SAFE MOVEMENT OF TRANSGENIC PLANTING MATERIAL

Transcription

1 SAFE MOVEMENT OF TRANSGENIC PLANTING MATERIAL RK Khetarpal Manju Lata Kapur, Rajan, Baleshwar Singh, Shashi Bhalla, V Celia Chalam and Kavita Gupta National Bureau of Plant Genetic Resources Gurinderjit Randhawa NRC on DNA Fingerprinting 1

2 Safe from Pests (insects, nematodes, fungi, bacteria, viruses and weeds) Quarantine Transgenes (terminator technology) Biosafety 2

3 Movement Transboundary Import/ Export International or within country Regional (Inter-state) Multilocation testing Trials 3

4 Regulatory Mechanism -International Quarantine WTO -Agreement on Application of Sanitary and Phytosanitary Measures-1995 IPPC -International Standards for Phytosanitary Measures Biosafety Convention of Biological Diversity 1992 Cartagena Protocol on Biosafety

5 Article 8 g of CBD (LMOs) Establish or maintain means to regulate, manage or control the risks associated with the use and release of living modified organisms resulting from biotechnology which are likely to have adverse environmental impacts that could affect the conservation and sustainable use of biological diversity, taking also into account the risks to human health 5

6 Convention on Biological Diversity (CBD) Article 19.3 provides modalities for safe transfer handling use of living modified organisms (LMOs) (Biosafety issues need to be addressed properly before trading in transgenics) 6

7 Adverse effects of LMOs on CBD conservation and biological diversity sustainable use of pose a risk environment to human health and gene flow emergence of new viruses induced genetic changes toxicity/ allergenicity to non target organisms Cartagena Protocol 7

8 Cartagena Protocol Criteria for risk assessment Biosafety Clearing House System for redressal Precautionary principle 8

9 Risk Assessment and Risk Management WTO vs CBD (Views submitted to Consultative Group of Biodiversity of the Ministry of Environment and Forests on 11 November 2005)

10 Biosafety and WTO WTO Agreement does not exactly share a comfortable relationship with international biosafety regulations that trace their foundation to the Cartagena Protocol. India is a signatory member to both WTO and CBD and their various Agreements/ Protocols. 10

11 Biosafety and WTO All the problems with WTO are closely linked to India s approach to biotechnology and Precautionary Principles (PP). 11

12 Where are we today? To date no internationally agreed standards have been finalized related to RA and RM of GMOs/ LMOs. 12

13 Where are we today? Within the WTO, biosafety in relation to GMOs and world trade appears to fall mainly under the SPS Agreement. The Biosafety Protocol under CBD in turn largely fails to establish standards for RA and RM, providing only broad guidelines for evaluating possible adverse effects of LMOs. 13

14 What India needs to do! More legal and technical opinion needs to be sought to keep a balance between WTO and CBD obligations. Being a signatory to both WTO and CBD we need to follow a rational middle path of compromise between trade and the environment. 14

15 What India needs to do! It has to first of all identify a nodal agency for RA and RM under the (or for the) Review Committee of Genetic Manipulation. The nodal agency should consist of experts from diverse disciplines. who should develop guidelines keeping in view the probability of risks associated with different kind of organisms separately for both to be imported and domestic production. 15

16 What India needs to do! A gap analysis has to be made in terms of facilities and expertise for carrying out various tests related to biosafety. 16

17 Finally.. To ensure that standards set under SPS Agreement of WTO also gradually deals with environmental issues as has been recently done for revising International Standard for Phytosanitary Measures (under SPS/ WTO) for pest risk analysis (Action: MoEF) 17

18 Regulatory Mechanism - National Quarantine Issues Destructive Insects and Pests (DIP) Act 1914 Plants Fruits and Seeds (regulation of import into India) Order 1984 New Policy on Seed Development 1988 Revised PFS Order 1989 Plant Quarantine Order 2003 Small samples for research and transgenics - NBPGR, New Delhi 18

19 Regulatory Mechanism National Biosafety Issues Environment Protection Act 1986 Ministry of Environment and Forests (MoEF) Department of Environment (DoE) Ministry of Science and Technology (MoST) Department of Biotechnology (DBT) Ministry of Agriculture (MoA) Department of Agriculture and Cooperation (DAC) 19

20 Biosafety Issues Basis Biosafety Guidelines DBT Implementation Through various committees 20

21 Committees/ Institutes Institutional Biosafety Committee (IBSC) Review Committee on Genetic Manipulation (RCGM) Monitoring cum Evaluation Committee (MEC) District and State level committees Genetic Engineering Approval Committee (GEAC) National Bureau of Plant Genetic Resources (NBPGR) 21

22 National Mechanism to Import Transgenics Apply through IBSC to RCGM RCGM reviews and grants Import Clearance Apply with Import Clearance to NBPGR NBPGR grants Import Permit 22

23 DBT Import Clearance Para 4 applicant to certify to NBPGR about material NBPGR to retain 5% of the seed in the safe custody Para 5 supplier to certify that about the transgenes and the absence of embryo-genesis deactivator (terminator) gene 23

24 DBT Import Clearance Para 6 The imported transgenic seeds should have durable primary as well as secondary packing a label/ insert describing the contents, quantity traits-name of the gene, the marker if any and any other genetic material the purpose for which the transformation has been carried out date of packing, date of expiry the safety instructions, if any to ensure safe handling of the transgenic material. 24

25 National Containment/ Quarantine Facility for Transgenic Planting Material Phase I April April 2002 Phase II July June 2006

26 Objectives Establishment of national quarantine/ containment facility Development of molecular probes/ markers for detection of transgenes Quarantine processing of transgenic planting material in the containment for detection of pests Human resource development 26

27 Containment Facility 27

28 28

29 Transgenic Planting Material Imported ( ) Crop Samples Source Consignee Brassica spp. 199 Australia, Belgium Pro Agro Chickpea 34 Australia, Scotland ICRISAT, AAU Cotton 48 China, USA MAHYCO, Syngenta, De-Nocil, Nath Seeds, Proagro, Ankur seeds Maize 48 Philippines, South Africa, USA MAHYCO, Monsanto Paddy 287 6,598 Belgium, Germany, Philippines, Switzerland, UK, USA, Vietnam Singapore CCMB, DRR, Hybrid Rice International, IARI, JNU, MAHYCO Metahelix Potato 10 USA CPRI Soybean 359 USA Monsanto Tobacco 3 Canada Univ. of Hyderabad Wheat 11 Germany MAHYCO Total 7,597 29

30 Quarantine Processing for Detection of Pests Visual Inspection All crops X-ray Radiography Soft X-rays generated at 22Kv, 3mA at a distance of 30 cm from the source for 15 seconds to detect hidden infestation of insects Chickpea, Cotton 30

31 Quarantine Processing for Detection of Pests- contd. Blotter Test Incubation at 20 C for 7 days to detect bacteria and fungi All crops Washing Test Soaking in water for 24 hrs and teasing the seeds to detect nematodes Paddy ELISA Test/ Electron Microscopy/ RT-PCR For detecting seed-transmitted viruses Soybean 31

32 Soil Clods, Insect Infestation and Fungal Infection in Transgenic Paddy

33 Pathogens Intercepted Interceptions Host Country Alternaria brassicae Brassica spp. Belgium A. brassicicola Brassica spp. Australia, Belgium A. longipes Tobacco Canada Cercospora sojicola Soybean USA Chaetomium spp. Curvularia lunata Paddy Germany, Singapore, Vietnam Drechslera oryzae Paddy Germany, Philippines, Singapore, Vietnam Fusarium dimerum Paddy Philippines F. equiseti B. juncea Belgium F. moniliforme Cotton Maize Paddy USA Philippines, South Africa, USA Singapore 33

34 Pathogens Intercepted- contd. Fusarium semitectum Cotton Paddy USA Singapore Nigrospora oryzae Paddy Germany, Vietnam Peronospora manshurica * Soybean USA Phoma glumarum Paddy Singapore P. lingam Brassica spp. Australia Tricochonis padwickii Paddy Philippines Soybean mosaic virus Soybean USA Verticillum albo-atrum Cotton USA V. cinnabarinum Paddy Vietnam Xanthomonas campestris pv. campestris Brassica spp. Australia *Not reported from India 34

35 Insect-pests Intercepted in Paddy from Singapore Cryptolestes pusillus Cryptolestes ferrugineus Rhizopertha dominica Sitotroga cerealella Sitophilus oryzae Tribolium castaneum Psocids 35

36 Salvaging of Infested/ Infected Germplasm Brassica Hot water treatment at 52 o C for 30 minutes against Alternaria brassicae, A. brassicicola, Phoma lingam, Xanthomonas campestris pv. campestris in 126 samples Rice Hot water treatment at 52 o C for 30 minutes against Nematode- (Aphelenchoides besseyi) Bacteria- (Xanthomonas campestris pv. oryzae) Soybean Post-entry Quarantine Growing to release harvest from disease free plants Soybean mosaic virus in 15 samples Peronospora manshurica in 141 samples (Rejected) 36

37 Terminator Gene Import banned Regulation of import by NBPGR 37

38 Detection of terminator technology in imported transgenic plants RECOMBINASE GENE PROMOTER B GENE B Cre F Cre R M bp 1200 bp 1000 bp 900 bp 1031 bp Agarose gel electrophoresis of PCR performed to detect terminator gene technology cassette in imported transgenic cotton samples (Lanes, 4-7). Lane 3, positive control giving an amplicon of 1031 bp. Lane 1 and 2, negative control. Terminator Cre-recombinase CRE-F 5 -CTAATCGCCATCTTCCAGCA -3 CRE-R 5 ATGTCCAATTTACTGA. 38

39 Human Resource Development From Organized Five Orientation Courses on Biosafety Considerations for Evaluation of Transgenic Crops Number of participants ~ 131 Speakers/ Panelists ~ 30/ training Number of lectures ~ 25/ training Lab visits ~ 3/ training 39

40 Future Thrusts Harmonization of Biosafety Protocol and SPS Agreement Internal harmonization of regulations Research prioritization Collaboration with industry Continuing the awareness generation 40