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Risk Assessment
Record information and status
Record ID
109883
Status
Published
Date of creation
2016-03-20 11:48 UTC (ralphklapps@gmail.com)
Date of publication
2016-03-23 02:08 UTC (estaciojulietafe@gmail.com)

General Information
Country
  • Philippines
Title of risk assessment
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
Date of the risk assessment
2014-10-28
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
Contact details of the main responsible risk assessor
Ms. Merle B. Palacpac
Chief
Post Entry Quarantine Station
Bureau of Plant Industry (BPI)
Economic Garden
Los Banos, Laguna
Philippines, 4030
Phone:+63 49 536 1678
Fax:+63 49 536 1678
Email:merle.palacpac@gmail.com
Url:http://bpi.da.gov.ph
Risk assessment details
Living modified organism
DAS-Ø15Ø7-1 x DAS-59122-7 x MON-ØØ81Ø-6 x SYN-IR6Ø4-5 x MON-ØØ6Ø3-6 - Insect resistant, herbicide tolerant maize
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
Scope of the risk assessment
  • LMOs for direct use as feed
  • LMOs for direct use as food
  • LMOs for processing
Risk assessment report / Summary
Methodology and points to consider
Likelihood that the potential adverse effects will be realized
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.  
Possible consequences:
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.
Estimation of the overall risk
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.
Recommendation(s)
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.
Need(s) for further information on specific issues of concern
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.
Receiving environment(s) considered
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.
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
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.
Other relevant website address or attached documents

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