This paper is extracted from the report “Managing The Effects of Nanotechnology” and has two purposes. The first is to describe the menu of possibilities for government action to deal with the adverse effects of nanotechnology. If there are important alternatives that are not described here it is because of inadvertence or ignorance.
The second purpose is to provide evidence relevant for determining what needs to be done to manage nanotechnology. When I began this work, my initial assumption was that there was no need for new statutory authority. As I learned more about the unique aspects of nanotechnology and thought more about the weaknesses of existing statutes, I was increasingly led to the conclusion that a new law is needed. This paper, however, is not an advocacy piece for a new law. It would have been written quite differently if that were its purpose. Rather, it is a policy analysis, intended to give the reader the information relevant for thinking about a course of action.
In short, the paper is intended to inform, not persuade.
Characteristics of Nanotechnology
Nanotechnology is the production and use of materials with purposely engineered features close to the atomic or molecular scale.
Nanotechnology deals with putting things together atom by atom and with structures so small they are invisible to the naked eye. It provides the ability to create materials, devices and systems with fundamentally new functions and properties.
The promise of nanotechnology is enormous. It has implications for almost every type of manufacturing process and product. Potential nanotechnology applications in the next few decades could produce huge increases in computer speed and storage capacity, therapies for several different types of cancer, much more efficient lighting and battery storage, a major reduction in the cost of desalinating water, clothes that never stain and glass that never needs cleaning. While the benefits are almost limitless, they will be realized only if the potential adverse effects of nanotechnology are examined and managed.
Nanotechnology is new, but the effort to understand and manage its effects will be long-term. As the world community tries to reduce the adverse effects of the technology, our understanding of these effects will steadily increase. At the same time, as the technology advances and commercial applications multiply, new challenges and problems will arise. The topics covered in this paper will be with us for decades.
Three aspects of the technology are relevant to questions of how to manage it. The first is its definition. Nanotechnology covers a wide variety of processes and materials. One must consider whether it makes any more sense to talk about regulating or managing nanotechnology than it does to talk about regulating or managing things that are blue or things that are very large. The second is the rapid development of the technology. It has quickly found new applications and it will continue to expand into new materials and new uses. The third is nanotechnology’s possible adverse effects. Right now, we know very little about these effects.
The definition of nanotechnology is subject to some confusion and controversy, and is complicated by the fact that there are naturally occurring nano-size materials and other nano-size particles that occur as byproducts of combustion or industrial processes. Size is critical in any definition of nanotechnology, but there are a variety of definitions in circulation. Some of the differences over definition are of only academic interest, but the way nanotechnology is defined in a regulatory context can make a significant difference in what is regulated, how it is regulated, and how well a regulatory program works.
The U.S. National Nanotechnology Initiative (NNI) defines nanotechnology as “the understanding and control of matter at dimensions of roughly 1 to 100 nanometers … nanotechnology involves imaging, measuring, modelling and manipulating matter at this length scale”. The Europeans tend to define it more simply as the technology dealing with applications and products with engineered structures smaller than 100 nanometers. For comparison, a single human hair is approximately 80,000 nanometers wide, and a red blood cell is approximately 7,000 nanometers wide.
In the context of this paper, the question of definition raises at least two important further questions: 1) Does it make sense to regulate or manage a collection of processes or materials on size alone? 2) Can a definition be formulated that allows both manufacturers and regulators to know what is included and what is not?
The basic reason that it makes sense to regulate nanotechnology as a separate category is that nanotechnology materials behave differently from conventional materials. The properties of nanotechnology materials are often not predictable from the laws of classical physics and chemistry. The laws of electricity that apply to bigger things may not hold for nanotechnology materials. A material that conducts electricity at normal size may be an electrical insulator at nanotechnology size, and vice versa.
We do not know enough about the toxicity and environmental effects to know whether nanotechnology materials are also different in these respects, but it is likely, for example, that the toxicity of nanotechnology materials is more related to their surface area than to their weight. Certainly the direct relationship between volume of material and exposure—assumed in most chemical regulation—is not a useful guide for dealing with nanotechnology.
Another factor that differentiates nanotechnology materials is the importance of structure in determining their physical and biological behavior. Some experts prefer to talk about “nanostructured materials” rather than nanomaterials.
In many cases, nanotechnology products start with some molecule or atom—carbon, titanium or gold, for example—shaped into a basic form such as a nanodot or nanotube. These forms are then combined into larger structures, and/or combined with other material such as textile, resin or glass. The behavior of the nanotechnology product cannot be predicted from the starting chemical, or often even from the basic nanotechnology form, because the structure of the material will be a major determinant. In this respect, chemical polymers are similar and interestingly, the Toxic Substances Control Act exempts polymers.
Given the above differences, the existing regulatory and management programs are not likely to be very useful in dealing with nanotechnology.
This does not necessarily mean that existing statutes cannot be used, but, at a minimum, they will require adjustment and adaptation.
When discussing the management of nanotechnology as a separate category, it may be useful to distinguish between nanotechnology processes and nanotechnology materials. The latter almost certainly will require basic changes in government regulatory programs. nanotechnology processes, on the other hand, may be more amenable to regulation under the Occupational Safety and Health Act (OSHAct) and existing environmental laws.
The answer to the definitional question - whether regulators and those regulated will be able to make a clear demarcation between what is and what isn’t considered nanotechnology - will depend on the details of the definition and the technical capability for applying it. These issues cannot be resolved at the present time, but it is relevant that manufacturers across various industries seem to be in general agreement about what is considered nanotechnology.
The current age is characterized by accelerating technological development, and nanotechnology is developing extraordinarily rapidly. The field was not identified until 1959, when Nobel physicist Richard Feynman called attention to the opportunities in the realm of the “staggeringly small”.
In 2001, Science magazine named nanotechnology the “breakthrough of the year.” Currently, there are several hundred different commercial applications of nanotechnology. The National Science Foundation predicts that nano-related goods and services could be a $1 trillion market by 2015.
Because of the ongoing speed of nanotechnology development, regulatory or other delays caused by government will be costly to the industry and could be deadly to small firms with little start-up capital. Government may try to avoid giving unfair advantage to any one firm or industry segment, but it will be impossible to maintain a “level playing field.”
Regulation inevitably will benefit some firms at the expense of others. Larger firms will have an advantage over smaller firms.
Firms dependent on rapid introduction of a product will be disadvantaged in relation to those that are not so dependent.
The rapid development of nanotechnology also means that government managers always will be operating with outdated information and that data about nanotechnology effects will lag behind commercial applications. Priorities for research and for regulation will need to shift constantly. We have moved into a world which is, as David Rejeski states, “dominated by rapid improvements in products, processes, and organizations, all moving at rates that exceed the ability of our traditional governing institutions to adapt or shape outcomes.” He warns, “If you think that any existing regulatory framework can keep pace with this rate of change, think again”
These consequences do not mean that government should not deal with the adverse effects of nanotechnology. Such difficulties need to be recognized and taken into account when designing and implementing an nanotechnology management system.
Lack of Effects Data
Given how little time has elapsed since the inception of nanotechnology, the lack of knowledge about its adverse effects is not surprising. The total number of research studies dealing with adverse effects of nanotechnology is small, but growing.
Concerns about nanotechnology’s potential adverse effects relate to both exposure and toxicity.
The very small size of nano-structured particles poses unique problems of exposure. Nanotechnology particles potentially can penetrate deep into the lungs when inhaled, may be absorbed through the skin, and may be circulated throughout the entire human body once they get into any single part of the body.
Once nanotechnology materials get into the ambient environment, it may be impossible to contain them. The concerns about exposure are not theoretical. Many of the current commercial applications of nanotechnology are high-exposure uses such as cosmetics, clothing and drugs.
The toxicity aspects of nanotechnology are just beginning to be explored. Particle surface area and activity may be better indicators of the pulmonary toxicity of nanoparticles than mass and bulk chemistry. Nanoparticles may be transported from the nasal region to the brain via nerve endings. Carbon nanotubes may lead to significant inflammation in the lungs. A few tests on fish have shown toxic, but not lethal, effects. This and other fragmentary knowledge we have of the adverse effects of nanotechnology is clearly rudimentary, but it is enough to show that there are potential or actual effects that warrant concern.
This article has been broken into parts due to its original length. The parts can be found as follows:
· Part 1
· Part 2
· Part 3
· Part 4
· Part 5
The original document is Managing The Effects of Nanotechnology