#1DEPARTMENT 10000 20000 OF 1898 AGRICULTURE COUNTRY-CASE PRESENTATION: PHILIPPINES Antonio A. Alfonso, Ph.D. Director, Biotechnology Program Ms. Amparo C. Ampil Chief, PALSD Policy Research Service Department of Agriculture Philippines VisualLightbox.com Presented during the FAO Technical Consultation on LLP March 20-21, 2014 in Rome, Italy#2RTMENT DEPARTM OF 1898 AGRICULTUR Policy on Modern Biotechnology • Promote the safe and responsible use of modern biotechnology and its products as one of several means to achieve and sustain food security, equitable access to health services, sustainable and safe environment and industry development --Policy Statement by then President Gloria Macapagal-Arroyo in July 2001#3RTMENT DEPARTME OF 1898 AGRICULTUR Modern Biotechnology Regulation Executive Order No. 430 s. 1990-addresses safety issues during research on GM • Executive Order No. 514 s. 2006-strengthened the National Committee on Biosafety of the Philippines • DA Admin Order No. 8 s. 2002 - regulates importation and release into the environment of GM plants and plant products E.O. 430 NCBP in Brief | Functions Composition Organizational Chart | NCBP Members | EO 430 EXECUTIVE ORDER NO. 430 MALACAÑANG MANILA FRAMEWORK, CONSTITUTING THE NATIONAL COMMI AND FOR OTHER PURPOSES BY THE PRESIDENT OF THE PHILIPPINES EXECUTIVE ORDER NO. 514 ESTABLISHING THE NATIONAL BIOSAFETY PRESCRIBING GUIDELINES FOR ITS IMPLEMENTATION, STRENGTHENING THE NATIONAL COMMITTEE ON BIOSAFETY OF THE PHILIPPINES, AND FOR OTHER PURPOSES of the use of modern biotechnology products for commercial releases and Republic of the Philippines DEPARTMENT OF AGRICULTURE Office of the Secretary Eliptical Road, Diliman, Quezon City WHE ar W April 03, 2002 WHE life ADMINISTRATIVE ORDER NO. 8 Series of 2002 SUBJECT: RULES AND REGULATIONS FOR THE IMPORTATION AND RELEASE INTO THE ENVIRONMENT OF PLANTS AND PLANT PRODUCTS DERIVED FROM THE USE OF MODERN BIOTECHNOLOGY WHEREAS, it is the declared policy of the State to accelerate agricultural development and enhance the production of agricultural crops by optimizing the use of resources and applying modem farming systems and technology to attain food security for domestic use and to expand and diversify agricultural production for export, WHEREAS, local agriculture can benefit from the safe and responsible use of modem biotechnology by opening the possibility of increasing the yield, improving the product pality, reducing the use of pesticides and other farm inputs, enhancing the integrity of , and reducing the exposure of farmers and consumers to hazardous the endues: pesticide WHEREAS, the Government has recognized, as early as October 15, 1990, with the issuance of Executive Order No. 430, the potentials of modem biotechnology in improving the lives of the people; WHEREAS, under Republic Act No. 8435, otherwise known as "The Agriculture and Fisheries Modernization Act of 1997, the Govemment has declared as one of its objectives the modemization of the agriculture sector by transforming it from a resource- based to a technology based sector; WHEREAS, on July 16, 2001, Her Excellency President Gloria Macapagal-Arroyo approved the Policy Statement on Modem Biotechnology, reiterating the govemment policy of promoting the safe and responsible use of modem biotechnology and its products as one of several means to achieve and sustain food security, equitable access to health services, sustainable and safe environment and industry development; WHEREAS, the products of modem biotechnology cannot be enjoyed fully by the people unless uncertainties regarding their risks to human health and the environment are minimized and managed, if not eliminated; WHEREAS, a responsive regulatory system is an essential component of the precautionary approach in dealing with the products of modem biotechnology com modern biotechnology's potential on biological diversity, on human State to promote the safe and d its products as one of the several , equitable access to health services, try development; on Biosafety to the United Nations e Philippines signed on 24 May 2000#4DEPARTME RTMENT SOF 1898 AGRICULT Activities under Regulation (Risk assessment is the cornerstone for a decision to issue a permit) Direct Use for Food, Feed or for Processing Risk Assessment and Permits DA BPI Contained (Lab, GH) • Risk Assessment (DOST BC) Biosafety Permits (DA BPI) Field Testing (CFT, MLT) • Risk Assessment • CFT (DOST BC) • MLT (DA BPI) • Biosafety Permits (DA BPI) Commercial Propagation • Risk Assessment (DA BPI) Biosafety Permits (DA BPI)#5MENT OF 1898 AGRICULT Strengthening of DA Admin Order 8 Administrative Order No.22 Series of 2007- Amending Specific Sections of Part V ⚫ clarifies further the approval process for registration and importation of regulated articles for direct use as food and feed or for processing reiterates the requirement to declare content or possible GMO content in regulated articles for importation Administrative Order No 31 Series of 2008- harmonizing with the Codex Guidelines stipulates adoption of the: (1) Codex Principles for the Risk Analysis of Food Derived from Modern Biotechnology (CAC/GL44-2003) and (2) the Codex Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant DNA Plants (CAC/GL 45-2003)#6MENT DEPARTMEN OF 1898 ICULTURE AGRICUL Incidents and Management involving Low Level (unintended) Presence 1. Liberty Link (LL) Rice 601 (mid-2006) ■ Host: Oryza sativa ■ Trait: Phosphinotricin (PPT) herbicide tolerance, specifically glufosinate ammonium ■ Trait Intro: Agrobacterium tumafaciens mediated ■ Field Trials: ■ Approval: plant transformation 1999-2001 at LSU AgCenter U.S.: Environment-2006 (thru its extension system) Colombia: Food & Feed - 2008 Alleged presence of LL Rice 601 in imported commercial long grain rice in supermarkets • NFA recalled all commercial rice alleged to contain LL601 March 2007: MTA between Phil DA and Bayer on detection methods to ensure zero presence in proposed rice imports from US under the commodity grant program#7DEPARTMENT OF 1898 ICULTURE AGRICUL GOP required testing of the shipment for presence of LL601 • A PQO was sent to US to check compliance with the requirements and to oversee loading in Port of Lake Charles and Jacinto Port February 2008: arrival of shipments; samples were tested negative to LL Rice#8DEPARTMEN MENT OF 1898 AGRICULTURE 2. Corn TC1507 (2008) • Unapproved event in the Philippines • The shipment of corn MON 810 for propagation was reported to have presence of the unapproved event • Quarantined the whole shipment while the manner of disposal was being addressed • Seed disposal (used as fuel in cement facility)#9DEPARTMEN MENT OF 1898 AGRICULTURE PHL did not have a policy on LLP at that time. However, DA AO 8 provides... Transformation events with no biosafety permit are not allowed into the country and subject to disposal Technology developers/importers are required to declare GM content in shipments ⚫ Disposal of unapproved events in a manner provided by law#10DEPARTME MENT OF 1898 AGRICULTU RICULTURE Adoption of Codex Annex 3 (Administrative Order no. 1 series of 2009) Stipulates adoption of the Annex 3 to the Codex Plant Guideline for the conduct of food safety assessment in situations of low-level presence of recombinant- DNA plant materials in food and feed WAND CONSULTATION ON THE PROPOSED DRAFT A.C PUES AND RELATION FOR THE APPLICATION OF ANEX TO THE COX PLANT GUIDELINE HOOD SAFETY ASSESSMENT WITIGATIONS OF LOW-LEVEL PRESENCE OF RECONOMANT-DA PLANT NATRIAL FOOD PURSUANT TO AR Fett 244 TEM 201 • Consultations on IRR were conducted. Issuance pending due to (1) issues during consultation, (2) acceptable threshold for LLP, (3) detection method#11DEPARTME TMENT OF 1898 AGRICUL GM Crops in the Pipeline Golden Rice Delayed Ripening Papaya Bt cotton Bt eggplant#12DEPARTMEN 1898 OF AGRICULTUR Institutional Capacity for GMO Regulation • Continuous upgrading of laboratory facilities (BPI PEQS Plant Pathogen and Molecular Biology Laboratory) to enhance competence in pathogen and GMO detection Strengthening of manpower skills on GMO testing, field evaluation monitoring, quarantine, and regulatory processes and procedures through local and international trainings • Successful participation in the EU- JRC Proficiency Testing Program in 2012 10 11 12 13 14 15 16 17 18 19 20 21 22 23 25 26 27 28 29 30#13DEPARTMEN MENT OF 1898 AGRICULTURE • Strengthened collaboration with other organizations, programs and advanced laboratories abroad such as EU-JRC, ASEAN GMFTN, USDA (through Cochran Fellowship Program), among others, to boost capacities on GM testing and regulation ⚫ Functional institutional biosafety committees; continuous training of members on risk assessment DA AO 8 is a living regulatory system; continuous strengthening of guidelines Trainees during the ISO17025 accreditation training activity conducted at the PEQS' GMO laboratory#14DEPARTME 1898 OF AGRICU Country Perspective on the Future Situation ⚫ The cornerstone of a decision for approval and issuance of a biosafety permit for direct use as food and feed or for processing is a food safety or risk assessment conducted in accordance with internationally accepted principles and practices • The regulatory framework of the Philippines adopts a zero- tolerance policy for unapproved events. ⚫ The Department to put in place a response system for future LLP incidents by adopting Annex 3 to the Codex Plant Guideline for the conduct of food safety assessment in situations of low-level presence (DA AO 01 S. 2009) and by continuously working on the rules and regulations to implement Annex 3#15DEPARTMENT 20000 OF AGRICULTURE 1898 VisualLightbox.com Thank you