Management of the Diamondback Moth and Other Crucifer Insect ...

egulatory approval and authorization for commercialrelease. Concern focused particularly around the liabilityfor unauthorized release, both in India during the nationalagronomic trials process run by ICAR and theAgricultural Universities, and through the unauthorizedmovement of seeds into counties in which they were notapproved and indeed which may have no approvalsprocess in place. In addition to seeking biosafety andgrowing approval in India, CIMBAA planned to seekimport approval in USA, Canada, Europe and Japan andcultivation approval in ‘second tier’ countries – such asBangladesh and the Philippines. Synchronizing theseapprovals with the registration process in India wasclearly going to be a very major challenge.Regulatory challenges and the Bteggplant experienceCIMBAA also had to consider the lack of progress withthe Maharashtra Hybrid Seed Company (Mahyco)Cry1Ac Bt eggplants in India, which had also been donorsupported, in particular by USAID. These plants had metall the regulatory requirements for approval and release,including the nation-wide agronomic testing of thetransformed material by mid 2009. The company hadmade breeding material available to AgriculturalUniversities and indeed to Bangladesh and thePhilippines. In late 2009 the decision on whether torelease the Bt eggplants was passed to the Minister ofEnvironment and Forests. He called for extensive publicconsultation over the following few months, ending inthe decision in Feb 2010 to delay any release pendingundefined further studies and setting up further reviewcommittees. The nature of these studies has not beendefined subsequently nor have the committees reported.For CIMBAA this made the regulatory environmenthighly uncertain, given the commercial rule of thumbthat ever year of delay in commercialisation of a newagricultural product knocks 10% of the net present valueof the product. The fact that plants containing Cry1Bprotein have not yet been commercialised anywhere andthat Bt cabbage would be the first GM food product to beconsumed raw, might trigger additional unforeseenregulatory hurdles.It became clear that the uncertainties in timelines andregulatory constraints made in extremely difficult toforecast the financial and human resources necessary tocomplete the program.DISCONTINUATIONTaking all these factors into account, a meeting of theCIMBAA Steering Committee in May 2010 agreed that,in the current uncertain climate, there was little choicebut to discontinue the development of the CIMBAAplant lines. In order to ensure that there was nounauthorized removal of plant material, all growing Btplants in India were destroyed in mid May with thestakeholders and regulators informed immediatelyafterwards. Small quantities of seeds of the Elite lines,the hybrids created from them, plus back-up lines arenow held only with Bayer Crop Science in Europe.Next stepsThe Indian Council for Agricultural Research has comeforward with a willingness to take full responsibility forthe CIMBAA material. However, it is private sectorpartner’s understanding that the CIMBAA plant materialcannot be made available to other developers as theresponsibility for the GM plant material will be linked tothe company as the developer of the plants, althoughthere are other views on the transferability of ownershipand with it liability. In any event ICAR and Bayer CropScience are discussing the production of a slightly alteredcry1B/cry1C gene construct to be wholly held in thepublic sector (ICAR) and used to transform importantcrop brassicas for eventual approval and release. Thearrangement may include rights to transformation in kale,with ICAR interested in facilitating its use in Africa.CONCLUSIONTechnically the CIMBAA program has been a greatsuccess, with complete, and most likely sustainable,control of diamondback moth, cabbage cluster caterpillarand cabbage webworm, the three most important pestspecies across large parts of the world. It is likely thatcabbage white butterfly would also be completelycontrolled in the open field. Although some damage fromleaf worm and especially cotton bollworm, might beexpected, these species are well controlled by theirspecies-specific NPVs. No significant scientific obstaclesto the successful registration of the CIMBAA material inIndia were seen. The Elite Events for commercializationwere selected and stakeholder support was high.However, in the current climate of over-regulation of Btcrops and excessive liability regimes, it seems unlikelythat public/private partnerships working on minor cropsfor the benefit of small farmers and consumers in poorercountries are going to be able to succeed. Using the reengineeredBt construct which is expected to beproduced for ICAR, will take at least four years ofbreeding, testing and selection before we again have highquality Bt lines ready for regulatory studies. There isalready a proposal to stack RNAi control of aphids withthe cry1B/1C Bt genes to produce the next generationplants.AcknowledgementsCIMBAA is a large program with many partners but theauthors would like to particularly acknowledge thefinancial support (in various combinations and over nineyears) of USAID’s Program for Biosafety Systems, theDepartment for International Development (UK), theDepartment of Biotechnology, India, the AustralianDepartment of Industry Innovation and ScientificResearch, the Council of Agriculture of Taiwan and theEiselen Foundation. Important contributions to the workreported here were made by A. Shelton of CornellUniversity; R. Srinivasan and K. Weinberger of26 AVRDC - The World Vegetable Center