Authorizing the Executive Director to Approve the Guidelines for the Registration of Plant-Incorporated Protectants (PIPs) in Pest-Protected Plants (PPPs) and Other Agricultural Pesticidal Substances Derived from Modern Biotechnology

July 18, 2017

FPA BOARD RESOLUTION NO. 002-17

AUTHORIZING THE EXECUTIVE DIRECTOR TO APPROVE THE GUIDELINES FOR THE REGISTRATION OF PLANT-INCORPORATED PROTECTANTS (PIPs) IN PEST-PROTECTED PLANTS (PPPs) AND OTHER AGRICULTURAL PESTICIDAL SUBSTANCES DERIVED FROM MODERN BIOTECHNOLOGY

WHEREAS, Presidential Decree (P.D.) No. 1144 created the Fertilizer and Pesticide Authority (FPA) to regulate, control and develop the agricultural pesticide industry, including the licensing of all handlers and the registration of all agricultural pesticide products that are intended to be imported, exported, manufactured, formulated, stored, distributed, sold or offered for sale, transported, delivered for transportation or used in the country;

WHEREAS, pesticides refer to any substance or product intended to control, prevent, destroy, repel or mitigate directly or indirectly, any pest; and these include plant-incorporated protectants (PIPs) or active ingredients contained within pest-protected plants (PPPs) and other agricultural pesticidal substances derived through the use of modern biotechnology;

WHEREAS, on April 3, 2002, the Department of Agriculture Administrative Order No. 8 (DA A.O. No. 8) entitled "Rules and Regulations for the Importation and Release into the Environment of Plants and Plant Products Derived from the Use of Modern Biotechnology" was issued where Part IV, Section 9-iv provides that "if the regulated article is a pest-protected plant, its transformation event has to be duly registered with FPA";

WHEREAS, there is a need to update existing FPA regulatory policies and issuances to include the registration of PIPs and other agricultural pesticidal substances derived from modern biotechnology through the issuance of supplementary guidelines by identifying specific requirements for the registration thereof;

WHEREAS, the FPA has conducted several technical meetings and consultations with the relevant stakeholders from government, academe, and industry to identify the technical requirements for the registration of PIPs and the mechanisms for its implementation, which served as basis of the guidelines on the registration of PIPs;

WHEREAS, in November 2014, FPA sent copies of the draft PIP guidelines for review to Dr. Romulo G. Davide, Chairman of the Pesticide Policy and Technical Advisory Committee (PPTAC) CY 2014, and to the members of PPTAC. In April 2015 the FPA Biotech Secretariat consolidated and summarized the actions and recommendations sent by PPTAC;

WHEREAS, the PPTAC Chairman and members recommended for the approval of the PIP guidelines;

WHEREAS, on November 27, 2015, the proposed PIP guidelines was presented to the previous FPA Board for its consideration and some technical and legal recommendations were made;

WHEREAS, on December 8, 2015, the Supreme Court declared DA A.O. No. 8 as null and void and required the DA and other government agencies to promulgate new rules and regulations that would comply with the National Biosafety Framework;

WHEREAS, the DA and other government agencies drafted the required rules and regulations and subjected the same to extensive stakeholder consultations;

WHEREAS, on March 30, 2016, the DOST-DA-DENR-DOH-DILG Joint Department Circular No. 1, series of 2016 (JDC No. 1) was approved and published fifteen (15) days in the newspaper of national circulation and became effective on April 14, 2016;

WHEREAS, Rule No. 4, Section 15 of Article VI of JDC No. 1 states that no regulated article shall be released for commercial propagation unless if the regulated article is a pest-protected plant, its transformation event that serves as plant-incorporated protectant, has been duly registered with the FPA;

WHEREAS, Rule C.3., Section 16 of Article VI of JDC No. 1 provides the procedures for evaluation by the Scientific and Technical Review Panel and other agencies which states that if the regulated article is a pest-protected plant, the FPA determines if the applicant is duly licensed as pesticide handler in accordance with P.D. No. 1144 and if tolerance levels and good agricultural practices have been established for registration of the transformation event;

WHEREAS, on September 14, 2016, the FPA held another stakeholder consultation, as recommended by the FPA Board, to provide opportunity for the relevant stakeholders to comment on the draft PIP guidelines; DETACa

WHEREAS, during the stakeholder consultation, the stakeholders made some clarifications and suggestions which was included in the contents of the PIP guidelines;

WHEREAS, the FPA revised the PIP guidelines based on the outcome of the stakeholder consultation;

NOW, THEREFORE, upon motion duly seconded, the Board RESOLVES that the FPA Executive Director be AUTHORIZED as it is hereby AUTHORIZED to approve the Guidelines for the Registration of Plant-Incorporated Protectants (PIPs) in Pest-Protected Plants (PPPs) and other Pesticidal Substances Derived from Modern Biotechnology.

DONE this 18th day of July 2017 at Quezon City.

(SGD.) HON. KELVIN LESTER K. LEEAssistant Secretary, Office of the President

HON. MARK DENNIS Y.C. JOVENAssistant Secretary, Department of Finance

(SGD.) HON. NESTOR A. ESPENILLA, JR.Governor, Bangko Sentral ng Pilipinas

(SGD.) HON. RAMON M. LOPEZSecretary, Department of Trade and Industry

(SGD.) HON. RAUL V. ANGELESExecutive Director — Investment Assistance Center,

HON. NELA CHARADE G. PUNODirector General, Food and Drugs Administration

HON. JACQUELINE A. CAANCANOfficer-in-Charge, Office of the Director

(SGD.) VICENCIO R. MAMARILOIC-Director, Bureau of Plant Industry

(SGD.) HON. GEORGE Y. CULASTEOIC-Director, Bureau of Plant Industry

HON. SALVADOR C. MEDIALDEAExecutive Secretary, Office of the President

(SGD.) HON. CARLOS G. DOMINGUEZ IIISecretary of Finance