Regulatory Mechanisms for Bio-Safety Evaluation and release system/protocol

12.1   After analyzing the current procedures for biosafety evaluation/ protocol, the Task Force came to the conclusion that the existing system of approval of GM Varieties for cultivation needs review and rationalization. The Task Force recognizes the need for reduction in the levels and number of steps required in evaluation and environmental clearance of GM products/transgenics and the need for transparency and professionalism in the regulatory process.

12.2   The Task Force is, of the view that the implementation of the procedures under the Rules for the Manufacture, on Use/Import/Export and Storage of Hazardous Micro-organisms/ Genetically Modified Organisms or Cells, formulated under the EPA 1986, involves avoidable loss of time. It will be appropriate to review the existing procedures so that biosafety can be assessed concurrently with agronomic performance. There is a need for streamlining the procedures for commercial release of genetically modified crops, without compromising on principles of bio- and environmental safety. The urgency is further highlighted by mushrooming of illegal varieties of Bt. Cotton seed in Gujarat, which is reported to have spread to Andhra Pradesh, Maharashtra, Madhya Pradesh and Punjab as well. The production and sale of unauthorised Bt. Cotton seed also underscores the need for a further strengthening of the relevant provisions of law under the Seed Act and Environment (Protection) Act. The provision of mandatory registration under the proposed Seed Act is a welcome step in this direction. The provisions relating to breeders’ rights under PPV&FR Act will also to some extent, help in addressing the problem. There is, however, need for constant vigil and monitoring and for initiating measures to plug the loopholes in collaboration with State level authorities.

12.3   It is suggested that while the present system of granting approval for contained and open field trials for biosafety may continue to rest with the RCGM, the multilocational farmer’s field trials for Value for Cultivation and Use (VCU) should be the sole responsibility of ICAR and the concerned company / institution. The Monitoring and Evaluation Committees (MEC) should report to GEAC, which may continue to handle biosafety and environmental safety issues of GM crop candidates until the proposed National Agricultural Biotechnology Regulatory Authority comes into existence. ‘Commercial release’ /notification/registration, however, should be with ICAR/DAC as the release for use by farmers comes under the domain of the Ministry of Agriculture. No GM crop variety should be allowed to be released for use by farmers by any agency other than ICAR/DAC who have a system of VCU evaluation and also a regulatory mechanism for release and notification of varieties. ICAR would devise a mechanism to concurrently run the VCU trial of such GM crop candidates for which GEAC clearance has been given and for which large-scale seed production/multiplication has been recommended by GEAC. An All India Coordinated Research Project (AICRP) solely for the testing of GM crop varieties should be organized by ICAR with the requisite technical expertise. Multilocational/regional testing should be carried out with the help of the concerned State Agricultural University centers under the AICRPs. The Agricultural Production Commissioner of the concerned State should be given full details of trials with GMOs in the respective State

12.4   The above suggestions are represented in the flow chart given in the next chapter :