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Creating and Implementing Biosafety Regulations: The Philippine Experience

  1. Evolving Agrifood Systems in Asia: Achieving Food and Nutrition Security by 2030 Yangon, Myanmar October 30-31, 2019 Carlo G. Custodio Jr. Philippines Country Coordinator Program for Biosafety Systems In-country services for biosafety development Creating and Implementing Biosafety Regulations: The Philippine Experience
  2. Content of the Presentation Technology Agriculture Economy Public Opinion Domestic Politics International Developments Executive Order 430-1990 Executive Order 514-2006 DOST Biosafety Guidelines 1991 1998 2014 DA AO 8 - 2002 JDC 1- 2016 Biosafety Regulations
  3. A way of looking at how policy develops … • Streams and Window Policy Model (Kingdon, 1995) Problem Stream Public matters needing attention Policy Stream Proposals for change (at least 1 ready) 3 streams are always flowing Politics Stream Receptive political climate Policy window For policy change Policy entrepreneurs are people who promote solutions. 1, 2, 3 New item on agenda 1 Guldbrandsson and Fossum, 2009; 2 California State University, 2002; 3 Erik Paredis & Thomas Block, 2013.
  4. Creation: Executive Order 430-1990 • Public matters needing attention o Scientists from UPLB (University of the Philippines Los Banos) and IRRI (International Rice Research Institute) recognized the need to regulate their own experiments • Proposal for change o Committee was formed in 1987; guidelines were drafted; • UPLB, IRRI, DA- BPI (Dept. of Agriculture - Bureau of Plant Industry), and DOST (Dept of Science and Technology) PCARRD • Political climate o Committee  NAST  DOST  Fmr. Pres. Corazon Aquino in 1990 4 4 Mendoza, et al
  5. Highlights: EO 430 - 1990 • Created the National Committee on Biosafety of the Philippines (NCBP) • Chair: DOST Undersecretary for Research and Development o 1 representative each from DA, DENR, and DOH to be designated by the respective Heads of Offices o Experts 1 biological scientist, 1 environmental scientist, 1 physical scientist, 1 social scientist, 2 respected members of the community • Top listed functions o Technical: Identify and evaluate potentials hazards involved in initiating genetic engineering experiments; o Policy: Formulate and review national policies and guidelines on biosafety; o (Others)
  6. Highlight: Biosafety Guidelines • NCBP Biosafety Guidelines 1991 o Introduction (importation), o Movement (domestic transport), o Field release • NCBP Biosafety Guidelines 1998 – Guidelines on Planned Release (Field Test) o More detailed on field release o Note: Legally, the regulation of exotic plants belongs to the Plant Quarantine Service of BPI and the Bureau of Animal Industry (BAI) for exotic animals; both of DA 4
  7. Creation: DA Administrative Order 8 – 2002 • Public matters needing attention o NCBP recognized the need for assessment that includes short and long term effects of GMOs on the environment and human health o Bt Corn: contained experiments (1996 and 1997); field trials (1998 and 200) o Locally developed GM crops contained experiments: 1997-2000 controlled ripening papaya, bacterial blight resistant rice, introduction of beta carotene in rice varieties 6 • Proposal for change o DA developed draft guidelines that includes evaluation for commercialization propagation • Political climate o National policy statement on modern biotechnology was endorsed by cabinet secretaries and signed by Fmr. Pres. Gloria Macapagal Arroyo in 2001 • “we shall promote the safe and responsible use of modern biotechnology…to achieve and attain food security” o DA AO 8 signed in April 2002 4, 5 5 Cariño 6 NCBP
  8. Highlights: DA AO 8-2002 • Permits under DA AO 8-2002; 5-year effectivity o Importation for contained use o Field testing o Propagation o Direct use for food, feed, processing o Delisting • BPI as regulatory agency (Plant Quarantine Service) • Still with NCBP o Contained use o Policy setting
  9. Regulations for development stages of GM crops and products completed with EO 430 and DA AO 8 Contained Experiments Confined Field Trials Commercial Propagation Direct Use for Food, Feed, Processing Photo by Marlo Asis 7
  10. Experience with Bt Corn • Corn is the second most important agricultural crop in the Philippines 8 • Asian Corn Borer Yield: losses 30-100% 8 • Bt Corn (MON 810) can reduce ACB problem o Approved for commercial propagation in December 2002 under DA AO 85; o The gene was in varieties preferred for feed • Impact to farmers in the 1st year of Bt Corn o Unit yield increases of as much as 37% o Pesticide savings of 60% o Translating to an additional profit of PhP 10,132/ha. 9 • The academics/scientists who had to explain what GMOs and biosafety to the public10 • Farmers who saw the field trials believed in the technology and spoke out 10 8 Gerpacio, et al, 2004 9 Yorobe and Quicoy, 2006 10 Ramirez
  11. Creation: Executive Order 514 - 2006 • Public matters needing attention o Cartagena Protocol: Philippines became a signatory in 2000; Entry into force 2007 o Philippines became a beneficiary of the UNEP GEF Project on Development of National Biosafety Frameworks (NBF) in October 2002 o Thus an NBF was drafted • Proposal for change o DENR is focal agency to the Convention on Biological Diversity o DENR PAWB: Drafting of NBF • Political climate o Project’s Coordinating Committee and DENR Sec  to Secretaries of DA, DOST, DOH, DTI, DILG, and DFA, for concurrence, and/or endorsement or further comments  For approval by the Office of the President  signed by Fmr. Pres. Gloria Macapagal- Arroyo in 2006 11 11 DENR PAWB, 2004
  12. Highlights: EO 514 - 2006 • NCBP became a policy body; Chair is DOST Sec; o Members Secretaries of DA, DENR, DOH, DTI, DILG, DFA, plus other sectors o DTI, DILG, DFA classified as associated Departments (Sec. 4.11) • Provision for transition from EO 430 to EO 514 (Sec 5.4) • DA, DENR, DOH, and DOST had separate mandates Mandate Focal (Art 19 Cartagena Protocol) DA Biosafety issues related to food security Evaluating and monitoring plant and plant products as provided for in DA A0 08 DENR Ensure that environmental assessments are done Bioremediation, forest genetic resources, and wildlife genetic resources Sustainable use of biodiversity. DOH Health impacts Evaluating and monitoring processed food Pharmaceuticals DOST Ensuring that the best available science is used Contained use
  13. Impact of GM corn to society • Let’s pick a sample year: 2015 – Benefited 350,000 resource poor farmers15 – Half the area of corn for feed is GM • Yellow corn: 1,296,440.30 ha16; • GM corn: 688,218.10 ha14 – Unquantified impact of GM corn to the livestock industry • Chicken 1,660,800 MT liveweight 17 • Hog 2,120,300 MT liveweight 17 – Direct use food, feed, fiber Area Planted to GM Corn, BPI Data 12 13 James, Clive, 2015 14 Philippine Statistics Authority 15 Philippine Statistics Authority, 2016
  14. Creation: JDC 1 - 2016 • Public matters needing attention o Court case filed against the Bt Eggplant in 2012 (Writ of Kalikasan, and others) o DA AO 08 declared null and void in December 2015 • Proposal for change o Drafting and consultations for new regulations to replace DA AO 8 o New regulation to comply with legal interpretations on biosafety regulations • Political climate o JDC 1-2016 signed in March 2016 by Department Secretaries
  15. Highlight: JDC 1 - 2016 • Concerned Departments were required to constitute Biosafety Committees to fulfill mandates Roles (consistent with EO 514) Involvement in Regulatory Stage Contained Test Confined Test Comm Propa Direct Use DOST BC ensure that best available science is used and applied  DA BC agricultural productivity and food security    DENR BC ensure that environmental assessments are done    DoH BC environmental health impact assessments lead in evaluating and monitoring processed food    DILG conduct of public consultations as required under the Local Government Code
  16. What is the situation after JDC 1-2016 was signed? • In July 2016, the Supreme Court stated set aside its December 2015 ruling o The Bt eggplant field trials were already completed by the time the Court of Appeals gave it’s decision in May 17, 2013 o DAO 08-2002 has already been superseded by JDC No. 1, series of 2016 o “the Court should not have even delved into the constitutionality of DAO 08-2002” • Applications per year is less, yet decision time is longer Confined Field Trials Commercial Propagation Applications Ave app/yr Ave Days Decision Applications Ave app/yr Ave Days Decision 1998 Guideline 2 0.5 421 DA AO 8 21 1.5 212 9 2.5 109 JDC 1 1 0.25 811 5 1.25 295 (JDC 1 processing) 6 1.5 178 +++ Comparison 1998 Guideline vs AO 8 vs JDC 1 (Data as of Oct 23, 2019)
  17. The Program for Biosafety Systems Who we are • Operations in Africa and Asia • Sustained on-the-ground support • Science-based regulatory services • Independent policy research by IFPRI that informs decision-makers Activities in the Philippines • Early focus on DA – Risk assessment – Insect Resistance Management • Expanded capacity building to DENR & DoH • Information sharing and capacity building on focused topics – Biosafety and law – Socio-economic impacts and considerations – Public participation – GM food labeling – Others • Information sharing with other countries: Kenya, Vietnam, Indonesia, Water Efficient Maize for Africa (WEMA)
  18. Wrapping up: Philippines experience • Public matters needing attention o Efforts were needed to get people to pay attention to the public matter o Scientists understood the technology and spoke out o Step-wise science and political persuasion gave rise to an enabling environment o GM corn helped farmers and corn productivity o Public matters can and do come from technology, economics, legal issues, etc. • Proposals for change o Guidelines were drafted by mainly by academics at first, regulators later, consultations done o Regulators adapt to challenges and are now developing the appropriate additional regulations to advance this valuable technology in the country. • Political climate o The higher the level of the regulation, the higher the politician who needs to get involved o A higher level politician or a group of politicians provide justification for another decision- maker
  19. Regulations • Executive Order 430-1990 Constituting the National Committee on Biosafety of the Philippines (NCBP) and for Other Purposes. • Executive Order 514-2006 Establishing the National Biosafety Framework, Prescribing Guidelines for its Implementation, Strengthening the National Committee on Biosafety of the Philippines, and for Other Purposes • National Committee on Biosafety of the Philippines. (1991) Philippine Biosafety Guidelines. • National Committee on Biosafety of the Philippines. (1998). Biosafety Guidelines for Planned Release of Genetically Modified Organisms (GMOs) and Potentially Harmful Exotic Species. • Department of Agriculture Administrative Order No. 8-2002 Rules and Regulations for the Importation and Release into the Environment of Plants and Plant Products Derived from the Use of Modern Biotechnology. • Joint Department Circular 1-2016 Rules and Regulations for the Research and Development, Handling and Use, Transboundary Movement, Release into the Environment, and Management of Genetically- Modified Plant and Plant Products Derived from the Use of Modern Biotechnology
  20. List of Acronyms • BAI: Bureau of Animal Industry • BPI: Bureau of Plant Industry • DA: Department of Agriculture • DENR: Department of Environment and Natural Resources • DFA: Department of Foreign Affairs • DILG: Department of Interior and Local Government • DOH: Department of Health • DOST: Department of Science and Technology • DTI: Department of Trade and Industry • NAST: National Academy of Science and Technology • NBF: National Bisoafety Framework • NCBP: National Committee on Biosafety of the Philippines • PAWB: Protected Areas and Wildlife Bureau
  21. References 1. Karin Guldbrandsson and Bjoorn Fossum. (2009). An exploration of the theoretical concepts policy windows and policy entrepreneurs at the Swedish public health arena. Health Promotion International, Vol. 24 No. 4 2. California State University Long Beach, Graduate Center for Public Policy and Administration. (2002). Models Of Public Policy-making. 3. Erik Paredis & Thomas Block. (2013). The Art Of Coupling: Multiple streams and policy entrepreneurship in Flemish transition governance processes. Centre for Sustainable Development, Ghent University. 4. Mendoza, Evelyn Mae T, Garcia, Roberta N., Sahagun, Maridon, and Laurena Antonio C. (2009). Biosafety Regulations in the Philippines: A Review of the First Fifteen Years, Preparing for the Next Fifteen. National Academy on Science and Technology (NAST), Department of Science and Technology (DOST), National Committee on Biosafety of the Philippines (NCBP), and the Program for Biosafety Systems (PBS). 5. Cariño, F.A. (2009). Marked “Approved”: Bt Corn was First. In Gonzales, L.A., Javier E.Q., Ramirez, D.A., Cariño, F.A., and Baria, A.R. Modern Biotechnology and Agriculture: A History of Commercialization of Biotech Maize in the Philippines. STRIVE Foundation. ISBN 978-971-91904-8-6 6. NCBP Contained Experiments 1991-2008 experiments-1991-2008 7. Marlo Asis. (2017). GMO cotton could prompt renaissance of Philippine cotton industry. cotton-industry/ 8. Gerpacio, R. V., J. D. Labios, R. V. Labios, and E. I. Diangkinay. (2004). Maize in the Philippines: Production Systems, Constraints, and Research Priorities. Mexico, D.F.: CIMMYT.
  22. References 9. Yorobe J. Jr. M., and Quicoy, C.B. (2006). Economic Impact of Bt Corn in the Philippines. The Philippine Agricultural Scientist 89 (3), 258-267 10. Ramirez, Dolores A. (2009). The R&D Commercialization Continuum: Biosafety Risk Assessment of Bt Corn (MON810). In Gonzales, L.A., Javier E.Q., Ramirez, D.A., Cariño, F.A., and Baria, A.R. Modern Biotechnology and Agriculture: A History of Commercialization of Biotech Maize in the Philippines. STRIVE Foundation. ISBN 978- 971-91904-8-6. 11. Department of Environment and Natural Resources-Protected Areas and Wildlife Bureau. 2004. The National Biosafety Framework for the Philippines. Quezon City, Philippines. 12. Bureau of Plant Industry. IRM Monitoring. 13. James, Clive. 2015. Global Status of Commercialized Biotech/GM Crops: 2015. ISAAA Brief No. 51. ISAAA: Ithaca, NY 14. Philippine Statistics Authority. (Accessed May 11, 2018). Palay and Corn: Area Harvested by Ecosystem/Croptype, by Quarter, by Semester, by Region and by Province. 15. Philippine Statistics Authority, (2016). Selected Statistics on Agriculture 2016
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