are no more likely to occur in a GM crop than they are in conventionally bred crops (Cellini et al. 2004). There are no reports of a novel toxin or allergen being produced as a result of conventional breeding (Steiner et al., 2013). Therefore, there is no evidence to suggest that a new allergen or toxin was produced in the TC1507 x DAS59122 x MON810 x MIR604 x NK603 maize breeding stack.
There are no known anti-nutritional factors for the individual events. Thus, TC1507 x DAS59122 x MON810 x MIR604 x NK603 maize has no known anti-nutritional factors.
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Combined Trait Product Maize TC1507 x DAS59122 x MON810 x MIR604 x NK603 is found substantially equivalent to conventional counterpart and does not pose any significant risk to animal and human health.
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A biosafety notification for combined trait product maize TC1507 x DAS59122 x MON810 x MIR604 x NK603 and all progenies derived from crosses of the product with any conventionally bred maize and maize containing approved-biotech events for direct use as food and feed or for processing was issued to Pioneer Hi-Bred Philippines Inc. Combined Trait Product Maize TC1507 x DAS59122 x MON810 x MIR604 x NK603 is found substantially equivalent to conventional counterpart and does not pose any significant risk to animal and human health.
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Combined Trait Product Maize TC1507 x DAS59122 x MON810 x MIR604 x NK603 is found substantially equivalent to conventional counterpart and does not pose any significant risk to animal and human health.
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This application is not for propagation of the Combined Trait Product Maize TC1507 x DAS59122 x MON810 x MIR604 x NK603. This LMO will be directly used for food, feed and for processing.
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Quantitative diagnostic lateral flow strips, ELISA and PCR for routine quantitative and semi-quantitative detection of transgenes. For higher sensitivity, real-time PCR may be used.
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Combined Trait Product Maize TC1507 x DAS59122 x MON810 x MIR604 x NK603 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 and DA Regulatory Agencies during the evaluation of this event.
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All relevant references submitted by the technology developer in their application; other references requested by the Scientific and Technical Review Panel (STRP) members and DA Regulatory Agencies during the evaluation of this event.
- OECD [ English ]
| Record type | Field | Record(s) | |
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| Country's Decision or any other Communication | Risk assessment | 1 | |
