38 <strong>Bt</strong> <strong>Brinjal</strong>: <strong>The</strong> <strong>GEAC</strong> <strong>environmental</strong> <strong>risk</strong> <strong>assessment</strong>• grey weevil,• little leaf wilt,• Fusarium wilt, <strong>and</strong>• root-knot nematodes ( Meloidogyne spp.).<strong>The</strong> Dossier (volume 6) reports on limited field trials where <strong>the</strong>se potential secondary pests were counted. As discussedin <strong>the</strong> text above, <strong>the</strong>se limited trials provide little useful information about potential secondary pest status. To generate moreuseful data, <strong>the</strong> list <strong>of</strong> potential secondary pests should be prioritised so that <strong>the</strong> most serious potential secondary pests areidentified. This can be done using multi-criteria decision analysis (MCDA; Fenton <strong>and</strong> Neil 2001, Dodgson et al. 2009), asdemonstrated in Nguyễn et al. (2008). Several factors are probably involved in releasing secondary pests, including release frominsecticides, release from competition, <strong>and</strong> so on. <strong>The</strong>se factors can be evaluated for each <strong>of</strong> <strong>the</strong> high priority species identifiedin <strong>the</strong> MDCA.A similar approach can be used to identify potentially significant biological control agents (farmer’s friends) that could bedestabilised by <strong>Bt</strong> brinjal. This analysis, however, may be unlikely to identify many potentially significant c<strong>and</strong>idates becausebrinjal fields are sprayed with insecticides so many times that few biological control agents are likely to persist in brinjal fields.This fact, however, indicates that a significant biological control agent might be one that colonises brinjal rapidly from sourcesoutside <strong>of</strong> brinjal fields.Resistance Risk in Target SpeciesConclusion 7. <strong>The</strong> evolution <strong>of</strong> resistance in BFSB (Leucinodes orbonalis) to overcome <strong>Bt</strong> brinjal is a real <strong>risk</strong>that must be managed. EC-II does not acknowledge this <strong>risk</strong> <strong>and</strong> <strong>the</strong> Dossier does not propose effectivemeans to manage it.<strong>The</strong> evolution <strong>of</strong> resistance is a real <strong>risk</strong> that is widely acknowledged worldwide (Gould 1998, Tabashnik et al. 2008), includingin developing countries (Fitt et al. 2008) <strong>and</strong> India (Hanur 2008). Every regulatory authority that can claim <strong>scope</strong> over this issuehas chosen to regulate this <strong>risk</strong>, typically by imposing post-commercialisation restrictions on <strong>the</strong> use <strong>of</strong> <strong>Bt</strong> crops to manage <strong>the</strong>evolution resistance in BFSB. Resistance can cause many kinds <strong>of</strong> adverse effects (Box 9). For <strong>Bt</strong> brinjal, <strong>the</strong>se adverse effectsmay be (a) loss <strong>of</strong> whatever benefits <strong>Bt</strong> brinjal provides by controlling BFSB, leaving society to bear only <strong>the</strong> <strong>risk</strong>s associated with<strong>Bt</strong> brinjal. (2) Harm to brinjal farmers who use Bacillus thuringiensis-based insecticides to control BFSB. Presently, microbialapplications <strong>of</strong> B. thuringiensis are being encouragedfor use in pest control in India because this is much Table 3. Possible methods for delaying <strong>the</strong> evolution <strong>of</strong> resistance to a <strong>Bt</strong>crop in target pestssafer for human health than <strong>the</strong> syn<strong>the</strong>tic insecticidesbeing used. Resistance could make farmers more MethodGoalMeansreliant on syn<strong>the</strong>tic chemical insecticides. InEnsures survival <strong>of</strong>RefugeDelays resistanceaddition, some <strong>of</strong> <strong>the</strong> local insecticide technologiessome susceptible peastsmay incorporate B. thuringiensis. If resistance to <strong>Bt</strong>Kills heterozygousHigh doseDelays resistancebrinjal occurs, <strong>the</strong>se o<strong>the</strong>r farmers may find it moreresistant pestsdifficult to control BFSB, increasing <strong>the</strong>ir control Seed mixtures <strong>of</strong> <strong>Bt</strong>Ensures survival <strong>of</strong><strong>and</strong> non - <strong>Bt</strong> seedDelays resistancesome susceptible pestscosts or reducing <strong>the</strong>ir brinjal yields.In <strong>the</strong> following we evaluate potential ways toMay kill homozygousGene pyramiding Can delay resistanceresistant pestsmanage this <strong>risk</strong>. Some <strong>of</strong> <strong>the</strong> steps that have beenSuppresses homozygousused by o<strong>the</strong>r regulatory authorities to determine IPMCan delay resistanceresistant pest populationshow to manage resistance include: determining <strong>the</strong>Replace with new Respond toProvides new mode“dose” <strong>of</strong> <strong>the</strong> transgene, estimating <strong>the</strong> frequencytoxin genesresistance failure <strong>of</strong> toxicity<strong>of</strong> resistance alleles in <strong>the</strong> target population prior
Environmental Risk Assessment 39BOX 9Adverse Consequences <strong>of</strong> Resistance <strong>and</strong> Benefits <strong>of</strong> Managing ResistanceResistance in insects to pest control is a serious problem worldwide. Although resistance problems have been knownfor nearly 100 years, resistance became a significant agricultural problem after World War II, when modern, intensiveagricultural technologies proliferated. Resistance has occurred quickly when <strong>the</strong>re has been strong, uniform selection ona pest population for sufficiently long periods <strong>of</strong> time over spatially extensive areas. Modern intensive agriculture, with itsreliance on pesticides, monoculture <strong>and</strong> uniform production practices has provided <strong>the</strong>se conditions, <strong>and</strong> resistance hasproliferated. It took most <strong>of</strong> <strong>the</strong> 20th century before an entomological consensus was reached about <strong>the</strong> seriousness <strong>of</strong> <strong>the</strong>problem (NRC, 1986). Resistance to <strong>Bt</strong> toxins has been documented in 17 insect species (Tabashnik, 1994; Huang et al.,1999), so it is now widely assumed that resistance to transgenic insecticidal crops, such as <strong>Bt</strong> brinjal can occur.• Insecticide use. In <strong>the</strong> USA alone, resistance costs about US$133 million/ year in extra insecticide applications,measured in 1980 dollars (Pimentel et al., 1980). Unexpected yield losses from resistance have not been estimated, butare likely to be a similar amount. In nor<strong>the</strong>astern Mexico <strong>and</strong> <strong>the</strong> Lower Rio Gr<strong>and</strong>e <strong>of</strong> Texas, resistance to insecticidescaused about 700,000 acres <strong>of</strong> cotton to be lost (Adkisson, 1971; 1972), devastating many local communities, some <strong>of</strong>which have never recovered.• Farm income. Effective management <strong>of</strong> resistance will allow farmers to benefit from a transgenic insecticidal crop for along period <strong>of</strong> time. For example, <strong>Bt</strong> maize can increase net income to farmers <strong>of</strong> US$10-60/ha (Rice <strong>and</strong> Pilcher, 1998).Resistance would mean loss <strong>of</strong> this income which would have significant detrimental effects on farm families. <strong>Bt</strong> maize,however, can also result in no yield increase, <strong>and</strong> a farmer can lose US$35/ha.• Seed company. Resistance will harm companies that sell transgenic insecticidal crops. However, if pr<strong>of</strong>its <strong>of</strong> seedcompanies were <strong>the</strong> only reason for managing resistance, <strong>the</strong>re would be no need for society to intervene. However, seedcompanies are only one <strong>of</strong> <strong>the</strong> many stakeholders, <strong>and</strong> <strong>the</strong>ir concerns do not match <strong>the</strong> concerns <strong>of</strong> <strong>the</strong> o<strong>the</strong>r importantstakeholders, including consumers <strong>and</strong> farmers, hence <strong>the</strong> need to regulate resistance.• O<strong>the</strong>r farmers. Resistance may harm o<strong>the</strong>r farmers who depend on <strong>Bt</strong>-based insecticides <strong>and</strong> do not or will not usetransgenic insecticidal <strong>Bt</strong> crops.• Pesticide regulation. Resistance destabilizes pesticide regulation. For example, <strong>the</strong> USA Environmental ProtectionAgency (EPA) normally registers pesticides only after in-depth <strong>risk</strong> <strong>assessment</strong> <strong>and</strong> review. A large loophole is thatunregistered pesticides can be used under an emergency exemption with very little review. During 1991-1994, about 30% <strong>of</strong> all emergency exemptions requests were made because <strong>of</strong> resistance (Matten et al., 1996). With effective resistancemanagement, <strong>the</strong> need for emergency exemptions could be significantly reduced.to commercialisation, characterise <strong>the</strong> genetic structure <strong>of</strong> <strong>the</strong> target population, measure <strong>the</strong> distances adults will move beforemating, develop <strong>and</strong> test practicable management practices that farmers can implement, <strong>and</strong> so on.Several approaches have been suggested to delay <strong>the</strong> evolution <strong>of</strong> resistance (Table 3). Some are known to delay resistance,while o<strong>the</strong>rs can delay resistance when <strong>the</strong> circumstances are right (Table 3). Replacing an old toxin with a new one is aresponse to resistance failure, <strong>and</strong> is not a method to delay resistance. O<strong>the</strong>r approaches that are not listed here are speculative,<strong>and</strong> it is not known if <strong>the</strong>y can delay resistance evolution. Of <strong>the</strong> methods that are known to delay resistance, <strong>the</strong> high dose/refuge strategy has been highly successful. Seed mixtures are better than no strategy, but not as effect as a refuge strategy.Rotation <strong>of</strong> different <strong>Bt</strong> varieties is not feasible because two different <strong>Bt</strong> transgenes are not even being considered. Rotationwith o<strong>the</strong>r varieties containing EE-1 does not delay resistance at all. Tissue-specific expression <strong>and</strong> temporary expression <strong>of</strong> a <strong>Bt</strong>transgene have not even been developed, so <strong>the</strong>y are not practical approaches to resistance management.<strong>The</strong> proposed insect resistance management (IRM) plan for <strong>Bt</strong> brinjal <strong>and</strong> BFSB is described in Vol. 8 <strong>of</strong> <strong>the</strong> Dossier.When evaluating an IRM plan, it is critical to determine if <strong>the</strong> IRM plan will delay <strong>the</strong> evolution <strong>of</strong> resistance <strong>and</strong> <strong>the</strong> onset