Protocol-I: For New Transgenic Event
    

Institutional Biosafety Committee (IBSC) Preparation and/submission of application data
Review Committee on Genetic Manipulation (RCGM) Evaluation of application data from Institutional Bio-safety Committee (IBSC)*; Approval for Laboratory and Green House Trials & contained field trials for generation of environmental, toxicity and allergenicity data. Evaluation/monitoring of contained field Trials through Monitoring-cum-Evaluation Committee (MEC)
Genetic Engineering Approval Committee (GEAC) Approval for large scale Field Trials and Evaluation Protocol**
	Concurrent
Farmers Field Trials by Company		ICAR Trials for VCU Involving SAU's and other appropriate State Agencies
	GEAC
	Evaluation of data Environmental Clearance of the event/gene
	Ministry of Agriculture
	Approval for commercial release / notification / registration of variety(ies)  / hybrid(s) by DAC / ICAR
	DAC / ICAR Ministry of Agriculture & State Governments Post-release monitoring and vigilance

*        Representatives to be nominated by DBT. However, DBT officials should not be part of IBSC.

**       i) GEAC to issue permission to applicant for (a) multi-location coordinated trials to be conducted by ICAR (b) conduct of field trials by applicant at suitable locations in different agro ecological zones as per approval of GEAC.

ii) The applicants will hand over the seed/planting material of requisite quantity to ICAR for coordinated trials. GEAC should inform all stakeholders including State Govts. In case of conduct of large-scale trials of transgenic crops, the experimental design and the number shall be decided by GEAC in collaboration with ICAR. 

12.5     Once an extant/transgene has been declared bio-safe, its derivatives need not always be evaluated for bio-safety to the same extent again. Such derivative crop varieties may be considered for biosafety clearance after case verification and need-based trial by RCGM. Studies on gene stability and expression levels will however have to be repeated for new varieties. Thereafter, such varieties (derivative) GM Crop varieties can be evaluated through large-scale trials by ICAR and released after satisfactory VCU performance, provided no adverse linkages are observed. For example, cotton Cry 1Ac gene has been found to be safe. Therefore, the use of this gene for improvement of other varieties in the same crop need not be subjected to the same degree of biosafety assessment as in case of a new transgenic event in case the gene does not show a position effect. This should be done on a case by case basis. After the biosafety of a new transgenic crop is established, it could be allowed to be cultivated after evaluating its agronomic potential and genetic behaviour because of the presence of the gene in a new genetic background. In such cases where both the gene and the genetic background/ initial variety have been earlier approved/ released, even the VCU testing by company could be for one season/year only. Trials for biosafety and agronomic evaluation should be conducted in tandem in order to save time and resources. Also, the commercial release of GM crops should rest with respective Ministry viz. the Ministry of Agriculture which would deal with release and notifications/registration of GM crops. State Variety Release Committees should be involved appropriately.

12.6  Post-release monitoring should be ensured by Department of Agriculture & Cooperation and ICAR and the concerned State Agricultural Universities. Such monitoring would include aspects such as gene flow to wild relatives and non-targeted crop species, building up of resistance, observance of maintenance of refuge and other post-release requisites. The above procedure is represented in the flow chart given in next chapter :