Biosafety regulation in the Philippines: past present & future


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Biosafety Regulation: Opening up the debate - Lessons from Kenya and Philippines

Workshop in Kenya, 15 - 16 November 2010

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Biosafety regulation in the Philippines: past present & future

  1. 1. Biosafety Regulations: Opening Up the Debate Lessons from Kenya and the Philippines Nairobi, Kenya November 15-16, 2010 Biosafety Regulations in the Philippines: Past, Present & Future Jose Maria A. Ochave Former Member and Legal Adviser, NCBP Current Member and Legal Adviser, DOST Biosafety Committee
  2. 2. Outline of Presentation <ul><li>Introduction </li></ul><ul><ul><li>State Policy on Modern Biotechnology </li></ul></ul><ul><ul><li>Regulatory Architecture </li></ul></ul><ul><li>Primary Regulatory Instruments and Approvals </li></ul><ul><li>Defining Moment - The Bt Corn Experience </li></ul><ul><li>Concluding Remarks: After Twenty Years </li></ul>
  3. 3. State Policy on Modern Biotechnology Issued on 16 July 2001 by the President of the Philippines “ We shall 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”
  4. 4. Stages in the development of GMOs requiring regulatory approvals <ul><li>Contained use (laboratory, greenhouse, screenhouse) </li></ul><ul><li>Confined environmental release </li></ul><ul><li>Large Scale release </li></ul><ul><li>Unconfined environmental release (commercialization) </li></ul><ul><li>Use for Food, Feed and For Processing </li></ul>
  5. 5. Twenty Years of Biosafety Regulation <ul><li>Originally, regulation was through a multi-sectoral, inter-agency National Committee on Biosafety of the Philippines (NCBP) established on October 15, 1990 under E.O. No 430 and working through the line agencies. NCBP was composed of 10 members: 4 scientists, 2 community representatives, and representatives of 4 line agencies (DENR, DA, DOST and DOH). </li></ul><ul><li>In 2006, E.O. 514 created a new NCBP composed 15 members: 5 scientists, 1 representative each of consumers, industry and community, and representatives 7 line agencies (DENR, DA, DOST, DOH, DFA, DILG, DTI). Risk assessment and approvals are by line agencies. </li></ul>
  6. 6. <ul><ul><li>E.O. 430, s. 1990 (NCBP) </li></ul></ul><ul><ul><li>Contained use </li></ul></ul><ul><ul><li>Department of Agriculture Administrative Order No. 8, s. 2002 </li></ul></ul><ul><ul><li> Field testing and commercialization, </li></ul></ul><ul><ul><li> Direct Use for food, feed & processing </li></ul></ul><ul><ul><li>E.O. 514, s. 2006 </li></ul></ul><ul><ul><ul><li>National Biosafety Framework (NBF) </li></ul></ul></ul>PRSV-resistant Papaya PCR Harvest of Xa-21 rice IRRI Primary Regulatory Instruments
  7. 7. <ul><li>Executive Order No. 430, </li></ul><ul><li>Series of 1990 </li></ul><ul><li>Scope: </li></ul><ul><li>Contained Use </li></ul><ul><li>Confined Use </li></ul><ul><li>Originally, limited field testing </li></ul><ul><li>Potentially harmful exotic species </li></ul>
  8. 8. E.O. 430, s. 1990 <ul><li>Established the NCBP due to advocacy efforts of scientists </li></ul><ul><li>Mandate of NCBP: </li></ul><ul><ul><li>Identify and evaluate potential hazards in GE experiments </li></ul></ul><ul><ul><li>Formulate and review national policies on biosafety and guidelines in risk assessment </li></ul></ul><ul><ul><li>Develop working arrangements with quarantine services in evaluation, monitoring & review of projects </li></ul></ul><ul><ul><li>Assist in development of technical expertise for quarantine services & risk assessment </li></ul></ul>
  9. 9. <ul><ul><li>Recommend development and promotion of research programs to establish risk assessment protocols and assessment of long-term effects of bio research </li></ul></ul><ul><ul><li>Publish results of internal deliberation and agency reviews </li></ul></ul><ul><ul><li>Provide assistance in formulation, amendment or pertinent laws, rules and regulations </li></ul></ul><ul><ul><li>Call upon the assistance of any government agency or GOCC. </li></ul></ul>
  10. 10. Contained use <ul><li>Work is done under containment, i.e. laboratory, greenhouses or screenhouses, confined field </li></ul><ul><li>Physical, spatial, biological isolation is imposed to ensure that no viable GMOs or microorganisms are introduced into the environment </li></ul><ul><li>Activities are generally performed subject to specific biosafety guidelines and under specific levels of containment </li></ul><ul><li>Biosafety guidelines series 1 and Planned Release of GMOs and PHES, series of 1998 are used </li></ul>
  11. 11. Information requirements for EVALUATING WORK UNDER CONTAINMENT <ul><li>Transformation protocol (biolistic, A grobacterium -mediated </li></ul><ul><li>Genetic & physiological analyses of donor and recipient organisms </li></ul><ul><li>Adequacy of the facility, (level of containment will depend on the type of work to be conducted) </li></ul><ul><li>Biosafety measures, i.e. disposal procedures </li></ul>
  12. 12. <ul><li>Greenhouse/Screenhouse : </li></ul><ul><li>Potential ecological impacts </li></ul><ul><li>Genetic stability of GMOs </li></ul><ul><li>Reaction/interaction with </li></ul><ul><li>organisms found in </li></ul><ul><li>actual ecosystems </li></ul>
  13. 13. Applications received: 248 Applications approved: 204 Lab and screenhouse; 9 Confined field tests Golden rice IBS lab inspection IRRI CL4 facility Transformation IRRI biological cabinet Golden rice expt IRRI screenhouse
  14. 14. Confined field releases : Crops and events eligible for confined tests: <ul><ul><li>GM crops whose size & growth habits require areas not afforded by standard screenhouse, i.e. papaya </li></ul></ul><ul><ul><li>GM crops already commercially available in the country where they were developed, if sufficient info relevant to RP are available </li></ul></ul><ul><ul><li>Locally developed GM crops with sufficient information generated in the lab/screenhouse – sufficient for RA </li></ul></ul><ul><ul><li>Other crops and events that warrant limited release under contained confined conditions </li></ul></ul>
  15. 15. Confined Field tests <ul><li>Confined Field Test of Pro-Vitamin A enriched ‘ golden rice’ introgressed lines of IR64, IRRI, Approved: Dec. 2007 </li></ul>
  16. 16. <ul><li>Development and Commercialization of PRSV Resistant GM Papaya for Fresh Fruit and Papain Production: Confined Trial for Generation Advance and Line Selection in Candidate PRSV-CP Transformation Events (E-124, E-132 and E-142) and Other Biosafety-Related Studies </li></ul>Confined field test: 2 sites (2007-2009 )
  17. 17. <ul><li>Researches by Public Research Institutions </li></ul><ul><li>Papaya ringspot virus (PRSV) resistant and delayed ripening transgenic papaya </li></ul><ul><li>Banana bunchy top virus (BBTV) resistant transgenic banana </li></ul><ul><li>Regeneration and transformation of mango & coconut </li></ul><ul><li>Bt eggplant </li></ul><ul><li>Virus resistant tomato </li></ul><ul><li>Beta carotene rice </li></ul>
  18. 18. 1998: Planned Release guidelines on GMOs and PHES <ul><li>10 applications for field testing of insect resistant and herbicide tolerant corn, and combination of two traits </li></ul><ul><li>Carried out in Isabela, Pangasinan, Bicol, Bukidnon, North and South Cotabato and Lanao del Sur. </li></ul><ul><li>Xa-21 (blight resistance) PhilRice and IRRI: 2 seasons 2001-2003 </li></ul>Heat treatment Plowing under Data gathering Post harvest monitoring
  19. 19. <ul><li>Department of Agriculture </li></ul><ul><li>Administrative Order No. 8, Series of 2002 </li></ul><ul><li>Scope: </li></ul><ul><li>Field testing </li></ul><ul><li>Commercialization/Propagation </li></ul><ul><li>Use of GMOs for Food, Feed and For Processing </li></ul><ul><li>Delisting </li></ul>
  20. 20. D.A.-A.O. No. 8, Series of 2002 <ul><li>Served to formalize existing arrangements between NCBP and Department of Agriculture </li></ul><ul><li>Transferred field testing decision-making to the agency most equipped to handle it. </li></ul><ul><li>Ensures that socio-economic considerations are included in decision-making process. </li></ul>
  21. 21. <ul><li>No person shall be allowed to import or release into the environment any regulated article without a satisfactory risk assessment conducted in accordance with the Rules. </li></ul>Risk Assessment Policy
  22. 22. <ul><li>Carried out in scientific & transparent manner; based on available scientific & technical information </li></ul><ul><li>Lack of scientific knowledge or consensus not to be interpreted as indicating a particular level of risk, absence of risk, or acceptable risk </li></ul>Risk Assessment Principles
  23. 23. <ul><li>To be carried out on a case-by-case basis </li></ul><ul><li>Identified characteristics of GMO and its use shall be compared to those of non-GMO from which it is derived and its use under the same conditions </li></ul><ul><li>If new information becomes available, risk assessment shall be readdressed </li></ul>
  24. 24. <ul><li>Applicant for the import or release into the environment of GMO shall appoint a Responsible Officer – </li></ul><ul><ul><li>its highest ranking officer and </li></ul></ul><ul><ul><li>resident of the Philippines – </li></ul></ul><ul><li>who shall ensure that all appropriate measures are taken to prevent adverse effects on human health and the environment. </li></ul>Responsible Officer
  25. 25. TYPES OF PERMIT <ul><li>Permit to Import GMOs </li></ul><ul><li>Permit for Limited Release into the Environment </li></ul><ul><li>Permit for General Release into the Environment </li></ul>
  26. 26. Completed Field tests under A.O.#8 (10) <ul><li>Round-up ready (DK818/NK603) </li></ul><ul><li>Round-up herbicide (360 g ge/L IPA salt) </li></ul><ul><li>MON 810/NK603 </li></ul><ul><li>Herculex I </li></ul><ul><li>Herbicide tolerant Maize (GA21) </li></ul><ul><li>Papaya with delayed ripening trait </li></ul><ul><li>Agronomic equivalency MON89034, </li></ul><ul><li>Agronomic performance of </li></ul><ul><li>MON89034; MON89034/NK603 </li></ul><ul><li>Multilocation trials of Stacked trait Bt11xGA21 </li></ul>D
  27. 27. Approved Transformation Events for Propagation Corn (5): MON 810, Bt 11, NK603 GA21, MON810/NK603 (stacked ) <ul><li>Approved for Direct Use as Food, Feed or Processing </li></ul><ul><ul><li>49 Articles, 19 Events, 19 stacks ( Corn, soybean, potato, sugarbeet, canola and cotton; 2 traits – Insect resistance & Herbicide tolerance) </li></ul></ul>D
  28. 28. <ul><li>Executive Order No. 514, Series of 2006 </li></ul><ul><li>- The result of a UNEP-funded project. </li></ul><ul><li>- Established the so-called National Biosafety Framework, which was essentially a description of a regulatory framework that was already in existence. </li></ul><ul><li>Created a New NCBP, a super-body </li></ul><ul><li>Identified the national competent authorities for purposes of the Cartagena Protocol </li></ul>
  29. 29. E.O. No. 514, series of 2006 <ul><li>New NCBP to: </li></ul><ul><ul><li>coordinate and harmonize inter-agency and multi-sector efforts in developing biosafety policies, setting scientific, technical & procedural standards on biosafety </li></ul></ul><ul><ul><li>oversee the implementation of the National Biosafety Framework </li></ul></ul><ul><ul><li>act as clearing house for biosafety matters </li></ul></ul>
  30. 30. Defining Moment The Bt Corn Experience <ul><li>August-December 1996: First greenhouse evaluation of Bt corn expressing Bt CryllA(b) gene under CL4 confinement facility at IRRI using transgenic hybrid materials from Pioneer Hi-Bred </li></ul><ul><li>1997-1998: Second greenhouse evaluation with Event 176 with materials from CIMMYT under CL4 confinement facility </li></ul><ul><li>December 1999-March 2000: Limited field trial evaluation in General Santos City by IPB-UPLB and Agroseed Corporation </li></ul><ul><li>2001-2002: Multi-location field trials by Monsanto and Pioneer Hi-Bred </li></ul><ul><li>[ 2003: Bt corn approved for commercialization]* </li></ul><ul><li>* By the Department of Agriculture </li></ul>
  31. 31. The Bt Corn Approval <ul><li>The Bt Corn episode: </li></ul><ul><ul><li>Was NCBP’s first encounter with those opposed to modern biotechnology </li></ul></ul><ul><ul><li>Forced NCBP and scientists to explain biotechnology to laymen </li></ul></ul><ul><ul><li>Highlighted the fact that biosafety is not only science-based risk assessment, but involves other issues which NCBP is ill-equipped to handle </li></ul></ul><ul><li>NCBP was later criticized because: </li></ul><ul><ul><li>Risk management measures required of the applicant were too strict </li></ul></ul><ul><ul><li>It took a long time to approve the application </li></ul></ul><ul><ul><li>It was very expensive for the applicant </li></ul></ul>
  32. 32. <ul><li>1st Limited Field trial: MON810 </li></ul><ul><li>Agroseed Corporation , 25 August 1999 to 18 March 2000 </li></ul><ul><li>Risk mitigation measures: </li></ul><ul><li>Reproductive and Spatial isolation: </li></ul><ul><li>Detasseling ; 500 meters isolation distance; </li></ul><ul><li>Enclosure of the experimental area with 10 feet synthetic cloth </li></ul>
  33. 33. After Twenty Years . . . <ul><li>Functional biosafety regulatory system </li></ul><ul><li>Rigorous/Robust Risk assessment </li></ul><ul><li>First country in Asia to commercialize GMOs </li></ul><ul><li>49 Approvals for food, feed and processing </li></ul><ul><li>Guidelines for agricultural crops in place; </li></ul><ul><li>Harmonization between and among regulatory agencies continues </li></ul><ul><li>Compliant with international obligations as per Cartagena Protocol on Biosafety </li></ul><ul><li>Established the BCH Pilipinas: Biosafety Clearing House </li></ul>
  34. 34. Thank you Please feel free to access our websites: NCBP: Approvals on contained use and field testings till 2002 Department of Agriculture Approved Field tests, Commercial release, Direct Use BCH Pilipinas: Approvals for direct use Link to the BCH Central Portal * Some slides supplied by Ms. Julieta Fe Estacio, Head of NCBP Secretariat.