Indonesia policy on biosafety 2011


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Indonesia policy on biosafety 2011

  1. 1. INDONESIA’S POLICY POSITION ONCARTAGENA PROTOCOL ON BIOSAFETY Sugeng Harmono Biosafety Division Ministry of Environment Hotel Borobudur, 1 Juni 2011
  2. 2. IntroductionPolicy & RegulationInstitutionRelease & DistributionNext Agenda
  3. 3. INTRODUCTIONAs a megabiodiversity country Indonesia is very concernedwith the conservation and sustainable use of biodiversity.On the other hand, due to the struggle in providing food for itslarge population, Indonesia is also extremely concerned withfood security..Indonesia believes in the potential of Genetically EngineeredProduct for food production, medicine development andhuman health.However, biotechnology application may create some risk onenvironment, biological diversity, and human healthIndonesia has been aware of the controversy about the safetyaspects of modern biotechnology, and chooses to take theprecautionary approach to avoid the potential adverseimpacts on food and animal safety as well as the environment
  4. 4. Cartagena ProtocolIndonesia has been ratified UN Convention onBiological Diversity in 1994 by Law of 5, 1994.Biosafety is one of the issues addressed by theConvention on Biological Diversity. This conceptrefers to the need to protect human health and theenvironment from the possible adverse effects of theproducts of modern biotechnology.In May 2000, Indonesia signed the CartagenaProtocol and on October 19th, 2004, the President ofthe Republic of Indonesia signed Law No 21, 2004on Ratification of Cartagena Protocol.
  5. 5. Objective of the Protocol to contribute to ensuring an adequate level of protection in the field of the safe transfer, handlingand use of living modified organisms resulting frommodern biotechnology that may have adverse effectson the conservation and sustainable use of biological diversity, taking also into account risks to human health, and specifically focusing on transboundary movements.
  6. 6. Legal & Administratif ImplicationEach Party shall take necessary and appropriatelegal, administrative and other measures toimplement its obligations under this Protocol.• Ratify the Protocol• Development national regulation on Biotechnology• Establish an institutional arrangement to implement the protocol and the regulation
  7. 7. RegulationLaw No. 32 of 2009 on Environmental Protection &ManagementLaw No. 7 of 1996 on FoodLaw No. 18 of 2002 on National System Research,Development and Application of Science and TechnologyLaw No. 18 of 2004 on PlantationLaw No. 23 of 1992 on HealthLaw No. 23 of 1992 on Animal, Fish, and Plant QuarantineLaw No. 41 of 1999 on ForestryGovernment Regulation No. 21 of 2005 on Biosafety ofGenetically Engineered ProductPresidential Decree No. 39 of 2010 on Biosafety Commision ofGenetically Engineered Product
  8. 8. INSTITUTIONAL ARRANGEMENTBiosafety CommisionEstablish by Presidential Decree No. 39/2010Biosafety Technical TeamIn the establishment process.Biosafety Clearing HouseRegarding Article 20 of the Cartagena Protocol, Indonesiahas been establish a Biosafety Clearing House to facilitate theexchange of scientific, technical , environmental and legalinformation on LMO. BCH is coordinated by Ministry ofEnvironment in cooperation with Indonesia Institute ofScienceSecretariat of Biosafety Commission
  9. 9. Law 32/2009Every activities may create important risk onenvironment, biodiversity and human healthand human safety have to carry outEnvironmental Risk Analysis• Risk Assessment• Risk Management• Risk Communication
  10. 10. Government Regulation 21/2005The purpose of this Government Regulation: to realize environmental safety, food safety and or animal feed safety of GEP and its use in the area of agriculture, fishery, forestry, industry, environment and non pharmaceutical health. to improve efficiency and effectiveness of GEP use for people welfare based on principle of health and biological resource management, consumer protection and certainty in operating business
  11. 11. Government Regulation 21/2005Principle Arrangement applied in this government regulation is a precautionary approach in realizing environmental safety, food safety and or animal feed safety based on an accurate scientific method by considering religious, ethic, socio- cultural and esthetic norms.
  12. 12. Government Regulation 21/2005Scope Type & requirement of Genetically Engineering Product (GEP); Research & Development of GEP; Importance of GEP from abroad; Assesment, Release and Distribution and use of GEP; Supervision & control of GEP; Institution; Finance.
  13. 13. ASSESSMENT, RELEASE AND DISTRIBUTION, AS WELL AS USE OF GEPAssessment of GEP shall be conducted prior to release anddistributionBiosafety Commision to conduct assessmentIn the event that the assessment relates to technicalevaluation, KKH assign TTKH to conduct assessment oftechnical document and advanced test.BKKH to publicize the summary of the result of GEPassessment conducted by TTKH through mass media bothprinted and electronic in addition to official newsBased on the result of TTKH’s assessment and input from thecommunity, KKH shall propose its recommendationCompetent Minister or Competent Head of LPNK shall usethe certificate and recommendation as basis for considerationfor the issuance of Decree on the Release and or Distributionof the said GEP, in accordance with applicable legislations.
  14. 14. Recommendation Process for Environmental Safety 4. Aplication for Recomendation 5. MOE 3. Competent Minister 16. Recommendation (safe/not) Recomendation Recomendation 15. Proposed 6. Assign 17. Final Decission 2. Application Proposed Assign Final Decission Application 14.Report CR 12.BCH 10.Biosafety Commision 7. 9. Result 11. Assign Assign1. APPLICANT 13.Community Response (CR) 8. Biosafety TT
  15. 15. Competent AuthorityEnvironmental safety: Ministry of Environment(MoE)Variety Release, Feed Release: Ministry ofAgricultureFish Release: Ministry of Marine and FisheriesTrees Release : Ministry of ForestryFood release: Food & Drug Control Agency
  16. 16. What Next ???
  17. 17. Next AgendaDevelopment Goverment Regulation on Risk Assesmentof GEPDevelop Ministerial Environment Decree EnvironmentalRisk Assesment of GEPFormulate Procedure for GEP research and developmentProvide biosafety test guide for laboratory and limitedtest facilityEstablish a Guide to monitoring the impact and riskmanagement of distributed GEP on the environmentDevelop Regulation on withdrawal GEP that createnegative impact to the environment
  18. 18. MOP 5 Cartagena ProtocolAdoption Process to the Nagoya Kuala LumpurSuplementary Protocol on Liability and RedressFormulate Second National Report onImplementation Cartagena Protocol
  19. 19. Any Question