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Risk Assessment
Record information and status
Record ID
114755
Status
Published
Date of creation
2019-05-30 03:39 UTC (estaciojulietafe@gmail.com)
Date of publication
2019-05-30 03:39 UTC (estaciojulietafe@gmail.com)

General Information
Country
  • Philippines
Title of risk assessment
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
Date of the risk assessment
2018-04-05
Institution responsible for the risk assessment
Department of Agriculture
Elliptical Road, Diliman
Quezon City
Philippines, 1100
Phone:+632 920-3986,+632 924-1278 local 2802
Fax:+632 920-3986
Email:osec.da@gmail.com
Url:DA
Department of Environment and Natural Resources
Visayas Avenue
Quezon City
Philippines, 1100
Phone:+632 925-2329, +632 920-4352
Fax:+632 920-4301
Email:osec@denr.gov.ph
Url:DENR,PAWB
Department of Health
San Lazaro Compound, Sta. Cruz
Manila
Philippines
Phone:+632 651 7801; +623 651 7800
Fax:+632 743 1829
Email:etona@co.doh.gov.ph
Url:DOH Website
Contact details of the main responsible risk assessor
Ms. Ma. Lorelei U. Agbagala
Supervising Agriculturist
Post Entry Quarantine
Bureau of Plant Industry (BPI)
Economic Garden
Los Banos, Laguna
Philippines, 4030
Phone:+63 49 536 1678
Fax:+63 49 536 1678
Email:lorelieu5@gmail.com
Url:Bureau of Plant Industry
Risk assessment details
Living modified organism
SYN-BTØ11-1 x DAS-59122-7 x SYN-IR6Ø4-5 x DAS-Ø15Ø7-1 x MON-ØØØ21-9 - Agrisure® 3122
Mannose tolerance Resistance to diseases and pests - Insects - Coleoptera (beetles) - Western corn rootworm (Diabrotica virgifera), Lepidoptera (butterflies and moths) Resistance to herbicides - Glufosinate, Glyphosate Selectable marker genes and reporter genes
Show detection method(s)
Scope of the risk assessment
  • LMOs for direct use as feed
  • LMOs for direct use as food
  • LMOs for processing
Methodology and points to consider
Potential adverse effects identified in the risk assessment
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.
Likelihood that the potential adverse effects will be realized
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.
Possible consequences:
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.
Estimation of the overall risk
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.
Recommendation(s)
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.
Need(s) for further information on specific issues of concern
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.
Receiving environment(s) considered
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.
LMO detection and identification methods proposed
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.
Additional Information
Additional Information
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.
Other relevant website address or attached documents