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Decisions taken in the 63rd Meeting of the India's Genetic Engineering Approval Committee (GEAC) held on 8th February 2006
India
February 8, 2006

Decisions taken in the 63rd Meeting of the Genetic Engineering Approval Committee (GEAC) held on 8th February 2006

Excerpts relevant to seed professionals

10.0:     Report of the Sub-Committee on Bt cotton and related issues.

10.1      The Member Secretary briefed the Committee on the views expressed by Members on this matter in the previous GEAC meeting and placed the recommendation of the sub-Committee on Bt cotton and related issues for reconsideration of the Committee. The Committee reiterated the following points:

  • The number of locations proposed by the Sub-Committee is rational as it takes into consideration the agro-climatic zones and area under cotton cultivation in each zone.  However, the Company should provide a detailed justification for the selected locations. 

  • The GEAC is following a case-by-case approval of each hybrid and therefore the Sub-Committee’s recommendation in respect of GEAC released gene/event needs reconsideration.

  • One view was that once the biosafety studies have been completed and approved by RCGM all hybrids should be treated on par for LST.

  • It was also opined by some members that  1 year MLT followed by two years of LST and two years of ICAR testing in tandem should be applicable in all cases as interpretation of data based on 1 year LST may  not provide any scientific conclusion. 

  • While some members were of the view that a CVRC notified hybrid/variety has been extensively field tested for agronomic performance and its suitability for a particular zone and therefore 1 year of LST and 1 year of ICAR testing is adequately provided, the Company is able to submit documentary evidence through DNA finger printing that the transgenic Bt cotton hybrid / variety is equivalent to its non-Bt counter part. 

  • The new policy and procedure should be applicable only in prospective for new cases only and not retrospectively. The new cases would mean those hybrids that are refereed to the GEAC for the first time for LST during Kharif 2006.

10.2      The Committee also gave an opportunity to M/s Nath Seeds for presenting their views and concerns on the sub-committee’s recommendations. The Company expressed concern regarding the new policies recommended by the sub-committee in respect of two years of LST for ‘new gene/event’. They requested the GEAC to consider their case based on one year LST on the following grounds:-

  • All the Bt cotton hybrids approved by the GEAC are either those of Mahyco-Monsanto (Monsanto’s technology) or their sub-licensees.  Because of the sole monopoly of a multi-national, the price of Bt cotton seed being charged remains  exorbitantly high.

  • Nath Seeds have ventured to come up with alternative Bt cotton technology, through indigenous efforts.  Through  4 years of various testing,  they have completed all the mandatory requirements of biosafety studies, one year MLT, two year ICAR trials and one year LST under GEAC as per prescribed regulatory procedures.   

  • About 16 such Bt hybrids were approved last year (2005), after one year of Large Scale Trials.

  • It is difficult to comprehend as to what exactly is meant by the term  ‘micro-variants’ (Cry 1 Ac-1, Cry 1 Ac-2, etc).   Scientific literature does not recognize any such genetic nomenclature and the Sub-Committee has not elaborated upon except to say that “they do not have complete DNA homology, but have some base pair differences and hence may have some variation in the protein system”.  It is very important to specify as to what that ‘some variation’ would be.   

10.3      During the deliberations, the members were of the views that there is merit in the Company’s argument regarding the term  ‘micro-variants’ (Cry 1 Ac-1, Cry 1 Ac-2, etc) and therefore Protocol –II recommended by the sub-Committee  in respect of  ‘micro-variant’ needs reconsideration. After detailed deliberation on the various issues mentioned above, the Committee concluded that the matter may be referred back to the sub-Committee for its reconsideration in  the light of the views expressed by the members of the GEAC and also representations given from time to time by the industry representatives.  The Committee further recommended that two more members (Dr R P Sharma and Dr Sushil Kumar) may be co-opted in the Sub-Committee in view of their expertise on the subject matter.  It was also decided that the new policy and procedures would be applicable in prospective for new cases only and not retrospectively.  It was also agreed that the new cases would mean those hybrids which have not been approved by the GEAC for large scale trials.

11.0:       Representations received from NGOs in respect of Bt Cotton field trials.

11.1      The Member Secretary, GEAC briefed the Committee on the representation received from the  Centre for Sustainable Agriculture, Greenpeace and other NGOs regarding the performance of Bt cotton as well as regarding alleged irregularities during large scale trials of Bt cotton approved by GEAC.  She further informed that the representations have been forwarded to the respective State Dept of Agriculture and MOA for verification and submission of a factual report.  Since the evaluation of the Bt cotton trials under RCGM / GEAC and AICCIP trials under ICAR are also in progress, the reports have also been forwarded to Member Secretary RCGM and AICCIP project co-coordinator.  The reports received from Member Secretary RCGM and AICCIP project co-coordinator in respect of the complaint received from Centre for Sustainable Agriculture was also placed before the committee.

11.2      The Committee opined that the representations received need to be addressed in proper perspective. The Committee was of the view that a separate meeting to discuss the above issue may be convened by the Chairman GEAC to which the respective State Govts and other agencies associated with the monitoring of Bt cotton may also be invited for facilitating scientific discussion.

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