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

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ii Bt Brinjal: The GEAC environmental risk assessmentPrefaceOn 14 October 2009 the Bt Brinjal Expert Committee IIReport (EC-II), dated 8 October 2009 was tabled at the97th Meeting of the apex Regulator, the GEAC (GeneticEngineering Appraisal Committee). The GEAC acceptedthe recommendations of the EC-II and approved thecommercialisation of Bt brinjal, Event EE1 developed by: TheMaharashtra Hybrid Seeds Company Ltd. (Mahyco), Mumbai,a subsidiary of Monsanto Company, and the University ofAgricultural Sciences (UAS), Dharwad and Tamil NaduAgricultural University (TNAU), Coimbatore.On 15 October 2009, the MOS, (Minister of State),Independent Charge, (MoEF (Ministry of Environment andForests), the Honourable Shri Jairam Ramesh, intervenedto stop the approval process of Bt brinjal because of thenationwide criticism of the EC-II and the apparent haste withwhich the GEAC gave its assent. The Minister instituted aprocess by which he invited documented responses to theEC-II. The Minister also contacted the United States NationalAcademy of Sciences (US-NAS) for a scientific evaluation ofthe EC-II. The research arm of the US-NAS organised andsolicited comment from a small group of about 10 notedUS scientists, including the author of this report, who areinternationally-acknowledged experts on the environmentalrisks of genetically engineered crop plants. The US-NASis held in great esteem by its ability to generate balanced,objective scientific comment to complex social controversies,injecting logic and structure to help policy makers betterunderstand the issues and take more reasoned decisions.The author of this report along with other solicited scientistssubmitted such comments to the Minister, which were dulyincluded among the responses he received to his invitation.Minister Jairam Ramesh’s initiative is unique, and the globalresponse he received is also unique. The global scientificcommunity responded to his invitation with an outpouring ofcomment, significant both in number and quality. Together,these provided a searching critique of Mayhco’s Bt brinjalbio-safety dossier and the EC II Report. Such a response isastonishing because it is based purely on altruistic concerns –none of the commenting scientists received compensation fortheir efforts – but it reflects the importance of the implicationsof releasing the world’s first major GM food crop, the brinjaland in a centre of diversity and origin of that crop.On 9 February 2010, Jairam Ramesh declared a moratoriumon the commercial approval of Bt brinjal, citing the need forfurther safety testing.This Report is the outcome of a series of discussions withseveral scientists, at the request of Aruna Rodrigues, LeadPetitioner to the Supreme Court, following the moratoriumon Bt brinjal called by Minister Jairam Ramesh. The aim ofthose discussions was to provide a comprehensive appraisal ofthe bio-safety impacts of Bt brinjal and the regulatory protocolsthat were used by the GEAC. In a meeting in Delhi during19-21 February 2010, it was decided that the author with theassistance of Dr. G. K. Veeresh would present an analyses ofthe EC-II assessment of the environmental effects of Bt brinjal.This is expected to be the first of two appraisals of EC-II tobe produced during 2010. The other analysis is expected toaddress the human and animal health effects of Bt brinjal, andwill be undertaken by other scientists. An initial draft of thisreport was completed in March 2010.This report, “Bt Brinjal: The scope and adequacy of theGEAC environmental risk assessment,” addresses thescientific issues related to the risk assessment and moratoriumon Bt brinjal. The experiences of the author during the19-21 February 2010 meeting in Delhi and subsequent studyof the scientific literature relevant to the issue has deepened,broadened, and increased verisimilitude of the originalcomment submitted by the author to Minister Jairam Rameshvia the US-NAS. The value of the many scientific submissionsto the Minister and subsequent deliberations will only berealised if they help guide the emergence of a comprehensiveand accurate bio-safety regulatory protocol in India for Btbrinjal and other GM crops. This report is designed toexamine and assess EC-II and associated materials to highlightareas where the regulatory protocols can be improved withrespect to environmental impacts.I would like to thank Dr. G. K. Veeresh, Association forthe Promotion of Organic Foods, Bangalore, and formerlyVice Chancellor of the University of Agricultural Sciences,Bangalore for his many insightful observations about vegetableproduction in India, extensive comment on early drafts of thisreport and assistance in acquiring some of the publicationscited herein. I also acknowledge with gratitude critical reviewsof parts of this report from Professor Norman Ellstrand,University of California, Riverside, Professor Allison Snow,The Ohio State University, Dr. Douglas Gurian-Sherman,Union of Concerned Scientists, and Dr. Jack Heinemann,University of Canterbury. I thank Dr. Gabor Lövei, DanishInstitute for Agricultural Science, University of Aarhus forstimulating discussions that helped my thinking about valuesand Professor Paul B. Thompson, Michigan State Universityfor some comments that lead to the framing of this report.Finally, I thank Aruna Rodrigues whose efforts brought forththis report and whose comments helped focus and clarifyit. All this attention considerably improved this report, butresponsibility for its content and faults rests with the author.David A. AndowSt. Paul, MN, USAAugust, 2010
Summary and Conclusion 1Summary and ConclusionThis report evaluates the scope and adequacy of the environmental risk assessment (ERA) for hybrid EE-1 Bt brinjal requestedby the Genetic Engineering Approval Committee (GEAC) in response to the Maharashtra Hybrid Seeds Company Ltd.,Mumbai (Mahyco) application for permission to commercialise hybrid EE-1 Bt brinjal. The assessment is reported in the Report ofthe Expert Committee (EC-II) on Bt Brinjal Event EE-1. Event EE-1 expresses a genetically engineered crystalline (Cry) proteintoxin from the soil bacterium Bacillus thuringiensis Berliner (Bt). The Cry toxin is similar but not identical to Cry1Ac. It isa chimeric protein of Cry1Ac and Cry1Ab, and designated Ccry1A in this report. EE-1 was inserted into improved brinjalhybrids, which are modern cultivars of Solanum melongena L. [Solanaceae: Leptostemonum]. It was developed to control thebrinjal fruit and stem borer, Leucinodes orbonalis Guenee [Lepidoptera: Crambidae], which is abbreviated BFSB in the rest ofthis report. This report does not address the potential risks of hybrid Bt brinjal as human food or animal feed, and does notfully analyse the need for, requirements of, and methodologies for post-commercialisation monitoring of hybrid Bt brinjal.The report is based on an analysis of EC-II, the eight volumes of supporting information to the EC-II, which are referred to asthe Dossier in the rest of this report, Supplemental Materials submitted to the GEAC by Mahyco, which comprise 13 technicalreports, and publicly available scientific literature on Bt brinjal, BFSB and brinjal.The main thesis of the report is that the GEAC set too narrow a scope forenvironmental risk assessment (ERA) of hybrid Bt brinjal, and it is because ofthis overly narrow scope that the EC-II is not an adequate ERA.Context and NeedThis report holds the EC-II environmental risk assessment (ERA) to the standard of assessing outcomes about concreteenvironmental risks of Bt brinjal, and does not dwell much on the more narrow concern of whether the EC-II ERA meets theregulatory standards of the GEAC. By doing so, this report points out where the scope of the EC-II ERA is too narrow andchallenges the adequacy of the ERA framework established by GEAC and under which Bt brinjal has been assessed. At manypoints in this report, the EC-II is criticised not for whether it has accomplished what it set out to do, but whether it set outto do the right thing in the first place. Such errors of omission are sometimes invisible, especially when everyone focuses onpotential errors of commission. However, these omissions are probably more critical for India, in that serious concerns are leftunexamined.Brinjal plays a unique role in Indian society, and it will be important to evaluate if and how Bt brinjal may affect these values.Brinjal is one of the most important vegetable crops in India, especially for the rural and urban poor. About 61% is grown inthe three eastern states of West Bengal, Orissa and Bihar by small-scale resource-poor farmers. These States have banned theuse of Bt brinjal. India is the centre of the world’s biological diversity in brinjal with over 2500 varieties grown in the country.Some local varieties have significant religious and cultural value.EE-1 Bt brinjal is proposed as a hybrid, and is unlikely to fit well in the small-scale production systems relying on openpollinatedvarieties (OPVs) of brinjal. For small-scale resource-poor farmers it is critical for creating economic security, primarilyby facilitating cash flow, insuring against income variation from other crops, and providing families with needed food andnutrition. It may fit in large-scale commercial brinjal production systems that already use brinjal hybrids. Brinjal is producedfor net income by large-scale commercial producers.
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Bt Brinjal The scope and adequacy of the GEAC environmental risk assessment

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