Framing nanotechnology now: hands-off or hands-on? CIELAP shares elements of a Canadian policy framework for nanotechnology.

Last year in the U.S., the Environmental Protection Agency stepped in under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), to regulate a Samsung washing machine that generated antibacterial nanosilver particles. That legislation, however, is applicable only to products claiming efficacy for those uses. It is unclear at this time whether the Toxic Substances Control Act (U.S. legislation comparable to CEPA) will also be used or adapted to apply to nanomaterials.

It is unrealistic to expect comprehensive regulations to be created immediately, since much is still unknown about a long list of crucially important factors. These factors include the potential human health hazards, exposure routes, mechanisms of action, and nanomaterial properties, behaviour, environmental fate, including bioaccumulation and transport, dispersion, and sensitive species and ecosystems. Using a life cycle approach, every effort must be made to prioritize what needs to be known and to acquire that information quickly. An appropriate risk assessment model, such as that developed jointly by DuPont and Environmental Defense in the U.S., could assist in determining priorities for a defensible regulatory system and, in the immediate future, for voluntary and precautionary action. An interim approach to assessing risks and developing appropriate controls is needed right now for medical uses, consumer products, laboratory, medical, and industrial wastes and other items in the waste stream with nanomaterials that come in direct contact with humans or can enter the environment.

Scientists and government officials should also recognize that risk assessment alone does not provide automatic answers to many regulatory questions. Many of these issues bring forth a range of legitimately differing ethical and social perspectives, and there must be mechanisms to include many different opinions and stakeholders in the regulatory process.

7. Labelling and consumer worker safety

Especially in the absence of a comprehensive regulatory regime, legal requirements to label consumer products with nanomaterials that can come in contact with humans, animals, or enter the environment directly should be imposed. Similarly, protocols for the protection of workers and researchers must be put in place at once, and updated as soon as possible as more information is available.

8. Liability and intellectual property regimes

Producer responsibility and legislated strict liability should be considered as essential principles for commercial applications of nanotechnology and a process to institute them should be put in place. Intellectual property rules should, as much as possible, encourage open access to scientific information.

9. Science and research support

Much more science in support of regulatory action is clearly needed. Granting councils should emphasize safety and the environment as design requirements in each project from its inception, along with supporting work on so-called N[E.sup.3]LS, i.e., nanotechnology and ethical, environmental, economic, legal, and social concerns.

10. Commercialization and social and economic benefits

Most of the public discussion to date has focused on nanotechnology's potential for generating economic benefits, on how best to position Canada's industry in that regard, and on how to encourage research that leads to commercial developments. It is generally assumed that Canadian efforts will be in particular applications, such as information/ communication technology, health, energy, biotechnology, and environment-related niches. Should Canadian governments take a handsoff approach and let research develop where it happens to go, or should there be more support for targeted niches? How should these decisions be determined? There are also questions about whether research should be deliberately supported for particular social or environmental ends. The EPA, for example, is especially interested in supporting work in nanotechnology on environmental sensors and environmental remediation applications. There must be a discussion and decision process about which of these paths to follow to maximize Canadian economic benefits, and about what social and environmental needs and opportunities exist in Canada that should be supported.

11. Training

Increased support for and expansion of training in this new field, with a particular emphasis on worker health and safety, is essential.

12. Security concerns

There are many potential military applications of nanotechnology. For example, a centre for such research was established at Massachusetts institute of Technology in 2002. It is possible to imagine criminal and terrorist possibilities for nanotechnology. Understanding these potential threats and determining ways to avoid them and to prepare for and minimize their consequences should be a part of the policy agenda. As with land mines, Canada should be prepared to lead international efforts to outlaw military uses that create environmental damage and civilian casualties.

At present, for its insiders, the world of nanotechnology is full of enthusiasm and promise. Outside, dark clouds of public suspicion and concern can be seen gathering. Environmentalists will rightly point out that many scientific and technological innovations that were at first optimistically hailed as modern wonders have ultimately impacted us in varying ways. Some technologies become so widely employed that they are embedded in the very fabric of society. Managing their negative effects can become an intensely difficult problem, as with the internal combustion engine and the use of fossil fuels. If nanotechnology is to fulfill its positive potential, governments must make an unprecedented effort to bring precautionary foresight, speed, and open dialogue into policy development for this fascinating field.

References

(1.) Information posted on Environment Canada's New Substances Web site at www.ec.gc.ca/substances/ nsb/eng/home_e.shtml (August 20, 2007).

(2.) Gunter Oberdorster, "Nanoparticle Toxicology: Into the Respiratory Tract, Across the Skin, and Beyond?," Keynote Plenary Lecture, Symposium 3, Canadian Federation of Biological Societies 51st Scientific Conference/5th Northern Lights Summer Conference, University of Waterloo, Waterloo, ON, June 21, 2007.

Susan Holtz is the senior policy analyst at the Canadian Institute for Environmental Law and Policy (CIELAP). Founded in 1970, CIELAP is an independent, not-for-profit policy research organization, focusing particularly on emerging and less publicized environmental issues.