When intense public controversy erupted around agricultural biotechnology in the late 1990s, critics found opportunities to challenge risk assessment criteria and test methods for genetically modified products. In relation to GM food, they criticized the concept of substantial equivalence, which European Union and United States regulators had adopted as the basis for a harmonized, science-based approach to risk assessment. Competing policy agendas framed scientific uncertainty in different ways. Substantial equivalence was contested and eventually recast to accommodate some criticisms. To explain (...) how the concept changed, this article links two analytical perspectives. Regulatory-science perspectives illuminate how the scientification of politics and politicization of science led to shifts in the boundary between science and policy. Governance perspectives illuminate how the collective problem for policy was redefined to provide a new common ground for some stakeholders. Overall, substantial equivalence was recast to govern the social conflict and address legitimacy problems of regulatory procedures. (shrink)

Just as a stream of genetically modifiedcrops looked set to be approved for commercialproduction in the European Union, the approvalprocedure appears to have become bogged down onceagain by disagreements among and within member states.Old controversies have resurfaced in new forms. Theintractability of the issues suggests that theregulatory procedure has had too narrow a focus,leaving outside its boundary many of the morefundamental aspects that cause people in the EuropeanUnion most concern. Regulators have come underconsiderable pressure to ensure their risk assessmentdecisions are (...) soundly science-based. Ethical issueshave been deemed to lie beyond the scope of theregulatory procedure, as a matter to be consideredseparately by professional ethicists. Yet it has beensuggested that all environmental controversies at rootinvolve disputes about fundamental ethical principles.This paper examines how the ethical issues arecurrently suppressed or sidelined. It discusses how anappreciation of systems thinking and a check on thevalues that underpin decisions, using boundary testingquestions, might contribute to a more constructiveregulatory dialogue, with ethical issues considered asintegral in a way that takes better account ofpeople's concerns. (shrink)

The Knowledge-Based Bio-Economy has gained prominence as an agricultural R&D agenda of the European Union. Specific research policies are justified as necessary to create a KBBE for societal progress. Playing the role of a master narrative, the KBBE attracts rival visions; each favours a different diagnosis of unsustainable agriculture and its remedies in agro-food innovation. Each vision links a technoscientific paradigm with a quality paradigm: the dominant life sciences vision combines converging technologies with decomposability, while a marginal one combines agro-ecology (...) with integral product integrity. From these divergent visions, rival stakeholder networks contend for influence over research policies and priorities, especially within the Framework Programme 7 on Food, Agriculture, Fisheries and Biotechnology, which has aimed to promote a Knowledge-Based Bio-Economy. Although the FAFB programme has favoured a life sciences vision, agro-ecological approaches have gained a presence, thus overcoming their general lock-out from agricultural research agendas. In their own way, each rival paradigm emphasises the need for collective systems to gather information for linking producers with users, as a rationale for the public sector to fund distinctive research priorities. (shrink)

In public debate over agricultural biotechnology, at issue hasbeen its self-proclaimed aim of further industrializingagriculture. Using languages of ’risk‘, critics and proponentshave engaged in an implicit ethics debate on the direction oftechnoscientific development. Critics have challenged thebiotechnological R&D agenda for attributing socio-agronomicproblems to genetic deficiencies, while perpetuating the hazardsof intensive monoculture. They diagnosed ominous links betweentechnological dependency and tangible harm from biotechnologyproducts.In response to scientific and public concerns, theEuropean Community enacted precautionary legislation for theintentional release of genetically modified organisms (GMOs). (...) Inits implementation, choices for managing and investigatingbiotechnological risk involve an implicit environmental ethics.Yet the official policy language downplays the inherent valuejudgments, by portraying risk regulation as a matter of’objective‘ science.In parallel with safety regulation, thestate has devised an official bioethics that judges where to’draw the line‘ in applying biotechnological knowledge, as ifthe science itself were value-free. Bioethics may also judge howto ’balance‘ risks and benefits, as if their definition were notan issue. This form of ethics serves to compensate for theunacknowledged value-choices and institutional commitmentsalready embedded in R&D priorities.Thus the state separates’risk‘ and ’ethics‘, while assigning both realms to specialists.The risk/ethics boundary encourages public deference to theexpert assessments of both safety regulators and professionalethicists. Biotechnology embodies a contentious model of controlover nature and society, yet this issue becomes displaced andfragmented into various administrative controls. At stake arethe prospects for democratizing the problem-definitions thatguide R&D priorities. (shrink)

As products of the "new biotechnology," genetically modified organisms have provoked a wide-ranging risk debate on potential harm, especially from herbicide-tolerant crops. In response to this legitimacy problem, the European Community adopted precautionary legislation, which left open the definition of environmental harm. When the U.K. proposed Europe-wide market approval of a herbicide-tolerant oilseed rape, the proposal encountered dissent from some countries and environmentalist groups. Further debate on normative judgments became necessary to implement the precaution ary legislation. In dispute were several (...) regulatory boundaries—of administrative re sponsibility, causality, acceptability, and evidence. The boundary disputes expressed divergentframings of biotechnological risk, each with its implicit model of the socionatu ral order. In this way, the disputes can illuminate the sorts of risk framings that have already become embedded and standardized in other regulatory sectors. (shrink)

Le différend commercial sur les OGM dans le cadre de l’OMC a mobilisé une expertise scientifique de façon quelque peu inédite. Dès le départ, le Groupe spécial a situé le différend dans le cadre de l’Accord sur l’application des mesures sanitaires et phytosanitaires de l’OMC grâce à une nouvelle ontologie juridique. Ce groupe a mis en scène l’expertise scientifique en suivant des approches spécifiques définissant de quelle manière les experts seraient interrogés, les réponses qu’ils donneraient, leur rôle spécifique dans le (...) domaine juridique et la façon dont leurs déclarations viendraient compléter ses conclusions. De plus, le Groupe spécial a procédé à un tournant procédural en présentant ses conclusions sous forme d’un jugement purement juridico-administratif tout en gardant implicites ses propres jugements sur les questions de fond liées aux risques.The high-profile WTO trade dispute on GMOs brought in scientific expertise in somewhat novel ways. From the outset, the Panel placed the dispute under the WTO Sanitary and Phytosanitary Agreement by drawing on a new legal ontology. The Panel brought scientific expertise into play in specific ways that defined how experts were questioned, the answers they would give, their specific role in the legal arena, and the way their statements would complement the Panel’s findings. Furthermore, the Panel created a procedural turning point in WTO jurisprudence by representing its findings as a purely legal and administrative assessment of whether the EC’s regulatory procedures violated the SPS Agreement, with its own assessments on substantive risk issues remaining implicit. (shrink)