Precautionary governance and the limits of scientific knowledge: a democratic framework for regulating nanotechnology.

Author:Perez, Oren
  1. INTRODUCTION II. A PRINCIPLE IN SEARCH OF MEANING: THE NORMATIVE FLUIDITY OF THE PRECAUTIONARY PRINCIPLE A. Introduction: On the Pragmatic Nature of the Precautionary Principle B. The Normative Fluidity of the Precautionary Principle: A Close Look 1. The Hazard Condition 2. The Knowledge Condition 3. The Prescriptive Dimension III. FROM AMBIVALENCE TO POLITICS: THE PRECAUTIONARY PRINCIPLE AS A POLITICAL FRAMEWORK FOR REGULATING RISKS A. Why Politics: Legitimacy, Reflexivity and Creativity B. The Politics of Precaution: Generic Building Blocks 1. The Hazard Condition 2. The Knowledge Condition 3. The Prescriptive Dimension IV. RE-POLITICIZING THE GOVERNANCE OF RISK: FIVE CHALLENGES IN THE DEMOCRATIZATION OF RISK REGULATION IN THE CONTEXT OF NANOTECHNOLOGY A. Extending the Horizon of Civic Participation: From the Regulation of Risks to the Governance of Innovation and Scientific Policy B. Changing the Institutional Framework of Doing Nanoscience: Science Shops as Mediating Agents C. E-deliberation 1. Multi-layered Participation--Confronting the Attraction Problem 2. Using Computer Supported Argumentation and Collaborative Decisionmaking Systems D. Risk Visualization E. De-Biasing the Decisionmaking Process V. BRINGING DEMOCRACY INTO THE PRECAUTIONARY PRINCIPLE: CONCLUDING REMARKS I.


    Nanotechnology presents regulators with a difficult challenge. Nanomaterials and nanoprocesses involve deep uncertainties regarding their potential benefits and health and environmental risks, reflecting the embryonic state of the underlying science. These uncertainties are exacerbated by the fact that nanotechnology is not a uniform domain, but encompasses a broad range of technologies and products, including bionanotechnology, supramolecular chemistry, nanostructured materials, and self-assembly nanoprocesses. (1)

    Given these uncertainties, there have been various calls to use the precautionary principle (PP) as a governing principle in the regulation of nanotechnology. Thus, for example, the Intergovernmental Forum on Chemical Safety (IFCS) recommended in September 2008 that the precautionary principle be used "as one of the general principles of risk management throughout the life cycle of manufactured nanomaterials." (2) A recent joint statement by several environmental NGOs notes similarly that "It]he Precautionary Principle must be applied to nanotechnologies because scientific research to-date suggests that exposure to at least some nanomaterials, nanodevices, or the products of nanobiotechnology is likely to result in serious harm to human health and the environment." (3) Drawing on the PP, many environmental groups have called for a moratorium on the sale (and even research) of products containing nanomaterials, arguing that the research to date is insufficient to guarantee the safety of nanoproducts, and that whatever safety research has been conducted has not been properly disseminated to the public. (4)

    The need to apply a precautionary strategy in the regulation of nanotechnology has also been recognized by legal scholars, (5) advisory bodies (6) and 'regulators. (7) These calls rest on several assumptions:

    * There is plausible support for the claim that nanotechnology is possibly risky, and is risky in novel and non-uniform ways. (8)

    * There is an expanding gap between the pace at which new products containing nanomaterials are being developed and the generation of relevant environmental, health and safety data. This gap also reflects the fact that current methods of risk assessment are not necessarily appropriate for the evaluation of nanomaterials. (9)

    * There are various gaps in the regulatory framework that apply to nanoproducts (in particular, within the field of chemical regulation). (10)

    Another important theme which underlies the various interventions of civic groups concerns the need for stronger public participation in the regulatory process concerning nanotechnologies. Thus, for example, the Dakar statement emphasizes the need for continued dialogue between governments and stakeholders on the benefits and risks of manufactured nanomaterials and on strengthening the capacity of civil society so that it may effectively take part in decisionmak!ng related to manufactured nanomaterials. The Principles for the Oversight of Nanotechnologies and Nanomaterials state similarly that the "potential of nanotechnologies to transform the global social, economic, and political landscape makes it essential that the public fully participate in the deliberative and decision-making processes." (11) Both documents also highlight the need for transparency. (12) The need to develop participatory mechanisms was also recognized by various government agencies. (13) Despite these calls, the contemporary regulatory landscape is governed by expert-led decisionmaking bodies. While there has been some effort to incorporate the public into the decisionmaking process, primarily in Europe, most commentators agree that the impact of civic voice on the actual decisionmaking process was generally negligible. (14)

    This Article seeks to highlight the intrinsic link between the calls to apply the PP to the domain of nanoregulation and calls to subject the regulation of nanotechnologies to deeper public scrutiny. Reinterpreting the PP as a political framework for regulating risks provides a way, I argue, to respond to these concurrent demands. This political understanding of the PP is motivated by the principle's deep vagueness and the normative impasse generated by this vagueness. After presenting my general argument, I conclude the Article by exploring some of the key challenges underlying this political reframing of the PP, placing it in the context of the governance of nanotechnology.



    1. Introduction: On the Pragmatic Nature of the Precautionary Principle

      The PP reflects an attempt to arbitrate between two competing social concerns: an increased anxiety about the possible adverse environmental and health effects of novel technologies and the scientific-economic drive for technological innovation. On the one hand, the PP provides a response to the broadening demand for a more proactive risk regulation. This demand was boosted by several highly publicized ecological disasters and public-health scandals at the 1980s and 1990s (such as the 1984 disaster at Bhopal, and the outburst of the mad-cow disease in England). (15) On the other hand, the PP also seeks to respond to the concerns of industry by rejecting demands for the introduction of a complete ban on potentially risky technological innovation. This is achieved by setting bounds on the ability of regulators to intervene in the development of new technologies. Since the 1980s, the PP was endorsed and incorporated by numerous legal instruments, both international and national, (16) and has dominated the discussion of risk in the regulatory domain. However, despite its widespread adoption, the PP remains deeply contested. (17) One way in which the ambiguities underlying the PP can be resolved, I argue, is by developing a political understanding of precautionary governance. This interpretation does not constitute the only possible solution to the interpretative puzzle underlying the PP. Indeed, various other interpretations have been offered by scholars, regulators and courts. (18) However, the political understanding of the PP responds, I believe, to wide-ranging social expectations regarding the way in which the governance of risk should be carried out in a democratic society.

      To set the stage for the discussion, consider the language of the two most dominant formulations of the PP. Principle 15 of the Rio Declaration on Environment and Development states:

      In order to protect the environment, the precautionary approach shall be widely applied by States according to their capabilities. Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation. (19) The 1998 Wingspread Statement on the PP states:

      Where an activity raises threats of harm to the environment or human health, precautionary measures should be taken even if some cause and effect relationships are not fully established scientifically. In this context the proponent of an activity, rather than the public bears the burden of proof. (20) Before moving to discuss the ambiguity of the PP, I want to consider the nature of the PP. In particular, should the PP be understood as an epistemic principle, setting universal criteria for the justification of beliefs in situations involving environmental and health risks? (21) Or should it be interpreted as a decisionmaking principle, setting guidelines for action? (22) Given the institutional context in which the PP is primarily invoked--legal and regulatory discourse--I argue that the PP is only intelligible as a prescriptive principle. Legal norms belong to the realm of practical reasoning; their main concern lies in actions, not beliefs. (23) Law makes no claim to provide universal epistemic criteria. (24) By focusing on actions rather than beliefs, law enables people to accept behavioral generalizations, despite profound disagreements regarding the fundamental justification of these practices. (25) Furthermore, legal prescriptions maintain their validity even in the face of contradictory experiences. (26) It is, of course, true that law also contains rules regarding the treatment of evidence, pertaining both to the ways in which they can be introduced (admissibility) and the inferences that can be drawn from them (weight, causality). (27) However, these are not epistemic rules, but rather secondary norms, which are needed in order to allow the generation (whether by court or a regulatory agency) of action-guiding prescriptions.


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