Introduction and Exchange of Plant Genetic Resources

Transcription

1 Introduction and Exchange of Plant Genetic Resources Vandana Tyagi, Principal Scientist, Germplasm Exchange Unit, ICAR- National Bureau of Plant Genetic Resources New Delhi

2 Germplasm Exchange Activities Introduction (import) of PGR Export of PGR National supply of PGR

3 Import/Introduction of Plant Genetic Resources

4 Import Procedure ICAR- NBPGR nodal institution for import of seeds/ planting material for research under the provisions of Plant Quarantine (Regulation of Import into India) Order, 2003, referred to as PQ Order, 2003

5 Procedure for Import for Research/ Experimental purposes Two mandatory requirements i) Import permit (IP) before import of any material and ii) Phytosanitary certificate (PC) from the country of origin. These two documents must accompany every seed/planting material consignment imported from abroad.

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7 PQ Form 09-Import Permit

8 Custom Clearance Consignment should be addressed to Director, ICAR- NBPGR, New Delhi. The port of entry for all the material is New Delhi. The supplier may be requested to fax the details of shipment. Air way bill number Date of shipment Custom value Invoice copy etc.

9 Quarantine Inspection & Release Imported germplasm is examined for associated pests. Healthy material is released and allotted EC/ ET numbers. Indentor informed for payment of quarantine fee. Material dispatched to the indentor

10 Documentation IQ No./Date, IP No. PC No. Source country Source address Common name Botanical name Variety, Identifying traits EC No. Alternate identity no., Country of Origin Name of the indentor, Distribution* Whether imported under MOU Whether imported from CGIAR institute. Whether imported under MTA/SMTA Additional Information For all transgenic material 5% seeds are sent to National Genebank

11 Issuance of Import Permit For Transgenics Rules for the Manufacture, Use, Import, Export and Storage of Hazardous Microorganism/ Genetically engineered organisms or cells and as per Plant quarantine (Regulation of import into India) order 2003, came into force from 1st April 2004 For importing transgenic material prior permission from Review Committee on Genetic Manipulation (RCGM)/ Department of Biotechnology (DBT)

12 Review Committee on Genetic Manipulation (RCGM) Authorized agency of the Government of India functioning under Department of Biotechnology (DBT), handles the import of the transgenic material for research purposes 1. Department of Biotechnology 2. Indian Council of Medical Sciences 3. Indian Council of Agricultural Research 4. Council of Scientific and Industrial Research 5. Other expert in their individual capacity

13 RCGM examine the desirability of import of transgenic line, from the safety point of view under the Environment (Protection) Act-1986[EPA-1986] EPA-1986 has the following committees 1. Recombinant DNA Advisory Committee (RDAC) 2. Institutional Biosafety Screening Committee (IBSC) 3. Review Committee on Genetic Manipulation (RCGM) 4. Genetic Engineering Appraisal Committee (GEAC)

14 IBSC the nodal point for interaction within institute/ university/ commercial organizations involved in r- DNA research for the implementation of the recombinant DNA guidelines. The committee is approved by the DBT and has a nominee from DBT who oversees the activity to ensure the safety aspect.

15 Transgenic can be allowed to be imported by the RCGM for research use only, based on applications submitted through IBSC. DBT (RCGM) provide the permission for import of transgenic material with the stipulation that all import will be routed through ICAR- NBPGR for quarantine clearance and national accessioning.

16 Genetic Engineering Appraisal Committee (GEAC) functioning under the Ministry of Environment, Forest and Climate Change (MoEFCC) handles the commercial introduction (large scale use / experiment) of transgenic material into the country RCGM give the recommendation to Genetic Engineering Appraisal Committee for consideration of the release of the transgenic material which would be found environmentally safe

17 For transgenics/gmo permit is issued subject to the approval of RCGM set up by DBT. After getting permission the applicant shall apply to the Director, ICAR- NBPGR in the prescribed form (PQ form 8) for the issuance of import permit. Alongwith the application form, the indentor is also required to furnish the information and provide undertaking as per para 6 of the DBT permission

18 Para 6 All transgenic materials available for inspection, whenever required All the unwanted transgenic materials may be destroyed by burning after the experiments are conducted All precautions would be taken to prevent the escape of the genetic material into the open environment and shall follow the Recombinant DNA Safety Guidelines of the Government of India certify that the transgenic has the genes as has been described in the permission The transgenic materials do not contain any embryogenesis deactivator gene sequence.

19 Important All introduced material is imported by the Bureau under MTA/ SMTA. The Agreement has implications for the country. Transfer of introduced material to any third party requires consent of the Bureau/ ICAR. National Identity numbers (EC/ET) allotted to specific accessions by Bureau must not be changed. Required for documentation, use, reference, benefit sharing, legal purposes etc.

20 Phytosanitary Certificate Document regarding the health status of consignment, issued by the official plant quarantine agency of the provider country. Every consignment must be accompanied by PC with additional declarations for freedom from specific pests and diseases if specified in the IP. PC is also issued by ICAR- NBPGR for all germplasm material meant for export to foreign countries.

21 Export of Genetic Resources under different Regimes Before 1983 Free access After 1993 Regulated access with PIC* and MAT** *PIC- Prior Informed Consent; **MAT-Mutually Agreed Terms Sovereign right of nations CBD/ UNEP Biological Diversity Act (2002)/ Biological Diversity Rules (2004) After 2004 Multi-lateral facilitated access ITPGRFA, 2004 (only for PGRFA, with SMTA) Guidelines for implementation

22 The Biological Diversity Act, 2002 (BDA, 2002) CBD entered into force on 29 December 1993, and sovereign rights of the states over their biological resources were reaffirmed. India being signatory to the Convention promulgated the Biological Diversity Bill and introduced it in the Parliament. The Biological Diversity Bill received the assent of the President on 5 th February, It came on the Statue Book as The Biological Diversity Act, 2002 (18 of 2003)

23 Section 3 Regulation of access to Biological Diversity All non-indian entities are required to take prior approval of NBA for access to Biological resources occurring in India Non-Indian entities as per BDA, 2002 A person who is not a citizen of India; A citizen of India, who is non resident as defined in Clause (30) of Section 2 of IT Act,1961 (43 of 1961); A body corporate, association or organization - (i) not incorporated or registered in India; or (ii) incorporated or registered in India under any law for the time being in force which has any non- Indian participation in its share capital or management.

24 Section 4: Transfer of Research Results All non-indian entities are required to take prior approval of NBA Transfer of results of any research relating to any biological resource occurring in, or obtained from India, to any person covered under section 3, for monetary consideration or otherwise Exemption: Does not include publication of research papers or dissemination of knowledge n any seminar or workshop, if publication is as per the guidelines issued by Central Government

25 Section 5 (Exemption) Section 3 and 4 not to apply to certain Collaborative Research Projects (CRPs) Collaborative Research Projects involving transfer or exchange of biological resources or information relating thereto between institutions, including Government sponsored institutions of India, and such institutions in other countries, if such collaborative research projects satisfy the conditions as below are however exempted (i) Conform to the policy guidelines issued by the Central Government in this behalf; (ii) be approved by the Central Government. (Guidelines issued vide SO1911 (E) dated 8 November 2006)

26 BDA, 2002 (Institutional Mechanism) National Biodiversity Authority (NBA) Access of biodiversity by Foreigners State Biodiversity Board (SBB) Access of biodiversity by Indians for commercial use Biodiversity Management Committee (BMC) Access of biodiversity in consultation by NBA and SBB for commercial purposes 26

27 Categories of Germplasm Export Category 1 Category 2 Category 3 Export of Annex 1 crops under ITPGRFA and FAO designated accessions of CG Centres located in India Export of germplasm under collaborative research projects Indian researcher/ Government institution to carry/send germplasm for non-commercial research/ or research for emergency purposes other than collaborative research Category 4 Export of germplasm not covered categories 1, 2, 3 i.e access by non-indian entity not under ITPGRFA, CRPs or non-commercial research.(as per Section 3 (2) of the BDA, 2002) 27

28 Category 1 (MoEF & CC Guidelines dated and DAC OM dated ) Processing of Applications for the Export of PGRs for Research Purposes under ITPGRFA Requests for export under MLS of ITPGRFA for Annex I crops of the Treaty and FAO designated accessions of mandate crops of CGIAR DAC notification- ITPGRFA N /2013-SD V dated MoEF & CC notification- S. O (E), To be approved by DAC (NFP) for implementation of ITPGRFA, as per established procedure Information to NBA in the prescribed format

29 Category 2 Export of Germplasm under Collaborative Research Project (Section 5 of the BDA, 2002) Requests for export under CRPs compliant to the MoEFCC guidelines be verified as per the Checklist by NBPGR Recommendations/ Comments from concerned crop Director/PD/PC Recommendation of Director, ICAR-NBPGR Recommendations submitted to DARE through ICAR- SMD CHECKLIST-

30 I. Details of the proposal: Checklist 1. Name of the Institute proposing export 2. Names of the Principal Investigators / Collaborators 3. Name, designation and address of the Recipient 4. Name, designation and Address of the Provider 5. Purpose of access : screening/breeding/evaluation / augmentation/ multiplication/ any other, please specify II. Details of the Collaborative Research Project: 6. Whether the Collaborative Research Project is covered under a valid Work plan/ MoU/ Multilateral/ Bilateral Agreement 7. Copy of the Collaborative Research Project duly approved and signed by the Competent Authority enclosed 8. Validity/ duration of the Collaborative Research Project 9. Specific activity related to germplasm export covered under the Collaborative Research Project

31 III. Details of material to be exported : Crop-wise number of accessions/samples to be transferred Type of material proposed for export: variety/ germplasm/ trials/ nurseries/ any other: please specify Form of material to be transferred -Seeds/ planting material/ In-vitro/DNA/ others please specify Quantity to be exported/ permissible quantity for each accession Whether the material to be supplied is of Indian origin Pedigree/ parentage/ passport data/ national accession no./ other identity of the material if available IV.Other relevant information Type of Material Transfer Agreement (enclose signed copy) Undertaking enclosed from the collaborators that the collaborative Research Project is in conformity with the MoEF Guidelines conferred by Clause (a) of Sub-section (3) of Section 5 of the Biological Diversity Act, 2002 (18 of 2003) of the Central Government of India for International Collaborative research Projects notified vide S.O (E), F.No. 26/4/2006-CSC dated 8 th November Comments of Director/ Project Director /Project Coordinator of the concerned Crop: Recommendation of Director, ICAR-NBPGR: 31

32 Category 3 Processing of Applications for the Export of PGRs for Research Purposes under BDA, 2002 Indian researcher/ Government institution to carry/send biological resources for non-commercial research/ or research for emergency purposes other than collaborative research MoEF&CC Notification G S R 827, (Clause 13) Contact NBA Approval within 45 days

33 Category 4 Export of Indian Germplasm by non-indian entity (do not fall in category 1, 2 or 3) Written approval from the NBA, in the prescribed format Apply in Form 1 under Rule 14 of the BDR, 2004) along with the prescribed fee 33

34 Who and What is excluded by the BDA What is excluded under the BDA, 2002 Indian citizens/entities for research, bio- survey and bioutilization* Section 40 Section 7 NTCs (Normally traded commodities) (for material used only as commodity by traders) Local people and communities of the area, growers and cultivators of biodiversity, and vaids and hakims practicing indigenous medicine Publication of research papers/ presentation in seminar/workshops* For conventional breeding or traditional practices in agriculture, horticulture, poultry, dairy farming, animal husbandry, bee keeping in India* Section 5 Section 40 Collaborative research projects conforming to policy guidelines issued by Central Government and approved by Central Government* Annex 1 crops of ITPGRFA** * Further reinstated in MoEF &CC Notification G S R 827 dated ** MoEF& CC Notification S. O (E) dated 17 th December,

35 Regulations for Access Biological Resources GRFA PGRFA MLS

36 Procedure for Indenting Germplasm from ICAR-NBPGR Requests in requisition proforma for supply of seed/ planting material (GEX01) to Director, ICAR-NBPGR Filled in and signed Material Transfer Agreement (MTA) Feed back information on the performance or utilization of material along with sufficient qty. of multiplied seed must be sent to Director, NBPGR, New Delhi

37 Thank you