Science and the Consequences of Mistruct: Lessons from Recent GM Controversies

In 2001, it was announced thattransgenic DNA had introgressed intotraditional strains of maize in Mexico. Acontroversy erupted and raged throughout 2001and 2002. This episode represents an acutebreakdown in scientific discourse. Given thestakes in the genetically modified organismdebate, a breakdown in scientific discourse isalarming. The following inquiry looks into thecauses of this breakdown. Ultimately, it willbe argued that the underlying problem is thecurrent institutional structure of science,particularly in the United States. If thediagnosis is correct, then the proper course oftreatment is to pursue a program ofinstitutional reconstruction.     

The Food Debate: Ethical versus Substantial Equivalence

Substantial equivalence (SE) has beenintroduced to assess novel foods, includinggenetically modified (GM) food, by means ofcomparison with traditional food. Besides anumber of objections concerning its scientificvalidity for risk assessment, the maindifficulty with SE is that it implies that foodcan be qualified on a purely substantial basis.SE embodies the assumption that only reductivescientific arguments are legitimate fordecision-making in public policy due to theemphasis on legal issues. However, the surge ofthe food debate clearly shows that thistechnocratic model is not accepted anymore.Food is more than physico-chemical substanceand encompasses values such as quality andethics. These values are legitimate in theirown right and require that new democraticprocesses are set up for transverse,transdisciplinary assessment in partnershipwith society. The notion of equivalence canprovide a reference scale in which to examinethe various legitimate factors involved:substance (SE), quality (QualitativeEquivalence: QE), and ethics (EthicalEquivalence: EE). QE requires that newqualitative methods of evaluation that are notbased on reductive principles are developed. EEcan provide a basis for the development of anEthical Assurance as a counterpart of QualityAssurance in the food sector. In France, asecond circle of expertise is being set up toaddress the social issues in food public policybeside classical risk assessment by the firstcircle of expertise. Since ethics is likely tobecome an organizing principle of the secondcircle, the equivalence ethical framework canprove instrumental in this context.     

The Precautionary Principle: Scientific Uncertainty and Omitted Research in the Context of GMO Use and Release

Commercialization of genetically modified organisms (GMOs) have sparked profound controversies concerning adequate approaches to risk regulation. Scientific uncertainty and ambiguity, omitted research areas, and lack of basic knowledge crucial to risk assessmentshave become apparent. The objective of this article is to discuss the policy and practical implementation of the Precautionary Principle. A major conclusion is that the void in scientific understanding concerning risks posed by secondary effects and the complexity ofcause-effect relations warrant further research. Initiatives to approach the acceptance or rejection of a number of risk-associated hypotheses is badly needed. Further, since scientific advice plays a key role in GMOregulations, scientists have a responsibility to address and communicate uncertainty to policy makers and the public. Hence, the acceptance of uncertainty is not only a scientific issue, but is related to public policy and involves an ethical dimension.     

Beyond Substantial Equivalence: Ethical Equivalence

The concept of substantial equivalence,introduced for the risk assessment of geneticallymodified (GM) food, is a reducing concept because itignores the context in which these products have beenproduced and brought to the consumer at the end of thefood chain. Food quality cannot be restricted to meresubstance and food acts on human beings not only atthe level of nutrition but also through theirrelationship to environment and society. To make thiscontext explicit, I will introduce an ``equivalencescale' for the evaluation of food chains (GM or notGM). By contrast with substantial equivalence, whichinvolves mainly quantitative, analytical methods ofevaluation, ``qualitative equivalence' refers to ``less'or non-substantial factors that require new methodsof evaluation based on qualitative principles.``Ethical equivalence' refers to factors that show themoral value contained in food products. To analyze thedifferent levels at which ethics is needed in foodchains, I will use the French principles: ``Liberty,Equality, Fraternity,' or freedom, equality,solidarity, and add a fourth principle:sustainability. Sustainability, solidarity, andfreedom can be applied to the evaluation ofenvironmental, socio-economic, and socio-culturalethical equivalence, respectively. Equality refers tojustice and should operate so as to guarantee thatsustainability, solidarity, and freedom are satisfied.I suggest that ethics can provide a basis for arenewal of the food chain concept. Besides QualityAssurance, it is now essential to develop an ``EthicalAssurance' and this equivalence scale could provide abasis to set up ``Ethical Assurance Standards' (EAS)for food chains.     

Between Precautionary Principle and “Sound Science”: Distributing the Burdens of Proof

Opponents of biotechnology ofteninvoke the Precautionary Principle to advancetheir cause, whereas biotech enthusiasts preferto appeal to ``sound science.' Publicauthorities are still groping for a usefuldefinition. A crucial issue in this debate isthe distribution of the burden of proof amongthe parties favoring and opposing certaintechnological developments. Indeed, the debateon the significance and scope of thePrecautionary Principle can be fruitfullyre-framed as a debate on the proper division ofburdens of proof. In this article, we attemptto arrive at a more refined way of thinkingabout this problem in order to escape from theexisting polarization of views between ``guiltyuntil proven innocent' and ``innocent untilproven guilty.' This way of thinking alsoenables a critical review of currentdemarcations between risk assessment and riskmanagement, or science and politics, and of themorally laden controversy on the relativeimportance of type-I and type-II errors instatistical testing.     

You Are What You Eat: Genetically Modified Foods, Integrity, and Society

Thus far, the moral debateconcerning genetically modified foods (GMF) hasfocused on extrinsic consequentialist questionsabout the health effects, environmental impacts,and economic benefits of such foods. Thisextrinsic approach to the morality of GMF isdependent on unsubstantiated empirical claimsand fails to account for the intrinsic moralvalue of food and food choice and theirconnection to the agent's concept of the goodlife. I develop a set of objections to GMFgrounded in the concept of integrity andmaintain that food and food choice can beintimately connected to the agent's personalintegrity. I argue that due to the constitutionof GMF and the manner in which they areproduced, such foods are incompatible with thefundamental values and integrity of certainindividual moral agents or groups. I identifythree types of integrity that are threatened byGMF: religious, consumer, and integrity basedon certain other moral or metaphysical grounds.I maintain that these types of integrity aresufficiently important to provide justificationfor political and societal actions to protectthe interests of those affected. I conclude byproposing specific steps for handling GMFconsistent with the moral principles ofinformed consent, non-maleficence, and respectfor the integrity of all members of society.They include mandatory labeling of GMF, theimplementation of a system for control andregulations concerning such foods, andguaranteed provision of conventional foods.     

Ethics in the Societal Debate on Genetically Modified Organisms: A (Re)Quest for Sense and Sensibility

Via a historical reconstruction, this paper primarily demonstrates how the societal debate on genetically modified organisms (GMOs) gradually extended in terms of actors involved and concerns reflected. It is argued that the implementation of recombinant DNA technology out of the laboratory and into civil society entailed a “complex of concerns.” In this complex, distinctions between environmental, agricultural, socio-economic, and ethical issues proved to be blurred. This fueled the confusion between the wider debate on genetic modification and the risk assessment of transgenic crops in the European Union. In this paper, the lasting skeptical and/or ambivalent attitude of Europeans towards agro-food biotechnology is interpreted as signaling an ongoing social request – and even a quest – for an evaluation of biotechnology with Sense and Sensibility. In this (re)quest, a broader-than-scientific dimension is sought for that allows addressing the GMO debate in a more “sensible” way, whilst making “sense” of the different stances taken in it. Here, the restyling of the European regulatory frame on transgenic agro-food products and of science communication models are discussed and taken to be indicative of the (re)quest to move from a merely scientific evaluation and risk-based policy towards a socially more robust evaluation that takes the “non-scientific” concerns at stake in the GMO debate seriously.     

Sustainable Development and Norwegian Genetic Engineering Regulations: Applications, Impacts, and Challenges

The main purpose of The NorwegianGene Technology Act (1993) is to enforcecontainment of genetically modified organisms(GMOs) and control of GMO releases.Furthermore, the Act intends to ensure that``production and use of GMOs should take placein an ethically and socially justifiable way,in accordance with the principle of sustainabledevelopment and without detrimental effects tohealth and the environment.' Hence it isobvious that, for the Norwegian authorities,sustainable development is a normativeguideline when evaluating acceptableconsequences of GMO use and production. Inaccordance with this, we have investigated theextent to which the sustainability criteriawere decisive for the destiny of one approvedand one declined application of geneticallymodified plant release. The presentunderstanding of the ecological,socio-economical, and cultural consequences ofGMO use and release is fragmentary anduncertain. We consider the PrecautionaryPrinciple and the notion of equitabledistribution as key issues within thesustainable development framework, henceconstituting important foundations for ouranalyses. The Act is legitimizingsustainability criteria, but does not seem tosecure their conversion into concrete action.We envisage a more conscious implementation ofthe Norwegian Gene Technology Act.Sustainability concerns ecological, economical,and social values, and these can only beensured through long-term thinking, initiationof independent risk-associated research, andbroad involvement of all stakeholders in theevaluation of GMO issues and concerns.