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Risk Assessment
Record information and status
Record ID
Date of creation
2019-05-30 03:44 UTC (estaciojulietafe@gmail.com)
Date of publication
2019-05-30 03:44 UTC (estaciojulietafe@gmail.com)

General Information
  • Philippines
Title of risk assessment
Determination of the Safety of Syngenta's Corn MIR604 for Direct use as Food, Feed, or Processing
Date of the risk assessment
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
Department of Environment and Natural Resources
Visayas Avenue
Quezon City
Philippines, 1100
Phone:+632 925-2329, +632 920-4352
Fax:+632 920-4301
Department of Health
San Lazaro Compound, Sta. Cruz
Phone:+632 651 7801; +623 651 7800
Fax:+632 743 1829
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
Url:Bureau of Plant Industry
Risk assessment details
Living modified organism
SYN-IR6Ø4-5 - Agrisure™ RW Rootworm-Protected maize
Mannose tolerance Resistance to diseases and pests - Insects - Coleoptera (beetles) - Western corn rootworm (Diabrotica virgifera) 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
Likelihood that the potential adverse effects will be realized
Results of the digestibility, heat inactivation, amino acid sequence comparison and acute oral toxicity studies indicates that mCry3A and PMI proteins being expressed in MIR604 corn are not toxic or allergenic to humans (Syngenta, n.d.).
Possible consequences:
Anti-nutrients, including ferulic acid, p-coumaric acid, furfural, inositol, phytic acid, raffinose and trypsin inhibitor in grain were analyzed and compared with those of commercial corn varieties. Statistically significant differences are noted for both ferulic acid and p-coumaric acid, with lower levels of both in the transgenic samples as compared to the control samples. Other antinutrients analyzed have no statistically significant differences between the transgenic and the control

Therefore, based on the above statements, there is no safety issue related to the consumption of MIR604 seed, since the contents of all anti-nutrients were comparable to the contents in seeds from other commercial corn lines. The relevance of the statistically significant differences found between the non-transgenic and transgenic control and the transgenic event MIR604 was negligible from a biological and nutritional standpoint.
Estimation of the overall risk
Corn MIR604 is found substantially equivalent to conventional counterpart and does not pose any significant risk to animal and human health.
Based on the results of the risk evaluation of the submitted scientific data and other information relevant to the application of Syngenta Philippines Inc., it is concluded that corn MIR604, and all progenies derived from crosses of the product with any conventionally-bred corn, and corn containing approved-biotech events for direct use as food, feed or for processing,  is as safe and substantially equivalent to its unmodified counterpart, and is therefore approved for direct use as food, feed or for processing.
Need(s) for further information on specific issues of concern
Corn MIR604 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 MIR604. 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 MIR604 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