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)

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)

In February 2000, the EuropeanCommission adopted a Communication on theprecautionary principle. This states how theCommission intends to apply the principle andestablishes guidelines for its application. Thedocument is intended to inform discussions oninternational agreements. In particular, itprovides a defense of European Union (EU)precautionary policies in case of tradedisputes, for example, in case the EU isaccused of imposing unfair trade barriers onexports of genetically-modified (GM) productsfrom the United States under the rules of theWorld Trade Organisation. In the communication,the Commission emphasizes the scientificaspects (...) of the precautionary principle, perhapspartly to counter claims from US officials thatthe EU's reluctance to accept GM imports is notbased on science but is politically-motivated.However, a principle is by definition a moralguide to behavior. In other words, it is anethic. The precautionary principle should beviewed as a complement to science, to beinvoked when a lack of scientific evidencemeans that outcomes are uncertain. Anyinterpretation of this principle needs to placeat least as much emphasis on its ethical andvalue-based aspects as on its scientificjustification. The Commission's interpretationrisks undermining the painstaking progress madeamong European Union member states inresponding to public concern about GM crops andfood by adopting increased precaution. Thispaper explores the balance between thescientific and ethical/value-based aspects ofthe precautionary principle as set out in theCommission's communication, to make the casethat it is the ethical and value-based aspectsrather than the scientific aspects of theguidelines that need strengthening. (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)