The Hindu Business Line : `Event-based' clearance for GM crops likely

In what could expedite release of new genetically modified (GM) crops into the market, the Union Government is considering `event-based' clearance against the existing system of approving each individual hybrid or variety.

An `event', in biotech parlance, basically refers to a specific gene construct that can be incorporated in a number of existing hybrids or varieties. For instance, Monsanto's `Bollgard' is an event involving a series of steps developed by it for inserting cry1Ac (a foreign gene isolated from a soil bacteria, Bacillus thuringiensis) into a parental cotton line. This `event' — representing a stable genetic transformation of the parent cotton host — can be replicated across other hybrids/varieties by backcrossing them with `Bollgard'.

Current system

In the current system of commercial release approvals, every GM hybrid/variety has to undergo a minimum three years of official trials, irrespective of whether it incorporates an existing or new `event'.

This includes one year of multi-locational trials for generating bio-safety data monitored by the Department of Biotechnology's Review Committee for Genetic Manipulation (RCGM), followed by two years of large-scale field trials under the aegis of the Genetic Engineering Approval Committee (GEAC). Along with this, the company owning the hybrid has to supply seeds to the Indian Council of Agricultural Research (ICAR), which conducts independent tests for assessing its agronomic performance over a two-year period. In the third year, the GEAC also allows the company to carry out seed multiplication to enable commercial release in the subsequent year.

In case of an `event' introduced for the first time in the country, the genetically transformed crop has to additionally go through one year of lab-level data generation and greenhouse trials, and another year of contained open field tests under RCGM supervision. That makes it a total of five years.

Multi-stage clearance

The proposal under consideration now is to do away with the multi-stage clearance mechanism for GM crops incorporating existing events, whose bio-safety, environmental and agronomic suitability has already been demonstrated before. "In such cases, we would only ascertain whether the said event is present in the particular hybrid, there is adequate expression of protein produced by the gene and the crop is morphologically the same even after transformation. All this can be done through simple DNA fingerprinting and a one-year confirmatory field experiment in any State Agricultural University. Once this basic data is known, the GEAC will register the hybrid for commercial release," officials told Business Line.

"It is a welcome proposal because there are so many pending applications and the ICAR does not have the capacity to carry out agronomic trials for each and every hybrid. In fact, they have now even stipulated that a company can offer only one hybrid per zone every year for trial. This inhibits competition," said Mr R.K. Sinha, Executive Director, All India Crop Biotechnology Association.

The proposed `event-based' regulatory system was discussed at GEAC's last meeting on May 22. "There was general consensus among all members, except ICAR, which has sought clarifications," the officials said.

59 GM hybrids approved

Till date, the Government has approved a total of 59 GM hybrids — all Bt cotton — for commercial release.

According to information compiled by Mr Bhagirath Choudhary of the International Service for the Acquisition of Agri-Biotech Applications (ISAAA), the 59 hybrids cover four different `events'.

These include the original `Bollgard' (technically called Mon-531) event developed by Monsanto, which has been incorporated in 44 out of the 59 hybrids. In addition, eight hybrids incorporate `Bollgard-II' (Mon-15985 event), which contains a stacked combination of cry1Ac and cry1Ab Bt genes.

Of the remaining seven, there are four hybrids expressing the cry1Ac gene construct developed by JK Agri Genetics Ltd (`Event-1') and three having the fused cry1Ac/cry1Ab construct (`GFM event') of Nath Seeds Ltd.

Out of the total 59 Bt hybrids, Maharashtra Hybrid Seed Company (Mahyco) and Rasi Seeds Ltd account for 14 each. The rest belong to Nuziveedu Seeds (four), JK Agri-Genetics (four), Ankur Seeds (three), Nath Seeds (three), Ajeet Seeds (three), Ganga Kaveri Seeds (three), Emergent Genetics (two), Pravardhan Seeds (two), Vikram Seeds (two), Krishi Dhan Seeds (two) and Vikki's Agrotech, Prabhat Agri Biotech and Tulsi Seeds (one each). - H.D.

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