Nanotechnology and Risk

Nanotechnology is the science and application of manipulating matter at the scale of individual atoms and molecules. All natural processes, from the growth of human embryos to plant photosynthesis, operate in this way, but only recently have we developed the tools that allow us to build and analyze things at the molecular level. For the first time in human history, we are close to being able to manipulate the basic forms of all things, living and inanimate, taking them apart and putting them together in almost any way the mind can imagine. The world of the future will be defined by how we use this mastery.

The benefits of nanotechnology, both current and future, are hard to exaggerate. Nanotechnology is used now to make car bodies stronger and lighter, to make batteries and solar panels more efficient, to make glass that never needs cleaning and neckties that are stainproof, and to deliver medicines to individual cells in the body. In the future, assuming that the technology is not impeded by public opposition, "nano" will bring us water desalination at a fraction of the current cost, materials that can make objects invisible, revolutionary new types of computers, and medicines that will cure many major diseases.

The technology also has potential risks, and no nation—including the United States—has the oversight policies and institutions needed to deal with these risks.

We actually know very little about the risks of nanotechnology. To date, there are no documented instances of anyone being harmed by the technology or its applications. However, we know enough about the technology and have enough experience with other technologies to confidently predict that some kinds of problems will arise and that other kinds of problems should be guarded against. Here I will discuss three facets of risk: risk to human health and the natural environment, concerns about social values, and the importance of perceived risk.

There is a dearth of information about the health and environmental risks of nanomaterials because the technology is relatively new and insufficient resources have been devoted to understanding its risks. Of the $1.5 billion the U.S. government is spending annually on nano research and development, less than 3 percent is for research to identify health and environmental risks, and even this small amount is not being spent in accordance with any well-formulated strategy.

But there are several reasons to be concerned about nano's health and environmental effects. First, nanomaterials commonly behave differently from materials of ordinary size—often following different laws of physics, chemistry, and biology. For example, aluminum is harmless when used in soft drink cans, but nanoscale aluminum is so explosive that it is being considered as bomb-making material by the military. The differences between nanomaterials and ordinary materials mean that much of our existing knowledge about risks is not applicable to nanotechnology.

Second, one of the defining characteristics of nanomaterials is their very large surface area relative to their mass. It is on the surface of materials that chemical and biological reactions take place, so one would expect nanomaterials to be much more reactive than bulk materials. This is an advantage in many nano applications but can also be a potential hazard.

Third, the small size of nanomaterials means that they can get to places ordinary materials cannot. For example, there is some evidence that nanomaterials can penetrate the blood–brain barrier. This could be an advantage for delivering medications but could be a serious danger if certain types of materials were inhaled or ingested.

If one defines risk as the possibility of an adverse consequence, health and environmental risks are not the only kinds of risks a technology may pose. People are often concerned about a technology being used in a way that conflicts with some deeply held value, and some uses of nano may create such conflict.

A 2004 study by Grove-White and others compared the issues in the controversy over biotechnology to those that might be expected in relation to nanotechnology. Their findings showed that there are potentially strong similarities, including concerns about: "global drives towards new forms of proprietary knowledge; shifting patterns of ownership and control in the food chain; issues of corporate responsibility and corporate closeness to governments; intensifying relationships of science and scientists to the worlds of power and commerce; unease about hubristic approaches to limits in human understanding; and conflicting interpretations of what might be meant by sustainable development." As the authors point out, these kinds of concerns cannot be accommodated within a framework of risk assessment of individual nanotechnology products.

Nano is also likely to raise a number of ethical questions that cannot be addressed within the usual risk assessment framework. If nanotechnology can be used to improve the functioning of the human brain, should it be used that way? And, if so, for whose brains? If nanoscale materials are incorporated in foods to improve nutrition, shelf life, or taste, should the food have to be labeled to show that nano has been used? If synthetic biology, which is becoming increasingly merged with nanotechnology, can create new life forms, should it be allowed to do so? (Synthetic biology is a new area of biological research that combines science and engineering in order to design and build, or "synthesize," novel biological functions and systems.) These and many other issues likely to be raised by nanotechnology in the not-too-distant future may pose potential risks to values.

The greatest threat to the development and application of nano may not be any actual documented risk but rather a perception that the technology is risky and dangerous. Such perceptions are produced by an amalgam of real risks, people's cultural orientation, information disseminated about the technology, perceptions of the adequacy of safeguards against risk, and probably other factors.

Because nanotechnology is new, invisible, and hard to explain in ordinary language, it lends itself to nonrational opinions. Polls show a large majority of people have little or no knowledge of the technology, but this is no bar to many of those polled having strong opinions on the subject. The experts, seeking to gain support for the technology or at least foster a more elevated debate about it, have supported public education about nano. They have been cheered by studies showing that support for nano correlates with knowledge about the technology. However, Dan Kahan and others have shown that the direction of causation is probably the reverse of what has been assumed. People who are culturally inclined to support new technologies are also more inclined to learn about the technologies. In experiments, providing added information about nanotechnology to people whose cultural views were mistrustful of new technologies left the people more mistrustful of nano even though the information was quite balanced.

It may be tempting to dismiss views based on a lack of information or on misinformation. However, perceived risk is a real factor in people's behavior. If we want them to buy products containing nanomaterials or not support bans on nanotechnology research, we need to understand that perceived risks are at least as important as "real" risks.

The U.S. regulatory system is not prepared to deal with nanotechnology or the other technological advances that lie ahead. In the near term, many of the changes needed to deal with nanotechnology are the same as those needed to remake the currently dysfunctional regulatory system. All four of the major environmental health and safety regulatory agencies—the EPA, Food and Drug Administration (FDA), Occupational Safety and Health Administration (OSHA), and Consumer Product Safety Commission (CPSC)—are hobbled by antiquated and perverse laws and totally inadequate resources. The agencies need more money and more personnel with relevant expertise. And there needs to be a significant increase in research on the risks posed by nanomaterials.

Under their existing authority, the regulatory agencies could take numerous steps to improve oversight of nano products and materials. However, to provide even minimally adequate oversight, legislative action is essential. The Toxic Substances Control Act (TSCA) is the only law that can regulate nanomaterials generally. It is a deeply flawed act that needs major overhauling, not just for nano but for any type of chemical. The Federal Food, Drug, and Cosmetic Act regulates a variety of important uses of nanomaterials, such as nano drugs and the use of nanomaterials in food. However, it contains language that prevents oversight of two uses that involve high human exposure to nanomaterials—dietary supplements (vitamin pills, herbal remedies, and the like) and cosmetics.

In the longer term, the revolutionary scientific and technological innovations that are on the horizon will require totally different ways of dealing with potential risk. The future will be characterized by rapid scientific advancement, rapid utilization of science, frequent product changes, technical complexity, and a variety of novel ethical, social, health, and environmental challenges. A regulatory system that takes two years to issue a rule cannot deal with an economy where product lines typically change every six months. A regulatory law focused on types of chemicals cannot deal with something like nanomaterials where often the same chemical substance can have radically different effects depending on small changes in its shape or in the method by which it is manufactured.

Many longer-term changes are needed. One of the most important would be the creation of a new Department of Environmental and Consumer Protection, which would incorporate six existing agencies—EPA, CPSC, OSHA, the National Oceanic and Atmospheric Administration, the U.S. Geological Survey, and the National Institute of Occupational Safety and Health. This new meta-agency would focus on science and monitoring although it would have a strong oversight component. It would foster more integrated approaches, requiring new legislation. There is a clear need for a more integrated law focusing on dangerous products that would supersede such existing laws as TSCA and the Consumer Product Safety Act.

The United States is not prepared to deal with the challenges posed by 21st-century science and technology. Thinking and discussion about new approaches should start now. The future context for dealing with risk will be unlike anything we have known, and the policies of the past will not provide the protection we need.