U.S. approaches to oversight of research and technological products have developed over time in an effort to ensure safety to humans, animals, and the environment and to control use in a social context. In modern times, regulatory and oversight tools have evolved to include diverse approaches such as performance standards, tradable allowances, consultations between government and industry, and pre-market safety and efficacy reviews. The decision whether to impose an oversight system, the oversight elements, the level of oversight (for example, federal, state, local), the choice of approach (for example, mandatory or voluntary), and its execution can profoundly affect technological development, individual and collective interests, and public confidence in technological products. Oversight is conducted by a range of institutions with various capabilities, cultures, and motives. Avenues for disputing oversight decisions are also important, and some argue that the U.S. operates in an adversarial regulatory culture in which Congress, the media, and stakeholders regularly contest the decisions of federal agencies.

This article evaluates the oversight of drugs and medical devices by the U.S. Food and Drug Administration (FDA) using an integration of public policy, law, and bioethics approaches and employing multiple assessment criteria, including economic, social, safety, and technological. Throughout, assessments employing both the multiple criteria and a method of expert elicitation are combined with the existing literature, case law, and regulations providing an integrative historical case study approach. The goal is to provide useful information from multiple disciplines and perspectives to guide discussions regarding appropriate oversight frameworks for nanobiotechnology applications under the FDA’s purview.

Nanotechnology is a collection of different technologies and approaches dealing with manipulating matter with dimensions on the nanometer scale. The growth of nanotechnology has been rapid in recent years and encompasses a range of industries including pharmaceuticals, chemicals, robotics, medicine, agriculture, electronics, national defense, fiber optics, and energy. Nanoparticles with shapes, morphologies, and chemical compositions engineered for specific functions and applications are now common. While estimates of the numbers of new types of nanoparticles being produced in academic and industrial labs that combine these different characteristics are uncertain, it is likely that they run into the hundreds.

Nanotechnology is the “next small thing” in technological innovation. Spanning a range of science and engineering disciplines, nanotechnology will dramatically alter products and processes upon which we currently rely and promises significant advances in technology. Federal agencies taking part in the National Nanotechnology Initiative (NNI) have attempted to articulate a suitable definition for nanotechnology. The NNI definition refers to “[r]esearch and technology development at the atomic scale, molecular or macromolecular levels, in the length scale of approximately 1-100 nanometer range[; creating] and using of structures, devices and systems that have novel properties and functions because of their small size and/or intermediate size[; and the ability] to control or manipulate at the atomic scale.” Nanotechnology thus refers to material engineered or altered at the nanoscale, in order to take advantage of unique properties that emerge at that scale.

Devising appropriate oversight for nanotechnology is a challenge. The field spans many scientific disciplines and product areas, capitalizing on the unusual properties and capabilities of material at the atomic scale. The critical feature of nanotechnology is not only the size at which manufacture occurs (˜1-100 nanometers), but also the ability to control and manipulate the novel chemical, physical, and mechanical properties that emerge at this scale, including increased conductivity, optical properties, and reactivity. As nano-products enter the research and development (R&D) phase, hit the market, and enter consumer households, debate has emerged on oversight approaches. Regulators, manufacturers, and commentators are considering whether existing oversight systems are sufficient, those oversight systems need adjustment, or new oversight systems are needed.

How should we oversee new and emerging technologies and their products? What lessons can we discern from existing regulatory examples and from past mistakes? How do these lessons learned translate into informed recommendations for adequate oversight for nanotechnology to avoid repeating the mistakes of the past? The investigators of this interdisciplinary project undertook this endeavor intending to answer these questions among others.

In parallel with the project team putting together this symposium, another, very different process on the oversight of nanotechnology took place. An international coalition of non-governmental organizations (NGOs) formed to address the nanotech policy dialogue. The first goal of this NGO group was to agree upon and draft fundamental principles of oversight, which it completed in 2007-08. These principles close with a call for their adoption and/or internalization by all relevant actors and bodies. In effect, they serve a function in the policy dialogue similar to that of this project’s forthcoming recommendations.

Nanotechnology is the latest in a growing list of emerging technologies that includes nuclear technologies, genetics, reproductive biology, biotechnology, information technology, robotics, communication technologies, surveillance technologies, synthetic biology, and neuroscience. As was the case for many of the technologies that came before, a key question facing nanotechnology is what type of regulatory oversight is appropriate for this emerging technology. As two of us wrote several years ago, the question facing nanotechnology is not whether it will be regulated, but when and how.

Yet, appropriate regulation of nanotechnology will be challenging. The term “nanotechnology” incorporates a broad, diverse range of materials, technologies, and products, with an even greater spectrum of potential risks and benefits. This technology slashes across the jurisdiction of many existing regulatory statutes and regulatory agencies, and does so across the globe. Nanotechnology is developing at an enormously rapid rate, perhaps surpassing the capability of any potential regulatory framework to keep pace. Finally, the risks of nanotechnology remain largely unknown, both because of the multitude of variations in the technology and because of the limited applicability of traditional toxicological approaches such as structure-activity relationship (SAR) to nanotechnology products.

Societal evaluation of new technologies, specifically nanotechnology and genetically engineered organisms (GEOs), challenges current practices of governance and science. When a governing body is confronted by a technology whose use has potential environmental risks, some form of risk analysis is typically conducted to help decision makers consider the range of possible benefits and harms posed by the technology. Environmental risk assessment (ERA) is a critical component in the governance of nanotechnology and genetically engineered organisms because the uncertainties and complexities surrounding these technologies pose such risk potential. However, GEOs are unique technologies, and there is widespread, international recognition (e.g., the Cartagena Protocol on Biosafety of Living Modified Organisms) that many traditional forms of ERA are not well-suited for evaluating them. Nanotechnology products are also likely to need different models of risk assessment, as there is very little information on their fate, transport, and impacts in the environment.

That cacophony you hear is coming from the growing number of commentators addressing ethical, social, and policy issues raised by nanotechnology. Like many novel technologies that disturb the status quo, nanotechnologies raise questions about the adequacy of oversight systems; the extent to which the technologies push legal, moral, and political boundaries; and ultimately, the implications for human health and well-being. Because nanoscale techniques and products challenge our ways of thinking about biology, physics, and chemistry, nanotechnology forces us to reconsider accepted wisdom on toxicity, mutagenicity, contamination, biocompatibility, and other interactions among humans, the environment, and technologies. The sheer scale and reach of nanotechnologies demands institutions, collaborations, and conventions that can cross-link knowledge across organizations, disciplines, and locales. If ever there was an occasion to rethink the limits of disciplinary-specific knowledge, norms about regulatory processes, and societal implications of new technologies, nanotechnologies provide the opportunity.

Regulatory oversight and public communication are intimately intertwined. Oversight failures, both actual and perceived, quickly galvanize attention from both the media and the public, as has occasionally happened in all of the historical cases with which this symposium is concerned — gene therapy, workplace chemicals, drugs and devices, and genetically modified organisms (GMOs), especially those used as (or in) foods. Some developments, such as GMOs, seem to have more cultural significance or “cultural resonance” than others and are especially likely to garner public attention. Developments in nanotechnology, on the other hand, do not seem to have captured as much popular attention. However, the accelerating convergence between nanotechnology as material science and biotechnology, health, and medicine could easily change this situation.

Many of today’s uses of nanotechnology and nanomaterials can comfortably fall under the current regulatory system with minor adjustments. However, the Woodrow Wilson Center’s Project on Emerging Nanotechnologies has pointed out that the U.S. regulatory system is not prepared to deal with successive generations of nanotechnology and emergent technologies. Nanotechnology presents a challenge. The current regulatory standards and methods are no longer sufficient to help ensure the public’s safety. It is an area of high uncertainty in which environment, health, and safety information is scarce; there is no single index such as concentration to measure toxicity; standards do not yet exist; the ready environmental transport of nanomaterials can increase the chance of exposure; real-time monitoring is not available; and nanomaterials might have systemlevel human and environmental risks. Thus, there is a need for a new and improved oversight system. Within this system there is a need for quickly assessing risks of emergent technologies so that informed policy decisions can be made.

Hailed as the “foundation of the next industrial revolution,” nanotechnology is reshaping the landscape of technological innovation and creating hope around the world. Some believe that nanotechnology can address the critical needs of developing countries, but others are less optimistic. At one end of the spectrum, scientists predict that, among other accomplishments, nanotechnology can alleviate poverty, provide safe drinking water, and cure diseases. At the other end, skeptics warn that nanotechnology can further widen the gap between the rich and the poor, contributing to an already imbalanced global landscape. What can nanotechnology bring to the 21st century? How and in what ways should it intersect with law, public policy, and the plight of the developing world?

This article argues that the international community can harness nanotechnology to create sustainable development, particularly in the field of water remediation and treatment, but it must learn from its past missteps and adopt a strategy that combines two competing theories: instrumentalism and contextualism. Instrumentalism is the concept that technology is superb and stakeholders can easily transfer it from one application to another. In contrast, contextualism places technology in a socioeconomic context and conditions technological success on the stakeholders’ ability to meet local needs.