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PERSPECTIVES Economic & Political Weekly EPW july 30, 2011 vol xlvi no 31 31 Esha Shah ([email protected]) is with the Department of Technology and Society Studies, Maastricht University, The Netherlands. ‘Science’ in the Risk Politics of Bt Brinjal Esha Shah Drawing on the literature on controversies, especially on the health risk assessment of genetically modified organisms in Europe, and long-standing debates in science and technology studies, this article argues that science-based risk assessment has inherent limitations, however rigorous, independent, and peer reviewed the work may be. In this context, the debate on Bt brinjal needs to broaden its frame from science-based assessment of consequences to evaluate society-oriented causes and objectives. We need to ask questions such as: What kind of society do we wish to live in? What kind of science and technology do we want? Who sets the agenda for science and technology development and who controls the science and technological decisions? S cience is the main actor and even the stage upon which the recent controversy about the genetically modified brinjal, Bt brinjal is unfolding. Civil society organisations and represent- atives, independent scientists and citizens (henceforth civil society actors – CSAs), have displayed commendable vigilance and the Ministry of Environment and Forests ( MOEF )’s response too has been com- mendable in applying precautionary prin- ciples. However, when it comes to the pub- lic debate on genetically modified organ- isms ( GMOs) not only has the risk assess- ment acquired overwhelming importance but the only player imbued with any sig- nificant agency in the risk assessment seems to be science. In this essay, drawing from the literature on similar controver- sies in other parts of the world, especially on the health risk assessment of GMOs in Europe, and drawing from long-standing debates in science and technology studies ( STS ), I intend to show that the science- based risk assessment has inherent limita- tions, however rigorous, independent, and peer-reviewed it might be. Below is a brief recount of the course of events. After six years of development of Bt brinjal, in 2006 the Maharashtra Hy- brid Seeds Company popularly known as Mahyco submitted biosafety and efficacy data to the Genetic Engineering Approval Committee ( GEAC) and applied for permis- sion to conduct large-scale trials. At the same time the Supreme Court issued a ban on the ongoing field trials of Bt brinjal responding to the public interest litigation ( PIL) filed by civil society representatives. The GEAC then constituted an expert committee (now known as expert committee – I ( EC-I )) to look into the concerns raised by several civil society actors. The EC-I reviewed the biosafety data already submitted by Mahyco as also the concerns raised by civil society organisations and independent scientists and submitted its report in 2007. It per- mitted large-scale field trials but also rec- ommended that seven more studies on biosafety and socio-economic aspects be carried out mainly to reconfirm the data already generated during the confined multi-location trials. Accordingly, the Supreme Court lifted the ban on field trials. In 2009, the results of the large-scale trials were submitted to the GEAC at the same time that a number of national and inter- national scientists, civil society represent- atives, and citizens also submitted their concerns to the GEAC (actually to the MOEF to which the GEAC reports). It might be noted here that out of the 18 scientists from abroad – several of them well known in their fields – who made submissions to MOEF, only eight supported Bt brinjal. The rest were critical of it. There were 26 sub- missions from scientists in India, 16 in support and 10 opposing. The GEAC consti- tuted a second expert committee ( EC-II ) to review the adequacy of biosafety and effi- cacy data and also to look into the con- cerns raised by the civil society organisa- tions and independent scientists. In Octo- ber 2009, the EC-II submitted its report based upon which the GEAC approved the environmental release of Bt brinjal. How- ever, responding to the strong opposition expressed by civil society actors the Min- ister of State for Environment and Forests, Jairam Ramesh, announced a nationwide series of public consultations in January 2010. Based on these consultations held in seven cities, he declared a moratorium on Bt brinjal in February 2010. From the start the protocol and man- date of the GEAC seems to have been to produce biosafety and efficacy “data” on the impact of Bt brinjal on human health and environment. The GEAC and, for that matter, the MoEF have framed the prob- lem of GM food in such a way that it can be solved only with science-based risk assess- ment. As a result, the approval processes are heavily hinged on the risk science des- pite the fact that civil society actors have time and again questioned this narrow mandate of the GEAC. Imprisoned by this narrow mandate, an overwhelming majority of a wide range of issues raised by the civil society actors also concern the nature of

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  • PERSPECTIVES

    Economic & Political Weekly EPW july 30, 2011 vol xlvi no 31 31

    Esha Shah ([email protected]) is with the Department of Technology and Society Studies, Maastricht University, The Netherlands.

    Science in the Risk Politics of Bt Brinjal

    Esha Shah

    Drawing on the literature on controversies, especially on the health risk assessment of genetically modified organisms in Europe, and long-standing debates in science and technology studies, this article argues that science-based risk assessment has inherent limitations, however rigorous, independent, and peer reviewed the work may be. In this context, the debate on Bt brinjal needs to broaden its frame from science-based assessment of consequences to evaluate society-oriented causes and objectives. We need to ask questions such as: What kind of society do we wish to live in? What kind of science and technology do we want? Who sets the agenda for science and technology development and who controls the science and technological decisions?

    Science is the main actor and even the stage upon which the recent controversy about the genetically modified brinjal, Bt brinjal is unfolding. Civil society organisations and represent-atives, independent scientists and citizens (henceforth civil society actors CSAs), have displayed commendable vigilance and the Ministry of Environment and F orests (MOEF)s response too has been com -mendable in applying precautionary prin-ciples. However, when it comes to the pub-lic debate on genetically modified organ-isms (GMOs) not only has the risk assess-ment acquired overwhelming importance but the only player imbued with any sig-nificant agency in the risk assessment seems to be science. In this essay, drawing from the literature on similar controver-sies in other parts of the world, especially on the health risk assessment of GMOs in Europe, and drawing from long-standing debates in science and technology studies (STS), I intend to show that the science-based risk assessment has inherent limita-tions, however rigorous, independent, and peer-reviewed it might be.

    Below is a brief recount of the course of events. After six years of development of Bt brinjal, in 2006 the Maharashtra Hy-brid Seeds Company popularly known as Mahyco submitted biosafety and efficacy data to the Genetic Engineering Approval Committee (GEAC) and applied for permis-sion to conduct large-scale trials. At the same time the Supreme Court issued a ban on the ongoing field trials of Bt brinjal res ponding to the public interest litigation (PIL) filed by civil society representatives. The GEAC then constituted an expert committee (now known as expert committee I (EC-I)) to look into the concerns raised by several civil society a ctors. The EC-I reviewed the biosafety data already submitted by Mahyco as also the concerns raised by civil society organisations and independent scientists

    and submitted its report in 2007. It per-mitted large-scale field trials but also rec-ommended that seven more studies on bio safety and socio-economic aspects be c arried out mainly to reconfirm the data already generated during the confined multi-location trials. Accordingly, the S upreme Court lifted the ban on field trials. In 2009, the results of the large-scale trials were submitted to the GEAC at the same time that a number of national and inter-national scientists, civil society represent-atives, and citizens also submitted their concerns to the GEAC (actually to the MOEF to which the GEAC reports). It might be noted here that out of the 18 scientists from abroad several of them well known in their fields who made submissions to MOEF, only eight supported Bt brinjal. The rest were critical of it. There were 26 sub-missions from scientists in India, 16 in support and 10 opposing. The GEAC consti-tuted a second expert committee (EC-II) to review the adequacy of biosafety and effi-cacy data and also to look into the con-cerns raised by the civil society organisa-tions and independent scientists. In Octo-ber 2009, the EC-II submitted its report based upon which the GEAC approved the environmental release of Bt brinjal. How-ever, responding to the strong opposition expressed by civil society actors the Min-ister of State for Environment and Forests, Jairam Ramesh, announced a nationwide series of public consultations in January 2010. Based on these consultations held in seven cities, he declared a moratorium on Bt brinjal in February 2010.

    From the start the protocol and man-date of the GEAC seems to have been to produce biosafety and efficacy data on the impact of Bt brinjal on human health and environment. The GEAC and, for that matter, the MoEF have framed the prob-lem of GM food in such a way that it can be solved only with science-based risk assess-ment. As a result, the approval processes are heavily hinged on the risk science des-pite the fact that civil society actors have time and again questioned this narrow mandate of the GEAC. Imprisoned by this narrow mandate, an overwhelming majority of a wide range of issues raised by the civil society actors also concern the nature of

  • PERSPECTIVES

    july 30, 2011 vol xlvi no 31 EPW Economic & Political Weekly32

    science the science of genetic modifica-tion, and science of risk assessment. The bones (actually, genes) of contention there-fore are: (1) the inadequate description of the transgene inserted in Bt brinjal and the consequences of its intended and actual expression,1 (2) the insertion of two anti-biotic marker genes which is considered problematic and unnecessary, (3) inade-quacy and ineffectiveness of relatively older event EE 1 of Monsanto produced in the late 1980s and early 1990s as a basis for the genetic modification of Bt brinjal which might amount to transgene dumping, (4) the use of surrogate gene in biosafety studies, (5) a series of problems with pol-len flow, soil impact and crossability stud-ies conducted during confined and large-scale trials, (6) the inadequacy of the de-sign, in terms of the duration and scale, of the health impact studies too small a number of animals tested for too short a duration for any biologically and statisti-cally significant results to emerge, (7) a series of problems with the way biosafety data are read and interpreted towards the no-harm conclusions, (8) the disputes about the inserted transgenes impact on human gastric and intestinal fluids, (9) the disagreements on whether or not the transgenic DNA could be horizontally transferred to other organisms, (10) the lack of compliance of EC-II with the Codex Alimentarius the international guide-lines for food safety assessment for GMOs, which are themselves heavily based on risk-science, and (11) the clash of interests of the members of EC-I and EC-II and the product developers resulting into biased science.2

    The CSAs have also raised a wide range of socio-economic, cultural, and agrarian concerns. However, their most significant demand is to make the science of risk as-sessment rigorous, independent, and peer-reviewed. They have accordingly demanded that a long range research over many years on environmental and human health risk assessment be rigorously conducted by i ndependent scientists. Driven by this d emand and also bound by its own initial mandate, the MOEF also took two science-based substantive actions soon after dec-laring the moratorium. First, along with the National Planning Commission, it asked Indias top seven science academies

    to provide a report on transgenic crops in the wake of the ongoing controversy. The Inter-Academy Report on GM Crops which was released in September 2010 was widely discredited on charges of plagiarism. Even the MOEF rejected the report on the grounds that it lacked scientific rigour. Second, the MOEF has asked the GEAC to consult scientists to draw up a fresh proto-col for the specific tests to be conducted in order to generate public confidence. This is where the debate is precariously hang-ing presently.

    The controversy which is therefore un-folding over a long period significantly r evolves around one pivot science-based risk assessment. Science here plays many roles. We have good science the CSAs d emand for independent, peer-reviewed, normal, and rigorous science; we also have bad science the industry-sponsored science approved by EC-I and EC-II is widely discredited by CSAs as erroneous, flawed, biased, misleading, inadequate, and in-complete. We also have ugly science the i ndustry-sponsored science described as un- science, pseudoscience, scientific fraud, including the recent allegations of plagia-rism concerning the Inter-Academy Report.

    Reviewing the literature on STS, I in-tend to show that all forms of science good, bad, and ugly will always be val-ue-laden, performed from a situated loca-tion of theory and politics and hence a lways be inherently biased. More impor-tantly, both industry-sponsored and civil society-performed independent sciences are embedded in the same epistemologi-cal frameworks shaped by risk discourses and hence they share the same methodo-logical limitations. I therefore want to a rgue that while it is absolutely necessary even essential to make the science of risk assessment transparent, accountable, systematic and reproducible in a democracy, however, a rigorous, independent, and peer-reviewed science in itself will not be sufficient to provide a singular answer to the public controversies like Bt brinjal. The debate on Bt brinjal needs to come out of the narrow consequentialist frame of science of risk assessment and to broaden its frame of analysis to social and scientific appraisal of GMOs. This should be struc-tured around more fundamental ques-tions such as: What kind of society do we

    wish to live in? What kind of science and technology do we want? Who sets the agenda for science and technology devel-opment and who controls the science and technological d ecisions? The debate needs to broaden its frame from science-based assessment of consequences to evaluating society- oriented causes and objectives.

    To prevent any possible misunderstand-ing, I would like to clarify at the begin-ning that I strongly support the morator-ium declared by the MOEF. I also whole-heartedly applaud and support the civil society actors opposition to Bt brinjal and their demands. This is not a critique of e ither the moratorium or the CSAs de-mands. This essay aims to question the adequacy of science-based risk assessment as an approach to settle the controversy. It aims to broaden the scope of appraisal process. It is a critique of the method and the approach and not of the actors.

    I first review some key literature on health risk assessment of GMOs in Europe followed by a critique of science-based risk assessment. I conclude this essay by a brief sketch of the methodology of social and scientific appraisal of technology based on a revisited concept of risk.

    Science in Health Risk of GMOs

    Many opinions but few data is not an u ncommon complaint about health risk assessment of GMOs. In 2000, Domingo (2000) r eviewed the literature on health risk of GM foods using the Medline data-base. He searched the data base for toxicity of transgenic foods and found 44 cita-tions of which one study corresponded to an experimental study in mice. For the second search on adverse effects of trans-genic foods he found 67 citations of which only one was a 38-day feeding study that evaluated whether standard broiler diets prepared with transgenic Event-176-de-rived corn had any adverse effects on broiler chickens. For the third search ge-netically modified food he got 101 cita-tions of which only four corresponded to experimental studies on the adverse health effect of GM food. Two of these cita-tion studies evaluated the safety of the GM soybean consumption by rats, the third citation was about the famously contro-versial study by Ewen and Pusztai (1999) which evaluated the e ffects of GM potatoes

  • PERSPECTIVES

    Economic & Political Weekly EPW july 30, 2011 vol xlvi no 31 33

    on rats, and the forth citation was the study of the effects of insecticidal lectin GNA on human blood cells (Domingo 2000).

    The situation is not very different in 2009. Reviewing the literature on health risk of genetically modified food, Dona and Arvanitoyannis (2009) report that the studies concerning GM safety are still very few compared to the toxicity studies that must accompany the application of a novel drug for approval. They have reviewed a fairly exhaustive list of studies conducted mainly in Europe, most of them published in peer reviewed journals or accepted by European regulatory authorities, to con-clude that the duration of exposure is too short in order to fully evaluate any poten-tial disruption in biochemical parameters and to evidence possible signs of pathology within the limited subchronic exposure of animals. They conclude that the results of most of the rather few studies conducted with GM food indicate that they may cause hepatic, pancreatic, renal, and reproduc-tive effects and may alter hematological, biochemical, and immunologic parame-ters the significance of which remains un-known (emphasis mine). In their conclu-sion they recommend that a large number of animals should be used in toxicity stud-ies which should comply with the guide-lines for the toxicity testing for drugs. They also recommend additional tests to understand the effect of GM food on muta-genesis and carcinogenesis and to evalu-ate protein allergenicity in humans. They eventually conclude that many years of careful, independent research with ani-mals and also clinical trials with humans will be needed to understand and forecast possible consequences (Dona and Arvani-toyannis 2009).

    These conclusions do not sound any dif-ferent from the objections raised on the findings of EC-I and EC-II. The only signifi-cant difference is that the science of EC-I and II is declared as biased, not rigorous enough, and not peer-reviewed, whereas the scientific studies discussed by Dona and Arvanitoyannis are rigorous enough to have been published in the peer- reviewed journals. This raises a funda-mental question (which is also the ques-tion that Arpad Pusztai, the scientist who b ecame the centre of controversy on GM potatoes a decade ago, asked), Can science

    give us tools for recognising possible health risks of GM food? (Pusztai 2002).

    Case of GM Potatoes

    For a moment I want to step back and revisit the famous case of the GM potatoes before returning to the above-mentioned question. Pusztais work and his position on the health impact of GM food are not un-known to those who closely follow the Bt brinjal debate. The murky politics that fol-lowed the public disclosure of Pusztais preliminary findings on the health impact of GM potatoes in 1998 has been reported and discussed elsewhere (Dubhashi 2004; Rowell 2003); here I wish to comment on the scientific issues underscored by this case.

    Pusztai was regarded as a world expert on plant lectins defensive proteins that kill insects and other invaders at the time in 1998 when his long and distinguished re-search career at Rowett Research Institute at Aberdeen abruptly came to an end. At that time he had been commissioned a study to evaluate the safety of GM potatoes modified with the addition of a lectin gene called GNA from snowdrops (Randerson 2008). He was investigating in a rat-feeding trial if potatoes modified with the GNA lectin were substan-tially equivalent to parent potatoes. His conclusion was that the rats on the GM diet grew less well, their vital o rgans like liver, heart, and brain got smaller in size, and they developed immunity problems even when the lectin itself caused no adverse effects at high concentration. Pusztai declared in a television interview that the genetic modifi-cation had somehow made the potatoes less nutritious. At the time when he declared his preliminary findings (not yet peer-reviewed and published) on the TV show, he had sub-mitted a paper for publication in the prestig-ious medical journal Lancet. Following his public appearance he and his wife, who was also at Rowett, were suspended and were subjected to a series of inquiries including that of the House of Commons Select Com-mittee and Royal Society (Dubhashi 2004). The editor of Lancet also came under severe pressure not to publish the pending article. How ever, the journal decided to publish the research letter (as it is called) after a s tringent peer review spread over 18 months.

    Richard Horton (1999), the editor of Lancet, justified the publication as a

    welcome d ialogue of accountability that needs to be forged between scientists and the public in order to raise the standard of public conversation on science. Howev-er, he also opined that the publication would allow all parties to see data for themselves and draw their own conclu-sions (Horton 1999). Even when he did not mean that the data speak for them-selves and that he intended to facilitate the process of interpretation through seeing the publication, his assertion that the peer-reviewed data is the basis upon which either a dialogue between scientists and public be fashioned or a controversy like on GM potatoes could be settled is rather suspect.

    The research letter by Ewen and Pusztai was examined vigorously by six instead of the usual three referees a nutritionist, a human pathologist, a veterinary patho-logist, an agricultural geneticist, a plant molecular biologist, and a statis tician. The authors revised their letter three times to meet reviewers criticism. Four referees eventually approved the l etter for publica-tion, the fifth referee deemed the study flawed but favoured publication to avoid suspicion of a conspiracy, and the sixth referee objected to the publication (Horton 1999). In their letter (finally published in Lancet in October 1999) the authors focused not on the stunted growth of the GM-fed rats, but on the abnormalities in the intes-tines of rats fed for 10 days only on geneti-cally modified potatoes. They reported that the m ucosal lining of the colon and jejunum a part of the small intestine of the rats fed on the GM diet had thickened which did not happen in the rats fed with non-transgenic potatoes and non-trans-genic potatoes just spiked with GNA (not genetically modified with GNA). They con-cluded that the genetic modification might have caused the silencing or activating of other genes and the inserted gene was not i tself responsible for the changes in the GM-fed rats (Ewen and Pusztai 1999).

    Further, on peer review, in the com-mentary in the same issue of Lancet three (independent) scientists (to whom Arpad Pusztai himself referred to in his later work) from the National Institute for Quality Control of Agricultural Products in Wageningen commented that the sam-ple size of six rats in each group was too

  • PERSPECTIVES

    july 30, 2011 vol xlvi no 31 EPW Economic & Political Weekly34

    small and that the consistent pattern of changes was not observed. They also opined that the monotonous diet of pota-toes made all the rats protein-starved which was not a good basis for assessing toxicity levels, and that the effects in GM-fed rats could have stemmed from the nutritional difference between potatoes that might not have anything to do with g enetic modification. They thought that the difference was physiological response and not toxicological significance. They concluded that the experiments done by Ewen and Pusztai were incomplete and that such studies warrant further studies. They also questioned the adequacy of ex-isting test methods and strategies for the assessment of the safety of GM food (Kuiper Noteborn and Peijnenburg 1999). There were also institutional responses for instance, the president of UKs Acad-emy of Medical Sciences objected to the publi cation of the paper in Lancet, while the editor-in-chief of the New England Journal of Medicine called the paper unin-terpretable. She described the publication of the paper as dropping the bar (of

    standards), and the UKs Biotechnology and B iological Sciences Research Council called the journal irresponsible (Enser-ink 1999; Horton 1999).

    My aim here is to show that it is impos-sible to take sides based on peer-reviewed science. What this controversy demon-strates is that the peer-reviewed rigor-ous normal science (the science of GM potatoes was more rigorous than normal because it was performed in the glare of public and media scrutiny and was r efereed by six instead of three peers) is necessarily incomplete and ambigu-ous science. In fact, as Horton puts it, the arguments over scientific study are per-fectly normal and in that sense all forms of normal science are necessarily incom-plete and ambiguous sciences. The trouble is when science, which is normally in-complete and ambiguous, is attributed an agency to be solely responsible to settle the public debate on GMOs.3

    In this sense, the question that Arpad Pusztai eventually asked, approvingly quoting his adversaries the three scholars from Wageningen who disapprovingly

    commented on his research letter in L ancet is more relevant, Can science give us tools for recognising possible health risks of GM food? (Pusztai 2002). Pusztais own answer was positive, but I want to discuss and answer this question in the negative to show that science-based risk assessment has inherent limitations.

    Risk in regulatory processes is common-ly understood as potential harm or hazards or potential negative events in the future. Accordingly, the common risk discourse is about calculating probability and severity of effect of the event in question (Adams 1995). In this sense the common discourse of risk brings the future into a calculative relation to the present (Levitas 2000) and thereby colonises the future to determine the present. Such a view of time under-mines the space for history and importance of past in determining the present (Beck 1992; Giddens 1995). Risk in this sense is regarded as wholly external to the social processes that gene rate risk. It is merely a measurable and calculable consequence.

    Such calculations actually originated in the late 19th century in the field of

    53rd Annual Conference

    INDIAN SOCIETY OF LABOUR ECONOMICS17-19 December, 2011

    Mohanlal Sukhadia University, Udaipur, Rajasthan

    Call for PapersLast Date: 30 September, 2011

    The 53rd Annual Conference of the Indian Society of Labour Economics (ISLE) will be held during 17-19 December, 2011 at Mohanlal Sukhadia University, Udaipur, Rajasthan. Prof. S.S. Gill, Director General, Centre for Research in Rural and Industrial Development, Chandigarh, will preside over the Conference. The topics for this years conference are: (i) Womens Work, (ii) Labour and Environment, and (iii) Social Protection for Workers in India. Those who wish to contribute may send papers along with a summary of about 1000 words in hard as well as soft copy latest by 30 September, 2011 to the Hon. Secretary, The Indian Society of Labour Economics, NIDM Building, IIPA Campus, I.P. Estate, Mahatma Gandhi Marg, New Delhi 110002, INDIA. The soft copies may be emailed to: [email protected]. The summaries of the selected papers will be brought out as a publication of conference summaries while selected papers will be reviewed and published in the future issues of the Indian Journal of Labour Economics.

    Two awards have been instituted for best paper writers, below 40 years: Ruddar Datt Memorial Award and Sanjay Thakur Young Labour Economist Award (carrying prize money of Rs. 10,000 each). Those willing to be considered for the awards have to furnish age proof along with their full paper before the deadline.

    Latest information on the conference can be obtained from www.isleijle.org or in email from [email protected]

    For registration and reservation of accommodation for the conference, please contact either the Organising Secretary or Co-organising Secretary of the Conference: Prof. Anju Kohli (Mob: 09414165756/ Res: 0294-2521614/ Email: [email protected]), Dean and Professor of Economics, Department of Economics, University College of Social Science & Humanities, Mohanlal Sukhadia University, Udaipur 313001, Rajasthan, India Dr. Anuprabha Choudhary (Mob: 09414158614/ 07597911168/ Res: 0294-2521614/ Email: [email protected]) at the same address.

    The registration fee is Rs. 600 for India, US$ 75 for SAARC countries and US$ 100 for other countries. For spouse or an accompanying person, the fee is Rs 500 for India, US$ 50 for SAARC countries and US$ 75 for other countries. Payments should be made in favour of the Local Organising Secretary, 53rd Annual Conference of ISLE through Demand Draft payable at ICICI Bank, University Campus Branch, Udaipur, Rajasthan.

    Those who are not members of ISLE have to separately send the societys membership fee along with the filled out form available on the website, to the Hon. Secretary at the society address mentioned above. The annual membership fee for individuals in India is Rs. 400 and for overseas US$ 60. Individual life membership in India is for Rs. 4000.

  • PERSPECTIVES

    Economic & Political Weekly EPW july 30, 2011 vol xlvi no 31 35

    maritime shipping and trade as issues fun-damental to the processes of fixing insur-ance. This was later applied to the medical health professionals and their clients, to dangerous sports, and even to gambling (Adams 1995). Risk calculations were meant to neutralise negative events by prescribing monetary compensation which attributed negative events to mere chance or fate external to any social processes. Risk in this sense is purely a calculative and cognitive concept embedded in proba-bility-thinking and statistics. In such prob-abilistic framework of risk, for instance, in the 19th century there were debates whether child labour in the mines was harmful, whether it stunted and deformed childrens growth or whether it was good for children and they enjoyed it (Levitas 2000). Levitas argues that experts were prepared to defend the latter theory (Levi-tas 2000). Beck called such processes as sub-politicisation in which fundamentally political issues were transformed into i ssues of (scientific) expertise (Beck 1997).

    Problems with Risk Assessment

    The science-based risk assessment of GM biotechnology is epistemologically (and philosophically) rooted in these earlier and outdated versions of risk. What is c onsidered as a scientifically rigorous a pproach are actually reductive-aggrega-tive statistical methods of probability of risk occurrence, an analysis of things that might happen and the degree of likeli-hood or probability associated with it. Risk is thus a reductive-aggregative entity which Andy Stirling contends is based on a variously incomplete and problematic know ledge (Stirling 2008). Stirling thinks that a diversity of indeterminate circum-stances are rolled together under the term risk. Instead, he proposes to use the term incertitude. He contends that risk usually used in the policymaking and regulatory processes often means a singular entity a number or a formula or statistical equi valent of probability that represents the condition of hazard or outcome it does not include the conditions of uncertainty, ambiguity and ignorance. The controversy then revolves around these varieties of incomplete, inde-terminate and ambiguous knowledges.

    There are other epistemological issues with the science of risk assessment. This

    science is based on the statistical methods in which risk becomes an empirical (statis-tical) entity that denotes the probability of a hazard or harm. A number of experts challenge the correspondence between the statistical entity as an objective measure of probability. A celebrated probability theo-rist said that probability does not exist (Finetti 1970). De Finetti rejects the idea of objective probability and proposes that the only meaningful interpretation of the word probability is subjective probability.

    First we admit that every probability has at least a subjective meaning as a degree of be-lief of somebody (either real or hypothetical) agreeing with a given evaluation. only rules of probabilities are logically founded, but whole set of probability is an opinion, its an assertion, not a fact.. Probability is a degree of belief that an event is true says De Finetti (1970).

    Karl Popper, another such authority in science, also argued that the concept of probability only has meaning insofar as it refers to the limiting values of a relative frequency in a long series of observations. A probability historian Lindsay Prior a rgues that probability belongs to the s eries and not the individual event. In o ther words, probability is a property of the collective. The risks induced by genet-ic modification must also be considered to be a property of populations rather than of a few select entities/individuals (Prior, Glasner and McNally 2000).

    Another problem with the subjective probabilistic judgments is that they may take a number of plausible forms resulting in competing prescriptive recommenda-tions. With this narrow philosophical foundation of risk embedded in probabil-istic science, the controversies on risk a ssessment often become a confrontation between two sets of statistical calcula-tions each subjectively equally plausible. Brian Martin (2005), an applied mathe-matician and social scientist, placing the antibiotic debate in the context of other such public controversies such as fluorida-tion of public water and nuclear winter argues that many scientists believe that if we just had sufficient evidence on one side or the o ther, the controversy would be re-solved. Martin argues that public debates are always about more than just evidence and evidence is sometimes secondary to political concerns. He shows how the

    antibiotic debate remains inconclusive with genuine disagreement about the evidence, because the controversy encompasses more than the disputed data or lack of data. This more than what cannot be summed up in data an essential feature of almost all controversies of this n ature is what Stirling includes in the condition of ambiguity. Ambiguity covers a range of contending experts/disciplines, contested mandates and framing of questions, and contending interests, politics and ethics. Often the disputes about risk that are ar-ticulated on the site of evidence and data are actually disputes about these surplus elements. Here the framing of questions and the interpretations of outcomes are controversial. On such questions over contradictory certainties the rigorous science-based risk assessment alone is u nable to provide any definitive answers. And when the issues of broader values, epistemologies and ontologies are added, the resolution of controversy becomes even more challenging, complex and in-tractable. Lastly, Stirling adds conditions of ignorance in this conundrum. Quoting Donald Rumsfelds unknown unknowns, Stirling (2008) characterises the we dont know what we dont know as prospects of ever-present surprise which would be pro-foundly impossible to include in the risk assessment however rigorous this assess-ment might be.

    As we have already seen, scientists themselves have time and again declared the incompleteness of their science. Dona and Arvanitoyannis in their literature r eview conclude that the significance of effects of GM food that have been already studied remains unknown. They also contend that the possibility of predicting toxicity will remain low due to complex metabolic pathways (Dona and Arvani-toyannis 2009). A common suggestion by almost all parties involved in a scientific controversy, for instance by both Ewen and Pusztai and their critics from Wage-ningen, that a large number of animals need to be tested over a long period of time and that further studies need to be conducted is also symptomatic of the fact that the science-based risk assessment is considered incomplete and ambiguous. Although Pusztai thinks that risk science needs to be further improved, he also

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    reports that regardless of how sophisti-cated the analysis may be, it cannot re-veal the presence of unknown toxic/aller-genic components resulting from unin-tended effects of the insertion of a novel gene into the plants genome.

    Here I must emphatically mention that I do not wish to undermine the importance of science-based risk assessment. My aim is to question the exclusive agency as-cribed to it to provide conclusive evidenc-es towards cooling the crucible of public controversy as Horton puts it. If science-based risk assessment is not an appropri-ate method and approach towards the resolution of such controversy, what is? Below I propose a brief sketch of an a lternative approach to social and scien-tific appraisal of technology based on the revised concept of risk and a review of d ebates in STS and agrarian studies.

    Risk Revisited

    Both Ulrich Beck and Anthony Giddens ar-gue that the currently dominant discourse on risk adopted by regulatory authorities worldwide is no longer adequate. Beck and Giddens, including a range of other social scientists have offered alternative ways of understanding and positioning risks. Beck defines risk as a systematic way of dealing with hazards of insecuri-ties induced and introduced by moderni-sation itself (emphasis mine) (Beck 1992). Giddens on the other hand distin-guishes between external risk and manu-factured uncertainty (Giddens 1995). Risk is external, but by contrast, manufactured uncertainty risk actively confronted within frames of action organised in a re-flexive way deals with the causes of risk. As other scholars argue, if risks are perceived as external only consequences are addressed and if they are considered manufactured the causes will be called into question (Levitas 2000).

    For Beck risks are manufactured in the production of scientific knowledge. In his seminal work Risk Society, he ar-gues that in late modernity there is a shift from class society to risk society a shift from the questions of production and distri bution of wealth to the produc-tion, definition, and distribution of risks. He distinguishes between early moder-nity as the conflict field of wealth

    (goods) production and late modernity as the conflict field of hazard (bad) pro-duction. He also thinks that this shift from class society to risk s ociety is not complete because it entails a relation-ship between structural change and dis-cursive change. The central political is-sue in late modernity is the discursive field of reduction and legitimation of risks rather than the reduction or legiti-mation of inequality which was a central feature of class society in early moderni-ty. He claims that the qualitative shift from class society to risk society occurs not just because the hazards have in-creased in number and intensity but be-cause the pre-occupying issues in society are legitimation of risks, rather than the legitimation of inequality. Becks distinc-tion between early and late modernity has been criticised by many as a crude distinction implying a linear under-standing of historical change which do not correspond to the actual material or discursive conditions. See Scott (2000) for a spirited critique. However, the larg-er point in terms of the discursive shift in the focus from i nequality to insecurity still remains valid.

    In the background of this repositioning of risk, here are a few revisions in the concept of risk. First, risks are not exter-nal and out there and which need to be

    deciphered and controlled. They are manufactured, not only through the ap-plication of technologies but also through production and management of scientific knowledge. If risks are manufactured then the risk assessment must also ad-dress the causes of risks instead of confin-ing its mandate to assessing risk as a con-sequence. Second, all interpretations and knowledge of risks, including empirical-ly-driven scientific knowledge, are inher-ently a matter of perception and hence subjective and political. As Haraway (1988) points out, knowledge is tied to a particular location objective knowledge is possible only from a subjective political location. All knowledge is thus situated knowledge. It is in the production of knowledge that the complexly c onditioned subjectivities are expressed (Longino 1993). To produce objective knowledge is thus to take up a subjective position. And taking up a position and being positioned is inevitably a matter of politics and ethics (Haraway 1988). There are no unambi-guous, objective, scientific facts that can apply to all political and ethical positions possible. There is no one truth; there are no facts outside the interpretation of values based on context, position, per-spective, interest, and power. Third, in risk assessment, therefore, the politics and sub-politics of risk definition become

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    extremely important. In risk definitions it is no longer interests alone that domi-nate the politics but the claims about the legitimacy of particular forms of knowl-edge replace the politics based on inter-ests. This revised concept of risk funda-mentally problematises the role of s cientific expertise in the assessment of Bt brinjal. The contestation is not about what kind of science can or cannot be reliable. The revised concept of risk highlights the contested nature of who is d efining what risk is and how. This contestation also calls for a re-examination of the role of scientific expertise in not only assessing but manufacturing risks.

    Social and Scientific Appraisal

    In conclusion, the problematic of Bt brinjal raises two, mutually intertwined, chal-lenges. As argued above, revisiting the concept of risk creates what Wiebe Bijker and his colleagues call, a paradox of scien-tific authority (Bijker, Bal and Hendriks 2009). How can scientific advice be influ-ential in an age when the nature of science and the status of scientists are increasing-ly questioned is what Bijker et al call the paradox of scientific authority. Scientific authority is no longer a technocratic mon-archy as it was a 100 years ago when sci-ence could speak with one and unchal-lenged voice. Nowadays, the interplay bet-ween scientific authority and democratic institutions is sensitive and tricky. Bijker et al suggest that in order to be effective, the scientific expertise has not only to learn to work with the democratic institu-tions and public participation, but first and foremost, it has to be aware of its own limi-tations (Bijker et al 2009).

    The acknowledgement of the limitation of scientific expertise opens up newer forms of appraisal of technologies such as GMOs that must, in addition to the ques-tions of insecurity and risk, include the broader assessment of agrarian develop-ment on the interface of what Vinay Gid-wani calls, nature of work and work of n ature (Gidwani 2001). The second such challenge therefore pertains to the wider appraisal of GMOs and its relationship with agrarian development.4 In this ap-praisal, risks are not consequences, but are manufactured in the organisation of techno-scientific institutions such as the

    green revolution whose application not only create and perpetuate newer forms of risks but also produce and reproduce newer forms of injustice and inequality. It is a well known fact in agrarian studies that the increase in the newer and potent forms of pests is a result of the intensive use of chemicals in the green revolution technological paradigm. Pests and conse-quently the newer forms of risks that pest-killing GMOs may entail are thus manufac-tured by the green revolution paradigm.

    What is rarely acknowledged and dis-cussed, however, is that GMOs reinforce and even produce newer forms of inequal-ity. In my work on Bt cotton cultivation in Gujarat, I have shown how only resource rich farmers profitably cultivate Bt cotton. It has been commonly acknowledged that the cultivation of Bt cotton extracts sub-stantial nutrition from the soil and that continuous cultivation for four to five years is likely to leave the soil unfit for any other cultivation. Farmers compensate the loss of soil nutrition by rotating cotton with wheat and pulses. Approximately four tractor-loads of green manure are ploughed into the field after each crop of cotton, and in addition, a crop of wheat or pulse is cultivated on the same piece to a llow the green manure to weather suffi-ciently. Only in the third season is cotton cultivated again on the same piece of land. Moreover, while hybrid cotton needs w ater once in 15 to 17 days, Bt cotton needs water once in 10-12 and even five to seven days during an exceptionally hot season. This means that for the continuous cultivation of at least a few acres of cotton to maintain a profitable standing in the market, a c otton-growing farmer needs to be hold-ing more than four to five acres of well- irrigated land. The cotton cultivation by resource rich farmers is thus a significant reason why groundwater has plummeted to 1,200 ft in central and northern Gujarat. There are other forms of injustice that Bt cotton entails. For instance, Bt cotton seeds are multiplied by importing seasonal, migrant, child and young female labour from south Rajasthan (Shah 2005, 2008).

    The social and scientific appraisal of Bt brinjal thus needs to be based on a metho-dology that can combine, as Bijker et al put it, scientific expertise with democratic participation, and such an appraisal also

    needs to include the issues of injustice in the assessment of insecurity. A fuller ar-ticulation of this methodology would need a separate paper which my colleagues and I hope to write soon.

    Notes

    1 To explain this point further when scientists de-velop transgenic plants, plant cells are trans-formed with foreign DNA individually. Every cell that successfully incorporates a gene of interest represents a unique event. Marker genes, most commonly antibiotic or herbicide resistance genes, are used to identify transformed cells. The event EE 1 from which Bt transgenic line has emerged was developed by Monsanto in late 1980s and early 1990s.

    2 This section is based on the following literature (Andow 2010; Kuruganti 2010; Manjrekar 2010; Rao 2010; Ray 2010; Seralini 2009; Kuruganti 2006). It includes following reports, articles, newspaper items, and submission to the MOEF: Report of the Expert Committee (EC-II), 2009; Independent Scientists write to Prime Minister (2010); Letter from Citizens to Prime Minister (2010); Centre for Environment Education (nd); Inter-Academy Report on GM Crops, 2010; Seralini answers to EC-II Report, 2010.

    3 It is far more important to understand the extent to which the pressures from civil society in o ther words, the requirement for external legiti-mation, relevance, and accountability have in-duced theory change within the practices of risk science. This is what Aant Elzinga in his celebrat-ed paper called epistemic drift (1997). More re-cently, these have been speculated as a shift from Mode 1 (disciplinary) to Mode 2 (multidiscipli-nary) science inaugurating what is called post-normal science. Unfortunately, due to the space limitations these discussions cannot be included in this paper.

    4 This point is also made by other scholars (Purka-yastha and Rath 2010; Rao and Dev 2009).

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