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Crop Biotech Update

India Operationalizes Event Based Approval Mechanism

March 27, 2009

Taking into consideration recommendations for streamlining the current regulatory approval process for GM crops, an "Event Based Approval Mechanism" was adopted in respect of Bt cotton hybrids expressing approved events in the Genetic Engineering Approval Committee (GEAC) meeting held on 2 April 2008.

The Ministry of Environment and Forest (MoEF) recently notified a new procedure for commercial release of Bt cotton hybrids expressing approved events called "Event Based Approval Mechanism (EBAM)" while considering the approval of a new mechanism by the GEAC in its meeting held on 14 Jan 2009. This mechanism will be applicable to new cotton hybrids expressing four approved events including MON531 (cry1Ac gene) and MON15985 (cry1Ac and cry2Ab genes) of Mahyco-Monsanto, Event-1 (cry1Ac gene) of JK Agri-Genetics and GFM Event (cry 1 Ab + cry Ac genes) of Nath Seeds.

The approval mechanism which is initially applicable to approved cotton events, will speed up the introduction of new GM crops to the country without compromising biosafety and environmental safety. In 2008, 274 Bt cotton hybrids expressing four approved events were marketed by 30 indigenous seed companies throughout India. ISAAA estimates that a record 50 lakh small and resource-poor farmers planted these Bt cotton hybrids over 7.6 million hectares, or 82% of the total area under cotton, making India the fourth largest adopter of biotech crops in the world. It is noteworthy that for the seven-year period, 2002 to 2008, there was a 150-fold increase in Bt cotton in India, which is more than twice the 74-fold increase in global biotech crops during the 13-year period 1996 to 2008.

For more information about the "New Procedure for Commercial Release of Bt Cotton Hybrids Expressing Approved Events" visit http://www.envfor.nic.in/divisions/csurv/geac/New%20procedure%20under%20EABM.pdf For more information about biotech development in India contact: b.choudhary@cgiar.org and k.gaur@cgiar.org