Bt Brinjal The scope and adequacy of the GEAC environmental risk assessment

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60 Bt Brinjal: The GEAC environmental risk assessmentSequencing the Needed RiskAssessment ActivitiesAlthough the GEAC and Mahyco have already invested considerable time and effort into environmental risk assessment (ERA)for EE-1 hybrid Bt brinjal, much of the effort was misdirected and did not assess actual adverse environmental consequencesin India. The needs for ERA that are outlined here are developed with an eye towards improving oversight of geneticallyengineered crops in India, and redirecting efforts to issues that actually matter to India.Addressing these needs will provide a sound scientific basis for assessing these more serious issues. The needs are compiledhere in abbreviated form from the separate sections above, listed according to section and preserving the original numberingfor easier cross-reference. An expanded description including some rationale is provided in the previous sections, which theinterested reader may consult.Characterisation of Transgene – Inserted Transgene1. Probe sensitivity. Provide the size and sequence of the Bt probe and identify the part of the transgene to which it isexpected to bind.2. Transgene number. Use additional probes to explore for incorporated transgene fragments associated with other parts ofthe brinjal genome.3. Transgene sequence. Sequence the inserted transgene and any other inserted fragments identified in 1) and 2).4. Flanking regions. Sequence the regions flanking the inserted transgene (and transgene fragments).5. Gene disruption. Identify the brinjal DNA in the flanking regions and determine if it is associated with a potentiallyfunctioning brinjal gene.Characterisation of Transgene – Transgene Expression1. Amino acid sequence. Provide the amino acid sequence of the expressed Ccry1A protein.2. Ccry1A expression. Quantify expression levels of Ccry1A in pollen.3. Marker expression. Quantify expression levels of antibiotic marker genes.4. Heterologous system. Develop a heterologous expression system to produce sufficient quantities of Ccry1A that can beused for risk assessment research.Environmental Risk Assessment – Gene Flow and Its Consequences1. Fitness of intraspecific hybrids and backcrosses. Quantify the relative fitness of hybrids and backcrosses between Bt brinjaland brinjal landraces, and between Bt brinjal and intraspecific wild relatives, such as S. melongena insanum.2. Identification of wild relatives. Determine if there are additional species of Leptostemonum that occur in India.3. Hybridisation. Determine which identified wild relatives are known not to hybridise with brinjal.4. Overlap. For the species that remain from 3), determine overlap of flowering time and geographic distribution withbrinjal.5. Cross-compatibility. For species with potential overlap, experimentally evaluate cross-compatibility and explainingexperimentally any discrepancies with previously published results.6. Fitness of interspecific hybrids and backcrosses. For cross-compatible species, quantify the relative fitness of hybrids andbackcrosses between Bt brinjal and these species.7. Gene flow rates. Additional gene flow experiments are not recommended.8. Identify pests of wild relatives. Determine whether brinjal fruit and shoot borer (BFSB) or other susceptible lepidopteranspecies feed on wild or weedy relatives of brinjal.
Sequencing the Needed Risk Assessment Activities 619. Fitness advantage of Bt transgene. If lepidopteran larvae are on these wild or weedy relatives, determine whether a Bttransgene could enhance the survival or fecundity of wild/weedy plants.10. Quantification of fitness advantage. If there is a fitness advantage of the Bt transgene, determine if it is enough to increaseweediness, reduce genetic diversity of wild relatives, or have unwanted effects on non-target lepidopteran insects.Environmental Risk Assessment – Risks to Biological Diversity1. Kinds of risks to biological diversity. Determine the kinds of risks to biological diversity that are important for India inthe use of Bt brinjal. Possibilities are: increased secondary pests; reduced soil quality or health; reduced value of non-cropeconomic activities; reduced cultural value; increased conservation concern; and reduced environmental quality.2. Specify risk hypotheses. Specify scenarios (aka risk hypotheses) by which the kinds of risks listed in 1 could occur inIndia.3. Test risk hypotheses. Test the risk hypotheses either to falsify them (and conclude that there is insignificant risk) orestimate the risk (qualitatively or quantitatively).4. Secondary pests. Prioritise key secondary pests and natural enemies and conduct experiments to determine the risk ofsecondary pest outbreaks.Environmental Risk Assessment – Resistance Risk in Target Species1. Develop resistance monitoring method. Develop and implement a pedigreed F1 screen.2. Prioritise resistance management tactics. Evaluate and prioritise alternative resistance management tactics usingmathematical models.3. Determine scale of monitoring. Determine appropriate spatial scale for monitoring.4. Find resistance. Discover resistance alleles in BFSB.5. Parameter estimation. Estimate biological parameters relevant to resistance evolution. These include plant-to-plantmovement of larvae, movement of male and female adults, density-dependent larval mortality, and average fecundity.6. Farmer acceptance of tactics. Determine if brinjal farmers are willing to plant a non-Bt refuge on their farms or implementother tactics.7. Monitor compliance. Physical surveys of farmers using Bt brinjal should be conducted to determine if they are using theresistance management tactics.Socioeconomic Analysis1. Brinjal yield gap. Compile scientific literature on yield gaps for brinjal.2. Returns to alternatives. Estimate net economic returns from traditional, local, and organic practices to limit damage fromBFSB.3. Economic security. Assess the effect of hybrid Bt brinjal on the short- and long-term economic security of large-scalecommercial farmers and small-scale resource-poor farmers.4. Non-utilitarian values. Assess the indirect effects of Bt brinjal on human health, religion and culture.5. Large-scale indirect effects. Assess risks associated with indirect loss of brinjal biological diversity, and government plansto expand the vegetable export market.6. Rapid response capacity. Evaluate the capacity of the Indian extension service to respond quickly to production demandsthat will appear soon after hybrid Bt brinjal is commercialised.This may seem a daunting list of needs for an adequate ERA. However, if these issues had been addressed in a timely fashion,the actual workload at any one time is not that great. In addition, if some of the ERA issues had been considered earlier, theycould have influenced how a developer of a genetically engineered plant would have proceeded.The needs are analysed according to three qualitative criteria. First, in what kind of environment can the work be done?Environments vary from very artificial to realistic of brinjal production. Four environments are distinguished for this report:
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