THE ACADEMIC EXPERTS BRIEF FOR THE WTO GMO DISPUTE:

An international team of scholars of science, technology and society from the US and UK has submitted an Amicus Curiae brief (www.lancs.ac.uk/fss/ieppp/WTOamicus) to the WTO disputes resolution panel on the Biotech Products (EC: Measures affecting the Approval and Marketing of Biotech products) case. The Brief

• draws the WTO?s attention to major recent developments, modifying the conventional understanding of risk assessment, particularly concerning GMOs;
• analyses relevant recent WTO case law, developments in risk assessment practice, and international legal and social scientific literature;
• suggests that the charge of ?undue delay? directed at the EU is unwarranted; and
• urges that the role of the WTO disputes panel should be one of reviewing the procedural adequacy of executive decision-making processes in the various jurisdictions involved, rather than one of arbitrating on the substantive merits of the individual risk assessments themselves.

The analysis

The Biotech Products dispute centres on the interpretation of key provisions of the Sanitary and Phytosanitary Agreement, especially those concerning 'scientific justification' and 'risk assessment.' As exemplified in the US submission, risk assessment has been conventionally understood as a factually grounded, objective, and value-free, analytic exercise requiring (1) precise identification of possible harms to human health and the environment, and (2) use of formal, expert-based assessments of the likelihood of such harms. Public values and concerns are thought to be relevant and appropriate only in the phase of risk management, which is perceived to follow risk assessment and remain separate from it.

By contrast, the Brief shows that recently both national and international regulatory frameworks have been developing in ways that call into question this account of risk assessment. Key problems for the 'conventional' account of risk assessment include:

• The variable degree of maturity and/or comprehensiveness of the scientific knowledge base;
• The extent to which scientific risk assessments in particular national contexts are shaped necessarily by contingencies, both scientific and cultural, which help determine the selection of particular analytic foci and strategies as relevant or valid;
• Wider background assumptions and value commitments that are unavoidably embedded within the bodies of scientific knowledge generated for policy applications.

The Brief offers and urges the WTO now to rely upon a characterization of risk assessment that adequately embraces recent scholarship and practice (which the US submission has failed to do).

Low certainty, low consensus

Risk assessment is neither a single methodology, nor a 'science'. Rather, 'risk' situations lie within a matrix defined by two variables: certainty and consensus. At one extreme are cases characterized by high certainty with respect to the knowledge base to be relied upon, and high consensus with respect to the parameters of the scientific issues to be addressed, the analytic methods to be applied, and the values to be protected. At the other extreme are low certainty and low consensus on such matters. The nature and adequacy of any risk assessment will depend on the position of an issue within this matrix - and GMO technologies fall squarely in the low certainty, low consensus range:

• It is an emergent suite of technologies whose biological properties and environmental and social impacts are neither well defined nor certain;
• Differences in public values regarding health and the environment exist that are relevant not only to the management of hazards, but also to the initial definition of hazards, their characterization and assessment;
• The scientific basis for risk assessment is fluid and changing within national and international decision-making contexts in both the US and EU;
• Its impact will depend on the behaviour of users and consumers in widely varied social and environmental contexts.

Previous WTO dispute cases such as Importation of Salmon (1998) and Prohibition of Asbestos and Asbestos Products (2001) were characterized by high certainty and high consensus with respect to the basic parameters, scientific knowledge, analytic methods, and values relied upon in risk assessment.

Recommendations to the WTO panel

1. Relevant scholarship: full consideration should be given to the range of relevant scholarship, prominently including the social sciences, for helping interpret the meanings of key terms such as 'risk', 'risk assessment', 'rational', 'objective', and 'sufficient scientific evidence.'
2. Necessary limitations of science: full recognition should be given to the fact that risk assessments of GMOs conducted within specific national or institutional settings are necessarily limited and partial, being constrained by the decision-making cultures within which such assessments are produced.
3. Public deliberation and cultural context: risk assessment is not a singular concept but one that has to vary with context. Thus processes of public deliberation and review are often essential components of risk assessment, especially for low certainty, low consensus technologies such as GMOs, and most especially in relation to the transfer of the technological products across national borders.
4. No 'undue delay': in light of the developing status of risk assessment techniques associated with GMOs; the important role of public confidence in regulating new food technologies; and the time which the European Commission has committed to collecting additional necessary information for better risk assessment of GMOs (in order to conduct, e.g., farm-scale trials and public consultations), the alleged European moratorium should not be deemed an "undue delay".
5. WTO's role: the appropriate role of the WTO dispute resolution panel should be that of an administrative tribunal reviewing the adequacy of executive decision-making processes ? not that of an adjudicatory body reviewing the substantive merits of the parties' risk assessments.

The expert academic group:

Lawrence Busch is Distinguished Professor of Sociology at Michigan State University.

Robin Grove-White is Professor of Environment and Society at Lancaster University.

Sheila Jasanoff is Pforzheimer Professor of Science and Technology Studies at Harvard University?s John F. Kennedy School of Government.

David Winickoff is Adjunct Lecturer in Public Policy at Harvard University?s John F. Kennedy School of Government.

Brian Wynne is Professor of Science Studies and a member of the Centre for the Economic and Social Aspects of Genomics at Lancaster University.