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Risk Assessment generated by an independent or non-regulatory process
(IRA)
last updated: 30 May 2019
ASSESSORS' CONSOLIDATED REPORT ON SYNGENTA'S APPLICATION FOR DIRECT USE AS FOOD AND FEED, OR FOR PROCESSING OF COMBINED TRAIT PRODUCT CORN BT11 X DAS59122-7 X MIR604 X TC1507 X GA21
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05 Apr 2018
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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, -
Competent National Authority:Department of Environment and Natural Resources ()Visayas Avenue, DilimanQuezon City, Metro Manila
1100, PhilippinesPhone: (02) 8925-8277,Fax:Email: actioncenter@denr.gov.ph, osec@denr.gov.ph,Website: http://www.denr.gov.ph, -
Competent National Authority:Department of Health ()Tayuman, Sta. CruzManila, Metro Manila
1003, PhilippinesPhone: (632) 8651-7800,Fax:Email: callcenter@doh.gov.ph,Website: http://www.doh.gov.ph,
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Person:Ms. Ma. Lorelei U. AgbagalaSupervising Agriculturist, Post Entry QuarantineEconomic GardenLos Banos, Laguna
4030, PhilippinesPhone: +63 49 536 1678,Fax: +63 49 536 1678,Email: lorelieu5@gmail.com,Website: http://bpi.da.gov.ph,Related OrganizationBureau of Plant Industry (BPI)Economic GardenLos Banos, Laguna
4030, PhilippinesPhone: +63 49 536 1678,Fax: +63 49 536 1678,Email: lorelieu5@gmail.com,Website: http://bpi.da.gov.ph,
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SYN-BTØ11-1 × DAS-59122-7 × SYN-IR6Ø4-5 × DAS-Ø15Ø7-1 × MON-ØØØ21-9 - Agrisure® 3122| Resistance to diseases and pests (Insects, Coleoptera (beetles), Western corn rootworm (Diabrotica virgifera), Northern corn rootworm (Diabrotica barberi), Lepidoptera (butterflies and moths)), Resistance to herbicides (Glufosinate, Glyphosate)
The STRP agreed with the report that the likelihood of interaction among the eight proteins (Cry1Ab, Cry35Ab1, mCry3A, Cry1F, PAT, PMI and mEPSPS) is unlikely because of their different modes of action. Based on the Allergy and Toxin homology analyses, the STRP reported that the abovementioned proteins show no homology to any known mammalian allergen or toxin and there is no evidence of interaction among
them.
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them.
The BPI-PPSSD added that Cry1Ab in Bt11, PAT (phosphinothricin acetyltransferase) in Bt11, DAS-59122-7, and TC1507, Cry34Ab1 in DAS-59122-7, Cry35Ab1 in DAS-59122-7, mCry3A in MIR604, PMI in MIR604, Cry1F in TC1507, and mEPSPS (5-enol pyruvylshikimate-3-phosphate synthase) in GA21 have been assessed individually using different bioinformatics analyses and showed that these proteins have no significant homology and similarity to any known allergen and toxins that could lead to potential adverse effect on human and animal health.
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The assessors concurred that there are no possible unintended effects of stacked genes on the metabolism of the plant based on the previous assessments of individual transformation events.
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After a thorough scientific review and evaluation of the documents, DOH find sufficient evidence that the Corn BT11 x DAS59122-7 x MIR604 x TC1507 x GA21 applied for direct use will not pose any significant risk to the health and environment and that any hazards could be managed by the measures set by DOH.
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After a thorough scientific review and evaluation of Syngenta’s duly accomplished Environmental Risk Assessment (ERA) and Project Description Report (PDR) forms, the Department of Environment and Natural Resources – Biosafety Committee (DENR-BC), recommended for the issuance of a biosafety permit for this regulated event provided that the conditions set by DENR are complied. Also, the Department of Health – Biosafety Committee (DOH-BC), after a thorough scientific review and evaluation of the accomplished Environmental Health Risk Assessment form, concluded that BT11 x DAS59122-7 x MIR604 x TC1507 x GA21 will not pose any significant risk to the health and environment and that any hazards could be managed by the measures set by the department. Hence, the DOH-BC also recommended for the issuance of biosafety permit for the stacked trait product. Lastly, after assessing that there will be no negative socio-economic, ethical and cultural concerns that will arise from the adoption of Genetically Modified Organisms, the Socio-economic, Ethical and Cultural (SEC) expert recommended for the approval and issuance of biosafety permit of BT11 x DAS59122-7 x MIR604 x TC1507 x GA21 for direct use as food and feed, or
for processing.
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for processing.
Corn BT11 x DAS59122-7 x MIR604 x TC1507 x GA2 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 Corn BT11 x DAS59122-7 x MIR604 x TC1507 x GA2. 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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Corn BT11 x DAS59122-7 x MIR604 x TC1507 x GA21 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, BAI, PPSSD, DENR, DOH and SEC Expert 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, BAI, PPSSD, DENR, DOH and SEC Expert during the evaluation of this event.
- ISAAA [ English ]
