Submission to the WTO by academics

INTRODUCTIONA. Summary of ArgumentRegulatory polarization in the agricultural biotechnology sector has created tensions inthe world trading system and threatens to develop into a full-blown trade conflict.1Before that happens, the Dispute Settlement Panel at the World Trade Organizationhas a chance to render informed judgment on these issues in the present case of EC –Measures Affecting the Approval and Marketing of Biotech Products (hereinafterBiotech Products). The case results from complaints against the EuropeanCommunity brought by a number of other Member States, including the United States,Canada and Argentina.2 Contrary to the arguments advanced by the recent U.S.submission in Biotech Products, both the risks and benefits of this family oftechnologies remain the subject of ongoing scientific and political contention aroundthe world.3As the U.S. submission makes clear, the Biotech Products dispute will center on theinterpretation of key provisions of the Sanitary and Phytosanitary Agreement,4especially those concerning ‘scientific justification’ and ‘risk assessment.’ Indeed,‘risk assessment’ is a key term underpinning the free flow of trade under the WTO’sscience-based disciplines.5 As exemplified by the U.S. submission, risk assessmenthas been conventionally understood as a factually grounded, objective, and value-free,analytic exercise requiring (1) precise identification of possible harms to human healthand the environment, and (2) use of formal, expert-based assessments of thelikelihood of such harms. Public values and concerns are thought to be relevant andappropriate only in the phase of risk management, which is perceived to follow riskassessment and remain separate from it.By contrast, over the past few decades, both national and international regulatoryframeworks have been developing in ways that systematically call into question thisaccount of risk assessment. Social scientific research has identified and analyzed thesedevelopments and their implications for policy practice in various institutionalcontexts. The issues identified as problematic for conventional accounts of risk assessment include:•The degree of maturity and/or comprehensiveness of the scientific knowledge basein which particular risk assessments may need to be grounded;•The extent to which scientific risk assessments in particular national contexts arenecessarily shaped by contingencies – scientific and cultural – which helpdetermine the selection of particular analytic foci and strategies as relevant orvalid; and•Wider background assumptions and value commitments that are unavoidablyembedded within scientific knowledge generated for policy applications.The complexities inherent in risk assessment are now becoming explicit in theparticular circumstances of the GMO case. This being so, it is vital to offer – and forthe WTO to rely upon – a characterization of risk assessment that adequatelyembraces the results of current scholarship, one that was not taken into account in theU.S. submission. In offering such an alternative, this amicus curiae brief hopes toassist not only the Panel’s consideration of the present case, but also the developmentof more scientifically and politically robust procedures for comparable cases in thefuture.For this purpose, it is essential to recognize that risk assessment is neither a singlemethodology, nor a ‘science’. Rather, contrary to the view advanced in the U.S.submission, we must reconceptualize ‘risk’ situations as lying within a matrix definedby two variables: certainty and consensus. At one extreme are cases characterized byhigh certainty with respect to the knowledge base to be relied upon, and highconsensus with respect to the parameters of the scientific issues to be addressed, theanalytic methods to be applied, and the values to be protected. At the other extremeare low certainty and low consensus on such matters.The nature and adequacy of any risk assessment depends on the position of an issuewithin this matrix, and GM technologies fall in the low certainty, low consensusrange. Previous cases such as Salmon6 and Asbestos7 (and even, in some respects,Japanese Apples8 and Hormones)9, were characterized by high certainty and highconsensus with respect to the basic parameters, scientific knowledge, analyticmethods, and values relied upon in risk assessment. The GMO issue by contrast ischaracterized by low certainty and low consensus with regard to these matters becausethe case presents:•An emergent suite of technologies whose biological properties and environmentaland social impacts are neither well defined nor certain;•Differences in public values regarding health and the environment that are relevantnot only to the management of hazards, but to the initial definition of hazards,their characterization and assessment.•A scientific basis for risk assessment that is fluid and changing even withinnational decision-making contexts, and where international guidelines andunderstandings are still emerging and not yet universally accepted;•Technologies whose use and impact will depend on the behavior of users andconsumers in widely varied social and environmental contexts, necessitatingdeeper understanding of the social and behavioral dimensions of risk.In the light of these characteristics of the present dispute, the followingrecommendations are specially merited:1. Full consideration of the range of relevant scholarship, prominently includingthe social sciences, in interpreting the meanings of key terms such as ‘risk’, ‘riskassessment’, ‘rational’, ‘objective’, and ‘sufficient scientific evidence.’2. Recognition that risk assessments of GMOs conducted within specific nationalor institutional settings are necessarily limited and partial, constrained by thedecisionmaking cultures within which such assessments are produced.3. Recognition that risk assessment is not a singular concept but that it has tovary with context; processes of public deliberation and review are essentialcomponents of risk assessment, especially for low certainty, low consensustechnologies such as GMOs, and most especially in relation to the transfer of thetechnological products across national borders.4. In light of the developing status of risk assessment techniques associated withGMOs, and the important role of public confidence in regulating new foodtechnologies, the alleged European moratorium should not be deemed an “unduedelay” under Article 8, annex C; for the same reason, the period of time which theEuropean Commission has committed to collecting additional necessary informationfor better risk assessment of GMOs (in order to conduct, e.g., farm-scale trials andpublic consultations) should be deemed ‘reasonable’, especially in light of thedeveloping regulatory approach to GMOs within the United States itself. ‘Undue’ and‘reasonable’ are legal standards that cannot be interpreted without reference to actualregulatory experience.5. Recognition that the WTO dispute resolution panel’s appropriate role inreviewing the arguments of the parties should be that of an administrative tribunalreviewing the adequacy of executive decision-making processes – not that of anadjudicatory body reviewing the substantive merits of the parties’ risk assessments.B. This Amicus Curiae BriefOnly the SPS agreement, and no other WTO agreement, imposes on its Members anobligation to base regulations on scientific evidence, regardless of whether there isdiscrimination. This so-called ‘sound science’ obligation means a higher justificatoryburden on all WTO Members wishing to regulate GMOs and permits complainingparties to challenge such regulations on the basis of the underlying scientific evidenceand reasoning.10 The centrality of these concepts is widely recognized. For example,U.S. Under-secretary of State for Economics Business and Agricultural Affairs, AlanLarson has said, “The only way to maintain a free and fair trading system is forproducts traded in that system to be regulated in a logical, objective and science-basedmanner…[This] must be based on scientific risk assessment and risk management.”11The authors of this amicus curiae brief argue that statements of this misinterpret themeanings of key terms of the WTO agreements. Both recent WTO case law andnational regulatory practice in the US and EU have been evolving in ways thatindicate the need for a more complex understanding of risk assessment as practiced inreal-world conditions. This brief analyzes these developments in law and regulatorypolicy in the light of current social and policy sciences so as to assist the DisputeSettlement Panel in its consideration of the present case—a case in which tensionsbetween different versions of what may constitute adequate risk assessment haveemerged as central and salient. These differences cannot be understood simply as theresults of better or worse scientific risk assessments. Rather, risk assessment can takea number of forms, and the choice of an appropriate method depends on the scientificand regulatory context.At stake in the resolution of the dispute are the global development of agriculturalbiotechnology, the democratic governance of risks in world trade, and, not least, thelegitimacy of the WTO as an institution of global governance. The GMO disputeimplicates not only technical concerns about barriers to trade but also politicalconcerns about a democratic deficit in the design and operation of the WTO itself.Given these large stakes, it is important that the Panel receive the best possibleinformation and opinion pertinent to the resolution of the case.12 The authors of thisamicus brief aim to provide such information with respect to two fundamentaldimensions of the dispute: (1) the interpretation of the terms ‘science’, ‘riskassessment’, and ‘risk management’ in the context of evaluating agriculturalbiotechnologies; and (2) the relationship of risk assessment to the broader role ofpublic deliberation and rational decisionmaking in supporting the free flow of trade.The authors are a team of international scholars of science, technology and society.13Our collective scholarly expertise is in the areas of risk and regulation, with individualcompetences in environmental law, international trade law, scientific advice,comparative studies of risk assessment and management, public understanding ofscience and technology, and food and agricultural policy. We have contributedextensively to the literature on risk in general and the regulation of GMOs inparticular. Our expertise also includes extensive practical experience as advisers tonational governments, international organizations, and national science academies,and as officers of scientific professional societies and NGOs actively engaged withGMO issues.This submission seeks to promote a more informed resolution of the present dispute.In presenting the brief, we draw upon widely accepted understandings of the role ofamici curiae in complex judicial disputes.14 In particular, we aim to provide:* Discussion and citation of relevant social science information and authorities notlikely to be contained in the submissions of the parties;* Arguments based on pertinent social science research that the parties may beunable or reluctant to make in the context of this dispute;* Assistance to the panel in entering a novel and complex area of dispute resolutionrequiring interdisciplinary expertise;* Expert knowledge of risk and regulation that bears on the broader implications ofthe decision in the present case, and goes beyond the particular interests of theparties;* Information from social science research bearing on the public understanding andappreciation of issues related to GMOs.1 See generally, THOMAS BERNAUER, GENES, TRADE, AND REGULATION: THE SEEDS OF CONFLICT INFOOD BIOTECHNOLOGY 44-66, 118-167 (2003).2 The US, Canada and Argentina first called for consultations on 14 May 2003 concerning Europe’salleged ad hoc moratorium on GM crops. The U.S. (WT/DS291/23), Argentina (WT/DS293/17) andCanada (WT/DS292/17) each requested a panel on 8 August 2003.3 First Submission of the United States in European Communities – Measures Affecting the Approvaland Marketing of Biotech Products, WT/DS291, 292, and 293 (Apr. 21, 2004).4 Agreement on the Application of Sanitary and Phytosanitary Measures, Apr. 15, 1994, WTOAgreement, at