Cartagena Protocol on Biosafety. Dr. Manoranjan Hota Additional Director Ministry of Environment and Forests New Delhi

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1 Cartagena Protocol on Biosafety Dr. Manoranjan Hota Additional Director Ministry of Environment and Forests New Delhi 29 December, 2006

2 GENETIC BASICS CELL: SMALLEST UNIT OF LIFE NUCLEUS: BRAIN OF THE CELL CHROMOSOMES: STRUCTURE CONTAINING THE GENETIC INFORMATION GENES: SMALLER PIECES OF GENETIC INFORMATION DNA: BUILDING BLOCK OF THE GENE, DOUBLE HELIX STRUCTURE

3 HOW TO MAKE TRANSGENIC PLANTS

4 Key Questions? 1. What are LMOs? 2. What are the potential benefits of LMOs? 3. What are the potential risks to biodiversity? 4. What are the provisions of the protocol? 5. What are the issues and controversies? 6. Usefulness of the Protocol?

5 WHAT IS A LMO Living modified organism means any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology.

6 What are the potential benefits? Pesticide/drought/insect tolerance Better nutrition Novel products Improved crop yields

7 BENEFITS OF GMOs IN AGRICULTURE Increased production to ensure food security Reduced need for clearing more land for farms Improved productivity of marginal lands Fall in the irrigation and agrochemical requirements

8 What are the potential risks? Genetic pollution Impact on other species Unintended changes to target species Habitat and biodiversity loss

9 POTENTIAL ENVIORNMENTAL AND RELATED PROBLEMS Development of insect resistance Effect on non target herbivore insects, pollinators etc. Gene flow to wild relatives leading to gene contamination Health hazard for human beings and cattle Possible transfer of antibiotic resistant genes to other soil bacteria Loss of local biodiversity Capture of market from Non-GMO seed

10 Cartagena Protocol on Biosafety 1992 Rio Declaration on Sustainability 1992 CBD 2000 CPB countries ratified Protection of biodiversity from threats posed by Living Modified Organisms (LMOs) Focus on transboundary movement of LMOs Use of Precautionary Principle

11 History of the Protocol : CBD 1995: UNEP set up a working group to look into the issues of the proposed Protocol. Feb, 1999:-Cartagena (Colombia): Rep of 135 countries discussed but this ws collapsed due to to US led grain exporting countries 2000 Jan, 29 th : Montreal: Protocol came into being, but respected Cartagena.

12 Ratification of the Protocol Ratifies the Agreement (CBD). Protocol comes into Force, as a legal binding, after 90 days once 50 countries ratifies.

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14 Essence of the Protocol This Protocol shall apply to the trans-boundary movement, transit, handling and use of all living modified organisms that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health.

15 What are the Provisions of the Protocol? Assistance to less developed countries Non-member party compliance Does Does not apply to products in-transit, pharmaceuticals, processed foods

16 Key Provisions of the Protocol? Precautionary Principle Risk Assessment Biosafety Clearing House Advance Informed Agreement

17 Precautionary Principle To avoid or minimise any harm to biodiversity or human health importing country may impose conditions or refuse the shipment on the ground of lack of scientific certainty on the potential adverse effects

18 AIA Exporting countries must obtain consent of the importing country if the GEO is destined for intentional introduction to environment ; 270 days to decide whether or not the shipment is to proceed further. Importer would do the RA Exporter may assist the importer in his including bearing the cost of the RA etc.

19 Exclusion for AIA All GEO that are: Commodities (i.e. intended for FFP) Destined for contained use ( for labs etc.) For pharmaceuticals for humans In transit

20 Liability Willingness to accept the demands for a strict system of liability & redress under which the exporting countries would be held responsible for any damage caused by them. This is still under discussion for consensus.

21 Labeling Requirements Exporting country must clearly label the shipment the following: Identification of consignment as LMO Specific identity and relevant traits and/or characteristics. Any requirement for safe handling, storage, transport and use. Contact point for further info. Declaration in conformity with the Protocol

22 Exclusions from the Protocol Products from the GEOs viz. papers, soy protein, etc. (as the protocol only applies to GEOs that can replicate or reproduce genetic material)

23 Biosafety Clearing House (BCH) A web based information dissemination system. Administered by the CBD secretariat. Parties are required to send info on the decisions of the country on LMO. Four categories of BCH.

24 Capacity Building

25 Areas of Capacity Developments AIA RA RM RC Public awareness BCH Implementation of Regulations

26 Public consultation Consult the public in all decisionmaking process regarding LMO. Provide access to info on LMOs that may be imported Publicize the results of any decisions made

27 Unintentional movements of GEOs Each country need to take appropriate measures to prevent any such movements They need to notify the BCH about such movements/info etc.

28 What are the Issues and Controversies? Implementation Issues Funding and technology assistance Legal institutions and provisions Conflict with trade agreements Scientific uncertainty Risk Assessment discrepancies

29 What are the Issues and Controversies? Scientific Uncertainty Human health risks Environmental risks Science underlying genetic engineering

30 What are the Issues and Controversies? Risk Assessment Primary tool of the Protocol Identification of: n Harmful agents n Vulnerable population Exposure pathway between the two Substantial equivalence

31 What are the Issues and Controversies? Risk Assessment (cont.) o o o o o o Different interpretations of substantial equivalence Testing limitations Lab tests Field tests Subjective acceptance or rejection of scientific studies Public acceptance

32 Usefulness of the protocol Effects on biodiversity Implementation Level Economic impacts

33 Where do we stand?

34 RANGE OF GM CROPS DEVELOPED/ BEING DEVELOPED

35 GM CROP APPROVED IN INDIA Only one crop i.e. Bt cotton approved recently with various conditions for a period of three years by GEAC based upon recommendations of the Monitoring and Evaluation Committee (MEC), ICAR and biosafety evaluation. Results of insect infestation on Bt (right) and non-bt (left) cotton bolls

36 Biosafety Regulations The Genetically Modified Organisms (GMOs) and products thereof are regulated articles in India in view of potential risks to human health and environment by indiscriminate use.

37 Government Rules for GMOs Environment (Protection) Act, Rules, 1989 Seed Policy, 2002

38 Indian Regulatory Mechanism for GM Crops R & D Funding Applicant / Investigators IBSC To Note To Approve To recommend & Seek approval of RCGM Applic/Investi to report periodically RCGM To Note T o Approve / recommend Permits. To monitor trials To recommend course of action Conveys its decision to applicant / investigator GEAC Applicant / Investigator to conduct trials Large scale trials conducted/ Commercial release

39 Applications of 1989 Rules Manufacture, import and storage of microorganisms and gene technological products. Genetically engineered organisms/ microorganisms and cells and correspondingly to any substance and products and food stuffs, etc., of which such cells, organisms or tissues form part. New gene technologies in addition to cell hybridization and genetic engineering.

40 The complexities of controversy Recent developments in the agricultural biotechnology arena claim different degrees of trust in regulatory institutions. Risks are not resolved easily once they become public controversies. Public risk perception is influenced as much by social relations and feelings of power.

41 There is a need for developing integrated information systems through networking of institutions, databases, and establishment of a biosafety-clearing house that would interalia cover information on transboundary inventories of GMOs.

42 In addition to the scientific assessments, socio-economic evaluation is also important for acceptance of GMOs. In this regard, creating awareness amongst various stakeholders is extremely important.

43 Indian R & D institutions has expertise for conducting research in this area. However,they need to be strengthened meet the challenges that are emerging with the rapidly changing biosafety scenario. Information sharing protocols and additional data capacity are needed to be enhanced to keep pace with the expected increase in trans-boundary movement of LMOs.

44 Capacity enhancement in assessment of risks associated with LMOs and an understanding of the transgenic sequence. Increasing awareness building programmes for participation of all stakeholder groups play an important role.

45 The information system on biotechnology and biosafety information system needs to be strengthened and converted into the Biosafety Clearing House. Stakeholder participation and public information provision in the capacity building component through the BCH mechanism, be widened.

46 Capacity building enhancement for effective coordination between the responsible agencies to assess and manage risks associated with the trans-boundary movement of LMOs.

47 Knowledge and methodologies on Biosafety will be shared and transferred to the state agencies through training programmes.

48 strengthen institutional capacity for coordination and decision making across ministries, specialized agencies and in state government in areas related to biosafety and the CP. strengthen technical capacity to assess, manage and monitor risks associated with biosafety through the provision of training for core capacity development in relevant stakeholder ministries, specialized agencies and in state governments.

49 Capacity Building in Biosafety in India Efforts are being made towards capacity building within the country with the key thrust on training and awareness. Currently two such projects are underway: FAO Regional Capacity Building Project on Biosafety of GM Crops in Asia and; GEF-World Bank aided Capacity building project.

50 Physical mile stones Four institutions are being strengthened in terms of institutional and technical capacities to assess, manage and monitor risks associated with biosafety

51 Project Life Start Year: 2004 Conclusion Year: 2007

52 Current status of the project Developed a news letter An information toolkit Developed the Biosafety Project website Developed the Biosafety Clearing House (

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56 GM Crop Database

57 Result Page for the Query Submitted

58 Synergy between CPB EPA Linkage of National Policy and legislation need to be dovetailed to the International Agreements Rules & the CPB

59 Harmonisation of Capacity Development: A necessity!!

60 Thank You