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

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20 Bt Brinjal: The GEAC environmental risk assessmentProduct Quality of EE-1 Bt BrinjalConclusion 2. The EE-1 transgene may be a second-rate Bt brinjal product. EE-1 was probably produced inthe late 1980s or early 1990s, its control of BFSB is low, and other Cry toxins might perform better.During the late 1980s, Monsanto developed Event 531, the cry1Ac transgene in Bt cotton Bollgard I. This transgene wasformed from a plasmid with nptII and aad, which are marker genes for kanamycin and streptomycin resistance respectively (see,e.g., Zambryski 1992). During the early 1990s, Monsanto developed Event 15985, the cry2Ab transgene in Bt cotton BollgardII (McCabe and Martinell 1993). This transgene was formed by co-transformation with two plasmids. One contained nptIIand the other uidA, which was eliminated from the final product by segregation. During the early 1990s, Monsanto developedMon810, the cry1Ab transgene in Bt maize, Yieldgard (AGBIOS 2003). This transgene was formed by co-transformation withtwo plasmids. Segregation eliminated some of the undesired elements from the final product, which contained only nptII.More recent methods used by Monsanto produce transgenes with no antibiotic markers. Because EE-1 contains both nptII andaad, this suggests that it was produced by Monsanto sometime during the late 1980s or early 1990s, before Event 15985 andMon810.As will be reviewed below, efficacy of EE-1 is low. It provides only 73% control of BFSB in the MST field trials (Dossiervol. 6) and sometimes requires an insecticide application to control BFSB. BFSB is in the family Crambidae in the orderLepidoptera. Several other stem boring Crambids have been targeted for control by other Bt crops. These include Ostrinianubilalis (European corn borer), Diatraea grandiosella (southwestern corn borer), Diatraea saccharalis (sugar cane borer), andChilo partellus (spotted stemborer). Bt maize typically shows 100% control for all these Crambid species.There may be a better transgene than Ccry1A for control of BFSB. Mon810 is based on the Cry1Ab toxin, which affects thehigh level of control of Crambids. A comparison of susceptibility in O. nubilalis to Cry1Ab and Cry1Ac suggests that it is moresusceptible to Cry1Ab than Cry1Ac (Denolf et al. 1993, Marçon et al. 1999). Thus, it is possible that a more modern transgenebased on Cry1Ab would control BFSB better and reduce concerns associated with the marker genes.Given these considerations, it seems clear that the applicant (either Monsanto or Mahyco) has invested little in thedevelopment of a useful Bt brinjal product for India. Indeed, an inflammatory characterisation of the process so far would bea case of “transgene dumping.” It would seem in India’s best interest to require a modern transgene that exhibits much betterefficacy against BFSB. Such a request, if fulfilled, would eliminate several risk issues associated with inadequate transgenecharacterisation of EE-1 and would diminish other environmental risk issues, especially related to resistance evolution in BFSB.
Characterisation of Transgene 21Scientific Opinion on Regulatory ComplianceConclusion 3. The assessment does not comply with the Guideline for the Conduct of Food SafetyAssessment of Foods Derived from Recombinant-DNA Plants (Codex, 2003, CAC/GL 45-2003).Compliance to Codex (2003), Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNAPlants (Codex, 2003, CAC/GL 45-2003) is a complicated issue, and this report is not intended to address this issue in acomprehensive manner. Instead, the report focuses narrowly on scientific dimensions related to compliance to Codex (2003),In addition, this report does not evaluate whether or not the applicant has complied with the Indian regulations or the requestsof the Indian regulators.The justification for evaluating compliance to Codex (2003) from a scientific perspective lies in the statement:“The goal of each safety assessment is to provide assurance, in the light of the best available scientific knowledge, that thefood does not cause harm when prepared, used and/or eaten according to its intended use. (Codex 2003, paragraph 21, ouremphasis).”This section raises the issue of scientific standards for risk assessment. There are two reasonable standards that couldbe considered: (1) scientific knowledge that is commonly used by GMO regulatory authorities around the world and (2) newscientific knowledge that can be used for the evaluation of Bt brinjal. Standard (2) would imply that India be a leader in riskassessment and evaluate and adopt new approaches as they become available. Standard (1) only requires that India followregulatory practice that is commonly used. The purpose here is not to conduct a comprehensive analysis of how the presentassessment does not comply with Codex, but to provide a few illustrative examples, using the much lower and conservativestandard in (1). Under this standard, it takes only one instance of non-compliance to demonstrate non-compliance to Codex(2003). Here is presented two instances.Example 1. Information on the DNA insertions into the plant genome should include: “the organisation of the insertedgenetic material at each insertion site including copy number and sequence data of the inserted material and of the surroundingregion (Codex 2003, paragraph 31C).” Regulatory authorities in the USA, Canada, the European Union, and many othercountries require the DNA sequence of the inserted transgene and flanking regions. This information is not reported in EC-II,the Dossier or the Supplemental Materials.Example 2. “Information should be provided … to demonstrate whether deliberate modifications made to the amino acidsequence of the expressed protein result in changes in its post-translational modification or affect sites critical for its structure orfunction (Codex 2003, paragraph 33B).” Regulatory authorities in the USA, Canada, the European Union, and many othercountries require this information. EC-II and the Dossier report that there are several deliberate modifications made to theamino acid sequence of Ccry1A in the chimeric transgene, but neither provides any information to evaluate potential changes inpost-translational modification. In addition, neither document provides information to evaluate their claims that the amino acidmodifications do not affect sites critical for determining the structure or function of Ccry1A.
Page 1 and 2: Table of Contents 1Bt Brinjal Event
Page 3 and 4: Table of Contents iBt Brinjal:The s
Page 5 and 6: Summary and Conclusion 1Summary an
Page 7 and 8: Summary and Conclusion 3The EE-1 t
Page 9 and 10: Summary and Conclusion 5Event EE-1
Page 11 and 12: Summary and Conclusion 7Conclusion
Page 13 and 14: Context and Need 9standards for ER
Page 15 and 16: Context and Need 11and seek to incr
Page 17 and 18: Context and Need 13the reported yie
Page 19 and 20: Characterisation of Transgene 15Cha
Page 21 and 22: Characterisation of Transgene 17wor
Page 23: Characterisation of Transgene 19In
Page 27 and 28: Environmental Risk Assessment 23Gen
Page 29: Environmental Risk Assessment 25thi
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Sunray HarvestersBungalow 69Mhow Ca
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