Governing Uncertainty

Environmental Regulation in the Age of Nanotechnology

Christopher Bosso

• Publisher: Routledge
• Year: 2012
• Print ISBN:
  9781933115801
• eBook ISBN:
  9781136527807
• Topic: Politics & International Relations
• Subtopic: Ecology
• Index: Politics & International Relations

Nanotechnology promises to transform the materials of everyday life, leading to smaller and more powerful computers, more durable plastics and fabrics, cheap and effective water purification systems, more efficient solar panels and storage batteries, and medical devices capable of tracking down and killing cancer cells or treating neurological diseases. Policy analysts predict a radical change in the industrial sector; at present, the U.S. government spends nearly $2 billion annually on nanotechnology research and development. Yet the nanotechnology revolution is not straightforward. Enthusiasm about nanotechnology's future is tempered by recognition of the hurdles to its responsible development, including the capacity of government to support technological innovation and economic growth while also addressing potential environmental and public health impacts.

This is the first volume to engage scholarly perspectives on environmental regulation in light of the challenges posed by nanotechnology. Contributors focus on the overarching lessons of decades of regulatory response, while posing a fundamental question: How can government regulatory systems satisfy the desire for scientific innovation while also taking into account the direct and indirect effects of 21st century emerging technologies, particularly in the face of scientific uncertainties? With perspectives from economics, history, philosophy, and public policy, this new resource illuminates the various challenges inherent in the development of nanotechnology and works towards a reconceptualization of government regulatory approaches.

CHAPTER 1

POLICY CONSEQUENCES OF THE “NEXT INDUSTRIAL REVOLUTION”

Christopher J. Bosso

A simple query on the Google search engine in February 2009 listed nearly 10 million articles, reports, and websites on some facet of nanotechnology. Of those, more than 450,000 matched up the term “nanotechnology” with “revolution,” and 11,000 with the even more precise phrase “next Industrial Revolution,” echoing oft-cited claims about the transformative impacts of this enabling technology going back to when the Clinton White House kicked off the cross-agency National Nanotechnology Initiative (NNI) in January 2000 with its report National Nanotechnology Initiative: Leading to the Next Industrial Revolution (White House 2000). That language of “revolution” is rife in professional circles, perhaps even more than in the popular press. Note, for example, this depiction by the Society of Manufacturing Engineers:

Nanotechnology promises to usher in the next Industrial Revolution and replace our entire manufacturing base with a new, radically precise, less expensive, and more flexible way of making products. These pervasive changes in manufacturing will leave virtually no product, process, or industry untouched. Nanotechnology has the potential to disrupt entire industries while leading to the creative destruction of current business models. (SME 2006; emphasis added)

Such heady predictions yield equally dramatic forecasts about nanotechnology’s commercial potential, with widely bandied estimates of a global market ranging anywhere from $ 1 trillion to $3 trillion a year within a decade (Roco 2003). This, in turn, has prompted significant public- and private-sector investments to promote rapid development and commercialization of nanotechnology-based applications and products. Under the umbrella of the NNI, the U.S. federal government alone is spending nearly $1.5 billion annually in nanoscale science and engineering research and development (NNI 2008), a level of targeted federal spending on nondefense specific science and technology not seen since the heyday of the U.S. space program. Private-sector investments are estimated to equal, if not exceed, that figure, and state governments from New York and California to Ohio and Oklahoma are funding their own nanotechnology research and development programs to ensure their future economic competitiveness (EOP 2003). Similar initiatives are evident in any number of nations, notably but not exclusively South Korea, Germany, the United Kingdom, and China.

So nanotechnology, most everyone agrees, is the next big thing—the next Industrial Revolution. As a result, and not surprisingly, there are very high expectations, if not wildly inflated dreams, about the promise of nanotechnology to shape life in the twenty-first century in the same way that the petrochemical revolution defined a broad spectrum of basic materials and applications in second half of the twentieth century.

Yet enthusiasm about nanotechnology is partially tempered by recognition of the hurdles along the road to widespread commercialization, particularly the societal implications of this emerging technology, ranging from immediate concerns about the potential environmental and human health and safety effects of nanoscale materials on laboratory researchers and production workers to longer-term and more profound impacts of nanotechnologies directed toward enhancing the human body. Many of these concerns reflect previous experiences with the environmental and health side effects of the petrochemical revolution, such as the harm to bird populations caused by chemical pesticides (Bosso 1987) and concerns about systemic human health impacts of discarded pharmaceuticals in drinking water (Daughton and Ternes 1999). Indeed, in enacting the 21st Century Nanotechnology Research and Development Act in 2003, the U.S. Congress required that the National Science Foundation (NSF) in particular fund research into unspecified “ethical, legal, environmental, and other appropriate societal concerns” about nanotechnology and mandated that “public input and outreach to be integrated into the Program by the convening of regular and ongoing public discussions, through mechanisms such as citizens’ panels, consensus conferences, and educational events, as appropriate” (U.S. Congress 2003).

Largely because Congress so mandated, concerns about societal implications are being addressed in tandem with technological development—if not exactly at the same level of funding—in contrast to the days when concerns about environmental and health impacts of new technologies often did not emerge until they became more clearly, and sometimes disastrously, manifest (Bosso 1987). In this regard, mounting concerns that too little is known about the possible environmental and human health impacts of nanomaterials prompted the NSF and U.S. Environmental Protection Agency (EPA) to jointly fund two new Centers for Environmental Implications of Nanotechnology—one at Duke University, the other at the University of California–Los Angeles—as part of a five-year, $25 million initiative dedicated to “understanding the interactions of nanomaterials with organisms, cellular constituents, metabolic networks and living tissues; understanding environmental exposure and bioaccumulation and their effects on living systems; and determining the biological impacts of nanomaterials dispersed in the environment.” The NSF is clear that this initiative’s value lies in “reducing uncertainty about the environmental health and safety implications of nanotechnology through research, education, public outreach and dissemination” (CEIN 2006; emphasis added).

Reducing uncertainty is critical on a number of fronts and for a great many potential stakeholders, and such basic research will yield important information on the fundamental properties of nanomaterials and risk factors they pose. Left unanswered, however, is exactly how any information obtained from this research will be used, by whom, and for what purposes. It is expected but unstated that any data obtained through toxicological and epidemiological research will help corporate and government leaders shape appropriate responses, but in what form and by whom is not clear. It is even less certain what role, if any, government will play in deciding the shape, application, or enforcement of any rules or procedures directed toward the prevention or swift remediation of environmental, health, and safety effects.

More troubling for the long term is a relative absence of open discussion about the capacity of government to use any information obtained. For all the expressed concern in government and industry circles about pro-actively addressing the possible environmental, health, and safety effects of nanotechnology—if only to obtain greater public acceptance of new technologies—to date relatively little attention has been paid to understanding the current institutional capacity and anticipated informational needs of the agencies and officials that researchers, firms, investors, and citizens expect to make critical decisions on a wide range of emerging nanotechnology applications.

And we know that such challenges will occur. After all, the Chemical Age that so defined the twentieth century, for all of its multiform benefits, ultimately generated tremendous direct and indirect environmental and human health consequences, ranging from toxicity and carcinogenicity in humans to impacts on wildlife populations. Public concerns about such effects—some of them misplaced—eventually prompted government at several levels to respond with an array of regulatory institutions, laws, and policy tools intended to obviate harmful environmental effects and protect human health (Bosso 1987). In some minds, nanotechnology, broadly conceived, may pose similar, if not greater, challenges.

Thus comes the core challenge for democratic government. Whatever our general ideological or partisan views about the “proper” role of government, most of us at some level do expect it to protect us from those risks we as individuals can neither comprehend nor control. As individuals, we may have some say about what we drink, eat, or even smoke, but we have little control over the basic technologies that underpin our daily lives, be they the genetic map of new grain hybrids; the materials that make up our electronics, modes of transportation, and buildings; or the core substances in our pharmaceutical and medical devices. So we enlist a third party—usually the government—to act on our behalf in ensuring that the stuff of everyday life does not cause us undue harm. And as citizens in the contemporary age, we usually expect government to be reasonably open and responsive to our concerns in devising any policy responses to those risks. As we have seen in other instances, such as the muddled government response to the outbreak of bovine spongiform encephalopathy, or “mad cow” disease, in the United Kingdom in the 1990s (Tarrow 2000), any apparent failure to respond to perceived risks in an effective, responsive, and transparent way undermines public trust in government itself. Citizens’ loss of faith in government capacity or transparency, in turn, can undermine public receptivity to policymakers’ claims that new technologies pose little risk. Based on even cautious estimates of nanotechnology’s expected reach and impacts (discussed in Chapter 2), this basic challenge to government will only grow more acute.

ABOUT THIS BOOK

Questions about the fundamental capacity of government to balance a desire to foster technological innovation and economic growth with the protection of public health and the natural environment prompted the NSF to support a range of research efforts, one being the multiyear project on nanotechnology and government capacity out of which this volume grew (Bosso et al. 2006). The overall project evaluates existing government capacity—defined here as sufficiency in scientific expertise, legal authority, organizational design, and relevant regulatory frameworks—to address the societal and policy challenges posed by nanoscale innovations and products and, where appropriate, to make recommendations for building requisite capacity to address these challenges.

Such concerns are not simply reducible to more money, more people, or more time, and instead focus on the following core questions: What have we learned from decades of government understanding about, concern with, and response to environment, health, and safety effects generated by new technologies and their applications, and how do we apply those lessons to new technologies of as yet unknown properties and uncertain effects? How should democratic government approach inevitable questions of responding to the direct and indirect effects of new and potentially revolutionary technologies? How does government balance the imperatives of technological innovation and economic growth with citizen demands that it protect public health and the natural environment? And, of concern to students of democratic government in particular, who decides?

In an early assessment on the applicability of the federal Toxic Substances Control Act (TSCA) to nanoparticles, the Foresight and Governance Project at the Woodrow Wilson Center for International Scholars offered four conclusions with relevance to nanotechnology more broadly conceptualized:

• The unique properties inherent in nanotechnology will pose new challenges to existing regulatory structures and, in the process, create confusion within both industry and government about the nature and scope of regulation.

• Little attention has been paid to the adequacy of the current regulatory system to protect human health and the environment, or about possible alternatives to existing regulatory regimes.

• The absence of any conclusive understanding about the health risks of nano-based substances makes more urgent the need for attention to and a dialog on regulatory adequacy and needed changes.

• Misguided or poorly designed regulatory approaches could have enormous economic consequences. (Wardak 2003)

In sum, there are expressed concerns about existing federal and state government capacity to respond to, much less proactively address, the societal and policy challenges posed by nanoscale substances and innovations. Though it may not be clear how nanotechnology will affect, and be affected by, the regulatory landscape, no doubt these interactions will occur, with real consequences. Those interested in nanotechnology therefore have a keen interest in how these as-yet-uncertain dynamics will play out. Moreover, these concerns bear immediate attention, even if wide-scale commercialization in some sectors is still years off.

In this volume, we offer preliminary, though certainly not premature, thoughts centered around two central questions: First, how does government confront conditions of acute uncertainty about environmental and health risks? Second, given such uncertainty, how does government structure its relationship with the regulated? To shed light on these questions, this book brings together an array of scholars to ponder lessons from experience in dealing with environmental consequences of technological development, ranging from post–World War II era chemical pesticides to late-twentieth-century genetically modified organisms. These scholars address a set of key issues, including the dilemma of regulating under conditions of uncertainty, the possibilities and limitations of business self-regulation, the organizational capacity of the EPA to adapt to challenges posed by new technologies, and the strengths and weaknesses of regulatory federalism in the United States.

Our focus in this volume is on those areas of environmental and human health most likely to fall within the jurisdiction of federal and state environmental and public health agencies. This distinction is in many ways an artificial one, given that many of these same challenges to government capacity confront other frontline regulatory agencies; for example, nanomedical therapeutics and devices fall within the primary jurisdiction of the U.S. Food and Drug Administration, and nano-enhanced consumer products within that of the Consumer Product Safety Commission. These agencies face an array of challenges compelling enough in their own right to warrant separate studies, even as many of the lessons set forth in this volume apply more broadly. We also confine our immediate attention to the United States, although we acknowledge that any emerging U.S. nanotechnology regulatory regime will be informed by similar discussions taking place in the European Union and elsewhere around the globe, and not only in advanced industrial societies, where the bulk of current research and development takes place. In short, this volume is but a first take on a more expansive agenda of inquiry.

OUTLINE AND CHAPTER SUMMARIES

Contexts

We begin by setting the broader contexts within which debates over the proper form of environmental regulatory approaches to nanotechnology are taking place. In Chapter 2, Sean O’Donnell and Jacqueline Isaacs examine nanotechnology first as an area of exciting scientific inquiry and technical manipulation of matter; then as an inchoate yet highly promising (maybe even “revolutionary”) sector with multiform economic, environmental, human health and longevity, and other material benefits; and finally, as a set of emerging concerns about proximate and long-term health and environmental effects of nanomaterials. Their chapter is intended to give nonexperts—which we assume to mean most readers—a basic understanding of the science involved, current and potential applications, and reasons why this study is appropriate.

Central Questions

If policymakers did want to act proactively to address the challenges posed in Chapter 2, does government have the capacity to do so? To address this core question, the book moves on to practical considerations obtained from experience. In Chapter 3, Marc Eisner considers the role of uncertainty in environmental policy in light of the possible challenges posed by nanotechnology. Responses to uncertainty can take multiple forms. One is procedural, as when policymakers try to manage uncertainty through institutional and regulatory design decisions that either empower regulators to act or constrain bureaucratic discretion in ways that limit their capacity to adapt to changing regulatory challenges. Other responses focus on what to regulate. Unable to manage the universe of environmental and health risks, policymakers set priorities, or at least focus limited resources on some subset of risks. Controversy then ensues over the decision rules or metrics applied to make these tough decisions. Regulators also must decide how much to regulate, what constitutes a reasonable level of risk, and how such determinations should be made. Finally, regulators must make decisions about how to regulate, including which regulatory instruments are appropriate given the features of the challenges they face. Yet under conditions of extreme uncertainty, it may be impossible to identify and prioritize problems, design appropriate regulatory responses, and evaluate performance. Thus an ongoing concern is how regulators manage uncertainty under existing legal and institutional constraints, with consequent ramifications for the regulation of nanotechnology and its effects.

Chapter 4 follows logically, in which Cary Coglianese ponders how the absence of prescriptive information about the health and environmental effects of nanotechnology challenges the relationship between regulators and the regulated. In this one respect, nanotechnology is not so novel, Coglianese argues, as regulators...

Table of contents

• Cover
• Halftitle
• Title
• Copyright
• Contents
• Acknowledgments
• Contributors
• Foreword: Nanotechnology, Risk, and Governance
• 1 Policy Consequences of the “Next Industrial Revolution”
• 2 A World of Its Own? Nanotechnology’s Promise—and Challenges
• 3 Institutional Evolution or Intelligent Design? Constructing a Regulatory Regime for Nanotechnology
• 4 Engaging Business in the Regulation of Nanotechnology
• 5 EPA and Nanotechnology: The Need for a Grand Bargain?
• 6 Nanotechnology and the Evolving Role of State Governance
• 7 Nanotechnology and Twenty-First-Century Governance
• Index