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FPA BIOTECH CORE TEAM SUMMARY EVALUATION OF SYNGENTA Bt11 CORN

I. PRODUCT DESCRIPTION Product SYN-Bt 11 Corn Trade Name Yieldgard Company/Registrant Information Syngenta Philippines, Inc. Taguig City, Manila Host Organism / Variety Zea mays L. L. (Maize) Trait Resistance to European corn borer (Ostrinia nubilalis); phosphinothricin (PPT) herbicide tolerance, specifically glufosinate ammonium. Trait Introduction Direct DNA transfer system. Proposed Use Production of Z. mays for human consumption (wet mill or dry mill or seed oil), and meal and silage for livestock feed. These materials will not be grown outside the normal production area for corn.

II. REGULATORY STATUS A. BPI Biosafety permits for Bt 11 Corn 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 and for propagation were issued to SYNGENTA Philippines Inc. on July 22, 2003 and April 14, 2005 respectively. This Biosafety Permit was renewed in April 23, 2010. B. FPA In 2005, Dr. Sabularse and Dr. Bautista released an evaluation report and recommendation for Syngenta Bt11.

In December 2011, BPI Director Barron inquired at FPA for the status of PIP registration of different GM crops. It was found out that Bt11 had no PIP registration prior to its propagation and commercialization in the Philippines. In February 2012, FPA forwarded the Syngenta Bt11 dossier and other related studies to Biotech experts and who are at the same time the FPA Biotech Consultants in the person of Dr. Candida B. Adalla and Dr. Dolores A. Ramirez. Both experts recommended for the approval of PIP registration for Syn Bt11. Attached herewith are the Bt11 evaluations of both FPA Biotech Consultants. III. REMARKS With due consideration to the favorable recommendations of the experts on biotechnology and complete submission of needed data requirements for the registration of PIP in Syn Corn Bt 11 by Syngenta Philippines, the FPA Biotech Core Team hereby agreed to recommend the issuance of a conditional PIP registration for Cry1A protein contained in the Syn Corn Bt11 in view of the FPA mandate under the DA Administrative Order no. 8, s.2002, or the Rules and Regulations for the Importation and Release into the Environment of Plants and Plant Products Derived from the Use of Modern Biotechnology.

Recommending Approval

MR. AUGUSTO L. CANLAS Chair, FPA Biotech Core Team

MS. JEROLET C. SAHAGUN Member, FPA Biotech Core Team

MS. CECILIA A. QUIMBO Member, FPA Biotech Core Team

MS. JULIETA B. LANSANGAN Member, FPA Biotech Core Team

Approved by:

NORLITO R. GICANA, CESO III Executive Director

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